Bayer sued over birth control Yaz’s risks

After 13 hours of intensifying pain, two trips to the emergency room and two CT scans, doctors finally found what was ailing Lottie Green.

In her left lung, the pulmonologist told her, was the largest blood clot they had ever seen and there were others in her right lung as well, she said.

Soon after the 41-year-old Bethesda, Md., resident was released from a hospital last month, Ms. Green joined hundreds of other women in lawsuits against Germany’s Bayer AG, the maker of the popular oral contraceptive Yaz.

Her attorneys say thousands more lawsuits are forthcoming after the British Medical Journal in August published a study that found higher risks of clots, heart attacks and strokes with Yaz and its predecessor, Yasmin, compared with other contraceptives.

Bayer and the U.S. Food and Drug Administration cite other studies - Bayer funded two of them - that reported no increased cardiovascular risk for the company’s products compared with others. All oral contraceptives’ users are at higher risk of cardiovascular side effects than the general population - as the products’ labels warn.

A spokeswoman said the FDA is funding another study, which won’t be ready for a year.

Bayer has drawn enough scrutiny from the FDA that plaintiffs’ attorneys have been on the case for more than a year, said Tim O’Brien, a partner in the law firm Levin Papantonio in Pensacola, Fla.

“They had poor dosage control at their manufacturing plant and they aggressively marketed Yaz to the teenage and immediate post-teenage crowd” for unapproved uses, said Mr. O’Brien, who has 260 clients for lawsuits against Bayer.

Among them are 21 Washington-area clients such as Ms. Green who are also represented by Andrew Bederman, a partner in the law firm Greenberg & Bederman of Silver Spring, Md.

“Virtually every client is young and healthy,” Mr. Bederman said. “They seem to have no previous relevant medical problems.”

The FDA reprimanded Bayer late last year for overstating the benefits and downplaying the risks of Yaz in television advertisements. The slogan for Yaz was “beyond birth control.”

Bayer marketed Yaz to women in their 20s. Commercials cultivated a hip, youthful image set to rock music, and advertised Yaz as a treatment for acne and premenstrual syndrome (PMS).

But the FDA said “the TV ads are misleading because they broaden the drug’s indication, overstate the efficacy of YAZ, and minimize serious risks associated with the use of the drug,” in the warning letter to Bayer HealthCare Pharmaceuticals, a Montclair, N.J., unit of Bayer.

Yaz has not been approved as a treatment for PMS and the drug should be used to treat acne only by those who want to use an oral contraceptive, the agency said.

Yaz is approved - only among women who want to take oral contraceptives - for premenstrual dysphoric disorder, a severe form of PMS that afflicts up to 10 percent of menstruating women, according to the Mayo Clinic Web site. PMS is much more widespread, affecting nearly eight times more women, according to the clinic.

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