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J&J Paid $68 Million to Settle Ortho-Evra Lawsuits

According to court recordsJohnson & Johnson has spent at least $68.7 million to settle hundreds of lawsuits filed by women who suffered blood clots, heart attacks or strokes after using the company’s Ortho Evra birth-control patch.

Majority of users claimed that the patch caused deep-vein thrombosis, (blood clots in the legs), and pulmonary embolisms, (when the blood clots from the legs travel into the lungs). The complaints blamed Ortho Evra for the deaths of 20 women, strokes and heart attacks.

Lawsuits allege that the company hid or altered data about the risks of high levels of estrogen released by Ortho Evra. The New Jersey-based company voluntarily strengthened the warning label in 2005, 2006 and 2008 with the approval of the U.S. Food and Drug Administration.

J&J claims that when used according to the FDA- approved label, Ortho Evra is a safe and effective method of hormonal birth control.

The company’s current label warns that Ortho Evra exposes women to 60 percent more estrogen than the typical birth-control pill and that higher estrogen increases side effects. Clinical studies show Ortho Evra can double the risk of serious blood clots compared with the pill, according to the label.

The pace of J&J settlements has increased as the U.S. Supreme Court will hear arguments on the legal doctrine of pre-emption. The Supreme Court could rule that pre-emption bars consumers from relying on state law, to sue for damages linked to products approved by federal regulators.

J&J has argued that state jurors cannot conclude that a drug is unreasonably unsafe if the FDA’s experts say it is safe and effective and the warning label is adequate.

The FDA’s Web site has two studies which showed a doubling of the risk of serious blood clots compared with typical birth-control pills. The results “support FDA’s concerns regarding the potential for use of Ortho Evra to increase the risk of blood clots in some women.”
Lawyers said J&J typically settles death cases for more than $1 million, deep-vein thrombosis cases for $125,000 to $175,000, and pulmonary embolisms for $140,000 to $300,000.

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