Wednesday, February 20, 2008

If the FDA makes a mistake....

It doesn't matter. Medical device users, such as insulin pumpers, can't sue the pump-maker. Why? The Supreme Court of the United States says so. A court ruling Wednesday sided with devicemaker Medtronic, holding that if federal regulators approved a device, a suit couldn't be filed under state laws.

This case stemmed from a New Yorker who was injured after a Medtronic-made catheter burst during an angioplasty procedure 12 years ago. He needed emergency bypass surgery. As a result, he sued the company and alleged design and manufacturing defects in the catheter, as well as inadequate labeling on the device's packaging. The patient later died, but his widow continued the lawsuit on his behalf.

The case probed whether manufacturers of sophisticated medical devices approved for sale by the FDA can be sued under consumer-friendly state laws, or whether they are preempted from such lawsuits.

Writing for the court, Justice Antonin Scalia called the FDA's current "premarket" method for approving sophisticated devices "rigorous." The agency spends an average of 1,200 hours reviewing each company's application, which includes studies testing devices on real-world subjects to prove they are safe and effective.

One of the lawyer's involved said this ruling is "particularly scary after hearing recent reports that say the FDA isn't up to the job of protecting the public from dangerous drugs and medical devices. We know that people will be injured as a result, and some of them will have no remedy."

Hmm. Does this ruling do more harm than good? Some people sue these medical devicemakers for no adequate reason, making unreasonable claims that shouldn't be in court to begin with. Sure, they're frivolous. But that's why we have the court system - to weed out those frivolous cases and let those warrant court action to get that far. When the Supreme Court lays out a blanket rule disallowing any of these claims, they're also doing away with the ones that may be legimate and taking away state courts' power to judge the validity. This is a business-friendly ruling that flies in the face of a logical law. Bummer.

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