Yaz Lawsuits – FDA Recall

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Young Women Suffer As Big Pharma Profits

Yaz Lawsuits Reap Settlements To Rebuild Victims’ Lives

Yaz and Yasmin contain a fairly new form of synthetic progestin called drospironone. They are the most popular drospirone-containing contraceptives on the market and are manufactured by Bayer Healthcare. Other drospironone-containing birth control medications include Ocella, Beyaz, Gianvi, Zarah, Loryna and Seyda. All have received FDA warnings. None have been subject to FDA recall. 

The answer to the question whether these medications are in fact putting women at unnecessary risk of serious injury or death depends largely upon to whom the question is posed.  Of course, Bayer representatives would likely say “no” pointing to the very low incidences of serious injury (less than one percent) and to their own studies that found no real difference in incidences of blood clots between users of their contraceptives and those using older non-drospirenone containing medications. They may also point to the December 2011 FDA study where a joint panel of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 15-11 that the benefits of drospironone-containing drugs like Yaz and Yasmine outweigh the medical risks associated with these drugs. That 15-11 vote essentially secured a place for these drugs on the market despite claims of serious risks including blood clots, pulmonary embolisms, deep vein thrombosis and stroke.

Those claiming injury from Yaz, Yasmine, or other drospirenone-containing medications, such as Cindy Rippe who’s daughter died of pulmonary embolisms two months after switching to Yasmin from another contraceptive, likely have a much different view of these drugs. To begin with, injuries from widely used drugs such as Yaz and Yasmin could number in the tens of thousands. In fact, Bayer currently faces about 11,300 claims in federal court in the United States by women who claim to have suffered serious and fatal injuries caused by these popular birth control drugs.  As of February 12, 2013, Bayer had reached agreements, without admission of liability, to settle the claims of approximately 70 plaintiffs in the United States claiming injury, primarily relating to blood clotting.2  Regarding Yaz lawsuits are the only way to seek justice.

Certainly, to a parent who lost her child to pulmonary embolisms after that child took Yasmin for only two months, the assertion that only a small percentage of users will develop such injury is no consolation.  A recent study in the British Medical Journal found that women who use Yaz or Yasmine are about three times as likely to suffer thromboeembolism as those using other birth control medications that do not contain drospirenone.3 A 835,000-woman study commissioned by the FDA itself found about a two-fold increase.

The same 2011 FDA-funded study that voted 15-11 to keep these drug on the market did result in a safety announcement regarding the 26 member panel’s concern about “the potential increased risk of blood clots with the use of drospirenone-containing birth control pills.”# In fact, that FDA’s advisory panel of experts voted 21-5 that the labeling for Yaz and these other widely used birth control drugs is inadequate and should be updated to warn users that these contraceptives may indeed cause blood clots.

Since alternative non-drospirenone containing contraceptives exist that achieve substantially the same desired result as Yasmin and Yaz, one might ask why these drugs are still on the market.  The short answer to that question may be that they probably would have been removed from the market but for that 15-11 FDA panel vote in December of 2011.  The FDA almost always goes with the decisions of its advisory committees, and this was no exception. Interestingly, however, several members of that advisory committee allegedly had financial ties to Bayer or other distributors of drospirenone.  The acting chairwoman of the Committee, according to an investigation by Washington Monthly and the British Medical Journal, conducted four clinical trials for Bayer or its subsidiary Berlex, a manufacturer of drospirenone.4  Paula Hillard, another committee member is said to have served as a paid consultant to Bayer Schering to the tune of between $5,000 and $10,000 in 2010.  A third advisor, Elizabeth Raymond is said to have conducted studies funded by Barr which has a licensing agreement with Bayer for generic versions of Yaz.  A fourth advisor, Anne Burke, has reportedly received research funding from Bayer-Berlex and Duramed, which also has a licensing agreement with Bayer for Generic versions of Yaz as well as Yasmin.  Finally, a fifth advisor is said to have received consulting fees from a law firm that represented Bayer in 2006.  Each of these committee members were among the 15 who voted that the benefits of the drospirenone-containing contraceptives outweighed the risks. Had they not been permitted to vote due to real or perceived conflicts of interest, it is very possible that the FDA would have been advised to pull these drug from the market.

To make matters even more interesting a sixth panel member, Sidney Wolfe, was not permitted to vote because of a conflict of interest stemming from his failure to disclose his work as author of “Worst Pills/Best Pills” wherein he warned readers to avoid dropirenone-containing products due to increased risk of blood clots.  If forming an independent scientific opinion as to the risks and benefits of a drug prior to committee meeting is grounds for disqualification, haven’t we lost the benefit of the meetings.  Aren’t these exactly the people we want to be voting in the meetings.

The controversy surrounding these committee members may actually pale, however,  in comparison to the controversy that surrounded former FDA Commissioner David Kessler’s 196-page document accusing Bayer of hiding critical data regarding the link between Yaz and Yasmin and the risks of developing blood clots.  Kessler stated, “By failing to disclose all thromboembolic event risk information and marketing Yaz and Yasmin off-label, Bayer needlessly exposed large numbers of women to risks of serious or fatal thromboembolic events.”5   Unfortunately, the FDA advisory committee was not afforded the opportunity to review Kessler’s documents prior to their vote because the date by which to submit papers for the committee’s review had already expired prior to the papers being unsealed by a federal court judge in Illinois.

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