Proposed Legislation May Compromise Incentive to Present Unbiased Presentation of Research Data

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Notes

1. The inclusion of device manufacturers in the Bill may seem redundant because the Medical Device Amendments (Public Law 94–295 (90 Stat. 539)) to the Food, Drug and Cosmetic Act already preempts many tort claims against manufacturers of FDA approved devices. However, the Supreme Court decision in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), which upheld preemption of these claims, also reminded potential plaintiffs that states could pursue claims that “parallel” federal requirements. Since the Supreme Court offered no guidance regarding which state law claims are parallel, theoretically, plaintiffs can bring product liability claims against manufacturers of FDA approved devices. In Wyeth v. Levine, 555 U.S. 555 (2009), the Supreme Court made it clear that federal preemption did not apply to pharmaceuticals.