Yaz, Yasmin and You

Yaz MDL Judge called upon to consider FDA links to Bayer

2012-01-25T09:41:00.000-05:00

A potential conflict of interest is causing an outcry of concern, and U.S. District Judge David Herndon has been called upon to examine what is really going on in the FDA.

As mentioned in our previous blog, four of the FDA voters that made up a portion of the panel making decisions on Yaz are financially linked to the birth control’s maker, Bayer. Currently, Yaz, Yasmin, Ocella and their generics are the only birth control pills on the market that contain the hormone drospirenone.

The FDA panel convened on December 8th to determine the following:

1. If the benefits of taking drospirenone-containing pills outweigh the risks. The main benefit of taking Yaz is pregnancy prevention, while risks include an increased risk of blood clots, stroke and pulmonary embolism, among others.

Committee members (including the four that are paid by Bayer) voted 15-11 that the benefits outweigh the risks.

2. If current labeling on the drugs adequately reflect the increased risk benefit profile for the product.

Only five panelists believed that the increased risks are clearly outlined in the drugs’ warning label,while 21 voted that they did not.

While the finding that the warning for these drugs is inadequate is an important victory, the question still remains: How would the votes to keep the drug on the market have changed had 15% of the members not been paid the drug manufacturer in question? Would this dangerous drug, which has been determined to have an increased risk of clots and other complications, finally be pulled from the market?

That is why both watchdog groups and women injured while taking Yaz birth control have asked the Judge to investigate the relationships within the Committee, most recently in the form of an opposition to a motion to exclude from the Yaz Multi-District Litigation the opinions of former FDA commissioner David Kessler that there is a conflict of interest within the FDA. Specifically, the impartiality of FDA panelists Paula Hillard, Anne Burke, Melissa Gilliam and Julia Johnson should be questioned after their backgrounds showed a strong financial tie to Bayer.

Kessler was also quoted as saying that one of the FDA members linked to Bayer is a “huge advocate” for Yaz and a “Bayer-trained speaker.” The former FDA commissioner also stated:

"Due to the complex dynamics that are part of the FDA advisory committee meetings, and in light of the fact that a reasonable person with knowledge of the relevant facts could question the above members' impartiality, it is my opinion that the FDA advisory committee was not independent of Bayer, and its recommendations and votes need to be viewed as such."

For more information on the Yaz birth control litigation, or for answers to questions about blood clots, stroke or pulmonary embolisms while taking Yaz, contact us toll-free at 888.841.9623, email us at Anneke@ToledoLaw.com or visit www.ZKBLaw.com.

Watchdog group urges re-vote on blood clot issue after discovering FDA voters were financially linked to maker of Yaz

2012-01-16T15:26:00.000-05:00

We were interested to read that watchdog group Project on Government Oversight (POGO) is urging the FDA to re-vote on the Yaz birth control issue from December’s FDA’s Advisory Committee for Reproductive Health Drugs and the FDA’s Drug Safety and Risk Management Advisory Committee meeting, after it was discovered that four of the panel members had ties to Bayer Corporation, the maker of Yaz.

During the meeting the panel had voted 15-11 that the benefits of drospirenone-containing birth controls outweighed the increased risk of blood clots in women; a decision that ultimately led to the drug being allowed to stay on the market.

Bayer’s Yaz, Yasmin, Ocella and its generics are the only birth control pills that contain drospirenone.

As we discussed in our previous blog, the panel members were paid by Bayer to work as researchers, consultants and speakers for the mega pharmaceutical company.

All four of these panelists voted to keep the drug on the market, but it is hard to assume that they were completely unbiased in their decision, seeing as how Bayer was putting money in their pockets.

"The American public must be able to trust that the FDA and its advisory committees are making decisions based on science, not industry influence," POGO Executive Director Danielle Brian said.

An FDA study estimated that 10 in 10,000 women taking the drospirenone-containing drugs would get a blood clot per year, compared with about six in 10,000 women taking older contraceptives.

For more information on the Yaz birth control litigation, or for answers to questions about blood clots, stroke or pulmonary embolisms while taking Yaz, contact us toll-free at 888.841.9623, email us at Anneke@ToledoLaw.com or visit www.ZKBLaw.com.

Three FDA Panel members linked to Bayer, maker of Yaz

2012-01-11T17:33:00.002-05:00

A recent article by the Wall Street Journal has many people, including the lawyers here at ZKB Law, contemplating whether or not the FDA Advisory Panel’s decision on Yaz birth control was completely free from bias.

The Journal reported that three of doctors who sat on the advisory panel had financial ties to Bayer Corporation, the maker of Yaz, Yasmin and Ocella birth controls. Working as researchers, consultants and speakers for the mega pharmaceutical company, the doctors were paid by Bayer but also asked to be on the FDA’s panel.

The December 8, 2011 joint meeting between the FDA’s Advisory Committee for Reproductive Health Drugs and the FDA’s Drug Safety and Risk Management Advisory Committee was held to discuss the FDA’s preliminary findings that women using birth control pills containing the hormone drospirenone have a 1.5 to 2 times greater chance of developing a blood clot than women using the older types of birth control pills.

Bayer Corporation’s Yaz, Yasmin, Ocella and their generics are the only pills on the market that contain drospirenone.

The panels convened, and voted 15-11 that the benefits of the drugs outweighed the risk of the blood clots. But with the three of the panelists tied to Bayer Corporation, it seems that the Advisory Committee’s role is compromised.

According to the article, the FDA advisory committees “are designed to give the agency independent judgments on medical issues. The FDA says members of the public speaking before advisory committees must declare any financial relationships to the relevant drug maker, to ‘ensure … transparency.’”

Frequent FDA panel member and well-known Cleveland Clinic cardiologist, Dr. Steven Nissen, agrees. He states, “if panelists have significant financial ties to a drug maker whose product is under review, it can ‘bias the proceedings.’ Lack of disclosure undermines the credibility of the advisory committee process and undermines public trust in the fairness of the regulatory process.”

For more information on the Yaz birth control litigation, or for answers to questions about blood clots, stroke or pulmonary embolisms while taking Yaz, contact us toll-free at 888.841.9623, email us at Anneke@ToledoLaw.com or visit www.ZKBLaw.com.

Bellwether trials halted as Judge orders mediation in Yaz birth control cases

2012-01-10T23:07:00.000-05:00

A short nine days before the first bellwether trial was set to begin on the Yaz lawsuits involving a woman who suffered a pulmonary embolism while taking Yaz, U.S. District Court Judge David R. Herndon ordered that they be halted, so that both sides could discuss the possibilities of settling the cases.

This process is called mediation, and is meant to foster a compromise between the plaintiffs’ attorneys who represent the thousands of women injured by Yaz, and the defense attorneys who represent Bayer Corporation.

George Washington School of Law’s Professor Stephen Saltzburg will be overseeing the mediation as Special Master. Read Judge Herndon’s December 31st Order encouraging the parties to engage in good-faith mediation, Case Management Order Number 53.

The bellwether trials that were ordered stayed by Judge Herndon were meant to be a way for each side to determine how juries would most likely respond to the facts and evidence that will be present in majority of the cases.

It is very important to note, however, that mediation is not a sign that Bayer is offering settlement, nor does it mean that any of the cases have settled. If you have a current claim against Bayer, we will not, under any circumstances, agree to a settlement without your express consent. Only if Bayer offers a full and fair settlement, will we contact clients on an individual basis to discuss options.

If there is ever any news on your case, we will contact you directly. Until then, check back frequently for updates on the Yaz litigation, either on this blog or on www.ZKBLaw.com. If you have updated contact information, including name change, phone number, mailing or email addresses, please send them to Anneke@ToledoLaw.com.

If you do not currently have a case against Bayer, but you have experienced serious health problems while taking Yaz, including a blood clot, stroke or pulmonary embolism, you need information. Contact our office toll-free at 888.841.9623 to receive answers to your questions or email us at Anneke@ToledoLaw.com.

Trial put on Hold Pending Mediation

2012-01-03T20:40:00.000-05:00

The first bellwether trial and other deadlines have been stayed by Judge Herndon. He has ordered the parties to meet with a mediator in an effort to get the cases resolved. Please be assured that your case will NOT be settled until and unless we have discussed the matter with you. Each client will be contacted personally and we will obtain their full consent. We will not recommend any settlements unless Bayer agrees to pay a full and fair settlement. At the present time there is no indication that Bayer is willing to be reasonable.

If and when there is a reasonable offer of settlement then we will communicate that offer to our clients with our recommendations.

We will continue to communicate with our clients by letter, telephone and email.

To repeat, at this time the Judge has simply stayed the litigation to give the parties time to discuss the possibility of settlement. So far Bayer has failed to show that it understands the magnitude of its responsibility and liability in this important case.

If you or someone you love has suffered a serious injury or worse while on Yasmin, YAZ or Ocella, please call us immediately for a consultation. There is charge to discuss this matter and the call is toll free: 1-888-841-9623.

ZKB Law pleased that FDA vote will force Bayer to change Yaz warning label

2011-12-09T12:25:00.001-05:00

Yesterday’s highly-anticipated FDA meeting on the controversial drospirenone-containing birth controls Yaz, Yasmin and Ocella ended in a victorious vote that could quite possibly save the lives of women taking the drug.

The FDA’s Reproductive Health Drugs Advisory Committee and their Risk Management Advisory Committee met yesterday at the University of Maryland University College in Adelphi, Maryland, to weigh the risks of the hormone, drospirenone (DRSP), that is only found in Bayer’s Yaz family of pills.

The panels voted 21-5 in favor of changing the labeling on the drug packaging, in hopes to heighten awareness about the serious side-effects of the pill.

"Clearly the wording is inadequate and incomplete," said Dr. Richard Bockman of New York's Hospital for Special Surgery. "Adverse events have to be made graphic so physicians and patients are aware of the consequences."

Previous FDA studies found that women taking the DRSP drugs are 75% more likely to suffer from serious blood clots than women who are taking the older generation pills. Serious blood clots can lead to strokes and pulmonary embolisms, and even death.

Families from across the country came to speak to the panel on behalf of women who lost their lives as a result of taking Yaz, and sadly they are just a small percentage of the 10,000 women and families who have filed lawsuits against the mega pharmaceutical company, Bayer, for misleading labels ands advertisements.

ZKB Law applauds the FDA panel for choosing to better-educate women about the dangers that Yaz, Yasmin, Ocella and their generics pose to their health, and look forward to the label change. Currently there is no timetable or deadline set for Bayer to make this change.

For more information on health problems related to Yaz, Yasmin and Ocella, or to obtain immediate answers to your questions, contact us toll-free at 888.841.9623 or via email at Anneke@ToledoLaw.com.

ZKB Law thanks ABC News journalist Chris Cuomo for his Yaz birth control investigation

2011-12-08T14:03:00.001-05:00

ZKB Law would like to extend a special, “Thank you!” to Chris Cuomo of ABC News not only for his in-depth coverage on the dangers of Yaz, Yasmin and Ocella birth controls, but also for helping us spread the word to women across the country.

Mr. Cuomo was gracious enough to pass along our drug-advocacy website, www.YazYasminAndYou.com, to his 993,400 Twitter followers, which resulted in a tremendous response from our readers, as well as from women taking the drug.

In case you missed his program, you can watch the video of the ABC News story on Yaz, or read the transcript from the show. Mr. Cuomo focused on the health issues that many women are facing, including blood clots or deep-vein thrombosis (DVT) and stroke. He also highlighted the fact that Bayer, the maker of Yaz, allegedly withheld information from the FDA about the increased risks of taking Yaz. The FDA is addressing problems surrounding the Yaz family of birth controls in their Meeting of the Reproductive Health Drugs Advisory Committee today in Maryland. Check out the Agenda for the FDA Yaz meeting, and check back to our site frequently as we continue our coverage of this important event.

Chris Cuomo assured us that he would continue his investigation on Yaz. Check out Chris Cuomo’s website, and follow Chris on Twitter to keep apprised of his great work for ABC News.

ZKB Law applauds ABC News for coverage of the dangers of Yaz, Yasmin and Ocella

2011-12-07T11:36:00.000-05:00

We applaud ABC News for airing a story on the dangers of Yaz, Yasmin and Ocella birth controls, just days before an FDA hearing on the drugs.

The story highlighted former FDA Commissioner Dr. David A. Kessler’s belief that Bayer, the maker of Yaz, was dishonest when relaying the health risks of the oral contraceptives.

Kessler is accusing Bayer of withholding vital information and concealing the real risks of the drugs.

In court documents, Kessler states, "Bayer violated its duties under FDA regulations and state law by selectively presenting data as to [blood clotting] events.” While Kessler acknowledges that Bayer did conduct their own independent studies on the drospirenone-containing drugs, he believes that the mega company failed to report all of their findings, since some of those dangerous findings would prevent the drug from being released onto the market.

Kessler also pointed out that if he were the head of the FDA in 2000, not only would he have ordered further investigation, but he may not have allowed the drug to enter the market at all.

Instead, Bayer allegedly kept quiet on the fact that Yaz could increase a woman’s risk for serious blood clots, resulting in millions of Yaz, Yasmin and Ocella prescriptions and tens of thousands of serious injuries to women.

The ABC News story also addresses the fact that Bayer misrepresented what the pill can really do. Yaz was advertised as the only birth control on the market that can fight the commonly-suffered problems of pre-menstrual syndrome (PMS) and mild acne in women. In reality it was only cleared to treat a more rare and serious from of PMS, called premenstrual dysphonic disorder, or PMDD, and moderate acne.

But Bayer continued to release flashy and colorful commercials; advertisements that were quickly scooped up by television executives across the country.

ABC News even acquired internal emails between executives, some of which were encouraging the “miracle pill.” One email read:

"[T]his is outstanding!!! can we get good morning america to do the same segment!!!???!! (tee hee)."

Further information on Yaz, Yasmin and Ocella, the only birth control family of pills to contain the controversial hormone, drospirenone, will be discussed at this week’s FDA meeting on the drugs. Keep checking our website as we provide full coverage of the meeting, which is taking place at the University of Maryland University College on December 8th.

For immediately answers to your questions, call us toll-free at 888.841.9623 or via email at Anneke@toledolaw.com.

New generic for Yaz birth control released days before FDA meeting DRSP health warnings

2011-12-06T14:16:00.000-05:00

Watson Pharmaceuticals has released a generic form of Yaz birth control that contains drospirenone (DRSP), despite preliminary FDA reports that pills containing DRSP are harmful to a woman’s health.

The FDA study, which is discussed further on our Yaz website, found that drospirenone-based birth control pills may increase the risk of blood clots by 75% compared to some older, progestin-only pills. The report also discusses the increased risk of deep vein thrombosis, pulmonary embolism and strokes. The FDA also warned that women taking the newer-generation pills containing DRSP could be at double the risk for heart attack than those women who take pills that do not contain DRSP. Watson Pharmaceutical’s new oral contraceptive, Vestura, contains both ethinyl estradiol and drospirenone.

Yaz oral contraceptives and its generics are the only birth control pills on the market that contain drospirenone. Other forms of Yaz include:

- Yasmin (the older version of Yaz)

- Gianvi (generic of Yaz)

- Loryna (generic of Yaz)

- Ocella (generic of Yasmin)

- Syeda (generic of Yasmin)

- Zarah (generic of Yasmin)

- Beyaz (newest version of Yaz containing folic acid)

Concerns about the hormone drospirenone are so strong that the FDA’s Reproductive Health Drugs Advisory Committee and their Risk Management Advisory Committee will be discussing blood clots caused by DRSP-containing birth control in a panel meeting this Thursday, December 8, at the University of Maryland University College in Adelphi, Maryland.

Check back frequently as more information becomes available about this meeting, or contact us toll-free at 888.841.9623 for immediate answers to your questions. For more information on Yaz birth control and injuries resulting from the medication, email us at Anneke@ToledoLaw.com.

Bayer emails/internal files point to misleading ads and refusal to disclose dangers of Yaz birth control

2011-11-29T14:51:00.001-05:00

The Yaz, Yasmin and Ocella litigation takes another twist as internal Bayer emails obtained as part of the Multi-District Litigation (MDL) discovery process confirm that the mega-pharmaceutical company misled women about the health risks of the birth control pills.

As reported recently in numerous news reports, including one from Bloomberg News, emails and other internal company files obtained from Bayer confirm that the company sought to market Yaz and Yasmin birth-control pills for unapproved uses and misled women about the health risks the drug posed.

These documents were also used during depositions of key witnesses, many of which were taken by the attorneys at Zoll, Kranz & Borgess.

Click here to read more on the Bayer allegations of Yaz false advertising.

Apparently the ads worked, as Bayer’s contraceptives generated $1.58 billion last year alone.

Unfortunately, there are still thousands of women who remain unaware of the FDA’s recent finding that women taking Yaz, Yamin, Ocella and similar drospirenone-containing birth control pills are 74% more likely to suffer blood clots than women on other low-estrogen contraceptives!

The FDA set a hearing for December 8th to discuss these findings, and Zoll, Kranz & Borgess will continue to keep readers apprised of any new developments. Immediate questions and requests for additional information on injuries from Yaz birth control can be made by calling us toll-free at 888.841.9623 or by emailing us at anneke@toledolaw.com.

Additional Evidence confirms women taking Yaz have higher risk of blood clots, pulmonary embolism

2011-10-26T16:07:00.002-04:00

A recent Danish study published in the BMJ (British Medical Journal) found that women taking oral contraceptives containing drospirenone, including Yasmin and Yaz, are at least at twice the risk of a venous thromboembolic event (VTE) than women taking older forms of oral contraceptives.

VTE consists of two potentially life–threatening conditions: deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT occurs when a blood clot forms in the deep veins of the legs, whereas a PE is when a blood clot (often a DVT) travels from somewhere else in the body and blocks the main artery of the lungs.

The study was performed over the course of nine years, and evaluated 1.3 million women on Denmark’s National Registry on Patients. All patients reviewed were aged 15-49, non-pregnant and had no history of thrombotic disease..

BMJ published these findings yesterday, and the results have drawn special attention in light of the lawsuits involving Yaz, Yasmin and Ocella that continue to mount.

The suits are filed against Bayer Corporation, the maker of the above-mentioned birth control pills, and the cases have been consolidated into Multi-District Litigation in the Southern District of Illinois under U.S. District Court Judge David R. Herndon.

The Food and Drug Administration (FDA) is also investigating the link between drospirenone-containing birth controls and blood clots, and according the New York Times, the FDA’s preliminary findings also confirm that women taking these drugs are at least 1.5 times more likely to suffer a clot.

