Nicholas Malfitano May 2, 2016, 9:08am


PHILADELPHIA – A Philadelphia judge has dismissed the first Paxil lawsuit against GlaxoSmithKline to go to trial in Philadelphia after determining the plaintiffs' evidence would lead to a guessing game by the jury.

But Philadelphia Court of Common Pleas Judge Arnold L. New also ruled April 21 to grant the plaintiffs' request to have the multi-district litigation proceeding against GSK stayed until the finalization of their post-trial appeal. Plaintiffs allege the drug caused cardiac birth defects.

The lawsuit was brought by plaintiff Braden Rader and his mother, fellow plaintiff Elisabeth Balser, both of Meridian, Miss. Rader was born with Tetralogy of Fallot, a rare congenital birth defect comprised of four abnormalities in the heart.

These abnormalities cause oxygen-deficient blood to be carried from the heart to the rest of the body, which may result in the skin of those afflicted with the condition having a blue pallor.

Balser was prescribed Paxil at the outset of her pregnancy in 2003 and alleged Rader’s Tetralogy of Fallot birth defect was a direct result of her taking the drug.

Paxil carried a mild warning at the time Balser was prescribed it in 2003, but its warning was later updated in 2005 to a “Category D” substance for pregnant women.

When associated with a given drug, “Category D” signifies a positive evidentiary risk to fetal health.

Judge Kenneth J. Powell Jr., also of the Philadelphia County Court of Common Pleas, granted compulsory nonsuit in Rader and Balser’s case against GSK on April 5, due to a lack of substantial evidence from the plaintiffs to support their causation claims.

“Based on the testimony presented by the plaintiff, all the jury could do is guess. I cannot permit the jury to speculate,” Powell said.

Powell had not permitted the jury to view videotaped deposition testimony from Balser’s physician, Dr. Robert Kiehn, who stated he would not have prescribed Paxil to Balser had it carried the “Category D” warning at the time of her pregnancy.

In making the decision to bar Kiehn’s deposition, Powell cited a pre-trial order that prevented any mention to the jury of remedial measures GSK may have taken to address issues with Paxil.

These measures included the updating of Paxil’s warning to “Category D”.

According to Rader and Balser’s attorney, Adam Peavy of Bailey Peavy Bailey Cowan Heckaman in Houston, Texas, an appeal of Powell’s decision is currently being prepared for the Superior Court of Pennsylvania.

“I think it’s a rather simple appeal, and it’s one that we’re ready to go up and fight,” Peavy said. “I think it’s a rather clear-cut issue.”

Peavy added guidelines from both the Superior Court and Supreme Court of Pennsylvania regarding exceptions to subsequent remedial measures are “well-defined.”

“They’re in every case about learned intermediary [doctrine] that I’ve read,” Peavy said. “I think they’re dispositive of the issue.”

Peavy pointed to precedent from Daniel v. Wyeth Pharmaceuticals, Inc., which stated subsequent remedial measures were in fact admissible for purposes of the learned intermediary doctrine.

“We’ll see what the Superior Court says about the exclusion of that testimony, and hopefully, they’ll see it the same way I did,” Peavy said.

On the subject of New’s ruling to stay proceedings in the Paxil multi-district litigation, Peavy indicated it was the correct decision.

“We requested the stay of Judge New, in light of the decision by Judge Powell to exclude the prescribing doctor’s testimony about how he would change his prescribing habits based upon the new warning that is out on Paxil,” Peavy said.

“We think it’s the right decision to stay the cases, because every single pharmaceutical case that’s tried in Pennsylvania would be impacted by the exclusion of a prescribing doctor’s testimony,” Peavy said. “We think the decision [from New] to stay was appropriate.”

Counsel for GSK, Todd Davis of King & Spalding in Atlanta, Ga., was contacted but could not be reached for comment.

GSK’s Director of United States External Communications, Jenni Brewer Ligday, provided comment on behalf of the pharmaceutical company.

“GSK is pleased with the trial court’s ruling in the Rader v. GSK case. After almost two weeks of trial, the court recognized that the plaintiffs did not present sufficient evidence to submit the case to the jury,” Ligday said. “We firmly believe that GSK is not liable in this case that alleges the use of Paxil during pregnancy caused Braden Rader’s heart defect.”

Ligday stated scientific evidence did not establish that fetal exposure to Paxil caused Rader’s Tetralogy of Fallot, and no studies exist which make such a conclusion. Ligday continued the “vast majority” of causes connected to congenital heart defects are “still unknown”, with genetics also playing a role.

“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,” Ligday said. “Patient safety is our highest concern. Throughout the plaintiff mother’s pregnancy, the Paxil label provided adequate warnings and information regarding use in pregnancy.”

As to New’s decision to stay proceedings in the multi-district litigation involving Paxil, it was a move GSK did concur with.

“GSK does not agree that a stay of the cases should take place because of a decision by the trial court in the Rader case,” Ligday said.

From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at nickpennrecord@gmail.com

Organizations in this Story

GlaxoSmithKline
5 Crescent Dr
Philadelphia, PA 19112

Superior Court of Pennsylvania
Harrisburg, PA 17120, United States
Harrisburg, PA 17120

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