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Belmont Health Law Journal

Abstract

This Note argues that in the absence of an updated statute and FDA regulation, states should permit plaintiffs to recover under the theory of innovator liability. Despite the theory’s arguable contravention of “traditional common law tort principles” and potentially unfair results against brand-name manufacturers, victims of defective drugs and inadequate warnings should have an avenue for recourse. Forfeiting one’s ability to recover potentially hundreds of thousands of dollars in damages in exchange for paying a cheaper price for medication is not a fair trade. Indeed, the Supreme Court in PLIVA, Inc. v. Mensing (discussed in Section II and arguably the most consequential case involving innovator liability) concedes that the opinion and pertinent federal regulations created an “unfortunate hand” for the plaintiffs and “others similarly situated.” However, this Note recognizes the substantial shortcomings and legal obstacles that innovator liability poses. Nevertheless, this Note argues that adopting innovator liability in more jurisdictions throughout the United States will exert greater pressure upon the federal government to rethink the current state of the law.

Thus, in the presence of statutory latitude, state courts should permit plaintiffs harmed by generic pharmaceuticals to recover under the theory of innovator liability against brand-name manufacturers due to the current federal legal framework. Alternatively, if a state’s statutory code explicitly rejects innovator liability, thereby preventing the courts from adopting it in the common law, legislatures in those states should reverse their current approach. As discussed further below, adopting innovator liability would likely incentivize a change to the current federal framework. Ideally, the federal government should alter the current statutory and regulatory scheme involving prescription drugs in order to strike a better balance of providing recourse to generic prescription drug consumers, while also continuing to strive for the FDA’s policy goals involving cost and safety.

Section II of this Note provides the history and current background involving pharmaceutical failure-to-warn claims, innovator liability, and prescription medication law. The statutory and common law progression leading up to the current state of the law is further detailed in Section II. Section III of this Note analyzes two defenses raised by brand-name manufacturer defendants, including more typical arguments relating to the tort law, as well as the less-explored issue of personal jurisdiction as it relates to innovator liability. Specifically, Section III highlights recent case law involving personal jurisdiction serving as a useful threshold question if a jurisdiction decides to adopt innovator liability, as well as the obstacles of more rigid common law tort principles. Section IV presents this Note’s primary proposal relating to innovator liability with the goal of attaining both short-term and long-term legal recourse for consumers involving pharmaceutical drug failure to- warn claims. In summary, this Note argues that state governments should adopt innovator liability to accomplish two objectives: (1) provide injured plaintiffs with a more short-term stopgap avenue for recovery and (2) encourage the federal government to implement a more sustainable long-term solution involving pharmaceutical drug failure-to-warn claims.

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