The FDA is set to hear from two advisory committees on the risks and benefits of the drug on December 8th of this year.

For more information on Yaz, Yasmin and Ocella birth control, blood clots and pulmonary embolisms, contact us toll-free at 888.841.9623 or via email at Anneke@ToledoLaw.com.

A Message to our Clients Regarding the Ongoing Yasmin/Yaz/Ocella Litigation Against Bayer Corporation

2011-09-29T15:41:00.000-04:00

As the Yaz/Yasmin/Ocella mass tort litigation against Bayer progresses, we are providing our Clients and others whom follow this blog with an update on the current state of the litigation.

The litigation is nearing the first trials, and you may start to see increased attention paid by the media to this important case. The reason for this increase in interest stems from the current litigation schedules adopted by The U.S. District Court for Southern District of Illinois and The Courts of Common Pleas in both Philadelphia County, Pennsylvania and Bergen County, New Jersey.

As part of these schedules, the Courts will conduct trials of “Bellwether” cases. The Bellwether process allows the Parties and the Courts to address issues of law and fact that are common to all Plaintiffs, and are meant to offer guidance on the cases. It is important to note, however that the Bellwether trials and their decisions would never eliminate anyone’s right to individual trial - it is this distinction, among others, that makes Bellwether cases different than Class Action lawsuits.

The first bellwether trial is scheduled to take place beginning on January 12, 2012, before Judge Herndon in the U.S. District Court for the Southern District of Illinois. This initial trial will address the claims of a Plaintiff who suffered a pulmonary embolism as a result of her Yaz/Yasmin use. The Court of Common Pleas of Philadelphia County, Pennsylvania will commence its bellwether process with two pulmonary embolism trials scheduled to begin on January 23, 2012, and February 21, 2012, respectively.

Before the bellwether trials can begin in any jurisdiction however, the Courts must first decide whether the expert witness testimony proffered by the Parties will be admissible as evidence in court. In order to make this determination, the Courts must first assess the weight, sufficiency, and reliability of the scientific evidence presented by respective witnesses to ultimately decide whether the expert witness testimony will assist the jury in deciding a particular case. These hearings are commonly referred to as Daubert or Frye hearings, and are set to begin on December 5, 2011.

Following the conclusion of these initial trials, additional bellwether trials will commence on a rolling basis throughout 2012. Below is a rough schedule for each injury category which identifies the major deadlines in 2012:

Pulmonary Embolism Cases
December 5, 2011 – Daubert/Frye Hearings
January 12, 2012 – MDL Trial in St. Louis, IL
January 23, 2012 – Pennsylvania State Trial #1
February 21, 2012 – Pennsylvania State Trial #2

Gallbladder Cases
Week of March 19, 2012 – Daubert/Frye Hearings
April 2, 2012 – MDL Trial in St. Louis, IL
April 23, 2012 – Pennsylvania State Trial #1
May 21, 2012 – Pennsylvania State Trial #2

VTE (Venous Thromboembolism) Cases
Week of June 11th 2012 – Daubert Hearings
June 25, 2012 – MDL Trian in St. Louis, IL
July 23, 2012 – Pennsylvania State Trial #1
August 20th 2012 – Pennsylvania State Trial #2

What Does This Mean for ZKB Law Clients?

We will continue to update this blog every time we receive new or pertinent information regarding the Yaz cases. If we need additional information from you, or have specific information about your individual claim, we will contact you directly.

If you have moved or changed phone numbers, please email us at Anneke@ToledoLaw.com and provide us with any new contact information.

What Does This Mean for Women Who May Have a Claim, But Have Not Yet Retained an Attorney or Filed a Case?

While the litigation is currently progressing and trials are scheduled to begin, this does not mean that it is too late for you to initiate a claim if you suffered injury as a result of using Yaz or Yasmin. The Firm of Zoll, Kranz & Borgess is still accepting cases in an effort to assist all persons injured by these drugs. For a free consultation or for more information please call us toll-free at 888.841.9623 or via email at Anneke@ToledoLaw.com.

FDA acknowledges that birth control pills containing drospirenone may increase risk for blood clots | Yaz birth control injury

2011-09-27T12:10:00.001-04:00

Blood clot

Nearly 800,000 U.S. women were recently studied by the U.S. Food and Drug Administration to determine if taking drospirenone-containing birth control pills, like Yaz, increases a woman’s chance of developing a blood clot.

While the results are not yet final, the FDA did find the early data disturbing enough to release preliminary findings showing that women taking the new contraceptives stand a 1.5 to 2 times greater chance of experiencing the potentially fatal side effect than women using the older types of birth control pills.

Other, older types of birth control typically contain the active ingredient levonorgestrel instead of drospirenone.

The FDA-funded study analyzed women taking one of 11 different types of birth control pills, most of which are the same as or the generics of Yaz, Yasmin and Ocella. The FDA also released additional information for patients about the pills containing drospirenone, and advised women to be aware of blood clot symptoms, including persistent leg pain, severe chest pain, or sudden shortness of breath. It is suggested that women experiencing any of these symptoms call their healthcare professional immediately.

Bayer Corporation, the maker of Yaz, Yasmin and Ocella, has been under scrutiny since the FDA publically warned the company about their marketing techniques that “minimize serious risks associated with the use of the drug [Yaz]” in an October 2008 letter.

The letter also reprimanded Bayer for their “misleading” commercials about the efficacy of Yaz, Yasmin and Ocella, which leads views to believe that the birth control pills will alleviate symptoms like irritability, moodiness, feeling anxious, bloating, fatigue, muscle aches, headaches, increased appetite, and acne, even though there are no clinical studies to prove this claim.

The FDA’s Advisory Committee for Reproductive Health Drugs and the FDA’s Drug Safety and Risk Management Advisory Committee will be holding a joint meeting regarding the findings of this study on December 8, 2011.

Zoll, Kranz and Borgess will be providing complete coverage of the issues discussed in this meeting, which we will post on our blog. For answers to additional questions on what to do if you have experienced a blood clot while taking Yaz, Yasmin or Ocella, contact us toll-free at 888.841.9623 or via email at Anneke@ToledoLaw.com.

What is the link between Yaz, Yasmin and Ocella birth control and gallbladder disease? | Yaz injury lawsuit

2011-09-06T14:55:00.001-04:00

Many women who have taken the birth control Yaz, Yasmin or Ocella have experienced gallbladder disease, or complications from the presence of gallstones in the gallbladder. The purpose of the gallbladder is to store bile until the body needs it to aid in the digestion of food in the small intestine.

If there is too much cholesterol present in the gallbladder, the cholesterol can harden into crystal-like stones, with sizes ranging from that of a grain of salt up to the size of a golf ball. Gall stones can also form from the excess cholesterol if the gall bladder does not empty itself frequently enough.

The chemicals in Yaz birth control have been shown to increase the levels of cholesterol, which may be why so many previously-healthy women have developed gall stones while on the drug.

Yaz birth control and its generics, Yasmin and Ocella, are also the only oral contraceptives on the market that contain the progestin, Drospirenone. Drospirenone has strong diuretic qualities, which rid the body of salt and water, but it can also cause dehydration. During dehydration, the bile in the gallbladder can become over-saturated, which in turn can cause the gallbladder to slow down and gall stones to form.

Gallbladder disease develops when the gall stones cause some sort of other problem in the body, with the most common problems being:

- Severe pain and swelling from a buildup of pressure that occurs when the gall stones obstruct the cystic duct and prevent the flow of bile

- The gall stones blocking the biliary duct, preventing bile from flowing to the intestine and causing bilirubin, the active ingredient in bile, to build up in the blood. This results in jaundice, when the skin and eyes become yellow from the bilirubin

When either of these conditions develops, doctors often opt to surgically remove the gallbladder, as some women taking Yaz have had to go through. Risks of the surgery include bleeding, infection, injury to the common bile duct or small intestine and pancreatitis.

If you have had your gallbladder removed while taking Yaz birth control, and would like more information, contact Zoll, Kranz and Borgess toll-free at 888.841.9623 or via email at Anneke@ToledoLaw.com.

Communication key when dealing with a Yaz birth control injury

2011-08-29T16:58:00.001-04:00

Filing a lawsuit after you have been injured by the negligence of another person can be daunting; especially at a time when all you want to do is focus on regaining your health.

The lawsuits against Bayer, the maker of Yaz birth control, have been especially tough to deal with. A number of young, previously healthy women are facing serious injuries that no one their age should have to endure. Gallbladder disease, stroke, pulmonary embolisms and strokes have threatened the lives and health of countless women across the U.S. – women who still continue to face health issues and must deal with the financial and emotional aftermath that the Yaz birth control injury has caused.

Many have filed claims against Bayer Corporation, in hopes of recouping the costs associated with these injuries, including medical bills, lost wages, future medical costs as well as pain and suffering. The lawsuits have been consolidated into a Multidistrict Litigation, or “MDL,” in the U.S. Federal Court for the Southern District of Illinois U.S. District Court with Judge David R. Herndon presiding over the cases.

As with any lawsuit, one of the key ways to help you stay informed about what is going on in your case is to openly communicate with your attorney. Lawyers involved in multidistrict litigation are up against mass amounts of paperwork, strict deadlines and judges’ orders, and most strive to provide excellent customer service to their clients.

At Zoll, Kranz and Borgess, one of the ways we strive to do provide exceptional service is through this blog on Yaz birth control, in order to provide both clients and the community with information on adverse side effects from the drug, updates on the MDL, orders made by Judge Herndon, and more.

In addition to frequently checking back to this site, women who have lawsuits filed against Bayer are encouraged to contact their attorney any time there is a life change that may be pertinent to your case. Good times to check in with your lawyer include:

- Anytime you move or change your phone number

- If your name changes due to marriage or divorce

- After the birth of a child

- After any developments in your medical treatment

- If you have any questions pertaining to your claim

If you have not filed a claim against Bayer Corporation, but suffered serious, life-threatening injuries while taking Yaz, contact Zoll, Kranz and Borgess for more information by 888.841.9623 toll-free or via email at anneke@toledolaw.com.

Handling financial stress after a Yaz birth control injury | Yaz injury lawsuits

2011-08-12T09:51:00.000-04:00

While it may seem obvious that injuries from defective products have severe and long-term implications to one’s physical health, what is often not as readily apparent is the disastrous negative effect that these injuries can have on a person’s financial and fiscal well-being.

It is especially difficult for the young women who have suffered serious injury while taking Yaz birth control. Many of the women are in their early 20’s, and working one or more jobs while trying to earn a college degree.

Unfortunately, the gallbladder removals, blot clots, strokes and pulmonary embolisms that have resulted from taking Yaz are leaving the women unable to work and incapable of attending classes.

But bill collectors won’t wait, and they often do not consider a medical condition as a reason not to pay debts, so the women are left facing defaulted student loans and constant calls from creditors, along with a long-term negative impact on their credit score, liens, lawsuits and judgments.

The insurmountable debt paired with the inability to return to work has many women seeing red for more than one reason. Anger at the fact that the medical condition was caused by the negligence of Bayer Corporation in failing to disclose the health risks of taking Yaz, as well as frustration of having to struggle with finances at a time when she should be focusing on recovering her health can cause additional, unneeded stress.

That is why Zoll, Kranz and Borgess want to provide women affected by Yaz with a series of blogs on how to handle the financial stress of an injury resulting from the birth control.

Check back frequently for tips on staying organized and keeping open lines of communication with your doctors and attorney. We will also discuss how to recognize the disadvantages of working with companies who may offer a settlement advance, and what the fine print really means. For more information on injuries caused by Yaz, contact Zoll, Kranz and Borgess toll-free at 888.841.9623, via email at Anneke@toledolaw.com or by visiting our Yaz injury website.

Misleading Yaz TV ads should have never been allowed to air

2011-08-03T14:35:00.000-04:00

As advocates for drug safety who have seen firsthand how false advertising led to the injuries caused by Yaz birth control and affected the lives of hundreds of young women, we couldn’t agree more with a recent article by the Huffington Post.

This important article makes a plea to the mega pharmaceutical companies, urging them to take down the flashy, misleading prescription drug commercials without first making sure that the product is safe and effective.

“Regulators must do more than pull spots and mandate corrections when pharmaceutical ads are determined to be inaccurate -- at that point the damage is done,” Author Jerrold Parker writes. “Instead the FDA must tighten regulations on pharmaceutical ads, monitoring accuracy as well as tone, before they're ever approved. It could literally save lives.”

And while we applaud the FDA for regulating misleading ads and requiring them to be removed from the air, the article raises a good point – the ads should have never been there in the first place.

Take for instance the catchy, but deceptive TV ads that Bayer produced to promote their birth control pills, Yaz and Yasmin. Yasmin and YAZ are the first types of birth control to contain a different kind of hormone, called DRSP or drospirenone .

In putting the interest of corporate profits over public safety, Bayer’s advertisements focused almost exclusively on the positive affects of its newest drug creation, while continually omitting or minimizing the very significant risks associated with or increased by the novel birth control pill. These major risks include:

Blood clots

Deep vein thrombosis (DVT)

Pulmonary embolism (PE)

Strokes

Gallbladder disease

Other serious injuries and sudden death

These life-threatening risks include, but are not limited to, those risks that Bayer knew or should have known are associated with or increased by the unprecedented use of this new hormone. Bayer’s ads also improperly encouraged the use of Yasmin/YAZ/Ocella in circumstances other than those in which the drug has been approved and over-stated its benefits.

For example, the ads were targeted at women who suffered from PMS – yet Yaz was not approved to treat PMS. As a result of the fraudulent ads, the U.S. Food and Drug Administration (FDA) repeatedly reprimanded Bayer for marketing the drug in a way that minimizes these very serious side effects, thereby misleading millions of women and their prescribing physicians about the safety of this new type of birth control.

While the advertisement helped generate more than $616 million in sales for the drug company, it came at a great cost to the American public. Thousands of women, many who asked their doctors for a prescription after seeing the ads, have died or have suffered severe, debilitating injuries because of Yaz and Yasmin.

For more information contact Anneke Kurt toll-free at 888.841.9623, via email at Anneke@toledolaw.com or by visiting our Yaz injury website.

Bayer CEO blames Yaz sales decline on generics

2011-07-30T09:50:00.001-04:00

The transcript of this week’s Bayer quarterly conference call contained a glimpse of the spin Bayer continues to put on its troubled Yaz franchise. Rather than accept the fact that its drosperinone based products are unreasonably dangerous and have greater risks than older safer oral contraceptives, Bayer continues to hold out hope and market these products, blaming sales declines on generic completion. Here are the relevant quotes from the conference call:

The ongoing genericization of Yaz in the United States as well as the adverse effects of the health system reforms in various countries were the main reason for this development. Yaz sales were down 7%, mainly due to the generic competition in the U.S. as I already mentioned. Outside the U.S., the Yaz family of products advanced by 8%

Women’s health, yes, it’s correct. We’re, of course, under pressure especially in the oral contraceptive field especially now also in Europe. In the U.S., as you know, (inaudible). We do have plans and you know that we have a number of lifecycle management activities in this field, be it our patch for example that we are developing, the Flex system that we developed.

And you can be rest-assured that we will continue to invest in this field and look for new opportunities to capitalize on the market leadership that we have in the contraceptive field. What exactly will happen over the next two to three years, I would like to ask you to give us little bit more time to elaborate on that. But we have not written off the franchise at all.

The entire transcript can be found at Seeking Alpha
But as Yaz trial attorneys we are seeing a much different picture. Doctors who previously prescribed Yaz have testified that they no longer voluntarily write prescriptions for the drug, and one of our treating doctors actually now requires women to sign a waiver if they insist on a Yaz Rx. That is because they now recognize the greater risk from Yaz, with no corresponding benefit. The reduction in sales of Yaz has, in part, been a result of the recognition by women's health care advocates that Yaz presents unacceptable increased risks for women.

Yaz has always been about one thing, increased profits for Bayer and increased risks for women.

If you are one of the women who has suffered injury at the expense of increased profits for Bayer, you need information. Contact the drug and medical device advocates for safety at Zoll, Kranz and Borgess by contacting Anneke Kurt toll-free at 888.841.9623 or via email at Anneke@toledolaw.com. You can also visit our website by clicking here.

Yaz manufacturer rakes in over $1 billion in profits in three months; Yaz sales continue decline

2011-07-28T16:45:00.000-04:00

Bayer Corporation continues to rake in the profits. But at what cost?

Bayer Corporation had a 40% jump in second quarter profits from last year. The pharmaceutical giant made a whopping €747 million Euros ($1.07 billion!) in profits in the short time of April to July 2011, up from €530 million for the same period of time last year.

Sales of Yaz/Yasmin/Yaminelle continued to decline; however Bayer still had €505 million ($722) in Yaz sales in the first half of the 2011, down from €576 million in the first half of last year.

The numbers that our drug safety advocates would really like to see are how much Bayer made off of the thousands of women who were hospitalized because of Yaz, and now face permanent injuries.

The drug and medical device advocates for safety at Zoll, Kranz and Borgess ask this question every time they meet with the injured women they represent. Women who trusted their health and contraceptive needs to this company, but received a product that ultimately caused life-threatening conditions like deep vein thrombosis, stroke, gallbladder disease and pulmonary embolisms.

That product is Yaz birth control.

So Bayer releases their catchy, misleading Yaz commercials, the women buy it up and take the pills, and now they are stuck nursing injuries that will affect them for the rest of their lives.

If you are one of these women, you need information. Contact the drug and medical device advocates for safety at Zoll, Kranz and Borgess by contacting Anneke Kurt toll-free at 888.841.9623 or via email at Anneke@toledolaw.com. You can also visit our website by clicking here.

New Yaz decision will hear from 100 oldest cases of injury

2011-07-27T16:48:00.000-04:00

The drug and medical device safety lawyers at Zoll, Kranz and Borgess were very interested to learn that Judge David R. Herndon, the judge who is overseeing all of the Yaz and Yasmin cases in the United States federal court system, has expanded the scope of discovery beyond the 24 cases selected last year to serve as a pool of bellwether lawsuits.

This means that the U.S. District Court judge is allowing discovery for the 100 oldest cases filed, which would include depositions from the women who suffered injuries due to Yaz birth control.

And since Zoll, Kranz and Borgess was one of the first firms to file complaints on behalf of women experiencing problems like pulmonary embolism, stroke and gall bladder disease during or after taking Yaz, we are expecting that as many as 20 of our clients will be disposed and asked to tell their story.

If you are a woman who has enlisted the help of Zoll, Kranz and Borgess to take on the Bayer Corporation, and your case is chosen for discovery, expect to hear from us shortly.

