Lawsuits Allege Yaz and Yasmin Side Effects

Pharmaceutical manufacturer Bayer HealthCare faces a series of federal lawsuits alleging that its oral contraceptives Yaz and Yasmin (brand names for the drugs drospirenone and ethinyl estradiol) have serious side effects that Bayer did not adequately disclose to consumers.

The birth control related lawsuits were filed last week in Ohio and Wisconsin, according to a press release by the law firm representing the plaintiffs. The four women who filed suit allege that they suffered side effects including deep vein thrombosis, pulmonary embolism, and stroke while taking Yaz or Yasmin pills. The suits allege that Bayer failed to warn of these potential complications.

Failure-to-warn claims are one of several legal theories under which pharmaceutical-drug-liability suits typically proceed. Pharmaceutical manufacturers are required to disclose known side effects to consumers, either directly or by making relevant information available to physicians, and to take reasonable steps to continue to ascertain and disclose side effects as long as the drug is on the market. Besides having a significant profit motive, a drug's manufacturer is assumed to be the leading expert on the drug's chemistry, with a responsibility to share this expertise in the name of consumer safety.
In that context, Bayer's run-in with the FDA over Yaz advertising, as reported by the New York Times, in late 2008 may be informative. Facing a complaint from the government that its ads for Yaz "misbranded" the drug by broadening its indication, overstating its efficacy, and minimizing its risks, Bayer spent millions of dollars revamping two TV spots to include more details about the risks and limitations of the drug.

It is not immediately clear whether the Yaz plaintiffs are alleging that they suffered harm specifically as a result of these misleading advertisements, or if they are perhaps alleging separate and more recent disclosure lapses by Bayer.

• Pharmaceutical Drug Liability (FindLaw)
• Defective & Dangerous Products (FindLaw)
• Yaz Overview (FDA.gov)
• Yasmin Overview (FDA.gov)
• FDA Warning Letter to Bayer HealthCare (PDF) (FDA.gov)
• Personal Injury from Defective or Dangerous Products (provided by The Law Offices of Frederick J. Brynn, P.C.)
• Types of Products Liability Cases (provided by Winters Enright Salzetta & O'Brien, L.L.C.)