Summary:

Paragraphs 17 through 19 read:  "According to the suit, Lois Colacicco complained to her oncologist of mild fatigue and depression and was given a prescription for Paxil in October of 2003."

"Soon after, she began taking the generic version of the drug, paroxetine hydrochloride, which is a bio-equivalent of Paxil and manufactured by Apotex."

"On Oct. 28, 2003, after 22 days of ingesting the drug, Lois Colacicco committed suicide in her home."


http://www.law.com/jsp/article.jsp?id=1149510921000


The widower of a woman who committed suicide after taking a generic version of the anti-depressant drug Paxil may not pursue product liability claims premised on an alleged failure to warn of suicide risks because the Food & Drug Administration strictly controls the content of such warnings and did not demand it at the time, a Pennsylvania federal judge has ruled.

In his 66-page opinion in Colacicco v. Apotex Inc., U.S. District Judge Michael M. Baylson found that the plaintiffs' state law tort claims are pre-empted by the federal Food, Drug & Cosmetic Act.

In the suit, plaintiff Joseph Colacicco alleged claims against GlaxoSmithKline, the maker of Paxil, and Apotex, the manufacturer of the generic version of Paxil taken by his wife.

The suit cast blame on both manufacturers on the theory that GSK had authored the warnings used by Apotex.

Now Baylson has ruled that both defendants are entitled to dismissal of all claims against them because the FDA controls the content of warnings and because the Hatch-Waxman amendments to the FDCA explicitly require generic manufacturers to use the same labeling as approved for the drug's innovator.

Because the 3rd U.S. Circuit Court of Appeals has never squarely addressed the question, Baylson asked the FDA to submit an amicus brief.

In response, the FDA's lawyers filed a brief that urged Baylson to rule in favor of the manufacturers and dismiss the suit.

"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 [the generic term for 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 and misleading, and thus contrary to federal law," the FDA's brief said.

"Although the 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 the FDA's authority to protect the public health through enforcement of the prohibition against false or misleading labeling of drug products... . In such a case, federal law must prevail," the FDA's brief said.

Baylson agreed, saying "we must afford deference to the FDA's position that the claims are pre-empted."

The ruling is a victory for GSK's lawyers, David J. Stanoch and Joshua G. Schiller of Dechert in Philadelphia, along with Thomas Bayman, Erica M. Long and S. Samuel Griffin of King & Spalding in Atlanta, and Apotex's lawyers, Arthur B. Keppel and Charles A. Fitzpatrick III of Mylotte David & Fitzpatrick's Broomall office.

Colacicco's lawyers -- Harris L. Pogust, Derek T. Braslow, Robert N. Wilkey and T. Matthew Leckman of Cuneo Pogust & Mason in Cohshohocken, Pa. -- argued that there were several reasons the suit should not be pre-empted.

The FDCA merely establishes "minimum standards," the plaintiff's team argued, and permits manufacturers to unilaterally strengthen warning labels.

Deference to the FDA's position would be wrong, the plaintiff's team said, because the FDA's policy has been inconsistent, and would violate the principle forbidding retroactive application of new rules.

Under Pennsylvania law, the plaintiff's team said, both GSK and Apotex owed a duty of care to Lois Ann Colacicco.

The plaintiff's team also urged Baylson to reject the defense arguments to dismiss the suit under the "learned intermediary doctrine," arguing that such a defense requires an analysis of the adequacy of the warnings, which is a question of fact that may not be determined prior to discovery.

According to the suit, Lois Colacicco complained to her oncologist of mild fatigue and depression and was given a prescription for Paxil in October of 2003.

Soon after, she began taking the generic version of the drug, paroxetine hydrochloride, which is a bio-equivalent of Paxil and manufactured by Apotex.

On Oct. 28, 2003, after 22 days of ingesting the drug, Lois Colacicco committed suicide in her home.

Paxil is one of a class of drugs known as selective serotonin reuptake inhibitors, or SSRIs, which are prescribed for the treatment of depression and anxiety.

The suit alleges that despite peer-reviewed scientific literature published from the mid-1990s onward linking SSRIs to an increased risk of suicidality, the FDA-approved label did not include any warning of suicide risk.

But the manufacturers' lawyers moved for dismissal of the entire suit, arguing that allowing the case to proceed would thwart the purpose of, and actually conflict with, the FDCA, and that the court must afford deference to the FDA's position that its regulations pre-empt state tort claims.

GSK also argued that, as an innovator drug manufacturer, it owes no legal duty of care to a consumer of the generic equivalent of its drug.

Apotex argued that, under the statute governing FDA approval of generic drugs, it was not responsible for the form or content of the paroxetine hydrochloride labeling, and therefore it, too, did not owe a duty of care to the plaintiff.

Now Baylson has ruled that the case hinged on the "threshold issue" of pre-emption, and specifically "whether regulations of a federal agency, promulgated pursuant to a federal statute, and implementing that statute, require the court to dismiss this pharmaceutical products liability suit based on common law tort principles alleging that inadequate labeling of a prescription drug led to the suicide of plaintiff's wife."

The answer, Baylson said, is "yes," because when Congress passed the FDCA, it granted control to the FDA over the regulation of the prescription drug industry, and vested the agency with authority to regulate "the specifics of drug labeling, making important judgments of what is required for safety of the consuming public, what new drugs may appear in the marketplace, and what warnings their instructions and labels must carry."

In his research, Baylson said he found "many conflicting court decisions on this topic," but that a series of decisions from the U.S. Supreme Court "point this court in the direction of deference, and require dismissal of this case."

Baylson also found that the FDA's view, as expressed in its amicus brief, was "critical to this court's analysis" because U.S. Supreme Court precedent dictates that an agency's interpretation of the statute and regulations it administers is entitled to deference.

In the context of pre-emption specifically, Baylson said, the Supreme Court held in its 1985 decision in Hillsborough County v. Automated Medical Laboratories Inc. that, in the absence of clearly expressed congressional intent or subsequent developments that reveal a change in that position, the FDA's position on the pre-emptive scope of its regulatory authority "is dispositive."

And in its 2000 decision in Geier v. American Honda Motor Co. Inc., Baylson said, the Supreme Court "made clear that such pre-emptive intent may properly be communicated in amicus briefs."

In recent years, Baylson noted, "each time the Supreme Court has confronted the question of whether the FDCA pre-empts state law, it has deferred to the FDA's pre-emption position."

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