Law Commons^™

Corporate Misconduct In The Pharmaceutical Industry, Richard C. Ausness

Law Faculty Scholarly Articles

Sadly, many pharmaceutical companies have engaged in unethical or illegal behavior. The current opioid crisis is the most recent example of misconduct by pharmaceutical companies. Moreover, this pattern of conduct is neither rare, nor recent. Instead, it is long-standing and pervasive in nature. Furthermore, unlike wrongdoing by other businesses that cause primarily economic or environmental harm, wrongdoing by pharmaceutical companies, like that of asbestos or tobacco companies, may cause personal injuries and death on a large scale.

Causation And Apportionment Issues In Opioid Litigation, Richard C. Ausness

Law Faculty Scholarly Articles

In November 2019, an Oklahoma trial court judge, sitting without a jury, ruled that Johnson & Johnson and its subsidiary Janssen Pharmaceuticals were guilty of creating a public nuisance because their production and marketing of prescription opioid painkillers significantly contributed to the current opioid epidemic in the State of Oklahoma. The judge also held that Johnson & Johnson must contribute $65 million to pay for the State's program to abate this nuisance. Although the case has been appealed, it is significant because it was the first government sponsored opioid case to actually go to trial. Although there are many issues …

A Scholarly Life In Vistas: Marshall Shapo's Products Liability, Mary J. Davis

Law Faculty Scholarly Articles

To read and reread Professor Marshall Shapo’s products liability scholarship is to learn the important lesson of how to build a body of work that continually sees the same landscape from fresh vistas. Like watching the same landscape from different angles, during different seasons, and over several years, Professor Shapo’s vistas provide us with a remarkably vivid view of the products liability landscape over the past fifty years and beyond. In doing so, he has constructed a vision of the richness and promise of products liability law while continually reminding us to be aware of the vista from which we …

Time For A Fresh Look At Strict Liability For Pharmaceuticals, Mary J. Davis

Law Faculty Scholarly Articles

Part I provides a brief and basic explanation of pharmaceutical liability treatment. Part II explains the impact of federal preemption doctrine, which has dramatically limited the operation of tort law in pharmaceutical liability cases. Part III explains the parallel trends in the marketing and use of pharmaceuticals that increase the incidence of adverse drug events, affect prescribing practices, and fail to enhance informed practitioner and consumer choice in use of pharmaceuticals. Part IV provides support for the application of strict liability given the convergence of these trends. This Part also provides a theoretical justification for strict liability in tort for …

Sailing Under False Colors: The Continuing Presence Of Negligence Principles In "Strict" Products Liability Law, Richard C. Ausness

Law Faculty Scholarly Articles

Dean Prosser, in his celebrated article, The Assault Upon the Citadel, compared the assault on warranty law's privity requirement to an attack on a stoutly defended fortress during the Middle Ages. Since that time, another conflict has arisen among students of products liability, namely whether product sellers should be subject to strict liability or whether certain aspects of this field should instead be controlled by negligence principles. However, unlike the assault some sixty years ago on the privity requirement, this present conflict bears a greater resemblance to the protracted trench warfare of World War I than it does to the …

Gun Control Through Tort Law, Richard C. Ausness

Law Faculty Scholarly Articles

I have been asked to respond to an article by Professor Andrew Jay McClurg that recently appeared in the Florida Law Review. In this article, the author, a longtime advocate of firearms regulation, argues that owners and commercial sellers of firearms who negligently fail to secure them against theft should be held liable when persons are killed or injured by firearms used in the commission of a crime.

