The Presumption Against Implied Preemption: How State Law Fraud-on-the-FDA Claims Complement, Rather Than Conflict With, Federal Law
Imagine an individual who visits his or her doctor after developing a hernia. The doctor informs the individual of a new implant-or mesh-that involves minimally invasive surgery with very little healing time. Many individuals would not hesitate to accept this offer. However, after the surgery, the individual experiences painful side effects and ultimately must undergo subsequent surgeries to remove the defective implant. Following remedial action, the individual files suit against the manufacturer of the implant-or rather the manufacturer of the medical device-alleging multiple state common law claims for monetary compensation and punitive damages for pain and suffering. Whether courts will allow such claims to survive is the focal point of this Note and the current circuit split regarding the preemptive effect of the Medical Device Amendments to the Food, Drug, and Cosmetic Act. While the Medical Device Amendments include an express preemption provision, allowing courts to maneuver within the limits of its possible interpretations, the question of whether claims are impliedly preempted requires a much more technical and in-depth analysis from the courts. Buckman Co. v. Plaintiffs' Legal Committee laid the framework for the contours of implied conflict preemption, and how and to what extent implied preemption may be invoked. Buckman held that "state-law fraud-on-the-FDA claims" are impliedly preempted by the Medical Device Amendments because, inter alia, such claims "inevitably conflict with the FDA's responsibility to police fraud consistently with the Administration's judgment and objectives." However, this holding is susceptible to attack; state-law fraud-on-the-FDA claims should not be so readily held as preempted. These claims undoubtedly assist the FDA in policing fraud, and such claims should be available for injured plaintiffs when medical device manufacturers fail to fully comply with FDA rules and regulations during premarket approval or postmarket requirements. This Note discusses the unfair and unjust application of implied preemption as applied to state common law claims of fraud-on-the-FDA. Part I will examine the societal need that prompted the creation of the Medical Device Amendments with respect to premarket approval of Class III medical devices. Part II will discuss the current state of the law, addressing the Riegel, Lohr, and Buckman cases, as well as highlight the current split among circuits with regard to implied conflict preemption. Part III proffers that state-law fraud-on-the-FDA claims should ultimately survive preemption and become a readily available avenue for injured plaintiffs to obtain recourse and hold manufacturers responsible for negligent and/or intentional unlawful conduct. Finally, this Note concludes by reiterating the importance of state-tort law in the realm of medical device regulation; for without such common law avenues, medical device manufacturers would be on track to receive complete immunity from tort liability.
The Presumption Against Implied Preemption: How State Law Fraud-on-the-FDA Claims Complement, Rather Than Conflict With, Federal Law,
45 Fla. St. U. L. Rev.