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J&J Settles Fatal Patch Cases, So Why Is This Thing Still on the Market?

ortho_evra_patch.jpgJohnson & Johnson has paid $68 million to settle hundreds of cases brought by women who used the Ortho Evra birth control patch. The settlements raise a question: Why is this patch still on the market when it is now well-established that its risk of causing fatal blood clots is far greater than ordinary pills, and J&J itself no longer promotes the brand to consumers?

The patch has killed at least 40 women so far, mostly through blood clots, which tend to be an old person's affliction, not something you find in teens and women of child-bearing age.

The back story is worth repeating, because it's pretty horrifying: J&J introduced the patch to replace revenues from its existing -- and safe -- pill, Ortho TriCyclen, which was going off patent. It was targeted at women who might forget to take a regular pill every day. J&J allegedly fired one doctor who had warned the company internally he believed there were problems with the device. It hired another doctor who had a history of faking test results in contraceptive devices. And an FDA analyst reviewing J&J's NDA warned -- in a memo written in capital letters -- that the rate of blood clots caused by the patch was possibly double the rate that J&J believed it was.

The patch was nonetheless approved.

Of 34 print ads created to promote the patch, five contained no warnings of blood clots (even though all estrogen-based contraceptives carry that risk) and only seven contained warnings in anything more than legal-size type.

Once a pattern emerged of young women being felled by pulmonary embolisms and strokes, J&J's reps began a rearguard action to assure doctors the patch was safe, and the company even bought up URLs with anti-patch sentiments (such as so they could not be used by critics. Later, J&J quietly stopped its consumer promotion of the patch (although it is still on the market).

The question asked by Sydney Wolfe of Public Citizen is a valid one: If there are other equally effective contraceptives on the market that are less dangerous than the patch, why has this device not been withdrawn?

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