In the past, believing that existing federal and state laws were inadequate to halt the spread of gun-related deaths and injuries, proponents of stricter gun control measures proposed a number of tort …

“Danger Is My Business”: The Right To Manufacture Unsafe Products, Richard C. Ausness

Law Faculty Scholarly Articles

While no one would dispute that safety is a desirable objective, it may not always be an absolute priority. Rather, in some cases, other societal interests such as personal autonomy, consumer choice, product cost, and performance may trump legitimate safety goals. This is reflected in some of the doctrines and defenses that have evolved to protect the producers of unsafe products against tort liability. Some of these doctrines, such as those determining liability for the producers of optional safety equipment, inherently dangerous products, products with obvious hazards, and prescription drugs and medical devices, are part of the law of products …

The Role Of Litigation In The Fight Against Prescription Drug Abuse, Richard C. Ausness

Law Faculty Scholarly Articles

Prescription drug abuse problems have prompted a number of responses by both drug users (and abusers) and by various federal and state government agencies.

Part I of this Article examines the impressive array of liability theories that individual litigants have relied upon in their lawsuits against Purdue. These theories include: negligence; strict products liability, including design defect and inadequate warning claims; breach of the implied warranty of merchantability; violation of state consumer protection statutes; negligent marketing; fraudulent misrepresentation; civil conspiracy; and "malicious conduct." Purdue, the company that developed OxyContin, has pursued an aggressive "no settlement" policy and has chosen to …

"The Disorderly Conduct Of Words": Civil Liability For Injuries Caused By The Dissemination Of False Or Inaccurate Information, Richard C. Ausness

Law Faculty Scholarly Articles

This Article is concerned with the potential liability of those who disseminate false or inaccurate information that causes physical injury or property damage to those who rely upon it. However, this Article will not address the question of whether those who advocate or depict violence or other antisocial activities should also be subject to liability. For the most part, such publications are considered to be a form of constitutionally protected speech, even when they directly cause physical harm to others. Although the issue of liability for the publication of factually inaccurate information is narrower in scope than liability for the …

"Fasten Your Seat Belt, Orville!": Exploring The Relationship Between State-Of-The-Art, Technological And Commercial Feasibility, And The Restatement'S Reasonable Alternative Design Requirement, Richard C. Ausness

Law Faculty Scholarly Articles

This Article begins by examining some of the case law involving the state-of-the-art concept and finds that it is principally concerned with technological feasibility. It also concludes that most cases do not treat state-of-the-art as conclusive on the design defect issue; rather, they merely consider it one of several factors that the fact finder may take into account when deciding whether a product's design is defective or not. Part II is concerned with technological development. This part examines two basic patterns of technological development and provides a number of historical examples for each. The first is a linear pattern, exemplified …

Risky Business: Liability Of Product Sellers Who Offer Safety Devices As Optional Equipment, Richard C. Ausness

Law Faculty Scholarly Articles

This Article examines the question of whether (or when) product sellers should be allowed to offer optional safety equipment without fear of being held strictly liable for selling a defectively designed product. Part II of this Article examines several approaches to risk-bearing. At one end of the spectrum, the principle of personal autonomy dictates that consumers should decide how much risk they wish to accept. On the other hand, products liability law assumes that if consumers are allowed to subject themselves to greater risk, producers will be quick to take advantage of their inability to make rational decisions about what …

The Case Against Preemption: Vaccines & Uncertainty, Mary J. Davis

Law Faculty Scholarly Articles

This article begins with a brief recap of the state of current preemption doctrine and how it governs the interaction of federal regulation of product manufacturers and state tort actions related to the actions of those manufacturers. Second, the article provides observations on how that doctrine might apply to vaccine injury litigation. Bruesewitz v. Wyeth, Inc. involves the preemptive scope of the Vaccine Act and the unique compensation system Congress created to respond to vaccine injuries. Bruesewitz was decided on February 22, 2011, and held that design defect claims are expressly preempted by the Vaccine Act. This article endeavors …

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 …

Loss Of Parental Consortium: Why Kentucky Should Re-Recognize The Claim Outside The Wrongful Death Context, Collin D. Schueler

