Riegel v. Medtronic: The FDA Preemption Super Bowl

Today, the Supreme Court will hear argument in Riegel v. Medtronic. The issue is whether the Food, Drug and Cosmetic Act forecloses state law personal injury lawsuits for injuries from the design, manufacture and labeling of a Medtronic medical device that was granted pre-market approval by the Food and Drug Administration. This case is a product defect case involving a Medtronic balloon catheter that killed the patient but, this case could have ramifications for the Medtronic lead recall lawsuits that are being filed all over the country. [Update: “Could” is the understatement of the decade.] While technically this case focuses on a specific statutory provision, no one would be surprised if the Supreme Court’s holding provides a comprehensive framework for preemption that would apply to all drug and medical device cases.

Naturally, the Bush administration has lined up squarely behind the pharmaceutical companies. This is ironic because there is a strong presumption against preemption, particularly in cases where the issue involves the individual states’ power to protect public safety and health.

The Supreme Court has consistently found that preemption of state law does not apply unless “the nature of the regulated subject matter permits no other conclusion” or “the Congress has unmistakably so ordained.” Chicago & N.W.Transp. Co. v. Kalo Brick & Tile Co., 450 U.S. 311, 317(1981) (quoting Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142 (1963)).

Preemption limits the states’ ability to protect its own citizens. The requirement that express preemption provisions be unambiguous follows this administration’s line of thinking: the states should be allowed to decide what is best for its citizens whenever possible, accordingly we should err on the side of states’ rights unless the preemption provisions are crystal clear. Yet, in this case, this administration supports usurping the states’ power even when it is clear that there is no express legislative intent for preemption.

The Bush administration is a big proponent of states rights. The President clearly believes that if the state of Kentucky finds that all of its citizens should be permitted to walk into shopping malls with AK-47s, it is all good and the federal government should just stay out of it. Yet all of this high minded capital “F” Founding Fathers and Federalism gets trumped because pharmaceutical and medical device companies do not want to be held accountable for their own negligence. The lesson, as always, is that protecting big business prevails over all, even at the expense of deeply held core values.

Update: We lost, obviously. Big.

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