For those women who are not familiar with the cases, Yaz, Yasmin and Ocella birth controls have been under scrutiny since the FDA issued a warning to their manufacturer, Bayer Corporation. The FDA publicly chastised the company for failing to properly research the drug before making claims that it was the best option for birth control.

Yaz’s adverstising campaigns featured women dancing to the song, “We’re not going to take it,” while punching and kicking animated words like, “irritability,” “moodiness” and “feeling anxious,” implying that the drug could cure the feelings that women commonly have once a month. Yet these are symptoms of pre-menstrual syndrome (PMS), not Premenstrual dysphoric disorder, which is a more severe disorder where women suffer from serious emotional problems that are closely linked to the pre-menstrual cycle.

The misleading ads led women to believe that Yaz would be the perfect treatment for PMS, when in reality:

1. There were no clinical studies to prove that Yaz is a good treatment for PMS

2. Yaz was actually formulated to treat PPD, but still not clinically proven to do so in more than three menstrual cycles

In addition to the misleading TV ads, the FDA accused Bayer Corporation of the following:

- Overstating the effectiveness of Yaz

- Broadening Yaz’s indication (i.e. claiming that it can treat PMS when it cannot)

- Claiming that Yaz was superior to other similar products on the market when there were no clinical studies or other forms of proof to support the claim

And, most importantly….

- Minimizing the risks associated with the use of Yaz

This last claim is one that the drug and medical device advocates at Zoll, Kranz and Borgess believe is the hardest pill to swallow. Thousands of women watched this catchy, colorful ad; asked their doctors for a prescription for Yaz birth control in hopes to cure their PMS symptoms; and then ended up with horrific injuries like:

- Pulmonary embolism, or a blockage of the main artery of the lung typically caused by a blood clot

- Deep Vein Thrombosis, or a blood clot in the deep veins of the leg

- Stroke

- Heart attack

- Gallbladder disease

Not only are these injuries horrific and life-threatening, but they are also happening to non-smoking, active and otherwise healthy young women.

If you are a woman who at any time took the birth control pill Yaz and you have experienced any of these serious medical problems, contact drug advocate for safety, Attorney Michelle Kranz, toll-free at 888.841.9623 or via email at michelle@toledolaw.com.

An update on the status of the Yaz, Yasmin litigation.

2011-07-12T10:17:00.005-04:00

The next step in the litigation is the selection of "bellwether" trials in each major jurisdiction for the various types of injuries suffered by women taking Yasmin and Yaz. These trials are designed to be representative cases. Once verdicts are reached, they will provide both sides with valuable information about resolution. We have cases that have been selected as bellwether trials in all three jurisdictions. If your case has been selected you will be hearing from us directly.

For the MDL litigation pending in St. Louis and Pennsylvania state litigation, there is a bellwether trial schedule order in place and final determinations have been made for case selection from the thousands of pending cases. The first bellwether trial for the MDL is scheduled to begin in January 2012, as is the first bellwether trial in Pennsylvania. In the New Jersey litigation, the initial selection of bellwether trials is also underway, and from that group, 6 will be selected for trial. The first New Jersey case will go to trial next August.

To read a copy of each order regarding the bellwether selection and trial schedule, please click on the following: MDL Case Management Order No. 32, Pennsylvania Case Management Order No. 14, New Jersey Case Management Order No. 25.

Before the cases will go to trial there will be hearings on the scope and strength of the underlying scientific and medical issues. These hearings, sometimes called Daubert, or Frye hearings, will determine whether the cases can survive. A more detailed explanation of a Daubert hearing or the standard can be found on Wikipedia, by clicking here.

The outcome of the bellwether trials will be the next step. If a resolution is not reached after the completion of those trials, the Court will allow us to proceed with case specific work on our individual files. Until that time, we must await the Daubert/Frye rulings and decisions on the bellwether cases.

For most of our clients, all of the necessary filings have been made in each individual case, including the Plaintiff Fact Sheet, and we have received the Defendant Fact Sheet as well. At this time, there are no other specific steps that can currently be taken with each individual case.

The leadership of the Yasmin litigation in both federal and state courts have been working tirelessly to develop the necessary witnesses for all cases. Literally millions of documents from the defendants have been reviewed and analyzed. To date, at least 43 depositions have been completed of Bayer employees and scientists, both here in the U.S. and overseas, with some more yet to be completed. Our firm is playing a critical role in the development of the causation and damage theories on gallbladder injuries, as well as other issues.

If you would like to discuss this litigation or a potential claim with an attorney, you can contact Attorney Michelle Kranz, toll free at (888) 841-9623, or by email at michelle@toledolaw.com.

FDA Announces It Will Investigate Reported Increased Risk of Clotting from Yasmin and Yaz

2011-05-31T18:49:00.003-04:00

The U.S. Food and Drug Administration (FDA) announced today that it will investigate and evaluate the risk of blood clots in women who use birth control pill containing drospirenone, such as Yasmin and Yaz. (5/31/11 FDA Public Announcement)

This is an important step as published studies have reported a greater risk of blood clots for women taking birth control pills containing drospirenone as compared to the risk in women taking birth control pills containing another progestin known as levonorgestrel.

The European Medicines Agency (EMA) announced on May 27, 2011, that it is updating the product information on oral contraceptives containing drospirenone and ethinyl estradiol regarding the risk of venous thromboembolism after review of all available data, including the same newly published data FDA is reviewing.

For more information on the dangers of Yasmin and Yaz, visit our Yasmin/Yaz Webpage and Video.

Two new studies report 2 – 3 times higher risk of dangerous blood clots for users of oral contraceptives with drospirenone, like Yasmin

2011-04-23T23:02:00.015-04:00

Two new studies published by the British Medical Journal last week showing a significant increased risk of dangerous blood clots for users of oral contraceptives containing the 4^th generation progestin drospirenone when compared to users of oral contraceptives containing levonorgestrel. Drospirenone is one of the hormones contained in Yaz, Yasmin, Yasminelle, Beyaz, and the newest addition, Safyral.

The risks to women taking oral contraceptives with drospirenone may be 2 -3 times more likely to suffer from a non-fatal venous thromboembolism (non-fatal VTE) than users of other oral contraceptives. Thromboembolis means a blood clot in the veins, often in the legs, that dislodges and can cause fatal clogging in the lungs' arteries, and may also be called a pulmonary embolism.

The first study, published in the BMJ on April 21, 2011, found that users of oral contraceptives containing drospirenone were two times more likely to suffer from non-fatal VTEs than users of oral contraceptives with levonorgestrel, a 3^rd generation progestin. The researchers, Susan Jick and Rohini Hernandez, both affiliated with the Boston Collaborative Drug Surveillance Program, used U.S. claims data to compare the risk of non-fatal VTEs in users of oral contraceptives containing drospirenone versus those containing levonorgestrel. They looked at claims records for women between the ages of 15 and 33, with no other risk factors.

The second study, by Lianne Parkin, Katrina Sharples, Rohini Hernandez, and Susan Jick, was based on data from the British General Practice Research Database. The authors are affiliated with the Department of Preventive and Social Medicine, Dunedin School of Medicine in New Zealand and the Boston Collaborative Drug Surveillance Program. The study concluded that users of an oral contraceptive containing drospirenone were three times more likely to suffer from non-fatal VTEs than users of oral contraceptives with levonorgestrel.

Bayer, the manufacturer of Yasmin, YAZ, Beyaz, and Safyral, immediately issued a press release criticizing these studies, claiming both studies were significantly flawed. Relying upon its own internal studies, Bayer stated, “these studies do not change the overall assessment about the safety of Bayer’s oral contraceptives.”

Bayer currently is facing more than 6,000 lawsuits over its oral contraceptives containing drospirenone. In 2010, Bayer agreed to put additional risk warnings on Yasmin here in the U.S., as well as in Europe. Although sales have slipped, following Bayer’s multi-million dollar advertising campaign, Yasmin remains the top selling oral contraceptive in the United States.

Bayer Witnesses must come to the US for depositions

2010-11-28T12:29:00.000-05:00

Judge Herndon ruled last week that the Bayer witnesses must come to the United States for the scheduled Rule 30(b)(6) depositions. Bayer wanted the depositions to be held in Brussels, Belgium. Although Bayer is headquartered in Germany, German law does not permit depositions, providing additional protection to the German companies. However if a foreign company wants to make profits from selling in the United States marketplace, it automatically submits to the jurisdiction of the United States.

This ruling is important and fair. Any company that wants to market its products, particularly dangerous products, ought to be required to submit to questioning in the country where the harm caused by those products occurs.

For news coverage of the ruling, click here.

Even though this ruling was issued only in the MDL litigation, which is pending in East St. Louis, Illinois before Judge Herndon, the ruling benefits the various state court proceedings as well, since lawyers from all of the various jurisdictions participate in the depositions.

Many doctors on drug company payrolls have tainted record, media report alleges.

2010-10-19T09:50:00.000-04:00

ProPublica (10/19, Ornstein et al.) reports that despite drug companies saying "they hire the most-respected doctors in their fields for the critical task of teaching about the benefits and risks of their drug," an investigation by ProPublica "uncovered hundreds of doctors on company payrolls who had been accused of professional misconduct, were disciplined by state boards or lacked credentials as researchers or specialists." A "review of physician licensing records in the 15 most-populous states and three others found sanctions against" more than "250 speakers, including some of the highest paid." Their "misconduct included inappropriately prescribing drugs, providing poor care or having sex with patients," and "some of the doctors had even lost their licenses."

In Georgia, a state appeals court in 2004 upheld a hospital’s decision to kick Dr. Donald Ray Taylor off its staff. The anesthesiologist had admitted giving young female patients rectal and vaginal exams without documenting why. He’d also been accused of exposing women’s breasts during medical procedures. When confronted by a hospital official, Taylor said, “Maybe I am a pervert, I honestly don’t know,” according to the appellate court ruling.

Last year, Taylor was Cephalon's third-highest-paid speaker out of more than 900. He received $142,050 in 2009 and another $52,400 through June.

The Chicago Tribune (10/19, Graham) reports that "doctors are drawing an extra paycheck...for speaking to other medical professionals about pharmaceutical products at company-sponsored, company-scripted events in Illinois and across the country."

"Let's be honest: The purpose of these talks is to influence doctors to buy a company's drugs," said Eric Campbell, an associate professor of health policy at Harvard Medical School.

The Tribune adds that drug companies have started "publicly releasing data about their relationships with physicians, information that until now has been a closely guarded secret." While most doctors received small payments, "pharmaceutical data show that 11 Illinois physicians each earned more than $100,000 between January 2009 and June 2010 from seven companies," and an "additional 13 medical providers earned between $75,000 and $100,000, primarily for participating in speakers' bureaus and educational forums." The Tribune goes on to detail views on both sides of the "medical moonlighting" practice.

Dr. Catherine DeAngelis, editor of the Journal of the American Medical Association, criticized the speaking arrangements, saying they posed "a conflict of interest" and threatened to put doctors' "own financial benefit before that of the patients who trust them."

The Boston Globe (10/19, A1, Kowalczyk) reports on its front page, "The Harvard brand, unrivaled in education, is also prized by the pharmaceutical industry as a powerful tool in promoting drugs," and "its allure is evident in a new analysis of all publicly reported industry payments to physicians." Data show that "doctors and researchers affiliated with Harvard Medical School collected 45 percent of the $6.3 million given to Massachusetts doctors in 2009 and 2010 by seven pharmaceutical companies that disclosed their payments for parts of those years. The money was mostly for talking to other physicians about the companies' drugs and the diseases they treat, but also for consulting on research and marketing." Notably, "doctors said they created their own presentations" initially, but "now, companies generally make them, and they are reviewed by" the FDA.

Bellwether Order Amended

2010-10-14T14:11:00.000-04:00

Following the status conference this week, Judge Herndon amended the bellwether order, as follows:
12 cases will be selected by each side, for a total of 24.
8 of these cases will be VTE cases, and 4 will be gallbladder cases, leaving the following pools:
8 cases for the first trial (PE case), 8 cases for the second trial (a gallbladder (GB) case), and 8 cases for the third trial trial (a VTE case).

The first case tried will be a Pulmonary Embolism case (this is not a change, just a clarification of my previous blog).
The trial dates and deadlines will stay the same.
Basically this amendment reduces the number of cases which will be subjected to discovery from 50 to 24.
The end result will still be pretty much the same.
There will be a slightly different strike system, with each party getting 2 strikes, one VTE/PE strike and one GB strike. The Court will then select a lead case and two back up cases from the remaining pool for each of the three trial dates.
This means that the Court will have 6 cases from which to choose a gallbladder case and 14 cases from which to choose the PE and VTE cases.

One other important change. All Plaintiffs MUST waive Lexicon. That means that every case selected by either side must waive venue and agree to have their case tried before Judge Herndon. If ANY Plaintiff refuses to waive Lexicon, then the Judge can (and probably will) totally withdraw the trial bellwether plan.

Trial Dates set for Bellwethers in MDL

2010-10-12T20:50:00.000-04:00

Judge Herndon has set the initial trial schedules for the first three cases to be tried in federal court in East St. Louis, Illinois. The first trial will be a VTE case (venous thrombotic event, such as a pulmonary embolism). The second case will be a gall bladder case, and the third case will be another VTE case.

The first trial is set for September 12, 2011, the second January 9, 2012, and the third case April 20, 2012. This will require an extraordinary level of work to get the cases prepared. Bayer still has not produce many documents, and many that were produced were improperly redacted, requiring duplication of effort and delay.

Selection of these bellwether cases is to be made by October 27, 2010. Each side will submit 25 cases, 13 VTE cases and 12 gallbladder cases, forming a pool of 50 cases from which the selection of the three will be made. If a case is selected and there is no completed Plaintiff Fact Sheet, the case may be dismissed without prejudice.

Discovery in the 50 selected cases will begin November 1st, and must be completed by March 14, 2011. Thereafter the Plaintiffs and Defendants will each pick three cases for each of the three trial dates, and the Court will then select three cases from the proposed group. So there will be three cases set for each of the three trial dates. In this way there will be back up cases in case the first scheduled case cannot proceed.

The schedule also contains dates for expert reports and other deadlines. All in all it is a very thorough and aggressive schedule that will require a tremendous amount of work.

Bayer Sales drop 44%

2010-08-03T14:54:00.000-04:00

Bayer announced this week that sales of Yasmin and YAZ receded by a 44% in the United States "due to the debate surrounding the risk of thrombosis and the market entry of a generic version of YAZ." Transcript of earnings call.

This is a tremendous impact on Bayer's earnings. Bayer had planned for continued growth in this big money maker. Clearly women and their doctors are getting the message of the dangers of Yaz!

Our fight for those harmed by this combination oral contraceptive continue, with hard work on experts, documents and science.

If you or a loved one have suffered a stroke, PE, DVT, or gall bladder injury while taking Yaz you should immediately seek qualified legal advice. You can call us toll free during regular business hours at 888-841-9623 or email us any time: michelle@toledolaw.com; malina@toledolaw.com; pamela@toledolaw.com.

Thank you for trusting us with your important case.

Bayer Drops Lawsuit on Yaz generic Gianvi

2010-07-01T12:17:00.001-04:00

According to Reuters News Agency, Bayer has dropped one of its lawsuits against Teva, in which it claimed Teva was infringing Bayer's Yaz oral contraceptive drug by selling the generic version, called Gianvi.

Teva is the world's largest generic drug maker. It makes knock off generic versions of drugs. Teva will soon find itself as a defendant once its Ocella and Gianvi versions of Yaz and Yasmin start to cause the harmful effects suffered by those who take Yaz and Yasmin.

Apparently Bayer has engaged in a little "forum shopping" and will pursue Teva in Nevada on a claim of patent infringement.

The Delaware case is Bayer Schering Pharma AG and Bayer Healthcare Pharmaceuticals Inc v Teva Pharmaceutical Industries Ltd and Teva Pharmaceuticals USA Inc, Barr Pharmaceuticals LLC and Barr Laboratories Inc, U.S. District Court, District of Delaware, No. 10-cv-00474.

The Nevada case is Bayer Schering Pharma AG and Bayer Healthcare Pharmaceuticals Inc v Teva Pharmaceutical Industries Ltd and Teva Pharmaceuticals USA Inc, Barr Pharmaceuticals LLC and Barr Laboratories Inc, U.S. District Court, District of Nevada, No. 10-cv-00872.

If you or a loved one have been harmed by Yaz, Yasmin, Ocella or, now, Gianvi, please contact an experienced attorney. You can reach us by toll free at 1-888-8419623 during normal business hours or directly by email to Pamela@toledolaw.com.

New story on Swiss TV discloses dangers of Yaz and Yazmin

2010-06-25T22:42:00.001-04:00

The courageous Swiss TV investigators have turned the public lights on the hazards of Bayer's Yaz and Yasmin. In a documentary released earlier this month, Uebersetzung Beitrag Pille describes in great detail the number of deaths attributed to these drugs. Although the story is in German, my friends in Switzerland have given me the following translation of the story:

Uebersetzung Beitrag Pille auf Englisch

Presenter:

There was love, there was desire – and the fear of getting pregnant. Then, 50 years ago, the first birth control pills hit the market and became a milestone on the way towards female sexual self-determination. But as other drugs, hormonal contraceptives do have side-effects: swollen legs, headaches, pulmonary embolisms. These rare subsequent damages are only documented in international databases of regulatory authorities – and hard to access. Now, our reporter Mario Poletti achieved to have an in-depth look into these records – and he stumbled across hundreds of dead women.

Story:

0.01
She was sweet 17, in rude health – and ended up with an embolism in Basel’s university hospital. A blood clot in her lung. The young woman died last November.

Chief physician Stephan Krähenbühl confirms the diagnosis: side-effect of a birth control pill.

0.18
Quote Stephan Krähenbühl:
"This is a known complication of birth control pills. Even though it is rare, I have to confirm: We had cases like this, yes.”

0.28
The young woman is Switzerland’s 11st officially documented deadly victim of birth control pills since the 1990s. But which contraceptive did she take? Hospital and authorities remain silent.

The 17-year-old originated from a nearby German boarder district

0.41
Now, Germany’s Federal Institute for Drugs and Medical Devices names the pill she used: Yasmin, a top-selling product worldwide. According to studies, it doesn’t carry a higher risk than other comparable products.

0.52
Deadly side-effects – a taboo. Two months before the 17-year-old German woman died,

0.59
the same happened to this 22-year-old in the canton of Nidwalden. „She left us completely unexpectedly after a short disease.“ [the obituary states]

Dead after the intake of contraceptive pills - only a few cases can be found in international press archives and in specialist literature.

