The FDA Approved Man's Medical Injury

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The Supreme Court issued a ruling on February 20, 2008 that leaves some consumers who have been injured by medical devices out of luck. The ruling protects the companies that manufacture medical devices that have passed the most rigorous federal review standards by banning lawsuits against them from consumers who allegedly have been injured by them.

The Washington Post reported that Charles Riegel, a man who died three years ago, and his wife sued Medtronic under New York law after Charles was seriously injured in 1996 when a balloon catheter manufactured by the company burst while he was undergoing angioplasty. The Riegels claimed in their personal injury lawsuit that the balloon catheter's design was faulty and that its labeling was deficient.

The Supreme Court ruled 8-1 against Riegel's estate and wrote that federal law preempts a finding of product liability under state law for medical devices that have passed through the Food and Drug Administration's most stringent pre-market approval process.

In 1996 the court ruled that the makers of medical devices that were approved under a less stringent process could be sued under state law. However, in 2004 the decision was reversed and when Riegel vs. Medtronic was argued in December, the government's position was that lawsuits against the makers of federally approved medical devices undermines the authority of the FDA.

Some legal experts say that the Supreme Court ruling and those like it are a result of a narrow interpretation of the federal law specific to the preemption clause in the Medical Device Amendments of 1976. That law was passed in response to the many lawsuits that were filed after consumers were injured by the Dalkon Shield intrauterine device. The MDA of 1976 set strict and detailed guidelines for the FDA to test medical devices. It also prevented state law from imposing "any requirement which is different from, or in addition to, any requirement applicable under this chapter."

The court has interpreted the word "requirement" to mean the award of damages under state law. That means that the makers of medical devices that have been approved by the FDA are not liable for consumer damages under state law.

In the Supreme Court decision, Justice Antonin Scalia, writing for the majority, said that devices such as the balloon catheters manufactured by Medtronic are subjected to almost a year of study and that they are designed to be used on people with serious high-risk medical conditions. Because of the nature of the functions of these devices, they sometimes carry huge risks for patients. The job of the GDA is to weigh the risks against the benefits and make a determination as to whether or not the device can be approved.

Scalia went on to write that it would be unfair to allow a jury to award damages in a case when something went wrong with one of these medical devices because a jury would not be concerned with the benefits of the device. According to Scalia, if juries awarded damages to the patients who were injured by the medical devices, other patients would suffer because new medical devices would not be developed.

In other words, it's just not practical or beneficial for the FDA or the manufacturers of medical devices to be sued. As bad as that sounds, that is what the Supreme Court has decided.

Some hope remains for patients who have been injured by medical devices. If the manufacturer of the device somehow violated the FDA regulations then they may be sued under state law. Also, the preemption clause only protects the manufacturers of medical devices from product liability claims and does not apply to drugs approved by the FDA.

Additionally, the Washington Post reports that some lawmakers were also disturbed by the Supreme Court's decision.

"The Supreme Court's decision strips consumers of the rights they've had for decades," said Rep. Henry A. Waxman of California, the chairman of the House Committee on Oversight and Government Reform. "This isn't what Congress intended, and we'll pass legislation as quickly as possible to fix this nonsensical situation."

We can only hope that Waxman jumps on it and makes good on that promise.


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