Law Faculty Scholarly Articles

The term "consortium" has been defined as "[t]he benefits that one person . . . is entitled to receive from another, including companionship, cooperation, affection, aid, [and] financial support." Under Kentucky law, "[e]ither a wife or husband may recover damages against a third person for loss of consortium, resulting from a negligent or wrongful act of such third person.” Furthermore, "[in] a wrongful death action in which the decedent was a minor child, the surviving parent, or parents, may recover for loss of affection and companionship that would have been derived from such child during its minority…” In Giuliani v. …

Product Liability's Parallel Universe: Fault-Based Liability Theories And Modern Products Liability Law, Richard C. Ausness

Law Faculty Scholarly Articles

Strict liability has always been the heart and soul of American products liability law. As early as 1963, Justice Roger Traynor in Greenman v. Yuba Power Products, Inc. stated that "[a] manufacturer is strictly liable in tort when an article he places on the market, knowing that it will be used without inspection for defects, proves to have a defect that causes injury to a human being." Shortly thereafter, the drafters of section 402A of the Restatement (Second) of Torts made it clear that the exercise of due care would not shield sellers from liability when their products caused injury. …

On Restating Products Liability Preemption, Mary J. Davis

Law Faculty Scholarly Articles

This Article provides a brief explanation of the state of preemption doctrine and explains how the Court altered, quite dramatically, its treatment of preemption of common law tort actions in the last two decades. The Court's almost exclusive focus on the interpretation of express preemption provisions, which never specifically address common law tort claims one way or the other, turned "traditional" preemption analysis of common law tort claims on its head. The Court then, almost as suddenly, signaled a retreat from the emphasis on express preemption analysis and returned, awkwardly, to implied preemption doctrine. The Court has only recently begun …

“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 …

Providing A Safe Harbor For Those Who Play By The Rules: The Case For A Strong Regulatory Compliance Defense, Richard C. Ausness, H. Lee Barfield, David A. King, Joshua R. Denton, Stephen J. Jasper

Law Faculty Scholarly Articles

On September 25, 2003, a fire broke out at the National Health Care (NHC) nursing home facility in Nashville, Tennessee, causing sixteen deaths and a number of injuries from smoke inhalation. Thirty-two victims subsequently filed suit against the nursing home, alleging that NHC was negligent for failing to install sprinklers in its facility. This claim was made notwithstanding the fact that applicable federal, state, and local safety regulations did not require the installation of sprinklers in this particular type of building, and notwithstanding that the NHC facility had been inspected by state fire inspectors just months before the fire and …

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 …

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 Welding Fume Case And The Preemptive Effect Of Osha’S Hazcom Standard On Common Law Failure-To-Warn Claims, Richard C. Ausness

Law Faculty Scholarly Articles

The Occupational Health and Safety Act (the OSH Act) affects more than ninety million workers in the United States. The OSH Act is administered by the Occupational Health and Safety Administration (OSHA), which promulgates health and safety standards for the workplace. Although OSHA standards do not regulate product manufacturers directly, they may affect liability when manufacturers are sued by workers who are injured by allegedly defective products provided by their employers. With increasing frequency, manufacturers are contending that the OSH Act or OSHA standards preempt these claims. In particular, manufacturers argue that the Hazard Communication Standard (HazCom Standard) should preempt …

“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, …

Products Liability In The Twenty-First Century: A Review Of Owen’S Products Liability Law, Richard C. Ausness

Law Faculty Scholarly Articles

Professor Richard C. Ausness reviews Products Liability Law, a treatise by David Owen.

