News Archive for January, 2012

Background

On December 8, 2011, an FDA advisory committee held hearings on the safety of Yaz and Yasmin. After nearly a full day of testimony, the committee voted 21-5 that the information about the risks of Yaz provided to doctors and patients were inadequate. The panel voted narrowly, however, that the benefits outweigh the risks overall, and therefore voted not to remove Yaz from the market. The second vote was 15-11.

In the weeks following the votes described above, some disturbing details have come to light about the members of the expert panel that is advising the FDA.

• Five members of the committee, including the committee chair, have financial ties to Bayer
• A sixth member was stripped of his voting rights for an “intellectual conflict of interest” because he had the foresight to question the safety of Yaz a few years ago.
• A detailed report on the safety of Yaz, authored by former FDA Commissioner David M. Kessler, M.D., was not considered by the committee. The report was submitted in the Yaz litigation under seal, and although the Judge ordered it released to the public, the order did not come out until after the deadline for submitting materials to the advisory committee. The FDA declined to make an exception in this case.

Further Developments

Simple maths suggests that if the committee members with financial ties to Bayer were not permitted to vote, and if the sixth expert who was disqualified at the last minute was allowed to vote, then the committee might have decided, 12-10 to recommend removing Yaz and Yasmin from the market.

In addition, Lopez McHugh has reviewed the transcript of the vote and found that several of the experts who voted to keep Yaz on the market had significant concerns about the safety of the drug. For example:

• Dr. Clark voted to keep Yaz on the market, but thought there was a “modest increase in absolute risk.” (Transcript, p. 109).
• Dr. Johnson, the chairperson of the committee, explained that she does not think “there is one advantage for this pill over any other,” and if an additional study found an increased risk, would vote to remove Yaz from the market. (Transcript, p. 110).
• Dr. Morrato explained that the absolute risk was low, but if she were making a comparative assessment, she would vote no. (Transcript, p. 110).
• Dr. Hennessy explained that “it was a difficult vote,” and that the drug “out to be rarely used”. (Transcript, p. 112).
• Dr. Burke believed that Yaz had a “moderate increased risk,” but didn’t believe it was necessary to take off the market “at this point.” (Transcript, p. 112).
• Dr. Espey compared the risk of blood clots on Yaz to the risk of blood clots while pregnant, apparently ignoring the fact that there are other methods of birth control with lower risk. (Transcript, p. 109).
• Several other experts appeared to follow the same logic as Dr. Epsey, and compared Yaz to the risk of getting pregnant rather than comparing Yaz to other forms of birth control (Dr. Hoeger, Dr. Tepper, and Dr. Rice, p. 110; Dr. Wild, p. 111; and Dr. Raymond, p. 112).

The experts who voted to remove Yaz from the market expressed additional concerns. For example:

• Dr. Orzsa explained that there was no benefit from Yaz over any other drug, and pointed out that even a “small” increase in risk could cause thousands of unnecessary [life-threatening] blood clots. (Transcript, p. 110).
• Dr. Woods saw no clear benefit and a modest, but “potentially catastrophic risk.” (Transcript, p. 110).
• Dr. Kaboli saw no clear benefit, so no reason to subject women to even a small increase risk.  He stated that he wouldn’t recommend it to his patients and wouldn’t have his daughter take it. (Transcript, p. 111).
• Dr. Winterstein took issue with how the question was worded–weighing overall risk against overall benefit (prevention of pregnancy), rather than comparing to potentially safer drugs on the market. (Transcript, p. 111).
• Dr. Suarez-Almazor explained that she did not believe there was clear evidence of benefits over other oral contraceptives. Further, she was “disturbed” by the fact that every independent study showed an increased risk while only the industry-sponsored studies showed no increased risk. (Transcript, p. 111).

As the above examples demonstrate, even if the FDA decides to keep Yaz on the market, a panel of experts had serious concerns about the risks versus the benefits of Yaz.

New Vote?

The non-profit group Project on Government Oversight has written an open letter to the FDA, calling for it to put aside the committee vote and hold new hearings, this time with experts that do not have ties to Bayer. Whether the FDA addresses the Project’s concerns remains to be seen. Updates will be posted here.

If you suffered blood clots, pulmonary embolism, or stroke while on Yaz, Yasmin, Ocella, or Beyaz, then you should consider calling for a free case evaluation. You can contact Lopez  McHugh using the form on the right, or by clicking here.

