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.'"
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.
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.
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.
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.
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]
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 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.
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.
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.
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.
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.
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.
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.
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.)
... with Diana Levine would be a good opportunity for people like you and me to ask Diana Levine questions about this new AFJ documentary film which delves into her drug injury situation, including the looming federal preemption issue. ...
Read What The Attorneys For Diana Levine And Wyeth Argued, And What Questions Were Asked By The Justices Regarding Possible Federal Preemption Of This Drug Injury Case (Posted by Tom Lamb at DrugInjuryWatch.com) In the run up to the ...
It is my position that any application of the 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 ...
If Drug Companies Put Sales Above Efficacy And Safety, Should They Get Legal Immunity By Means Of Federal Preemption Doctrine? (Posted by Tom Lamb at DrugInjuryWatch.com). In the first part of October 2008 we learned of yet another ...
In several earlier posts I have advocated that any application of the federal preemption doctrine to drug injury lawsuits would effectively eliminate a significant incentive for the drug company to ensure that its drug labels reflect ...
Tom Lamb Comments on Federal Preemption of Drug Injury Lawsuits
US FDA advises that you should not stop taking any prescription
medication before talking to your doctor.
Reports of serious drug side effects should be made to the US FDA MedWatch program.
The prescription drug names are registered trademarks of the respective drug companies.
DrugInjuryLaw.com is not affiliated with any of the drug companies, nor US FDA.
Law Offices of Thomas J. Lamb, P.A.
Lumina Station Suite 225
1908 Eastwood Road
Wilmington, NC 28403
Tel: (910) 256-2971 Fax: (910) 256-2972
Toll Free: (800) 426-9535 email: ThomasJLamb@DrugInjuryLaw.com Disclaimer
