After I had fnished reading the recent Supreme Court decision in Riegel v. Medtronic (MDT) and some news reports describing the supposed implications of the decision for pharma, I was confused. Were the implications for pharma product liability cases broad and profound or narrow and limited?
Certainly, the upcoming Wyeth (WYE) Supreme Court case will have its own implications for pharma, but, in the meantime, I turned to my colleague Greg Glass, editor/owner of the Paragraph Four Report, to lend his opinion to the Court’s Medtronic decision. Here’s what he said:
As for the [Medtronic] case, you have to read it very narrowly. It appears that the gist of the lawsuit was that the plaintiff did not have much to go on in suing Medtronic. The product [apparently] was contraindicated for the use for which it was administered to the poor guy, and the balloon was filled to 10 atmospheres, rather than the maximum [recommended] pressure of 8. So, it appears that there was not much product liability theory to go on. ([The situation would have been different] if the facts instead were that the product was used for its intended use and the balloon ruptured at 4 atmospheres).
So, the plaintiff, being “creative,” asserted the product failed to meet certain design and manufacturing standards.
The point of the law [MDA], and the FDCA for that matter, was to create a uniform approval and safety standard. For example, what would happen if Texas passed a law that required new drugs to have three controlled studies before the product could be sold in Texas? So, the idea is to have one set of rules — federal law — to control these things.
[Following this ruling], you can still sue under state laws in state courts for product liability cases — but those laws can’t create higher manufacturing and approval standards than what federal law creates. Federal courts are harder to get into and usually don’t hear the standard product liability cases.
That seems pretty clear to me. If the device doesn’t work as it’s supposed to, according to the FDA, plaintiffs still have the opportunity to sue in state court under product liability laws. But if the device is pushed beyond its recognized (labeled) limits, as the facts supported in this case, plaintiffs can’t sue in state court using a state law that creates a tougher standard for the product than the FDA recognizes.