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« Johnson and Johnson faces thousands of Ortho Evra lawsuits | Main | Ortho Evra Lawsuits Increasing »

September 24, 2007

Ortho Evra Company Downplayed Risk

Johnson & Johnson improperly claimed its Ortho Evra birth-control patch posed a low safety risk to women, a product-safety executive told Chief Executive Officer William Weldon in a 2005 letter, court records show. J&J faces lawsuits by more than 2,400 of the 5 million women who used the patch. Most claim they suffered strokes or clots in their legs or lungs. The company hasn't publicly identified reserves for the Ortho Evra litigation. The author of the letter investigated an “unusually high number” of blood clots caused by the patch and cited more than 20 reported deaths, according to the letter, made public on Aug. 25 by a New Jersey judge who oversaw some of the lawsuits. The executive, whose name was removed from the letter, said J&J conducted two studies and emphasized “partial and incomplete” results of the one that found the patch no riskier than birth control pills. The writer resigned because the company's conduct undermined his ability to evaluate product safety, t he let
ter said. The writer was a vice president who spent seven years at Johnson & Johnson, overseeing benefit and safety risk analysis in reproductive medicine and oncology, according to the letter.

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