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Federal preemption is an important defense available to drug manufacturers defending
product liability lawsuits. The question of whether certain federal laws conflict with and preempt state laws is a highly litigated one. Courts throughout the country continue to
address the issue and their decisions bear monitoring. This article highlights some key preemption opinions issued in the pharmaceutical context as well as the government’s
Various federal courts have split on the issue of whether federal law preempts state law in failure to warn cases against prescription drug manufacturers. While some courts hold
that federal law does preempt state law, others disagree, holding that federal and state laws can coexist. The Supreme Court has stated in Crosby v. National Foreign Trade
Council, 530 U.S. 363, 372-73 (2000) that conflict preemption occurs either “where it is impossible for a private party to comply with both state and federal law” or where state law
“stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.”
In 2004, two Texas District Courts held that federal law preempts state law in failure to
warn cases. Both cases have recently been consolidated for appeal before the Fifth Circuit, which is currently pending. In Dusek v. Pfizer, Inc., 2004 U.S. Dist. LEXIS 28056
(S.D. Tex. 2004) and Needleman v. Pfizer, Inc., 2004 U.S. Dist. LEXIS 15495 (N.D. Tex. 2004), the courts held that the plaintiffs’ respective failure to warn claims were preempted
by both the Food, Drug, and Cosmetic Act (FDCA)’s labeling provisions and by the FDA’s rulings on the warnings required for the drug Zoloft. Both cases involved persons who had
committed suicide after being prescribed Zoloft. Each plaintiff asserted that Pfizer was liable because it failed to warn of the connection between the drug and suicide.
The defendants, however, argued that the plaintiffs’ failure to warn claims were in direct
conflict with the FDA’s determination that no explicit language connecting Zoloft to suicide was scientifically justified. The defendants relied heavily on an amicus brief written by the
federal government on behalf of Pfizer in a previous failure to warn case. The brief stated in pertinent part: “any warning, no matter how worded, that could reasonably have been
read as describing or alluding to such a relation [between Zoloft and suicide] would have been false or misleading, and therefore in conflict with federal law because there was no
(and still is not) scientific support for such a warning.” The courts held that because of this conflict, the plaintiffs’ failure to warn claims were preempted by federal law.
In 2005, however, a Minnesota District Court and a different Texas District Court held that federal law did not preempt plaintiffs’ failure to warn suits in Witczak v. Pfizer, Inc., 377
F.Supp.2d 726 (D. Minn. 2005) and Cartwright v. Pfizer, Inc., 369 F.Supp.2d 876 (E.D. Tex. 2005). Both cases concluded that federal labeling laws were minimum standards and
states were free to impose stricter requirements regarding labeling and warnings if they chose. Thus there was no conflict preemption as both the federal and state law standards
could coexist. Both courts discounted the significance of the federal government’s amicus brief for various reasons. The Minnesota court declined to treat “statements from a single
FDA legal brief as declarations afforded the preemptive force of law.” The court also noted that the FDA later recommended labeling changes reflecting concerns about the
association between Zoloft-type drugs and suicide, leaving the continuing validity of the brief in question. The Texas court, echoing that sentiment, noted that evidence now
existed contrary to the assertions in the brief concerning the drug’s link to suicide. Thus, neither court found a conflict between federal and state laws and allowed each failure to
warn claim to go forward. In December 2005, the Supreme Court of Illinois reversed a $10.1 billion verdict against a tobacco company in Price v. Philip Morris, Inc, 2005 Ill. LEXIS 2071. Though not a failure
to warn case, the Price case involved product labeling issues. The lower court held the defendants liable in violation of two Illinois state laws, the Consumer Fraud Act and the
Uniform Deceptive Trade Practices Act. Relying on an exemption from the state law for actions “specifically authorized by federal law,” the Illinois Supreme Court reversed the
lower court ruling. The court relied in part on the federal circuit court case Bober v. Glaxo Wellcome PLC, 246 F.3d 934 (7th Cir. 2001) in coming to its decision. Bober involved a
claim for fraud in the marketing of a pharmaceutical product. The Seventh Circuit held that the Illinois Consumer Fraud Act “will not impose higher disclosure requirements on parties
than those sufficient to satisfy federal regulations.” The majority in Price followed the Bober court and though they found no express authorization from federal law, they held that the defendants’ marketing statements fell
“within the boundaries established by federal law.” The dissent disagreed with the majority’s application of Bober, however. In Bober, the dissent argued, the alleged
deceptive statement was authorized by a rule formally adopted by the FDA and codified in the Code of Federal Regulations. The dissent found that this formal published opinion
differentiated the situation in Bober from that in Price, where no express authorization existed.
Thus there has been no consensus in the courts on the issue of federal preemption. Recent cases have provided little clarification as to how future cases will be decided.
There has, however, been some clarification of the government’s stance on the issue. Due to the questions regarding the validity of the previous FDA amicus brief, the court in
the pending district court of Utah case Kallas v. Pfizer, Inc., Case No. 2:04-CV-0998 PGC (D. Utah) asked the government to clarify its position. The United States filed a new
amicus brief, and in it reaffirmed the points made in the original brief. The brief noted that the government’s position was that the state tort law claims “are preempted because they
would punish Pfizer for not using a label that, as of November 2002, would have misbranded the drug.” The U.S.’s position was driven by the need to ensure that state tort
law does not undermine the FDA’s responsibility to protect the public health through the FDCA’s prohibition of false and misleading labeling of drug products. The brief noted that
holding Pfizer liable for the failure to warn of a link between Zoloft and suicidality when at the time, in the FDA’s judgment, there was not reasonable evidence of a link, would be to
demand a warning statement that was false and misleading in violation of federal law. While the new amicus brief reiterates the government’s stance that federal labeling laws would preempt state law in these failure to warn cases, the scope of the brief may be
limited. The Kallas case involved a fifteen year girl, and the FDA has noted that the effect of the drug on minors and adolescents differs from the effect on adults. In October of
2004, the FDA concluded that reasonable evidence of an association between SSRIs such as Zoloft and suicidality in children and adolescents existed, and directed manufacturers to
include a “black box” warning on their labeling. In addition, the brief is also limited to the time period of October/November 2002. The brief argues the FDCA labeling laws preempted state law at that time, but does not clarify the
status of preemption after the time period. Nor does the brief specify whether federal preemption is currently applicable in pharmaceutical labeling cases and if not, when its
applicability ceased. Though the scope of the brief in Kallas may be limited, the FDA has just recently broadened its stance on preemption. In January 2006, the FDA issued a new rule that will
require major changes to the design of package inserts for prescription drugs. In a preamble to the rule, the FDA states that if it gives a prescription drug label its approval,
that approval “pre-empts conflicting or contrary state law.” According to the provision, preemption would also apply in lawsuits filed against health care providers who do not
inform patients about safety risks “beyond what is included in the label.” The new provision does not have any legal or regulatory authority, however. Time will tell whether
the courts and legislatures give any weight to this new provision.
The issue of federal preemption of state law will continue to be highly litigated in U.S. courts. In the pharmaceutical context, courts throughout the country have split as to
whether federal labeling law preempts state laws in both fraud and failure to warn cases. While the FDA supports the proposition that federal law preempts state law in the labeling
context, their stance does not have the force of regulation or law behind it. It is important to continue monitoring the trends in the case law to determine the applicability of federal
preemption as a defense in future litigation.
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