Should preemption apply in a pharmaceutical context? An analysis of the preemption debate and what regulatory compliance statutes contribute to the discussion

Should the Food and Drug Administration (FDA)'s determination that a product is safe negate a private litigant's cause of action under state law in all circumstances, unless the FDA determines that the manufacturer withheld relevant information regarding the safety of the product? This Note concludes that such federal preemption is proper because the FDA is fully capable of making a determination regarding the adequacy of the information disclosed by a pharmaceutical manufacturer without state interference. Additionally, such interference on the state level hinders the FDA's objectives and effective functioning. Thus, determinations about the adequacy of the information provided to the FDA should remain in the Agency's sound discretion and not be questioned at the state level.     

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.     

Dragon's Blood incense: misbranded as a drug of abuse?

An unknown red substance was being sold and used with other drugs of abuse in Virginia (often being used in conjunction with marihuana). The red substance was identified as Dragon's Blood incense from Daemonorops draco. In bioassays, Dragon's Blood incense exhibited a low, but measurable cytotoxicity in in vitro cell lines. Dragon's Blood incense or Volatilized Dragon's Blood had no adverse effect on mouse motor performance based on the inclined screen and rotorod tests. delta(9)-Tetrahydrocannibinol (THC) produced a dose-related decline in mouse performance on the rotorod test. The combination of Dragon's Blood incense or Volatilized Dragon's Blood with delta(9)-THC did not contribute further to the impairment of the mice on the rotorod. This data suggests that the abuse potential for Dragon's Blood incense alone or in combination with marihuana is minimal.     

Does the federal Family and Medical Leave Act of 1993 create a hole in ERISA preemption?

ERISA's board preemption provision has survived many challenges to its scope and effect. Now it may have succumbed in the face of a few statements tucked into the legislative history of the federal Family and Medical Leave Act (FMLA). Language in the legislative history presents the view that the Act was meant to overturn ERISA preemption of state family and medical leave laws. The text of the FMLA contains no corroborating language to support that view. However, at least one court found the statements in the legislative history to be persuasive and ruled that under the FMLA, ERISA does not preempt state family and medical leave laws that regulate ERISA plans. If other courts follow that decision, there will be great implications to employee benefit plan regulation and administration. This article explores the court's decision and the relationship between the FMLA and ERISA preemption.     

Patient termination of a life-sustaining medical device: Suicide or natural death?

Medical technology has made tremendous strides in extending the lives of patients who have suffered organ failure. Machines can now replace the function of the kidneys, the heart, and other vital organs. Much has been written about a patient's right to refuse or direct the withdrawal of medical treatment, especially at the end of life, under the guise of “death with dignity.” However, little attention has been paid to the situation where a patient elects to deactivate their life-sustaining medical device without a physician's involvement. This raises the challenging question of whether the patient's manner of death should be classified as suicide or natural. Surprisingly, common law, statutes, medical ethics, and public health practice are not in alignment on the answer. This article will explore the ramifications and far-reaching impact that such divergence has on the survivors and the medical community, as well as recommend corrective actions and practical approaches for the medical and legal practitioner.