Piecemeal Tort Reform
A Supreme Court ruling on medical devices is cause for cheers as well as concerns.

Saturday, March 1, 2008

BUSINESSES ARE usually all too eager to paint regulation as a bureaucratic beast that imposes extraordinary burdens and stifles innovation. So it's curious that in some key cases before the Supreme Court this term, business has praised the effectiveness of federal regulation and used it as a shield from an even bigger enemy -- litigation.

Take the recently decided case of Riegel v. Medtronic. A balloon catheter manufactured by Medtronic burst during a heart procedure performed on a New York man. The man survived and sued the company in state court. Medtronic essentially argued that it was immune from liability because its medical device had been preapproved for sale by the Food and Drug Administration. In an 8 to 1 decision last week, the Supreme Court agreed.

There are reasons to cheer. Consistent and clear nationwide rules for such companies and products are essential for innovation; allowing a jury of laypeople to second-guess the experts at the FDA could be counterproductive for companies and consumers. The Supreme Court's decision covers only a relatively small class of medical devices on the market, and these devices undergo the most rigorous level of FDA review before coming to market. Most medical devices fall into a different category, and because they're not as closely scrutinized, they are subject to lawsuits.

The case is only one of several on the Supreme Court docket that address whether federal laws preempt lawsuits in state courts. One case scheduled for argument in the fall will consider whether pharmaceutical companies are entitled to immunity. There are reasons to worry. If the court continues to find that manufacturers of medical devices should be shielded from lawsuits, victims of defective products or drugs could be left with little or no legal recourse. It would also leave the FDA, which has been understaffed and underfunded, as the first and final arbiter of safety.

Having failed to win comprehensive litigation reform in Congress, business has taken its agenda to the courts, where piecemeal rulings run the risk of skewing the system in favor of manufacturers. Sen. Edward M. Kennedy (D-Mass.) and Rep. Henry A. Waxman (D-Calif.) have said they will introduce legislation to restore the right to sue manufacturers, but that only risks inviting the kind of questionable litigation and arbitrary judgments that this Supreme Court decision legitimately addresses.

Lawmakers should instead consider creating a government-run compensation fund for patients harmed by medical devices, similar to the one established for those harmed by vaccines. They should also continue to strengthen the FDA through increased funding and oversight muscle. And they should return to the task of fashioning comprehensive tort reform that would significantly reduce frivolous litigation while ensuring that the rights of real victims are safeguarded.