Life Sciences

J&J paid $68M to settle birth-control patch lawsuits

Pharma Compliance Alert, October 15, 2008

Johnson & Johnson paid at least $68.7 million to settle hundreds of lawsuits by women who claim they were harmed by the patch, according to a Bloomberg.com article.

The company allegedly hid or altered data about the risks of high levels of estrogen released by its Ortho Evra birth control patch. J&J voluntarily strengthened the warnings on the patch’s label in 2005, 2006, and 2008. The current label warns Ortho Evra contains 60% more estrogen than the typical birth-control pill and that higher estrogen increases side effects. Studies show Ortho Evra can double the risk of serious blood clots compared with the pill, according to the label.

Most of the lawsuits claim the users suffered blood clots in the legs and in the lungs as a result of using the patch. Ortho Eva is also blamed for 20 deaths as well as causing strokes and heart attacks.

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