Riegel v. Medtronic in Light of the Recent Trend in Preemption Cases: a Case for Amending the Medical Device Act

• Jurisdiction: United States,Federal
• Citation: Vol. 11 No. 2009
• Publication year: 2009

Julie C. Solms⁰

The Medical Device Act of 1976 governs the Food and Drug Administration's premarket approval process for medical devices. In Riegel v. Medtronic, Inc., the United States Supreme Court held that the Act preempts state tort claims against medical device manufacturers. This Recent Development contends that the Court appropriately decided Riegel in light of its recent trend towards a more textual approach to statutory interpretation in federalism cases in the administrative context. Post-Riegel decisions, however, are improper in view of legislative intent and unfavorably deprive plaintiffs of state tort remedies. Congress should now amend the Medical Device Act in order to clarify its purpose and to produce the effect originally intended.

I. Introduction

On December 4, 2007, Riegel v. Medtronic, Inc.¹ presented the United States Supreme Court with the issue of whether premarket approval ("PMA") by the Food and Drug Administration ("FDA") preempts state claims against the manufacturer of a medical device.² Just over two months later, the Court determined, based on the relevant language of the Federal Food, Drug and Cosmetic Act,³ that PMA of a device does preempt a state claim,⁴ a decision which this Recent Development contends is contrary to congressional intent.⁵ Although the modern trend of deciding federalism cases according to the theory of textualism⁶ properly led to the Riegel decision, the legislative intent behind the Medical Device Act ("MDA") makes it clear that legislation should be passed to invalidate the Riegel decision to preserve the originally envisioned protections.

Part II of this Recent Development outlines the FDA's PMA process and discusses the Riegel decision. Part III describes the Supreme Court's trend towards textualism⁷ and how this trend helps to explain the Riegel decision. Part IV discusses how the legislative history of the MDA⁸ would support the passage of legislation invalidating Riegel. Part V describes the post-Riegel world and explores some of the decisions' unfavorable consequences. Part VI introduces the proposed Medical Device Amendments of 2009⁹ and argues that these Amendments should be passed.

II. The FDA's Premarket Approval Process and Riegel v. Medtronic, Inc.

A. The FDA's Premarket Approval Process

Until the MDA¹⁰ was passed, the regulation of medical devices was largely left to the discretion of each state.¹¹ The Dalkon Shield intrauterine device was introduced in 1970, and its association with many deaths, serious infections, and pregnancies led to the filing of thousands of claims against the manufacturer.¹² Through this disaster, many saw the failure of the common law tort system to handle the risks associated with medical devices appropriately¹³ . Several states, including California, passed legislation requiring medical devices to be approved prior to their introduction into the market.¹⁴ In 1976, Congress passed the MDA which included an express preemption provision in § 360,¹⁵ stating that no state shall enforce any regulation "which is different from, or in addition to, any requirement applicable under this chapter to the device, and . . . which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter."¹⁶

The MDA created three classes of medical devices based on the risks of injury or illness associated with their use.¹⁷ Class III devices, such as the Evergreen Balloon Catheter in Riegel, discussed infra at Part II.B, require PMA by the FDA due to the serious risks they present.¹⁸ Manufacturers of new Class III devices must submit to the FDA a lengthy application, each of which requires approximately 1,200 hours of FDA review.¹⁹ After balancing the possible benefits with the potential risks of utilizing the device, the FDA may grant PMA only if it finds "reasonable assurance of [the device's] safety and effectiveness."²⁰

Not all Class III medical devices, however, are required to undergo this lengthy review process.²¹ Many devices that were on the market prior to the passage of the MDA were authorized to remain on the market without premarket approval until the FDA passed a regulation requiring PMA.²² Other new devices "need not undergo premarket approval if the FDA finds it is 'substantially equivalent' to another device exempt from premarket approval."²³ The FDA reviews such devices for substantial equivalence under a process described by § 510(k) of the MDA and aptly called the "section 510(k) process."²⁴

