Generic Drug Manufacturer Liability: Achieving a Balance between Consumer Affordability and Safety

By James, Sarah S. | Journal of Corporation Law, October 1, 2012 | Go to article overview

Generic Drug Manufacturer Liability: Achieving a Balance between Consumer Affordability and Safety


James, Sarah S., Journal of Corporation Law


I. INTRODUCTION

In its 2011 Pliva v. Mensing1 ruling, the Supreme Court refused to hold generic drug manufacturers liable for state failure-to-warn claims because federal regulation regarding warning labels preempted state law.2 In an earlier case, however, the Supreme Court refused to grant preemption for brand-name manufacturers that it found could have complied with both state and federal laws.3 This Note considers the implications of holding brand-name manufacturers liable while allowing generic manufacturers to avoid responsibility, including creating a regulatory gap that leaves consumers of generic medications without protection under state failure-to-warn claims. It also explores changes that could be effected to treat generic and brand-name manufacturers equally with respect to conflict preemption.

In Part II, this Note introduces what conflict preemption is generally and when the Court applies it. Specifically, it gives a brief summary of current federal laws regulating the approval of prescription medications and introduces the two recent Supreme Court cases addressing preemption with respect to federal drug regulations and state tort laws protecting consumers. Part III analyzes different alternatives for how federal preemption of state claims in the prescription drug context might be avoided in the future, exploring the public policy considerations and the effect each might have on the prescription medication market. Taking these possible effects into consideration, Part IV recommends that Congress amend current federal law to require generic prescription drug manufacturers to contact the Food and Drug Administration (FDA) with label changes as soon as manufacturers deem a change necessary. This Note argues that this is the most effective and efficient solution available, considering public policy issues and fairness to the consumer.

II. BACKGROUND

With the total amount spent on medications in the United States surpassing $307 billion in 2011,4 the pharmaceutical industry is, and will continue to be, an essential part of politics and consumer health.5 To appreciate how this industry balances providing the products consumers need at a price they can afford, it is essential to have a basic understanding of the legal structure and agencies that regulate prescription medications in the United States.6 This Part first explores when and how courts find conflict preemption and then considers two recent Supreme Court cases addressing conflict preemption with respect to safety warning labels on prescription medications.

A. Conflict Preemption Generally

The Constitution enumerates federal law "shall be the supreme Law of the Land . . . any Thing in the Constitution or Laws of any State to the Contrary notwithstanding."7 Commonly referred to as the Supremacy Clause, this part of Article VI of the Constitution provides that if there is direct conflict between state and federal law, federal law is supreme and state law is preempted.8 Direct conflict occurs when it is impossible to simultaneously comply with both state and federal requirements in a given area.9 Conflict preemption is sometimes a simple issue for the judiciary, but preemption is often more complicated and requires the court to determine congressional intent.10 Because intent is scarcely transparent, the courts decide how to promote the policy behind a federal law through their interpretation.11 In preemption cases dealing with areas of law typically regulated by the states, the Court "start[s] with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress."12

B. Current Federal Law, State Law, and Regulations

Recent examples of conflict preemption exist in cases involving federal and state drug labeling requirements.13 Federal law does not currently allow a manufacturer of generic prescriptions to unilaterally modify its own warning label because it must remain identical to the brand-name drug's warning label. …

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Generic Drug Manufacturer Liability: Achieving a Balance between Consumer Affordability and Safety
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