On December 4, 2007, the U.S. Supreme Court heard oral arguments in Riegel v. Medtronic Inc. The Court's much-anticipated decision—expected in July 2008—should provide a definitive resolution to the issue of federal preemption for medical devices approved by FDA under the premarket approval (PMA) path. This article provides background on previous cases and rulings leading up to the Supreme Court hearing of Riegel, as well as an analysis of several key arguments the judges will be weighing before making their final decision.

Prior to Riegel

In its final ruling, the Court will be deciding "whether the express preemption provision of the Medical Device Amendments to the Federal 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."¹

The medical device amendments state the principle that federal rules preempt requirements established under state law. This express preemption clause provides, in part, that no state may establish a requirement related to the safety or effectiveness of a device that is different from, or in addition to, the requirements contained in the medical device amendments.

More than a decade ago, the Supreme Court considered the issue of preemption in regard to medical devices cleared under FDA's requirements for premarket notification (510(k)) products. In 1996, in the case of Medtronic v. Lohr, the Court ruled that state-law tort claims brought by patients injured by medical devices cleared under FDA's 510(k) requirements were not preempted by the provisions of the Medical Device Amendments of 1976.^2,3

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 510(k) devices and those reaching market via the PMA path. The effect of the decision was to permit plaintiffs injured by 510(k) devices to bring certain state-law tort claims to recover damages for their injuries. However, in making a distinction between 510(k) and PMA devices, the Supreme Court left the preemption question as it relates to PMA devices unanswered. P>Until now, the Court had declined to make a ruling in regard to devices cleared via the more rigorous PMA path. However, Riegel is not the first time the Supreme Court had been asked to review the case of a plaintiff claiming injury by a PMA device. On nine prior occasions, the Supreme Court had declined to hear cases that posed a virtually identical question to that 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.

Riegel's Case

The device at issue in Riegel is Medtronic's Evergreen balloon catheter used by physicians during angioplasty to open patients' clogged arteries. Charles Riegel, now deceased, sued Medtronic for injuries he suffered when the balloon catheter burst during angioplasty. Contrary to the catheter's warning label, Riegel's physician inflated the device beyond its specified rate burst pressure. Moreover, the catheter was contraindicated for use in patients who, like Riegel, had diffusely diseased and heavily calcified coronary arteries. P>The federal district court dismissed Riegel's claims of negligence—other than that of negligent manufacture—strict liability, and breach of implied warranty on the grounds they were preempted by the medical device amendments. The negligent manufacturing claim was also dismissed, not on preemption grounds, but because the Riegels were unable to produce any evidence that the catheter was negligently manufactured.

The Second Circuit Court of Appeals affirmed the dismissals and 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." The court further concluded that successful state-law claims would result in state requirements that differed from, or added to, the PMA-approved standards.⁴ In short, the court declared that some of Riegel's state claims were preempted by the express preemption provision of the medical device amendments.

In narrowly defining its holding, the Second Circuit was clear that preemption applied only to those claims that might result in the imposition of state requirements that would differ from or add to federal requirements. As indicated by its handling of Riegel's negligent manufacturing claim, the court did not apply preemption to all state-law tort claims regarding PMA devices.

Interested Parties

Not surprisingly, the Riegel case has garnered a good deal of attention among politicians, advocacy groups, the legal community, and medical device manufacturers. In addition to the parties' briefs submitted to the Supreme Court, the U.S. Solicitor General—on behalf of FDA—submitted a brief in favor of express preemption.

Amicus curiae—or friend of the court—briefs were submitted in support of Riegel's position by Senator Edward M. Kennedy (D–MA), the American Association of Retired Persons, the Public Health Advocacy Institute, the Consumer Union of the United States, and a group of states, among others.

Briefs supporting Medtronic's pro-preemption position were submitted by industry association AdvaMed, the Product Liability Advisory Council, the U.S. Chamber of Commerce, the Washington Legal Foundation, and CropLife America.

On the day of the oral arguments, AdvaMed general counsel Christopher White issued a statement calling on the Supreme Court to reaffirm the two previous lower court rulings that made clear the medical device amendments expressly provide for FDA's ultimate regulatory authority in the matters at issue in Riegel.

"The safety and efficacy of medical technologies are best determined by Food and Drug Administration scientists—not by lawsuits filed in courtrooms across the country," White said. "Allowing states to serve as secondary regulatory bodies would undermine the established science-based review process in place for medical devices and diagnostics and slow down patient access to these lifesaving and life enhancing products.

