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Product Liability spring 2014 Generics

Prof. George Conk Adjunct Professor and Senior Fellow, Stein Center for Law & Ethics Fordham Law School gconk@law.fordham.edu

Article VI Constitution of the United States

This Constitution, and the laws of the United States which shall be made in pursuance thereof; and all treaties made, or which shall be made, under the authority of the United States, shall be the supreme law of the land; and the judges in every state shall be bound thereby, anything in the Constitution or laws of any State to the contrary notwithstanding.



6 Liability of Commercial Seller or Distributor for Harm Caused by Defective Prescription Drugs and Medical Devices
* manufacturing defects * design defects * warning defects

6 (c) Design defects

(c) A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.

Conk, Is There a Design Defect in the Restatement (Third) of Torts: Products Liability? 109 Yale L. J. 1087, 1128-1129 (1999-2000)

"The FDA does not claim to review products for optimal design . . . . FDA review thus asks less of drug . . . manufacturers than the common law of products liability asks of other kinds of manufacturers


Vautour v. Bodymasters (NH 2001) Whether a product is unreasonably dangerous to an extent beyond that which would be contemplated by the ordinary consumer is determined by the jury using a risk-utility balancing test. Under a risk-utility approach, a product is defective as designed "if the magnitude of the danger outweighs the utility of the product. " W. Keeton et al., Prosser and
Keeton on the Law of Torts 99, at 699 (5th ed. 1984).

21 USC 355(d)

In order for FDA to consider a drug safe for use under conditions rescried, recommended or suggested n the proposed labeling, the drugs probable benefits must outweigh its risk of harm Is that more or less demanding than New Hampshire common law? Than 2(b) of the Products Restatement? Than 6(c)

Mutual Pharmaceutical v. Bartlett (2011)

NH embraces 402A not 6(c)

Defect determined by risk-utility


Design: unalterable

Labeling: unalterable without permission of FDA

Implied preemption impossibility


21 CFR 379r National Uniformity for prescription drugs

(a) In general. Except as provided in subsection (b), (c)(1), (d), (e), or (f), no State may establish or continue in effect any requirement-(1) that relates to the regulation of a drug that is not subject to the requirements of section**** and (2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this Act

Mutual Pharmaceutical v. Bartlett

Because Mutual was unable to change sulindac as a matter of both federal law and basic chemistry New Hampshires design defect [law] effectively required Mutual to change sulindacs label to provide stronger warnings. Did they have to change the label? Or just sell at risk of strict liability for harm?


Mutual Pharmaceutical v. Bartlett (2013)

Federal law provides no safe harbor from drug companies but it does prevent them from taking certain remedial measures. Justice Alito How does it prevent remedial measures? Is Mutual obligated to sell? Is Mutual free to injure unsuspecting patients?

Sotomayor, dissenting

Mutual has three options: 1) Change the design or label 2) Remove the product from the market 3) Pay the damages as a cost of doing business Does this meet the majoritys impossiblity argument?


The FDAs proposed rule

What does it provide? Is it overdue as Public Citizen argues? Will liability costs drive up generic prices and thus undermine Hatch Waxman Act? If sellers can change their labels will it create confusion? Should FDA impose uniformity as the manufacturers urge and bar unilateral changes?

FDA Notice of proposed rule-making

The proposed rule would create parity among application holders with respect to such labeling changes by permitting holders of abbreviated new drug applications (ANDAs) to distribute revised product labeling that differs in certain respects, on a temporary basis, from the labeling of its reference listed drug (RLD) upon submission to FDA of a changes being effected (CBE-0) supplement.

Cornett v. J&J (NJ 2012) To the extent plaintiffs allege defendants have deviated from labeling and instructions for use through voluntary statements to third aprties int eh course of its marketing efforts this claim is not preempted.

How does that differ from a traditional product liability claim?