Imagine that you urgently need a life-saving medical device. What questions would you ask your physician? Would you want to know what your available options are? Would you ask if the model that your doctor selected has ever been reported to fail? Would you ask how thoroughly the Food and Drug Administration (”FDA”) investigated the selected device before approving it for sale in the United States? Most Americans are unaware of the importance of asking any or all of these questions.1 Most of us would simply trust the choice of our physician, believing that he or she is sufficiently informed about the device’s safety profile to make the best choice.2 In addition, most Americans assume that the FDA would not permit a manufacturer to market a device that was unsafe or negligently designed.3 However, like any other administrative agency, the FDA has limited financial and human resources. Sometimes, despite the most thorough evaluation possible, a device poses risks that were not evident during the FDA approval process.4 Tragically, those risks can result in serious injury or even death to the patient.

Imagine further that because of a defect undetected by both the manufacturer and the FDA you have been seriously injured by the very device that was meant to restore your health. Yet, you are told that you have no recourse in the American legal system because the FDA’s approval of the device bars your claims against the manufacturer via the legal doctrine of preemption. This is precisely what happened in the recent Third Circuit case, Horn v. Thoratec Corp.

In January 1998, Daniel Horn suffered a heart attack.6 A week later, a medical device, known as the HeartMate, was implanted into his body to aid blood circulation through his heart.7 Because of a defect in the device, air entered the closed system and an air embolus traveled to Mr. Horn’s brain, ultimately causing his death.8 Mrs. Horn, as executor of Mr. Horn’s estate, brought common law tort claims against the manufacturer in the United States District Court for the Middle District of Pennsylvania.9 The district court dismissed the case, finding Mrs. Horn’s state claims preempted because they would impose requirements on the manufacturer that were different from, or in addition to, the requirements imposed by the FDA’s approval process.10 On appeal, the Court of Appeals for the Third Circuit affirmed the district court’s ruling.11

This Comment proposes that the Third Circuit was too hasty in finding that Mrs. Horn’s state tort claims were preempted by the Medical Device Amendments to the Food, Drug and Cosmetic Act (”MDA”). Part I will explain the background of the MDA and the preemption defense, and will describe the Horn decision. Part II will demonstrate that the presumption against preemption, as informed by the legislative intent and the statutory structure of the MDA, supports the conclusion that Mrs. Horn’s state tort claims should not have been deemed preempted. Part III will discuss the importance of the FDA’s view of preemption and will show that FDA regulations require a court to evaluate a plaintiffs tort claims individually before finding preemption. Part IV will illustrate that the Horn court did not adequately evaluate the nature of each of Mrs. Horn’s tort claims to determine whether they would impose requirements different from or in addition to those imposed by the FDA. Finally, a more exhaustive analysis of Mrs. Horn’s claims will show that some-but not necessarily all-of the claims should have survived preemption.

I. MDA PREEMPTION OF STATE CLAIMS IN HORN v. THORATEC

A. Background of the Preemption Defense and the Medical Device Amendments

The American tort system has two major functions. First, it is a “vehicle of legal redress” for victims who have been injured at the hands of another.12 second, it deters wrongful or negligent conduct with the threat of large damage awards.13 Within this system, every manufacturer is under a common law duty to use due care to avoid foreseeable dangers in the products that it sells.14 However, where the product at issue is federally regulated, manufacturers often argue that state common law tort claims must be preempted by the federal regulation.

Preemption is the doctrine under which federal law supersedes state law by operation of the Supremacy Clause of Article VI of the United States Constitution.16 When a court upholds the preemption defense in a products liability controversy, the injured party is often left with no legal recourse.17 Therefore, it is imperative that a court evaluate Congress’ intended scope of preemption,18 each of the plaintiffs claims, and the applicable federal requirement before deciding that a conflict exists.

Congress enacted the MDA in 1976 in response to injuries caused by a contraceptive device known as the Dalkon Shield.19 With new, more complicated devices entering the market, Congress sought to protect the public health by “assuring] the reasonable safety and effectiveness of medical devices intended for human use.”20 Although Congress also noted its intention to encourage the development of new medical devices by instituting a uniform regulatory scheme, commentators have recognized that the chief goal of the MDA was the protection of public health.