Today, the U.S. Supreme Court issued a one-line decision affirming the lower court’s ruling in Warner-Lambert v. Kent. This decision will allow certain Michigan residents to hold drug manufacturers accountable for their negligence. This decision does not apply broadly to all state tort claims.
Washington, DC—"The result today affirming the 2nd Circuit’s decision will allow Michigan residents harmed by drugs that are unsafe or provide inadequate warnings to have a fair chance in our courts, and hold companies accountable for their actions.
"While those plaintiffs will get justice in the courtroom, we hope the Supreme Court’s decision in Levine v. Wyeth this fall will continue to allow Americans in any state to hold drug companies accountable."
As the world's largest trial bar, AAJ promotes justice and fairness for injured persons, defends the constitutional right to trial by jury, and strengthens the civil justice system through education and disclosure of information critical to public health and safety. Serving members worldwide, AAJ provides attorneys with the information and professional assistance they need to serve clients successfully and protect the democratic values of the civil justice system. Visit http://www.justice.org.
WILL REGULATORY AGENCIES, COURTS CONTINUE TO UNDERMINE STATE LAW?
FACT SHEET: WARNER-LAMBERT V. KENT
AMERICAN ASSOCIATION FOR JUSTICE POSITION ON PREEMPTION
While Congress is expressly granted power under the Constitution to enact federal laws that supersede state laws, federal regulatory agencies inside the Bush administration have taken the unprecedented step of creating rules that preempt state law and state tort remedies. This practice, called preemption, usurps the authority of Congress, state legislatures, and state courts and is harmful to Americans. Agencies seeking preemption are doing so without Congressional or constitutional authority.
The idea that if minimum federal standards are met, all state tort claims should be discarded is a direct affront to the authority of state courts, state legislatures, and Congress. State remedies were designed to complement, not conflict with, federal health and safety regulations.
The civil justice system offers corporations a powerful incentive to make their products safer. All people should have a fair chance to receive justice through the legal system when they are injured by the negligence or misconduct of others – even when it means taking on the most powerful corporations.
This dispute stems from several suits against the drug manufacturer Warner-Lambert, which is now owned by Pfizer Inc, over its diabetes drug Rezulin. The Food and Drug Administration (FDA) ordered Rezulin off the market in 2000 after it was linked to hundreds of deaths caused by liver failure.
That year, a group of plaintiffs from Michigan brought suit against the company for negligence and defects in the design and manufacture of the drug. Under Michigan law, a drug which has been approved by the FDA cannot be deemed defective or unreasonably dangerous, in effect giving the manufacturer of the drug immunity and preventing victims from seeking justice in the courtroom.
The only exception for this blanket immunity occurs in instances where the drug’s approval by the FDA was obtained through fraud. Therefore, drug manufacturers can be subject to suit for victims’ injuries caused by their products if they intentionally withheld or misrepresented information presented to the FDA, and the FDA would not have approved the drug if all the information had been accurately submitted.
The question before the U.S. Supreme Court is whether state courts can consider allegations that a drug company misled the FDA to win approval for a drug, or if cases presented under this exemption are preempted.
The plaintiffs in this case, led by Kimberly Kent, claim that Warner-Lambert misled the FDA about the severity and pervasiveness of the liver damage among patients in the company's clinical trials and, therefore, is liable for damages under the Michigan statutes exemption. Warner-Lambert contends that state courts should not decide such claims because it would "intrude upon an exclusively federal domain" and "inevitably conflict with the FDA's authority” to police fraud against it.
Unlike the Court's latest rulings on issues of regulatory preemption, most notably Riegel v. Medtronic, the ruling is expected to have narrow implications. There are a handful of states that have laws that are similar to the Michigan statute but only Michigan has the additional requirement to prove the FDA would not have approved the drug if the information was accurately submitted.
- Supreme Court granted certiorari on 9/25/07
- Oral Arguments: 2/25/08
- Decision: 3/3/08
RECENT FDA ACTIONS
A 2006 FDA rule on drug labeling declared state tort law was preempted, although the agency had long held the opposite view. [i] In fact, when the rule had been proposed five years earlier, it had specifically stated "this proposed rule does not preempt state law."[ii] In a letter to the FDA, Senators Edward Kennedy and Chris Dodd, senior Democrats on the committee that oversees the FDA, criticized the agency for adding the language without allowing comments, and described the assertion of preemption as, "a drastic reversal of policy with … far-reaching implications."[iii]
The FDA's drug labeling rule did not include the preemption provision in draft form. Only after the comment period had ended and the final version of the rule was issued was the preemption language publicly seen. There was an immediate outcry from Congress and states' groups. In a letter to the FDA, Representative Lee Terry (R-NE) stated that because the "preemption language did not appear in any earlier versions of the proposed rule FDA's response that no state or local government responded is disingenuous."[iv] The National Conference of State Legislatures (NCSL) complained that "[i]t is unacceptable that FDA would not permit the states to be heard on language that has a direct impact on state civil justice systems nationwide."[v]
The FDA's turnaround on preemption was led by FDA Chief Counsel Daniel Troy, who was the most senior FDA executive from 2000 to 2002.[vi] Troy had previously received hundreds of thousands of dollars in compensation from tobacco and pharmaceutical companies whom he had represented, often against the FDA.[vii] In Troy's three years at the FDA he held 129 meetings with representatives of industries with interests in the regulatory processes of the FDA.[viii] At an industry conference in 2003, Troy stated that he was the initiator of the amicus briefs filed on behalf of manufacturers, which had been the agency's first vehicle for advocating preemption.[ix]
[i] Professor James O’Reilly, quoted in: Anne C. Mulkern, Watchdogs or Lap Dogs? When Advocates Become Regulators, Denver Post, May 23, 2004.
[ii] See Requirements on Content and Format of Labeling for Human Prescription Drugs and Biologics: Requirements for Prescription Drug Product Labels, 65 Fed. Reg. 81082, 81103, proposed December 22, 2000.
[iii] Letter from Sen. Edward M. Kennedy & Sen. Christopher J. Dodd to Michael O. Leavitt, Secretary, Health & Human Services, February 23, 2006.
[iv] Letter from Rep. Lee Terry to Andrew C. Von Eschenbach, Acting Commissioner, FDA, March 31, 2006.
[v] Letter from Sen. Steven J. Rauschenberger, President, National Conference of State Legislatures (NCSL) to Michael O. Leavitt, Secretary, Health & Human Services, January 13, 2006, available at: http://www.ncsl.org/programs/press/2006/060113Leavitt.htm.
[vi] Frank, Thomas, "Friends on the Inside, "Newsday, October 11, 2004.
[vii] Dart, Jessica R., "Preemption Issues and Prescription Drug Litigation," Mealey's Litigation Report, 1(8), March 2005; Fleischer-Black, Matt, "Cosmetic Advocacy," Corporate Counsel, October 2003, 116.
[viii] Frank, Thomas, "Friends on the Inside," Newsday, October 11, 2004.
[ix] "8th Annual Conference for In house Counsel and Trial Attorneys, Drug Medical Device Litigation," December 15, 2003, as reported in affidavit in Motus v. Pfizer and In re Paxil.