Articles on Preemption
Wyeth v. Levine and Its Implications (May 2009) Copyright The Bureau of National Affairs, Inc.
Former Public Citizen Litigation Group Director Brian Wolfman has written an article on the Supreme Court's decision in Wyeth v. Levine, which held that FDA approval of a prescription drug and its labeling does not preempt a state-law suit seeking damages based on injuries caused by the failure of the drug's manufacturer to warn about the drug's dangers. The article describes the Court's decision in detail and discusses its implications for future litigation. Mr. Wolfman served as one of the lawyers for Diana Levine, the plaintiff in the case.
US Supreme Court Case: A Victory for Patients. (April 2008) Copyright Informa UK Ltd 2008.
Litigation Group attorney Allison Zieve discusses the implications for patients of the Supreme Court's decision in Warner-Lambert v Kent.
Supreme Court Decision May be Hazardous to Patients. (March/April 2008) Copyright Informa UK Ltd 2008.
For 32 years, the US Food and Drug Administration has regulated the entry of medical devices onto the market. Throughout that time, US consumers injured by medical devices have been able to bring, and often to win, product liability lawsuits seeking compensation from device manufacturers for injuries caused by medical devices. In February 2008, the Supreme Court held that the law that provides authority for the FDA to regulate devices also severely limits the right of injured patients to sue device manufacturers. In this article, Litigation Group Attorney Allison Zieve explains why this decision creates a hazardous hole in the US system for protecting public health.
Why Preemption Proponents Are Wrong. (March 2007) Posted with permission of TRIAL. Copyright American Association for Justice.
Corporations defending products liability cases — concerning defective cars, mislabeled drugs, dangerous pesticides, or hazardous household cleaners, to name a few — argue that federal regulation of their products bars (or "preempts") any recovery by people injured by those products. The corporations claim that tort cases interfere with federal regulation. In this article, Litigation Group Director Brian Wolfman provides insights into defeating preemption defenses and explains that, in fact, protection of the public is maximized when court remedies are allowed to work alongside federal regulation.
The FDA's Argument for Eradicating State Tort Law: Why It Is Wrong and Warrants No Deference
(March 27, 2006)
In January 2006, in a notice announcing the issuance of new drug labeling regulations, the Food and Drug Administration stated that FDA approval of a new drug preempts a range of product liability claims brought by patients injured by prescription drugs. In this article, attorneys Allison M. Zieve and Brian Wolfman explain why the FDA's preemption position is bad law, bad policy, and warrants no deference from the courts.
Cases on Preemption Involving the Food, Drug, and Cosmetic Act
Cases About "All Natural" Foods and Beverages
In a series of cases, plainitffs have argued that marketing foods and beverages as "all natural" when they contain high fructose corn syrup, is false and misleading under state unfair and deceptive trade practices laws. Some of the cases also allege that labeling and advertising beverages by using the names and images of fruits that are not contained in the products also violates these state laws. The defendants have moved to dismiss the cases, arguing that these claims are preempted by the Food, Drug, and Cosmetic Act and FDA regulations. We have appeared as co-counsel in several of these cases to oppose the preemption motion. In one case pending on appeal, we filed an amicus brief to explain why the claims are not preempted.
Lockwood v ConAgra (Jan. 2009)
Hitt v. AriZona Beverage Corp. (2008)
Covington v. AriZona Beverage Corp. (2008)
Holk v Snapple (Dec. 2008)
McKenney v. Purepac Pharmacuetical Company
In this case, a generic drug manufacturer, Purepac Pharmaceutical Company, maintains that state-law claims alleging personal injuries from use of generic prescription drugs are preempted by the federal Food, Drug, and Cosmetic Act. The plaintiff won on the preemption issue in the California Court of Appeal, and Purepac sought discetionary review in the California Supreme Court. The plaintiff opposed review, and the court denied the company's petition.
Warner-Lambert v Kent
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 was whether the exception to the statutory defense is impliedly preempted. The Supreme Court divided 4-4 on the question, and the Michigan patients therefore were able to pursue their claims against the drug company whose product had caused them very severe injury
Fellner v. Tri-Union Seafoods (3d Cir.)
In this case, defendant Chicken-of-the-Sea contended that Deborah Fellner's claims that she was not adequately warned about the dangers of mercury in tuna fish are impliedly preempted by the FDA's "approach" to mercury in seafood. In its brief on behalf of Ms. Fellner, Public Citizen explained that the FDA's few informal actions on mercury in seafood do not preempt Ms. Fellner's state-law claims. In August, 2008, the Third Circuit agreed that the FDA’s actions did not constitute federal law that preempt Ms. Fellner’s state-law claims. The Supreme Court denied Chicken-of-the-Sea’s petition for it to hear the case.
New York State Restaurant Association (NYSRA) v. New York Department of Health, et al.
A fast-food industry group filed two lawsuits challening New York City's landmark regulation requiring fast-food restaurants to post calorie information on their menus. The industry argued that the regulation was preempted by federal law and violated the First Amendment.
