The state Supreme Court has denied an appeal by the maker of Children’s Motrin in a case that resulted in a $10 million verdict for a family of a 3-year-old severely injured after taking several doses of the medicine.
The ruling Wednesday denying allocatur in Maya v. Johnson & Johnson followed a July 2014 decision by the Superior Court upholding the damages for injuries the child suffered that included being left blind in one eye, damage to her reproductive system and permanent disfigurement of much of her skin.
The $10 million in compensatory damages was awarded by a Philadelphia Court of Common Pleas jury against Johnson & Johnson subsidiary McNeil on the claim that the drugmaker failed to adequately warn of the risks of taking over-the-counter Children’s Motrin. The jury did not award punitive damages nor did it find that Children’s Motrin was negligently designed.
On appeal to the Superior Court, McNeil argued it was entitled to judgment as a matter of law because its warning label was drafted by the U.S. Food and Drug Administration. The pharmaceutical company argued it couldn’t have been found negligent for not including in its list of symptoms “skin reddening,” “rash” and “blisters” when it wasn’t required to do so by the FDA.
But Superior Court Judge Kate Ford Elliott said in her 37-page opinion that the company was mistaken, citing to the court’s 2011 ruling in Daniel v. Wyeth Pharmaceuticals, in which the court rejected a federal pre-emption argument and found it was the manufacturer that bears responsibility for providing an adequate label.
McNeil further argued on appeal that Brianna Maya failed to show her use of Children’s Motrin was the cause of her symptoms, Ford Elliott said. The company argued Maya’s mother testified she would have relied on the doctor’s advice to administer the drug regardless of what the warning said.
But Ford Elliott said the mother testified she would not have given the drug had the warning label contained the word “blisters” or warned of skin rashes.
“Therefore, there was testimony that an adequate warning would have prevented Brianna from receiving the last four or five doses of Children’s Motrin,” Ford Elliott said. “Moreover, two of [Maya's] expert witnesses testified that stopping the Children’s Motrin sooner would have substantially improved Brianna’s prognosis.”
Ford Elliott went on in her opinion to reject some claims by McNeil related to the jury instructions given at trial. She did find in favor of the drug company on one such argument, however, but ultimately determined the trial court’s error didn’t warrant a new trial.
McNeil argued the trial court mistakenly told the jury that it could consider the conduct of other pharmaceutical manufacturers whose drugs were taken off the market when the court should have said the jury could “not” consider such evidence.
“Ultimately, however, the issue does not compel a new trial because McNeil was not prejudiced by the trial court’s alleged mistake,” Ford Elliott said. “As [the Mayas] point out, the instruction really only pertains to their claims for negligent design defect and punitive damages, both of which the jury resolved in favor of McNeil.”
Alfred W. Putnam Jr. of Drinker Biddle & Reath represented McNeil during the appeals process. He declined to comment on the Supreme Court’s decision.
Howard Bashman of Willow Grove argued the case on appeal for the Mayas and Keith Jensen of Jensen & Associates in Fort Worth, Texas, represented them at trial. Bashman said he was pleased the court denied review given it wasn’t a case for which he felt review was warranted.
Jensen had said at the time of the Superior Court ruling that Maya was the first verdict holding McNeil liable for failure to warn consumers of the symptoms of deadly skin diseases allegedly caused by Motrin.
Maya, now a teenager, was given doses of Children’s Motrin when she was 3 years old in alternation with over-the-counter Children’s Tylenol because she had a fever over the course of two-and-a-half days, according to the trial court’s opinion.
On the morning of the third day, Maya was taken to a local hospital in Martin, Tennessee, because of a rapidly spreading rash over her entire body, including blisters on her mouth, chest and vaginal area, according to the opinion. She underwent several forceful debridements of her skin, followed by skin grafts of pig skin or skin from cadavers, because of the risk of infection from so many open wounds and blisters.
Two days after being taken to the hospital, Maya was transferred to Shriners Burns Hospital in Texas, according to the opinion. At that point, 84.5 percent of Maya’s body was estimated to be covered with open wounds.
Maya’s injuries were not from burns, however, but from Stevens-Johnson syndrome/toxic epidermal necrolysis, which is part of the same disease process in which the human body attacks its own skin and mucous membranes, according to the opinion.
The medical staff at Shriners determined that Maya’s use of pediatric ibuprofen, or Children’s Motrin, was the cause of her disease, according to the opinion.
Maya has undergone 16 eye surgeries, and she required surgery to stop her menses from backing up in her abdomen, according to the opinion.