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Ortho Evra Risks May Have Been Concealed by Johnson & Johnson

Sep 23, 2010 | Parker Waichman LLP

Johnson & Johnson is facing more heat over its Ortho Evra birth control patch. According to an NBC News report, internal documents indicate that the drug maker may have known about Ortho Evra’s blood clot risks years before they were made known to the public, and perhaps even before it came to market.

When Ortho Evra was introduced in 2002, Johnson & Johnson touted it as a convenient alternative to daily oral contraceptive pills, and its original safety label stated that the patch’s health risks were similar to those of oral contraceptives. But in 2005, the Food & Drug Administration (FDA) warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who use oral contraceptive pills. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries. As of November 2005, the FDA had received twenty-one reports of life-threatening blood clots and other ailments associated with the use of Ortho Evra.

In 2006, a study was published that showed women using Ortho Evra were twice as likely to suffer a type of blood clot called venous thromboembolisms (VTEs) — a clot that can travel to the lungs and cause a fatal pulmonary embolism – as those taking oral birth control pills. That study prompted the FDA to request a change on the Ortho Evra label to include a stronger safety warning. In January 2008, the FDA asked that the Ortho Evra label be changed yet again to include information on another study that indicated the patch doubles the risk of developing VTEs compared to the Pill.

According to the NBC news report, conflicts over the safety of Ortho Evra have led to some high-level resignations at Johnson & Johnson:

“In 2005, Johnson & Johnson Vice President Dr. Patrick Caubel suddenly quit, saying in his resignation letter, ‘I have been involved in the safety evaluation of Ortho Evra since its introduction on the market. … The estrogenic exposure [of the patch] was unusually high, as was the rate of fatalities.’

His letter, which was obtained by NBC, said the research was ‘compelling evidence’ that the company ignored. Therefore, he wrote, ‘it became impossible for me to stay in my position as VP.’”

Another former vice president, Dr. Joel Lippman, claims in a lawsuit that he was fired by Johnson & Johnson because he expressed concerns about the patch’s dangerously high estrogen levels prior to its coming to market. The company, he says, “disregarded his concerns and launched the product anyway.”

Thousands of Ortho Evra users have filed lawsuits against Johnson & Johnson for injuries, including blood clots, heart attacks and strokes, which they claim were the result of the patch. At least two dozen of the women named in the lawsuits died after using it. So far, it is known that Johnson & Johnson has spent $68 million to quietly settle Ortho Evra lawsuits.

Still, Ortho Evra remains on the market, despite numerous calls to have it pulled. In spite of its risks, the birth control patch is still a big money maker for Johnson & Johnson, which has earned $1.6 billion on its sales.

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