In both cases, Public Citizen filed briefs and presented oral argument in support of the regulation, arguing that it was not preempted because it fills a regulatory gap that Congress intentionally left open to states when it passed the Nutrition Labeling and Education Act (NLEA) in 1990. The NLEA requires nutrition labeling on packaged food but exempts restaurants.
Public Citizen's briefing was joined by a distinguished list of individuals and organizations, including Congressman Henry Waxman (D-CA), who was the NLEA's chief sponsor; David Kessler, MD, who was Commissioner of the FDA at the time the NLEA and its regulations were implemented; the Center for Science in the Public Interest, which played an instrumental role in getting both the NLEA and the New York City rule enacted; the American Medical Association, the American Public Health Association, the American Diabetes Association; and a host of prestigious health and medical organizations and distinguished professors of medicine, nutrition, and public health.
In the first lawsuit, filed in 2007, federal judge Richard J. Holwell ruled that an earlier version of the city’s calorie rule was preempted by federal law because it applied only to restaurants that already made nutrition information public. But the judge also ruled that the city was free to require fast food restaurants to disclose calorie counts,as long as it redrafted its rule to apply to all chain restaurants (defined as restaurants with 15 or more restaurants nationally).
In the second lawsuit, the case went back before the same judge, who agreed with our arguments against the restaurant industry's constitutional challenges. The industry then took an appeal and the U.S. Court of Appeals for the Second Circuit affirmed the lower court's decision. New York's rule remains in effect and has become a model for similar state and local laws throughout the country. Public Citizen is also working with public health advocates on legislation that would implement menu labeling at the federal level.
To read the article in the ABA Journal, click here.
Wyeth v. Levine
Public Citizen was co-counsel for respondent Diana Levine, a professional musician, who went to the hospital for treatment of a headache and, after being injected with a drug manufactured by Wyeth, left with injuries that led to the amputation of her right arm. Ms. Levine prevailed in a jury trial, and the verdict was sustained byt e Vermont Supreme Court. Wyeth petitioned to the Supreme Court, which took the case to consider whether approval by the Food and Drug Administration of a drugs label preempts state-law product-liability claims for failure to provide adequate warnings or instructions for use. Upholding the jury's verdict, the Supreme Court held in a 6-3 decision that Ms. Lvine's claims were not preempted.
Colacicco v. Apotex and GlaxoSmithKline (3d Cir.)
In the past few years, pharmaceutical companies have been arguing that the Food, Drug, and Cosmetic Act impliedly preempts state-law actions brought by patients who have been injured by prescription drugs. The decisions in these cases are likely to be the first appellate court decisions on this issue since the FDA reversed its longstanding position against preemption. Public Citizen filed amicus briefs in support of the plaintiff in each case.
Riegel v. Medtronic
After suffering serious injury when a balloon catheter burst while he was undergoing an angioplasty procedure, Charles Riegel and his wife sued the catheter's manufacturer, Medtronic, Inc. Medtronic moved to dismiss the lawsuit, arguing that the Food, Drug, and Cosmetic Act expressly preempts state-law damages actions brought by patients who have been injured by medical devices that received premarket approval from the Food and Drug Administration. The court agreed and dismissed the case.
Public Citizen represented the Riegels on appeal and before the U.S. Supreme Court. In February 2008, the Supreme Court ruled for the manufacturer, holding that the express preemption provision of the Act preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the FDA.
Horn v. Thoratec
Ms Horn's husband died after a heart pump implanted in his chest broke and sued the manufacturer of the heart pump. The manufacturer sought dismissal of the case, arguing that the Food, Drug, and Cosmetic Act expressly preempted state-law actions brought by patients who have been injured by medical devices that received premarket approval from the Food and Drug Administration. The Third Circuit sided with the manufacturer. The case then settled.
Dowhal v. SmithKline Beecham et al.
Under the California law commonly known as Proposition 65, companies that manufacture products sold in the state and retailers of those products are required to warn consumers about certain risks associated with the products, such as the risk of reproductive toxicity or cancer. When Paul Dowhal brought a Proposition 65 action in state court to force manufacturers and retailers of over-the-counter nicotine replacement products that nicotine poses a risk to pregnant women and their babies, the defendant companies moved to dismiss the suit by arguing that Proposition 65 is "impliedly preempted" with respect to over-the-counter drugs. In our amicus brief, Pubic Citizen argued that Propositon 65 is not preempted. Unfortunately, the California Supreme Court decided that Dowhals' claims were preempted.
Motus v. Pfizer
In this case, defendant Pfizer argued that the Food, Drug, and Cosmetic Act impliedly preempts state-law actions brought by patients who have been injured by prescription drugs. Public Citizen filed an amicus brief in support of the plaintiff. The Ninth Circuit decided the case without addressing preemption.
Weiland v. Telectronics Pacing Systems
Mr. Weiland was injured by two defective pacemakers implanted in him and brought suit against the manufacturer of the pacemakers. The manufacturer sought dismissal of the case, arguing that the Food, Drug, and Cosmetic Act expressly preempts state-law actions brought by patients who have been injured by medical devices that received premarket approval from the Food and Drug Administration. The Illinois Supreme Court agreed with us that Mr. Weiland's claims were not preempted.
