Food and Drug Law Commons^™

Direct-To-Consumer Advertising Of Prescription Drugs: After A Decade Of Speculation, Courts Consider Another Exception To The Learned Intermediary Rule, Mae Joanne Rosok

Seattle University Law Review

This Comment will explore whether Washington courts should recognize direct-to-consumer advertising as an exception to the learned intermediary rule. With the ultimate goal of advocating the best protection for the consumer, the discussion will suggest that Washington courts should not create an exception. A review of other exceptions to the learned intermediary rule does not support abandoning the doctrine when a drug company advertises its product directly to consumers. Nevertheless, advertising does affect consumer purchases and does influence consumer choices, and drug companies should accept the responsibility to present balanced information. This responsibility should encompass more than meeting the minimum …

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 …

Formed By Thalidomide: Mass Torts As A False Cure For Toxic Exposure, Anita Bernstein

Faculty Scholarship

No abstract provided.

Des Third-Generation Liability: A Proximate Cause, Tracey I. Batt

Cardozo Law Review

The drug DES has been associated with multigenerational injuries. Although courts in a number of states have allowed many second-generation DES victims to recover from the drug's manufacturers, this remedy, to date, has not been extended to thirdgeneration DES casualties. A number of reasons have been cited for this refusal, but the fear of requiring a drug manufacturer to be perpetually liable to descendants of those who ingested DES as well as the tricky issue of proximate causation predominate. This Note argues that at least some third-generation DES victims could (and should) be allowed to recover, without changing any laws …

Meeting The Objectives Of The Mda: Implied Preemption Of State Tort Claims By The Medical Device Amendments, Theresa J. Pulley Radwan

Journal of Law and Health

This article attempts to reconcile the competing purposes of the MDA, and to offer one alternative to effectuate Congress' purposes without preempting some claims and permitting others. First, this article will describe the arrangement of the MDA, including the classification provisions for medical devices and the preemption provision of the MDA. Next, this article will interpret the caselaw regarding preemption in general, and specifically preemption of state tort claims by the MDA. Finally, this article seeks to reconcile two competing purposes of Congress in enacting the MDA through implied preemption of state tort claims, with exceptions for devices which have …

Assembling A Theory Of Infringement: Third Party Liability Based On In Vivo Production Of Patented Pharmaceuticals, Eitan Alexander Ogen

Cardozo Law Review

This Note addresses the novel and still unresolved issues raised by the facts underlying Zenith. Part I describes the patent law system and its importance to the pharmaceutical industry. Part II discusses statutory interpretation issues raised by Zenith, relating to direct infringement and associated third party liability, as they pertain to the metabolic processes of living beings. Part III analyzes these issues in light of the existing case law. Part IV integrates the discussion by proposing a set of factors to be weighed in analyzing infringement actions against third parties that is consistent with the prevailing jurisprudence, the …

The Impact Of The Cipollone Case On Federal Preemption Law, Richard C. Ausness

Law Faculty Scholarly Articles

The United States Supreme Court handed down an opinion in the Cipollone case on June 24, 1992. Justice Stevens, writing for the majority, concluded that the Federal Cigarette Labeling and Advertising Act preempted all tort claims against cigarette manufacturers based on failure to provide adequate warnings about the health risks of smoking. However, the Court also held that claims based on breach of express warranty, misrepresentation, and conspiracy were not preempted by the Act. Thus, although Cipollone represents a clear victory for tobacco companies, it also leaves the door open for future litigation. The first part of this Article will …

Strict Liability In The Manufacture Of Pharmeceuticals: The Halcion Homicide, Martin J. Macneill

Brigham Young University Journal of Public Law

No abstract provided.

Judicially Imposed Liquor Liability And Developments In West Virginia Negligence Actions, R. Scott Summers

West Virginia Law Review

No abstract provided.

Strict Products Liability: The Original Intent, George L. Priest

Cardozo Law Review

No abstract provided.

Federal Preemption Of Prescrption Drug Labeling: Antidote For Pharmaceutical Industry Overdosing On State Court Jury Decisions In Products Liability Cases, 22 J. Marshall L. Rev. 629 (1989), John F. Del Giorno

UIC Law Review

No abstract provided.

Dralle V. Ruder: Did The Decision Close The Book On Recovery For Society And Companionship In Illinois Or Just Turn The Page, 22 J. Marshall L. Rev. 721 (1989), Frank I. Powers

UIC Law Review

No abstract provided.

