When Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson went to appeals court to fight a previous ruling they hoped the judge might give a different ruling than the Court of Common Pleas, but that’s not what happened at all.
The original Florida birth injury case was filed by Kelly and Brian Anderson with the help of their medical malpractice attorney Jhon Bales. In the paperwork, they claimed that Janssen Pharmaceuticals was responsible for their daughter’s birth injuries which included a bilateral cleft palate. The parents were convinced that the only reason their daughter suffered these particular birth injuries was because Kelly had used Topamax the anticonvulsant drug during her pregnancy.
The case ultimately went to trial and the jury ruled that the drug manufacturer was responsible for their daughter’s injuries since the company failed to make the potential side effects clear on the Topamax packaging. The jury felt that since neither Kelly nor her doctor had been adequately warned about the potential side effects associated with Topamax, they were unable to decide if the drug’s benefits justified the increased risk of birth injuries. The family was awarded a $3 million verdict.
Since the initial ruling, Janssen Pharmaceuticals has pursued an appeal, but on May 11, 2016 the company’s hopes were dashed when the Superior Court of Pennsylvania agreed with the original jury and ruled against the pharmaceutical company.
During the appeal process, the drug manufacturer felt that they shouldn’t have been held accountable for failing to change the information printed on the Topomax because they’re unable to make any changes without the express permission of the U.S. Food & Drug Administration.
The appeal was heard by a three-judge panel. After listening to Janssen Pharmaceutical’s argument, the judges disagreed. It’s their belief that even though the FDA might not have approved the change in labeling, there were other steps that Janssen could have taken to make sure that both doctors and patients understood the potential risks connected to Topomax.
They issued an opinion so the public could better understand the ruling. “Janssen’s argument fails to differentiate between the nonspecific, potential risk that Topamax’s Category C label implied and a known risk in which the drug has been scientifically established to cause particular birth defects,” the opinion said. “The evidence presented at trial indicated that Janssen knew of a causal relationship between Topamax and specific birth defects, including cleft palate, but failed to disseminate the information so that Kelly’s physicians would be adequately warned.”
The plaintiff’s attorney, Andrew Williams, who works for Simmons Hanly Conroy was pleased with the end results of the case, though not surprised. “The Superior court’s decision again proves that big pharmaceutical companies consistently hide dangerous side effects from the American public, but that our legal system allows consumers and families to level the playing field and hold them accountable. Simmons Hanly Conroy is pleased to secure justice for this well-deserving family and ensure their little girl receives the quality care and treatment she deserves.”
Florida birth injury John Bales Attorneys is pleased that the Court of Appeals agreed with the jury and the Florida Court. “This ruling proves that the justice system isn’t going to kowtow to big drug companies. I hope it encourages more people whose children suffered a birth injury, either as the result of drug or medical malpractice in the birthing room, will seek legal retribution.”