1.13
Pharmaceutical companies and European authorities have so far remained silent about worldwide death numbers.

1.19
This CD-ROM we receive from the FDA - after month-long insisting. A huge amount of data reporting worldwide side-effects of the most used hormonal contraceptives of the last 10 years – reported by medical doctors, hospitals, pharmaceutical manufacturers and private individuals.

Every report – also called spontaneous adverse event report – documents a side effect.

1.47
Harmless headache

1.48
Swollen lips

1.50
dizziness

1.51
vomiting

1.53
insomnia

1.54
But we also come across hundreds of life-threatening pulmonary embolisms and, over and over again, the very one report: death.

These reports are not proven doctor’s reports, but signals of suspicion.

2.06
Death after embolism – age 16

2.10
Death after cerebro-vascular accident - age 20

2.13
Death after pulmonary embolism – age 46

2.17
Death after thrombosis – age 14

2.20
We present the reports – a total quantity of more than 10.000 and among them hundreds of death cases – to chief physician Stephan Krähenbühl. As president of Swissmedic’s national drug admission commission, he is Switzerland’s highest ranking watchdog over side-effects of drugs.

2.33
Quote Krähenbühl:
“It is emotionally touching and very tragic that there are these death cases. But one knows: Every contraceptive pill can cause complications, i.e. deep venous thrombosis. And there are pulmonary embolisms as well – and if they [the blood clots] are big enough, they can always cause death.“

2.56
The top-selling products are, according to market researchers of IMS Health:

3.01
The contraceptive pills from Bayer: Yasmin, Yaz and Yasminelle

3.07
The contraceptive transdermal patch Evra from Janssen Cilag, which dispenses the hormons directly through the skin.

3.13
And the Nuvaring from Essex Chemistry, which dispenses the hormones within the vagina.

3.19
We comb through the reports of market leader’s products. The wider spread a contraceptive is, the more reports it creates. After extinguishing double reports, the following numbers remain:

3.28
Yasmin: about 140 dead ones

on the market only since 2006: Yas with about 50 dead ones

Nuvaring: around 40 dead ones

Evra: around 130 dead ones

3.44
Included in these numbers are miscarriages of women who started to take hormonal contraceptives when they were already pregnant. What is Krähenbühl’s comment on these numbers?

3.52
Question of reporter

3.54
Quote Krähenbühl:
„It is surprising, but on the other hand, the taking is so wide-spread that one has to expect it.“

4.00
Overall, about 140 million women worldwide take hormonal contraceptives. All modern methods of hormonal contraception, Krähenbühl says, carry a comparable risk.

4.09
The FDA doesn’t grant us an interview related to the data it has provided to us itself. They just let us know: A large-scale study about the death cases is under way. Waiting for this study are also several law firms.

4.24
Quote lawyer:
„I am a lawyer for victims which have been hurt by or lost their lives.“

4.29
US law chambers do search for victims of hormonal contraceptives by TV commercials.

4.37
Bayer claims to be confronted with 1750 complaints in the US and 8 class actions in Canada.

4.47
Essex Chemie doesn’t comment on the complaints concerning the Nuvaring.

4.52
Jannssen Cilag doesn’t comment on complaints concerning Evra patch. Just this: that there weren’t any in Switzerland so far.

5.00
We also present the records of more than 10.000 reports including a couple of hundred deaths to Daniel Brügger, a committed gynecolist. For a long time, Brügger has warned about the new birth control pills, vagina rings and contraception patches – but he hasn’t expected such an amount of reported side-effects.

5.15
Qute Brügger :
„I’m shocked about the hight of this stack. And I’m even more shocked, figuring that each page documents at least one human destiny. The death rates should have been communicated better. Me as a gynecolist working at the front, I would be dependent on obtaining such figures.“

5.41
This critic refers to Swissmedic, Switzerland’s National board of drug admission control. We march up with the US figures – and they immediately turn to a matter for the boss. And for the first time, a regulatory authority comment on the FDA figures.

5.56
Question of reporter

6.03
Quote Mathys:
„If you take a look on the international securitiy data – the FDA figures don’t only contain US incidents – then they do meet this scale.“

Question of reporter:
Why don’t you inform the public?

Quote Mathys:
„If we published the adverse events of all pharmaceutical drugs – and there are many – we would cause uncertainty among the public – using numbers which are not reliable.”

6.33
Indeed, in the extreme case, a lot of drugs do have deadly side-effects.

The pharmaceutical manufacturers either aren’t willing to grant us an on-camera interview regarding the FDA-numbers:

Bayer , Jannsen Cilag and Essex Chemistry just deliver general congruent statements:

Adverse events, they point out, were

-    Not always complete, because information about simultaneously taken drugs are often missing. The reports
-    Don’t prove the cause of an incident, pre-existing conditions and predispositions might as well be complicit. Adverse event reports would carry
-    No validity about the risk of a drug.

7.09
Adverse events reports of all drugs would show only a suspicion, authorities say, the frequency of a risk could only be evaluated with studies.

7.20
Quote Mathys, Swissmedic:
“It is for sure frightening that there are such kinds of side-effects, but one has to know that hormonal contraceptives are drugs, and drugs carry risks – one should therefore only intake them after clarifications with a physician. And, one has to be aware of the risks.”

7.37
Of 1000 women taking hormonal contraceptives over the period of a year, about one of them will suffer from a dangerous venous thromboembolism.

7.47
A year ago, the fate of 16-year-old Celine rocked Switzerland. After taking contraceptive pills for four weeks, she suffered from a grave pulmonary embolism. She barely survived and has been heavily handicapped ever since.

8.00
After investigations of Switzerland’s National board of drug admission control Swissmedic, Bayer had to aggravate the package insert of Yasmin, Yaz and Yasminelle. Now, it mentions that the pills can cause grave and lasting health damages or be deadly.

8.15
Bayer however states: „The benefit/risk profile of Bayer’s combined hormonal contraceptives has been confirmed as positive by experts, authorities as well as in extensive scientific studies.”

8.30
Janssen Cilag and Essex Chemistry state the same about their respective products.

8.37
Gynecolist Brügger is unsettled. How to interpret the death numbers? He impatiently awaits the US study from the FDA.

8.47
So does the highest ranking Swiss drug safety official.
The President of Swissmedic’s national drug admission commission, Prof. Stephan Krähenbühl of Basel University, comments

8.52
Quote Krähenbühl:
“If I was the head of a body receiving such a big amount of death case reports, I as well would want to further investigate this.”

9.01
The risk may be marginal. Nevertheless, Krähenbühl recommends women to go see a doctor if they have symptoms such as swollen legs, shortness of breath and increased pulse. Rather a day too early that a day too late.

Length of pictures: 9.20

Congratulations and thanks go to
Mario Poletti
Schweizer Fernsehen
Fernsehstrasse 1-4 8052 Zürich
www.sf.tv
For strength, courage and honor in standing up for the rights of women in the face of the powerful Bayer Corporation.

If you or a loved one have been harmed by Yaz, Yasmin, Ocella or, now, Gianvi, please contact an experienced attorney. You can reach us by toll free at 1-888-8419623 during normal business hours or directly by email to Pamela@toledolaw.com.

Teva admits making false claims about Gianvi, the latest generic version of Yaz

2010-06-19T13:55:00.000-04:00

Teva went public with a generic version of Yaz. The combination oral contraceptive (COC), Gianvi, is made by Teva Pharmaceutical Industries. On Thursday Teva admitted before a federal court to making false statements about the generic oral contraceptive (drospirenone and ethinyl estradiol). The admission came in a lawsuit filed in federal court by Bayer HealthCare Pharmaceutical, the US distributor of Yaz.

Bayer had sued Teva in the U.S. District Court for the Northern District of Illinois for false advertising and patent infringement, accusing the world’s largest generic drug maker of falsely claiming in Gianvi’s prescribing information that the ethinyl estradiol uses the chemical beta-cyclodextrin as a “clathrate” to stablize it and prolong its shelf life, a patented Bayer technology. In its lawsuit, Bayer said an analysis of Gianvi found it did not use beta-cyclodextrin as a clathrate.

Teva said it would rectify the situation by sending weekly e-mails and faxes to pharmacists throughout the United States for three months that contain corrected prescribing information and had already provided the corrected information to the Food and Drug Administration. It also agreed not to ship any more Gianvi products containing any material claiming that the drug uses beta-cyclodextrin as a clathrate.

Teva received FDA approval for its version of the drug on June 1. Yaz had $782 million in sales in 2009, according to IMS Health.

Teva jumped into the generic Yaz market this month, no doubt in a big hurry to rake in some profits off Yaz before it loses the ability to do so because of the rash of injuries and deaths being attributed to the drug.

Personally I find it highly ironic that Bayer would criticize Teva for making false claims about Yaz. Bayer's reckless failure to disclose the harm its Yaz and Yasmin cause to women is the real crime.

If you or a loved one have been harmed by Yaz, Yasmin, Ocella or, now, Gianvi, please contact an experienced attorney. You can reach us by toll free at 1-888-8419623 during normal business hours or directly by email to Pamela@toledolaw.com.

Judge Herndon Orders Bayer to produce records from Sales people in Yaz litigation

2010-06-18T11:19:00.003-04:00

On June 10, U.S. District Judge David Herndon ordered production of files from any sales representative who had contact with plaintiffs' doctors. This is very critical because Bayer spent millions of dollars marketing this dangerous drug directly to the prescribing physicians.

The order covers "all written materials, video and or audio tapes in the possession of the sales representative."

Judge Herndon ordered Bayer Health Care Pharmaceuticals, Bayer Schering Pharma, Barr Laboratories and Teva Pharmaceuticals to produce records from their facilities, third party storage vendors, or homes and automobiles of sales representatives. Sales representatives who handled hormone replacements Yasmin, Yaz, Ocella, and Gianvi must produce their complete files.

The U.S. Judicial Panel on Multi District Litigation appointed Judge Herndon last year to preside over suits from federal courts around the nation claiming the drugs harmed women. Judge Herndon has ordered that Bayer provide important information.

We have begun submitting individual fact sheets, and defendants must respond with fact sheets of their own in 45 days. Defendants must produce files of sales representatives no later than 60 days before plaintiffs start taking depositions.

Bayer must also produce:

Training materials related to "physician detailing and obstacle handling," including workbooks and forms representatives completed.
E-mails, bulletins, memoranda, activity reports, call notes, belief notes, tactical plans, voice mail transcripts, and summaries of meetings.
Materials from national, regional or district sales meetings.
Physician prescribing data and ratings.
Incentive plans and goal attainment reports.
Promotional and cross promotional marketing materials.
All documents representatives signed reflecting business and ethics practices and policies.
Documents representatives provided to doctors.
Budgets and materials for speaker's programs.
Materials relating to tests representatives took.
All communications between representatives and managers.

So far over 20 million pages of documents have been produced, making this one of the largest document productions in the history of pharmaceutical litigation.

Yesterday I was in Philadelphia attending the Pennsylvania State Court Yaz status conference. A number of agreed orders were also entered at the state court level. The litigation continues to progress very well. We have a great team of lawyers working for injured women and their families around the country.

It is essential that all clients promptly complete their Plaintiff Fact Sheets and return to us in a timely manner so we can keep the pressure on Bayer and obtain the critical sales records from the detailers who pushed the pills on the doctors.

Story in Madison / St. Clair Record.

Thanks!

Litigation Update - Yaz, Yasmin and Ocella Injury and Death Cases: FAQ

2010-06-02T16:44:00.002-04:00

I want to update everyone on the status of the Yaz / Yasmin / Ocella litigation. I will try to answer the most Frequently Asked Questions we get from potential clients.

These cases are for women who have been injured or killed after taking Yaz, Yasmin or Ocella. There are 3 basic types of injuries:

Venous Thrombotic Events (VTEs) which include stroke, pulmonary embolism (PE) or deep vein thrombosis (DVT)
Gallbladder or pancreatic injuries, usually involving the removal of the organ, and
Heart problems caused by hyperkalemia.

The cases are being filed in four different jurisdictions. Each jurisdiction has particular advantages.

Philadelphia State Court, Philadelphia County, PA. These cases are consolidated under Judge Sandra Moss and are the furthest along.
Federal court in East St. Louis, Illinois. This is the "MDL" where most cases are filed. The litigation is progressing very well and is almost as advanced as the PA cases. Jurisdiction is based on diversity of citizenship.
New Jersey State Court. These cases are just getting organized. The first status conference has been held and Pretrial Orders are being entered.
California State Court. These cases are also in the process of getting underway.

Generally we are filing most of our cases in the MDL, but we also have a good number of cases in New Jersey and Pennsylvania. The choice of where to file a particular case is a complex one. Each attorney will use his or her best judgment on where to file the case, based on a host of factors including the state of citizenship of the Plaintiff, the statute of limitations, choice of law issues, the particulars of the individual case and other matters.

Discovery is well underway in the MDL and PA. The first deposition has been taken and over 4 million pages of documents have been produced. The documents are housed in an electronic depository accessible only by attorneys on the discovery team. These attorneys (including lawyers from our law firm) review documents produced by Bayer to establish liability on the part of Bayer. Most all of these documents are marked confidential and cannot be discussed or shared publicly. All reviewing attorneys are bound by confidentiality, although eventually many of these critical documents will be made public in a courtroom at trial.

Many women ask about settlement. Some advertisements seem to imply that there has already been a settlement. The truth is that there has NOT been any settlement yet. There is still lots of hard work we must complete before Bayer will pay up. I am confident that eventually, however, these cases will be settled; however in my 33 years of experience representing injured clients the ONLY way to handle these cases is to work very very hard and get them ready for trial. You cannot sit back and hope. You must work hard. And that is what we are doing.

Another question we get is what about class actions? Can I just sit back and wait for money under a class action? The truth is that in the Yaz, Yasmin and Ocella cases there will NOT be a class action settlement. Under the law, class actions are NOT appropriate in cases where there are individual injuries UNLESS there is a limited fund. This is a common misunderstanding that many lawyers don't even understand. For example, in Vioxx, the settlement was NOT a class action. Each injured person needed to file a claim to be eligible for the settlement. So it is important that each woman or her surviving family hire a qualified attorney.

Finally, we are asked what the chances are of success? The likelihood of success in these cases is excellent. Based on our careful review of the science and medicine, including the pharmacology and epidemiology underlying these cases, we are very confident that these cases are strong cases and do have significant merit. For that reason we strongly urge any woman or her surviving family to immediately seek qualified legal advice. There is a lot of work to be done in each case, including ordering medical records, expert review, and filing of claims. Some states only have a one year statute of limitations, while there may be savings clauses or other methods to save a statute of limitations in a particular case.

Please feel free to browse this blog for more information, or call us toll free at 1-888-841-9623 during regular business hours (8:30 a.m. - 5:00 pm Eastern Time) or email us anytime at pamela@toledolaw.com michelle@toledolaw.com or malina@toledolaw.com. Our attorney / doctor, Donato Borrillo, will review your case along with the rest of our team. You can also learn more by watching our You-Tube video recorded by Dr. Borrillo and ZKB partner Pamela Borgess.

Bayer's Profits from Yaz fall, sales drop 10%.

2010-04-29T10:41:00.000-04:00

Bayer announced today that its first quarter sales from the YAZ® family of oral contraceptives declined by 10.2 percent, due to concerns about the increased risks from the pill.

I noticed that they were advertising strongly on television this week, trying to boost their sales back up to prior high levels. The ads are powerful, claiming all kinds of positive effects for women. Hopefully the ads will NOT lure more women to this dangerous drug. The warnings in the new ads continue to be woefully inadequate to alert potential users to the increased risks of harm, particularly from venous thrombotic events and gall bladder disease.

On the litigation front the MDL discovery effort is starting to get powered up. Bayer will have its hands full. We have put together a powerful team of lawyers from across the country who will be able to bring Bayer to justice. It is just a matter of time before the victims' voices are heard.

If you or a loved one have been injured by Yaz you should seek immediate legal assistance as the statute of limitations is running. Contact us toll free at (888) 841-9623 during regular hours or email us at pamela@toledolaw.com or malina@toledolaw.com.

Bayer tries to Update the Yaz Label

2010-04-15T10:16:00.002-04:00

On Friday, Bayer issued a press release announcing the label update for Yaz and Yasmin. The release stated:

“The updated labels confirm that the body of evidence continues to support that the relative risk of developing venous thromboembolism (VTE) in YAZ and Yasmin users is comparable to that of other combination oral contraceptive preparations, including those containing levonorgestrel. The labels also state, unchanged, that there is a risk of VTE among all combination oral contraceptives (a class effect), and provides additional information and context about data specific to drospirenone containing oral contraceptives.”

Bayer's press release continues:

"The new information is based on two large, multiyear studies of more than 120,000 women taking contraceptives in the U.S. and the U.K., Bayer said.

• With regard to the case-control study, the label indicates that, “…the number of Yasmin cases
was very small (1.2% of all cases) making the risk estimates unreliable.”
• Concerning the retrospective cohort study, the label indicates that, “The relative risk for
Yasmin users in the retrospective cohort study was greater than that for users of other COCs
when considering women who used the products for less than one year. However, these one year estimates may not be reliable because the analysis may include women of varying risk
levels. Among women who used the product for one to four years, the relative risk was similar
for users of Yasmin to that for users of other COCs.”

These claims represent a desperate effort at spin by Bayer to avoid responsibility. Bayer wants to continue to rake in profits while limiting its risk. However if you carefully read what they are saying, the facts simply confirm that the many lawsuits and claims have strong merit.

First Bayer claims that risks between 2nd generation and DRSP based COC's are "comparable." Well, certainly they can be compared. And when you do compare the risks, it is clear that the 2nd generation pills have a much lower risk!

They then denigrate the recent studies because of the large number of injuries to women taking Yaz within the first year. In other words, Bayer wants to ignore the women who were injured in the first year of taking Yaz. This is when most of our client's suffered their injuries and death. It is precisely these women who are most at risk. The addition of the Yaz / Yasmin / Ocella DRSP to their systems throws off the balance of hemostasis and generates the clot that can kill. It is simple science.

But as long as Bayer continues to see the opportunity for profits over people, it will continue to market market market. And critically, Bayer has still failed to acknowledge the huge risk of injury from gall bladder disease posed by Yaz. The misleading way in which Bayer wrote the press release suggests that the FDA agreed with Bayer's analysis of the studies. The FDA has not performed its own analysis. It simply consented to the label change.

While some may believe these modest acknowledgments of increased risk are sufficient to protect Bayer from future lawsuits, in my opinion they do nothing to limit future liability of Bayer, even for those women who consume the pills after the revised label.

