Democrats Opposing Supreme Court Decision In Favor Of Pre-Emption Pandering To Tort Lawyers, Wall Street Journal Editorial Says

Main Category: Medical Devices / Diagnostics
Also Included In: Litigation / Medical Malpractice
Article Date: 14 Aug 2008 - 5:00 PST

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The U.S. Supreme Court's "sensible" 8-1 ruling in the case of Reigel v. Medtronic, stating that medical devices approved by FDA are exempt from product liability lawsuits in state courts, "makes sense for many reasons" but has "nonetheless sent up yowls" from Democratic members of Congress who have proposed the Medical Device Safety Act (S 3398, HR 6381) to overturn the ruling, a Wall Street Journal editorial states. The pre-emption principle avoids "creating a sort of double-jeopardy for companies -- first having to run the FDA approval maze, then allowing a nationwide quilt of different laws and standards to second-guess that approval," the Journal states.

House Oversight and Government Reform Committee Chair Henry Waxman (D-Calif.) said the decision "strips consumers of the rights they've had for decades." The editorial continues, "Far from representing a radical departure in the law, the Court's reasoning upheld what had become a common opinion in the federal court system." In addition, "Reigel only applied to products in the strictest FDA tranche known as premarket approval products, which represent 1% to 2% of the overall medical device market," and accounts for about 40 approvals annually, the Journal states, adding, "Those who believe they've been injured by medical devices can still sue for a poorly manufactured product, or they can attempt to show that the FDA didn't get all the necessary information when the device was approved."

According to the Journal, "What Mr. Waxman really wants to restore is the trial lawyer bingo that can net jackpot jury awards while wreaking havoc on national standards." If "Democrats want tort lawyers and juries of lawmen to be the ultimate arbiters of new devices, then they should do away with the FDA entirely and go to an underwriters laboratory system that gets devices to patients more rapidly," but "they want it both ways -- agonizingly slow device approvals and open tort season after the fact." The editorial concludes, "If Congress really wants to improve the quality of medical products for consumers, it would better spend its energy on reforming the bureaucratic morass that is the FDA" (Wall Street Journal, 8/13).

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