Entering a crowded market with a slight twist on a well-established product is often a successful strategy. But Bayer is learning what Johnson & Johnson learned: modest changes to hormonal birth control products can produce lawsuits as much as they drive sales.

Bayer is facing a flurry of product liability suits alleging its birth control pills Yaz and Yasmin are defective in design and that the company did not adequately warn of the risks of taking the drugs. To date, at least 19 complaints have been filed against Bayer, 17 in federal courts and two in state courts.

"This is just the beginning of major litigation," said Janet Abaray, of Burg Simpson Eldredge Hersh Jardine, who is representing plaintiffs in several cases. "It is at least on the line of Ortho Evra litigation."

Approximately 900 claimants have filed suit against J&J alleging injuries from its Ortho Evra Patch (norelgestromin/ethinyl estradiol).

Abaray said she would be filing several additional cases against Bayer in the coming weeks. She contends that the adverse events reported with Yaz and Yasmin are far greater than with other hormonal products on the market.

More than 300 Reports of Pulmonary Embolism

Even adjusting for the larger market share of the other drugs, she said there have been 18 times more reports of pulmonary embolism with Yaz and Yasmin compared to Ortho's Tri-cyclen (norgestimate/ethinyl estradiol) and Tri-cyclen Lo . She calculated that there have been 308 reports of pulmonary embolism among women who took Bayer's drugs from the first quarter of 2006 to the third quarter of 2008.

Yaz and Yasmin contain ethinyl estradiol and drospirenone; Yaz contains a lower dosage of the ethinyl estradiol component. In Eakins v. Bayer, the plaintiff describes drospirenone as a fourth generation progestin that was never marketed in the U.S. prior to its use in Yasmin. The plaintiff alleges that she suffered multiple bilateral pulmonary emboli while using Yaz.

The complaint cites an article published in the British Medical Journal in April 2002 which reported that the Dutch College of General Practitioners recommended that older second generation birth control pills be prescribed in lieu of Yasmin since there had been 40 cases of venous thrombosis among women taking the drug.

The complaint also states that from the first quarter of 2004 through the third quarter of 2008, more than 50 reports of death among women taking Yasmin and Yaz had been filed with the FDA.

Bayer Fights On Multiple Fronts

Bayer said in a statement that it stands behind the safety and efficacy of Yaz and Yasmin when used as directed. "Bayer can't comment on individual matters of litigation. However, we remain confident in our defenses of these claims and will vigorously defend against them."

Bayer has already had to deal with the fallout from its Yaz direct-to-consumer advertising campaign, which suggested the drug was appropriate for treating premenstrual syndrome and acne. FDA sent the company a warning letter last year and required the company to run corrective ads.

States attorneys general also went after Bayer for the misleading ad. In a judgment issued in February, 27 state AGs ordered Bayer to give FDA oversight of all Yaz DTC advertising (¹ Also see "Bayer Loses Oversight Of Yaz DTC Ads Under Agreement With States Attorneys General" - Pink Sheet, 10 February, 2009.).

The judgment supplemented an earlier 2007 agreement with state AGs in which Bayer agreed to pay $8 million for allegedly deceptive ads that failed to warn of the risks associated with Baycol (cerivastatin). The cholesterol drug was withdrawn form the market in 2001 due to its association with a sometimes fatal muscle disease.

- Brenda Sandburg (b.sandburg@elsevier.com)

Product Refinements Can Bring Product Liability: Bayer's Yaz And Yasmin Hit With Wave of Personal Injury Suits

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