If you or a loved one have suffered a DVT, Pulmonary Embolism (PE), stroke or gall bladder disease after taking Yaz you should immediately get legal assistance. You can call us toll free at 888-841-9623 or send an email to our dedicated Yaz paralegal, Malina, malina@toledolaw.com. We are proud to represent over 300 victims of Yaz nationwide in the courts of the MDL, Pennsylvania and New Jersey and look forward to bringing Bayer to justice on their behalf.

Bayer to Update Yasmin Label in the European Union

2010-03-29T17:36:00.007-04:00

On Friday, March 26, 2010, Bayer agreed to update its label for Yasmin, at least in the European Union, to inform women and their doctors of the link between use of the contraceptive and an increased risk of venous thromboembolism (VTE).

VTE is a term used to describe a blood clot (thrombus) in a vein, which may partially or completely block the flow of blood in that vein. If this occurs in one of the deep veins in the body, commonly in the legs, pelvis or arms, it is called a deep venous thrombosis (DVT). The major danger from a deep venous thrombosis is that the clot or part of it may break off and travel through the blood stream to the heart and lungs. This is called a pulmonary embolism (PE) and can be fatal.

Although VTE has a known association with combined oral contraceptives, epidemiological studies have shown that the incidence of VTE associated with levonorgestrel (“second generation pills”) is substantially less than those with desogestrel/gestodene (“third generation pills”).

As discussed in this blog, two epidemiological studies were recently published that assessed the risk of VTE in current users of different types of oral contraceptives. These studies are:

-The venous thombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study, van Hylckama Vlieg, Helmerhorst, Vandenbroucke, Doggen & Rosendaal, BMJ 2009;339:b2921; and

-Hormonal contraception and risk of venous thromboembolism: national follow-up study, Lidegaard, Lokkegaard, Svendsen, & Agger (all of Copenhagen, Denmark), BMJ 2009;339:b2890.

These two important studies in the British Medical Journal contained some very significant findings. First, the studies found that women taking combination oral contraceptives containing the hormone, drosperinone, such as Yaz and Yasmin, have a six to seven time increase in the risk of thromboembolism (including DVT or PE). This risk is closer to third generation birth control pills, which have a higher level of risk than second generation oral contraceptives containing levonorgestrel. (The studies also questioned whether Yaz / Yasmin actually provide any increased benefit for acne or weight loss, and also noted the lack of evidence that these drugs help to alleviate premenstrual symptoms.) Thus, the studies contradict Bayer’s marketing of Yasmin and Yaz, which it claims are just as safe, if not safer than other pills, and have multiple additional benefits, such as improvement of acne and premenstrual dsysphoric disorder.

The Pharmacovigilance Working Party (PhVWP) of the Committee for Medicinal Products for Human Use (CHMP) was the force behind the addition of these two independent studies to now be included on Yasmin’s label.

Bayer, of course, questions “several methodological issues” in these studies and also wants to include two 2007 studies that it sponsored (EURAS and Ingenix). Not surprisingly, Bayer argues that its own studies only found that the risk for VTE was comparable to second generation oral contraceptives containing levonorgestrel.

Well, at least some limited acknowledgement and warning of the increased risk to women is a step in the right direction. Now, if we could work on that U.S. label...

More about Yaz in Bayer's Annual Report

2010-03-02T09:11:00.005-05:00

Digging deeper into Bayer's 2009 annual report, it discloses that about 1,100 lawsuits have been filed against it alleging its top-selling Yaz birth control pill causes personal injuries and death.

The disclosure establishes that Bayer’s Yaz problem is far larger than it previously anticipated. The cases are pending in Philadelphia, federal multidistrict litigation in Illinois’ Southern District, New Jersey and California.

The disclosure does not say how many women have died after taking Yaz. Nor does it disclose the problem related to gall bladder disease alleged to be caused by Yaz. Bayer said:

Bayer has also been served with three putative consumer class actions claiming economic loss, one of them also claiming personal injuries. All cases pending in u.s. federal courts have been consolidated in a multidistrict litigation (mdl) proceeding for common pre-trial management.

In addition, two Canadian class actions have been served upon Bayer. Additional lawsuits are anticipated.

Based on what we are seeing, only a small percentage of the cases have been filed. We continue to get new cases in every day, many from new injuries. Hopefully Bayer will soon recognize and admit to the Dangers of Yaz and either recall the drug or add the appropriate warnings.

Bayer also discloses that it is insured for these claims "to the extent customary in the industry."

The number of gall bladder injuries from this pill is truly staggering. The rates of gall bladder disease are more than 10 times greater than that normally seen in this population. Bayer runs the risk of shareholder suits by failing to disclose the magnitude of the gall bladder problem.

Even more troubling are Bayer's plans to expand the Yaz line with "Yaz Plus" and "Yaz Flex." Bayer is adding a folate to Yaz, and no doubt using this trick to extend its patent coverage. Folate is the natural source of vitamin B9 found in a variety of foods, most often, in leafy green vegetables, dried beans, and peas. When folate is used as an additive in foods, generally in bread, grains or breakfast cereal, or when it is taken as a supplement it is called folic acid. It is a vitamin.

If you or a loved one have suffered injury or death from this product you should immediately seek legal advice from an experienced lawyer. We are handling cases in the MDL, Philly and Jersey. We will file your case in the jurisdiction that is most suited for the facts of your case.

Contact us free of charge at our toll-free number (888) 841-9623.

Bayer continues to Profit from Yaz

2010-03-01T08:44:00.005-05:00

Bayer continues to profit from its dangerous combination oral contraceptive, Yaz. In its latest financial report for fiscal year 2009 Bayer reported that the YAZ line generated sales of 1.3 billion euros ($1.8 billion), up 4.6 percent compared to the year before.

Quarterly revenue from the company's YAZ family of oral contraceptives was unchanged at 314 million euros ($426 million).

Bayer's fourth-quarter revenue from its HealthCare division reached 4.2 billion euros ($5.7 billion), up from last year's fourth quarter.

The HealthCare unit revenues rose 3.8 percent to 16 billion euros ($21.7 billion), due to growth "particularly in the emerging markets." Sales of pharmaceutical products were up 4.4 percent to 10.5 billion euros ($14.3 billion).

The Company as a whole generated revenue for 2009 of 31.2 billion euros ($42.4 billion), down 5.3 percent compared to 2008.

The flattening out of the increase in revenues from Yaz is a hopeful sign that consumers (and their physicians) are getting the message about the Dangers of Yaz.

If you or or a loved one have been injured by Yaz, Yasmin or Ocella contact us free of charge at our toll-free number (888) 841-9623.

Litigation Update

2010-02-14T09:01:00.004-05:00

As more and more women suffer injury and death every day the profits of Bayer from this dangerous pill continue to climb. Yet at the same time the number of cases against them continues to grow. This week we received over a dozen calls and emails from women and other lawyers around the country referring cases to us in which women have been injured or died from Yaz, Yasmin or Ocella in just the past few months.

A college student from a southern state suffered a pulmonary embolism in January, 2010.
A 45 year old women in Ohio died from a pulmonary embolism in September.
A young lady in her 20's in New York lost her gall bladder in September.
Other calls with DVT and similar clotting injuries.

This is just a small sample of the cases that are pouring in every week. We are totally dedicated to developing the facts and science that will permit us to prepare, pursue, present and resolve these cases. Our goal is to be the best lawyer in the country for women, or their surviving families, who have suffered injury or death from this pill.

This week I will be in Philadelphia meeting with other lawyers from around the country, both counsel for other injured Plaintiffs and the lawyers for Bayer. I will attend the status conference with Judge Sandra Moss in Philadelphia on Tuesday as well.

In the meantime, our firm is proud to host the document depository for the Pennsylvania State Court litigation. So far we have over 3 million pages of documents produced by Bayer. We also are serving on the critical committees in the MDL litigation. Pamela Borgess and Dr. Donato Borillo are on the Science Subcommittee and I am on the Discovery Subommittee.

Finally, we are working with academics, scientists and doctors to document and catalogue the medical and scientific literature to establish the excessive risks presented by this pill, the lack of adequate warnings, and the medical causation of the injuries from Yaz, Yasmin and Ocella.

If you or someone you love has been injured by this pill please seek immediate legal advice. Our paralegal Malina, and me and my partners Michelle Kranz and Pamela Borgess are always willing to take your calls.

You may email us any time: pamela@toledolaw.com; michelle@toledolaw.com; malina@toledolaw.com.

You may contact us free of charge at our toll-free number (888) 841-9623 during business hours.

For more information go to our web site or watch our YouTube video: What You Should Know about Yaz, Yasmin and Ocella: The Dangers of Yaz.

Yaz Lawyer Litigation Update - Number of cases continues to climb

2010-01-18T09:42:00.006-05:00

The number of calls from injured women is keeping pace with the number of new cases being filed. A recent story by UPI predicted there would be 25,000 cases filed against Bayer for death and injury caused by Yaz, Yasmin and Ocella. We classify these cases into two categories: Venous Thrombotic Events (VTE) and Gall bladder injury. Amazingly for every one VTE case we see at least one gall bladder case.

VTE cases include injury and death from stroke, deep vein thrombosis (DVT) and pulmonary embolism (PE). Gall bladder cases include cases involving pancreatitis and other biliary tract organs.

One may ask why Bayer has not changed the warning label, withdrawn the drug, or taken other action to stop or limit the number of injuries caused by these drugs. The answer is simple: profits. Yaz continues to be a big moneymaker for Bayer, at the expense of thousands of women who develop life threatening injuries.

Rather than make a change which could be used to hold them responsible, Bayer continues to challenge the science. The facts are the facts, however. While big tobacco claimed there was nothing wrong with smoking, the statistics finally caught up with them. Similarly, the statistics, sooner or later, will catch up with Bayer. Its only hope is that it can continue to make more money in profits than it will pay out in claims. It is our goal to make sure it loses that bet.

If you or a loved one have suffered a VTE or Gall bladder injury we urge you to immediately get legal advice from an experienced attorney. You can contact us toll free without cost or obligation at 888-841-9623, or email us at pamela@toledolaw.com. We are handling cases in all three venues, namely New Jersey, Pennsylvania and Illinois.

Factor V Leiden – Do I Still Have a Viable Legal Claim?

2009-12-27T11:22:00.005-05:00

We are often asked what is Factor V Leiden and if a diagnosis of this genetic disorder has been made, whether there is still a viable Yasmin/Yaz/Ocella legal claim.

Factor V Leiden thrombophilia is a common inherited genetic disorder in which there is an increased tendency to form abnormal blood clots (thrombophilia) in blood vessels. People who have the Factor V Leiden mutation are at a higher than average risk for a type of clot that forms in veins, such as the deep veins of the legs (deep venous thrombosis or “DVT”), or a clot that travels through the bloodstream and lodges in the lungs (pulmonary embolism or “PE”). Most people with the Factor V Leiden mutation never develop abnormal blood clots, however.

The lawsuits against Bayer allege that the drug company knew or should have known that its novel birth control pills, Yasmin, Yaz and Ocella, carry an increased risk of serious complications, including an increased risk of thromboembolic events as compared to alternative birth control pills. However, in putting the interest of corporate profits over public safety, Bayer’s marketing has focused almost exclusively on the positive affects of its newest drug creations, while continually omitting or minimizing the very significant and deadly increased clotting risks to women. This missing information about an increased risk of deadly side effects is essential information that women and their physicians deserve and have the right to know when considering which birth control is the best and safest option, especially women who already have an increased risk due to Factor V Leiden or other clotting disorders.

We believe that women with Factor V Leiden who have suffered injury after taking Yasmin, Yaz or Ocella, still have strong legal claims against Bayer for its lies to the public, patients and their physicians. For more information, you can call us toll free during regular hours at 888-841-9623 or by email to pamela@toledolaw.com or malina@toledolaw.com. Your can also visit our Yasmin/Yaz/Ocella website at http://www.toledolaw.com/yasmin.php and our You Tube Video at http://www.youtube.com/watch?v=4Rg5fwjeNZ4

The Fight Continues: Plaintiff Fact Sheets

2009-12-14T20:06:00.006-05:00

What is a Plaintiff Fact Sheet (PFS)? Plaintiff Fact Sheets are basically questionnaires completed by Plaintiffs, with assistance from their counsel. These questionnaires take the place of interrogatories, or written questions, that are typically served in litigation.

In a mass tort case, like the Yaz litigation, the Parties negotiate the questions to be asked on the questionnaires. The Defendants are entitled to ask questions in a PFS that provide both basic information about the claimant (date of birth, marital status) and specific information (date of injury, type of injury, name of doctor).

On Friday of last week members of our Pennsylvania Plaintiffs litigation team presented argument to Judge Moss on the Plaintiff Fact Sheet, in an effort to minimize the level of intrusion into the private lives of women bringing claims for injury caused by Yaz, Yasmin or Ocella.

Even though the PFS is totally confidential, we still want to limit the degree of intrusion and the level of information to the minimum necessary to permit the Defendant to be apprised of the underlying facts.

The PFS being negotiated in Yaz will be finalized within the next few weeks. For many women completion of this questionnaire will be all that will be required of them in this litigation. The rest of the work will be done by the lawyers and paralegals, primarily the gathering of medical records, medical bills, and review of those records by the necessary experts.

The privacy of each women is critically important to us and we have and will continue to take every measure to preserve that privacy. We are indeed fortunate to have Judge Moss, a woman Judge, presiding over the Pennsylvania State Court proceedings. Once the negotiations and rulings on disputed matters are completed, we will start working with our clients to get these PFS completed fairly and accurately. We will have 75 days from the entry of the order, or the filing of the case, to get the PFS completed. Based on the questionnaire I am sure that all of our clients will have no problem answering the questionnaire. It will probably take less than an hour to complete, and much of the information will be found in the medical records.

So I wanted to get this information out there for those of you who may have questions about PFS. If you have not yet secured an attorney to assist you with your claim for stroke, pulmonary embolism, DVT, or gall bladder removal then I urge you to do so. In selecting an attorney you should be sure to find someone with experience and expertise in the field of mass torts and particulary with regard to Yaz.

Our firm was one of the early leaders in the litigation and continue to be deeply involved in the preparation and pursuit of these important cases. You can call us toll free during regular hours at 888-841-9623 or by email to pamela@toledolaw.com, malina@toledolaw.com, michelle@toledolaw.com, or david@toledolaw.com. Our team of attorneys and paralegals stands ready to support you in your fight for justice.

Yaz, Yasmin and Ocella Lawsuit Update

2009-12-13T13:41:00.005-05:00

I apologize for not updating this Yaz, Yasmin and Ocella blog. In the past month we have been extraordinarily busy reviewing new cases and working with other Plaintiff lawyers doing the hard work necessary to prepare, pursue and present these cases at trial.

We have successfully served the German Bayer Defendants, Bayer AG and Bayer Schering Pharma AG, and filed those proofs of service with the Court. I believe we are the first firm in the country to have done so. While many believe it is not necessary to serve the Germans, doing so will insure that we have the right to all necessary documents, many of which are in Germany.

The Data Protection Directive (European Privacy Law) is a tool used by foreign corporations to protect their documents from discovery. While the law was designed to protect individuals from invasion of privacy, in this case Bayer is using it to avoid its responsibility to produce documents that could establish liability for the tens of thousands of injuries and deaths caused by Yaz. To get around the restrictions, it was critical that we get service on these foreign corporations.

Now that Bayer and Bayer Schering have been served in Germany, we can proceed to force the Defendants to give us the documents.

We continue to look at each individual case carefully before filing suit. Some cases are better filed in Philadelphia, some in New Jersey, and others in the MDL which is located in East St. Louis, Illinois. Complex rules on choice of law and the discovery rule must be analyzed for each fact pattern.

Based on the number of cases we are seeing, our initial estimate of 10,000 cases now seems conservative. It may well be that this case becomes one of the largest ever mass tort cases, with over 20,000 cases of women who have suffered injury from gall bladder loss, stroke, Pulmonary Embolism (PE), Deep Vein Thrombosis (DVT), or other blood clot disorder.

We strongly encourage all women and their families who have suffered this type of injury to immediately seek legal advice from an experienced attorney. You may call us toll free during business hours at 1-888-841-9623 or email us anytime at pamela@toledolaw.com, malina@toledolaw.com, or david@toledolaw.com.

Bayer provides incomplete translation of Swissmedic Yaz Study

2009-10-24T11:05:00.010-04:00

Swissmedica is the Swiss medical authority responsible for the review and approval of drugs in Switzerland. Bayer claimed this week that Swissmedica found the risk of fatal venous thromboembolisms is about the same for Yaz as for other oral contraceptives.

Bayer said:

Swissmedic emphasizes that oral hormonal contraceptives containing the active substance drospirenone have a comparable safety profile to that of other preparations available on the market.

The report from Swissmedica is in German. We are in the process of translating the complete report. However it is clear that Bayer is spinning the report in their favor. The report summary actually says that Yaz, like other third generation pills, carries twice the risk of the second generation combination oral contraceptives.

The Swiss study involved a review by a panel of experts of existing studies, including the recent Danish and Dutch studies we previously reviewed. (See August 16, 2009 blog entry below reporting on studies released August 13, 2009).

Even using my rudimentary German skills it is clear that the Swiss did not give Yaz a clean bill of health. Rather they caution that there is a significant risk of venous thrombotic events, especially in the first year of taking the pill. The Swiss also warn that such pills should be taken only after careful evaluation by a physician.

Unfortunately Bayer chose to market Yaz by bypassing physicians, choosing instead to advertise directly to consumers with misleading advertisements and flashy bling.

As we reported earlier (see October 1, 2009 blog below) the study was commissioned after a 16-year-old was disabled by a pulmonary embolism (PE) in May after taking Yaz.

If you or a loved one suffered a VTE (such as a stroke, PE or DVT) or developed gall bladder disease leading to the removal of your gall bladder, you should immediately seek legal advice. You can reach us toll free from 8:30 to 5 Eastern at 888- 841-9623, or send an email to malina@toledolaw.com. Each case is carefully reviewed by our attorneys.

For more information check out my fellow attorneys Pamela Borgess and Dr. Donato Borillo on YouTube - Dangers of Yaz.

Each claim is filed in the jurisdiction best suited for that particular client's case. We also have accepted many referrals from other attorneys and continue to do so. If you are an attorney please email us at pamela@toledolaw.com or david@toledolaw.com.

