Pediatric Cardiologist Said Paxil (Seroxat) Heart Defect Link Exists

Earlier this week in a trial in Pennsylvania state court, a Rush University pediatric cardiologist said Paxil heart defect link exists when fetuses are exposed to the GlaxoSmithKline antidepressant while in utero. The case involves a 12-year old boy with a rare heart condition whose mother, Elisabeth Balzer, took Paxil while pregnant.

The cardiologist expert witness, Dr. Ra-id Abdulla, testified that a review of plaintiffs Braden Rader’s and his mother’s medical records showed that Braden’s tetralogy of fallot (a combination of four heart defects) was related to exposure to Paxil during his mother’s pregnancy. Dr. Abdulla, also the editor-in-chief of the Pediatric Cardiology Journal, informed the jury that Braden was exposed to Paxil during the first 30 to 35 days of life.

He said, “That is the critical period of time for heart development.”

This suit is the first of nine involving Paxil and heart defects to go to trial in a mass tort program in the Philadelphia County Court of Common Pleas.

Braden Rader, according to Dr. Abdulla, has already been through two heart surgeries, one several months after his birth and the second just last year. He will also need “future invasive surgery.” Braden’s medical condition, said Dr. Abdulla, “is a lifelong commitment.”

GSK’s defense attorney, Todd Davis of King & Spalding, put Dr. Abdulla through a rigorous cross-examination. His goal was to create doubt in the jurors’ minds as to Dr. Abdulla’s qualifications to testify regarding causation of Braden’s condition as well as the available science that links Paxil to Braden’s condition.

Mr. Davis posited that the doctor did not review all of Braden’s medical records, nor did he speak to Braden’s treating doctors. However, Dr. Abdulla’s testimony reflected that some of this is common practice.

He said, “Every week in every single medical center, we meet once or twice to discuss patients we haven’t seen. We rely on medical records to come up with plans for management.”

Dr. Abdulla’s testimony also included information from the American Heart Association, which has already “assessed, documented, and judged” the existence of a causal link between Paxil and heart defects, such as Braden’s. Mr. Davis’ response was to question the doctor on the apparent absence of studies revealing direct causal links between Paxil use during pregnancy and changes to animal or human embryos.

Toward the end of Mr. Davis’ cross-examination, Dr. Abdulla, while still remaining calm and professional, expressed his criticism of Mr. Davis’ line of questioning as “pseudoscience.”

Dr. Abdulla said, “Medically speaking, it’s [Mr. Davis’ demand for evidence of a direct causal link] utter nonsense. That’s not the way we come up with conclusions. The issue of Paxil causing heart disease – that ship has sailed.”

Paxil, image courtesy of
Paxil, image courtesy of

However, just days later, Judge Kenneth Powell of the Philadelphia Court of Common Pleas sided with GSK’s defense on the issue of Elisabeth Balzer’s testimony regarding emotional distress she suffered after Braden was born with tetralogy of fallot. He based his decision to block Mrs. Balzer’s testimony on the fact that, under Mississippi law (Mrs. Balzer’s home state), she could only recover for vicarious emotional distress if she’d been present when the injury occurred and suffered an immediate adverse reaction.

The issue of her testimony arose when she began speaking of her emotional response to Braden undergoing open-heart surgery as an infant. GSK’s legal team objected, leading to Judge Powell’s decision. He did, however, listen to Mrs. Balzer’s testimony after the jury had been excused.

Mrs. Balzer’s testimony before Judge Powell and the parties’ attorneys included the fact that she suffered vomiting, exhaustion and depression due to coping with Braden’s medical condition.

Judge Powell said, “I will not permit the plaintiff to testify about physical injury or physical manifestations or anything that denotes pain and suffering” in front of the jury.

He said he wanted to hear her testimony as it could affect her potential to recover on a negligence claim for physical injury or physical manifestation of emotional distress due to Braden’s condition. “I must allow her to testify because there are issues that I have to evaluate. I believe that claim is still extant, but she must have suffered physical injury or physical manifestation.”

Again citing Mississippi state law, Mr. Davis said, “She didn’t know that the injury happened to Braden. It occurred during the first trimester. There’s no way she could have any physical impact from an injury that she didn’t know had occurred.”

Mrs. Balzer’s lawyer, James Morris Jr., responded, “What could be more shocking or upsetting to a woman than to be advised that your baby has a birth defect? To talk about her as if she was a bystander is ridiculous. This child was inside her when the defect occurred. It was delivered, her own child, with the defect. I’m shocked that that type of argument would even be made. If the appellate courts and the Supreme Court want to go with Mr. Davis’s theory then I really regret where this country is headed.”

It remains to be seen where Braden and Mrs. Balzer’s case, as well as the eight others waiting to be tried, will go. One certainly hopes that, with Dr. Abdulla’s testimony and the supporting opinion of the American Heart Association, justice will be done and Braden, Mrs. Balzer and the other injured plaintiffs will be justly compensated for their injuries.


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