Ortho EvraÂ’s manufacturer faces wrongful death lawsuit

The mother of a woman who died in June 2003 after using the birth control patch made by Johnson & Johnson subsidiary Ortho-McNeil's 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. Celena Devault, a 26-year-old woman from Tennessee, began using the Ortho Evra birth control patch 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. According to FDA records, women using Ortho Evra in 2004 were three times more likely to die or develop nonfatal blood clots than women using birth control pills.  FDA in November 2005 updated the drug’s warning label to state that women who use Ortho Evra have a higher risk of experiencing blood clots and other side effects than previously stated.  In September, the FDA announced it had updated the warning label to include information from two conflicting studies on increased risk of blood clots among patch users.

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," said the prosecuting attorney in both lawsuits, adding, "Patches sold in other countries, including Canada, actually contain a smaller, less dangerous dosage." According to Ortho-McNeil’s spokesperson, Ortho McNeil does not comment on pending litigation.

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