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Lawsuits over drugs like Zyprexa, Vioxx, Rezulin have made headlines in the past decade. At the center of the lawsuits is if the pharmaceutical manufactures withheld research that indicated the drug had risk factors other than was presented to the Food and Drug Administration (FDA).

Currently there is a lawsuit over the birth control patch, Ortho Evra (Johnson & Johnson). Its outcome could affect future lawsuits against the pharmaceutical manufactures. The manufacture argues that the lawsuit should be dismissed because the FDA made the decision to approve the drug and the courts lack the agency’s expertise and should not second guess the FDA.

The term for this legal argument is pre-emption and something the drug manufactures have been pushing for some time. The Bush administration agrees with the pharmaceutical manufactures.

During the next Supreme Court term they will rule on a case that, if approved, could make pre-emption a de facto standard. Just a few months ago the Supreme Court had ruled that medical devices, like pacemakers, are pre-empted.

The argument against the pre-emptive status in the birth control lawsuit is that information was withheld from the FDA and later when corrections were made it was done in a way to obscure the changes. Once the FDA made the public aware of the changes and increased risk sales for the birth control patch decreased by 80%.

This summary is from The New York Times article “Drug Makers Near Old Goal: A Legal Shield,” April 6, 2008.

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