There was an argument that the Obama Administration's lawyers could have made—but didn't—in defending Obamacare's individual mandate against constitutional attack. That argument would have highlighted the role of comprehensive health insurance in steering individuals' healthcare savings and consumption decisions. Because consumer-directed healthcare, which reaches its apex when individuals self-insure, suffers from several known market failures and because comprehensive health insurance policies play an unusually aggressive regulatory role in attempting to correct those failures, the individual mandate could be seen as an attempt to eliminate inefficiencies in the healthcare market that arise from individual decisions to self-insure. This argument would done a better job than the Obama Administration's of aligning the individual mandate with existing Commerce Clause and Necessary and Proper Clause precedent, and it would have done a better job of addressing the conservative Justices' primary concerns with upholding the mandate. This Article lays out this forgone defense of the individual mandate.

Proponents of the 2010 Patient Protection and Affordable Care Act (PPACA) justify the Act's mandate that uninsured individuals either purchase a minimally defined health insurance policy (“Maintain Minimum Essential Coverage”) or pay a fine, as a necessary and proper exercise of Congress's express constitutional power to regulate interstate and foreign commerce. The United States Supreme Court will decide the correctness of that highly debatable position during its spring 2012 session.

Assuming, without by any means predicting, that the validity of all parts of the PPACA—including the individual insurance mandate—is upheld, the Court's (likely multiple) opinions will constitute a major development in the evolution of American constitutional jurisprudence, even if Congress subsequently repeals specific sections of the legislation. Several commentators have expressed concern about the ramifications of a judicially validated PPACA for attempts by the government, especially through the mechanism of Comparative Effectiveness Research (CER), to limit or ration particular forms of potentially beneficial medical care for some or all patients.

This Article analogizes early semiconductor technology and its surrounding economics with isolated genes, stem cells, and related bioproducts, and their surrounding economics, to make the case for sui generis (of its own class) intellectual property protection for isolated bioproducts. Just as early semiconductors failed to meet the patent social bargain requiring novelty and non-obviousness in the 1980s, isolated genes and stem cells currently fail to meet the patent bargain requirements of non-obviousness and eligible subject matter that entitle them to traditional intellectual property protection. Like early semiconductor chip designs, nevertheless, the high cost of upstream bioproduct research and development, coupled with the need to sustain continued economic growth of the biotechnology industry, mandates that Congress provide some level of exclusive rights to ensure continued funding for this research. Sui generis intellectual property protection for isolated bioproducts would preserve the incentive to continue innovation in the field. As illustrated by the semiconductor industry, however, such sui generis protection for this technology must include limitations that address the need to provide an appropriate level of public access to facilitate downstream product development and enrich the public domain.

Can private law litigation serve as a tool for advancing public health objectives? With this contentious and oft-asked question in mind, we tackle Canada's recent tobacco litigation. This Article first presents critical commentary regarding various lawsuits waged against Canadian cigarette manufacturers by citizens acting as individuals or as parties to class action lawsuits. We then turn to analyze how Canada's provincial governments rely on targeted legislation to facilitate private law recourses for recouping the healthcare costs of treating tobacco-related diseases. We address challenges to the constitutionality of this type of legislation, as well as attempts by manufacturers to transfer responsibility to the federal government.

Canadian litigation in this field is nothing like that of the United States with regards to both the volume and variety of its individual and class action litigation claims. This is also true with regard to the stage of advancement of governmental claims in Canada. Nevertheless, particularities of the Canadian context may provide interesting contrast with the situation in the United States.

The Supreme Court of the United States and other courts currently are considering the question of the extent to which the health care field should be subject to antitrust rules. This Article explores the special characteristics of the health care field, and the problems they create for antitrust analysis. Two current cases—Arizona v. Maricopa County Medical Society (awaiting decision by the Supreme Court) and Kartell v. Blue Shield of Massachusetts, Inc. (pending in the District of Massachusetts)—illustrate the issues raised by efforts to contain health care costs through the setting of maximum fees. This Article suggests that traditional antitrust principles should and will prevail over arguments that such restraints are in the public interest.

In March of 1998, a Connecticut jury awarded $400,000 under a claim for Negligent Infliction of Emotional Distress (“N.I.E.D”) to an employee who had only lost his job. The employee had been subject to unnecessary internal investigation, and his employment was terminated as a result of this investigation. In December of 1992, a North Carolina jury awarded only $100,000 for N.I.E.D. damages to parents who had lost their nine month-old infant. The parents actually witnessed the death of their infant, who died from swelling of the brain caused by improper administration of intravenous fluids. Both of these awards were meant to compensate plaintiffs for the mental distress caused by the defendants' negligent conduct. Yet considering the circumstances of these two cases, one wonders whether the jurors were really able to evaluate the nature and extent of the plaintiffs' mental distress and, more importantly, what kind of evidence the jurors considered to make their determination.

