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Injured By a Medical Device? Too Bad Says Supreme Court
Today the Supreme Court ruled that manufacturers of a federally approved medical device cannot be sued if the device causes an injury. To me this is just another disgusting act favoring big pharmaceuticals and medical companies. The case arose after a catheter burst, severely injuring a man undergoing an angioplasty in 1996. According to the man’s case, the catheter had been manufactured, labeled and designed in such a way it violated New York Law which had caused the defects leading to his injuries. The federal court dismissed the case on the grounds that the catheter had been given approval by the FDA, ruling in favor of the company, Medtronic. The Supreme Court upheld the ruling today. However, in 1996 the FDA was not shielded from state liability. That all changed in 2004 when the Bush Administration began to side with manufactures. At the time of the 1996 ruling in favor of Medtronic the administration said there would be a “serious undermining of FDA’s approval authority and its balancing of the risks and benefits” if cases could be brought against the agency. Justice Scalia wrote for the majority, citing that the FDA reviews each device and gives pre-market approval if it finds a reasonable assurance of safety and effectiveness. “It may thus approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives,” he wrote. He added that in the case of a ventricular assist device to help children with failing hearts it was approved “even though the survival rate of children using the device was less than 50 percent.” What this has to do with a catheter is beyond me. Obviously a device used to increase the lifespan of someone who would otherwise die sooner is an entirely different case than the extremely common use of a device such as a catheter. Justice Scalia however, deemed that jurors were in no position to examine pros and cons of medical devices. A jury “sees only the cost of a more dangerous designed, and is not concerned with its benefits; the patient who reaped those benefits are not represented in court,” he wrote. The lawyer representing the injured man’s wife told Bloomberg News, “Pretty bad for patients, pretty good for industry profits.” Representative Henry A. Waxman of California had this to say, “The Supreme Court’s decision strips consumers of the rights they’ve had for decades. This isn’t what Congress intended and we’ll pass legislation as quickly as possible to fix this nonsensical situation.” Senator Edward M. Kennedy of Massachusetts added that “Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices. Congress obviously needs to correct the court’s decision. Otherwise, F.D.A. approval will become a green light for shoddy practices by manufacturers.” The blanket ruling put forth by the Supreme Court flies in the face of citizens' rights. Only one of the Justices disagreed, saying that a “constriction of state authority" had been adopted by the majority and that Congress had not intended to create “a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices.” In my opinion it is about time for a “serious undermining of FDA’s approval authority” something the Bush Administration can’t seem to grasp. When private organizations are allowed to control the release of products for health reasons, it is absolutely imperative that it is held responsible for its actions. If the FDA was sued every time it sent out a faulty product, perhaps it would clean up its act a little. There’s no incentive better than constant scrutiny. The FDA is not nor ever should be a safety net simply because it approved something. If it is approving faulty products, it must pay the consequences. Fix it, or replace it with something that works. I’m tired of excuses and America should be too. |
New York Times
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This intel was contributed by The Rift
The Rift
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May, 2012
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