J&J Win in First Trial Against Tylenol Skirts Defective Design Claim

By | October 19, 2015

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, according to a J&J spokesman.

Jurors in New Jersey concluded that Regina Jackson, a state employee who said she spent a week in the hospital after overdosing on Extra Strength Tylenol, failed to prove her case, according to J&J spokesman Jake Sargent. 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 verdict, which couldn’t immediately be confirmed in court records, comes as J&J fights about 220 similar lawsuits against it and its McNeil Consumer Healthcare unit in state and federal court in New Jersey and Philadelphia. The first federal trial is slated for early next year in Philadelphia, where roughly 200 cases have been consolidated. Not all of the cases involve overdoses, with some plaintiffs saying they had liver damage from taking the recommended dose.

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.

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 is safe at the recommended dose of two pills every four hours, up to a maximum dose of eight pills a day. Warnings about liver damage are already on the label, and Jackson’s liver damage was 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.

Liver Toxicity

“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.

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).

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