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Back Issues and Articles
Back Issues and Articles

Table of Contents
Table Of Contents
Articles
Medical Advice from Lawyers: A Content Analysis of Advertising for Drug Injury Lawsuits
Elizabeth Tippett - [PDF]

This study focuses on television advertising for lawsuits relating to drugs and medical devices (hereinafter "drug injury advertising"). The purpose of the advertising is to recruit consumers for lawsuits against drug manufacturers. In particular, the ads seek to identify consumers that took a drug or used a medical device and subsequently experienced a particular medical problem that the drug manufacturer failed to disclose. The ads warn of the dangers associated with a particular drug or device. Ultimately, advertising attorneys hope that injured consumers will contact them for legal representation.
The Legal and Regulatory Status of Biosimilars: How Product Naming and State Substitution Laws May Impact the United States Healthcare System
Jordan Paradise - [PDF]

Alongside the constitutional controversy ultimately addressed by the Supreme Court, the colossal Patient Protection and Affordable Care Act (ACA) ushered in a new paradigm for regulation of biologics by the Food and Drug Administration (FDA). Nestled within the expansive ACA, the Biologics Price Competition and Innovation Act (BPCIA) set forth an abbreviated pathway to market for "biosimilar" and "interchangeable" biological products. While the current BPCIA implementation debate focuses chiefly on the scope of scientific and technical assessments by the FDA and the effect on the emergent biosimilar industry, two issues will prove essential for determinations of access to and costs of the resulting products: how the biosimilar and interchangeable biosimilar biologics are to be named, and whether pharmacist substitution is appropriate for products the FDA deems interchangeable. This article examines the current debate surrounding the use of nonproprietary names for biosimilar biologics, as well as state efforts to reconcile automatic substitution laws for the eventual products. In particular, the article addresses the implications for patients and the United States health care system, highlighting the potential negative effect on anticipated cost-savings, hindrances for effective tracking and reporting of adverse events, and a general lack of consistency in state laws.
Medical Evidence and Expertise in Abortion Jurisprudence
Aziza Ahmed - [PDF]

Medical literature on abortion largely supports pro-choice legal claims. In turn, progressive lawyers often call for "evidence-based approaches" to lawmaking on the assumption that it will produce pro-choice legal and regulatory outcomes. This article argues that the evidence-based approach is no longer a reliable or stable strategy for pro-choice lawyering given transformations in judicial treatment of medical knowledge and a shifting evidentiary base.
Priority Setting, Cost-Effectiveness, and the Affordable Care Act
Govind Persad - [PDF]

In drafting the Affordable Care Act (ACA), policymakers faced delicate and politically explosive tradeoffs between expanding access to medical care and controlling the ever-increasing cost of that care. This Article conducts a detailed examination of several provisions of the ACA, introduced as the ACA traced its tortuous path from introduction to enactment, that limit the healthcare system's use of cost-effectiveness analysis, a technique that quantifies the cost and expected benefit of medical interventions and enables actors within the system to set priorities.
Notes and Comments
Do You Own Your 3D Bioprinted Body? Analyzing Property Issues at the Intersection of Digital Information and Biology
Jeremy Thomas Harbaugh - [PDF]

By the end of 2013, almost 122,000 organ transplant candidates in the United States remained active on the national waiting list. The current number of candidates exceeds 123,000. To address this overwhelming need, researchers have been exploring methods to supplement traditional organ donations. At the forefront of this research is regenerative medicine, the field of regenerating or replacing tissue and organ function by studying the body's own healing mechanisms. Regenerative medicine is quickly fulfilling its promise of producing vascularized, functioning organs in vitro by combining two other areas of research: the replication of cell lines in vitro and the recent adaptation of three-dimensional printing for the health care industry. Today, physicians armed with the latest generation of bioprinters and imaging equipment are creating high-resolution airway splints and personalized bone replacements for human use. These techniques have even achieved success with more complicated structures, including human kidneys and livers.
The Medical Marijuana Catch-22: How the Federal Monopoly on Marijuana Research Unfairly Handicaps the Rescheduling Movement
Alexander W. Campbell - [PDF]

As of April 2015, twenty-three states and the District of Columbia permit the therapeutic use of marijuana to treat various illnesses or conditions, with legalization statutes currently pending in eight other states. Despite the growing number of states that allow for the prescription and use of medicinal marijuana, the federal government still classifies the drug as a Schedule I controlled substance, the strictest classification of controlled substances and the only type healthcare providers may not legally prescribe. As states continue to deliberate the merits of allowing access to marijuana for therapeutic use, it is useful to examine the structural and political forces that have prevented a similar movement at the federal level. This Note does so, and argues that proactive changes-either legislative or administrative-are necessary to remove the handicap that the current regulatory system places on attempts to change federal marijuana policy.
Recent Court Decisions
Recent Case Developments: Fifth Circuit Upholds the Enforcement of Two Abortion Provisions of a Texas Act - Whole Woman's Health v. Lakey
Cristina Cahn-Speyer - [PDF]

On August 29, 2014, the District Court for the Western District of Texas enjoined the statewide enforcement of two abortion provisions of a Texas act-the admitting-privileges requirement and the ambulatory-surgical-center requirement. Less than a month later, the United States Court of Appeals for the Fifth Circuit stayed the district court's injunction, permitting Texas to immediately enforce the two abortion provisions. On October 14, 2014, the Supreme Court of the United States issued an order to vacate the Fifth Circuit's stay, reinstating the district court's injunction. The Fifth Circuit is currently hearing arguments for the appeal of the district court's decision.