Law Commons^™

Sacrificial Lambs: Compensating First Subscribers To Fda-Approved Medications For Postmarketing Injuries Resulting From Unlabeled Adverse Events, Rodney K. Miller

Catholic University Law Review

No abstract provided.

Two Masters, Carl E. Schneider

Articles

American government rests on the principle of distrust of government. Not only is power within the federal government checked and balanced. Power is divided between the federal government and the state governments. So what if a state law conflicts with a federal law? The Constitution says that the "Constitution, and the Laws of the United States ... shall be the supreme Law of the Land; ... any Thing in the ... Laws of any State to the Contrary notwithstanding." Sometimes the conflict between federal and state law is obvious and the Supremacy Clause is easily applied. But sometimes ...

Generic Preemption: Applying Conflict Preemption After Wyeth V. Levine, Hannah B. Murray

Michigan Telecommunications & Technology Law Review

If a generic manufacturer does not have control over its safety warnings, can it comply with the obligations posed by state tort liability? State failure-to-warn actions evaluate whether a product manufacturer has met its obligation to warn consumers about known dangers associated with its product. In essence, if a manufacturer knows about a potentially dangerous outcome, it has a duty to warn its consumers. If the generic manufacturer can comply with a state duty to warn only by changing a label that the FDA will not allow it to change, it becomes impossible for the corporation to meet both requirements. …

Platitudes About Product Stewardship In Torts: Continuing Drug Research And Education, Lars Noah

Michigan Telecommunications & Technology Law Review

This Article focuses on one emerging aspect of tort litigation against pharmaceutical manufacturers that, if it gained traction, portends a dramatic (and potentially counterproductive) expansion in the prescription drug industry's exposure to liability. The traditional theories of products liability--mismanufacture, defective design, and inadequate warnings--no longer exhaust the potential obligations of sellers. In addition to increasingly popular claims of misrepresentation and negligent marketing, which seem more like extensions of the three defect categories than entirely novel theories, a growing chorus of commentators would impose on pharmaceutical manufacturers a broader duty to test and educate (aspects of what they call an obligation …

When And How To Defer To The Fda: Learning From Michigan's Regulatory Compliance Defense, Jason C. Miller

Michigan Telecommunications & Technology Law Review

Michigan's regulatory compliance defense properly recognizes that an FDA-approved drug carrying an FDA-approved label should not be considered defective. However, the statute's absolute immunity provides no compensation for injured parties in any circumstance, including situations where the FDA process has failed. Nevertheless, it is possible to treat the FDA's approval as significant without eliminating the possibility of all state actions against drug makers by providing a litigation back-up through state attorneys general ("AGs"). This Note examines the question of FDA approval in state tort actions in Part I, discusses Michigan's answer to that question in Part II, and offers a …

Conspiracy Theories: Is There A Place For Civil Conspiracy In Products Liability Litigation?, Richard C. Ausness

Law Faculty Scholarly Articles

A civil conspiracy is a group of two or more persons acting together to achieve an unlawful objective or to achieve a lawful objective by unlawful or criminal means. During the past two decades, plaintiffs have brought numerous civil conspiracy claims against product manufacturers. The defendants in these cases have included manufacturers or producers of tobacco products, asbestos, pharmaceuticals, lead-based paint, multi-rim truck wheels, and gasoline additives. Surprisingly, less than half of the civil conspiracy claims have made it to trial. This unimpressive success rate suggests that courts are not very receptive to civil conspiracy claims even when there is …

The (Legal) Pains Of Vioxx: Why Product Liability Can Make Products More Dangerous, Omri Ben-Shahar

Articles

Comparing the experience of Vioxx and Celebrex leads Omri Ben-Shahar to think that stiff product liability has the perverse effect of inducing manufacturers of defective products to leave these products on the market, rather than withdraw them.

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 …

The Proposed Products Liability Restatement: A Misguided Revision, Jerry Phillips

Touro Law Review

No abstract provided.

Unavoidably Unsafe Products And Strict Products Liability: What Liability Rule Should Be Applied To The Sellers Of Pharmaceutical Products?, Richard C. Ausness

Law Faculty Scholarly Articles

Injuries from adverse drug reactions have increased dramatically in recent years. This increase is largely attributable to the changing nature of pharmaceutical products. First of all, more pharmaceutical products are currently available to physicians than ever in history. Presently, there are more than ten thousand prescription drugs on the market, and each year four hundred to five hundred new ones are introduced. Second, modern drugs often are more potent than their older counterparts, thus increasing the likelihood of adverse reactions.

It should come as no surprise that this rise in the number of drug-related injuries has led to a comparable …