Academic journal article Fordham Urban Law Journal

The Contours of the Parallel Claim Exception: The Supreme Court's Opportunity to Define the Ill-Defined

Academic journal article Fordham Urban Law Journal

The Contours of the Parallel Claim Exception: The Supreme Court's Opportunity to Define the Ill-Defined

Article excerpt

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. …

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