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Bayer Sued Over Safety of Popular Birth Control Pills
The National Law Journal
July 14, 2009
First came the warning letter from the U.S. Food and Drug Administration; now it's lawsuits.
Bayer HealthCare Pharmaceuticals has been hit with four individual federal lawsuits -- three in Ohio, one in Wisconsin -- involving the safety of its popular birth control pills Yaz and Yasmin. And plaintiffs lawyers vow that plenty more are in the pipeline.
The back-to-back lawsuits -- which were filed on July 7, 9 and 10 -- come after Bayer reached an agreement with the Food and Drug Administration in 2008 to run a $20 million corrective ad campaign for overstating the benefits of Yaz and downplaying its risks. The FDA had issued Bayer a warning letter about the ads, noting that Yaz actually has additional risks compared to other birth control pills because it contains the progestin drospirenone, which can increase potassium levels.
Plaintiffs lawyers say the FDA letter will serve as handy evidence in their lawsuits, which allege that Bayer failed to warn women and their doctors of the pills' increased risk of injury -- most notably blood clots -- while overpromoting the benefits of the drugs.
"That's going to be important evidence -- overpromotion and downplaying the risks," attorney Janet G. Abaray, who is representing the plaintiffs, said of the FDA warning letter, noting that more lawsuits are coming. "We expect to be filing consistently over the next several weeks and months. We have many cases. It's just a matter of getting all of the medical records."
Abaray, a shareholder in the Cincinnati office of Burg Simpson Eldredge Hersh & Jardine, said that her law firm has amassed evidence that shows that there are many more adverse events reported to the FDA for Yaz and Yasmin than for other birth control pills that have been around longer. Yaz received FDA approval in 2006, Yasmin in 2001.
"It's a very large discrepancy," she said, stating that doctors are unaware of these adverse events figures unless they figure it out for themselves, which, she claimed, they often don't. "The drug companies have known [about the adverse effects] for some time, and they have not warned the doctors or their patients."
Bayer, meanwhile, defended the safety of Yaz and Yasmin. Bayer spokesperson Rose Talarico said, "Bayer is committed to the ethical manufacture, marketing and distribution of our products. Patient safety is our top priority. We continually evaluate the safety of all our marketed products." She continued: "All oral contraceptives contain clear labeling indicating the benefits and risks. Bayer stands behind the safety and efficacy of Yaz and Yasmin when used as directed. A woman and her health care professional should always discuss the benefits and potential risks of adverse health effects associated with all oral contraceptives."
Talarico could not comment on the litigation, citing company policy. But she did say, "We remain confident in our defenses of these claims and will vigorously defend against them."
