More on the Ortho Evra Patch and the FDA

The NY Times revealed on Sunday that Ortho, in reporting the results of a 1999 clinical trial of the contraceptive patch to the FDA, used a “correction factor” to adjust down the estrogen exposure in the patch by about 40%.

This adjustment was never part of the study protocol, a plan filed with the F.D.A…The company mentioned its decision to use the “correction factor” only once in a 435-page report filed with the F.D.A., and then only in a complex mathematical formula. When the study was published in 2002, there was no reference to the alteration.

The FDA recently updated the package labeling for the Patch to reflect the higher estrogen dosing and to warn users of the potential for blood clots from Patch. Ortho is now facing lawsuits from women who experienced blood clots they claim are related to the increased estrogen dose in the Patch.

According to the Times, the drug maker is attempting to block the suits, claiming that because the FDA approved the patch, Ortho should be immune to any lawsuits stemming from complications related to its use. It’s an argument that has made before, with recent success in favor of medical device makers.

If that’s the case, then doctors should be immune to lawsuits, since the Medical Board licenced us, right?

Somehow, I don’t think that’s gonna’ happen.
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My thoughts on the Patch