In a case that has been going on for almost a decade, a family successfully argued that the Johnson & Johnson should have included sufficient warnings about the risk of liver failure with the use of Infant Tylenol.
J&J argued that state failure-to-warn claims involving over-the-counter drugs are preempted under a Supreme Court ruling last year that did immune generic drugs from such lawsuits. Preemption is the notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA unsuccessfully argued three years ago before the Supreme Court that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. There are, however, exceptions in which preemption prevails.
The case goes back to January 3, 2003 when a Louisiana mother Christina Hutto, and her mother Theresa, took her infant daughter Brianna Hutto to Opelousas General Health System’s emergency room hospital, due to a fever and upset bowels.
According to the court, while waiting for Brianna to be seen by a physician, Christina showed OGH emergency department personnel the bottle of Infants Tylenol she had administered to Brianna that morning. Brianna’s 11:00 a.m. dose of 0.8 ml Infant’s Tylenol was noted on the Intake sheet generated with Brianna’s treatment that evening.
After Brianna was examined by the emergency physician, an OGH nurse gave Christina written after-care instructions which instructed that Brianna be given three-quarters of a teaspoon “Tylenol.”
The record reflects that Theresa questioned whether the dose was appropriate for such a young infant, and the nurse left her and Christina. The nurse returned and changed the instruction from three-quarters of a teaspoon to one teaspoon, explaining the higher dose would be more effective for Brianna’s weight.
Unbeknownst to Christina and Theresa, the nurse’s instruction referred to Children’s Tylenol not Infant’s Tylenol because OGH used Children’s Tylenol exclusively. Christina and Theresa assumed the instruction referred to the Infants Tylenol Christina used before bringing Brianna to the hospital because she had shown the bottle to OGH personnel.
At the time, OGH nurses, not doctors, calculated the appropriate doses of acetaminophen. OHG’s representative testified that the nurse did not consult the doctor who treated Brianna when he gave his ‘Tylenol’ dosing instruction.
The family later gave their daughter teaspoon doses of Infant’s Tylenol, which is approximately four times more concentrated than Children’s Tylenol. The infant developed acute liver injury and died five days later while awaiting a liver transplant.
“Christina and Eric’s testimony show that Brianna was in pain and suffered until near her death. She was cognizant of them being present and wanted to be held and comforted by them, but they could not give her what she sought”, their lawyer said.
Christina and husband Eric sued the hospital, physician and manufacturer.
The family charged that McNeil should have included warnings on the labeling for Infant Tylenol and a jury awarded them $1.7 million. J&J subsequently lost an appeal, as well. The jury found that McNeil could have prevented the tragedy if it had provided certain additional warnings about Infants’ Tylenol and held McNeil liable under the Louisiana Products Liability Act.
In seeking a review, J&J argued that the Infant’s Tylenol label was consistent with the OTC monograph for acetaminophen and could not be changed without prior approval from the FDA. And the healthcare giant maintained the failure-to-warn claim was preempted by last year’s ruling on generic drugs. J&J also offered an alternative – the court should rule that federal law preempts state law failure-to-warn claims for drugs marketed with an OTC monograph.
For their part, the Hutto family argued that Congress has expressly preserved state product liability claims involving OTC drugs from preemption; OTC drugmakers may add warnings to their labels without prior FDA approval, unless such warnings are prohibited by an applicable final monograph; at the time of their daughter’s overdose, there was no final monograph for acetaminophen; and there was no evidence that the FDA would have prohibited the warnings that the family claimed should have been provided.
Tylenol Liver Damage Information
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