FDA preemption of drug and device labeling: who should decide what goes on a drug label?

The Supreme Court decided an issue that is critical to consumer health and safety last year. In April 2009, the Supreme Court held that extensive FDA regulation of drugs did not preempt a state law claim that an additional warning on the label was necessary to make the drug reasonably safe for use. Thus, states--and even courts and juries--are now free to cast their vote on what a drug label should say. This is in direct contrast to medical devices, where the federal statute regulating medical devices expressly provides that state regulations are preempted. This Article discusses basic preemption principles and drugs, and explores the policy ramifications of pro- and anti-preemption policy in the healthcare industry.     

The neurological determination of death: what does it really mean?

The recent Canadian forum's recommendations regarding "neurological determination of death" claim to have determined a "Canadian definition, criteria, and minimum testing requirements for neurological determination of death." In this review the problems with this statement are discussed. The criterion of neurological determination of death does not fulfill the definition of death, because there is continued integration of the organism as a whole. The tests for neurological determination of death do not fulfill the criterion of neurological determination of death because they do not show the irreversible loss of all critical brain functions. The forum has provided no coherent argument for why neurological determination of death should be considered death. I suggest that one cannot invoke expert opinion to clarify a criterion of death, and tests for this criterion of death, without a clear concept of what death is. The forum has clarified tests for what they call "neurological determination of death," but this is not death itself; rather, it is a neurologically devastating state. Whether this state of "neurological determination of death" is enough to justify the morality of harvesting organs prior to death is the real question. A potential solution to this question is discussed.     

Ownership conversions in health care organizations: who should benefit?

Because equity capital is becoming an important financing source for health care organizations, the conversion of many such organizations from nonprofit to for-profit status is a significant public policy issue. Since many states require converting nonprofits to repay the "community" for its investment during the nonprofit status period, three questions arise: (1) How much is the entity worth? (2) How much of that worth should be returned to the community? (3) In what form should it be returned? The paper addresses these questions, and demonstrates why responsible public policy calls for them to be carefully considered if community interests are to be preserved.     

Fat and the law: who should take the blame?

The incidence of obesity in both adults and children is rising at a rapid rate in most developed countries, including in Australia. Some obese people are seeking to place the blame for their condition on the fast-food industry, as demonstrated by the recent litigation in the United States brought by two obese plaintiffs against McDonald's. This litigation was unsuccessful, and on existing Australian negligence principles any similar litigation commenced here is likely to suffer the same fate. Principles of personal responsibility, autonomy and free will should prevail to deny a negligence claim. The risk of obesity and concomitant health problems from eating fast food to excess is an obvious risk which the plaintiff should not have ignored and which he or she has voluntarily assumed. It is for the Australian Government, not the courts, to regulate the behaviour of the fast-food industry. The government should take action by requiring all major fast-food chains to label their products with nutritional information, and by imposing restrictions on the advertising of food to children.     

Constitutional pluralism: Chronicle of a death foretold?

What remains of the idea of constitutional pluralism in the wake of the Euro‐crisis? According to the new anti‐pluralists, the recent OMT saga signals its demise, calling to an end the tense stalemate between the ECJ and the German Constitutional Court on the question of ultimate authority. With the ECJ's checkmate, OMT represents a new stage in the constitutionalisation of the European Union, towards a fully monist order. Since constitutional pluralism was an inherently unstable and undesirable compromise, that is both inevitable and to be welcomed. It is argued here that this is misguided in attending to the formal at the expense of the material dimension of constitutional development. The material perspective reveals a deeply dysfunctional constitutional dynamic, of which the judicial battle in OMT is merely a surface reflection. This dynamic now reaches a critical conjuncture, encapsulated in the debate over ‘Grexit’, and the material conflict between solidarity and austerity. Constitutional pluralism, in conclusion, may be an idea worth defending, but as a normative plea for the co‐existence of a horizontal plurality of constitutional orders. This requires radical constitutional re‐imagination of the European project.