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Yaz, Yasmin, Ocella Side Effects Lawsuit News

Bayer Accused in Canadian Lawsuit of Hiding Yaz Risks

 

-Bloomberg

03/11/2010 - Bayer AG, Germany’s largest drugmaker, was accused in a lawsuit of ignoring health risks of the contraceptive Yaz and advertising the drug as safe to boost sales.

The Yasmin family of birth-control pills, known as Yaz and Yasmin, carries a four times increased risk of deep vein thrombosis and pulmonary embolism compared with other contraceptives, according to the suit, filed today in St. Catharines, Ontario, by two women. They seek class-action, or group, status to represent all women who used the drugs.

Yaz and Yasmin were Bayer’s top-selling drugs in 2008, bringing in about $1.8 billion, a 17 percent increase from 2007. More than 2 million prescriptions were written for the drugs in Canada last year, indicating hundreds of thousands of women were using them, said the plaintiffs’ lawyer.

“It’s a failure-to-warn case,” he said. “People need to be aware that if they choose to use the drugs they have a four times greater risk” of health problems.

Bayer stands behind the safety of Yaz and Yasmine, the company said in an e-mailed statement.

“Venous thrombosis is an unfortunate and rare side effect for women who take low-dose oral contraceptives,” the company said. Those risks have been publicized in studies sponsored by Bayer and are reflected in prescribing information of all combination oral contraceptive products, the company said.

U.S. Settlement

The Canadian suit follows about 300 similar lawsuits filed in the U.S. over Yaz. About 200 have been filed in federal litigation consolidated in East St. Louis, Illinois. Another 50 were consolidated in state court in Philadelphia.

In February 2009, Bayer Corp., a Bayer unit, said it would spend $20 million for “corrective advertising” as part of a 27-state settlement of claims it misled consumers about Yaz.

The accord resolved complaints that Bayer promoted the drug as an acne treatment and other conditions for which its use hadn’t been approved by the U.S. Food and Drug Administration.

The Canadian plaintiffs seek damages of C$500,000 ($487,000) for each person who was prescribed Yaz or Yasmin and C$20 million in punitive damages.

The case is Between Ann Schwoob and Bayer Inc., 52030/10, Ontario Superior Court of Justice ( St. Catharines).

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