Law Commons^™

Caremark's Irrelevance, Mercer E. Bullard

Mercer E Bullard

In re Caremark Int’l Inc. Derivative Litig. is commonly held out as the iconic corporate law case on liability for a failure of legal compliance, but the true source of corporate law as to legal compliance is the higher standard established by other sources of law. The expected cost of liability, both criminal and civil, for violations of federal healthcare regulations, for example, is a far stronger determinant of corporate compliance systems than potential liability under Caremark. Other areas of industry-specific regulation, such as for financial services, telecommunications and energy, similarly play a greater role than state corporate law in …

Prescription For Change: Third Circuit Diagnoses Pharmaceutical Sales Representatives As Exempt From Overtime Pay In Smith V. Johnson & Johnson, Brooke Burns

Brooke Burns

This Casebrief recognizes the current division developing among courts concerning whether PSRs have been wrongly misclassified as exempt from overtime pay since the World War II era. Despite the Second Circuit’s more recent decision in In re Novartis Wage and Hour Litigation, this Casebrief identifies the Third Circuit’s jurisprudence in Smith v. Johnson & Johnson as providing controlling guidance for practitioners navigating the current legal landscape.

" 'How's My Doctoring? Patient Feedback's Role In Physician Assessment", Ann Marie Marciarille

Ann Marie Marciarille

A society-wide consumer revolution is underway with the rise of online user-generated review websites such as Yelp, Angie’s List, and Zagat. Service provider reviews are now available with an intensity and scope that attracts increasing numbers of reviewers and readers. Health care providers are not exempt from this new consumer generated scrutiny though they have arrived relatively late to the party and as somewhat unwilling guests.

The thesis of this article is that online patient feedback on physicians is relevant and valuable even though it is also uncomfortable for health care providers. This is because the modern physician-patient relationship is …

Bending The Health Cost Curve: The Promise And Peril Of The Independent Payment Advisory Board, Ann Marie Marciarille, James Bradford Delong

Ann Marie Marciarille

Underlying today’s and the future’s health-care reform debate is a consensus that America’s health-care financing system is in a slow-moving but deep crisis: care appears substandard in comparison with other advanced industrial countries, and relative costs are exploding beyond all reasonable measures. The Obama Administration’s Patient Protection and Affordable Care Act (“ACA”) attempts to grapple with both of these problems. One of ACA’s key instrumentalities is the Independent Payment Advisory Board—the IPAB, designed to discover and authorize ways to reduce the rate of growth of Medicare and other categories of health spending. The IPAB is a peril. Expert boards to …

Interests In The Balance: Fda Regulations Under The Biologics Price Competition And Innovation Act, Parker Tresemer

Parker Tresemer

Recent biotechnology advances are yielding potentially life-saving therapies, but without FDA regulations designed to minimize product costs, patients will continue to be unable to afford these expensive biologic products. Many believe that these prohibitive costs stem from weak competition from generic biologic products, also known as follow-on biologics. To correct this deficiency, and to address the often conflicting regulatory and policy concerns associated with biologic products, Congress enacted the Biologics Price Competition and Innovation Act. The Act created an abbreviated approval pathway for biologic products and, if effective, could increase competition while driving down product costs. But legislation alone is …

Fda Accelerated Approval Program: Why Brake When You Can Get A Mandate?, Keren Frumkin

Keren F. Bisnauth

The FDA approval process is designed to ensure that the drugs released for public consumption are safe and effective. In 1992, the FDA implemented the Accelerated Approval process in order to expedite the approval of drugs to aid patients with life-threatening illnesses, who have little to gain from lengthy approval processes, and who cannot risk worsening health conditions. However, the questionable post-approval practices of drug manufacturers, coupled with the lax FDA enforcement of its required follow-up protocols have raised doubts as to the true value of expedited approval procedures, as well as an influx of drug recalls and lawsuits. In …