Riegel v. Medtronic

From ScotusWiki

Jump to: navigation, search

Authorship: This page is maintained by Stanford Law student Anna Neill.

Contents

[edit] Briefs and Documents

Docket: 06-179

Argument Transcript

AFFIRMED in an opinion by Justice Scalia.

Merits briefs

Amicus briefs

Certiorari Stage

[edit] Pre-Argument Articles

[edit] Argument Preview

The Court granted certiorari in this case on June 25, 2007 to consider “[w]hether 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.”

[edit] Background

Charles and Donna Riegel sued Medtronic for injuries Charles Riegel sustained when the Medtronic Evergreen Balloon Catheter used by his physician burst during an angioplasty procedure, requiring advanced life support and an emergency coronary bypass procedure.

The Riegels’ claims alleged that the catheter had been negligently designed, labeled, and manufactured, that Medtronic was strictly liable for Riegel’s injuries, and that the company had breached express and implied warranties.

Medtronic moved for summary judgment, arguing (inter alia) that the Riegels’ claims were preempted because the Food and Drug Administration (FDA) had approved the catheter pursuant to its premarket approval (PMA) process. The PMA process is codified in the 1976 Medical Device Amendments (MDA), 21 U.S.C. § 360c et seq., to the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., which substantially broadened the FDA’s authority to regulate medical devices. The specific provision at issue, 21 U.S.C. § 360k(a), provides, with respect to medical devices, that no state may establish any “requirement” that is “different from” or “in addition to” any federal requirement, or “which relates to safety or effectiveness of the device” included in a requirement applicable under the MDA

The district court granted summary judgment in part, holding that all of the Riegels’ claims were preempted except for those based on negligent manufacturing and express warranty. Following discovery, Medtronic moved for, and the district court granted, summary judgment on the remaining claims, which are not at issue here.

The Riegels appealed the preemption ruling to the Second Circuit. In a 2-1 decision, that court affirmed, holding both that the PMA process imposes device-specific preemptive “requirements” within the meaning of § 360k(a) and that the Riegels’ design and labeling claims are sufficiently “device-specific” to warrant preemption. Importantly, the court found that these claims “do not rest on the premise that the particular catheter” used during Mr. Riegel’s surgery was not in compliance with the standards approved by the FDA PMA, but rather that the “liability-creating premise of all of these claims is that the Evergreen Balloon Catheter itself, in its present PMA-approved form, is in some way defective.” Thus, the court observed, manufacturers of PMA devices would be in an untenable position if claims such as the Riegels’ were not preempted, as they would have to comply with federal regulations but could still be liable even when in full compliance.

Judge Pooler dissented. In her view, express preemption is a question of congressional intent, and there was no evidence that Congress intended the PMA procedures to preempt state-law damages claims. She observed that the majority opinion overlooked two important aspects of preemption: the presumption against preemption and congressional intent. Finding that both of these weigh against a finding of preemption in the PMA process, she would not have found the Riegels’ claims to be preempted here.

[edit] Petition for Certiorari

The Riegels filed a petition for certiorari, which was granted on June 25, 2007. They urged the Court to grant cert. because the Second Circuit’s decision below cannot be reconciled with the Supreme Court’s 1996 decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which addressed the MDA and preemption of state law claims. In Lohr, the majority held that (1) the MDA did not broadly preempt all state or local requirements that are equal to, or substantially identical to, requirements imposed under federal law; (2) state-law defective design claims were not preempted even though the FDA had cleared the device at issue for marketing under the “substantial equivalence” process outlined in 21 U.S.C. § 510(k); (3) claims were not preempted to the extent that they alleged that the manufacturer negligently failed to comply with duties equal to, or substantially identical to, federal requirements; and (4) claims based on allegedly defective labeling and marketing were not preempted.

Arguing that Lohr allows state-law damages suits notwithstanding the MDA, petitioners argued that their claims should not have been deemed to be preempted by the PMA process. Moreover, they asserted, the federal and state appellate courts are deeply divided regarding the proper application of Lohr to the question of preemption under the PMA process. While acknowledging that the majority of the federal courts of appeals that have considered the issue have agreed with the Second Circuit, petitioners pointed out that the Eleventh Circuit and the Illinois Supreme Court have held that the PMA approval process does not preempt state-law damages claims. They also contended that the divergent holdings of state and federal courts is particularly problematic, especially in states where claims would not be preempted in state court but would be in federal court. Finally, petitioners asserted that a finding of preemption leaves patients injured by medical devices without any remedy at all, a result which is inconsistent with the purpose of the MDA, which was enacted in response to the highly publicized Dalkon Shield injuries to make medical devices safer.

