Date of Verdict:

Oct. 13, 2009.

Court and Case No.:

C.P. Philadelphia No. 001813.

Judge:

Sandra Mazer Moss.

Type of Action:

Negligence.

Injuries:

Atrial septal defect, ventricular septal defect, interrupted aortic arch.

Plaintiff’s Attorneys:

Jamie L. Sheller, Sheller, Philadelphia; Roberta J. Karp, Scott A. Love, Riley L. Burnett and Clayton A. Clark, Clark Dean & Burnett, Houston; Sean P. Tracey and Shawn P. Fox, Tracey Law Firm, Houston; Esther Berezofsky, Williams Cuker Berezofsky, Philadelphia; Shelley Van Natter Hutson, Hutson Law Firm, Houston.

Plaintiff’s Experts:

Dr. Suzanne Parisian, anatomic and clinical pathologist; Dr. David Healey; Dr. Marvin Goldberg, nephrologist.

Defense Counsel:

Joseph E. O’Neil, Mary Grace Maley and Carolyn L. McCormack, Lavin O’Neil Ricci Cedrone & Disipio, Philadelphia; Matthew S. Harman, Robert B. Friedman, Jennifer C. Kane, Diane M. Janulis and Chilton D. Varner, King & Spalding, Atlanta.

Comment:

By a 10-2 vote, jurors awarded plaintiff Michelle David a $2.5 million verdict to compensate for her son’s congenital heart defects, which she argued were caused by her taking an antidepressant during her pregnancy.

David’s son, Lyam Kilker, was born Oct. 24, 2005, with three heart defects, all of which necessitated surgery at four months of age and a second open-heart procedure thereafter. His condition will require future open-heart surgeries, according to court papers.

During the time of her pregnancy, Michelle David was prescribed, and took, Paxil, a drug manufactured by GlaxoSmithKline.

According to the plaintiff’s opposition to Glaxo’s motion for partial summary judgment, David’s attorneys alleged Glaxo knew of the teratogenic effects of Paxil at higher dose levels ever since the manufacturer first studied the drug’s effects on rats and rabbits in 1980. Glaxo should have extensively tested the compound on humans thereafter, David’s attorneys argued, especially since the drug was to be sold nationwide.

David further maintained that Glaxo made a deliberate, concerted effort to not investigate the teratogenic effects of Paxil until late 2005, when the FDA forced the drug maker to do so, Jaime Sheller, one of David’s attorneys, explained. The FDA also required Glaxo to change its warning label, Sheller said.

As a result, David sought $1.2 million in punitive damages.

According to the defense’s motion for partial summary judgment, Glaxo said that their label, which said that animal studies are not always predictive of human response, adequately cautioned consumers. Glaxo also argued the label provided a warning that its drug should only be used during pregnancy if the potential benefit justified the potential risk to the fetus.

The court denied Glaxo’s motion for partial summary judgment, deciding the question of whether Glaxo acted recklessly or outrageously was a jury question.

After seven hours of deliberation, the jury of seven females and five males rejected the punitive damages claim, deciding that Glaxo’s conduct was not “outrageous.”

Sheller said she thought Glaxo’s argument swayed the jury in this matter.

Glaxo told the jury the plaintiff would have to show Glaxo intentionally manufactured and sold Paxil with the express wish that Paxil would cause congenital heart defects in children. The plaintiff made no such showing, Glaxo said.

The jury did, however, award David $2.5 million in compensatory damages to account for Lyam Kilker’s multiple surgeries, concluding that Paxil caused Lyam Kilker’s heart defects and that Glaxo negligently failed to warn doctors and pregnant women of the risks.

None of Glaxo’s attorneys would return calls seeking comment, but a statement released by the company indicated that Glaxo intends to appeal. The statement says Glaxo contends the scientific evidence does not establish a causal relationship between exposure to Paxil during pregnancy and birth defects.

Madeline Branden, for the Law Weekly