October 21, 2015
A jury in Atlantic City has handed Johnson & Johnson a victory in a lawsuit alleging that Tylenol, the popular pain reliever, was defectively designed.
On Friday, the jury decided the plaintiff, Regina Jackson, hadn't proven she took Extra Strength Tylenol. She had claimed that an overdose of the drug landed her in the hospital.
That meant the jury didn't address Jackson's other claims, including whether the margin of safety between a safe dose of Tylenol and a potentially harmful dose is adequate.
Jodie Wertheim, a spokeswoman for McNeil Consumer Healthcare, the Johnson & Johnson unit that makes Tylenol, said in a statement that the "jury's verdict reflects the facts in the case." She added that Tylenol has a long history of studies backing its "safety and efficacy, and, when used as directed, it has one of the most favorable safety profiles" among over-the-counter pain relievers.
Lawyers for the plaintiff did not immediately respond to a request for comment. But one of them, R. Clay Milling, told Bloomberg that the underlying question about Tylenol's safety margin, while not addressed by the jury in New Jersey, will be argued again in other pending Tylenol cases.
A federal judge in Philadelphia is overseeing some 200 cases claiming Tylenol is connected to deaths or serious liver injuries. McNeil is contesting all of the cases; the first is scheduled to go to trial next year. Tylenol's potential toxicity has been an issue in previous trials. McNeil has won the majority of those cases.
In 2011 McNeil lowered the maximum daily recommended dose for Extra Strength Tylenol from 4 grams, or eight pills, to 3 grams, after an FDA panel recommended the change.
As reported in 2013 by ProPublica and This America Life, McNeil has previously opposed warning labels, dosage restrictions and even public awareness campaigns over concerns about profitability.
The investigation also found that the Food and Drug Administration has delayed implementing suggestions to improve the safety of acetaminophen, the active ingredient in Tylenol. The ingredient is found in hundreds of over-the-counter products and is used by tens of millions of American every week.
The 3 1/2 week trial put into the public record new documents showing McNeil was aware that many doctors who told their patients to take Tylenol were recommending that they take less than the maximum dose described on the label.
The jury did not see other documents, including plans by McNeil and Johnson & Johnson to block potential new safety restrictions on acetaminophen by the FDA.
It is not clear what evidence would be heard by a federal jury in Philadelphia if one of the Tylenol cases goes to trial.
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