A federal judge in California on Jan. 31 awarded summary judgment to SmithKline Beecham Corp., doing business as GlaxoSmithKline (GSK), in a case involving the February 1997  death of a 13-year-old boy who died as a  result of injuries he sustained from a suicide attempt allegedly caused by his use of Paxil. The judge found that the plaintiffs' claims were preempted by Food and Drug Administration regulations.

Before I go on, I'm guessing you are just dying to find out if the judge gave the agency's opinions full deference under Chevron U.S.A. Inc. v. Natrual Resources Defense Council Inc. (467 U.S. 837, 842-843, 104 S. Ct. 2778 [U.S. Sup. 1984]) just like a federal judge in Oklahoma did on Jan. 17 in an Effexor suicide case. Well, U.S. Judge Frank Damrell Jr. of the Eastern District of California did not.

Sorry if I let some of you down.

While Judge Damrell acknowledged U.S. Judge Timothy DeGiusti's ruling in Dobbs v. Wyeth Pharmaceuticals, Inc., (2008 U.S. Dist. LEXIS 5754 [W.D. Okla. Jan. 17, 2008]), he explained that the claims asserted by Terri O'Neal and Barry Bratt directly conflicted with FDA regulations because there was no scientific evidence available in 1997 that warranted the addition of a stronger warning concerning an increased risk of suicide in pediatric and adolescent patients.

In fact, Judge Damrell pointed out that just months after Benjamin Bratt's death, the FDA denied a citizen's petition to add stronger suicide warnings to Prozac's label. Prozac, like Paxil, is a selective serotonin reuptake inhibitor (SSRI). Judge Damrell noted that there was not enough evidence to support a stronger warning about the increased risk of suicidal behavior in pediatric and adolsecent patients using SSRIs until 2004, when, following an analysis of pooled clinical data,  an FDA advisory panel urged the manufacturers of SSRIs to add a black box warning to their drugs' labels.

Interestingly, Judge Damrell and Judge DeGiusti both acknowledged that the concept of preemption in these cases presented a "very narrow" issue, but their underlying opinions seem very different. Judge Damrell used Paxil's regulatory history as the basis for his finding and expressly refused to defer to the FDA. On the other hand, Judge DeGiusti seemed to rely just a little more on the consistency of the FDA's stance on preemption than FDA guidelines.