Drug Product Liability And Health Care Delivery Systems, William M. Sage

Faculty Scholarship

This note will use the principles of law and economics to examine the interaction of market structures and product liability rules in a world of imperfect information. The goals of the analysis are to create incentives for optimal care by producers and consumers, induce the socially appropriate amount of consumption of each product (often referred to as the "activity level"), and minimize the costs of bearing the risk of injury. The note will conclude that the existence of health maintenance organizations ("HMOs") and similar prepaid providers with superior information capacity and total patient care responsibility may create a context in …

The Impact Of The Drug Export Amendments Act Of 1986 On Foreign Tort Victims, James C. Grant

Vanderbilt Journal of Transnational Law

In response to domestic pharmaceutical producers' demands, Congress amended the Federal Food, Drug, and Cosmetic Act (FFDCA) on November 14, 1986. The advantages of foreign drug producers over United States drug producers prompted Congress to enact the Drug Export Amendments Act of 1986 (DEAA) which was designed to help United States drug producers compete effectively in the world market. The DEAA now puts domestic producers on more of an equal basis with the rest of the market by allowing them to export unapproved drugs.

The first section of this Note will examine the new amendment and outline its requirements. Then, …

The Necessary Complement To Mandatory Immunizations: A National Vaccination Compensation Program, Barbara J. Connolly

Cardozo Law Review

No abstract provided.

Book Review Of Passion: An Essay On Personality , Richard F. Devlin Frsc

Articles, Book Chapters, & Popular Press

Passion is a cogently structured, compel Jingly argued and seductively enthralling masterpiece which, in years to come, will undoubtedly stand out as an inspirational source for many who seek social transformation. Unger's style, in this essay at least, is lucid and inviting. Substantively, Passion demonstrates not only the depth of his penetrating intellect but also his command of an array of' disciplines. Unger's polymathy is all the more impressive when we remember that ours is an era in which idiosyncratic specialization is the norm.

Charting The Future Course For Corporate Management Of Health Risks, Michael S. Baram

Faculty Scholarship

Corporations engage in technological activities of benefit to society, but thereby also create new health risks for workers, consumers, and communities. Government regulatory agencies deal with this chronic problem by conducting risk analyses and imposing various duties on private firms. Despite agency efforts and corporate compliance, health risks continue to arise and take their toll. To what extent will private firms voluntarily assume greater responsibility for preventing these health risks? This question is of increasing social importance, because the limitations of regulatory efforts are now obvious, whereas health risks are now being identified at what appears to be an increasing …

The Relevancy Of Drug Efficacy Evidence In Strict Liability Actions: Needham V. White Laboratories, Inc., 14 J. Marshall L. Rev. 629 (1981), Mary E. Kelly

UIC Law Review

No abstract provided.

Emerging Theories Of Proof In Products Liability: Resolving The Problem Of Identifying Des Manufacturers, Linda Mogul Madway

Villanova Law Review (1956 - )

No abstract provided.

Products Liability Based Upon Violation Of Statutory Standards, Joseph H. Ballway Jr.

Michigan Law Review

Regulatory enactments controlling production and distribution can give rise in several different ways to civil liability on behalf of persons injured by non-conforming merchandise. For instance, if a statute codifies existing common-law rules of negligence, its effect is merely to place the weight of legislative authority behind ordinary negligence principles. Since an injured party's recovery under such a provision still depends largely upon his proving in the traditional manner that a defendant failed to exercise due care, this kind of statute merits no further discussion. On the other hand, if particular legislation expressly states that a violator may be subjected …

Retail Druggist's Warranty Of Drugs, Thomas M. Schmitz

Cleveland State Law Review

Jurisdictions retaining a contractual warranty theory hold that a retail druggist warrants the wholesomeness, fitness, and merchantability of his products. This warranty applies to all drugs whether they are prescription drugs, proprietary drugs ,brand name drugs, or drugs sold in the original sealed containers. Liability for the sale of a prescription drug may be exempted if the patient relies on the physician's judgment, and liability for the sale of a brand name drug may be relieved if there is reliance on the manufacturer's reputation. Jurisdictions construing product warranty as a strict liability in tort will invariably hold a retail druggist …

The Basis Of Strict Products Liability, Reed Dickerson

Articles by Maurer Faculty

This paper was presented before the Division of Food Drug Cosmetic Law, Section of Corporation, Banking and Business Law of the American Bar Association at the Annual Meeting in St. Louis, August 9. It Is a companion paper to "Restatement or Reformation?" by William J. Condon, which appeared in the August, 1961 issue of this magazine. Mr. Dickerson Is Professor of Law at Indiana University and author of Products Liability and the Food Consumer.

