Court Excludes Cardiology Expert’s Testimony Regarding Impact of Antidepressants on Congenital Defects

Wendy Ketner, M.D.

Written by
— Updated on March 5, 2020

Court Excludes Cardiology Expert’s Testimony Regarding Impact of Antidepressants on Congenital Defects

Court: United States District Court for the District of Connecticut
Jurisdiction: Federal
Case Name: K.E. v. Glaxosmithkline LLC
Citation: 2017 U.S. Dist. LEXIS 13705

Facts

This case was filed against the pharmaceutical company, GlaxoSmithKline (GSK), concerning the side effects of its antidepressant, Paxil. The plaintiff, a mother, alleged that her child suffered from the congenital disability Bicuspid Aortic Valve (BAV) secondary to her consumption of Paxil during pregnancy. BAV leaves the aortic valve—which controls blood flow from the heart to the aorta—with two leaflets instead of three. The plaintiff mother claimed she consumed Paxil throughout her pregnancy. However, no conclusive evidentiary record detailed the amount of Paxil the plaintiff consumed, nor the frequency.

The plaintiff referenced epidemiological data indicating that the occurrence of some congenital disabilities is higher among women who consume Paxil while pregnant. The claim also referenced animal studies in which serotonin changes increased the chances of an embryo developing defects. The plaintiff retained a cardiology expert witness to testify about the causal link between BAV and Paxil.

The Cardiology Expert Witness

The plaintiff’s cardiology expert witness was an Assistant Professor of Pediatric Cardiology at Johns Hopkins University School of Medicine. He was also a Pediatric Cardiologist at Johns Hopkins Hospital. The cardiology expert witness was licensed to practice in Maryland and treated patients in several hospitals in the Baltimore area.

In his report, the cardiology expert referenced several studies on the causes of and risk factors for congenital heart disease. He also investigated the biological effects of serotonin on fetal development and the plaintiff’s medical history. The cardiology expert witness concluded that Paxil was a significant contributor to the child’s heart defect. In order to arrive at his conclusions, the expert assumed the plaintiff consumed Paxil in the first trimester of her pregnancy.

The defendants sought to exclude the expert’s testimony on specific and general causation, claiming he was unqualified.

Discussion

The defendant moved to exclude the expert’s causation opinions because his report ignored recent analyses of the relationship between Paxil and congenital disabilities. Furthermore, the defendant claimed the report did not eliminate other causes, including chance, bias and confounding in assessing the association. Lastly, the defendant claimed the expert did not follow a “set, written-down methodology” to establish general causation.

The court noted that the expert had sufficient practical and academic knowledge to understand the epidemiological literature. The expert was able to discuss the ways Paxil can possibly affect embryonic serotonin levels and cause heart defects. However, the court noted that some of the work the expert omitted from his report confirmed his stance. Although the cardiology expert’s research did not selectively reference supporting evidence, it provided an inaccurate interpretation of secondary literature.

GSK also claimed the second half of the expert’s report, which depended on “biological plausibility,” was misleading. GSK claimed this section should be inadmissible because it concluded Paxil’s human impact from animal or independent tissue evidence.

The court disagreed because there were significant limitations to the findings on which the expert depended. However, it concluded these concerns could be dealt with by prudential advice to the jury and thorough cross-examination. As a result, the expert’s testimony on the biological plausibility of Paxil’s production of BAVs was admissible, even though it depended on animal studies.

The court noted that the expert’s testimony that Paxil can generally cause BAV was of no value if he could not also testify that Paxil caused the plaintiff’s child to develop BAV. GSK argued the cardiology expert could not make that connection with certainty because he assumed the plaintiff took Paxil during her first trimester.

The court rejected the plaintiff’s argument that the absence of evidentiary backing was negated by the expert’s following of differential diagnosis. It stated that without sufficient and reliable evidence that the plaintiff had consumed Paxil during her first trimester. Furthermore, even if she had, no evidence indicated how much she had taken. Therefore, the cardiology expert could not provide reliable specific evidence of causation.

Held

Although the court found that the cardiology expert was qualified to give an opinion in this case, it ruled that his views on the issue of general causation were, in part, inadmissible and that his views on the topic of specific causation were inadmissible. The defendant’s motion to exclude was granted.

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