B. Riegel v. Medtronic, Inc.

The FDA's PMA process under § 360, specifically the express preemption provision in § 360(k), was at issue in Riegel. In 1996, Charles Riegel ("Riegel") suffered a myocardial infarction²⁵ and underwent coronary angioplasty²⁶ surgery.²⁷ His surgeon used an Evergreen Balloon Catheter²⁸ in an attempt to unblock a calcified artery.²⁹ In doing so, the surgeon overinflated the balloon, and the catheter burst.³⁰ Riegel then underwent emergency coronary bypass surgery after developing heart block³¹ and being placed on life support.³²

Riegel and his wife brought suit against Medtronic in April 1999,³³ alleging that Medtronic had violated New York common law by negligently designing, manufacturing, and labeling the catheter.³⁴ Through this negligence, the Riegels claimed, Medtronic had caused Riegel to suffer serious and permanent injuries.³⁵ The District Court held that the FDA approval of the Evergreen Balloon Catheter preempted the Riegels' claims of strict liability, breach of implied warranty, and "negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the catheter."³⁶ The Second Circuit Court of Appeals affirmed the District Court's decision because the Riegels' claims, "if successful[,] would impose state requirements 'different from, or in addition to' those imposed via PMA process."³⁷

Mrs. Riegel then appealed the case to the United States Supreme Court, which focused its decision on § 360k(a), the MDA's express preemption clause. The clause reads as follows:

[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.³⁸ Justice Scalia, writing for the majority, divided the issue into two parts: 1) whether the FDA regulations applied to the Medtronic catheter, and if so, 2) whether the Riegels' claims are based on New York regulations that are "different from, or in addition to" the FDA requirements, and whether the New York regulations "relate to safety and effectiveness."³⁹ The Court addressed the first issue by following the precedent established by Medtronic, Inc. v. Lohr,⁴⁰ determining that the PMA process established by § 360k(a)(1) focuses on the safety of a particular device, thus imposing "requirements."⁴¹ The Evergreen Balloon Catheter was approved via the PMA process, and therefore the safety of the Catheter had presumably been closely inspected. As such, Justice Scalia determined that the Riegels' claims were preempted by the MDA. Justice Scalia also adhered to the precedent set by Lohr when he discussed the second issue, stating that "common-law causes of action for negligence and strict liability do impose 'requirement[s]' and would be pre-empted by federal requirements specific to a medical device."⁴²

Justice Ginsburg dissented, focusing on the legislative intent of the MDA, and stating that "Congress, in [her] view, did not intend § 360k(a) to effect a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices."⁴³ She also focused on policy, stating that "[p]reemption analysis starts with the assumption that 'the historic police powers of the States [a]re not to be superseded . . . unless that was the clear and manifest purpose of Congress.' "⁴⁴ The goal of this assumption was to ensure that neither the courts nor Congress would inadvertently disturb the balance between federal and state laws.⁴⁵ The health and safety of citizens has generally been the concern of state governments,⁴⁶ and the federal government has traditionally deferred to state police powers "to legislate as to the protection of the lives, limbs, health, comfort, and quiet of all persons."⁴⁷

Justice Stevens concurred in part and concurred in the judgment based on a reconciliation of the majority opinion and the dissent.⁴⁸ While he agreed that Justice Ginsburg accurately laid out the historical foundation for and the congressional intent behind the MDA, Justice Stevens believed that "it is ultimately the provisions of our laws rather than the principal concerns of our legislators by which we are governed."⁴⁹ He therefore concurred with the majority in the judgment, believing that the text of the federal statute preempts the state claims.⁵⁰

III. Modern Trend in Federalism Cases: The Reasoning Behind Riegel

Although Part VI argues that the MDA should be amended in order to avoid the preemption of legitimate state claims against medical device manufacturers in the future,⁵¹ this Recent Development does not contend that the Supreme Court was out of line in deciding Riegel as it did. While the Riegel decision does not fall in line with a legislative intent approach to statutory interpretation,⁵² the Supreme Court appropriately decided the case in light of its recent trend of taking a textualist approach to statutory interpretation in federalism cases. The issue of federalism in the administrative context has recently drawn more notice than usual due to the Supreme Court's decision of several such cases since 2000, most recently in the 2009 term.⁵³ In the context of...