Product News and Recalls

Yaz Recall: Majority of Independent FDA Experts Vote to Withdraw Yaz from Market

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.