Federal Preemption of Drug Injury Lawsuits

March 2009 Update

The U.S. Supreme Court said patients can sue drugmakers for failing to provide sufficient warnings, upholding a $7 million award to a musician who lost her arm after being injected with Wyeth's Phenergan nausea treatment.

So pharmaceutical companies won't be shielded from lawsuits just by having the Food Drug Administration's approval and its packaging information.

Justice Paul Stevens commented that, Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness."

Read more >>

Read the U.S. Supreme Court Opinion

Wyeth v. Levine? What is that?

Does the fact that drugs are regulated by the federal government preempt drug companies from being sued in state court? On November 3, 2008, the Supreme Court will decide.

Background

Diana Levine is a Vermont musician and migraine sufferer who lost part of one arm due to side effects from Wyeth’s nausea drug Phenergan.

The problem wasn't with the drug itself, but with the way it was given to her. Phenergan causes gangrene if it comes in contact with arterial blood, so it's usually given by intramuscular injection or sometimes by IV drip. But it was given to Levine by "IV push," and the physicians assistant apparently missed the vein.

Nobody told Ms. Levine about the risks from IV push, whose benefits are, at best, faster more potent relief from nausea. "The benefit-risk is just outrageously ridiculous," Ms. Levine told the New York Times in an interview. "Any child could figure this out."

Levine argues that the Phenergan label, which did warn about the risks of inadvertent intra-arterial injection, should also have clearly warned against IV push. "All they had to do was change the label and say, 'Don’t give it this way.'"

Read the New York Times interview with Diana Levine.

Wyeth says the drug's label is set in accordance with federal regulations. "Wyeth could not change Phenergan's labeling to comply with Vermont law without violating federal law," the company’s lawyers wrote in a brief cited by the article.

Read what Wyeth has to say in Wyeth v. Levine: Preemption and the Facts.

What We Think

The application of federal preemption doctrine to drug injury lawsuits would effectively eliminate a significant incentive for the drug company to ensure that its drug labels reflect accurate and up-to-date safety information, i.e., the possibility of failure-to-warn product liability litigation.

Read more about Tom Lamb's perspective on federal preemption at DrugInjuryWatch.

What Do You Think?

Tell us at Hey Monkeybrain! Who is the FDA protecting: you or the pharmaceutical companies?

More Preemption Resources

Transcript of November 3, 2008 Wyeth v. Levine Supreme Court Hearing

Arguments page of US Supreme Court website.

Pharmaceutical Research and Manufacturers of America (PhRMA) November 3, 2008 Statement

One important point often remains silent in this debate: All medicines have some risks. FDA’s expert scientists must sometimes make tough choices when they approve a medicine that can help treat or save millions of patients, even as they recognize that some patients will experience serious side effects.

Journal of American Medical Association Editors Oppose Preemption

This article is from the Pharmalot blog, by Ed Silverman; there is an insightful discussion regarding Wyeth v. Levine and possible application of federal preemption to drug injury lawsuits in the Comments section. Earlier articles about preemption on the Pharmalot blog have also generated good Comments, pro and con, on the issue.

Why Doctors Should Worry About Preemption

July 3, 2008 article in New England Journal of Medicine starts by setting the stage:

A leading drug company may be poised to win a landmark legal victory next fall. If the drug manufacturer, Wyeth, prevails in a case soon to be argued before the U.S. Supreme Court (Wyeth v. Levine), drug companies could effectively be immunized against state-level tort litigation if their products that have been approved by the Food and Drug Administration (FDA) are later found to be defective.

A medical-device company won such a victory in April. In Riegel v. Medtronic, the Supreme Court determined that a product-liability lawsuit against Medtronic in a state court was preempted because the device had received FDA approval. Preemption is a legal doctrine based on the supremacy clause of the U.S. Constitution, which states that when federal and state laws are at odds, federal law takes precedence. Its application to state tort litigation is a radical extension of its original meaning. [footnotes omitted]

The FDA Is Not Ready For Federal Preemption Of Lawsuits Involving Drugs And Medical Devices

Something Old And Something New: Two Items From July 3, 2008 NEJM Show Why Preemption Applied In These Types Of Cases Is Bad Public Policy.

