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Friday, March 14, 2008

Pa. Judge Rules Paxil Labeling Suit Not Pre-empted

One small step for man...


A Philadelphia judge ruled this week that federal law can't pre-empt a state product liability claim centering around the alleged failure of the makers of Paxil to warn about increased risk of suicide.

Judge Allan L. Tereshko, the coordinating judge of Philadelphia Common Pleas Court's Complex Litigation Program, denied a defense motion for summary judgment Tuesday, ruling that the doctrine of federal pre-emption does not preclude the plaintiffs from arguing that GlaxoSmithKline failed to fulfill its duty to warn users of Paxil of an alleged association between the use of the drug and suicidality.

The defense argued that the plaintiffs should be precluded from making that argument in state court under implied conflict pre-emption, saying that allowing the state court action over the adequacy of the Paxil label would result in conflicts with the "FDA's exclusive authority to determine the content of the label," Tereshko said.

"Defendant asserts that such inquiry is precluded by federal law since the content of the drug's label is governed by federal law and the duty to supplement the label is somehow subsumed into the [federal Food and Drug Administration] regulatory scheme," Tereshko wrote. "Defendant's position is clearly not sustainable. Federal law in question unquestionably places the duty upon the manufacturer and does not pre-empt a state's ability to allow one of its citizens to inquire whether the manufacturer breached that duty."

Collins v. SmithKline Beecham Corp. d/b/a GlaxoSmithKline is the first Paxil case scheduled to go to trial in the common pleas court's mass tort program.

Sol H. Weiss, a shareholder of Anapol Schwartz Weiss Cohan Feldman & Smalley and the plaintiffs attorney in Collins, said he is not aware of any other Pennsylvania common pleas court opinions dealing with the federal pre-emption issue in pharmaceutical cases since the FDA unveiled revisions to its prescription drug labeling requirements in January 2006 and unveiled the "pre-emption preamble," which said that FDA approval of drug labels pre-empts conflicting or contrary state law.

"The Philadelphia mass tort program has always been regarded as one of the finest in the country," Weiss said. "I think it's a very important signal."

Andrew Bayman, national trial counsel for GlaxoSmithKline's Paxil litigation, is a partner with King & Spalding in Atlanta and that firm's practice group leader for its tort litigation and environmental group. He said he believes this is the first Philadelphia pharmaceutical case addressing the federal pre-emption issue.

Bayman said that recently there have been more decisions in other jurisdictions in favor of pre-emption than there have been against pre-emption.

"There are cases on both sides of this. The recent trend has been in favor of pre-emption. We're obviously disappointed with Judge Tereshko's decision," Bayman said.

GlaxoSmithKline is prepared to take the Collins case to trial and present evidence that there were other stressors, along with pre-existing depression, that led to the suicide in that case, Bayman said.

There are 60 cases pending in the Philadelphia Paxil program, according to Stanley Thompson, the director of the Complex Litigation Center.

Weiss said he believes that Tereshko's decision shows that claimants injured by defective drugs or relatives of people injured by defective drugs can maintain their lawsuits in state court.

"This is a very hot area of litigation because the pharmaceutical companies want a free pass," Weiss said. "If these claims are pre-empted, then all these people who are injured won't have a right to recovery. ... The people here, all the people who took all these SSRIs, these antidepressant drugs, and committed suicide, and families can't seek redress."

Tereshko said that it was not Congress' intent for federal law to pre-empt state causes of action and that the Federal Food, Drug and Cosmetic Act is silent on that issue. He noted that congressional hearings leading up to the passage of the Federal Food, Drug and Cosmetic Act included the decision to not include a provision for a federal cause of action because common law rights of action existed.

Bayman said GlaxoSmithKline's position has reflected the FDA position at the time that there was no scientific basis for the Paxil-suicide correlation allegation. Putting such a warning on the drug would thus violate federal law, he said, and a state court lawsuit determining that the warning should have been different would conflict with federal law.

Tereshko dismissed the defense's argument that use of beneficial drugs could be discouraged if they were mislabeled with warning information not based upon scientific evidence of known risks. He concluded such an argument is putting language into the federal law that is not there.

Bayman countered in an interview that the FDA has the exclusive power and authority to approve drugs as safe and to label those drugs with warnings. The FDA has warned of the dangers of "overwarning," he said.

"You run the risk of deterring people from seeking treatment or doctors from prescribing [drugs]. In this context, we know scientifically depression is seriously underreported ... because there's a stigma associated with treatment," Bayman said. "To put warnings on -- which some people say would only be on there to insulate manufacturers from liability -- if that warning is not based on good scientific evidence, that really runs the risk of deterring people from seeking treatment. That's why the FDA's job is to strike a balance."

GlaxoSmithKline also has a statute of limitations motion pending in the Collins case, Bayman said.

Tereshko also granted a plaintiffs' motion to strike amicus briefs filed by the FDA in similar federal lawsuits, which were submitted by the defense. The FDA had submitted amicus briefs in some SSRI litigation arguing that agency regulations pre-empt state tort claims over labeling requirements. The judge said that the briefs are hearsay documents under Pennsylvania law.

In one of the FDA amicus briefs submitted for Tereshko's purview, according to the judge's opinion, the FDA argued: "'Although FDA has the deepest sympathy for the plaintiff because of the loss of his wife, it is vital to ensure that state tort law does not undermine FDA's authority to protect public health through enforcement of the prohibition against false or misleading labeling of drug products in the Federal Food, Drug and Cosmetic Act. ... To base a tort judgment on a drug manufacturer's failure to warn in October 2003 of an association between adult use of paroxetine hydrochloride [Paxil] and suicide or suicidality, despite FDA's judgment at the time that there was not reasonable evidence of such an association, would be to demand a warning statement that would have been false or misleading, and thus contrary to federal law. In such a case, federal law must prevail."

The 3rd U.S. Circuit Court of Appeals heard arguments in December on two conflicting lower court cases over whether plaintiffs should be pre-empted from suing over allegedly inadequate warnings on prescription drugs because the FDA approved the warning labels.

U.S. District Judge Michael M. Baylson in the Eastern District of Pennsylvania held in Colacicco v. Apotex Inc. -- citing the FDA preamble -- that such claims are pre-empted, and U.S. District Judge Jerome B. Simandle in the District of New Jersey held in McNellis v. Pfizer Inc. that the claims aren't pre-empted.

The U.S. Supreme Court is slated to take up a pre-emption case, Levine v. Wyeth. Weiss said the 3rd Circuit may wait until the Supreme Court's ruling to decide its conflicting federal cases.

In the instant case, the survivors of Bobby R. Collins have brought a claim against GlaxoSmithKline, alleging that the Paxil prescribed to Collins for stress-related depression did not have an adequate warning of possible suicidality from taking the drug, according to Tereshko's opinion. Collins committed suicide Feb. 14, 2002.

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