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The Legal Intelligencer
May 25, 2011
Keith M. Jensen
Scott D. Levensten
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A Philadelphia jury has awarded more than $10 million in a case in which the plaintiffs argued that a young girl's use of Motrin caused a severe skin disease that left her blind in one eye and with skin sloughing off all over her body.
The jury in Maya v. Johnson & Johnson found in a 10-2 verdict that Johnson & Johnson's McNeil-PPC Inc. was negligent in not providing an accurate warning on the label of over-the-counter Children's Motrin and that it was the factual cause of plaintiff Brianna Maya's injuries, according to a transcript of the court proceedings.
The jury also found that McNeil was not negligent in designing the drug and that McNeil's conduct was not outrageous. Motrin is more commonly known as ibuprofen.
Philadelphia Common Pleas Court Judge Nitza I. Quiñones Alejandro presided over the trial, which ended in a plaintiffs' verdict Friday after nine weeks of trial.
Brianna Maya, a 13-year-old girl from Tennessee, and her mother, Alicia Maya, argued that Brianna Maya suffered from Stevens Johnson Syndrome/Toxic Epidermal Necrolysis after taking Motrin at the age of 3.
According to the plaintiffs' pretrial memorandum, SJS/TEN are part of the same disease process in which the human body attacks its own skin and mucous membranes.
In Brianna's case, the disease resulted in the loss of sight in one of her eyes; permanent disfigurement of much of her skin because her skin sloughed away from 84 percent of her body; damage to her reproductive system, including her menses backing up in her abdomen; and several other injuries.
Plaintiffs' attorney Keith M. Jensen, of Jensen Belew & Gonzalez in Forth Worth, Texas, said that after his co-counsel or he spoke to some of the jurors they were clearly convinced that the defendant drugmaker failed to warn and knew what could have been done to warn adequately on the Motrin warning label of SJS/TEN.
Reddening of the skin, rashes and blisters — the initial signs and symptoms of SJS/TEN — have been on the Motrin label since 2005, Jensen said.
Without that label, "moms and dads all across the country had no clue to associate when their young boy or girl had a rash with Motrin," Jensen said.
The jury deliberated for more than 10 hours, Jensen said.
Plaintiff co-counsel were Eric Roberson and Xavier Gonzalez, also of Jensen Belew & Gonzalez, and Scott D. Levensten of the Levensten Law Firm in Philadelphia.
Defense counsel were Christy D. Jones, Paul V. Cassisa Jr., Adam J. Spicer and Charles F. Morrow of Butler Snow O'Mara Stevens & Cannada in Ridgeland, Miss.
Jones argued during her closing argument that the labels on "Children's Motrin were always adequate for the safe and effective use of the product; and that an addition of a few words in 2006 doesn't mean that the former labels were inadequate, nor does it mean that there would have been any different outcome for Brianna Maya," according to the transcript of the arguments.
In contrast, Jensen said in an interview that the drug company, not the federal Food and Drug Administration, had the authority under then-law to make changes to the label.
Jones also argued that SJS/TEN is a very rare disease and that the FDA has estimated that 100 million people use over-the-counter ibuprofen, or Motrin, every year.
However, Jensen said that, even though SJS/TEN is so rare that there are 1.2 to six reported cases of SJS per one million people and 0.4 and 1.2 reported cases of TEN per one million people, warning of the risks of SJS/TEN because of Motrin is important because of the "dreadfulness" of the disease.
The plaintiffs also argued that four of Brianna's treating physicians said they were 99 percent certain that Children's Motrin was the cause of Brianna's injuries.
Brianna was diagnosed with the skin disease after taking eight doses of Children's Motrin, the plaintiffs said.
Jones also argued that the FDA concluded, even with the information about SJS/TEN, that it was in the interest of public health to have Children'sMotrin available as an option on the market.
Jones argued that Brianna used Children's Motrin several times, or that other drugs that Brianna took are more strongly associated with SJS/TEN, or that her symptoms were more likely to have been caused by a virus, or that ibuprofen is one of the drugs least likely to be associated with SJS/TEN.
During his closing argument, Jensen noted that the plaintiffs' witnesses testified that drugs alone are the cause of SJS/TEN, according to a court transcript.
The plaintiffs also argued that Motrin can be made more toxic when children also are taking Tylenol, Jensen said.
The plaintiffs also argued that Tylenol, by itself, is a safer, more effective drug, under a safer alternative product theory, Jensen said.
Jensen attributed the jury's finding against punitive damages to reasons including the jury repeatedly hearing that the FDA declared ibuprofen to be safe and effective and the judge's ruling against the plaintiffs' request to bring in evidence of the adverse effects of Motrin that has been developed in the last 10 years.
An alternative theory of safer alternative design that McNeil should have produced a different formulation of ibuprofen, dexibuprofen, as it does in other countries, was barred by the judge from the jury's consideration, Jensen said.
McNeil said in a statement issued Friday: "While we are sympathetic to the pain and hardships suffered by Brianna Maya and her family, McNeil-PPC, Inc. strongly disagrees with today's verdict, and we are considering legal options." •