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Full-Text Articles in Food and Drug Law
The Opioid Litigation: The Fda Is Mia, Catherine M. Sharkey
The Opioid Litigation: The Fda Is Mia, Catherine M. Sharkey
Dickinson Law Review (2017-Present)
It is readily agreed that federal preemption of state tort law alters the balance between federal and state power. Federal preemption is a high-profile defense in almost all modern products liability cases. It is thus surprising to see how little attention has been given to federal preemption by courts and commentators in the opioid litigation. Opioid litigation provides a lens through which I explore the role of state and federal courts and the Food and Drug Administration (FDA) in striking the right balance of power. My purpose here is not to resolve the divide among the few courts that have …
A Prescription Warning, Carlton Lee Harpst
A Prescription Warning, Carlton Lee Harpst
Pepperdine Law Review
No abstract provided.
California Expands Tort Liability Under The Novel Market Share Theory: Sindell V. Abbott Laboratories, N. Denise Taylor
California Expands Tort Liability Under The Novel Market Share Theory: Sindell V. Abbott Laboratories, N. Denise Taylor
Pepperdine Law Review
The California Supreme Court, in the novel and unprecedented case of Sindell v. Abbott Laboratories, eliminated the plaintiffs burden of identification of a negligent party, and thus the causation requirement, in a multiple party tort action. In the course of this decision, the court adopted the "market share" theory of liability which dictated in Sindell that nonidentifiable defendant-manufacturers of the generic drug DES would be liable for the damages in proportion to their share of business in the market. The author thoroughly examines various theories of recovery, such as "alternative liability," "concert of action" and "enterprise liability," which the court …
Fixing The Vaccine Act's Structural Moral Hazard, Brandon L. Boxler
Fixing The Vaccine Act's Structural Moral Hazard, Brandon L. Boxler
Pepperdine Dispute Resolution Law Journal
The article presents information on the Vaccine Injury Compensation Program. It discusses the U.S. Federal circuit case Hazlehurst v. Sec'y of Health & Human Servs., in which lawsuit against the defendant was filed by the plaintiff who sought claims against the liability of product to recover damages for alleged injuries which his son had received from vaccines. It also provides information on the structural moral hazard of the program which devolves it into a litigious adjudicatory process.
Uncertainty And Informed Choice: Unmasking Daubert, Margaret A. Berger, Aaron D. Twerski
Uncertainty And Informed Choice: Unmasking Daubert, Margaret A. Berger, Aaron D. Twerski
Michigan Law Review
This Article will first examine why it is that plaintiffs have been unable to prove causation under the Daubert guidelines in toxic tort litigation. Second, it will look at the two existing models for informed choice litigation medical malpractice and products liability-and demonstrate why neither of these models gives toxic tort plaintiffs a fair opportunity to recover for the deprivation of patient autonomy against drug manufacturers who have breached their duty to warn of known or knowable risks. Finally, this Article will explore the elements of a causation-free informed choice cause of action. It will suggest the appropriate standard for …
Statutory Compliance And Tort Liability: Examining The Strongest Case, Michael D. Green
Statutory Compliance And Tort Liability: Examining The Strongest Case, Michael D. Green
University of Michigan Journal of Law Reform
Professor Green addresses the matter of the proper balance between the tort system and regulation in the context of prescription drugs and the FDA's vigorous oversight of the industry. He articulates several reasons why a regulatory compliance defense, in which tort law would defer to FDA regulation, is quite attractive. Despite the superior expertise of the FDA in assessing the benefits and risks of a drug, a regulatory compliance defense is considerably more problematical than might appear at first glance. Ascertaining compliance with FDA requirements could be a lengthy and complicated inquiry that would either replace or supplement the issues …