Prescription Drugs and Strict Liability: Evaluating Nebraska's New Posture in Freeman v. Hoffman La-roche, Inc., 260 Neb. 552, 618 N.w.2d 827 (2000)

• Publication year: 2021

80 Nebraska L. Rev. 611. Prescription Drugs and Strict Liability: Evaluating Nebraska's New Posture in Freeman v. Hoffman La-Roche, Inc., 260 Neb. 552, 618 N.W.2d 827 (2000)

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Note*

James Beckmann

Prescription Drugs and Strict Liability: Evaluating Nebraska's New Posture in Freeman v. Hoffman La-Roche, Inc., 260 Neb. 552, 618 N.W.2d 827 (2000)

TABLE OF CONTENTS

I. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . 612 R
II. BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . 616 R
A. McDaniel v. McNeil Laboratories, Inc . . . . . . . . . . . 616 R
B. General Product Liability in Nebraska-the
Transition to Freeman . . . . . . . . . . . . . . . . . . 617 R
III. ANALYSIS . . . . . . . . . . . . . . . . . . . . . . . . . . 618 R
A. Technical Analysis of the Freeman Decision . . . . . . . . 618 R
1. New Nebraska Law: Section 402A, Comment k,
and the Learned Intermediary Doctrine. . . . . . . . . 619 R
a. Working Definitions of Both Tests . . . . . . . . . 620 R
b. Differences Between the Standards . . . . . . . . . 620 R
2. Application of Section 6(c) and Section 2(b) to
Prescription Drugs . . . . . . . . . . . . . . . . . . 621 R
a. Section 6(c). . . . . . . . . . . . . . . . . . . 621 R
b. Section 2(b). . . . . . . . . . . . . . . . . . . 622 R
B. Freeman Was an Insightful Decision . . . . . . . . . . . . 623 R
1. McDaniel to Freeman-Righting a Wrong . . . . . . . . . 624 R
2. Freeman: A More Precise and Protective
Standard . . . . . . . . . . . . . . . . . . . . . . . 625 R
3. Not Too Much, Not Too Little, but Just Right . . . . . 626 R
a. Section 6(c) Does Not Accurately Restate the
Law . . . . . . . . . . . . . . . . . . . . . . . . 627 R

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b. The Reasonable Physician-an Unreasonable
Standard . . . . . . . . . . . . . . . . . . . . . 628 R
c. Cosmetic vs. Therapeutic . . . . . . . . . . . . . 629 R
d. Ease of Claim Dismissal . . . . . . . . . . . . . . 630 R
4. 2(b) or Not 2(b). . . . . . . . . . . . . . . . 631 R
C. Possible Reasons for the Court's Decision . . . . . . . . 632 R
D. Projections of the Future Social and Legal Impact of
Freeman . . . . . . . . . . . . . . . . . . . . . . . . . 633 R
1. Legal . . . . . . . . . . . . . . . . . . . . . . . . 633 R
2. Social . . . . . . . . . . . . . . . . . . . . . . . . 635 R
a. Better Warnings and Testing . . . . . . . . . . . . 635 R
b. More Aware and Attentive Doctors .. . . . . . . . . 637 R
E. Life After Freeman-What Lawyers Should Expect . . . . . . 638 R
1. Plaintiffs' Attorneys . . . . . . . . . . . . . . . . 638 R
a. Pleading and Proof . . . . . . . . . . . . . . . . 638 R
b. The Effect of the Learned Intermediary . . . . . . 638 R
c. The Focus of the Litigation . . . . . . . . . . . . 639 R
2. Defense Attorneys . . . . . . . . . . . . . . . . . . 639 R
a. Lawyers Representing Manufacturers . . . . . . . . 639 R
b. The Workload: Not More, Just Shifted . . . . . . . 641 R
3. Innovation-The Linchpin of a Successful
Practice . . . . . . . . . . . . . . . . . . . . . . . 642 R
IV. CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . 642 R

I. INTRODUCTION

Comment k of the Restatement (Second) of Torts section 402A,(fn1) has been one of the most widely cited and hotly debated comments of the

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entire Restatement.(fn2) Comment k deals specifically with strict liability and unavoidably unsafe products, but it has grown to be the comment most generally associated with prescription drugs. Because of the exponential increase in both the number and variety of prescription products, as well as the harmful side effects that often accompany these new products, comment k has assumed a position of great importance in the evolving law of product liability.

Until recently, Nebraska, along with a relatively small number of other state jurisdictions,(fn3) used comment k to provide blanket immunity to prescription drug manufacturers. For over twenty years in Nebraska, so long as the product had FDA approval and included the accepted warnings described in section 402A, drug manufacturers in Nebraska and elsewhere were above reproach for the products they designed and manufactured.