But it does not matter to a man whether he acts at his own peril or not, unless harm comes of it, and there must always be some one within reach of the consequences of the act before any harm can be done.

—Oliver Wendell Holmes

[Scientists must be certain of their interpretation of the facts, that their priorities are correct, and that they are not bringing unnecessary and unjustified anxiety to many by over-statement or by expression of cancer risks in terms incomprehensible to the lay public.

—John Higginson, Director, International Agency for Research on Cancer

A federal requirement that donor blood be labelled as either “paid” or “volunteer” took effect on May 15, 1978. A major rationale for requiring such labelling is that physicians, now that they can distinguish between categories of blood, will fear liability for post-transfusion hepatitis resulting from the use of paid blood. Thus, supporters of the labelling requirement hope that it will deter the use of high-risk commercial blood. Some paid blood, however, is not commercial blood and in fact may be safer than volunteer blood. The labelling strategy for hepatitis control, therefore, has negative as well as positive attributes. This Article considers the efficacy of blood labelling as a hepatitis control measure and proposes an alternative strategy—the periodic publicizing of hepatitis rates of facilities that perform transfusions—that, if practiced responsibly, could significantly decrease hepatitis transmission rates.

Patent rights are recognized as a property asset with an attendant right to exclude. However, recent policy developments highlight that the right to exclude is not inviolable. This paper explores two rapidly evolving exceptions to patent exclusivity, both of which take the form of compulsory licenses. First, under the international Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”), national governments can compel patent owners to out-license technology in service of greater good. These egalitarian compulsory licenses improve access to technology but undermine patent value. Second, compulsory licenses are increasingly relied upon as an equitable remedy in U.S. patent litigation. Typically referred to as “ongoing royalties,” these court-mandated compulsory licenses are a modern alternative to injunctions against adjudged infringers. TRIPS compulsory licenses and ongoing royalties arise under independent legal frameworks, but necessarily invoke parallel economic considerations. While the wisdom of each has been discussed at length by others, this paper explores principles of royalty determination employed in each context. Considering both frameworks, an analysis of where each succeeds and fails is provided, together with an exploration of optimized royalty frameworks.

Recent advances in prenatal genetic testing have made testing for congenital disorders more accessible, with emerging technologies promising further expansion of available testing options. In particular, non-invasive prenatal testing (“NIPT”) has allowed women to identify more fetal disorders earlier in pregnancy than was possible only a decade ago. In addition to allowing women to prepare for the birth of a child with a disability, prenatal diagnoses give women the ability to terminate a pregnancy to avoid raising a child with a disability, a choice driven by myriad factors.

On August 22, 2009, when then-Speaker of the House Nancy Pelosi was asked by a reporter whether the Patient Protection and Affordable Care Act (PPACA) was constitutional, she answered: “Are you serious? Are you serious?” Two years later, many federal judges, more than half of the States, and a flood of distinguished constitutional scholars have examined the PPACA and found at least part of it to be unconstitutional. The question was indeed serious.

It remains serious today, as a Supreme Court decision on the constitutionality of the PPACA is expected in June 2012. Because the legality of the PPACA has emerged as perhaps the most publicly visible constitutional question since Roe v. Wade, clarity is vital not only for the PPACA itself, but also for general public understanding of the Constitution. Accordingly, our goals in this Article are to provide an opinionated but hopefully fair-minded guide to the constitutional issues of the PPACA and to clarify some misunderstandings that plague both popular and professional discussions of the issues.

Sales of brand and generic pharmaceuticals in the United States reached $274.7 billion in 2006. Consumers in this country, including the federal government, are paying tremendous amounts of money for drugs and the cost continues to be a growing concern for all parties involved. Part of this increased cost encountered by consumers can be directly attributed to the ever-increasing costs manufacturers must cope with in the development of new drugs. Economists estimate that it takes twelve to fifteen years to develop a single new drug and have it approved by the Food and Drug Administration (“FDA”). The average cost: $800 million. For every 10,000 compounds investigated, only five are ever tested as potential medicines in clinical trials and only one is ever approved for patient use. Of all the drugs approved by the FDA, only three out of ten generate revenues that meet or exceed average research and development costs.

Approximately 1.3 million of our nation's elderly live in nursing homes. Despite the increasingly important role of Medicare and Medicaid, many must bear the costs of their care. This Note examines one means of financing nursing home care—the life care contract. These require residents to pay an entrance fee and transfer to the nursing home all or part of their property in return for the home's promise to provide care for the remainder of the resident's life. The Note discusses the potential problems a life care resident may face, such as substandard living conditions or a home's financial instability. It concludes by delineating steps that potential residents can take in constructing life care contracts to ensure protection of their rights and needs.