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FAQs About Preemption
FREQUENTLY ASKED QUESTIONS ABOUT FEDERAL PREEMPTION/CORPORATE IMMUNITY AND VICTIMS' RIGHTS TO SEEK JUSTICE
Exactly what does "federal preemption" mean?
It is a generally accepted principle of the balance between federalism and states' rights that state laws may be more, but not less, stringent than federal laws. The concept of federal preemption, however, defines areas where federal law supersedes - and thus weakens or renders powerless - state laws. Federal preemption virtually erases state laws related to consumer protection and victims' rights to sue in state courts.
In the case of victims' rights to seek recovery through the civil justice system for illness or injury caused by negligent makers of medical devices, supporters of federal preemption argue that if the devices have been approved by the Food and Drug Administration, a federal agency, then states' rights to enforce stricter safety standards and remedies for recovery through the courts no longer apply. That's why we refer to the current federal preemption plot as corporate immunity.
What effect does this have on my right to sue the manufacturer of a product that has seriously injured me or caused a severe illness?
It means that regardless of the severity of your injury or illness, your reliance on inadequate labeling and warnings by the manufacturer, evidence of negligence or misconduct, or proof of a causal relationship between the product and your suffering . . . you cannot file a lawsuit against the manufacturer if the harmful product was approved by a federal agency such as the Food and Drug Administration.
Who is behind this move to take away my rights?
For many years, there has been a movement to weaken or outright abolish the tort system - our system for seeking recovery through the courts and holding wrongdoers accountable for their actions. A 2005 cover story in Business Week magazine on "How to Fix the Tort System" cited preemption as corporate America's preferred fix. It was supported by the Bush Administration, and advanced in FDA regulations by an aggressive former Chief Counsel. The Bush Administration threatened to kill FDA rules that included, for example, a consumer's right to sue drug manufacturers for failing to provide adequate or updated warning labels.
What kinds of personal injury claims are affected?
Right now, attention is focused primarily on federal preemption promulgated by the FDA in regard to medical devices and pharmaceuticals. But preemption applied to a number of other agencies is equally dangerous and is a nightmare for consumers.
For example, federal preemption language included in Environmental Protection Agency rules could preclude class action and mass tort lawsuits against negligent corporations on behalf of victims of toxic pollution and other environmental hazards. The National Highway Traffic Safety Administration claims that many of its new federal standards related to automobile safety preempt state tort law and prohibit injured motorists from seeking justice through the courts.
A new regulation by the Federal Railroad Administration and the Pipeline and Hazardous Materials Safety Administration contains preemption language that bars victims from seeking justice in the case of death or injuries related to railroad transport of hazardous materials. And cases are now emerging where victims of credit card fraud or identity theft may not be able to rely on state consumer protection laws because of alleged federal preemption language in the Fair Credit Reporting Act.
What is Congress doing to stop this disastrous idea?
In regard to medical devices, a Medical Device Safety Act was introduced into Congress in June 2008, in part as a result of a February U.S. Supreme Court decision supporting preemption in a case involving faulty medical devices that caused widespread injury. Although the 2008 bill did not even get to the floor of Congress, the Medical Device Safety Act of 2009 has been introduced in both houses of the 111th Congress, and sponsors have gained a significant number of co-sponsors and support.
The language of the proposed 2009 law amends the Federal Food, Drug and Cosmetic Act to bar preemption of state law, and makes the "no preemption" provision retroactively a part of the Medical Device Amendments of 1976.
What was the impact of the Supreme Court decision on medical devices?
The U.S. Supreme Court decision in Riegel v. Medtronic, Inc. has barred from the judicial process thousands of heart patients who were harmed by Medtronic defibrillators with defective Sprint Fidelis leads, some of whom suffered heart attack symptoms and required emergency surgery. Equally significant, this decision has encouraged other court challenges, including Wyeth v. Levine, which was decided by the U.S. Supreme Court in March 2009. In the Wyeth case, however, the Supreme Court rejected the premption argument and upheld a patient's right to legal recourse for injury from a pharmaceutical product.
What is the status of the Supreme Court case involving pharmaceuticals?
