Introduction I. The FDA Approval Process and the Preemption Doctrine A. The FDA Approval Process B. The Preemption Doctrine 1. The Supreme Court's Express Preemption Doctrine a. Medtronic, Inc. v. Lohr b. Riegel v. Medtronic, Inc 2. The Parallel Claim Exception Carved Out in Riegel and Lohr B. Implied Preemption C. The Narrow Gap II. Diverging Doctrine in the Wake of Riegel A. Genuine Equivalency B. General or Device-Specific Requirement 1. Scope of Implied Preemption III. Arguments in Stengel v. Medtronic, Inc A. The General/Device-Specific Argument in Stengel 1. The Argument for a Circuit Split 2. The Argument Against a Circuit Split 3. The Argument for the General/Specific Distinction 4. The Argument Against a General/Specific Distinction B. The Implied Preemption Argument in Stengel 1. The Argument for a Circuit Split 2. The Argument Against a Circuit Split 3. The Argument for Implied Preemption 4. The Argument Against Implied Preemption IV. Why the Supreme Court Should Have Allowed Stengels' Claim to Survive Express and Implied Preemption A. Violations of Generally Applicable Federal Requirements Should Survive Preemption 1. There Is a Circuit Split on Whether a Federal Requirement must Be Generally Applicable or Device-Specific 2. Generally Applicable Requirements Should Escape Preemption a. Why Violations of Generally Applicable Requirements Should Have no Preemptive Effect b. Why Generally Applicable Requirements Should Fall Within the Parallel Claim Exception B. Traditional State Law Tort Claims Should Not Be Impliedly Preempted 1. There Is a Circuit Split on Whether State Law Tort Claims Are Impliedly Preempted 2. Traditional State Law Tort Claims Should Not Be Impliedly Preempted by Buckman 3. Policy Arguments Against the Implied Preemption of Traditional State Law Tort Claims Conclusion INTRODUCTION
In 2000, Richard Stengel had a SynchroMed EL Pump and Catheter manufactured by Medtronic implanted into his abdomen to deliver pain relief medication to his spine. (1) Five years later, Stengel began to experience ascending paralysis caused by a granuloma, or an inflammatory mass in his spine that formed at the tip of the catheter. (2) Surgeons then removed the catheter and most of the granuloma, but it was not in time. The granuloma that formed at the catheter tip had rendered Stengel permanently paraplegic. (3) Stengel has since died, allegedly from injuries he suffered in connection with the device. (4)
Richard Stengel is just one of the many people who have been injured by Class III medical devices. Class III medical devices are devices that either are used to sustain human life or present an unreasonable risk of injury. (5) In 2009, the FDA issued over 160 Class I recalls of medical devices. (6) Over the past year, over 500 medical-device related injuries and over 500 medical-device related deaths were reported to the FDA. (7)
Preemption externalizes the harms of medical devices from the manufacturers to the government and the public. (8) In fact, the failures associated with Medtronic's Sprint Fidelis Leads could cost the government and the public up to $1 billion dollars. (9) A Sprint Fidelis Lead is a pacemaker lead that provides an electrical conduit between a pacemaker and heart, and thereby shocks the heart back into a normal rhythm when it detects an abnormality. (10) After the Sprint Fidelis Lead was implanted into (150,000) patients, Medtronic issued a worldwide recall, and the FDA then issued a Class I recall due to the high failure rate associated with the leads. (11) Medtronic advised that the leads implanted into patients prior to the recall remain implanted because of the risks involved with surgically extracting the leads. (12) Instead of replacement, patients with the leads implanted are either closely monitored, or their leads are turned off, capped, and then replaced with another lead. (13)
Monitoring and replacing these leads impose significant health care costs. (14) Because about eighty-five percent of the people who were implanted with Sprint Fidelis Leads were on Medicare, the Medicare program has paid millions of dollars in replacement and monitoring costs. (15) If preemption did not exist--and manufacturers were forced to internalize these costs by facing potential lawsuits--Medtronic may have acted more quickly in addressing the defects in their leads. (16) Quicker action by Medtronic could have saved the public millions, or perhaps even $1 billion, in Medicare costs. (17)
In 2008, the Supreme Court in Riegel v. Medtronic, Inc. made it more difficult for plaintiffs to bring common law claims against manufacturers of Class III medical devices. (18) The Riegel court essentially preempted common law claims in which the manufacturer complied with FDA's pre-market approval process. (19) Plaintiffs, though, were not left without judicial recourse. The Court made clear that parallel claims or state-law claims premised on an FDA violation escape preemption. (20) However, the "contours of the parallel claim exception were not addressed in Riegel and are as-yet ill-defined." (21) Consequently, lower courts have adopted conflicting interpretations of the parallel claim exception, especially in regards to two issues. (22)
