In the years following FDA approval of direct-to-consumer, genetic-health-risk/DTCGHR testing, millions of people in the US have sent their DNA to companies to receive personal genome health risk information without physician or other learned medical professional involvement. In Personal Genome Medicine, Michael J. Malinowski examines the ethical, legal, and social implications of this development. Drawing from the past and present of medicine in the US, Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercial personal genome sequencing and testing sectors and to assess their impact on the future of US medicine. Written in relatable and accessible language, the book also proposes regulatory reforms for government and medical professionals that will enable technological advancements while maintaining personal and public health standards.

The traditional legal framework for assessing liability for false and misleading advertising is whether the advertising is likely to deceive consumers acting reasonably under the circumstances. Typically, the plaintiff also has to show materiality – that the allegedly deceptive advertising would be important in a consumer’s decision to purchase the product or service.1

Puffery is a concept that purports to be about things consumers ignore and don’t rely on. It is in fact a concept about things courts ignore and won’t rule on. At the moment, marketing and other empirical work has essentially nothing to say about puffery in the courts; puffery consists of precisely the elements of advertising for which courts neither require nor allow empirical evidence of consumer reaction.1 That doesn’t make the doctrine wrong, but it does mean that explanations for the doctrine should not be founded on unsupported, mostly unsupportable judicial assertions about how consumers think and what advertising claims they disregard. Instead, this chapter will argue, puffery should be about what kinds of advertising claims are too difficult to evaluate for their truth in judicial settings. That’s an epistemological determination that judges are actually well qualified to make, unlike the idea that consumers don’t rely on puffery.

The chapter discusses the structure of public enforcement in the US antitrust system, with particular emphasis on the use of civil sanctions in public enforcement of laws governing marketplace competition, and a focus on civil sanctions under the Sherman Act, FTC Act, and parallel state law in the United States. It then argues that the use of civil sanctions in public enforcement is inextricable from the supporting remedial structure, including criminal enforcement and meaningful private enforcement. The chapter explains the theory of civil fines in law enforcement and reasons for a jurisdiction’s choosing one or the other form of sanctions. It then explains the structure of remedies for antitrust violations in the US system, highlighting the three forms of public enforcement and the backstop of private enforcement. It then turns to recent developments in civil remedies, including punitive fines as well as damages and related civil monetary relief. It criticizes the Third Circuit Court of Appeals decision in Abbvie Inc. and interrogates the current Supreme Court case involving AMG Capital, inquiring whether AMG Capital might influence the interpretation of the FTC Act as it applies to competition law enforcement as well as consumer protection enforcement.

This chapter addresses the Federal Trade Commission’s Nixing the Fix report, assessing both its promises and its limitations.

This chapter considers how the set of tools provided by consumer protection law can push back on repair restrictions. Consumer protection law is designed, in part, to ensure the accuracy of information in the marketplace. But even in absence of outright deception, it recognizes the need to prohibit unfair practices that take advantage of the natural information asymmetries that sellers enjoy. It also offers remedies when products fail to live up to minimal, baseline guarantees of quality. Although consumer protection cases rarely lead to dramatic, structural remedies,the law profoundly influences marketplace behavior and can improve the day-to-day experiences of consumers seeking repair.