Yaz Cases Move Ahead

2009-10-22T08:43:00.006-04:00

On Monday I attended the third status conference in the Philadelphia County, PA Yaz state court consolidated proceedings. We continue to move ahead negotiating the essential discovery plans. These plans are comprehensive, requiring an extraordinary level of detail.
For example, Bayer has advised us that they anticipate producing up to 30 million pages of documents. Therefore, before these documents are produced the parties must reach agreement on the format for the production, the timing of the production, and other critical details.
Similarly, Bayer will be required to review, and plaintiffs' counsel will be required to produce, a Plaintiff's Fact Sheet (PFS) for each of the tens of thousands of clients who were injured or killed by Yaz. Consequently there are detailed negotiations over the details of the PFS, the accompanying medical authorizations, and the related documentation.
The size and scope of the litigation continues to expand. Many women are just now making the link between their DVT, PE, stroke or gall bladder removal and Yaz, Yasmin or Ocella.
Based on the numbers we are seeing, I expect that there will be at least 20,000 women with valid claims, and possibly double that number.
If you or a loved one have suffered one of these yaz related injuries while taking yaz, yasmin or ocella, you should call us toll free at 1-888-841-9623. Ask to speak to our paralegal Malina. She spends 100% of her time every day helping women around the country understand their rights in the Yaz litigation.

Yaz Lawyer Litigation Update

2009-10-16T14:14:00.006-04:00

The Yaz litigation continues to progress. More and more women and their spouses and friends call us daily for information and help in pursuing their claims. We continue to work with experts and scientists to lay the foundation for the evidence that will be needed to prove these cases, and work with other lawyers to develop procedures and methods to obtain the necessary discovery.

There are now four geographic centers of the litigation: Philadelphia, New Jersey, California and East St. Louis, Illinois. Right now the litigation in Philadelphia is ahead of the other venues. We choose which venue is best for each client on the facts of each individual case. Some cases must be filed in their home states and then be transferred to the MDL. Others are better off in Pennsylvania or New Jersey. Jurisdiction in California is based on the fact that Bayer's distributor, McKesson, is located there.

On Monday we will have our 3rd status conference with Judge Moss. We continue to press Bayer to expedite their document production. We are working to establish a document production schedule that we expect will ultimately result in the production of about 15 million pages of documents.

Any production of this size must necessarily be done in stages, on a rolling basis, and must be indexed and reviewed electronically. Therefore we continue to work on an agreement for the format of that electronic information.

On the MDL front, there is currently a dispute over which lawyer will serve as interim liaison counsel, and when or how that appointment should be made. We have chosen to remain on the sidelines in this dispute and instead are focusing our attention on experts, scientific literature and review of client cases. At some point the MDL leadership issue will ultimately have to be decided by Chief Judge Herndon. Since that may take some time, we intend to use that time to proceed with discovery in state court.

The proceedings in New Jersey and California are similarly at the infancy stages while sufficient cases are filed and appropriate motions lodged for consolidation orders.

Finally, we continue to push our efforts to serve the German Bayer Defendants. Our complaint has been translated into German and was delivered into the hands of the German Court over 3 weeks ago. We expect that we should have service on them very shortly. While this is an expensive and time consuming step, Bayer has refused to accept service, and because the pills are all manufactured in Germany, we believe the prudent and safe way to handle this matter is to force them to come to court. We see no need to compromise with Bayer on this issue.

On this issue, as in all of the litigation, our guiding star is the best interests of the clients.

As discussed on this blog, our website, and our You Tube Video , there is solid evidence that these oral contraceptives are unsafe options, that the advertisements used by Bayer to promote Yasmin/Yaz intentionally obscured the serious health risks, and that the manufacturing plants producing Yasmin/Yaz are not even properly producing the drugs in accordance with U.S. current good manufacturing practices.

The most common injuries are pulmonary embolism (PE), deep vein thrombosis (DVT), stroke, and gall bladder disease resulting in the removal of the gall bladder. If you or a loved one have suffered one of these injuries while on Yaz you should immediately seek legal advice. We can be contacted toll free at (888) 841-9623 during regular business hours or anytime through email at pamela@toledolaw.com.

Yasmin / Yaz MDL Sent to Southern District of Illinois

2009-10-02T17:11:00.005-04:00

Yesterday, the United States Judicial Panel on Multidistrict Litigation found that the 32 pending federal actions, (almost half of which were filed by Zoll, Kranz & Borgess, LLC), “involve common questions of fact, and that centralization under Section 1407 in the Southern District of Illinois will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation.” Judge David R. Herndon is assigned to the litigation.

For a detailed explanation of the workings and purpose of an MDL, please visit our website at: http://www.toledolaw.com/pdf/yazminlink.pdf

There are also state court actions, (including state court actions filed by Zoll, Kranz & Borgess, LLC), that are pending before Judge Sandra Moss in Philadelphia, Pennsylvania.

Given the large number of women who have suffered injuries as a result of Yasmin and Yaz, including, but not limited to strokes, heart attacks, deep vein thrombosis (DVT), pulmonary embolism (PE) and sudden death, we expect that thousands of more lawsuits will be filed. We will continue to be involved at a leadership level with both the Yasmin/Yaz MDL and the state court action(s). For more information, please feel free to contact us at our toll free number (888) 841-9623 or by email at pamela@toledolaw.com.

Swiss Investigate Death of Young Woman

2009-10-01T13:14:00.003-04:00

According to a recent article in Reuters, Yaz is suspected to be the cause of the death of a young woman in Switzerland, causing Swiss medical authorities to continue with their investigation into the drug and its predecessor, Yasmin. The woman suffered a blood clot 10 months after being prescribed Yaz.

The article also reported that there have been at least nine deaths in Switzerland since 1990 that have been connected with oral contraceptives, according to Swissmedic. The authority said it began investigating all birth control pills after a 16-year-old was disabled by a lung embolism in May after taking Yaz.

To read a copy of the Reuters article, click here.

Recent Articles Shed Light on Dangers of Yasmin and Yaz

2009-09-28T10:30:00.007-04:00

On Saturday, the New York Times reported on the serious and potentially deadly health risks associated with Yasmin and Yaz. As discussed on this blog, our website, and our You Tube Video , there is and has been solid evidence that these oral contraceptives are unsafe options, that the advertisements used by Bayer to promote Yasmin/Yaz intentionally obscured the serious health risks, and that the manufacturing plants producing Yasmin/Yaz are not even properly producing the drugs in accordance with U.S. current good manufacturing practices!

You can read the New York Times story by clicking here.

There was also a posting this weekend on the Human Rights-World Affairs Blog Network that is worth reading. The article by Jessica Corsi discusses how drug companies’ greed for profit and lies about safety despite contrary scientific evidence, result in women being exposed to unnecessary health risks.

The article titled, “Yaz Birth Control Controversy: Pharmaceutical Profits, Unnecessary Risks, and the Gendered Distribution of Family Planning” is available by clicking here.

To learn more about Yasmin and Yaz, please click here.

Litigating Toxic Tort, Pharmaceutical and Medical Cases

2009-09-18T13:59:00.006-04:00

Pamela A. Borgess, one of our partners, will act as moderator for the AAJ annual “Litigating Toxic Tort, Pharmaceutical and Medical Cases” Seminar to be held on September 24-25, 2009 in Las Vegas at the Palazzo Hotel. Ms. Borgess will also present an update on the ongoing litigation involving the tainted Chinese heparin that killed hundreds of Americans in 2007 and 2008 and participate in the meetings on Yaz, Yasmin and Ocella.

This well-regarded seminar is attended by Plaintiff Attorneys from across the country, who come to get inside information on innovative trial techniques, strategies, and practices that leading attorneys have used to take on industry giants. Agenda highlights also include the latest updates on hot topics such as Hydroxycut, Paxil Birth Defects and Avandia; Electronic Discovery, and new topics such as "Facebook and Other Social Networking—What They'll Find Out About Your Client." Attendees will also learn how to access and maximize the necessary resources to go up against negligent companies.

Plaintiff Attorneys who are interested in this seminar can get more information and register at www.justice.org/education/pharmaseminaror by calling AAJ Education at 800-622-1791 or 202-965-3500, ext. 612.

**Open Only to Plaintiff Attorneys**

Judge Moss consolidates Yaz / Yasmin cases

2009-09-17T16:42:00.003-04:00

Yesterday I had the honor of meeting again with Judge Sandra Moss in the historic Philadelphia County Courthouse, Philadelphia, Pennsylvania, to participate in the second status conference on Yaz / Yasmin.

At the conference Judge Moss announced that she was accepting the Yaz / Yasmin cases as Mass Tort cases and consolidating them for purposes of pretrial management. The appropriate orders were issued. Bayer's attorneys announced that there were 77 cases filed to date, 14 of which are pending before Judge Moss.

We have filed one (1) case before Judge Moss and the balance of our cases in federal court, including fifteen (15) before Chief Judge James Carr in Toledo. Next week we will present argument in Richmond, Virginia on our petition to have all of the federal cases consolidated before Chief Judge Carr. There is unanimity among the parties that the cases should be consolidated. The only question is which venue is the most appropriate.

After the hearing we (myself and the other litigation leaders) met with defense counsel in an effort to work out continuing coordination of the litigation. The Parties are hopeful that the JPML Court will approve a venue that will permit close coordination between the State and Federal Courts.

In the meantime we continue to be impressed by the number of women who have suffered injury or death while on Yaz / Yasmin or Ocella. (Ocella is the generic equivalent and is actually made by Bayer). While we represent well over 100 women, we are currently only filing suit on those claims where it is necessary to do so to protect the statute of limitations. The other cases will be timely filed as soon as the location of the MDL is determined, so that we can then choose the best venue for our clients.

We will keep you posted. If you have not yet retained legal counsel and suffered serious injury from Yaz I encourage you to immediately contact a qualified attorney to review your case.

Yaz, Yasmin Manufacturer Warned Yet Again by FDA

2009-09-15T16:46:00.005-04:00

After repeated warnings by the FDA to Bayer and its predecessor Berlex for marketing its birth control drugs, Yaz and Yasmin in a way that overstates the drugs’ benefits and minimizes the very serious and potentially deadly side effects, the drug manufacturer is being warned yet again. This time, however, the problems concern the testing and quality of the pharmaceutical ingredients used its drugs, including Yaz and Yasmin.

In a letter released on Tuesday, the FDA warned Bayer about the testing and quality of pharmaceutical ingredients made at its Germany facility that are used in U.S. drugs, including the key ingredient in Yasmin and Yaz, called drospirenone. (See 9/15/09 “FDA Warns Yaz, Yasmin Manufacturer over Testing Problems” by Matthew Perrone, AP Business Writer.)

The letter followed a March 2009 inspection of the company’s plant in Berghamen, Germany, that “revealed significant deviations from U.S. current good manufacturing practices (CGMP) in the manufacture of non-sterile APls [Active pharmaceutical ingredients].”

The FDA gave Bayer 30 days to respond to the warning and advised that “failure to correct these deficiencies may result in FDA denying entry of articles manufactured by your firm into the United States.”

To view a copy of this warning letter, click here.

Yaz, Yasmin: Deep Vein Thrombosis, Pulmonary Embolism and Stroke: What's the Difference

2009-08-28T17:02:00.002-04:00

As previously discussed on our Yasmin/YAZ blog, website, and YouTube video, the life threatening injuries associated with the use of Yasmin, Yaz, and Ocella include, but are not limited to, heart attacks, cardiac arrhythmias, blood clots, deep vein thrombosis (DVT), pulmonary embolism (PE), strokes, gallbladder disease, hepatic adenomas or benign liver tumors, and other serious injuries and sudden death.

We are often asked to explain the difference between DVT, PE, and stroke. Therefore, we created the following presentation to discuss these specific injuries.
Dvt, Pe, Stroke

Yasmin MDL hearing Set for September 24, 2009

2009-08-19T18:42:00.005-04:00

The hearing on our Petition to consolidate the Yaz, Yasmin and Ocella product liability litigation in the Northern District of Ohio has been set for September 24, 2009 in Richmond, Virginia.

The hearing will be held before the Judicial Panel on Multi -District Litigation. If the case is consolidated as an "MDL" case it will be sent to a single judge for case management purposes. For a detailed explanation of the workings and purpose of an MDL you may go to our web site, http://www.toledolaw.com/pdf/yazminlink.pdf.

A decision by the Panel is normally issued within two to four weeks of the hearing. Meanwhile cases continue to get filed in both federal and state courts around the country. If you or a loved one has suffered serious injury such as stroke, pulmonary embolism, DVT or organ failure involving gall bladder or pancreas you should immediately seek legal advice.

As we have noted before, Yaz and Yasmin are different from other available birth control pills, as they contain drospirenone, which is a new type of progestin. Drospirenone is used in combination with ethinyl estradiol in the pills to prevent unwanted pregnancy, but it can also increase potassium levels and lead to hyperkalemia, which could increase the risk of various heart and other health problems. This is because Drospirenone has a diuretic action similar to Spironolactone, a potassium sparing diuretic.

Feel free to call this office toll free at 888 841-9623 or email my partner Pamela Borgess at Pamela@toledolaw.com. A video of Pamela and Dr. Borillo discussing the Dangers of Yaz is also available at http://www.youtube.com/watch?v=4Rg5fwjeNZ4.

A video of one of our clients can be seen at http://www.youtube.com/watch?v=9t_IhQxXMDQ.

Yaz & Yasmin Stroke, gall bladder and heart arrhythmias not covered by new studies

2009-08-16T10:12:00.013-04:00

New studies out on August 13th showed that Yaz and Yasmin (and generic forms such as Ocella) caused a six fold increase in the risk of blood clots, which cause such injuries as Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

Here are the links to the two new studies:

Danish Study:
The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study

Dutch Study:
The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study

But the studies did not evaluate the risks of gall bladder or other organ failure, stroke or heart arrhythmias. Our investigations have shown that there are also increased risks to women of developing gall bladder disease or similar organ failure, stroke and heart arrhythmias as well as DVT and PE.

We believe these increased risks stem from the fact that one of the hormones, drosperinone, is also a diuretic. Bayer fails to disclose this critical fact in its warnings. As a result women taking Yaz or Yasmin don't realize the importance of hydration. Nor do the warnings make clear that taking many common over the counter medicines such as NSAIDs (non steroidal inflammatory drugs) which include aspirin, ibuprofen, and naproxen, can in fact increase the diuretic effect of Yaz.

The scientific basis for these concerns is the fact that the diuretic works by increasing the level of potassium. Potassium regulates a number of critical functions, including heart beats.

Heart rhythm problems (heart arrhythmias) occur when the electrical impulses in your heart that coordinate your heartbeats don't function properly, causing your heart to beat too fast, too slow or irregularly

In addition to clients who have suffered injury from heart arrhytmias, many of our clients have developed significant injury from gall bladder disease, or worse, died of stroke.

So it is important to recognize that the recent studies only looked at thrombotic (blood clot) injuries. When the increased risks of gall bladder, stroke and heart arrhythmias are added to the blood clot risks, the full extent of risk becomes clearer.

We have been amazed at the number of women who have contacted us with gall bladder or pancreas injury that have required removal of the organ. We firmly beleive that Bayer is responsible for these injuries because of its failure to warn of the risks.

If you have not yet secured an attorney and you have suffered one of the serious injuries discussed in this post, you should immediately do so. More information is available on this blog and our web site or by calling toll free 888-841-9623.

Yaz Litigation update: Philadelphia State Court

2009-08-13T20:31:00.005-04:00

I attended a status conference today before Judge Moss in Philadelphia State Court in response to a request to consolidate the Philadelphia County cases under the Mass Tort program. In the meantime, Bayer has started to remove the Pennsylvania state court cases to federal court. Bayer claims that there are no proper Bayer "Yaz-related" defendants in Pennsylvania.

Bayer's claims are rather remarkable given its history and the facts. Bayer Corporation, which is wholly owned by Bayer A.G. in Germany, has its headquarters in Pittsburgh, PA. Recently Bayer Corp. was the sole signator in settlements reached by Bayer and several dozen state attorney generals. The attorney generals claimed that Bayer had engaged in improper advertising of Yaz and Yasmin. It is remarkable that Bayer Corp. would execute such agreements yet have no role in the claims now pending for injury and death stemming from Yaz. These injury and death claims include the same allegations of misrepresentation challenged by the state attorney generals.

In addition Bayer has sponsored clinical trials at University of Pennsylvania in Philadelphia, including one trial that is currently ongoing. Once a case is removed, it is up to the non-removing party, in this case the Plaintiff, to ask that the case be remanded to state court. Sometimes rulings on these motions to remand are made promptly by the initial court, and sometimes the rulings are deferred until the case is transferred under the MDL rules.

While no decision on consolidation of the state court cases has been made by Judge Moss at this time, it seems likely that she will consolidate the cases should there be cases before her. Of course it will be up to the federal judges before whom the cases are removed to decide if the claims do properly include a Pennsylvania defendant. Such a consolidation is similar to, but somewhat different from, a class action, discussed in an earlier blog.

In the meantime in federal court the Judicial Panel on Multidistrict Litigation will hold a hearing in October to determine if and where the cases should be consolidated at the federal level. As reported earlier we have filed papers asking that the cases be consolidated before Chief Judge James Carr in Toledo, Ohio. Other venues include Pennsylvania federal court and New York federal court. No doubt there will be some other venues suggested as well.

Judge Moss will have a follow up status conference next month. While this may seem confusing it is typical of the earlier stages of this type of litigation. The picture will begin to clear by the end of the year. My partner Michelle had met Judge Moss in San Francisco last month at a conference on Paxil and was very impressed. I am impressed too. I am certain she will work very closely with whatever Federal Judge ends up with the MDL, should the remand motions be successful in transferring the removed cases to Pennsylvania state court. She has a wealth of experience and the necessary energy to insure a fair resolution of these significant cases.

Whereever the state court cases end up, if the MDL comes to Toledo we are confident that Judge Carr will be proactive in insuring close coordination and cooperation between and among the various courts and counsel.

New Studies Challenge Bayer’s Yaz Claims: Update with links

2009-08-13T12:10:00.004-04:00

Updated August 16, 2009 with hotlinks to British Medical Journal Online:
Here are the links to the two new studies:

Danish Study:
The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study

Dutch Study:
The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study

From Zoll, Kranz & Borgess, LLC

New Studies Challenge Bayer’s Yaz Claims

Two new studies out today in the British Medical Journal Online contains some very significant findings. First, the studies found that women taking Combination Oral Contraceptives containing drosperinone, such as Yaz and Yasmin, have a six to seven time increase in the risk of thromboembolism (such as Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)). The risk is equal to other third generation birth control pills.

Second, the studies found that Yaz / Yasmin did not provide any increased benefit for acne or weight loss. Nor was there any demonstration or proof of improved effectiveness of treatment for PMDD or similar premenstrual symptoms.

