House Committee Considers Medical Device Bill

Bret Hanna

Attorney
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Last week, the House Energy and Commerce Subcommittee on Health heard testimony on the Medical Device Safety Act of 2009. This legislation was drafted to overturn the 2008 U.S. Supreme Court decision in Riegel v. Medtronic, Inc. This anti-consumer/pro-tort reform decision precludes those injured by some FDA approved medical devices from pursuing state law product liability claims for damages.

Predictably, pro-tort reform organizations like the American Tort Reform Association have launched a full-frontal attack on those dedicated to protecting the rights and interests of those injured by medical devices by calling the proposed bill a stimulus package for personal injury lawyers. Also, a former chief counsel for the Federal Drug Administration testified that oversight of medical devices is best left to the entity that approved them in the first place, the FDA. But even the most casual observer of the FDA's efforts on such matters knows how ineffective such oversight by the FDA has been.

The incoming Federal Trade Commission's chief of consumer protection, David Vladeck, however, provided contrasting testimony. Vladeck testified that since the FDA cannot have a perfect track record when it comes to approving medical devices, Riegel creates a catch-22 for injured consumers; there will be injuries caused by medical devices and there will be no recourse for those injured. Such sentiments were echoed by the American Association for Justice when it pointed out that the proposed legislation would simply restore victims' rights taken away by a pro-business Supreme Court decision.

We will track this bill as it progresses through the legislative process and keep you posted.