Yaz MDL Judge called upon to consider FDA links to Bayer

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

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

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

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

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

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

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.