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GSK Scores Midtrial Dismissal Of Paxil Birth Defect Suit

GlaxoSmithKline PLC on Monday scored a midtrial dismissal of claims that its antidepressant Paxil caused cardiac birth defects as a Pennsylvania state judge ruled that the plaintiffs hadn’t presented sufficient evidence to support their case.

Judge Kenneth Powell in the Philadelphia County Court of Common Pleas granted GSK’s motion for compulsory nonsuit after ruling that physician Robert Kiehn had not testified that he would have altered his decision to prescribe Paxil to plaintiff Elisabeth Balser if presented with more adequate warnings about potential risks associated with the drug.

“It is not reasonable to infer based on the testimony that was presented that Dr. Kiehn would not have prescribed Paxil had he known the additional risk,” Judge Powell said in a ruling from the bench on Monday afternoon. “Based on the testimony presented by the plaintiff, all the jury could do is guess. I cannot permit the jury to speculate as to causation.”

Attorneys for GSK moved for a nonsuit on Monday morning after the plaintiffs rested the nearly two-week-old case they presented on behalf of Braden Rader, who was born with tetraology of fallot, which is a combination of several congenital heart defects, allegedly caused by Balser's use of Paxil during the early stages of her pregnancy in 2003.

Balser’s is the first of nine cases queued up for trial as part of a mass tort program in Philadelphia.

Joseph O’Neil, an attorney with Lavin O’Neil Cedrone & DiSipio representing GSK, told Judge Powell during oral arguments on the nonsuit motion that a claim over the company’s alleged failure to provide adequate warnings could not go to the jury because Kiehn had not testified that he would have acted any differently if provided with additional information about the risk of potential birth defects.

“That is a deal breaker,” O’Neil said. “To allow this case to go to a jury is to allow the jury to engaged in pure, unadulterated speculation as to what Dr. Kiehn would have done."

Adam Peavy, an attorney with Bailey Peavy Bailey Cowan Heckaman PLLC, argued that portions of Kiehn’s videotaped deposition had been improperly excluded from their case under Judge Powell’s interpretation of a pretrial order barring mention of subsequent remedial measures GSK may have taken to address problems with the drug.

Among those, he said, was the fact that Paxil was upgraded under Food and Drug Administration guidelines to a so-called Pregnancy Category D drug in September 2005, which warned physicians that studies in pregnant women had demonstrated a risk to fetuses.

While court records indicate that Kiehn had testified in his deposition that he would never have prescribed a drug with a Category D ranking, Judge Powell barred those questions from being played for the jury.

“To suggest that the question was never asked is not accurate,” he said. “It was asked multiple times about what he would’ve done with a different warning, or if he was warned about Paxil causing birth defects. Your honor excluded that evidence.”

Todd Davis, an attorney with King & Spalding also representing GSK, said that the plaintiffs could have asked the question a different way during the deposition or, after the pregnancy category questions were barred from being played for the jury, flown Kiehl to Philadelphia to testify in person.

“Plaintiffs here had the opportunity to ask the right question of Dr. Kiehn and they didn’t do it,” he said. “They failed to present that evidence, and without that evidence they cannot proceed.”

Judge Powell agreed in his bench ruling.

“The court recognizes that the plaintiffs asked a question related to Paxil’s inadmissible Category D label, however the question was stricken,” he said. “Plaintiffs could have asked admissible questions of what Dr. Kiehn would have done had he known that Paxil was a potential teratogen or that it caused embryo-fetal death, but they did not do so.”

Peavy slammed Judge Powell’s ruling in a brief interview with Law360 on Monday afternoon.

“We’re disappointed with the judge’s exclusion of highly relevant evidence that would have proved that Dr. Kiehn would never have prescribed Paxil to Ms. Balser,” he said. “His exclusion of that evidence throughout the entire trial has impacted our ability to pursue our case.”

He said that the judge had barred mention of the new pregnancy category as a subsequent remedial measure “without reference or consideration to the exceptions to that well known rule.”

He was unequivocal when asked about the possibility of asking the state’s Superior Court to review Judge Powell’s decision.

“Oh, there will be an appeal,” he said. “Absolutely.”

GSK, meanwhile, praised the decision in a statement to Law360 and rebutted any alleged links between Rader's condition and Paxil.

"The scientific evidence does not establish that exposure to Paxil during pregnancy caused Braden Rader’s tetralogy of fallot heart defect," a company spokeswoman said. "In fact, there are no studies finding that Paxil causes tetralogy of fallot. It is always saddening when a child is born with a heart defect, which, unfortunately, can occur regardless of whether the mother was taking medication during pregnancy. The causes of the vast majority of heart defects are still unknown, although many are caused by genetics."

Rader is represented by Adam Peavy of Bailey Peavy Bailey Cowan Heckaman PLLC and James Morris Jr. of Morris Law Firm.

GSK is represented by Todd Davis of King & Spalding and Joseph O’Neil of Lavin O’Neil Cedrone & DiSipio.

The case is Braden Rader et al. v. SmithKlineBeecham Corp. et al., case number 110903672, in the Court of Common Pleas of Philadelphia County, Pennsylvania.

Courtesy of

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