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Ortho Evra Canadian Lawsuit Settled

Mar 3, 2009 | Parker Waichman LLP

Johnson & Johnson has agreed to settle an Ortho Evra class action lawsuit in Canada.  The drug maker has already spent more than $68 million to settle similar claims in the U.S.

When Ortho Evra was introduced in 2002, Johnson & Johnson touted the once-weekly patch as a convenient alternative to daily oral contraceptive pills. The drug’s original safety label stated that the patch’s health risks were similar to those of oral contraceptives.

 But in 2005, the U.S. 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.

It is believed that the difference in exposure is related to the delivery mechanism of the birth control patch. Hormones in birth control pills are partially diluted by the digestive system. However, hormones in Ortho Evra are absorbed directly into the blood stream, which causes a higher concentration of the medication to enter a patient’s body. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries.

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. Then in  January 2008, the FDA asked that the Ortho Evra label be changed again to include information on yet another study that indicated the patch doubles the risk of developing VTEs compared to the Pill.

According to a report, Johnson & Johnson subsidiary Janssen-Ortho has agreed to settle a class-action lawsuit started by Canadian women who claimed they were injured by Ortho Evra.  The plaintiffs in the lawsuit had charged that Janssen-Ortho failed to adequately warn them and their doctors about the patch's association with an increased risk of developing blood clots, pulmonary embolisms, strokes, heart attacks and deep vein thrombosis.

The claims will be settled on an individual basis, and the company will not admit any fault.  Janssen-Ortho also said it was prepared to settle any other valid claims that are brought forward, reported.

Since it was approved in Canada in 2002, Health Canada has received at least 16 reports of blood clots and one heart attack among Ortho Evra users. Two patients died, including a 16-year-old girl, said.

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