Judge Allows Testimony on Seroquel Risks
(CN) - A federal judge allowed testimony linking an antipsychotic drug to a woman's movement disorder in a lawsuit accusing her psychiatrist of failing to warn of the drug's risks.
U.S. District Judge James Boasberg found the testimony "sufficiently reliable," despite Dr. John Maloney's claim that his expert's study was more scientifically rigorous.
Maloney, a psychiatrist, began seeing Kay Patteson in May 2006 for her "depression, anxiousness, chronic insomnia and serious alcohol abuse/dependence," according to court filings.
For her insomnia, he prescribed Seroquel, a second-generation antipsychotic used to treat schizophrenia, bipolar mania and major depressive disorder, among other conditions. Though the drug is not federally approved to treat insomnia, some doctors prescribe it for this and other "off-label" uses.
About 10 months after she began taking Seroquel, Patteson experienced weakness in her legs and difficulty walking. In early 2008, her doctors concluded that she had tardive dyskinesia, a movement disorder characterized by repetitive, involuntary movements and uncontrollable muscular tics.
Patteson and her husband sued Maloney and drug manufacturer AstraZeneca in D.C. Superior Court, claiming they had failed to warn of the risks associated with Seroquel, including its link to tardive dyskinesia.
After AstraZeneca removed the case to district court, Boasberg dismissed the claims against the drug maker, finding that the duty to warn patients had shifted to the prescribing physician.
The judge held that the drug labels provided to Maloney contained adequate warnings of the risks associated with Seroquel, and that Maloney was aware of the risks of tardive dyskinesia. He also rejected the Pattesons' claim that AstraZeneca had "overpromoted" Seroquel.
Maloney then moved to exclude all testimony linking Seroquel to tardive dyskinesia, arguing that Patteson's expert testimony was unreliable and inadmissible under federal rules of evidence.
He asked the court to exclude testimony from Dr. Robert Rosenheck, a medical professor and researcher at Yale University School of Medicine, and from two physicians who had diagnosed and treated Patteson.
The psychiatrist said his expert's study, showing no link between the drug and Patteson's condition, was more rigorous than those used by Patteson's witnesses because it relied on sounder scientific methodology.
But Boasberg ruled Monday that the science linking Seroquel to Patteson's condition is sufficiently reliable to be heard by a jury.
He said the jury should decide whether Maloney's study - a clinical trial conducted by AstraZeneca - trumps Patteson's studies. Patteson's experts' theory had been tested, peer reviewed and sufficiently accepted by the medical community, Boasberg added.
The judge further noted that Seroquel's own label, approved by the Food and Drug Administration, warns of tardive dyskinesia as a potential side effect, and many reliable medical studies suggest that Seroquel and other antipsychotics can cause the condition.
Boasberg also allowed testimony from Patteson's treating physicians, who had used differential diagnoses to narrow the causes of Patteson's condition, finding that their methods were reliable and widely used.
The judge denied Maloney's request for a pretrial hearing regarding testimony.
Dan Singer, with the Washington, D.C.-based firm Schultz & Trombly, said Kay Patteson, who is now the only plaintiff in the lawsuit, is looking forward to her day in court.
"We were pleased with the decision and with the fact that the judge followed the case well and allowed us to present expert testimony," Singer told Courthouse News. "We're looking forward to the trial and to assisting Mrs. Patteson."
The trial is scheduled for Oct. 30, according to Patteson's attorneys.
Maloney's attorneys did not return requests for comment.