The mother of a woman who died in June 2003 after using Johnson & Johnson subsidiary Ortho-McNeil's birth control patch Ortho Evra recently filed a wrongful-death lawsuit in San Francisco Superior Court alleging that the company knowingly misinformed the public about the drug's risk of severe side effects, the AP/San Jose Mercury News reports.
Celena Devault, a 26-year-old woman from Tennessee, began using Ortho Evra in April 2003 and died of a pulmonary embolism in June 2003. Her mother, Mary Devault, filed the lawsuit alleging Ortho McNeil misled the public about the drug's risk of side effects, including pulmonary embolism, stroke, deep vein thrombosis and blood clots (AP/San Jose Mercury News, 12/12).
The Associated Press in July 2005 reported that, according to FDA records it obtained through a Freedom of Information Act request, women using Ortho Evra in 2004 were three times as likely as women using birth control pills to die or develop nonfatal blood clots. FDA in November 2005 updated its warning label for the drug to say that women who use Ortho Evra have a higher risk of experiencing blood clots and other side effects than previously stated (Kaiser Daily Women's Health Policy Report, 11/11/05).
FDA in September announced it had updated the warning label to include information from two conflicting studies on increased risk of blood clots among patch users (Kaiser Daily Women's Health Policy Report, 10/18). Another pending lawsuit filed by 55 women alleges they experienced blood clots and other serious illnesses that they claim were caused by Ortho Evra. "We believe that Ortho-McNeil knew of the dangers of the Ortho patch sold in the U.S. and choose to ignore them," Brian Kabateck -- whose law firm Kabateck Brown Kellner, along with the Law Offices of Shawn Khorrami, filed both suits -- said, adding, "Patches sold in other countries, including Canada, actually contain a smaller, less dangerous dosage." Ortho-McNeil does not comment on pending litigation, according to Gloria Vanderham, spokesperson for Ortho Women's Health and Urology (AP/San Jose Mercury News, 12/12).
source - Kaiser Network