Abruptly, the days of blanket immunity have ceased with the decision of the Nebraska Supreme Court in Freeman v. Hoffman La- Roche, Inc.(fn4) The plaintiff, Freeman, took a prescription drug called Accutane for two different one-month periods in an effort to treat her acne. Freeman alleged that as a result of taking Accutane, she developed several health problems, including colitis, inflammatory polyar

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thritis, nodular episclerritis OS, and optic nerve head drusen.(fn5) She alleged several theories of recovery including negligence, misrepresentation, failure to warn, breach of implied and express warranty, fear of future product failure, and a strict liability claim that is the focus of this Note.

Although her claim failed in the trial court, Freeman perfected an appeal to the Nebraska Supreme Court. The court ruled in her favor on the design defect and fraudulent misrepresentation causes of action, and reversed and remanded the case for further hearings pursuant to its new position. In Freeman, the Nebraska Supreme Court overruled twenty-four years of precedent, co-opting most of the new standard from the state's general law of products liability. Furthermore, the court declined to adopt either section 6(c) or section 2(b) of the Restatement (Third) of Torts: Products Liability, instead employing the consumer expectations test(fn6) and retaining comment k as a case-by-case affirmative defense.(fn7)

By taking this position, the Nebraska Supreme Court created a body of law that is considerably more plaintiff-friendly, more likely to trigger adjustments in the practice of law, and more apt to bring about changes in the way drugs are designed, manufactured, tested, and approved. Despite this shift, Nebraska maintains a high burden of proof for any plaintiff attempting to prove strict product liability against a drug manufacturer.(fn8) This burden, combined with the availability of the comment k affirmative defense, means that although changes will certainly occur throughout Nebraska's prescription drug law, the changes will be moderate and manageable.

This Note analyzes Nebraska's new prescription drug standards and requirements, as well as the nuances practitioners must become familiar with to effectively litigate under Freeman. It argues in favor of the scheme implemented by the Nebraska Supreme Court in Freeman and asserts that the blanket immunity standard, the risk utility balancing test (and its accompanying reasonable alternative design standard), and the proposed standards of both section 6(c) and section 2(b) of the Third Restatement are inappropriate and inferior to the standard adopted in Freeman.

Part I provides a technical analysis of the law necessary to examine and understand the Nebraska Supreme Court's decision in

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Freeman. This section examines the foundational tests of the new law and the criticisms of and alternatives to Nebraska's new scheme. Part I also supplies working definitions of all the relevant terminology and applicable standards discussed in this Note as well as in Freeman itself.

Part II ventures into the body of the Freeman decision to determine the prudence of such sweeping changes. It explores the process of sifting through all of the available standards to cobble together a rule that provides the most protection to all interested parties, while allowing for pragmatic implementation of the law handed down in Freeman. This section agrees with the approach of the Nebraska Supreme Court and it argues that, while the new standard is not flawless, the Freeman court made the best of a complex and continuously morphing body of law.

Part III examines possible rationales behind the court's decision in Freeman. The Author believes that three factors likely influenced the timing and result of this judgment: (1) the state of prescription drug law in other states; (2) the fact that Freeman involved a cosmetic, as opposed to a therapeutic, drug; and (3) the potential pitfalls of section 6(c). All three factors played a role in the outcome of Freeman, and the importance of these three factors becomes evident not only when reading the opinion itself, but also by examining the primary and secondary sources the Court used to formulate and defend its position. Part IV explores the potential impact of this decision on both Nebraska's legal and social frontiers. From adjusted pleading and proof requirements for both plaintiffs and defendants, to safer testing mechanisms and more attentive doctors, a host of changes loom on the horizon.

Part IV disagrees with critics' claims that increased strict liability for drug manufacturers will cause all of the costs associated with the production of prescription drugs to explode and the price to soar, making drugs less available to those who need them the most. Little evidence supports this claim and any new litigation that results from Freeman should have a lesser effect on drug prices than either market-share competition or availability of generic alternatives.

Part V looks to the future of practicing law under Freeman. Lawyers must realize that to maintain a successful practice, one must constantly adapt to meet new demands. This section explores the nuance of practicing law, and perhaps medicine, in Nebraska after Freeman, while offering suggestions to increase firm productivity and client service. Innovation and education are key to understanding Nebraska's new prescription drug law, and this Note aspires to begin part of that education process.

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II. BACKGROUND

A. McDaniel v. McNeil Laboratories, Inc.

From 1976 to 2000, Nebraska provided all prescription drug manufacturers with what scholars and advocates have called...