J&J Defeats First Lawsuit on Tylenol's Link to Liver Damageby
Ruling comes in first case to go to trial over claims
J&J faces about 220 similar suits in New Jersey, Philadelphia
Johnson & Johnson defeated a lawsuit claiming it had improperly designed its Tylenol pain reliever, in the first case to go to trial over the link between the widely used over-the-counter drug and liver damage.
Jurors in New Jersey concluded that Regina Jackson, 55, who said she spent a week in the hospital after inadvertently overdosing on the pain medication, failed to prove her case. The jury ruled she couldn’t prove she had actually taken Extra Strength Tylenol, and didn’t rule on the merits of her claim the pain medication was defectively designed.
The alleged defect is that the recommended dosage doesn’t provide enough of a safety margin to protect users from overdose.
The verdict gives hopes to plaintiffs pursuing about 220 lawsuits against J&J and its McNeil Consumer Healthcare unit in state and federal court in New Jersey and Pennsylvania.
“The important health issue that the Food & Drug Administration and the medical community has put on the table about Tylenol was not answered by this jury verdict,” said Clay Milling, a lawyer for Jackson. He said he intends to make the argument again in other suits pending against J&J.
The first federal trial is slated for early next year in Philadelphia, where about 200 of the cases have been consolidated. Not all of the cases involve overdoses, as some plaintiffs claim they got liver damage from taking the recommended dose.
“We are committed to providing consumers with safe, effective and high-quality products and recommend consumers always read and follow the product label,” said McNeil spokeswoman Jodie Wertheim. She said the jury’s verdict “reflects the facts” of the case.
The lawsuits aren’t expected to have a significant financial impact on J&J, said Damien Conover, an analyst at Morningstar Inc. While the pain medication is one of the company’s signature brands, “in the totality of the overall business, Tylenol is relatively small because J&J is such a large diversified company," he said.
Extra Strength Tylenol generates about $400 million in revenue a year for New Brunswick, New Jersey-based J&J, with the regular strength version adding another $14 million, according to the plaintiff’s court papers. J&J declined to confirm the number.
Lawyers for Jackson argued during the trial that J&J touted Tylenol’s safety even though it knew for decades that the painkiller could harm users who inadvertently exceeded the daily recommended dose.
J&J countered that the medicine was safe at the recommended dose at the time of two pills every four hours, up to a maximum dose of eight pills a day. The recommended dosage has since changed. Warnings about liver damage are already on the label, and Jackson’s problems were caused by an overdose, the drug maker’s lawyers said during the trial.
Jackson’s lawyers argued that the recommended dosage should be two pills three times a day, which would make people less likely to overdose.
The lawsuits come amid longstanding concerns about links between acetaminophen, the main ingredient in Tylenol, and liver damage. The American Liver Foundation warned in 2006 that at the maximum recommended dose for two weeks, healthy adults could have increased liver enzymes which could lead to liver damage, according to a past press release from the organization, which aims to cure liver disease.
"I do think if liver toxicity issues were more significant, that could hurt the drug’s sales but Tylenol has been around for so long and it’s been proven to be pretty safe,” Conover said.
Tylenol has more than 50 years of use and over 150 studies to support its safety and efficacy, Wertheim said.
The FDA is still evaluating a 2009 recommendation by one of its advisory committees that drugmakers lower the maximum recommended daily dose of acetaminophen because of the potential for liver damage.
In early 2014, J&J launched getreliefresponsibly.com, saying it wanted to make sure people don’t take more than the maximum daily dose of acetaminophen by combining drugs.
"Acetaminophen is safe when used as directed, but taking too much of it can harm your liver," Edwin Kuffner, vice president of medical affairs at McNeil at the time, said in a 2014 press release.
The case is Jackson v. McNeil Consumer Healthcare, ATL-L-880-13, Superior Court of New Jersey (Atlantic County). The multi-district case in Pennsylvania is In re Tylenol (Acetaminophen) Marketing, Sales Practices and Product Liability Litigation; 13-md-02436, U.S. District Court, Eastern District of Pennsylvania (Philadelphia).