(Aaron Couture)

The parents of a child born with a cleft lip and palate linked to the mother’s use of the anti-seizure drug Topamax during pregnancy have received a $3 million jury award in a failure-to-warn case in Philadelphia.

The jury’s award March 7 in Anderson v. Janssen Pharmaceuticals marks the third Topamax-related verdict issued against Janssen Pharmaceuticals, the Johnson & Johnson subsidiary that manufactures the drug.

The 12-person jury handed up the verdict in Philadelphia Court of Common Pleas Judge Ramy I. Djerassi’s courtroom.

One of the attorneys representing the plaintiffs in the case, Rosemary Pinto of Philadelphia-based Feldman & Pinto, said that four Topamax cases have gone to trial in Philadelphia so far, and the three that have resulted in awards for the plaintiffs ended up in the multimillion-dollar range.

The other cases that rendered verdicts were Powell v. Janssen Pharmaceuticals, producing an $11 million award Nov. 18, and Czimmer v. Ortho-McNeil-Janssen Pharmaceuticals, which resulted in a $4 million award Oct. 31.

Pinto, who noted that she is involved in approximately 40 to 50 additional Topamax cases in Philadelphia, said it was likely that the string of verdicts would prompt a greater willingness on behalf of the defendants to settle.

“It’s reasonable to conclude that parties will come together after these verdicts,” Pinto said. “I would hope that Johnson & Johnson would accept responsibility and that we won’t have to have any more trials.”

Drinker Biddle & Reath attorney Kenneth Murphy represented Janssen in Anderson and declined to comment.

Plaintiffs attorney Claudine Q. Homolash, who handles products liability cases, observed that the verdicts might cause a change in Janssen’s attitude toward taking Topamax cases to trial. Homolash was not involved in the Anderson litigation.

“I think the fact that there have been three plaintiffs verdicts in the Topamax litigation should cause Johnson & Johnson and Janssen some serious concern,” Homolash said, which may cause them “to revisit how they want to handle some of these cases.”

In terms of Janssen’s defense arguments in the Topamax cases, Homolash said, “From my understanding, the defense is that it’s the mother’s fault, and that defense doesn’t appear to be working.”

Several products liability defense attorneys outside of the Topamax litigation declined to offer comments on the issue.

The jury in Anderson divided the verdict into $1.5 million for non-economic losses and $1.5 million for future health care expenses. Pinto said she could not comment as to whether there were any pretrial settlement offers.

Plaintiffs Kelly Anderson and her husband argued in their pretrial memorandum that Anderson’s ingestion of Topamax during the first trimester of her pregnancy caused their baby’s birth defects.

Anderson, who took Topamax to treat her migraine headaches, learned she was pregnant Dec. 26, 2007. Court papers said that Anderson called her neurologist, Dr. Veronica Sosa, to discuss tapering off, but not eliminating, her Topamax use with the belief that her migraines would improve during pregnancy.

Court papers said that Anderson’s obstetrician told her that Topamax was safe to take during pregnancy.

The plaintiffs argued Janssen did not adequately warn about the potential risks associated with Topamax until the label was changed in March 2011.

The plaintiffs alleged that Janssen knew about the risk of birth defects associated with Topamax as early as a decade before the label change, as evidenced by internal Janssen documents.

Janssen employees also acknowledged Topamax’s potential to cause birth defects, court papers said, pointing to the testimony of Cathy Ellis, who served as Janssen’s associate director of regulatory affairs.

“She testified that based on preclinical information at the time, Topamax ‘was known to cause some birth defects’ in humans as early as 1996,” court papers said.

However, Janssen’s experts testified that it is uncertain as to whether exposure to Topamax during pregnancy causes birth defects, court papers said.

In the defendant’s pretrial memorandum, Janssen said that one of Anderson’s doctors informed her of the potential risks associated with taking Topamax during pregnancy and that Anderson “repeatedly refused” to go off the drug, despite her doctor’s warnings.

Additionally, the defendant argued that Sosa knew of the risks Topamax potentially posed when it was labeled as a pregnancy Category C drug before it was changed to Category D, and informed Anderson to stop taking Topamax during pregnancy.

“Accordingly, Dr. Sosa knew of and understood the precise warnings of which [the] plaintiffs complain,” defense papers said. “Janssen’s warnings were, therefore, adequate.”

Janssen maintained that a change to a different warning label for Topamax would not have affected Anderson’s decision to remain on the drug because she relied on the advice of her obstetrician or she needed the drug for relief of her migraine symptoms.

“Mrs. Anderson’s conduct, such as her failure to heed the warnings Janssen provided with Topamax and/or heed the warnings concerning the drug’s side effects provided by her prescribing physicians, not only prevents [the] plaintiffs from meeting their burden of proof, but also demonstrates Mrs. Anderson herself was negligent,” defense papers said.

Pinto reiterated that juries have found in three trials that Topamax is a teratogen, a substance that causes birth defects, and that its warnings aren’t strong enough.

“This third verdict shows that Janssen and Johnson & Johnson’s defensive strategy of placing the blame on the mothers and the doctors is not going to work,” Pinto said.

P.J. D’Annunzio can be contacted at 215-557-2315 or pdannunzio@alm.com. Follow him on Twitter @PJDAnnunzioTLI.