An $11 million verdict has been awarded to the parents of a child born with congenital defects due to an anticonvulsant drug his mother took during pregnancy.

Stanley Thompson, director of the Philadelphia Court of Common Pleas’ Complex Litigation Center, said that out of the 132 Topamax mass tort cases currently under way, Powell v. Janssen Pharmaceuticals was the second to render a verdict.

The first case to produce a verdict was Czimmer v. Ortho-McNeil-Janssen Pharmaceuticals, which rendered a $4 million verdict Oct. 31, according to Thompson.

The jury in Powell returned an $11 million verdict to Haley Powell and Michael Gurley, the parents of Brayden Gurley, on Nov. 18 after deliberating seven hours in the Philadelphia Court of Common Pleas. The verdict was divided into $335,000 for future health care expenses and $10.6 million for non-economic loss.

The plaintiffs were represented by Laura Feldman and Rosemary Pinto of Philadelphia-based Feldman & Pinto and Shelley Hutson of Clark, Love & Hutson in Houston.

Powell’s pretrial memorandum alleged that Powell’s ingestion of the drug Topamax (also called topiramate)—prescribed to control her migraine headaches and hand tremors during the first trimester of pregnancy in 2007—caused her son to be born with right unilateral cleft lip.

According to court papers, Janssen Pharmaceuticals, the maker of the drug, knew about the risk of birth defects associated with Topamax, but failed to provide adequate warning to users.

“A decade before Janssen got around to changing its label [in 2011], internal Janssen documents concluded that Topamax can cause birth defects,” court papers alleged, adding that a 2001 informed consent form draft from Janssen stated, “Topiramate has the potential to cause serious birth defects in children.”

Powell was prescribed several different anticonvulsant medications since 2005, when she suffered a single seizure. According to court papers, Powell’s doctor prescribed Topamax for her tension headaches and migraines in March 2006.

When Powell exhausted her supply of the drug, Powell’s mother—who was also prescribed Topamax—began sharing her supply with her daughter, court papers said.

Powell took Topamax regularly from March 2006 to December 2007. Powell discovered she was pregnant Nov. 21, 2007, according to court papers.

After being notified of the pregnancy, Powell’s doctor instructed her to taper off her dosage; however, neither Powell nor her doctor were aware that Topamax could cause birth defects, court papers said.

Brayden Gurley, diagnosed in utero with right unilateral cleft lip and alveolar defects, was born July 7, 2008. According to court papers, Brayden’s condition has not yet been corrected.

Brayden suffers from misalignment of teeth, overbite and speech and language disorders related to his cleft lip and alveolar defects. Court papers said he will require surgery and multiple treatments to address multiple complications “which will likely include” middle ear fluid accumulation, hearing loss, dental abnormalities, speech difficulties and “psychosocial problems that children born with clefts, such as Brayden, endure.”

The plaintiffs maintained in court papers that Powell’s previous use of the drug Keppra and maternal underweight were not causative of Brayden’s birth defects. Powell’s and Gurley’s families also showed no genetic history of clefting and Powell took prenatal vitamins during pregnancy, according to the court filings.

However, Topamax, the plaintiffs alleged, increased the risk of a child being born with birth defects, such as a cleft lip or palate, by 1,200 percent.

Janssen’s pretrial memorandum alleged that Powell received at least two warnings from her doctor as to the potential risks of anticonvulsant and antiepileptic drugs and “the importance of not becoming pregnant while taking the medication.”

Defense papers also said Powell’s doctor’s suggestion that she taper her Topamax dosage during pregnancy suggested his “concern for its potential effect on fetus.”

Additionally, defense papers asserted that the plaintiffs’ claims were barred by the applicable two-year statute of limitations in Pennsylvania.

Another claim made in Janssen’s papers was that Powell taking her mother’s medication prevented the plaintiffs from establishing causation.

“If Ms. Powell, in fact, took Topamax prescribed to her mother, this intervening act was not reasonably foreseeable to Janssen and Janssen, therefore, is immune from liability,” defense papers said.

Kenneth Murphy of Philadelphia-based Drinker Biddle & Reath represented Janssen and declined to comment on the case.

Pinto said her firm is handling the majority of the Topamax cases in Philadelphia, and she is serving as liaison counsel for plaintiffs for the entire series of cases.

Of the Powell case, Pinto said Brayden will have “a lot of emotional stress accompanying his surgeries. One of them involved taking bone from his hip to place it in the portion of the gum that they’re trying to repair. There’s scarring, trauma, it’s a tough road for the child.”

Pinto added that the defendants in the ongoing Topamax litigation “should be looking at these cases with a different view. They have to exercise extreme care and caution and follow the rules to make sure the physicians are aware of all the risks, so that doctors know not to prescribe it to pregnant women.”

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