A North Carolina father is suing Bayer claiming the contraceptive drugs Yasmin and Ocella caused his 15-year-old daughter to die from a pulmonary embolism. In 2007, Scott Prewitt’s daughter, Brittany Nicole, was prescribed Yasmin for acne treatment. Prewitt filed a lawsuit in Buncombe County Court against Bayer for wrongful death and product liability, alleging the drug manufacturer “aggressively” promoted Yasmin and Ocella for off-label uses and “ignored” the “serious risks associated with the drug,” reported Courthouse News Service.
According to Prewitt, his daughter started taking Yasmin at the age of 13 and was using the drug until August 2008 when her pediatrician changed the prescription to Ocella, a generic form of Yasmin. She continued taking the generic drug until her death in 2009. On June 13, Brittany Nicole collapsed from seizures and was rushed to Memorial Mission Hospital where she was pronounced dead.
Although the U.S. Food and Drug Administration approved Yasmin for contraceptive use, physicians are allowed to prescribe medication for off-label uses, while drug companies are prohibited from marketing a drug for non-approved use. Nonetheless, Prewitt claims Bayer “aggressively marketed” Yaz, a variation of Yasmin with smaller doses of estrogen, to dermatologists as effective for the treatment of acne.
The complaint states, “Yaz only received approval for ‘the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Yaz should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control,’” reported Courthouse News Service.
This is not the first time Bayer was accused of marketing Yasmin for off-label uses. In May, the Prescription Medicines Code of Practice Authority found the company’s advertisement promoting Yasmin for acne and premenstrual symptoms was “misleading, prejudiced patient safety and brought the pharmaceutical industry into disrepute.” The ad was published in a British medical journal, with the headline “Contraception and more,” stating the drug “has also been shown to have a beneficial effect vs. baseline on acne…and premenstrual symptoms.”
In April 2002, the British Medical Journal reported that the Dutch College of General Practitioners recommended physicians prescribe older second-generation contraceptive pills rather than Yasmin. Their conclusion was based on data showing 40 cases of venous thrombosis among women taking Yasmin, two of which were fatal, says the complaint. In February 2003, the Journal also cited additional reports of embolisms linked to Yasmin. Despite the numerous reports showing increased risks, Bayer “ignored the correlation between the use of Yasmin, Ocella, and Yaz and the increased risk of developing thromboses, despite the wealth of scientific and medical evidence available,” Prewitt alleged in his complaint.
He is also suing the Asheville Children’s Medical Center, Dr. William Bryan III and Kelly Klaaren for negligence claiming both pediatricians were aware his daughter was taking Yasmin and Ocella for an acne condition; both knew the increased risks of serious health conditions and misdiagnosed the signs of a pulmonary embolism which ultimately caused her death. Barr Laboratories, Teva Pharmaceuticals and Intendis Inc. are also mentioned in the suit for wrongful death and product liability.