The study also showed that the greatest risk for development of a thrombotic event is in the first three months of taking the pill. This is consistent with what we have seen in our clients.

Furthermore, the claims that Yaz /Yasmin reduce acne and body weight also are challenged by these studies.

One of the studies was supervised by the leading authority in the world on the subject, Dr. F. R. Rosendaal, Leiden University, Leiden, Netherlands, and involved 1524 women. The other study involved all of the women in Denmark, 10.4 million women years. Given the large number of women in the study and the credentials of the investigators, it is clear that Bayer will have to immediately reexamine its warnings on Yaz and do much much more to educate women about the risks of its products.

We will continue to vigorously pursue claims for women from around the country who have been injured by Yaz, Yasmin, or the generic Ocella. We believe Bayer is responsible for these injuries and in some cases deaths for failing to warn of these risks and exaggerating the benefits of the medications.

We have filed papers to have all of the cases consolidated in Ohio. A ruling on that motion is expected in October. Similarly we have appeared in Philadelphia and will be reporting on the outcome of a hearing set for today, August 13, 2009, separately.

The studies are:

The venous thombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study, van Hylckama Vlieg, Helmerhorst, Vandenbroucke, Doggen & Rosendaal, BMJ 2009;339:b2921;

Hormonal contraception and risk of venous thromboembolism: national follow-up study, Lidegaard, Lokkegaard, Svendsen, & Agger (all of Copenhagen, Denmark), BMJ 2009;339:b2890.

Questions may be addressed to:

Pamela Borgess, Partner, Zoll, Kranz & Borgess – Toll Free: 888 841-9623; pamela@toledolaw.com

Or

David W. Zoll, Managing Partner, Zoll Kranz & Borgess, Toll Free: 888 841-9623, david@toledolaw.com

Further information available on line at www.toledo.law.com

YouTube Video on the Dangers of Yaz

2009-08-09T18:41:00.007-04:00

Two attorneys from Zoll, Kranz & Borgess, LLC, who are working on the Yaz, Yasmin and Ocella cases have cut a video which has now been posted on YouTube entitled "Dangers of Yaz."

We hope this video will help women who have been injured understand a little more about the mechanism of injury. In the video, Attorneys Pamela Borgess and Donato Borillo, MD, discuss the Yaz hormone drosperinone and the potential for electrolyte imbalances, particularly from high potassium levels.

Although the manufacturer doesn't warn or explain, Yaz is a diuretic. So while it may make women feel good because of lower levels of water, it also increases risks associated with diuretics. Yaz behaves similarly to Spironalactone, which is a diuretic, and we believe carries the same or similar risks. It is the failure to disclose these risks that lies at the heart of our claims for women who have lost their lives due to stroke or suffered Pulmonary Embolism, Deep Vein Thrombosis, gall bladder disease, organ failure, or other serious side effect.

This week I will be in Philadelphia meeting with Judge Moss as she considers a petition to accept the Yaz cases as a Mass Tort case. I will blog on this development later in the week.

While we have filed papers to have the federal cases consolidated as Multi District Litigation, we also have cases filed in Philadelphia which we will ask Judge Moss to handle as a mass tort.

It is critical that both the state and federal court lawyers work together in order to develop a first class case against Bayer. To that end we will continue to share information with the legal community and seek to build bridges with other firms who are now starting to get involved in this litigation. We will also continue our dialogue with the lawyers representing Bayer.

If you have suffered a side effect from Yaz and have not yet secured an attorney I urge you to do so. More information on this is available at our web site, www.toledolaw.com.

Bayer continues to rake in the Profits from Yaz and Yasmin

2009-07-30T14:27:00.007-04:00

Even though we get many calls and emails every day from women around the country (or their surviving families) who have suffered strokes, DVT, Pulmonary Embolism (PE), or had their gall bladders removed, Bayer continues to aggressively market and profit from Yaz and Yasmin.

Yesterday (August 29th) Bayer announced its second-quarter sales of prescription products gained 9.1% to $3.7 billion from last year. The company reported that combined sales from the YAZ, Yasmin, and Yasminelle family of contraceptive products for the past three months were up 6.6 % to $456 million! This means that Bayer brings in over Five Million Dollars per day from these birth control pills!

As a whole Bayer HealthCare's division quarterly sales increased 8.3 % to $5.6 billion from the same time last year.

Bayer made a cool profit of $747 million in just the past 3 months! These profits come at the expense of serious injury and death. We need all women who have suffered at the hands of Bayer to come forward now and be heard so we can get this product off the market.

If you have a serious injury while taking Yaz you should immediately seek experienced legal counsel. Sooner or later justice will prevail. If you have any questions that are not answered by our web site, www.toledolaw.com, please feel free to email me at david@toledolaw.com or call toll free 888-841-9623.

Yasmin / Yaz Litigation Update - MDL Petition Filed

2009-07-24T20:34:00.005-04:00

Today our firm, along with two other national drug litigation firms, filed a motion to consolidate the Yasmin/YAZ Litigation in the United States District Court for the Northern District of Ohio.

We chose this path because we believe it is in the best interests of the thousands of women across this nation who have been injured by Yasmin / Yaz.

We look forward to working with our partner firms and other Plaintiff attorneys from around the country to obtain justice for our clients. We will be organizing the team of attorneys this weekend in San Francisco at the American Association for Justice meeting.

If you or a loved one has suffered an injury or death from Yaz, Yasmin or Ocella you should promptly seek legal advice from an experienced attorney. We continue to accept referrals from attorneys around the nation.

Below are highlights from the Press Release that we issued at noon today:

Three leading law firms representing 23 of the 32 filed cases around the country have filed a joint motion asking that the Yasmin/YAZ product liability litigation be consolidated and transferred to Chief Judge James G. Carr of the United States District Court for the Northern District of Ohio. The motion was filed today, July 24, 2009, before the Judicial Panel on Multidistrict Litigation in Washington, D.C.

The three law firms represent Plaintiffs from across the country who have suffered injuries, including deep vein thrombosis (DVT), pulmonary embolism (PE), heart attack, stroke, kidney failure, seizures, gall bladder injuries, and death after using the birth control pills Yasmin/YAZ and Ocella. The three firms and their lead lawyers handling this litigation are Dianne Nast and Daniel Gallucci of RodaNast, Lancaster, Pennsylvania; Janet Abaray and Michael Burg of Burg Simpson Eldredge Hersh & Jardine, Cincinnati, Ohio and Englewood, Colorado; and David Zoll, Michelle Kranz and Pamela Borgess, Zoll Kranz & Borgess, Toledo, Ohio.

The Defendants in the cases are Bayer Pharmaceuticals Corporation and other Bayer related companies. The FDA issued warning letters to Berlex Laboratories, the predecessor manufacturer to Bayer, in 2003, ordering the Defendants to immediately discontinue a television advertisement that promoted Yasmin’s fourth generation progestin, drosperinone, by stating, “Ask about Yasmin, and the difference a little chemistry can make.” The FDA objected and stated “FDA is not aware of substantial evidence or clinical experience demonstrating that Yasmin is superior to other COC’s [combination oral contraceptives] or that the drosperinone in Yasmin is clinically beneficial. On the contrary, FDA is aware of the added clinical risks associated with drosperinone.”

The FDA issued a second warning letter to Bayer on October 3, 2008, for another advertisement, this time concerning Yaz. The FDA determined that the advertisement was misleading because it failed to disclose that “YAZ has additional risks because it contains the progestin, drospirenone …”

We will post a copy of the MDL petition on our web site next week. In the meantime if you have any questions that are not answered by our web site, www.toledolaw.com, please feel free to email me at david@toledolaw.com or call toll free 888-841-9623.

Yasmin / YAZ Class Actions, Individual Suits and/or an MDL: What does it all mean?

2009-07-23T11:24:00.006-04:00

When most people hear about ongoing drug litigation, such as the litigation we are currently leading involving the birth control drugs, Yasmin, YAZ and their generic, Ocella, they often assume it is a “class action.” However, drug litigation for those injured or killed by a defective drug generally does not involve class actions, but rather individual lawsuits filed on behalf of those victims by leading drug litigation firms such as ours, which may result in multidistrict litigation (referred to as an “MDL”). This blog explains the difference between the various forms of lawsuits and methods of consolidation, as well as their application to the Yasmin / YAZ litigation.

If you or a loved one have suffered a serious injury or death, then you have an individual injury case. You should NOT rely on a class action filed by someone else to provide you with a remedy for your loss.

-What is the difference between individual suits and class actions?

In a class action, one or more individuals, called “Class Representatives,” sue on behalf of everyone else with similar claims. The rest of the “Class” or “Class Members,” are not individually named in the suit. In order for a court to certify a class action, the proposed class of individuals or business entities must have suffered common damages and/or the particular product defect applies to all proposed class members in a uniform manner. Because drug litigation for those injured or killed by a defective drug often involves a variety of injuries and resulting damages, class actions are generally not appropriate for those who have suffered serious injuries or death. Instead, many class actions tend to be consumer class actions. For example, one person might sue on behalf of thousands of other people who were overcharged for a product as a result of an illegal price-fixing conspiracy. Additionally, employment class actions are common, which may be brought, for example, by a member of a company for illegal hiring or salary practices.

In a class action, if the named plaintiff (the “Class Representative”) wins at trial or resolves his/her claims, then all of the claims of the un-named Class members are likewise resolved, with the exception of those that exclude themselves from the Class. Consumer class actions often result in "coupon settlements," which usually allow the plaintiffs to receive limited benefits, such as a small check or a coupon for future services or products with the defendant company.

The claims brought by our firm for injury and death resulting from Yasmin, YAZ and Ocella, are not class actions, but rather individual lawsuits. A few lawyers have filed consumer class actions for Yasmin and YAZ, but these have to do with monetary reimbursement for violations of consumer protection and advertising laws and do not seek compensation for the injuries and deaths that have been caused from the drug. In contrast, our individual Yasmin and YAZ claims for severe injury and death are being pursued and will eventually be tried individually, (unlike a class action where there is only one trial). That is, each Yasmin and YAZ plaintiff will have her claim evaluated and settled or tried based on the merits of the injury and the facts of the case. If the case is not settled she will have her day in court and is able to request the jury to award full and fair compensation for her loss.

-What is an MDL?

MDL is an abbreviation for Multidistrict Litigation. If enough individual lawsuits for a defective drug are filed in federal court against the same manufacturer for the same drug, a federal court, manufacturer, and/or plaintiff’s lawyer might ask the Judicial Panel on Multidistrict Litigation to “consolidate” all of the cases in an “MDL” before a single judge.

An MDL is not a class action. Instead, it is a way that the courts can collectively handle multiple lawsuits involving the same drug. There are some similarities however.

Suing a billion dollar drug company with almost unlimited resources who will fight at every turn is expensive. A single victim or her attorney would unlikely be able to finance such litigation alone. The combination of claims in a single forum increases the plaintiffs’ leverage by permitting counsel to pool their resources and to work for the plaintiffs’ common benefit.

An MDL also promotes efficiency and consistency of rulings. Instead of one hundred or even one thousand cases pending in different courts across the county, the litigation is coordinated and important decisions are made by a single court, saving substantial time and expenses and insuring consistent rulings.

-How is an MDL formed?

Although the Clerk of the Judicial Panel on Multidistrict Litigation is permanently stationed in Washington, D.C., the Judicial Panel on Multidistrict Litigation meets in different cities in the United States on a periodic basis to review requests that cases be consolidated. After an MDL request is made, a hearing will be held to determine whether to create the MDL proceeding.

If the panel agrees after the hearing to create an MDL, it will also decide where the MDL will be located. The judge who gets all the federal cases assigned to him is known as the "transferee judge." The judges throughout the United States who send cases to the MDL judge are known as the "transferor judges" or "transferor courts." The panel’s selection of the transferee court that is in charge of the MDL may affect the outcome of the litigation. There are friendly jurisdictions and not-so-friendly ones. Parties try to influence the panel by proposing, when they can, a single, consensus choice for the transferee court, or at least one offered by all plaintiffs and one by all defendants.

Generally, the transferee court (also called the “MDL court”) will then set standing orders or pretrial orders informing the lawyers involved of the ground rules, deadlines and procedures that the Court expects the litigants to follow. Although there may be hundreds or even thousands of cases in an MDL, if the Court makes a ruling, it generally applies to all of the cases. Indeed, this is one of the purposes of the MDL, as it is much more efficient to have one ruling on a general issue than possibly hundreds of conflicting rulings by many judges on the exact same issue.

Typically hierarchies of plaintiff “executive” and/or “steering” committees made of leading and experienced drug litigation lawyers, such as our firm, are then appointed. These committees are often referred to simply as the “PEC” and/or the “PSC.” These PEC and/or PSC are responsible for representing all the claimants in the MDL and managing the substance of the litigation. Under the supervision and direction of the PEC and/or PSC, volunteer lawyers will assist in reviewing documents, taking depositions, writing briefs, and developing and prosecuting the common aspects of the litigation. Ultimately, they will prepare and provide to all MDL plaintiffs a trial package consisting of documents that the plaintiff’s attorney will need to try his or her case.

In an MDL, all of the information-gathering and investigation is done at the same time on behalf of all of the plaintiffs. This is referred to as the “discovery” process and is designed to obtain the basic facts of the case. The MDL Judge also rules on discovery disputes and decides critical issues, including whether there is sufficient evidence for the claims to proceed to a jury trial.

During and/or at the conclusion of this process, the MDL Judge often works with both sides in an attempt to reach a global settlement (which if successful, may be a matrix based on various factors involved in each specific case and decided by neutral masters or arbiters who have experience in this area). To assist in trying to reach a settlement, the MDL Judge may even have a few jury trials on cases that were actually filed in his or her own court. Some MDL cases are settled individually, others as a group. Each claimant is typically free to accept or reject the award, but if they accept it, then they give up their claim and release the manufacturer of any further liability.

It is important to understand, however, that a settlement does not always occur in an MDL. If settlement cannot be reached, each of the cases is sent back for trial, to the court where it was originally filed. The only cases that would not be remanded are those cases originally filed in the court with the MDL Judge is seated. Unlike a class action where there is only one trial, MDL cases are tried individually. That is, each plaintiff gets his or her day in court.

-What experience does Zoll, Kranz & Borgess, LLC have with MDLs?

Our firm has been recognized on a national level for its work in MDLs. As a recent example, on February 14, 2008, Zoll, Kranz & Borgess, LLC was the first law firm in the nation to file suit against Baxter Healthcare Corporation and other related companies regarding contaminated batches of its drug, Heparin, and is now leading Heparin MDL 1953 in its position as Liaison Counsel and Chair of the Plaintiffs’ Executive Committee. In April of 2008, the firm was honored to have three of its clients speak before Congress at an investigational hearing on tainted Heparin entitled, “The Heparin Disaster: Chinese Counterfeits and American Failures.” Their stories have also been featured in news media, including on ABC Nightly News, Nightline, CNN, Bloomberg News and in Time Magazine.

Other MDL involvement includes, but is not limited to, the Plaintiffs’ Steering Committee for In Re: Yamaha Motor Corp. Rhino ATV, MDL No. 2016, acting as special counsel on behalf of Plaintiffs in In re: Inter-Op Hip Prosthesis Liability Litigation (Sulzer) MDL Docket No. 01-CV-9000, on the Discovery Committee in In re: Vioxx® Products Liability Litigation MDL Docket No. 1657, and involvement in Ford Crown Victoria, Bextra/Celebrex, and other mass tort litigation projects.

-What is the status of the Yasmin / YAZ litigation?

Zoll, Kranz & Borgess, LLC is one of the first of the few law firms to have filed Yasmin and YAZ cases, and has filed the most cases in the country to date. Many of the filed cases have been assigned to Chief Judge James G. Carr of the United States District Court in the Northern District of Ohio.

We have had our first case management conference with Chief Judge Carr, who has taken an active interest in the YASMIN/YAZ litigation. We are currently working on preliminary orders that will help set the stage for the litigation and expect to start receiving information/documents from Bayer as early as August of 2009. We are also continuing to investigate the drugs and strongly believe that the statistics and other data prove a much higher incidence of stroke, PE, DVT, gallbladder complications and other “adverse events” for YASMIN and YAZ over most other birth control pills, despite Bayer’s contrary advertising.

Although an MDL has not yet been requested, it is expected that an MDL will be requested shortly and our firm will be seeking a leadership role in any national litigation. We will continue to update you on the litigation.

If you or someone you love have suffered a serious injury that may be attributable to YAZ, Yasmin or Ocella (the generic version), you should immediately seek the advice of an experienced attorney.

Yaz Victims Express Frustration, Outrage and Fear

2009-07-16T17:57:00.005-04:00

As lead Yaz lawyers in the ongoing Yaz, Yasmin and Ocella litigation we hear, every day, the compelling stories of women from across the United States who have suffered serious side effects from these birth control pills. Tragically, these stories sometimes come from the families of those who have lost their mothers and daughters.

While each story is different, there are common themes expressed by the women that run through each of the cases, whether they come from a forty year-old woman in Wyoming or from a concerned mother of a teenager in Florida. First there is frustration. Frustration that neither they, nor their doctors, were told of the very serious side effects that are substantially increased with this unprecedented type of birth control. Side effects that are serious and can often be fatal, including heart attacks, cardiac arrhythmias, blood clots, deep vein thrombosis (DVT), pulmonary embolism (PE), and strokes. Frustration that they were robbed of their right to make an informed decision about the drug to be put in their bodies.

There is also outrage. Outrage that the drug giant Bayer, who, despite being reprimanded three times by the FDA for promoting the drug in a way that minimizes these very serious side effects and overstates the benefits, continues to have an unrepentant attitude of indifference. Outrage that the suffering and the deaths of hundreds of American women is being chalked up as just another “cost of doing business.” Outrage over the fact that Bayer continues to rake in the profits while many women suffer.

Finally, and most prevalent, is the fear. Fear as to what the future holds. Will they recover from this incident? Will they have another event in the future? If so, will they be able to survive it?

We unfortunately cannot change what happened to our clients. However, as evidenced by our brave clients like Angela Beck, who shared her experience on You-Tube, we continue to believe in hope, truth and justice. We believe that the corporate misconduct of Bayer will be exposed, that our civil system of justice will demand accountability, and that the lives of other innocent women will be saved as a result.

If you would like to discuss your experience as well, please contact us toll-free at (888) 841-9623.