Opposing certiorari, Medtronic countered that the Court had denied petitions for certiorari raising identical issues to petitioners’ five times in the past five years, and that the reasons for denying cert. here were even stronger than in past years. Contrary to petitioners’ contention that the lower courts were sharply divided on the preemption question, Medtronic described “a clear and growing consensus” among the lower courts that, pursuant to Lohr, FDA approval of a medical device under the PMA process preempts conflicting state law claims based on the design, manufacture, and labeling of the device. Respondent asserted that all recent decisions in the federal courts of appeals and in state courts of last result—namely, the Seventh, Sixth, Eighth, and Fifth Circuits and the states of Texas, Rhode Island, and Pennsylvania—have reached the same conclusion as the Second Circuit in this case. Medtronic acknowledged some “vestigial inconsistency” in the lower courts’ interpretations of Lohr, but it argued that this inconsistency is likely to disappear without the Court’s intervention. This is particularly so, respondent emphasized, in light of the recent position taken by the United States—in an amicus brief filed in the Third Circuit in 2004—that the PMA process does result in preemption.

On November 6, 2006, the Solicitor General was invited to submit a brief expressing the views of the United States. In that brief, the government contended that cert. was not warranted because the Second Circuit’s decision was correct. The PMA process, as the Second Circuit found, creates federal “requirements” for approved medical devices, and the imposition of tort liability based on the defective character of the device would subject the manufacturer to state law requirements that were different from (or in addition to) the federal requirements. While acknowledging both that the Eleventh Circuit and the Illinois Supreme Court have reached a contrary result and that its current position is in conflict with an amicus brief filed in the Supreme Court by the federal government in 1998, the government posited that the minority courts may now reconsider their earlier decisions in light of the government’s position in its 2004 amicus brief in the Third Circuit.

[edit] Merits Briefs

In their brief on the merits, petitioners argue that application of the traditional rules of statutory construction demonstrate the narrow reach of § 360k(a). Emphasizing that the Supreme Court generally does not construe a federal statute to preempt state law claims in the absence of clear preemptive language and intent, petitioners contend that the MDA does not explicitly mandate preemption. Additionally, petitioners allege that the Court has already determined that the MDA does not preempt state-law damages claims such as theirs: in Lohr, it held that the MDA preempts a state-law claim only when the claim corresponds to some device-specific federal requirement and the state law was developed “with respect to” such devices. Here, not only does the PMA not create device-specific requirements (it merely approves them), but the general common-law duties that apply to petitioners’ claims would certainly not be device-specific.

Petitioners also argue that the Court in Lohr unanimously agreed that state-law claims which seek to enforce duties substantially identical to federal requirements (as opposed to those that seek to enforce requirements that are “different” or “in addition to” federal requirements) are not preempted, and that their claims would only impose “identical” requirements. Finally, petitioners stress that—contrary to the Second Circuit’s assumption that the effect of preemption of state law remedies for those injured by medical devices will be limited—many patients are in fact injured by medical devices. Because federal law does not provide an independent damages remedy, the only recourse these injured patients have is through the state law tort system.

Respondent Medtronic urges the Court to affirm the decision below. It argues that the PMA process does in fact impose device-specific requirements, as it involves a rigorous and substantive evaluation of the device and prohibits a manufacturer from later modifying a PMA-approved device in any way that could affect its safety or effectiveness. Because the PMA process is far more thorough and comprehensive than the § 510(k) “substantial equivalence” process at issue in Lohr, the Court’s decision in Lohr actually supports respondent’s position. Respondent also contends that the Second Circuit correctly held that, if petitioners’ claims were allowed to proceed, state law would effectively impose additional “requirements” that are “specific” to the Evergreen Balloon Catheter and are expressly preempted by § 360k(a).

Respondent next argues that because it was not raised below, petitioners have waived any argument that their claims seek to enforce duties substantially identical to federal requirements. In any event, however, such an argument is unavailing because petitioners’ claims that the Evergreen Balloon Catheter was defective under state law are completely at odds with the requirements imposed by the PMA, with which the catheter complied fully. In conclusion, respondent contends that preemption for PMA-approved devices furthers the aims of the MDA by providing uniform regulatory standards that allow the innovation of safe and effective medical devices.

The United States filed an amicus brief supporting respondent. In addition to echoing Medtronic’s argument that the PMA process preempts petitioners’ claims because it imposes device-specific requirements, and the state law claims would seek to impose requirements that are different from and in addition to the federal requirements, the government’s brief also contends that a contrary finding would interfere with the FDA’s expert balancing of the health risks and benefits of medical devices.

Amicus briefs were filed on behalf of petitioners by New York et al., The Public Health Advocacy Institute et al., Edward M. Kennedy et al., The Consumers Union of United States, Inc., The American Association for Justice and Public Justice, and AARP et al.

In addition to the brief of the United States, amicus briefs were submitted on behalf on respondent by The Chamber of Commerce of the United States of America, CropLife America et al., The Washington Legal Foundation, the Product Liability Advisory Council, Inc., and The Advanced Medical Technology Association et al.

[edit] Oral Argument Recap

A transcript of the argument is available here.

