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J&J Paid $68M to Settle Lawsuits Over Birth-Control Patch, News Agency Says

Posted Oct 10, 2008, 11:59 am CST
By Martha Neil

It has cost the Johnson & Johnson pharmaceutical company an estimated $68.7 million to settle hundreds of lawsuits alleging that users were injured or, in 20 cases, even died as a result of using the company's Ortho Evra birth-control patch.

Complaints filed in state and federal court on behalf of 4,000 women contend that the New Jersey-based company concealed data that revealed the risk posed by estrogen released by the devices, reports Bloomberg. J&J voluntarily altered its labeling in 2005, 2006 and 2008 to strengthen warnings, with the approval of the U.S. Food and Drug Administration, the article notes.

Among the 562 complaints that the news agency reviewed, "the vast majority of users alleged the patch caused deep-vein thrombosis, or blood clots in the legs, and pulmonary embolisms, or blood clots in the lungs," the article states. "Some blamed it for heart attacks or strokes. The complaints blamed Ortho Evra for the deaths of 20 women."

A company spokesperson declined to comment on the confidential settlements and the company's labeling. However, Gloria Vanderham tells Bloomberg that the patch is safe and effective when used in accord with the FDA-approved label and provides a needed birth-control option.

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