Yaz Lawsuit Turns Up Evidence That Bayer Suggested Promoting It for Off-Label Uses

By November 25, 2011 July 18th, 2019 Dangerous Drugs

As a pharmaceutical liability attorney, I know that drug companies are not legally permitted to promote their drugs for any use the FDA has not approved. And of course, everyone knows or should know that drug makers may not withhold important safety information from consumers. That’s why I was interested to see a recent article in Bloomberg News, breaking the news of evidence that Bayer at least considered promoting the birth control pill Yaz for off-label use, and separately withheld evidence on safety risks. Yaz and its sister drug, Yasmin, are the subjects of numerous lawsuits after scientists turned up an increased risk of developing life-threatening blood clots, compared to older birth control pills. Bloomberg reports that one of those lawsuits turned up documents suggesting Bayer discussed promoting the drug for PMS.
One incriminating email came from a sales consultant for Bayer subsidiary Berlax Laboratories. The consultant cited a Woman’s Day article about Yaz, telling salespeople that it could be “a nice way of using Yaz for PMS treatment,” rather than just the narrower class of women diagnosed with premenstrual dysmorphic disorder. PMDD is a severe form of PMS. The consultant asked sales people to use the article to discuss with doctors the effects of Yaz on ordinary PMS. Yaz injury attorneys contend that this was an effort to promote the drug for off-label use. Another email discussed a contract with a gynecologist who appears on the Today show to talk about women’s health and writes a blog; it said she “definitely will mention the off-label benefits of our products.” The doctor later mentioned using Yasmin for PMS in at least two places.
Other emails cast doubt on a European safety study called the EURAS study. The lead author, Juergen Dinger, was the director of a health research center in Berlin, but had previously been a vice-president at Bayer acquisition Schering. In that role, he had overseen the development of Yaz and Yasmin. This association was not revealed when the study results were published, finding no increased risk of clots compared to other birth control pills. In emails uncovered by litigation, Schering official Maureen Cronin said she’d reached an agreement on EURAS results reporting with Dinger after a meeting. That message seemed to say Schering was structuring the report in ways that downplayed the blood clot risk. Dinger told Bloomberg the emails were out of context and that his relationship with Schering was not good.
Yasmin injury attorneys are seeking to have more emails unsealed as a result of these. As a dangerous drug lawyer, I am eager to see what might be in those new emails. The evidence that Bayer’s subsidiaries hid safety information is particularly important, because drug injury lawsuits frequently rely on claims that drug makers failed to warn patients about risks. And while any failure to warn is a basis for this kind of claim, knowingly covering up or minimizing evidence of safety risks is even more damaging. A jury may or may not agree that a company should have known enough to warn patients — but if the evidence shows that the company did know, it’s not hard to conclude that it should have shared the knowledge. This is especially true when the risk is potentially life-threatening, which certain kinds of blood clots are. As a defective drug attorney, I suspect these documents will provide a boost to the more than 10,000 Yaz and Yasmin lawsuits now pending.


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