Risks associated with the Ortho Evra birth-control patch were purposely downplayed by its manufacturer, a move that prompted one product safety executive to resign from Johnson & Johnson. These stunning revelations were made public by a letter the executive wrote to Johnson & Johnson CEO William Weldon in 2005. The letter was released by the New Jersey Superior Court at the request of plaintiffs suing the company over the defective Ortho Evra birth-control patch.
Johnson & Johnson faces more than 2,500 lawsuits over the Ortho Evra birth-control patch by users who say they suffered strokes or blood clots in their legs or lungs. On September 20, 2006, a study was released that confirmed previous studies showing an increased risk of blood clots associated with the use of Ortho Evra versus oral contraceptives. The study found that women using Ortho Evra were twice as likely to develop blood clots as those using oral contraceptive pills. As a result, the Food & Drug Administration requested the patch’s manufacturer to update the safety label on Ortho Evra to warn users about the risk of blood clots, heart attacks and strokes.
The letter released by the court is evidence that Johnson & Johnson had knowledge of the risks associate with Ortho-Evra, but chose to downplay concerns. The writer was a vice president at the company whose responsibilities included overseeing benefit and safety risk analysis of reproductive medicines. The author of the letter, whose identity has been kept secret, wrote that an investigation had revealed an “unusually high number” of blood clots caused by the patch and cited more than 20 deaths. The letter also said that of two studies conducted by Johnson & Johnson, the company deliberately emphasized “partial and incomplete” results of the one that was most favorable to the Ortho Evra birth-control patch. That study found the patch to be no riskier than oral contraceptives.
The writer resigned because Johnson & Johnson’s conduct interfered with the executive’s ability to evaluate the safety of Ortho Evra. “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 author wrote.
A Johnson & Johnson spokesperson told Bloomberg.com that CEO Weldon had never seen the letter. Instead, another senior executive investigated the letter’s claims, which is standard company policy. The spokesperson said that it is Johnson & Johnson’s normal procedure to pass correspondence on to the head of the business unit it falls under.
Johnson & Johnson has already settled dozens of Ortho Evra cases, and none have yet come to trail. The first trial is scheduled to begin in Manhattan on November. The plaintiffs in the case are the survivors of a 19-year old woman who died after using the patch.
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