Constitutional Tort “Reform”

This Constitution, and the laws of the United States which shall be made in pursuance thereof; and all treaties made, or which shall be made, under the authority of the United States, shall be the supreme law of the land; and the judges in every state shall be bound thereby, anything in the Constitution or laws of any State to the contrary notwithstanding.

So says the Supremacy Clause of Article VI of the U.S. Constitution.

Makes perfect sense on its face. After all, what’s the point in having a national legislative body if a state can within its own borders nullify the national body’s actions simply by passing contrary legislation? Uniformity is generally a good thing. And what nation would enter into a treaty with the U.S. if individual states were free to ignore it?

Yep, the supremacy of federal law makes sense. But what happens when federal regulatory statutes become more numerous and more comprehensive? More specifically, what happens when a federal regulatory scheme encroaches on territory traditionally considered to be the sole prerogative of the states?

Even more specifically, can manufacturers of defective products and other tortfeasors legitimately argue that a given federal statutory/regulatory scheme is so comprehensive that it prohibits people injured by their misconduct from suing and recovering damages under state tort law?

You betcha they can, and such arguments succeed with frightening regularity. Despite paying lip service to state sovereignty and purporting to indulge a presumption against preemption, federal courts applying preemption doctrine are arguably history’s most successful agents of tort “reform.”

Which brings us to the current subject. Back in the 1970s, thousands of women were severely injured or killed using an intrauterine device called the Dalkon Shield. Beginning in 1971, A.H. Robins Company aggressively marketed the Dalkon Shield as safe and effective despite actual knowledge of a defect that led to such delightful consequences as life-threatening infection, fulminating pelvic inflammatory disease, ectopic pregnancy, septic abortions, etc.

Before the Dalkon Shield catastrophe, medical devices weren’t subject to any real federal regulation. That changed in 1976 when Congress passed the Medical Device Amendments (“MDA”) to the federal Food, Drug, and Cosmetic Act. MDA empowered the federal Food and Drug Administration (“FDA”) to regulate medical devices in much the same way the Act authorized it to regulate food and drugs.

One of the ways Congress can displace state law is by saying so expressly. MDA had an express preemption provision, codified at 21 U.S.C. § 360k. That section prevents states from creating a “requirement” that is “different from” or “in addition to” a “requirement applicable under [MDA] to the device,” or “which relates to safety or effectiveness of the device . . . included in a requirement applicable to the device under [MDA].”

You’ve no doubt figured out where this is heading. What exactly does that shit mean? In particular, does it mean that compliance with FDA regulations promulgated under MDA immunizes the manufacturer of a medical device from state law tort liability on the ground that imposing such liability would constitute a state law “requirement” that’s “different from, or in addition to, any requirement applicable under [MDA]”?

That question came to the U.S. Supreme Court in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). There, a woman was injured when her Medtronic pacemaker malfunctioned on account of an allegedly defective lead (the component that carries the electrical current to the heart muscle), requiring emergency surgery. She and her husband filed a tort action in a Florida state court seeking money damages on negligence and strict liability theories based on the product’s design, manufacture and inadequate warnings.

Medtronic argued that MDA preempted all of plaintiffs’ state law tort claims. The Supreme Court produced three separate opinions that didn’t resolve much of anything. However, a majority of the Justices did agree that (1) state tort law can qualify as a “requirement” that § 360k would preempt, but (2) none of the claims in this particular case was preempted.

In May 1996, about a month before the Supreme Court decided Lohr, Charles Riegel underwent a balloon angioplasty designed to open a partially blocked coronary artery. The Medtronic balloon catheter used during the procedure burst, almost killing the patient and necessitating emergency coronary bypass surgery. Lengthy product liability litigation ensued, with Medtronic again claiming that § 360k preempts the plaintiffs’ claims.

What’s so different about the two cases that Medtronic’s lawyers (now headed by former Solicitor General Ted Olson) can claim with straight faces that an argument SCOTUS apparently rejected in 1996 is viable today? It has to do with differences in the FDA approval processes. As is true of a sizeable majority of medical devices, the pacemaker at issue in Lohr was approved under a rule allowing manufacturers to market medical devices by proving to the FDA’s satisfaction that the device is “substantially equivalent” to devices already on the market when MDA took effect in 1976. By contrast, the catheter at issue in Riegel received approval at the end of the FDA’s supposedly rigorous premarket approval (“PMA”) process. That distinction, Medtronic claims, makes all the difference.

In a 2-1 decision, the U.S. Court of Appeals for the Second Circuit mostly sided with Medtronic. See Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006) (pdf, 51 pages). All state law tort claims are preempted as to medical devices that survived the PMA process, so long as the device comports with the criteria on which FDA approval was based. Section 360k doesn’t preempt a negligent manufacturing claim based on the device’s failure to comport with the standards in its FDA-approved PMA application, but in this case the negligent manufacturing claim failed for lack of evidence.

Last year the Supreme Court agreed to hear Riegel and answer the following question:

Whether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. §360k(a), preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the Food and Drug Administration.

The parties’ briefs are available here courtesy of Public Citizen’s litigation group, which represents the plaintiffs. The Supreme Court held oral argument last month, and the transcript (pdf, 66 page) is available here.

It’s just a half-educated guess, but I suspect we’ll be seeing a very broad pro-preemption ruling here. So much the worse for consumers. Nothing keeps greedy product manufacturers in line like the threat of being compelled to pay for the harm they cause. Remove the threat, remove the incentive.

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  • iT  On January 10, 2008 at 9:06 am

    Great post. Please, no more three-month hiatuses.

  • genghishitler  On January 10, 2008 at 11:32 am

    Thanks, IT. And may I say that the new look Illusory Tenant is a thing of beauty, as is the always-first-rate commentary.


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