Bookmark and Share



» Access to Courts and Court Remedies

» Campaign Finance and Election Laws

» Constitutional Rights and Requirements

» Health, Safety, and Environment

» Open Government and Open Courts

» Representing Consumers

» Workers' Rights

Currently Featured Topics

Government Transparency
Consumer Justice
First Amendment
Health, Safety and the Environment


Read about our work helping lawyers
with cases in the Supreme Court.


  Public Citizen | Litigation Cases ***Search other cases***

Warner-Lambert v Kent

Topic(s): Preemption of Consumer Remedies
Docket: 06-1498



Preemption: FDA Approval / State Consumer Remedy

Traditional state tort law allows a manufacturer, alleged to have sold a defective product, to use compliance with federal standards or regulations as evidence that the product was not defective or that the manufacturer acted non-negligently. In most states, such evidence is not controlling. However, in 1995, Michigan enacted a statute providing that, with respect to drug manufacturers, federal approval and compliance with Food and Drug Administration approval requirements generally precludes liability for injuries caused by their products. The Michigan legislature chose not to extend this defense to situations in which it lacked confidence that the federal approval could be relied on as dispositive evidence that the manufacturer satisfied state-law duties of care. Accordingly, the statute also provides an exception to the defense such that, if a drug manufacturer did not comply with FDA disclosure requirements and the noncompliance affected the FDA's approval decision, the statutory defense does not apply.

The question before the Supreme Court is whether the exception to the statutory defense is impliedly preempted.

The decision below was affirmed by an equally divided Supreme Court. Allison Zieve of Public Citizen argued for the respondents.

Copyright © 2017 Public Citizen. Some rights reserved. Non-commercial use of text and images in which Public Citizen holds the copyright is permitted, with attribution, under the terms and conditions of a Creative Commons License. This Web site is shared by Public Citizen Inc. and Public Citizen Foundation. Learn More about the distinction between these two components of Public Citizen.

Public Citizen, Inc. and Public Citizen Foundation


Together, two separate corporate entities called Public Citizen, Inc. and Public Citizen Foundation, Inc., form Public Citizen. Both entities are part of the same overall organization, and this Web site refers to the two organizations collectively as Public Citizen.

Although the work of the two components overlaps, some activities are done by one component and not the other. The primary distinction is with respect to lobbying activity. Public Citizen, Inc., an IRS § 501(c)(4) entity, lobbies Congress to advance Public Citizen’s mission of protecting public health and safety, advancing government transparency, and urging corporate accountability. Public Citizen Foundation, however, is an IRS § 501(c)(3) organization. Accordingly, its ability to engage in lobbying is limited by federal law, but it may receive donations that are tax-deductible by the contributor. Public Citizen Inc. does most of the lobbying activity discussed on the Public Citizen Web site. Public Citizen Foundation performs most of the litigation and education activities discussed on the Web site.

You may make a contribution to Public Citizen, Inc., Public Citizen Foundation, or both. Contributions to both organizations are used to support our public interest work. However, each Public Citizen component will use only the funds contributed directly to it to carry out the activities it conducts as part of Public Citizen’s mission. Only gifts to the Foundation are tax-deductible. Individuals who want to join Public Citizen should make a contribution to Public Citizen, Inc., which will not be tax deductible.


To become a member of Public Citizen, click here.
To become a member and make an additional tax-deductible donation to Public Citizen Foundation, click here.