"The comprehensive premarket approval process at FDA subjects medical devices to intense scrutiny at every stage of development and marketing—from clinical studies to real-world clinical use," he added. "A state-law liability approach to assessing safety and effectiveness would undermine this approach to patient safety. It also would override the specific intent of the U.S. Congress that FDA be responsible for the timely approval of safe and effective medical technologies."

Oral Arguments

During the hearing before the Supreme Court, Allison Zieve of the Public Citizen Litigation Group argued on behalf of Donna Riegel, the widow of Charles Riegel. Theodore Olson argued on behalf of Medtronic Inc., and U.S. deputy solicitor general Edwin Kneedler argued on behalf of FDA.⁵ During the hearing, some justices expressed the sentiment that states cannot institute requirements upon medical devices that are different from, or in addition to those imposed by the medical device amendments—the position vigorously being asserted by Medtronic and the larger medical device community. Other highlights of the hearing included the following points.

Distinguishing PMA Devices. Riegel's attorney argued that the analysis in Lohr should be applied in the case of Riegel because PMA devices do not differ from 510(k) devices. However, Justice Antonin Scalia observed that 510(k) devices are not specifically approved by FDA as safe and effective—rather, they are grandfathered in because of their similarity to previously approved devices. Thus, Justice Scalia said, FDA never weighed the risks against the benefits of the device in Lohr as it does before issuing a PMA.

Federal versus State. Medtronic and FDA argued it was not the intent of Congress to permit state court juries to decide the safety and effectiveness of medical devices. Rather, such a decision is the responsibility of FDA, and a state court jury's finding should not supplant FDA's expert judgment, they argued.

Jury Judgments. Justice Scalia voiced skepticism that a jury could possess the expertise needed to determine that a safer device could have been used in a given procedure. If juries were granted such power, he said, "the manufacturer is placed at risk in selling a device that scientists at FDA have said is OK."

Device Design. During the discovery phase of the litigation, there was little development of the specific design defect asserted by Riegel. However, Riegel's attorney argued—in response to a question from Justice Stephen G. Breyer—that the catheter should have been designed of a different material, different thickness, or to burst in a different way. The label, Zieve said, was inadequate because it was misleading as to the rate of burst pressure. Specifically, the label indicated that the product should not be inflated beyond 8 atmospheres, but it also featured a chart showing inflation of up to 13 atmospheres. However, Chief Justice John G. Roberts Jr. compared the chart to a car's speedometer; just because it goes up to 120 miles per hour does not mean the car is supposed to be driven that fast, he said.

Intent of Congress. Medtronic argued that it was Congress's intent to balance the reasonable safety and effectiveness of lifesaving devices with the availability of such devices to the public. The company noted that Congress vested the responsibility for such judgments with FDA, the expert voice on such matters. Justice Ruth Bader Ginsberg—relying in part upon the brief submitted by Senator Kennedy, who sponsored the Medical Device Amendments—responded that Congress's only intent was to "cut out state premarket approval where states, like California, came in when there was a federal void" and instituted their own premarket approval regulations.

New Risks. Medtronic and FDA both said that state-law tort claims should be preempted during the period of time between which a new potential device risk is discovered and the point at which FDA acts upon the new information. A manufacturer can continue to sell the device during this period while labeling or design changes are being considered, they argued, but the companies would face other criminal and civil penalties if it did not apprise FDA of the newly discovered risk.

FDA's Position. Justices John Paul Stevens and Ginsburg pointed out that FDA itself had previously taken an antipreemption stance. The solicitor general, on behalf of FDA, explained that FDA's 1997 antipreemption position did not last long. Seven months after taking an antipreemption stance, the agency reversed its position when it withdrew a proposed rule that opposed federal preemption for approved devices, he said. FDA did not address the issue again until 2004, when it filed an amicus brief on a pending appeal in a case involving a Class III PMA heart device.⁶ The solicitor general further argued that FDA's judgment, which should be given considerable deference by the Court, would be seriously undermined if a state court jury could reweigh the balancing that FDA performs when reviewing an application for premarket approval.

Conclusion

It is yet to be seen whether the Supreme Court will defer to FDA's current position as an advocate of preemption. Other considerations likely to influence the Court's decision are the political leanings of the bench and the underlying medical facts of the case—particularly that Riegel's physician inflated the catheter beyond the specified burst pressure. Whatever the court may decide, its ruling will ultimately determine whether a valid preemption defense against certain state-law tort claims is available for device manufacturers that receive FDA approval of a Class III device through the PMA process.

References

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

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

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

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

5. Riegel v. Medtronic Inc., oral arguments, U.S. Supreme Court (4 December 2007); available from Internet: www.supremecourtus.gov/oral_arguments/argument_transcripts/06-179.pdf.

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

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

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