Goodlin v. Medtronic
Lisa Goodlin was injured by a defective pacemaker and brought suit against the pacemaker's manufacturer, Medtronic. Medtronic sought dismissal of the case, arguing that the Food, Drug, and Cosmetic Act expressly preempts state-law actions brought by patients who have been injured by medical devices that received premarket approval from the Food and Drug Administration. The U.S. Court of Appeals for the Eleventh Circuit agreed with us that Ms. Goodlin's claims were not preempted.
Medtronic, Inc. v. Lora Lohr and Michael Lohr
Preemption under the medical device amendments.
Other cases involving preemption of tort claims
Lundeen et al. v. Canadian Pacific Railway et al.
Eyl v. Ciba-Geigy
In this case, we asked the Supreme Court to review a decision of the Nebraska Supreme Court holding that the claims of a man severely injured by a herbicide are preempted by the Federal Insecticide, Fungicide, and Rodenticide Act. The petition was denied.
James Miles IIII v. S.C. Johnson & Son, Inc. et al
Preemption under Federal Hazardous Substances Act and the Poison Prevention Packaging Act, November 2002.
Lescs v. Dow Chemical Company
Preemption under the federal pesticide statute, FIFRA.
Roberts v. Florida Power and Light
Preemption under the Price-Anderson Amendments to the Atomic Energy Act.
US v Philip Morris
In this amicus brief, filed on behalf of Public Citizen, Inc., American college of Preventive Medicine, American Public Health Association, Association of Maternal and child Health Programs, National Association of Local Boards f Health, and the Oncology Nursing Society, we argued in support of the district court's finding that tobacco companies' use of descriptors such as "light" and "low-tar" was fraudulent and argued that the court's order that defendants cease using such descriptors did not conflict with Federal Trade Commission policy.
Aspinall v Philip Morris
In this amicus brief, Public Citizen, on behalf of itself, the Campaign for Toabcco-Free Kids, the Public Health Advocacy Institute, the American Lung Association, the American Lung Association of Massachusetts, and the American Cancer Society, argued that neither federal law nor the actions of the Federal Trade Commission immunize Philip Morris from liability for unfair and deceptive trade practices in connection with its marketing of "light" cigarettes.
Price v. Philip Morris
In this amicus brief, we argued that state-law fraud claims based on cigarette companies use of terms such as "light," "low tar," and "lowred tar and nicotine" are not preempted by federal law or the actions of the FTC.
Lorillard v. Reilly
This case raised the fundamental question of whether states may regulate tobacco advertising. Massachusetts had imposed a fairly broad regulation limiting outdoor tobacco advertising. The tobacco industry challenged the Massachusetts regulation on two grounds. First, industry claims that the federal cigarette labeling law "preempts" (or forbids) any state regulation. Industry's second argument was that the First Amendment to the U.S. Constitution bars states (and presumably the federal government as well) from imposing virtually any restraint on advertising. Our brief examined why the Court should reject both arguments. Unfortunately, the Court ruled in favor of industry.
Other preemption matters
S. 659, Protection of Lawful Commerce in Arms Act
In a letter to Senate Judiciary Committee Chairman Orrin Hatch, Public Citizen lawyers urged the committee to hold hearings on the constitutional concerns raised by S. 659, the Protection of Lawful Commerce in Arms Act. The bill would prohibit state-law suits for damages against gun manufacturers based on misuse of their products. The letter points out that the bill threatens to violate the Commerce Clause, the Due Process Clause, and the Tenth Amendment.
Petition Of The Wireless Consumers Alliance, Inc., to FTC
"Federal officer removal"
Watson v. Philip Morris
In this case, the U.S. Court of Appeals for the Eighth Circuit, in an astonishing and unprecedented decision, held that cigarette manufacturer Philip Morris is entitled to "remove" cases filed against it in state courts to federal courts, under a statute designed to protect federal officers and employees. We filed an amicus curiae brief in support of the plaintiffs' petition for rehearing in the Eighth Circuit, which was denied with two judges dissenting. The plaintiffs filed a petition for certiorari in the Supreme Court, and we filed another amicus brief supporting their petition. On May 22, the Supreme Court issued an order asking the United States to file a brief stating its position on whether the Supreme Court should review the Eighth Circuit's decision.
Isaacson v. Monsanto (Agent Orange Litigation)
The briefs were submitted in support of Agent Orange victims whose cases were dismissed by the U.S. District Court for the Eastern District of New York. The cases are now on appeal to the U.S. Court of Appeals for the Second Circuit. The briefs argue that the district court did not have jurisdiction because the cases were not properly subject to "removal" to federal court from state court where they were originally filed under a statute providing that federal officers, employees and agents can remove cases filed against them in state court. The briefs argue that the defendants here, private corporations who manufactured Agent Orange, do not qualify as federal agents for purposes of the removal statute.