On March 4, 2009, the U.S. Supreme Court upheld the decision of a Vermont jury in favor of Diana Levine, who lost her arm to gangrene because of an anti-nausea drug. In Wyeth v. Levine, plaintiff Wyeth Pharmaceuticals argued that federal preemption applies based on FDA approval of the warning label on its anti-nausea drug Phenergan. Defendant Levine had been awarded $7.4 million by a Vermont jury because of Wyeth's inadequate and out-of-date warning label.
The significance of this case is substantial because if the decision had favored Wyeth, it would have set a precedent for federal preemption in claims based on unsafe pharmaceuticals in addition to the previous decision related to faulty medical devices. Instead, the Court's reasoning in Wyeth v. Levine helps substantiate arguments against federal preemption when patients and families are devastated by harmful medical devices.
Where is the Food and Drug Administration in all this?
The FDA has been a major culprit in the expansion of federal exemption, partly because of a former Chief Counsel, Dan Troy. Previously a highly-paid attorney for tobacco and pharmaceutical companies, Troy spent much of his time meeting with lobbyists for industries with interests in the FDA's regulatory processes. In the past few years, the FDA has filed several amicus briefs and statements of interests arguing that agency regulation trumps state law when their interests conflict.
It must be noted that the FDA's reputation as a watchdog over public health and safety has been heavily criticized by consumer organizations and even the Government Accountability Office. A GAO report released in January 2009 states, "The agency is facing significant challenges that compromise its ability to protect Americans from unsafe and ineffective products." The GAO report specifically questioned the FDA's credibility in managing inspection of medical devices, and noted that the agency sometimes relies on suspect data sources in monitoring the safety of drugs after they are put on the market.
What difference can the Obama Administration make?
Already, the Obama Administration has acted by reversing some of the last-minute preemption actions of the Bush Administration. For example, thanks to President Obama's stay of pending FDA rules that included preemptive language, Michigan mother Kimberly Gueldenzoph retained the right to seek justice on behalf of her infant daughter. Two-week-old Kenndyl Gueldenzoph died from complications of a congenital heart defect caused by the drug Paxil, which her mother took during pregnancy. Neither Mrs. Gueldenzoph nor her physician was warned about Paxil's association with birth defects, but there is evidence that Paxil's manufacturer, GlaxoSmithKline, knew all along. Now, the Gueldenzophs will be able to have their day in court.
In response to an Obama Administration request for input to the Office of Management and Budget on improving the federal regulatory process, the American Associaton for Justice has expressed its concern about the previous Administraton's "lack of rational attention given to preemption issues during the regulatory review process." Citing federal agencies' inclusion of language seeking to preempt state tort law claims without consultation with state governmental organizations or interested parties, AAJ suggests that the U.S. Supreme Court's decision in Wyeth v. Levine serve as a roadmap for the Obama Administration on preemption issues.
Who is standing up against the big corporations on behalf of victims?
Altogether, there is a strong team working to guarantee the rights of victims to seek recourse through the courts when they have been harmed by defective medical devices. Many key supporters of preemption departed with the Bush Administration, and the Obama Administration appears to be moving toward restoring states' rights.
At the same time, members of Congress are stepping forward to support the Medical Device Safety Act of 2009, and political observers predict that it has a good chance of passage. As of March 2009, there are already numerous co-sponsors for the bill in the House of Representatives, in addition to sponsors Henry Waxman and Frank Pallone. In the U.S. Senate, sponsors Edward Kennedy and Patrick Leahy have been joined by many of their colleagues as co-sponsors. Iowa Governor Chet Culver is circulating a letter to the governors of other states, urging their support of this legislation.
In addition, a coalition of consumer organizations, academic institutions, legal associations, and consumer groups is organizing a citizen advocacy campaign for passage of the Medical Device Safety Act. We hope that you will consider playing an active role in this grassroots movement.
What can an ordinary citizen like me do to make a difference?
Right now, you can contact your Senators and member of the House of Representatives to persuade them to sign on as co-sponsors of the Medical Device Safety Act of 2009. Then, as the legislation moves toward a floor vote, you can help persuade your Congressional delegation to vote in favor of it. Click the "Speak Out" page of this website to learn more about what you can do, and how to do it most effectively.
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