YASMIN / YAZ / Ocella Litigation Update No. 1

2009-07-10T17:16:00.004-04:00

As many of you may already know, Zoll, Kranz & Borgess, LLC is one of the first drug litigation firms to have filed suit regarding the birth control drugs, YASMIN and YAZ (and its generic, Ocella) and is currently leading the nation in pursuit of these cases.

Many of the filed cases have been assigned to Chief Judge James G. Carr of the United States District Court in the Northern District of Ohio. Chief Judge Carr is the well-respected Judge in charge of Heparin MDL 1953, which is the multidistrict litigation concerning the dirty Chinese Heparin sold by Baxter last year that claimed hundreds of innocent American lives. (Zoll, Kranz & Borgess, LLC is also leading that litigation as well. See ZKB Website: http://www.toledolaw.com/heparin.php.)

We have had our first case management conference with Chief Judge Carr, who has taken an active interest in the YASMIN/YAZ litigation. We are currently working on preliminary orders that will help set the stage for the litigation and expect to start receiving information/documents from Bayer as early as August of 2009. We are also continuing to investigate the drugs and strongly believe that the statistics and other data prove a much higher incidence of stroke, PE, DVT and other “adverse events” for YASMIN and YAZ over most other birth control pills, despite Bayer’s contrary advertising.

We will continue to keep you updated on the status of the litigation. If you would like to discuss a potential claim or referral please contact us at our toll-free number (888) 841-9623 or via email to pamela@toledolaw.com. (If you choose to correspond via email, please keep in mind that sometimes spam filters or computer problems block correspondence. Therefore, if you do not receive a response to your email by the next business day, please call us.) Please also visit our Yasmin/YAZ website at: http://www.toledolaw.com/yasmin.php.

ZKB Yasmin/YAZ Client Featured on You Tube

2009-06-04T16:24:00.002-04:00

Angela Beck, a client of Zoll, Kranz & Borgess, LLC, who suffered several severe pulmonary embolisms (i.e. blood clots in the lungs) after taking the birth control YAZ, has bravely told her story on You Tube. You can watch this video by clicking here.

She has also been featured in the news media. To view the story, click here.

We thank Angela, as well as our other clients, who have graciously told their stories in order to alert the public to the dangers of Yasmin and YAZ.

For more information on Yasmin/YAZ, click here or feel free to call us tollfree at (888) 841-9623.

The Ugly History of Yasmin/YAZ’s Manufacturer: Part II

2009-06-04T16:07:00.002-04:00

Following its atrocities during the Nazi regime, Bayer’s pattern of corrupt practices and its arrogant disregard for human life and public safety has continued. As will be discussed in the next few parts of this blog, Bayer has been involved with numerous worldwide poisoning/contaminations, dangerous and controversial pharmaceutical drugs, development and sale of chemical warfare agents and poisons, false advertising, toxic dumping and worker abuse allegations. Two such incidents discussed in today’s blog involve Bayer’s blood-clotting medicine called “Factor VIII” and a contaminated, genetically altered rice called “Liberty Link” rice.

Factor VIII & The Spread of AIDS

Bayer sold a blood-clotting medicine for hemophiliacs called Factor VIII that was contaminated with HIV. As a result, in the United States, AIDS was passed on to thousands of hemophiliacs, many of whom died, in one of the worst drug-related medical disasters in history. Bayer promised to stop selling the product.

However, the thousands of deaths had little impact on Bayer. As uncovered by the New York Times in 2003, Bayer, through its business unit called “Cutter Biological,” continued to produce and sell the infected product to Asia and Latin America after February 1984 when a safe product was available.

According to corporate records obtained by the New York Times, Bayer claimed it was trying to avoid being stuck with large stores of a product that it could no longer sell. Yet, even after it began selling this stocked product, the company kept making the old medicine for several more months. Indeed, a company fax suggested that the company had several fixed-price contracts and believed that the old product would be cheaper to produce.

Dr. Sidney M. Wolfe, who as director of the Public Citizen Health Research Group had been investigating the industry's practices for three decades, was quoted in the New York Times as stating, "These are the most incriminating internal pharmaceutical industry documents I have ever seen.”

The documents uncovered by the New York Times also showed that federal regulators helped powerful Bayer keep the overseas sales out of the public eye. Dr. Harry M. Meyer Jr., a former Food and Drug Administration regulator of blood products knew that Bayer had broken its promise to withdraw the old contaminated medicine from the market and was selling the drug overseas. Yet, Dr. Meyer asked that the issue be "quietly solved without alerting the Congress, the medical community and the public.”

Not only has Bayer played a direct role in the spread of AIDS, but has also tried to deprive AIDS victims of desperately needed medication. In 1997, Nelson Mandela signed the Medicines Control Act. The Act allowed South Africa to declare medical emergencies and produce its own generic AIDS drugs or import said drugs at the lowest market price. However, in early 1998, Bayer was one of several large pharmaceutical companies that filed suit against the South African government for patent infringement and sought to nullify this and other important provisions of the Act. Suit was dropped in 2001 after international outrage.

For reference see, The New York Times, “2 Paths of Bayer Drug in 80’s: Riskier Type Went Overseas,” (05/22/03);You Tube Video, Bayer Exposed (HIV Contaminated Vaccine), Corporate Watch UK, “Bayer AG: A Corporate Profile,” (01/03/02); David Barnard, “In the High Court of South Africa, Case No. 4138/98: The Global Politics of Access to Low-Cost AIDS Drugs in Poor Countries,” Kennedy Institute of Ethics Journal-Vol. 12, No. 2, June 2002, pp. 159-174.

Liberty Link Rice

Bayer has also been directly involved with one of the worst cases of genetic engineering contamination of food in history.

In 2001, a North Carolina-based biotechnology company called Aventis Crop Science started running a handful of experiments genetically altering rice. Specifically, the company developed a rice called Liberty Link, because its genes had been altered to resist a weed killer called Liberty. This experimental genetically altered rice was not approved for human consumption.

Thereafter, Bayer bought Aventis Crop Science. Bayer claimed to have abandoned the genetically altered rice experiments. However, by January 2006, small amounts of the genetically engineered rice began turning up. Approximately seven months later, in August of 2006, it was determined that Bayer was at fault and that the company had allowed its genetically modified rice, which had not been approved for human consumption, to enter the food chain. Further, it was later discovered that trace amounts of the Liberty Link rice had mysteriously made their way into the commercial rice supply in all five of the Southern states where long-grain rice is grown: Arkansas, Texas, Louisiana, Mississippi and Missouri. As a result of the contamination, at least 63% of U.S. rice exports were affected and the contamination spread to at least 30 countries.

The contamination not only had public safety ramifications, but devastating economic consequences as well. As a result of the contamination, multiple countries closed or restricted their markets of U.S. rice. It has been estimated that the contamination cost U.S. farmers and other innocent producers over a billion U.S. dollars.

In a desperate attempt to lessen the damage after the scandal broke and restore the country’s tarnished international reputation, the USDA claimed that there were no health risks associated with Bayer’s genetically altered rice and even decided to approve the rice strain. However, the claims of the USDA and its hasty approval despite over 15,000 public objections, have been severely criticized nationally and internationally for relying on inadequate and disputed data supplied by Bayer, who was at fault for the contamination.

Bayer, of course, maintained that contamination wasn’t their fault, but instead claimed the contamination was “an act of God.”

For reference see, CNN Money, “Attack of the Mutant Rice,” (07/02/07), Greenpeace, “Greenpeace demands global ban on imports of U.S. rice,” (08/21/06) Health risks: Bayer’s Genetically engineered Liberty Link (LL) Rice 601,” (11/26/06) “Bayer CropScience contaminates our rice,” (10/8/07), “Costs of Bayer GE rice scandal could exceed 1.2 billion USD,” (11/6/07); Greenpeace and Friends of Earth-Europe, “Briefing: the risk of Bayer’s genetically modified LLRICE 62 rice,” 09/12/05; Coalition against Bayer-Dangers, “Europe Urged to Reject Modified Rice,” (03/22/04), “Open Letter to the European Food Safety Authority,” (09/13/06) “Anheuser-Busch using genetically engineered (GE) rice to brew Budweiser,” (10/08/07); Environment News Service, “Unapproved Transgenic Rice Found in U.S. Rice Supply,” (10/21/06)

The Ugly History of Yasmin/YAZ’s Manufacturer: Part I

2009-05-07T10:43:00.005-04:00

Bayer is the manufacturer of Yasmin and YAZ. It is a powerful billion-dollar drug company…the world’s third largest to be exact. Bayer is known by most for its original brand of aspirin.

However, Bayer’s rise to power has been ugly, and reflects a long and continuing legacy of putting corporate profits over human rights. In fact, for over 125 years, Bayer has had “a distinguished history of corporate crimes ranging from the manufacture and sale of controversial drugs (Heroin, Ciproxin and Baycol), the development of chemical warfare agents and poisons (Chlorine Gas, Zyklon B and VX), the use of forced labour during WW II, and numerous cases of poisoning, side-effects and environmental pollution connected to its chemical and pharmaceutical products.” (See March 2002, Corporate Watch.org, “Bayer AG: A Corporate Profile,” (March 2002)).

This is the first of a multi-part series that examines Bayer’s pattern of corrupt practices and indifference to human life from its inception until the present, including Bayer’s most recent deception concerning its blockbuster oral contraceptives, Yasmin and YAZ.

Bayer is a German drug company that was first founded in 1863.

During the WW I the company invented Chemical Warfare, including the chlorine gas used in the trenches, and even built a “School for Chemical Warfare.” (See Corpwatch.org, Mimkes, Philipp, “How and Why a Major Pharmaceutical and Chemical Company ‘Bluewashes’ its Image,” (7/19/2002). See also March 2002, CorporateWatch.org, “Bayer AG: A Corporate Profile,” (March 2002)).

As a result of its role in WW I, Bayer had its assets, including the rights to its name and trademarks, confiscated in the United States, Canada, and several other countries. (See Wikipedia: Bayer (last accessed 5/7/09)).

In 1925, Bayer formed a close association with other German chemical companies, including BASF and Hoechst, which resulted in the formation of the “IG Farben Trust.” (See March 2002, CorporateWatch.org, “Bayer AG: A Corporate Profile,” (March 2002)).

IG Farben continued to grow during the inter-war period as one of the most powerful chemical and pharmaceutical companies in the world. During Nazi-era Germany and WW II, Bayer through IG Farben, formed a part of the financial core of the German Nazi regime. (See Wikipedia: Bayer and IG Farben (last accessed 5/7/09)). IG Farben was the most powerful German corporate cartel in the first half of the 20th century and the single largest profiteer from the Second World War. (See Alliance for Human Research Protection, “Auschwitz: 60 Year Anniversary-- the Role of IG Farben-Bayer.” (01/27/05)). For example, IG Farben owned 42.5% of the company that manufactured Zyklon B, a chemical used in the gas chambers of Auschwitz and other extermination camps. (Wikipedia: Bayer (last accessed 5/7/09)). In fact, at the Nuremberg war crimes trial against 24 IG Farben bosses, the chief US prosecutor Telford Taylor indicated that if it wasn't for the financial interests of IG Farben, Hitler's rise to power and the Second World War would not have been possible. (See Dr. Rath Health Foundation.org, Oct. 31, 2006 Lecture, (last accessed 05/07/09)).

During World War II, the company also extensively used slave labor in factories attached to large slave labor camps, notably the sub-camps of the Mauthausen-Gusen concentration camp. (Wikipedia: Bayer (last accessed 5/7/09)). IG Farben was the only German company in the Third Reich that ran its own concentration camp. (See Alliance for Human Research Protection, “Auschwitz: 60 Year Anniversary-- the Role of IG Farben-Bayer.” (01/27/05)).

Bayer also sponsored the horrendous human experiments conducted on prisoners, including those by Nazi Dr. Josef Mengele. (Id. See also Jeffreys, Diarmuid, “Aspirin: The Story of a Wonder Drug,” Bloomsbury USA (August 11, 2005); Jeffreys, Diarmuid, "Hell’s Cartel: IG Farben and the Making of Hitler’s War Machine,” Metropolitan Books (July 22, 2008); and Wikipedia: Bayer (last accessed 5/7/09)). For example, in the Auschwitz files, correspondence between the camp commander and Bayer Leverkusen was discovered. It dealt with the sale of 150 female prisoners for experimental purposes and states as follows:

"With a view to the planned experiments with a new sleep-inducing drug we would appreciate it if you could place a number of prisoners at our disposal (...)" - "We confirm your response, but consider the price of 200 RM per woman to be too high. We propose to pay no more than 170 RM per woman. If this is acceptable to you, the women will be placed in our possession. We need some 150 women (...)" - "We confirm your approval of the agreement. Please prepare for us 150 women in the best health possible (...)" - "Received the order for 150 women. Despite their macerated condition they were considered satisfactory. We will keep you informed of the developments regarding the experiments (...)" - "The experiments were performed. All test persons died. We will contact you shortly about a new shipment (...)"

(Alliance For Human Research Protection, 01/27/05, “Auschwitz: 60 Year Anniversary-- the Role of IG Farben-Bayer.”)

Although the Bayer chemist who first discovered the aspirin, Arthur Eichengrün, was Jewish, he was not spared. Bayer rewarded the founder of its most popular drug by excluding him from the company’s version of it history, claiming that aspirin was discovered instead by an "Aryan" scientist, Felix Hoffman. Eichengrun also spent 14 months in a concentration camp. (See 09/07/99 Reuters, “Nazis denied Jewish Scientist Credit for Discovery of Aspirin.” See also “Aspirin's Paternity Debated,” Science, 286 (5437): 39 and Wikipedia: Bayer (last accessed 05/07/09)).

After WW II, in light of the atrocious war crimes IG Farben committed, the company was considered to be too corrupt to be allowed to continue to exist and the company was split back into its original constituent companies. (See Wikipedia: IG Farben (last accessed 5/7/09)). Bayer re-established itself as "Farbenfabriken Bayer AG" in 1951. (See March 2002, Corporate Watch.org, “Bayer AG: A Corporate Profile,” (March 2002)).

However, in never straying too far from its corrupt past, in 1956 Bayer reinstated Nazi Fritz ter Meer, as head of the supervisory board, despite the fact that he had sentenced at the Nuremberg trials to seven years in role in carrying out experiments on human subjects at Auschwitz. (See Jeffreys, Diarmuid, “Aspirin: The Story of a Wonder Drug,” Bloomsburg USA (August 11, 2005). See also Wikipedia: Bayer.)) His prison sentence had been commuted, due to the influence of powerful friends. (See Dr. Rath Health Foundation.org, “History of the Pharmaceutical Industry,” (last accessed 05/07/09)).

In 1972, the company changed its name to the current "Bayer AG." (See Corporate Watch.org, “Bayer AG: A Corporate Profile,” (March 2002)). Although Bayer often contends publicly that it is technically a different legal entity than IG Farben or the Bayer that pre-existed IG Farben, “a direct line of continuity can be traced between the personnel, infrastructure and technology of these 3 incarnations.” (Id.)

Although the Nazi regime now seems long ago to many, Bayer has been and continues to be criticized for its refusal to openly distance itself from its past, including from convicted war criminal, Nazi Fritz ter Meer. (See Coalition Against Bayer Dangers, “Bayer Honors War Criminal Fritz ter Meer,” (11/16/06)).

Further, as will be discussed in Part II of this blog, Bayer’s pattern of corrupt practices and indifference to human life have continued.

The Dangers of Yasmin/YAZ

2009-05-04T15:21:00.002-04:00

Yasmin is a different type of birth control originally developed by Berlex Laboratories (a U.S. affiliate of Schering AG, Germany) that was first approved for use in 2001. In 2006, the drug company, Bayer, acquired Berlex and marketed a more recent version of Yasmin, called Yaz. Ocella is a generic version.

Yasmin/YAZ/Ocella contains two types of hormones: an estrogen and a progestin. The estrogen is “ethinyl estradiol.” The progestin is “drsp” or “drospirenone” (pronounced dros-peer-eh-known). Yasmin/YAZ/Ocella is the first type of birth control to contain drsp. Yasmin contains 3 mg drsp and 30 mcg ethinylestradiol per tablet. YAZ contains 3 mg drsp and 20 mcg ethinylestradiol per tablet. The drug prevents ovulation by working against the usual body chemistry of a woman of childbearing potential by suppressing endogenous gonadotropins and, thereby, inhibiting ovulation and altering other changes associated with the menstrual cycle.

The manufacturers of Yasmin/YAZ/Ocella have touted its latest creation as a “pill that goes beyond the rest,” and promises multiple additional benefits above and beyond unwanted pregnancies. They also claim that this latest drug creation is as safe as other types of accepted birth control pills that are on the market. In light of these promises made in slick advertising campaigns, the new product has made Bayer/Berlex millions of dollars. For example, in 2008, sales of YAZ reached $616 million (an approx. 18% U.S. market share), and Yasmin sales reached $382 million (an approx. 11% U.S. market share). (See 2/10/09 NY TIMES article, “A Birth Control Pill that Promised too Much.”) It is now the best-selling oral contraception pill in the United States.

However, in putting the interest of corporate profits over public safety, Bayer/Berlex’ advertisements have focused almost exclusively on the positive affects of its newest drug creation. It has continually omitted or minimized the very significant risks associated with or increased by the novel drug, including heart attacks, cardiac arrhythmias, blood clots, deep vein thrombosis (DVT), pulmonary embolism (PE), strokes, gallbladder disease, hepatic adenomas or benign liver tumors, and other serious injuries and sudden death. These life-threatening risks include, but are not limited to, those risks that Bayer knew or should have known are associated with or increased by the unprecedented use of this new hormone, drsp.

Bayer has also improperly encouraged the use of Yasmin/YAZ/Ocella in circumstances other than those in which the drug has been approved and over-stated its benefits. In fact, the U.S. Food and Drug Administration (FDA) has repeatedly reprimanded Baxter/Berlex for marketing the drug in a way that minimizes these very serious side effects, thereby misleading millions of women and their prescribing physicians about the safety of this new type of birth control.

Indeed, as a result of these very serious side effects, Public Citizen, a non-profit public interest group that advocates for patient health and safety, has placed Yaz/Yasmin on its “Do Not Use” drug list. See Worstpills.org website. Public Citizen has also mentioned its concerns about Yaz/Yasmin to the FDA in letters and petitions.

If you, or someone you love, has suffered a serious injury or worse while on Yasmin, YAZ or Ocella, please feel free to call us at our toll-free number (888) 841-9623 for additional information. There is not a charge for this call.

We continue to review, investigate and pursue these claims. There are many women who have suffered DVT, PE, stroke and gall bladder disease from this drug whom we believe have valid claims.