13-year-old Benjamin Bratt committed suicide on February 14, 1997, by hanging himself. At the time of his suicide, Benjamin was under the influence of Paxil, an antidepressant medication manufactured and sold by SmithKline Beecham Corporation, d/b/a GlaxoSmithKline (“GSK”). In 2005, Black Box warnings were issued alerting physicians to the risk of suicidality in children and adolescents taking Paxil, or other antidepressants.
Ben’s parents (Terri O’Neal and Barry Bratt) initiated their lawsuit against GSK alleging that, despite knowledge suicide risks associated with Paxil prior to 1997, GSK concealed this information, failed to warn doctors, the medical community, and the public and, instead promoted Paxil as safe and effective for pediatric patients.
On January 30, 2008, Frank Damrell, a federal judge in the United States District Court, Eastern District of California (Sacramento), dismissed the Bratt family’s claims on federal preemption grounds. Judge Damrell ultimately held that, even if GSK had data about the risk of suicidal behavior for adult patients taking Paxil prior to 1997, which the Bratt family claims GSK did, that data is not sufficient to prove the risk in the pediatric population. (See Order at p. 29). The family maintains that in 1989, prior to Paxil’s approval for marketing in the U.S., GSK’s adult clinical trials showed a greater than 8 times risk of suicidal behavior for Paxil users, but GSK improperly manipulated the data to obscure the risk, then published the false suicidal behavior data throughout the ’90s in medical journal articles, health care professional convention presentations and the newsletter of the influential American College of Neuropsychopharmacology.
The Court held that, because the first pediatric clinical trial of Paxil (which began in 1994) did not finish until 1998, GSK could not have known about the suicide risks associated with Paxil in pediatric patients before that date. The Court held that, if GSK had warned about suicide risks associated with Paxil for pediatric patients prior to 1997, such a warning would have been subject to a misbranding action by the FDA. The judge accordingly ruled that all of the claims brought by the Bratt family are preempted.
Ironically, during oral argument, Judge Damrell commented:
As a practical matter, if I see there was an association of suicide ideation with anybody and enough of it, the last person I want to see using it is a child. That may not be scientific, but I’m just talking as a grandfather and a human being.
(Transcript, p. 13:6-10.) However, in his ruling, Judge Damrell wrote:
That later clinical studies ultimately led to a clear signal of pediatric suicidality, and that these studies arguably reflected the initial data in 1989 and 1991 of similar associations among adults, simply does not provide ‘reasonable evidence’ of the association of pediatric suicidality in February 1997.
(Court Order, p. 31:10-15.) Baum Hedlund Aristei & Goldman’s senior trial attorney, Ronald Goldman, commented:
The Bratt family intends to ask Judge Damrell to reconsider his ruling. They believe the judge committed error in holding that a drug that is not safe for adults is nonetheless safe for children until proven otherwise. The Bratt family contends that, prior to 1997, GSK had sufficient information based on its clinical trials and adverse event reports to conclude that there was reasonable scientific evidence of an association between Paxil and treatment-emergent suicidality; that GSK had a duty to warn the medical community about those risks.