Tags: Beyaz, Health, Legal Issues, Product Liability, Yaz
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With the recent Yaz settlement news, people are starting to wonder whether there will be a Yaz settlement in 2012. In early January two judges involved in the litigation put trial deadlines on hold and ordered mediation. The both sides were ordered to attempt to negotiation a Yaz settlement in good faith.

To date, there has been no additional public information released regarding a Yaz settlement in 2012, but no news is probably good news. If settlement talks break down, then the judges can be expected to issue orders scheduling cases for trial.

Lopez McHugh represents a number of women who were injured by Yaz, and is working diligently both to recover compensation for them and to bring details of Yaz and Yasmin to light. For example, we previously reported that although an FDA advisory panel narrowly voted to keep Yaz and Yasmin on the market, several of the expert advisers had financial ties to Bayer, the manufacturer. When counting the votes of the experts who were independent of Bayer, it appears that a majority thought the risks of Yaz outweighed the benefits.

For more information, or to discuss your specific situation, free of charge, click here to contact us, or call 877-703-7070.

Tags: Beyaz, Health, Legal Issues, Product Liability, Yaz
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There is little official news following the December 30, 2011 and January 6, 2012 mediation orders from two judges involved with the Yaz litigation. The parties were ordered to mediate without delay and in good faith. Since that time, Judge Herndon, the federal judge overseeing Yaz cases has issued what’s known as a “minute order. ” This ordered, entered on January 10, 2012, puts most deadlines on hold for 60 days to give the parties an opportunity to focus on settlement without preparing for trial. In the event the mediation breaks down and Plaintiffs are unable to obtain a Yaz settlement, the judge has ordered that the first case will be scheduled for trial on April 30, 2012.

If a Yaz settlement does not occur in the next two months, then hopefully this pause for mediation will not cause too much delay in the existing schedule, and bellwether trials will keep the litigation moving.

Tags: Beyaz, Health, Legal Issues, Product Liability, Yaz
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Based on recent news reports, Lopez McHugh has learned that a majority of independent experts advising the FDA about these safety of Yaz, Yasmin, and Beyaz, believe that a Yaz recall is in order.

The Washington Monthly reported on January 9, 2012, that it has conducted an investigation with the British Medical Journal and found that five experts selected by the FDA to advise it about a Yaz recall had ties to Bayer, the company that manufacturers the drug. Although the advisory panel voted narrowly to avoid a Yaz recall, this new report calls into question their conclusions.

On December 8, 2011, a panel of experts selected by the FDA heard a full day of testimony before voting on a Yaz recall. Fifteen experts decided the benefits of Yaz outweighed the risks. In other words, they believed that a Yaz recall was not warranted. Eleven experts voted for a Yaz recall, voting that the risks outweigh the benefits because several studies show an increased risk of blood clots.

While even this close vote is cause for concern, important information about the voting members was not revealed to the public until the Washington Monthly investigation this week. The report revealed the following:

• The chair of the committee was paid to conduct clinical trials for the manufacturer on the drug she was supposed to be considering.
• Another advisor has served for multiple years as a paid consultant to the manufacturer.
• A third committee member was paid to conduct studies on behalf of another defendant in the Yaz/Yasmin litigation, a company that markets Ocella, the generic version of Yaz.
• A fourth member was also paid to conduct research studies for the manufacturer.
• A fifth member was paid to be an expert for the manufacturer in a different drug case.

The amount of money involved has not been disclosed publicly, and may not be enough to create a clear conflict of interest, but the FDA should have disclosed the connections and should disclose the total amount of money so the public can make an informed decision about whether to trust the vote. Further, the FDA’s actions have been inconsistent with respect to preventing conflicts of interest. Just days before the advisory panel met on December 8, the FDA removed one expert who had been critical of Yaz in the past. Although there was no financial conflict, the FDA cited an “intellectual conflict of interest” because he called for a Yaz recall more than a year ago. If an expert opinion is enough to disqualify someone from the panel, then presumably a financial conflict should also cause disqualification. In that case, the vote would have been 10 against a Yaz recall and 11 in favor. In other words, the panel would have advised the FDA to recall Yaz from the market.

Lopez McHugh is continuing to investigate on behalf  of clients injured by Yaz, Yasmin and Beyaz. If a Yaz recall had occurred, it might have saved thousands of women from life-threatening injuries, and even death.

A copy of the news report can be found here.

Tags: Beyaz, Health, Legal Issues, Product Liability, Yaz
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