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Teen Paxil-related suicide case is not preempted, judge says.

A Philadelphia federal district court has ruled that a failure-to-warn lawsuit brought by the parents of a teenager who committed suicide while taking the antidepressant antidepressant, any of a wide range of drugs used to treat psychic depression. They are given to elevate mood, counter suicidal thoughts, and increase the effectiveness of psychotherapy.  Paxil is not preempted by federal law. The court rejected the argument made by manufacturer GlaxoSmithKline (GSK GSK GlaxoSmithKline plc (pharmaceutical company)
GSK Glycogen Synthase Kinase
GSK Gruppentraining Sozialer Kompetenzen (Germany)
GSK Greenland Shark (FAO fish species code) 
) that a Third Circuit decision earlier this year required a finding of preemption preemption

U.S. policy that allowed the first settlers, or squatters, on public land to buy the land they had improved. Since improved land, coveted by speculators, was often priced too high for squatters to buy at auction, temporary preemptive laws allowed them to acquire
. (Knipe v. SmithKline Beecham, 2008 WL 4090995 (E.D. Pa. Aug. 28, 2008).)

The plaintiffs in the lawsuit, New Jersey residents Marion Knipe and Harold Garrison Jr., are the parents of 16-year-old Harold "Jake" Garrison. A dermatologist who was treating Jake for acne prescribed Paxil off-label for treatment of his body dysmorphic disorder Body Dysmorphic Disorder Definition

Body dysmorphic disorder (BDD) is defined by DSM-IV-TR as a condition marked by excessive pre-occupation with an imaginary or minor defect in a facial feature or localized part of the body.
, a psychiatric condition in which a person is excessively concerned about a real or imagined defect in his or her physical appearance.

Shortly after Jake refilled his second Paxil prescription, he committed suicide by gunshot. Jake's parents claim that his death was the result of his ingestion ingestion /in·ges·tion/ (-chun) the taking of food, drugs, etc., into the body by mouth.

1. The act of taking food and drink into the body by the mouth.

 of Paxil and that GSK was liable for failing to warn them and Jake's physician about the risk of suicide that the drug posed to children and adolescents.

GSK filed a motion for summary judgment motion for summary judgment n. a written request for a judgment in the moving party's favor before a lawsuit goes to trial and based on recorded (testimony outside court) affidavits (or declarations under penalty of perjury), depositions, admissions of fact, answers , citing the Third Circuit's April ruling in Colacicco v. Apotex, Inc. (521 F.3d 253 (3d Cir. 2008) ). In that case, which involved a suicide by an adult that was allegedly caused by Paxil, the appeals court determined that the plaintiffs' failure-to-warn claims were preempted because they conflicted directly with the federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics.  and its implementing regulations. GSK argued that Colacicco was controlling in Knipe and contended that if GSK had included a pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children.

Of or relating to pediatrics.
 suicidality warning on Paxil's label, as proposed by the plaintiffs, the FDA FDA
Food and Drug Administration

FDA, See Food and Drug Administration.

FDA, the abbreviation for the Food and Drug Administration.
 would have deemed the drug to be misbranded mis·brand  
tr.v. mis·brand·ed, mis·brand·ing, mis·brands
To brand or label misleadingly or fraudulently.

Adj. 1.

Senior District Court Judge Ronald Buckwalter denied the motion, writing that Colacicco was not dispositive dis·pos·i·tive  
Relating to or having an effect on disposition or settlement, especially of a legal case or will.
 because "the Third Circuit explicitly limited its holding 'to circumstances in which the FDA has publicly rejected the need for a warning that plaintiffs argue state law requires.'"

Buckwalter noted that in Colacicco, the "Third Circuit focused solely on whether a claim for failure [to] issue a warning regarding adult suicidality was preempted. At no point did the court mention any studies that were done with respect to pediatric use of Paxil." Indeed, he continued, "Paxil has never been approved for pediatric use and, therefore, the FDA never reviewed any safety and efficacy data regarding pediatric use prior to approval of the drug."

"The most important thing about the decision is that it limits the contours of Colacicco. [The Third Circuit in] Colacicco said that it was a very limited ruling, and this court confirmed that," said Bijan Esfandiari of Los Angeles, lead attorney for the Knipe plaintiffs.

Following the summary judgment standard, Buckwalter found that there was a genuine issue of material fact as to whether GSK had "reasonable evidence" of an association between Paxil and pediatric suicidality before September 2002--the date of Jake's refilled Paxil prescription and subsequent suicide. The court held that the plaintiffs had made a sufficient showing that if GSK had added a pediatric warning to Paxil's label before September 2002, the FDA would not have rejected the change or have deemed it to be a misbranding of the drug.

Moreover, the plaintiffs' proposed warning did not conflict with federal regulations because "at the time Paxil was prescribed for Jake Garrison the second time in September of 2002, the FDA had yet to publicly state its position regarding a link between the pediatric use of Paxil, or other [selective serotonin reuptake inhibitors Selective Serotonin Reuptake Inhibitors Definition

Selective serotonin reuptake inhibitors are medicines that relieve symptoms of depression.
], and an increased risk of suicidality," Buckwalter wrote.

The court declined to defer to the FDA's position on the preemption of state failure-to-warn lawsuits, as stated in the FDA's 2006 preamble of its drug labeling regulations and in amicus briefs filed by the government on behalf of the FDA in other litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
. In so doing, it relied on the Third Circuit's recent decision in Fellner v. Tri-Union Seafoods to support its finding that, where the FDA has expressed only an informal policy opinion after a plaintiff allegedly suffered an injury, that opinion is not sufficient to preempt pre·empt or pre-empt  
v. pre·empt·ed, pre·empt·ing, pre·empts
1. To appropriate, seize, or take for oneself before others. See Synonyms at appropriate.

 a state tort lawsuit. (539 F.3d 237 (3d Cir. 2008).)

"The timing of the Fellner decision was fortuitous--it gave Judge Buckwalter an opportunity to rely upon a more recent Third Circuit precedent that confirmed not only the viability of the presumption against preemption, but also demonstrated that Colacicco is not the end all and be all" on preemption, Esfandiari said.

Esfandiari is handling a number of other Paxil pediatric suicide cases. However, "this is the first preemption ruling that involves a pediatric suicide that occurred in the time period after GSK completed its pediatric clinical trials and during a four-year window when GSK had knowledge of the risks but failed to issue a warning or seek a label change," he said.

And, as the court concluded in Knipe, "A state failure-to-warn action will not usurp or undermine the FDA's responsibilities to ensure an accurate label, but rather will close the void in the authority of the FDA, which can neither independently regulate off-label use nor require additional clinical trials."

In a separate ruling, Buckwalter denied GSK's motions for summary judgment on most of the plaintiffs' causes of action, allowing the case to proceed to trial. ( Knipe v. SmithKlineBeecham, 2008 WL 4442635 (E.D. Pa. Sept. 30, 2008).)
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Author:Heylman, Susan
Date:Nov 1, 2008
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