Preemption

Congress Must Act Quickly to Reinstate These Important Rights

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Dear (recipient name),

On February 20, 2008, the Supreme Court issued its decision in Riegel v. Medtronic, Inc., which limits consumer rights to hold negligent medical device manufacturers accountable for injuries caused by their products and constitutes a giant step backwards from making devices safer for consumers.  More consumers may be deprived of their rights after the Supreme Court decides two prescription drug cases later this year.  Congress must act now to preserve consumer rights.

The Court’s decision prohibits consumers injured by a medical device from holding a negligent device manufacturer accountable if the product met the FDA’s minimum requirements.  Thus, if a manufacturer of an FDA-approved device learns of a potential problem without notifying health officials and consumers, the manufacturer is immune from liability.

This decision eliminates the accountability of the civil justice system for medical device manufacturers.  With this decision, they will have little or no incentive to improve medical devices beyond the FDA’s minimal requirements or to conduct crucial post-market testing to determine the health and safety implications of their devices.

The decision will make medical devices less safe for consumers.  More warnings are likely to cause fewer people to use the product; therefore, manufacturers rarely disclose new hazards unless compelled to do so.  And, without tort suits triggering disclosure of hazard information, consumers will be less likely to obtain crucial safety information before it is too late.

With the Supreme Court also set to decide cases that will determine whether consumers can hold negligent drug manufacturers accountable, this erosion of consumers’ rights is poised to only get worse.  Congress needs to act to reiterate its intent to allow consumers to hold drug and device manufacturers accountable for injuries caused by their products to prevent any further destruction of consumer rights.

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