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Dottie Perry
Dottie Perry
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Supreme Court to Decide if FDA Approval Immunizes Drug Manufacturers

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The Supreme Court has recently heard oral argument in a case that presents the issue of whether the Food & Drug Administration's approval of pharmaceuticals for production, sale and consumption immunizes the manufacturer of that drug. That case, Mutual Pharm. Co. v. Bartlett, stems from a trial in federal court in New Hampshire, where a jury awarded the plaintiff $21 million in compensatory damages. The First Circuit Court of Appeals upheld the verdict and the matter was brought before the United States Supreme Court for oral argument on March 19, 2013.

Bartlett originally sued the manufacturer, Mutual, alleging products liability and design defect claims. In New Hampshire, where Bartlett resides, state law imposes strict liability against manufacturers for producing products in unreasonably dangerous and defective conditions.

The debate this case has sparked is heated. The issue on appeal became whether federal law preempted state law because it was impossible to comply with New Hampshire's law and also FDA regulations of the same product Mutual manufactured.

Presumably, when the Court decides the issues that this case raises about federal preemption and the role of state tort laws governing prescription drugs under the federal regulatory regime, it will adhere to precedence and preserve the states' role in governing drugs, which is complementary to the federal regulation of them.