Food Additives: Legal Recognition Of A Scientific Problem, Robert E. S. Post

Cleveland State Law Review

Food additives could create one of the nicest legal problems that courts have ever had to face. We are not concerned with theories of negligence, warranty, privity, or statutory interpretation as it applies to any of these three concepts. The real problem is twofold: establishment of harm arising from the presence of an additive or additives; and establishment of a judicial policy to contemplate the fact that, if and when such harm does befall someone, it will happen in spite of the utmost good faith on the part of the manufacturer, and in the face of legislative and administrative authorization …

Federal Food, Drug, And Cosmetic Act - 20 Years Of Health Protection, Irvin Kerlan

Cleveland State Law Review

Twenty years of major public health protection have been provided since enactment of the Federal Food, Drug, and Cosmetic Act of 1938. The Food and Drug Administration, a constituent of the United States Department of Health, Education, and Welfare, enforces this Act and thereby carries out the purpose of Congress to insure that foods are safe, pure, and wholesome, and made under sanitary conditions; drugs and therapeutic devices are safe and effective for their intended uses; cosmetics are safe and prepared from appropriate ingredients; and that all of these products are honestly and informatively labeled and packaged. Man and animals …

Torts-Liability Of Food Manufacturer To Ultimate Consumer, Michigan Law Review

Michigan Law Review

Plaintiff was injured by biting into a fishhook imbedded in a plug of chewing tobacco bought from an independent dealer and manufactured by defendant. There was evidence that another person had discovered a foreign particle in another plug made by defendant, but he did not know the exact identity of the substance. Held, that while the plaintiff's injury alone cannot raise an inference of negligence, the additional evidence of the second incident was sufficient to present the question to the jury, which found for the plaintiff. Caudle v. F. M. Bohannon Tobacco Co., 220 N. C. 105, 16 …

Sales - Nature Of Implied Warranty Of Fitness Of Food - Liability Of Intermediate Dealer, Michigan Law Review

Michigan Law Review

Plaintiff's husband purchased canned sauerkraut juice from a retail grocer, who, in turn, had purchased it from the defendant, a wholesale grocery company. The kraut juice, which had not been packed or canned by the defendant, contained deleterious substances that made the plaintiff ill. In an action for damages, the plaintiff recovered on the basis of an implied warranty of fitness for human consumption. Defendant appealed. Held, judgment sustained. Swengel v. F. & E. Wholesale Grocery Co., 147 Kan. 555, 77 P. (2d) 930 (1938).

Sales--Implied Warranty Of Canned Food, F. L. W.

West Virginia Law Review

No abstract provided.

Sales - Implied Warranty Of Fitness - Restaurateur

Michigan Law Review

Defendant, proprietor of a hotel and dining room, served unwholesome food to the plaintiff who became ill as a result of its impurity. The plaintiff sued for the damages resulting from his illness, on the theory that there was an implied warranty that the food was fit for human consumption. Held, the serving of food for immediate consumption on the premises was not a "sale" within the Uniform Sales Act, and therefore there was no warranty attached under the terms of the Act, and there was no implied warranty of fitness of food so served at common law. Lynch …

Torts - Negligence - Res Ipsa Loquitur As Applied To Foreign Matter In Foods

Michigan Law Review

The defendant manufactured and sold through a retailer a loaf of bread to the plaintiff's mother. The plaintiff, while eating the bread, saw a larva, five-eighths of an inch long in a slice she was about to eat, as a result of which she became sick. Held, on appeal, there was no error by the lower court in directing a verdict for the defendant on the ground that the plaintiff gave no sufficient proof of negligence, which was the basis of her action, and that negligence could not be presumed from the circumstances stated. Swenson v. Purity Baking Co. …

Sales-Absolute Warranty Of Purity Of Food--"Liability Without Fault"

Michigan Law Review

The plaintiff bought a bottle of Coca-Cola from a retailer; it was opened in his presence and he drank it at once. The bottle contained decomposed parts of a mouse or rat, and the plaintiff became violently ill after drinking the Coca-Cola. In an action against the manufacturer, held, that there was an absolute warranty of fitness for human consumption, and that the manufacturer was liable for the results of any impurities, regardless of whether or not he was negligent. Coca-Cola Bottling Works v. Simpson (Miss. 1930) 130 So. 479.