Termed “hypocritical “ by a federal judge, GSK’s argument for federal preemption failed last month, and now multiple other arguments for dismissal have been rejected.
A federal judge in Pennsylvania ruled this week that a lawsuit filed by the parents of a 16-year-old New Jersey boy who committed suicide while taking Paxil can proceed to a jury trial.
In their suit against GlaxoSmithKline (GSK), Marion Knipe and Gerald Garrison, the parents of teenager Jake Garrison, allege that GSK had known about the increased risks of suicide associated with its drug Paxil, yet intentionally hid these risks from the public and medical community. Jake Garrison was prescribed Paxil in 2001, and committed suicide within three days of resuming his Paxil treatment in 2005.
In March, 2004, a year before Jake died, the FDA mandated a black-box warning on all SSRIs and other antidepressants of the increased risk of suicide in teenagers and young adults. Several months after Jake’s suicide in 2005, GSK finally placed the warning on Paxil labels — a year after the FDA mandate. And remember, Paxil was never approved for children in the first place.
In his rejection last month of GSK’s attempt to invoke federal preemption, Senior Judge Ronald L. Buckwalter, of the United States District Court for the Eastern District of Pennsylvania, said the vital role tort (state level) litigation has played in protecting the health and safety of its citizens cannot be ignored. Judge Buckwalter’s rejections this week of GSK’s other arguments contain fascinating and very telling legal reasoning — you can read some of them here at the web site of Baum, Hedlund, Aristei & Goldman, who represent Jake’s family. For 18 years, the LA-based law firm has litigated more SSRI cases — more than 3,000 — than any other law firm in the country.
The judge’s response to GSK’s preemption defense was so enlightening I offer most of it here:
“Finally, the Court takes note of the inherent hypocrisy in Defendant’s argument. On one hand, Defendant contends that it had no duty to warn of known risks involved in off-label usage of the drug, whether or not it had reason to know of such off-label uses. On the other hand, it contends that once its drug was approved by the FDA for some indications, it was protected by the presumption of adequacy for FDA warnings for usage in all indications, even where the FDA had never considered the propriety of the warning. On a hypothetical third hand, it claims that any attempt to rebut the presumption by proof of nondisclosure is preempted by federal law, thereby making the presumption effectively unrebuttable. Applying such logic, a pharmaceutical manufacturer possessing information regarding hazards associated with off-label use of its drug would never have to warn the medical community of any off-label usage dangers or submit data regarding these dangers to the FDA. Such a result is contrary to New Jersey’s ‘strong interest in encouraging the manufacture and distribution of safe products for the public and, conversely, in deterring the manufacture and distribution of unsafe products within the state’…”
A Paxil Primer — Why GSK Mustn’t Skate On This Case
Paxil (paroxetine) is a selective serotonin reuptake inhibitor (SSRI) antidepressant, released in 1992 by GSK. In 2006 it was the fifth-most prescribed antidepressant in the United States with more than 19.7 million prescriptions.
Since the FDA approved paroxetine in 1992, approximately 5,000 Americans have sued GSK, most claiming they were not sufficiently warned of the drug’s side effects — particularly the horrendous withdrawal symptoms, considering GSK specifically advertised the drug as “not habit forming.”
On January 29, 2007, the BBC broadcast a documentary about Seroxat, the UK brand of paroxetine, focusing on three GSK pediatric clinical trials on “depressed” children and adolescents that showed Seroxat could not be proven to work for teenagers. And one trial indicated that adolescents were six times more likely to become suicidal after taking it.
In May 2007 a US court approved a settlement in a class action lawsuit brought on behalf of everyone in the United States who purchased Paxil or Paxil CR prescribed for a minor. The lawsuit alleged that GlaxoSmithKline promoted Paxil or Paxil CR for prescription to children and adolescents while withholding and concealing material information about the medication’s safety and effectiveness for minors (emphasis is mine). GSK denied all claims, but the settlement entitled everyone who purchased Paxil or Paxil CR for their child or ward to recover up to 100% of documented out-of-pocket expenses or $100 if documentation was not available.
Read more about Federal Preemption in these earlier Novus blogs:
Preemption and the FDA: Placing Our Trust In A Failed System
Lies And Misdirection From Big Pharma About Preemption