Medical progress trumps finger-pointing

By The SE Texas Record | Jun 6, 2009

In an era when the law has been used as a weapon to shake down productive American businesses and industries, it is refreshing to note one judge's refusal to bend in the litigious wind.

As reported this week by The Record, U.S. District Judge Richard H. Kyle of Minnesota dismissed hundreds of lawsuits alleging that Medtronic's "Sprint Fidelis" implantable defibrillator leads are defective. Judge Kyle dismissed the Master Consolidated Complaint in January, and in May denied the plaintiff's request to replead the case.

Judge Kyle concluded that the "plaintiffs assert claims for which the Court simply cannot provide a remedy," because those claims were preempted by federal law, specifically the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act.

"Congress has decided to limit medical-device manufacturers' liability in order to spur innovation," Judge Kyle observed in his January opinion, "even though individuals are sometimes injured when using medical devices. Plaintiffs' remedy, therefore, lies with Congress, and not with this Court (or any other court)."

Medtronic received FDA premarket approval for its Sprint Fidelis leads in 2004 and voluntarily suspended distribution of the product in 2007 after internal performance data showed a potential for fracture. For patients with life-threatening heart conditions, they're willing to take such a risk, which is clearly preferable to cardiac arrest or death.

Ironically, one of the frequent complaints lodged against the FDA is its stringent approval process. Critics say the FDA is over-cautious in delaying the introduction of drugs and medical devices that could improve and extend the lives of Americans.

Of greater concern is the impact of frivolous or opportunistic lawsuits which threaten to destroy the companies that make the medical marvels we already enjoy or discourage those companies from developing others. The rule of law cannot be that you're damned if you do and damned if you don't.

In this case, as Judge Kyle rightly noted, manufacturer liability is limited by federal law, and he is bound to apply that law. We're better off for his discretion.

Case closed.

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