By: Lisa Butler
Imagine that you urgently need a life-saving medical
device. 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
assume that the FDA would not permit a manufacturer to market a
device that was unsafe or negligently designed. However, like
any other federal 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. And sometimes, those
risks result in serious injury or even death to the patient.
Imagine that because of an undetected design defect, you have
been seriously injured by the very device that was meant to restore
your health. Yet, after the failure of both the manufacturer
and the FDA, you are told that you have no recourse in the American
legal system. Your claims against the manufacturer are barred
by the legal doctrine of preemption because the FDA’s approved the
device. You become only a statistic and no one is held
accountable for the failure of the device. This is precisely
what happened to the plaintiff in the recent Third Circuit case,
Horn v. Thoratec Corporation.
In January 1998, Daniel Horn suffered a heart attack, and a week
later a medical device, known as the HeartMate, was implanted into
his body to aid blood circulation through his heart. Because
of a defect in the device’s design, Mr. Horn died. 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. 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 approval of the device. On appeal, the Court of
Appeals for the Third Circuit affirmed the District Court’s
ruling.
This note proposes that the Court of Appeals 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”). First, it is asserted 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.
Second, this note discusses the importance of the FDA’s view of
preemption and shows that the FDA regulations require a court to
evaluate each of the plaintiff’s tort claims before finding
preemption. Third, this note illustrates 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. Instead, the court gave only a bundled and cursory
examination to Mrs. Horn’s claims. Finally, a more exhaustive
analysis of Mrs. Horn’s claims shows that some, but not all, of the
claims should have survived preemption.