It has been 11 years since the U.S. Supreme Court heard the case of Medtronic v. Lohr, and ruled that state-law tort claims brought by patients injured by medical devices cleared under FDA's requirements for premarket notification (510(k)) products were not preempted by the provisions of the Medical Device Amendments of 1976.^1,2

The medical device amendments state the principal that federal rules preempt requirements established under state law (Sec. 360k(a)). This express preemption clause provides, in part, that no state may establish with respect to a medical device any requirement "which is different from, or in addition to . . . any requirement under this act" and "which relates to the safety or effectiveness of the device."

In the Lohr case, which involved a Class III pacemaker cleared to market via the premarket notification path, the Supreme Court drew a distinction between such 510(k) devices and those reaching market via the more-rigorous premarket approval (PMA) path. The effect of the Lohr decision was to permit plaintiffs injured by 510(k) devices to bring certain state-law tort claims to recover damages for their injuries.

But until now, the Supreme Court had not agreed to decide whether state claims involving devices approved through the PMA process were preempted.

All of this changed at the end of June, when the Supreme Court granted certiorari in the case of Riegel v. Medtronic, to determine "whether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 USC 360k(a), preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the Food and Drug Administration."³

On nine prior occasions, the Supreme Court had declined to hear cases that posed a virtually identical question. Most federal courts of appeals have decided that a preemption defense is available to manufacturers of PMA devices for most tort claims. Only one, the 11th Circuit, has declined to extend preemption.

Riegel, till Now

The device at issue in the case of Riegel v. Medtronic is the company's Evergreen balloon catheter, a PMA device used by physicians during angioplasty to open patients' clogged arteries. Charles Riegel sued Medtronic for injuries he suffered when the catheter being used by his physician burst.

The Evergreen balloon catheter was contraindicated for use in a patient like Riegel, who had a diffusely diseased and heavily calcified coronary artery. Moreover, contrary to the product's warning label, Riegel's physician inflated the device beyond its specified rate burst pressure.

Riegel asserted state common law causes of action, including negligent design, testing, inspection, distribution, manufacture, marketing, sale, and labeling; strict liability; breach of express warranty; and breach of implied warranty. Medtronic moved to dismiss these claims.

The federal district court held that Riegel's claims of negligence (other than negligent manufacture), strict liability, and breach of implied warranty were preempted by the medical device amendments, and were thus dismissed.

The court also dismissed Riegel's claim of negligent manufacturing, but not because it was preempted. Instead, the court dismissed this claim because there was evidence that the catheter burst because it had been inflated beyond the rate burst pressure, because it had encountered a calcium spicule in Riegel's artery, or some combination thereof.

The Second Circuit Court of Appeals agreed and affirmed the dismissals (the dismissal of the express warranty claim, on other grounds, was not appealed).⁴ In doing so, it concluded that the Evergreen balloon catheter "was subject to the federal device-specific requirement of complying with the particular standards set forth in its approved PMA application," and that successful state-law claims would "result in state 'requirements' that differed from, or added to" the PMA-approved standards. Thus, certain state claims by Riegel were preempted by the express preemption provision of the medical device amendments.

In narrowly defining its holding, the Second Circuit was clear that its decision should not be construed to mean that all state-law tort claims regarding PMA devices are preempted (as indicated by its handling of Riegel's negligent manufacturing claim). Rather, preemption applies only to those claims that impose state requirements that differ from or add to federal requirements.

Riegel, who petitioned the Supreme Court to hear the case, argued generally that FDA approval of the Evergreen balloon catheter imposed no device-specific requirements. Consequently, state-law requirements did not differ from or add to those requirements; and thus, the Second Circuit's decision was incorrect.

Riegel also argued that the decision unreasonably leaves patients injured by PMA devices with no opportunity to bring suit to recover monetary damages, and Congress did not intend its provision to preempt all state-law claims.

FDA Turnabout

Medtronic and the U.S. solicitor general, on behalf of FDA, argued that the Supreme Court need not hear Riegel's appeal because the Second Circuit's decision was correct.

It was argued that premarket approval does establish federal device-specific requirements that preempt conflicting state-law requirements; the majority of federal courts of appeals deciding cases regarding PMA devices have held correctly that state-law claims that conflict with specific federal requirements of the PMA approval are preempted; the decision is consistent with congressional intent; the decision is "quite limited," as the Second Circuit wrote, in that it only affects a very small percentage of Class III devices undergoing the PMA process; and finally, injured consumers are not left without recourse.

This was an about-face for FDA. In 1998, the agency took a contrary position in its amicus brief to the Supreme Court, which was filed at the court's invitation.⁵ In that brief, FDA argued that the express preemption provision of the medical device amendments did not preempt state-law tort claims concerning PMA devices.

In 2004, when the Supreme Court again invited the agency to file an amicus brief on a certoriari petition in a case involving a Class III PMA heart device, FDA publicly switched its position to argue in favor of the preemptive effect of the medical device amendments on certain state-law claims.⁶ The Supreme Court declined to hear the case in question.

In the case of Riegel v. Medtronic, the Supreme Court's decision will turn, in large part, on its interpretation of the express preemption provision of the Medical Device Amendments of 1976—and whether it agrees with the majority of federal appeals courts that FDA approval of a Class III device through the PMA process constitutes federal device-specific requirements.

The case is scheduled to be heard during the Supreme Court's October 2007 term.

References

1. Medtronic v. Lohr, 518 U.S. 470 (1996).

2. Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act.

3. Riegel v. Medtronic Inc. (No. 06-179).

4. Riegel v. Medtronic Inc., 451 F.3d 104 (2d Cir. 2006).

5. Smith Industries Medical Systems Inc. v. Kernats, cert. denied, 522 U.S. 1044 (1998) No. 96-1405.

6. Horn v. Thoratec, 376 F.3d 163 (3d Cir. 2004), No. 02-4597.

Caryn M. Silverman is a partner in the law firm of Sedgwick, Detert, Moran & Arnold LLP.

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