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The House Energy and Commerce Subcommittee on Health began hearing testimony on the Medical Device Safety Act of 2009, which proposes the Supreme Court decision in Riegel v. Medtronic, Inc be overturned. The Reigel ruling prevents patients that were injured by certain federally approved medical devices from seeking compensation via state product liability suits – in other words, federal law trumps (preempts) state law in these cases. The House bill has been a catalyst in the legal community. The American Tort Reform Association, for example, claims the bill would be an economic stimulus for personal injury attorneys. The American Association for Justice, on the other hand, says the bill would restore victims’ rights.

The subcommittee’s hearing was just as divided. While the arguments within the subcommittee hearing were relatively tame, an argument broke out between Subcommittee Chairman Henry Waxman (Democrat) and Steve Buyer (Republican). Waxman argued the FDA’s ability to protect the American public has plummeted due to severe underfunding. Buyer claimed this was “bizarre logic.”

A former chief counsel of the Food and Drug Administration (FDA) testified at the hearing and argued ultimate authority should rest with the FDA and not a group of people that listen to lawyers “rant” at them. He further argues that making it easier for the companies to be sued would lead to limits in innovation because companies would be deterred from taking risks in developing new products. David Vladeck, who will become the Federal Trade Commission’s consumer protection chief next month, claims the Riegel decision gave consumers the “worst of both worlds” since the FDA cannot assure every medical device is safe and with Riegel, consumers can no longer rely on the tort system if they are injured.

Mr. Vladeck is dead-on with his comment. There have to be checks and balances on any system. It is no secret that the FDA (and most other federal oversight agencies) do not have adequate resources to police drug companies, medical device companies, automobile manufacturers, and much of the banking industry (Exhibit A being what has occurred in our economy over the past 12-24 months), just to name a few. While lawyers, especially trial lawyers, are not a favorite profession of most citizens, trial lawyers (of which I am a card-carrying member) are needed as an enforcement mechanism. The possibility of litigation is a deterrent, and it is also a means to hold those who place profits ahead of safety accountable.

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