Lawsuit Claims Yasmin, Ocella Caused Teen to Suffer Fatal Pulmonary Embolism

A new lawsuit claims the birth control pills <"">Yasmin and Ocella caused the death of a 15-year-old North Carolina girl from a pulmonary embolism. According to the complaint, which was filed in Buncombe County Court, Brittany Nicole Prewitt was prescribed the contraceptives to treat acne, despite the fact that she was not sexually active.

The girl’s father, Scott Prewitt, is suing Bayer, Barr Laboratories, Teva Pharmaceuticals and Intendis for wrongful death and product liability. His daughter’s pediatricians, as well Asheville Children’s Medical Center, are also charged with negligence.

According to the lawsuit, Brittany Nicole began taking Yasmin in 2007 at the direction of her dermatologist (not named in the suit) as a treatment for acne, an off-label use of the drug. She was switched to Ocella, a generic version of Yasmin, in 2008. She continued taking Ocella until June 13, 2009, when she died of a pulmonary embolism.

Doctors may prescribe approved drugs for off-label uses, but drug makers are barred from promoting medications based on such uses.

Brittany Nicole’s father claims Bayer “aggressively” marketed Yaz, a variation of Yasmin as a treatment for acne. Yaz was approved for the treatment of moderate acne vulgaris in women who are menstruating and who desire contraception, but Yasmin was never approved for this this use. “The Bayer defendants aggressively marketed Yaz to the dermatology community, and relied in part upon data assessing the effectiveness of Yasmin upon acne, thus persuading the dermatology community that both Yasmin and Yaz were safe and effective in the treatment of acne,” the complaint states. It continues: “Yasmin never received approval for treatment of acne.”

Prewitt also claims, among other things, that he and his wife and their daughter viewed marketing materials for Yaz and Yasmin, including TV commercials and print ads, which understated the drugs’ risks and overstated their benefits.

The lawsuit further claims that Brittany Nicole’s pediatricians knew she was using Yasmin and Ocella, and were aware of the increased risks she faced. However, they misdiagnosed the signs of the embolism that killed her.

Prewitt seeks compensatory and punitive damages for wrongful death, negligence, failure to warn, product liability, breach of warranty and unfair trade practices.

Yaz, Yasmin and Ocella all contain a type of progestin called drospirenone. According to the U.S. Food & Drug Administration (FDA), drospirenone can cause a complication called hyperkalemia in certain high-risk patients, which occurs when there is too much potassium in the blood.

Last month, the FDA announced that Yaz, Yasmin, Ocella and other contraceptives made with drospirenone were being monitored because of fears they might increase a woman’s risk of developing a blood clot more than birth control pills made with a different type of progestin. The Drug Safety Communication was issued after The British Medical Journal reported a two- to three-fold greater risk of blood clots, including pulmonary embolism, in women using oral contraceptives containing drospirenone rather than a progestin called levonorgestrel.

Yaz and Yasmin, along with Ocella and other generic versions of the drugs, have been named in thousands of lawsuits claiming the drugs caused users to suffer dangerous side effects, including blood clots, heart attacks, and strokes. Many of those lawsuits have been consolidated in a multidistrict litigation in federal court in the Southern District in Illinois.

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