Drug & Device News

Pennsylvania's Superior Court has upheld a $10 million verdict against pharmaceuticals manufacturer McNeil-PPC compensating a child who was injured after taking Children's Motrin. The Philadelphia Court of Common Pleas jury that heard the case concluded that McNeil-PPC, a subsidiary of Johnson & Johnson, failed to adequately warn the parents of the then-three-year-old girl of the risks of giving their child the over-the-counter product, resulting in damage to her reproductive system, permanent disfigurement of her skin and loss of sight in her left eye. On appeal, the pharmaceuticals company argued that negligence had not been proven because the Children's Motrin warning label contained all the cautionary information required of and approved by the U.S. Food and Drug Administration (FDA) ' and this information did not included warnings about rashes, blisters or skin reddening. Relying on Daniel v. Wyeth Pharmaceuticals, Judge Kate Ford Elliott wrote that the appellants could not shield themselves behind a federal preemption argument, but must take responsibility for providing adequate warning information on its product's label. In addition, although the injured child's mother testified that she would have relied on the girl's doctor's recommendation that she give Children's Motrin even if the label had warned of blisters or rashes, she also testified that she would have discontinued its use once her child developed these symptoms if such warnings had existed. “Therefore,” Judge Ford Elliott wrote, the manufacturer's argument that failure-to-warn did not cause the child harm must fail, as “there was testimony that an adequate warning would have prevented [the child] from receiving the last four or five doses of Children's Motrin.” This, along with expert testimony that the child's injuries would have been fewer had she stopped taking the drug sooner, supported a finding that the company was liable.