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3rd Cir. Rejects Suits Over Drugs' Lack of Suicide Warnings

The makers of two popular antidepressants cannot be sued for not including on the drugs' labels enhanced warnings about their alleged risk of suicide, the 3rd Circuit has ruled, saying the Food and Drug Administration did not mandate such disclosure.

The 3rd U.S. Circuit Court of Appeals ruled 2-1 that the failure-to-warn claims brought separately by the families of two suicide victims from Pennsylvania and New Jersey "conflict with, and are therefore preempted by, the FDA's regulatory actions."

The cases were consolidated after the District Court rulings in each were appealed.

The ruling affirms the dismissal of Joseph Colacicco's suit against drug makers GlaxoSmithKline and Apotex Inc. in the U.S. District Court for the Eastern District of Pennsylvania. His wife, Lois, committed suicide in 2003 after using Apotex's generic version of the GSK antidepressant Paxil for 22 days.

The 3rd Circuit's decision also reverses U.S. District Judge Jerome Simandle's decision to allow Beth Ann McNellis to sue Pfizer Inc. over her father's 2003 suicide after taking Zoloft to battle depression and anxiety.

In that suit, filed in the District of New Jersey, the judge denied Pfizer's preemption-based summary judgment motion in 2005 and its request to vacate the ruling a year later.

Both plaintiffs had argued that their state-law-based failure-to-warn claims did not usurp the FDA's authority to regulate drugs. However, the 3rd Circuit noted that the FDA submitted an amicus brief on behalf of the defendants in the Colacicco suit and "has repeatedly rejected the scientific basis for the warnings that Colacicco and McNellis argue should have been included in the labeling."

The appeals panel also noted that the FDA rejected citizen petitions in 1991, 1992 and 1997 asking it to withdraw its approval or to impose tougher suicide-related labeling for Prozac, an antidepressant similar to Paxil and Zoloft. All three products are from the family of drugs called selective serotonin reuptake inhibitors.

Further, the appeals court said, the FDA "repeatedly approved the Paxil labeling in effect at the time of Lois Colacicco's prescription of Paxil on Oct. 6, 2003," and her death later that month.

Although the FDA did issue a public health warning about antidepressant use by teens and adolescents in October 2003, the agency "continued to announce its rejection of adult suicidality warnings for SSRIs as it had for the decade before the prescriptions and deaths at issue in this litigation," the panel wrote.

Dissenting, Judge Jane A. Restani said the majority's ruling counters the FDA's stance over most of the past 75 years that state-law-based tort suits are "complimentary to its warning regulations." She said the agency's changed opinion favoring federal preemption in recent years "has not appeared in a regulation subject to notice and comment" and did not develop from a dialog between the federal and state governments.

"The plaintiffs' failure-to-warn claims stand near the heart of the states' police powers over matters of health and safety, and the existence and detailed nature of the federal scheme does not change our imperative to require clear congressional intent (whether expressed directly in a preemption provision or implied by an authorizing statute enabling an agency to act) to preempt state tort law," she wrote.

To comment, ask questions or contribute articles, contact West.Andrews.Editor@Thomson.com.

Colacicco's estate is represented by Harris Pogust, Derek Braslow and Matthew Leckman of Pogust & Braslow in Conshohocken, Pa.McNellis is represented by Gregory Spitzer and Sol Weiss of Anapol, Schwartz, Weiss, Cohan, Feldman & Smalley in Philadelphia.Charles Fitzpatrick III and Arthur Keppel of Rawle & Henderson in Philadelphia represent Apotex.GSK is represented by Chilton Varner, Andrew Bayman and Erica Long of King & Spalding in Atlanta and Joseph O'Neil of Lavin, O'Neil, Ricci, Cedrone & DiSipio in Philadelphia.Pfizer is represented by Karen Thompson of Norris, McLaughlin & Marcus in Somerville, N.J., and Malcolm Wheeler of Wheeler, Trigg & Kennedy in Denver.