FDA Staff Objected to Agency Preemption Policies

Just days before the Supreme Court hears Wyeth v. Levine, the House Oversight and Government Reform Committee issued a groundbreaking report that details objections made by career Food and Drug Administration employees to the Bush administration's repeated attempts to expand the preemption doctrine in ways that would harm American consumers. Based on internal FDA documents, the report reveals that many of the agency's long-time scientists and researchers strongly objected to the Bush administration’s efforts to shield manufacturers from liability.

The Pre-emption Prescription. The FDA is claiming total responsibility for drug and medical device safety. Some think it's a bad idea.

The FDA had been signaling its new attitude of tort reform regarding prescription drugs and medical devices since 2001, when a new administration at the FDA began gearing up to file "friend-of-the-court" briefs in state and federal courts claiming that federal regulations pre-empted the power of states to enforce deficiencies—or even deceptions—in prescription drug warnings. To critics like James O’Reilly [Univer­sity of Cincinnati College of Law], FDA pre-emption is part of a series of legal and political maneuvers that all but neu­tered the federal agency in the public eye as a regulator of public health and safety. To supporters, the agency has become far more responsive to the public need for development of new drugs and medical devices.

What Me Worry? The FDA Will Protect Me from Toxic Drugs (NOT!)

The looming probability that preemption of tort litigation, which translates into English as citizens giving up their right to have a day in court for toxicity or death related to FDA prescription drugs, will become the law of the land, is particularly chilling.

Supreme Court Could Shape Product Safety Warnings

From Business Finance, next month the Supreme Court will hear Wyeth v. Levine, a case that could shape product safety laws affecting everything from automobile makers to pharmaceutical companies.

Supreme Court Docket for Wyeth v. Levine.

QUESTIONS PRESENTED: Whether the prescription drug labeling judgments imposed on manufacturers by the Food and Drug Administration ("FDA") pursuant to FDA's comprehensive safety and efficacy authority under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use.

Read the interview on ClinPage

Tom Lamb's interview, commentary, and a history lesson.

Before You Take That Pill: Some of Us Doctors Actually Care About Our Patients

Preemption would effectively yank the protection that Americans get from the judicial branch of government and leave the executive and legislative branches in charge of protecting them. And what do they know about drug safety? Since the FDA's leadership is politically appointed, this would put the responsibility for guarding Americans in the hands of a small group of politicians who frequently benefit from donations from pharmaceutical companies.

Drug Companies in Michigan Already Enjoy Immunity

Essay by Henry Greenspan on preemption in the state of Michigan, where consumers were stripped of their right to a day in court for FDA approved prescription medication disasters 10 years ago -- which now threatens to become the law of the land. Henry Greenspan teaches social psychology and social ethics at the University of Michigan, Ann Arbor. He is a Faculty Scholar at the Program in Integrative Medicine at the University Michigan Medical School and the Founder of Justice in Michigan: an organization of policy analysts, social scientists, bioethicists, and physicians supporting legislation that would rescind Michigan’s draconian drug industry immunity law.

Compilation of Links to Documents Filed in Wyeth V. Levine

The American Bar Association has compiled a list of hyperlinks for the Amicus briefs filed in connection with the Wyeth v. Levine case for those of you who want to get an in-depth view of both sides to this very important legal and public policy issue.

What can you do??

Federal Agencies are threatening to usurp Congressional Authority to protect the health and safety of Americans

Write a letter to Congress.

Tell Congress Preemption Advances Corporate Irresponsibility

Send a Letter To The Editor

Enter your zipcode and this site will forward a letter to your local paper.

Petition: FDA Preemption = Bad Medicine

This petition is sponsored by Americans for Drug and Device Accountability, which describes itself as "a group of concerned citizens interested in protecting the civil rights of the American people". The online petition form allows you an opportunity to add a Comment along with your signature. Please know that the voluntary contribution form which pops-up after you click the "Sign Petition" button can be closed and your signature will still be recorded for the petition. (Of course, you can contribute to the online form company, which is where the money would go, if you want.)

Drug Injury Watch: Federal Preemption News Commentary

Tom Lamb Comments on Federal Preemption of Drug Injury Lawsuits