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.
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.
J&J, the world's largest maker of health-care products, faces lawsuits by more than 1,500 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 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. J&J is based in New Brunswick, New Jersey.
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, the letter said.
``I was faced lately with what I considered an inability to exercise this responsibility, which led me to consider a job opportunity outside the company,'' the writer said in the letter dated Oct. 31, 2005, after he left the company.
Much more at Bloomberg
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