Journal of health law最新文献

In an era filled with fears of bioterrorism, Congress approved the Public Readiness and Emergency Preparedness Act (PREPA) to encourage development of vaccines and other countermeasures. By providing pharmaceutical manufacturers with protection from liability for potential side effects, Congress has attempted to motivate manufacturers to produce a national stockpile of countermeasures. As part of PREPA, the government established a compensatory system intended to provide compensation to persons injured by countermeasures used during a public health emergency. Although the Act provides for a compensation fund, it fails to allocate monies for that fund. Thus, in the absence of further congressional action, PREPA will not provide compensation to those injured by countermeasures. Failing to assure the American public of a compensation program constitutes bad public policy and risks inspiring potential vaccinees to refuse necessary drugs. Additionally, arguments as to the constitutionality of the Act exist should Congress fail to adequately fund the program, and the existence of those arguments undermines the purpose of the Act--namely to assure pharmaceutical manufacturers that they will not be sued into oblivion should they attempt to aid national pandemic protection. In addition to detailing both the Act and the statutory precedent for congressional attempts to spur biodefense, this Article addresses important issues of healthcare, tort, and constitutional law that will continue to manifest themselves in this new era of bioterrorism.

Pharmacy benefit managers (PBMs), which generally administer prescription drug benefits as one component of an employer's or other sponsor's health insurance plan, have come under fire in recent years for turning profits at a time when consumer advocates and employers are struggling to contain the costs of health insurance and prescription drugs. Lawsuits alleging that PBMs are breaching certain fiduciary duties to the health plans they serve, however, have failed for the most part on grounds that PBMs are not "fiduciaries" under the Employee Retirement Income Security Act (ERISA). Moreover, states' attempts to regulate PBMs through legislation imposing fiduciary obligations and other related requirements have also generally failed for many different reasons. This Article examines the PBM industry, recent legal developments concerning PBMs' status as ERISA "fiduciaries", the arguments being made for and against stricter regulation of PBMs' business practices, and why litigation and legislation attempting to impose fiduciary obligations upon PBMs have generally failed. The authors conclude that it is market forces and competition, rather than litigation or legislation, that will effectively motivate PBMs to play a role in the cost containment of prescription drugs in the years ahead.

The much studied case of Moore v. Regents of the University of California is often considered important in property law for denying property rights in human tissue. This widespread misunderstanding of Moore has not only misplaced the legal emphasis of human tissue donations on property law instead of contract law, but has also hindered the creation of a much-needed default rule governing the issue of compensation for donated tissue. While it is possible that the majority of donors rarely consider compensation as an incentive to donate, without a legally recognized default rule the law remains blurred as to what contractual provisions apply to the exchange between donor and researcher. This Article argues that the solution is a weak default rule of no compensation that may be overridden by evidence that the parties intended otherwise.

This Article analyzes and critiques apology laws, their potential use, and effectiveness, both legally and ethically, in light of the strong professional norms that shape physicians' reaction to medical errors. Physicians are largely reluctant to disclose medical errors to patients, patients' families, and even other physicians. Some states have passed so-called apology laws in order to encourage physicians to disclose medical errors to patients. Apology laws allow defendants to exclude statements of sympathy made after accidents from evidence in a liability lawsuit. This Article examines potential barriers to physicians' disclosure of medical mistakes and demonstrates how the underlying problem may actually be rooted in professional norms-norms that will remain outside the scope of law's influence. The Article also considers other legal and policy changes that could help to encourage disclosure.