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In a significant victory for drug manufacturers, the 3rd U.S. Circuit Court of Appeals has ruled that the makers of Paxil and Zoloft cannot be sued for failing to warn of a risk of suicide because the Food & Drug Administration has explicitly refused to order such warnings.

Voting 2-1 in a pair of cases where the lower courts issued conflicting rulings, the 3rd Circuit found that such lawsuits must be pre-empted because they directly conflict with action already taken by the FDA.

Writing for the majority, U.S. Circuit Judge Dolores K. Sloviter said the FDA has “actively monitored” the possible risk of suicide from taking the class of anti-depressant drugs known as selective serotonin re-uptake inhibitors, or SSRIs, for two decades, and concluded that the suicide warnings demanded by plaintiffs “are without scientific basis and would therefore be false and misleading.”

But Sloviter, who was joined by visiting Judge Jane A. Restani of the U.S. Court of International Trade, emphasized that the ruling was a narrow one.

“Our holding is limited to circumstances in which the FDA has publicly rejected the need for a warning that plaintiffs argue state law requires,” Sloviter wrote in Colacicco v. Apotex Inc.

In dissent, U.S. Circuit Judge Thomas L. Ambro said he would have allowed both cases to go forward.

“The FDA has for over three-quarters of a century viewed state tort law as complementary to its warning regulations. Only for the last two years has it claimed otherwise,” Ambro wrote.

Ambro said the “sea change” in the FDA’s position on pre-emption did not come in the form of a formal regulation that was subject to notice and comment, but in a “preamble” to a regulation.

The majority, Ambro said, decided to defer to the FDA because the agency has expertise in deciding the “optimal warnings” drug labels should carry – not too lax, not too alarmist – and that “state tort lawsuits would disrupt this fine system.”

But Ambro said there is “an important contrary view that has prevailed until recently: state tort law complements FDA provisions on drug warnings, in part by eliciting more information than the FDA would glean otherwise from pharmaceutical manufacturers.”

That view, Ambro said, “has, I believe, the better argument in terms of legal doctrine on pre-emption, congressional intent and the history of state tort law alongside federal law.”

The pair of appeals, argued together in December, stemmed from lawsuits in Pennsylvania and New Jersey in which the trial judges reached opposite conclusions.

Both cases stem from suicides in which the plaintiffs claim that manufacturers of anti-depressant drugs failed to warn of the increased risk of suicidality.

In Colacicco v. Apotex Inc., U.S. District Judge Michael M. Baylson found that the plaintiffs’ state law tort claims were pre-empted because Congress granted control to the FDA to regulate the prescription drug industry, including the authority to regulate “the specifics of drug labeling.”

But in McNellis v. Pfizer Inc., U.S. District Judge Jerome B. Simandle concluded that a state tort claim was not pre-empted because the FDA’s regulations “empower drug manufacturers to enhance the labeling warnings beyond the approved text when new risks emerge.”

Sloviter said the conflicting lower court rulings forced the 3rd Circuit to “decide which of the two fine opinions authored by two of the ablest district judges in this circuit most closely expresses our view of the difficult issue presented.”

Most of Sloviter’s opinion focuses on the contours of the pre-emption doctrine, an area of law that requires judges to “delicately balance” federal and state interests

“Pre-emption is not a doctrine that lends itself to a black-letter rule. One size does notfit all. The decision must be based on the circumstances presented in the particular situation,” Sloviter wrote.

Sloviter found that because the FDA had specifically rejected a proposed enhanced warning about suicide risks for SSRIs, the court’s focus could be narrowed.

“We do not decide whether the FDA’s mere approval of drug labeling is sufficient to pre-empt state-law claims alleging that the labeling failed to warn of a given danger,” Sloviter wrote.

Likewise, Sloviter said, the court would not address “whether FDA approval of drug labeling constitutes minimum standards in the absence of the FDA’s express rejection of a specific warning.”

On the narrow question, Sloviter found that since both plaintiffs were suing over warnings that the FDA had explicitly refused to order, their failure-to-warn claims “conflict with, and are therefore pre-empted by, the FDA’s regulatory actions.”

But Sloviter emphasized that the court was expressing no view on the issue of whether SSRIs contribute to adult suicidality.

“We are not scientists and we do not purport to have any expertise on that issue. That is within the FDA’s authority,” Sloviter wrote.

In dissent, Ambro complained that the majority failed to recognize the value of lawsuits.

“Tort law and FDA regulation do not have conflicting goals. Both seek to strike a safety-efficacy balance,” Ambro wrote.

“Allowing multiple institutions to investigate the difficult question of how strong to make a warning can have important benefits. State courts provide a check on agency power,” Ambro wrote.

Ambro said society “relies on the FDA to an enormous degree to monitor the safety of pharmaceuticals,” but that “the FDA’s toolkit is imperfect and incomplete by design.”

The FDA relies on the information provided by drug manufacturers – and does no independent testing of its own – Ambro found, and as a result “will always lack the inside perspective on clinical trials and data analyses stemming from those trials.”

Discovery in state tort lawsuits, Ambro said, “provides a different way for third parties to raise questions about new and existing drugs.”

As a result, Ambro said, “I would not eliminate the potentially valuable information-gathering tools of state tort law.”

Attorney Sol H. Weiss of Anapol Schwartz Weiss Cohan Feldman & Smalley, lead attorney for the plaintiff in the McNellis case, said he was disappointed by the ruling and intends to seek reargument before an en banc panel of the 3rd Circuit.

“This is a fundamental change,” Weiss said, because the FDA until recently had recognized that tort suits were an important companion in policing drug companies.

Attorney Harris Pogust of Pogust Braslow & Millrood, lead lawyer for the plaintiff in the Colacicco case, could not be reached for comment.

(Copies of the 58-page opinion in Colacicco v. Apotex Inc ., PICS No. 08-0572, are available from The Legal Intelligencer . Please call the Pennsylvania Instant Case Service at 800-276-PICS to order or for information. Some cases are not available until 1 p.m.)

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