ASHEVILLE, N.C. (CN) - A father says his 15-year-old daughter, who was not sexually active, died of pulmonary embolisms from taking Yasmin and Ocella, contraceptives that a doctor prescribed for acne. The father claims Bayer "aggressively" promoted the contraceptives for off-label uses, and "ignored" the "serious risks associated with the drug."
Scott Prewitt claims his daughter's pediatrician dismissed her embolisms, which began in one leg, as a skin infection.
Prewitt sued drug manufacturers and distributors Bayer, Barr Laboratories, Teva Pharmaceuticals and Intendis for wrongful death and product liability, and the Asheville Children's Medical Center, Dr. William Bryan III and Kelly Klaaren for negligence, in Buncombe County Court.
Dozens of lawsuits have been filed in recent years claiming Yasmin's side effects increased the risk of heart attack, stroke, pulmonary embolism and other serious injuries. Ocella is the generic form of the drug.
Prewitt says his daughter, Brittany Nicole, started taking Yasmin when she was 13. He says a dermatologist prescribed the drug for acne in 2007. Brittany was 13 at the time.
The dermatologist, Dr. Hilary Krueger, of Hendersonville, N.C., is not named as a defendant. Brittany's "regular physician" had been "Dr. Bryan at ACMC" since September 2006, according to the complaint.
Brittany took Yasmin until August 2008, when Dr. Krueger changed the prescription to Ocella, "a generic form of Yasmin," according to the complaint. Brittany "continued taking the medication as prescribed by Dr. Krueger until her death on June 13, 2009," according to the complaint.
The USDA has approved Yasmin for contraception. Doctors may legally prescribe drugs for off-label uses, but drug companies are not allowed to promote them for that.
But Prewitt says Bayer "aggressively marketed" Yaz - a variation of Yasmin, with a smaller dose of estrogen - to dermatologists: "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.
"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.'"
Prewitt claims that he and his wife and their daughter "read magazines, newspapers, and other media, and watched television, all of which communicated Yasmin and the sister medication Yaz advertisements which minimized the risks of Yasmin and Yaz, and overstated the benefits and shaped their favorable perception of Yasmin, Yaz and Ocella."
He adds: "Use of the drug Yasmin and its generic counterpart Ocella are associated with increased risks of several serious health conditions, including thromboembolism. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors, including obesity." Brittany weighed 199 lbs.
Prewitt says Brittany's pediatricians were aware of these increased risks to his daughter. He adds that Klaaren, Bryan and ACMC "knew that Brittany Prewitt was taking Yasmin, and subsequently Ocella, on a regular basis as prescribed for her acne condition and made regular notes of same in Brittany Prewitt's medical records maintained at ACMC." And he says they misdiagnosed the signs of the embolism that killed her.
Prewitt says Brittany saw Dr. Bryan on May 20, 2009 for pain in her left leg behind the knee, which was red and swollen. The doctor noticed a red, warm area on her inner thigh, but diagnosed it as "superficial cellulitis" and prescribed an antibiotic, the complaint states. It adds: "Her current medication was noted as 'Yaz' and her weight was recorded as 199.6 pounds."
On June 4, 2009, Kelly Klaaren, a physician assistant supervised by Bryan, examined Brittany's rash, which had extended to her lower abdomen, between her breasts, on her wrists and under her neck, and diagnosed the condition as "dermatitis," according to the complaint.
Brittany collapsed on June 13, had seizures and was taken to (nonparty) Memorial Mission Hospital, where she was pronounced dead. An autopsy determined that Brittany died as a result of blood clots in both lungs, or pulmonary emboli.
Prewitt says that "the primary difference between Yasmin and Ocella and other oral contraceptives on the market is that [one of their ingredients, the hormone] drospirenone has never been marketed in the United States and is unlike other progestins available in the United States.
"In April 2002, the British Medical Journal reported that "the Dutch College of General Practitioners recommended that older second generation birth control pills be prescribed in lieu of Yasmin as a result of 40 cases of venous thrombosis among women taking Yasmin, two of which were fatal."
The British Medical Journal carried another report in February 2003 citing "additional reports of thromboembolism where Yasmin was suspected as the cause," the complaint states.
But Prewitt claims that "the Bayer defendants, Barr, and Teva 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."
He claims that the "Bayer defendants have been warned multiple times by the FDA for misleading the public through use of television advertisements which overstate the efficiency of Yasmin and Yaz and minimize serious risks associated with the drug."
Prewitt seeks compensatory and punitive damages for wrongful death, negligence, failure to warn, product liability, breach of warranty and unfair trade practices.