The family of a teenager who committed suicide in 2002 after taking the antidepressant drug Paxil is not barred from suing the manufacturer, because the U.S. Food and Drug Administration had not yet taken any position on whether there was a link between the use of such drugs by pediatric patients and an increased risk of suicidality, a federal judge has ruled.
In his 55-page opinion in Knipe v. SmithKline Beecham, Senior U.S. District Judge Ronald L. Buckwalter of the Eastern District of Pennsylvania concluded that a jury must decide whether the drug manufacturer "indeed possessed information, not available to the FDA, upon which it could have unilaterally added a warning to its labeling."
Buckwalter rejected arguments by SmithKline's defense team that the suit was pre-empted by FDA regulations which, at the time, did not call for suicide warnings for pediatric patients on drugs known as SSRIs, or selective serotonin reuptake inhibitors.
"As the FDA never had the opportunity, prior to Jake Garrison's suicide, to consider the propriety of the warning proposed by plaintiffs in this case, the 'balance of risks and benefits set by the FDA when it approves a drug label,' remains unaffected," Buckwalter wrote.
"Mere speculation as to whether the FDA would or would not have approved such a warning is insufficient to create a direct conflict upon which the court can find pre-emption," Buckwalter wrote.
Significantly, Buckwalter rejected SmithKline's argument that the decision earlier this year from the 3rd U.S. Circuit Court of Appeals in Colacicco v. Apotex -- an alleged Paxil-related adult suicide case -- directly controlled the outcome of the suit brought by Marion Knipe, the administratrix of the estate of Jake Garrison.
In Colacicco, the 3rd Circuit voted 2-1 in April in holding that the makers of Paxil and Zoloft cannot be sued for failing to warn of a risk of suicide because the FDA had explicitly refused to order such warnings.
Writing for the majority, U.S. Circuit Judge Dolores K. Sloviter said the FDA has "actively monitored" the possible risk of suicide from taking SSRIs for two decades, and concluded that the suicide warnings demanded by plaintiffs "are without scientific basis and would therefore be false and misleading."
But Sloviter also emphasized the ruling was a narrow one, saying: "Our holding is limited to circumstances in which the FDA has publicly rejected the need for a warning that plaintiffs argue state law requires."
In dissent, U.S. Circuit Judge Thomas L. Ambro said he would have allowed both cases to go forward because "the FDA has for over three quarters of a century viewed state tort law as complementary to its warning regulations. Only for the last two years has it claimed otherwise."
Now Buckwalter has ruled that Colacicco cannot apply to a suit over an alleged Paxil-related suicide by a teenager.
"This case is clearly exempted from the Colacicco holding," Buckwalter wrote. "The 3rd Circuit focused solely on whether a claim for failure to issue a warning regarding adult suicidality was pre-empted. At no point did the court mention any studies that were done with respect to pediatric use of Paxil."
Instead, Buckwalter found, 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."
Buckwalter also found that the 3rd Circuit "did not cite to any pre-September 2002 FDA document, public announcement or health advisory regarding the FDA's position on pediatric suicidality associated with Paxil."
And while the Colacicco decision noted that the FDA had "publicly dismissed any link between SSRIs and adult suicidality," Buckwalter said the court also recognized that the FDA had "expressly warned of a risk of increased suicidality in pediatric users of antidepressants."
As a result, Buckwalter said, "quite unlike the concerns regarding adult suicidality, the FDA had not 'clearly and publicly stated its position' dismissing any risk of pediatric suicidality" prior to the Paxil prescriptions given to Jake Garrison.
"As the 3rd Circuit left open the question of whether such evidence existed with respect to pediatric use of Paxil, we decline to deem Colacicco controlling of the outcome of this litigation," Buckwalter wrote. The ruling is a victory for attorneys Bijan Esfandiari, George W. Murgatroyd III, Kate E. Gillespie and Frances M. Phares of Baum Hedlund Aristei & Goldman in Los Angeles.
In an interview, Esfandiari called the decision a "huge victory" that shows the ruling in Colacicco was a narrow one.
SmithKline's lead lawyer, Andrew T. Bayman of King & Spalding in Atlanta, said he believed Buckwalter erred because the Colacicco decision "ought to be controlling here."
Bayman said the courts that have barred such suits as pre-empted premised their rulings on the notion that "the FDA is in the best position" to decide which warnings should be included on drug labels, and that the FDA has consistently held that "unsubstantiated" warnings must be avoided because patients will be unnecessarily discouraged from taking drugs they need.
SmithKline, he said, disputes the allegation that it had any evidence of a risk of suicide among teenagers and young adults that it withheld from the FDA.
But Buckwalter accepted the plaintiffs' allegations as true and found that a jury must decide whether SmithKline failed to add warnings as soon as it was aware of the increased risk of suicide among in pediatric patients taking Paxil.
"Drug manufacturers have [the] best information about the safety of their own products and, thus, under the regulations, they have the ability to alter a drug label prior to FDA evaluation and approval," Buckwalter wrote.
In such a situation, Buckwalter said, a state-law based failure to warn claim "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."
Such litigation, Buckwalter said, "will not result in exaggerated risks associated with drugs" because the standard for adding a warning under the FDA's rules requires only "reasonable evidence of association of a serious risk with the drug" while the state failure to warn claims under New Jersey law require "the more stringent proof of causation between the drug and the injury."
As a result, Buckwalter concluded that "only a drug manufacturer who, in fact, possessed such reasonable evidence, yet failed to add a warning, would be potentially liable."