Law Commons^™

Medical Device Artificial Intelligence: The New Tort Frontier, Charlotte A. Tschider

Faculty Publications & Other Works

The medical device industry and new technology start-ups have dramatically increased investment in artificial intelligence (AI) applications, including diagnostic tools and AI-enabled devices. These technologies have been positioned to reduce climbing health costs while simultaneously improving health outcomes. Technologies like AI-enabled surgical robots, AI-enabled insulin pumps, and cancer detection applications hold tremendous promise, yet without appropriate oversight, they will likely pose major safety issues. While preventative safety measures may reduce risk to patients using these technologies, effective regulatory-tort regimes also permit recovery when preventative solutions are insufficient.

The Food and Drug Administration (FDA), the administrative agency responsible for overseeing the …

Check Please: Using Legal Liability To Inform Food Safety Regulation, Alexia Brunet Marks

Publications

Food safety is a hotly debated issue. While food nourishes, sustains, and enriches our lives, it can also kill us. At any given meal, our menu comes from a dozen different sources. Without proper incentives to encourage food safety, microbial pathogens can, and do enter the food source--so much so that according to the Centers for Disease Control and Prevention (CDC), each year roughly one in six Americans (or forty-eight million people) gets sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases. What is the optimal way to prevent unsafe foods from entering the marketplace?

Safety in the food …

Drug-Drug Interaction Alerts: Emphasizing The Evidence, Sharona Hoffman, Andy Podgurski

Faculty Publications

Many analysts and users of contemporary clinical decision support ("CDS") systems have expressed grave concerns about the technology’s efficacy and functionality. Alerts generated by CDS systems are often inaccurate, and an excess of alerts leads some physicians to experience "alert fatigue" and to turn off CDS altogether. This article formulates recommendations to improve drug-drug interaction (DDI) alerts.

The paper comments upon a proposal by Susan Ridgely and Michael Greenberg, who call for the development of a consensus-based "clinically significant drug-drug interaction list" that could generate limited liability protection for users. We argue that instead of creating a list of always-contraindicated …

The Impact Of Wyeth V. Levine On Fda Regulation Of Prescription Drugs, Richard C. Ausness

Law Faculty Scholarly Articles

On March 4, 2009, the United States Supreme Court decided Wyeth v. Levine. In that case, the Court concluded that the plaintiff's failure to warn claim against the makers of the drug Phenergan was not impliedly preempted by the Food, Drug and Cosmetic Act (FDCA). In doing so, the Court rejected the argument of the U.S. Food and Drug Administration (FDA) that tort claims of this nature stand as an obstacle to federal regulatory objectives. This article evaluates the Court's opinion in Wyeth and examines that decision's impact on subsequent litigation in the area of prescription drug labeling. In …

Wyeth V. Levine And Its Implications, Brian Wolfman

Georgetown Law Faculty Publications and Other Works

The U.S. Supreme Court’s decision in Wyeth v. Levine sharply limited the availability of implied preemption as a defense in pharmaceutical cases. In this Analysis & Perspective, attorney Brian Wolfman discusses the decision and its implications for prescription drug litigation as well as litigation in other areas that are regulated by the federal government.

After Wyeth, Wolfman says, a defendant in a prescription drug case must demonstrate a ‘‘tight fit between the labeling change proposed by the manufacturer (and rejected by the FDA) and the labeling change that the plaintiff contends would have prevented her injuries.’’ Moreover, he says, …

Fda Regulatory Compliance Reconsidered, Carl W. Tobias

Law Faculty Publications

Many observers consider the Food and Drug Administration (FDA) vital for the protection of consumer health and safety. One hundred years ago, Congress established the entity that would become the FDA and authorized it to regulate foods and drugs, critical responsibilities that the agency has long discharged carefully. Throughout the past century, the FDA's regulatory power has expanded systematically, albeit gradually, while legislatures and courts in the fifty American jurisdictions broadened liability exposure for manufacturers that sold defective products that injured consumers. Observers have recently criticized the agency for overseeing pharmaceuticals too leniently, even as states increasingly narrowed manufacturers' liability …

“There's Danger Here, Cherie!”: Liability For The Promotion And Marketing Of Drugs And Medical Devices For Off-Label Uses, Richard C. Ausness

Law Faculty Scholarly Articles

Physicians often prescribe prescription drugs and other medications for uses that are not approved by the Food and Drug Administration ("FDA"), and such "off label" prescription is widely accepted within the medical community as a legitimate form of treatment. However, the federal government discourages off-label prescription and use in various ways. For example, the FDA restricts the dissemination of information by drug companies about potential off-label therapies. In addition, federally funded health insurance programs such as Medicaid do not reimburse health care providers for off-label uses. Because drug companies make large profits from off-label prescriptions, they are often tempted to …

The Battle Over Implied Preemption: Products Liability And The Fda, Mary J. Davis

Law Faculty Scholarly Articles

A mere five years ago, the Food and Drug Administration (the "FDA") began, for the first time in its 100-year history, to take the position that its prescription drug labeling regulations defeated the ability of injured plaintiffs to pursue common law tort claims based on the adequacy of the labeling. This position, radical to many and rational to others, places federal preemption of prescription drug labeling actions directly in the center of the debate over the proper roles of federal regulation and state tort laws in promoting product safety. The U.S. Supreme Court has contributed to this debate with several …

Reprocessing Single-Use Medical Devices: The State Of The Debate, Brian E. Ray, Mark Hermann

Law Faculty Articles and Essays

Reprocessing single-use medical devices is a growing but controversial industry subject to an increasingly complex and fast-developing set of regulations and a wide range of unresolved legal issues.

“After You, My Dear Alphonse!”: Should The Courts Defer To The Fda’S New Interpretation Of § 360k(A) Of The Medical Device Amendments?, Richard C. Ausness

Law Faculty Scholarly Articles

Under the provisions of the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act certain medical devices are subject to premarket approval of the Food and Drug Administration (FDA). Section 360k(a) of the MDA provides that states may not establish “any requirement” which relates to safety or effectiveness of a medical device and "which is different from, or in addition to" any requirement imposed by the FDA. Until recently, the FDA maintained that § 360k(a) did not preempt most common law tort claims; however, in recent amici briefs, the FDA has aggressively asserted that most, if not all, …

Prescription Drug Design Liability Under The Proposed Restatement (Third) Of Torts: A Reporter's Perspective, James A. Henderson Jr.

Cornell Law Faculty Publications

No abstract provided.