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Addressing the Conflict: FDA vs. Torts
Our legal system supports two regulators of the safety of prescription drugs ' the U.S. Food and Drug Administration and courts applying the tort liability regime. The FDA's mission, while narrowly circumscribed in its early years, grew dramatically over the last half of the twentieth century. Today, the FDA administers the most comprehensive drug regulatory system in the world. (See Jeffrey E. Shuren, The Modern Regulatory Administrative State: A Response to Changing Circumstances, 38 Harvard J. on Legis. 291, 299-315 (2001); Michael D. Green, Statutory Compliance and Tort Liability: Examining the Strongest Case, 30 U. Mich. J.L. Ref. 461, 464 (1997); Charles J. Walsh et al., Rationalizing the Regulation of Prescription Drugs and Medical Devices: Perspectives on Private Certification and Tort Reform, 48 Rutgers Law Rev. 883, 890-929 (1996) (detailing the 'pervasive' reach of FDA regulation as controlling 'nearly every aspect of the development and marketing of a prescription drug or medical device, from the earliest clinical testing to the contents of the final advertisements used to present the final product to health care providers.').
Yet despite the agency's pervasive oversight of drug safety and effectiveness, and its accumulated expertise, the state-law-based tort system routinely invites judges and juries to second-guess the agency's regulatory decisions in order to ensure compensation to plaintiffs who allege a drug-related injury. This second-guessing raises serious questions concerning the applicability of federal pre-emption principles to avoid inconsistencies between the two regulatory schemes. The tort system may actually have played a role in enhancing drug safety in the days when the FDA did not engage in a thorough review of prescription drugs for safety and efficacy both prior to their distribution and once on the market.
Today, however, tort lawsuits pose an increasing risk of conflicting with the greatly expanded regulatory scheme under which the FDA operates. Unbridled tort litigation also poses the risk of supplanting the FDA's rational, science-based regulation of drugs with judgments made by sympathy-driven lay juries. Indeed, as the FDA's chief counsel recently explained (See Daniel E. Troy, FDA Involvement in Product Liability Lawsuits, FDLI Update, Jan./Feb. 2003), the FDA itself has confronted these conflicts in a number of recent court submissions seeking pre-emption of actions brought under state law where the relief requested would conflict with the Agency's prior scientific determinations.
Yachts, Jets, Horses & Hooch: Specialized Commercial Leasing Models
Defining commercial real estate asset class is essentially a property explaining how it identifies — not necessarily what its original intention was or what others think it ought to be. This article discusses, from a general issue-spot and contextual analysis perspective, how lawyers ought to think about specialized leasing formats and the regulatory backdrops that may inform what the documentation needs to contain for compliance purposes.
Hyperlinked Documents: The Latest e-Discovery Challenge
As courts and discovery experts debate whether hyperlinked content should be treated the same as traditional attachments, legal practitioners are grappling with the technical and legal complexities of collecting, analyzing and reviewing these documents in real-world cases.
Identifying Your Practice's Differentiator
How to Convey Your Merits In a Way That Earns Trust, Clients and Distinctions Just as no two individuals have the exact same face, no two lawyers practice in their respective fields or serve clients in the exact same way. Think of this as a "Unique Value Proposition." Internal consideration about what you uniquely bring to your clients, colleagues, firm and industry can provide untold benefits for your law practice.
Risks and Ad Fraud Protection In Digital Advertising
The ever-evolving digital marketing landscape, coupled with the industry-wide adoption of programmatic advertising, poses a significant threat to the effectiveness and integrity of digital advertising campaigns. This article explores various risks to digital advertising from pixel stuffing and ad stacking to domain spoofing and bots. It will also explore what should be done to ensure ad fraud protection and improve effectiveness.
Turning Business Development Plans Into Reality
This article offers practical insights and best practices to navigate the path from roadmap to rainmaking, ensuring your business development efforts are not just sporadic bursts of activity, but an integrated part of your daily success.