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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.

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 …

"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 …

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. …

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 …

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, …

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 …

The Application Of Product Liability Principles To Publishers Of Violent Or Sexually Explicit Material, Richard C. Ausness

Law Faculty Scholarly Articles

There have been a number of tragic incidents during the past few years in which mentally unstable teenagers have carried guns into school and shot teachers and fellow students. These schoolyard killings have generated an intense debate about the problem of violence in our society. Some social commentators have attributed teenage violence to the widespread availability of firearms, while others blame parental neglect, lack of discipline in the schools, or the declining influence of religion and morality in contemporary culture. However, another source of concern is the popular media, which stands accused of purveying sex and violence on a massive …

When Warnings Alone Won’T Do: A Reply To Professor Phillips, Richard C. Ausness

Law Faculty Scholarly Articles

In his paper, Professor Phillips contends that questions about the adequacy of a product's design should be resolved by the use of a risk-utility test and that the existence of an adequate warning should merely be one factor for the jury to take into account. This is essentially the position espoused by the Restatement (Third) of Torts: Products Liability (hereinafter Third Restatement), section 2, comment l. On the other hand, Professor PhiIlips is very critical of subsections 6(c) and 6(d). These provisions establish liability for the sellers of prescription drugs and medical devices. Section 6(c), which is concerned …

Toward Justice In Tobacco Policymaking: A Critique Of Hanson And Logue And An Alternative Approach To The Costs Of Cigarettes, Richard C. Ausness, Paul A. Lebel

Law Faculty Scholarly Articles

Much of tobacco policymaking has been driven by economic and political forces. Professors LeBel and Ausness offer an alternative approach to tobacco policymaking that places justice concerns at the center of the analysis. Their article presents a detailed critique of a significant recent work by Professors Hanson and Logue advocating extensive tobacco industry liability on economic efficiency grounds. Asserting that a “fresh start” is necessary, LeBel and Ausness identify the interests at play in the tobacco policy arena. Instead of an ambiguous "interest balancing" approach, they construct a policy model that grounds those interests in justice considerations, demonstrating how claims …

Mass Tort Litigation: Congress's Silent, But Deadly, Reform Effort, Mary J. Davis

Law Faculty Scholarly Articles

This article explores the ways in which The Common Sense Product Liability and Legal

Reform Act (“Act”) treats mass tort litigation issues. The Act does so both directly and indirectly. The direct methods of reform are mostly industry-specific and, thus, almost inconsequential in contrast to the indirect treatment. The indirect, almost clandestine, methods of reform are the most insidious and provide the most cause for concern as Congress once again attempts to "reform" products liability by reintroducing the Act in 1997. Given the President's early indication that a reform measure could meet with his approval, but that this one in …

The Case For A "Strong" Regulatory Compliance Defense, Richard C. Ausness

Law Faculty Scholarly Articles

Federal administrative agencies have established safety standards or licensing procedures for airplanes, motor vehicles, pesticides, drugs, medical devices, and a variety of other products. At the same time, product sellers are subject to tort liability even though their products comply with applicable federal safety standards. Product sellers maintain that compliance with federal safety standards ought to protect them from liability under state tort law and have relied upon several legal principles to support this claim. The first, and most successful, theory is federal preemption. Under this concept, Congress may expressly or impliedly assert the primacy of federal law under the …

Federal Preemption Of State Products Liability Doctrines, Richard C. Ausness

Law Faculty Scholarly Articles

Federal agencies now regulate the manufacture, design, and labeling of hundreds of consumer products. For example, the Consumer Product Safety Commission promulgates "consumer product safety standards" for a number of consumer products. Likewise, the National Traffic and Motor Vehicle Safety Act of 1966 authorizes the National Highway Transportation Safety Administration to develop safety standards for automobiles and other motor vehicles. Additionally, the Food and Drug Administration (FDA) exercises extensive control over prescription drugs, biologics, medical devices, and over-the-counter drugs. The FDA also regulates food labeling.6 Finally, Congress has established statutory labeling requirements for cigarettes, smokeless tobacco products, and alcoholic beverages. …

Kentucky Law Survey: Torts, Richard C. Ausness

Law Faculty Scholarly Articles

This issue of the Survey of Kentucky tort law includes recent decisions on false imprisonment, intentional infliction of emotional distress, and products liability. The first case, Consolidated Sales Co. v. Malone, held that Kentucky's shoplifter detention statute authorized a personal search of suspected shoplifters by store personnel. In the second case, Eigelbach v. Watts, the Kentucky Supreme Court adhered to its longstanding rule that physical impact was essential to an action for intentional infliction of emotional distress. Finally, in the third decision, McMichael v. American Red Cross, the Court, utilizing the Restatement's “unavoidably unsafe” rationale, refused to impose …