Allison Zieve, arguing on behalf of the petitioner, began by discussing the PMA process and stressing what PMA is and what it isn’t. Notably, Ms. Zieve argued, the FDA grants the PMA if the information submitted by the manufacturer meets the statutory standard of reasonable assurance of safety and effectiveness, but it is the manufacturer, not the FDA, that chooses the design, labeling, and manufacturing practices. Justice Kennedy expressed a concern that if state-law damages claims were not preempted, the jury, in determining if a device was unreasonably hazardous, would be asked to engage in the same balancing already undertaken by the FDA during the PMA process. Justice Scalia followed up on that point by stressing that in Lohr, unlike here, the jury was not simply revisiting the same inquiry already addressed by the FDA. Justice Ginsburg inquired how the PMA process for devices compares with FDA drug approval, to which Ms. Zieve responded that, for drugs, FDA approval is a defense on the merits but not preemptive of claims. Justice Scalia pressed on this point, and seemed skeptical of the assertion that the States would be free to enforce additional requirements on drugs beyond those of the FDA, so long as those requirements did not conflict with the federal requirements; Justice Scalia seemed to think that field preemption would prevent the States from enacting such requirements on drugs.

Turning to the question of when preemption would be found based on PMA, Justice Ginsburg posed a hypothetical situation in which a manufacturer sought to improve a device, but the FDA denied approval, and then someone brought suit based on the failure to make that improvement. Ms. Zieve agreed that, if 360k(a) ever preempts tort claims, that hypothetical would be such a situation. Chief Justice Roberts followed up by posing the question of what would happen if a manufacturer knew of a design that was superior to its already PMA-approved device, but would not be able to market the new improved device immediately (because it would need to first go through the PMA process itself) – would it then be negligent to continue selling the old device? If so, then the manufacturer would have to remove it from the market, which would injure patients because no device would be available in the interim.

Theodore Olson argued next on behalf of the respondent. Mr. Olson immediately returned to Justice Kennedy’s line of questioning regarding the balancing that the FDA engages in when it weighs the safety and efficacy of a device against the public need for such a device. Mr. Olson stressed that Congress made the decision to trust this balancing to the expertise and the judgment of the FDA, and that further state-law requirements are preempted because they would make the process confusing and burdensome. Justice Ginsburg asserted that all of the same arguments could be made about new drugs, but Congress had failed to expressly preempt tort claims for drugs; accordingly, it could be argued that the preemption provision in 360k(a) was not meant to preempt tort suits, but rather state pre-market approval procedures that might conflict with the FDA process. Mr. Olson responded that regardless whether state requirements are created through a state pre-market approval process or through jury verdicts, the results would be the same and Congress’s intent to allow the FDA to balance the interests would be thwarted. In response to questioning by Chief Justice Roberts about newly discovered safety concerns that were not before the FDA during the PMA process, Mr. Olson replied that the FDA PMA process is ongoing, with reporting requirements for the manufacturers and options for doctors to report problems as well. It is then up to the FDA to decide if the risks outweigh the benefits and, if so, they can revoke the PMA. Mr. Olson agreed that a negligent manufacture claim (such as when the claim is that the manufacturer failed to comply with PMA requirements) would not be preempted by 360k(a), but said that in this case that claim was dismissed on summary judgment for lack of evidence. Justice Ginsberg expressed concern that once manufacturers receive the PMA, there would be a lack of incentives to improve their devices. Mr. Olson responded that the market would always encourage manufacturers to seek to create better and safer devices.

Edwin Kneedler argued next for the United States. Mr. Kneedler began by imagining what the consequences would be if 360k(a) was not preemptive; he said that the States would be free to impose requirements that might be in direct conflict with the requirements of the FDA. Justice Ginsburg again wanted to know why, if it were so important, no such express preemption was needed for new drugs. While Mr. Kneedler tried to offer a justification based on the differences between medical devices and drugs, Justice Scalia offered the obvious response that these provisions were enacted by different Congresses. In response to questioning from Justice Kennedy about what remedies exist for a manufacturer who fails to notify the FDA of known safety problems that arise after the PMA process, Mr. Kneedler responded that criminal penalties for failure to comply with the FDA, along with important reputational interests in providing safe products, would serve to keep manufacturers from hiding problems.

In her rebuttal, Ms. Zieve was questioned by Justice Souter regarding where petitioner would draw the line for preemption under 360k(a). Ms. Zieve responded that the States cannot enact positive law that imposes requirements on medical devices, but that jury awards under state tort actions are not preempted.

[edit] Opinion Analysis

[edit] Links and further information

[edit] Press

[edit] From the Blogosphere

[edit] SCOTUSblog

Court Asks for Advice on Medical Devices (Nov. 6, 2006)

Upcoming SG Invitation Briefs

Three More Invitation Briefs

[edit] Video

American Constitution Society panel discussion on Riegel v. Medtronic (Nov. 1, 2007)

Retrieved from "http://www.scotuswiki.com/index.php?title=Riegel_v._Medtronic"
Personal tools