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September 16, 2009

Tort Claims and Federal Regulation of Medical Devices vs Pharmaceuticals—Reply

JAMA. 2009;302(11):1169-1170. doi:10.1001/jama.2009.1334

In Reply: Mr Green provides another compelling reason why the Supreme Court should have allowed tort actions for medical devices, just as it did for pharmaceuticals. The court's contradictory decisions in Riegel and Wyeth make little sense and leave the field of FDA law in a quandary. The distinction drawn by the court was unfounded because pharmaceuticals and medical devices go through the same FDA approval process, and sometimes it is even unclear whether a particular product is a drug or a device. More importantly, as Green points out, the justification for tort litigation in medical device cases may be even stronger because the FDA does not approve their design features.

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