Mother of Tenn. woman sues birth control patch companyDec 12, 2006 | AP
The mother of a woman who died while using a popular birth control patch has filed a wrongful-death lawsuit against the maker of the patch, which she says caused her daughter's death.
The lawsuit filed in San Francisco Superior Court names Ortho Evra's developer and manufacturer Ortho-McNeil Pharmaceutical Co., a Titusville, N.J.-based subsidiary of Johnson & Johnson; and San Francisco-based distributor McKesson Corp.
Approved by the U.S. Food and Drug Administration in 2001, Ortho Evra is a birth control patch that delivers the hormones estrogen and progestin directly into the bloodstream through the skin.
The lawsuit alleges that Ortho-McNeil knowingly deceived the public about the drug's risk of severe side effects, including stroke, blood clots, deep vein thrombosis and pulmonary embolisms.
The company doesn't comment on ongoing litigation, said Gloria Vanderham, a spokeswoman for Ortho Women's Health and Urology.
Celena Devault, 26 of Hollow Rock, died from a pulmonary embolism and blood clots in June 2003. She had begun using the patch in April 2003.
Celena Devault's mother, Mary Devault, is named as the plaintiff in the lawsuit.
Another lawsuit has been filed on behalf of 55 women suffering from blood clots and other serious illnesses which they allege were caused by the birth-control patch.
"We believe that Ortho-McNeil knew of the dangers of the Ortho patch sold in the U.S. and choose to ignore them," said an attorney, whose firm along with another, filed both suits.
"Patches sold in other countries, including Canada, actually contain a smaller, less dangerous dosage," one of the attorneys said. "Now, young women across the country are suffering serious illness and even death."
In September, the FDA warned women that their risk of blood clots in the legs and lungs may be higher if they use the Ortho Evra birth control patch instead of the pill. The decision was based on one study showing higher risks for clots, although another study showed no increased risk.
An investigation last year by The Associated Press found that patch users die and suffer blood clots at a rate three times higher than women taking the pill. About a dozen women died in 2004 from blood clots believed linked to use of the patch, the AP reported. Dozens more suffered strokes and other clot-linked problems.