One issue that has plagued lower courts is whether a plaintiff must allege a violation of a generally applicable or a device-specific federal requirement to avoid express preemption. (23) While the Fifth, Sixth, Seventh, and Ninth Circuits have held that the federal requirement can be generally applicable, the Eighth and Eleventh Circuits have held that the requirement must be device-specific. (24)
Another issue that has been divisive for lower courts is whether traditional state tort law claims are impliedly preempted by Buckman Co. v. Plaintiffs' Legal Committee, (25) The Sixth and Eighth Circuits have impliedly preempted state tort law claims premised on a FDA violation. By contrast, the Fifth, Seventh, and Ninth Circuits have held that such state law tort claims are not impliedly preempted. (26) For the lower federal courts to be divided over this issue of federal law is problematic, as it is in contravention of Congress's intent to create a uniform framework for regulating medical devices. (27)
Stengel v. Medtronic, Inc. raised the very issues that have plagued lower courts, namely, whether a claim that a manufacturer failed to report adverse events fits within the parallel claim exception or is preempted, either expressly or impliedly. (28) The district court held that plaintiff's claims were expressly and impliedly preempted. (29) The Ninth Circuit affirmed, but then the full court reversed en banc. (30) Medtronic filed a petition for certiorari, arguing that the Supreme Court should clarify the contours of the parallel claim exception and overrule the Ninth Circuit's en banc decision. (31) Recently, the Supreme Court denied Medtronic's petition for certiorari, and thus the confusion surrounding the parallel claim exception continues. (32) Although the Supreme Court's rationale for denial of certiorari is unclear, it could have been persuaded by the respondents' arguments that Medtronic did not properly raise an argument below, or that the Ninth Circuit's decision lacked finality. (33)
This Note explores the split amongst the Circuits involving preemption of Class III medical devices and concludes that the Supreme Court should bridge the split in the near future. Part I provides a background on the FDA's statutory scheme and the Supreme Court's implied and express preemption doctrine in the context of medical devices. It also explores how claims that fit within the parallel claim exception avoid express or implied preemption. Part II of this Note explores the diverging interpretations to parallel claims that lower courts have adopted. Specifically, some courts have held that state law tort claims premised on an industry-wide violation are expressly or impliedly preempted, whereas others have held that such claims avoid preemption entirely. Part III outlines the arguments made in support and opposition of certiorari in Stengel. Finally, Part IV of this Note concludes that, based on sound public policy and precedent, traditional state law claims premised on violations of FDA regulations should survive both express and implied preemption.
THE FDA APPROVAL PROCESS AND THE PREEMPTION DOCTRINE
The Supreme Court decisions on preemption, as well as those of the lower courts, are based on their interpretations of The Medical Device Amendments of 1976 (MDA) to the Federal Food, Drug, and Cosmetics Act (FDCA). Accordingly, an understanding of the MDA's complex regulatory framework is crucial to understanding these court decisions. (34)
The FDA Approval Process
The MDA divides medical devices into three categories. (35) Class I devices, such as bandages, do "not present an unreasonable risk of injury" and thus are subject to only general controls, such as labeling requirements. (36) Class II devices pose a greater risk than Class I devices, and are subject to special controls, such as performance standards and post-market surveillance measures. (37) Class III devices, such as implantable pacemaker pulse generators and heart valves, pose the greatest risk and are subject to extensive regulations. (38) A device is classified as Class III if it cannot be classified as a Class I or Class II device, and the device is (1) "purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health," or (2) "presents a potential unreasonable risk of illness or injury." (39)
Class III medical devices must undergo a rigorous pre-market approval (PMA) process. (40) Manufacturers must submit the following to the FDA regarding Class III medical devices: (1) full reports of all studies that have been published or should reasonably be known by the manufacturer; (2) a full...