Tell Me What You Eat, And I Will Tell Whom To Sue: Big Trouble Ahead For “Big Food"?, Richard C. Ausness

Law Faculty Scholarly Articles

Overweight consumers are seeking damages from purveyors of fast food for obesity-related health problems. Plaintiffs claim that products that are high in fat, sugar, salt and cholesterol are defective. Other potential liability theories include product category liability, failure to warn, failure to disclose nutritional information, deceptive advertising, and negligent marketing. However, in order to prevail at trial, plaintiffs must overcome problems with causation, duty and proximate cause, shifting responsibility, federal preemption, comparative fault, and assumption of risk. If such litigation is successful, it may induce fast-food companies to produce healthier products. Nevertheless, this Article concludes that the problem of obesity, …

Preemption Of State Tort Law By Federal Safety Statutes: Supreme Court Preemption Jurisprudence Since Cipollone, Richard C. Ausness

Law Faculty Scholarly Articles

This article shall attempt to trace the twists and turns of Supreme Court preemption jurisprudence. Part I provides a brief overview of federal preemption law, considering the constitutional sources of preemption and the traditional preemption categories. Part II analyzes Cipollone v. Liggett Group, Inc., the source of modem Supreme Court doctrine regarding preemption of state tort law by federal safety legislation. Part III reviews seven post-Cipollone Supreme Court preemption cases: CSX Transportation, Inc. v. Easterwood, Freightliner Corp. v. Myrick, Medtronic, Inc. v. Lohr, Norfolk Southern Railway Co. v. Shanklin, Geier v. American Honda Motor …

Public Tort Litigation: Public Benefit Or Public Nuisance?, Richard C. Ausness

Law Faculty Scholarly Articles

One of the latest developments in products liability law is "public tort" litigation. Public tort or government-sponsored lawsuits are actions by federal, state, or local government entities to recover the cost of public services provided to persons who have been injured as the result of a defendant's alleged misconduct. The best known example is the tobacco litigation of the mid-1990s in which more than forty states brought suit against the leading tobacco companies to recoup the cost of providing health care services to indigent smokers. Eventually, the tobacco companies agreed to pay the states more than $200 billion and also …

Tort Liability For The Sale Of Non-Defective Products: An Analysis And Critique Of The Concept Of Negligent Marketing, Richard C. Ausness

Law Faculty Scholarly Articles

This Article will evaluate the concept of negligent marketing to see whether it ought to become a part of our legal jurisprudence or whether it should be discarded as doctrinally unsound, possibly harmful to important social and economic interests.

Part II of this Article provides an overview of the negligent marketing theory. Negligent marketing can be divided into three categories: (1) product designs that make the product more attractive to criminals; (2) advertising and promotional activities that target inappropriate users; and (3) product distribution practices that facilitate retail sales of dangerous products to vulnerable or unsuitable users. The first category …

Unmasking The Presumption In Favor Of Preemption, Mary J. Davis

Law Faculty Scholarly Articles

It is inescapable: there is a presumption in favor of preemption. Historically, the Supreme Court has said differently-that, rather, there is a presumption against preemption. There is no such presumption any longer, if, indeed, there ever really was one. Preemption doctrine has been exceedingly puzzling in the last decade, but when one recognizes that the Court's doctrine not only favors preemption, but presumes it, preemption doctrine is not a puzzle at all.

This Article argues that the Supreme Court's recent preemption decisions compel the conclusion that the Court's preemption analysis has, in effect, created a presumption in favor of preemption, …

Will More Aggressive Marketing Practices Lead To Greater Tort Liability For Prescription Drug Manufacturers?, Richard C. Ausness

Law Faculty Scholarly Articles

Manufacturers of prescription drugs have begun to market their products more aggressively than they did in the past. These marketing efforts are not confined to health care professionals alone; pharmaceutical companies now engage in extensive direct-to-consumer advertising on radio and television, in the print media, and even on the Internet. While these promotional efforts no doubt increase sales, they may also lead to greater tort liability for drug-related injuries. The most likely theories of liability are failure to warn and negligent marketing. Liability for inadequate warnings will almost certainly increase if courts abandon the learned intermediary rule and require drug …

Trade Secrets, Non-Competes, And Unfair Competition, Office Of Continuing Legal Education At The University Of Kentucky College Of Law

Continuing Legal Education Materials

Materials from the conference on Trade Secrets, Non-Competes, and Unfair Competition held by UK/CLE in October 2001.