Bayer CEO blames Yaz sales decline on generics

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

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

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.

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.