GOVERNMENTAL & LEGAL AFFAIRS

It has been 11 years since the U.S. Supreme Court heard the case of Medtronic v. Lohr. In that case, the Court 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 principle that federal rules preempt requirements established under state law (sect. 360k(a)). This express preemption clause provides, in part, that no state may establish with respect to a medical device any requirement that “is different from, or in addition to . . . any requirement under this act” and that “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 U.S. 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 other words, agreed to hear the appeal—in the case of Riegel v. Medtronic. The Court will decide “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

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

The Path to Riegel

Riegel is not the first time the Supreme Court has been asked to review the case of a plaintiff claiming injury by a PMA device. On nine prior occasions, the Supreme Court declined to hear cases that posed a virtually identical question to that now under consideration in Riegel—that of whether PMA device manufacturers have a preemption defense to most state-law claims.

Seven of the 11 federal circuit courts of appeals have faced this question and have decided that a preemption defense is available to manufacturers of PMA devices for most state-law tort claims. Only the 11th Circuit has decided otherwise.

Some of the unsuccessful plaintiffs in these cases, and others who have been unsuccessful in the highest appeals courts of their home states, have gone on to ask the Supreme Court for review during the time when FDA publicly held the position that the medical device amendments did not have a preemptive effect on state-law tort claims. FDA's position seemed not to have swayed the Supreme Court.

Riegel's Case

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 balloon catheter burst during angioplasty. 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. The federal district court dismissed Riegel's claims of negligence (other than negligent manufacture), strict liability, and breach of implied warranty on the grounds that they were preempted by the medical device amendments. The negligent manufacturing claim was also dismissed, for reasons unrelated to preemption.

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; 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 on Riegel's Case (and Others Like It)

On behalf of FDA, the U.S. solicitor general argued that the Supreme Court need not hear Riegel's appeal because the Second Circuit's decision was correct.⁵ This argument represents a continuation of FDA's revised position, first publicly stated in 2004, after years of holding an antipre-emption interpretation of section 360k(a).

The agency's earlier statement came at the invitation of the Third Circuit Court of Appeals to file an amicus brief on a pending appeal in a case involving a Class III PMA heart device. In that brief, FDA publicly switched its position and argued in favor of the preemptive effect of the medical device amendments on certain state-law claims.⁶

As it did in 2004, FDA argued against Riegel's petition on the grounds that premarket approval does establish federal device-specific requirements that preempt conflicting state-law requirements. A jury verdict on a state-law claim, FDA argued, would impose state requirements related to the safety and efficacy of the PMA device that would differ from the specific federal requirements. For example, a jury verdict finding that a PMA device's labeling was defective, or inadequate, would conflict with FDA's approval of that device's label.

FDA further contended that it is the expert, and it would undermine the regulatory scheme established by Congress to permit a jury deciding a state-law claim to determine if an FDA-approved PMA device is defectively designed or labeled. FDA even went so far as to state that its pre-2004 position was “erroneous.” In doing so, the solicitor general explained that FDA's pre-2004 position did not reflect the highly detailed nature of the process by which FDA reviews PMA applications and the resultant approval order, or the constraints that a PMA places on manufacturers that subsequently want to change a device's specifications.

Lastly, the solicitor general argued that FDA's prior position did not coincide with the agency's current risk-management principles, which now recognize that overwarning can discourage product use to the detriment of public health. Thus, the solicitor general concluded, the Second Circuit was correct in holding that premarket approval of Med-tronic's Evergreen balloon catheter imposed specific federal requirements that preempted inconsistent state duties sought to be imposed through state tort law.

FDA before Riegel

This position was an about-face for FDA, which, in 1998, announced a contrary position when it submitted an amicus brief to the Supreme Court at the Court's invitation.⁷Smith Industries Medical Systems Inc. v. Kernats consolidated the cases of three plaintiffs, each of whom claimed injury from a chorionic villus sampling catheter, a Class III device used to test for genetic abnormalities during early pregnancy. In two of those cases, the catheter was used under an investigational device exemption provision; in the third, it was used after a PMA order had been obtained.

In the Kernats brief, FDA argued that the express preemption provision of the medical device amendments did not preempt state-law tort claims concerning PMA devices. On behalf of FDA, the solicitor general distinguished between meeting minimum standards and meeting specific federal requirements beyond the PMA order. FDA argued that the medical device amendments' minimum standards applicable to medical devices “will typically not result in preemption of state tort claims.”

In essence, FDA's position was that premarket approval of a device was not a specific federal requirement unless FDA imposed a precise specification on the approval of the device above and beyond the PMA order. That precise design specification resulted in the preemptive effect of the PMA order. The PMA order itself, without this specification, did not.

The solicitor general reasoned that a manufacturer can select a design for a device that will meet minimum standards, and obtain premarket approval based upon that selection, if approved by FDA. However, because there is no specific substantive requirement on the design, there is no specific federal requirement that preempts state-law requirements.

Does the Supreme Court Care?

The Supreme Court was silent as to why it agreed to hear the Riegel appeal. FDA's current view aligns with that of most federal circuit courts of appeals that have had this issue before them. And in July, with the Riegel appeal pending, Wisconsin's highest court, relying in part upon FDA's revised 2004 position, agreed that the medical device amendments are preemptive.⁸

Since FDA's change of heart, Riegel is the third attempt to convince the Supreme Court to decide the preemption question.^9,10 The court had also declined opportunities to decide this issue during the time FDA held the position against the preemptive effect of the medical device amendments. Perhaps, then, the Supreme Court's decision to hear Riegel was not affected by FDA's current, or wavering position.

While it may do so, it is unclear whether the Supreme Court will defer to or give any weight to FDA's current thinking on preemption.¹¹ The Court's decision will ultimately turn on its interpretation of the express preemption provision of the Medical Device Amendments of 1976—and whether it agrees with FDA, the majority of federal appeals courts, and some state courts of appeals, which have found that FDA approval of a Class III device through the PMA process constitutes federal device-specific requirements providing a valid preemption defense for device manufacturers.

References

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

2. Medical Device Amendments of 1976 to theFood, Drug, and Cosmetic Act, 21 USC 360k(a).

3. Riegel v. Medtronic, no. 06-179.

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

5. Riegel v. Medtronic Inc., no. 06-179, WL1511526 (2007).

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

7. Smith Industries Medical Systems Inc. v. Kernats, cert. denied 118 S.Ct. 684, no. 96-1405 (1998).

8. Blunt v. Medtronic Inc., WI App. Lexis 667 (2007).

9. McMullen v. Medtronic Inc., cert. denied 126 S.Ct. 1464 (2006).

10. Knisley v. Medtronic Inc., cert. denied 126 S.Ct. 420 (2005).

11. United States v. Mead Corp., 121 S.Ct. 2164, 2171 (2001).

Caryn M. Silverman is a partner in the law firm of Sedgwick, Detert, Moran & Arnold LLP (New York City).

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