Johnson & Johnson won a Tylenol trial in New Jersey state court last week. A jury in Atlantic City cleared J&J subsidiary McNeil Consumer Healthcare of liability, voting that the plaintiff failed to prove she took extra strength Tylenol prior to her illness. Courtroom View Network (CVN) reported that the 10-person jury returned the verdict following a trial that began Sept. 22. The jury rejected 55-year-old plaintiff Regina Jackson’s claims the companies are responsible for her liver damage after she accidentally took Extra Strength Tylenol for longer than the recommended dosage period.
Ms. Jackson’s was the first of hundreds of Tylenol lawsuits to go to trial. The suits allege J&J and McNeil failed to adequately disclose the risks of liver damage from taking Extra Strength Tylenol.
200 Tylenol Lawsuits
Some 200 similar Tylenol suits are pending in state and federal courts. Most are centralized in multidistrict litigation in Pennsylvania being overseen by U.S. District Judge Lawrence F. Stengel. According to court records, a bellwether trial in the MDL, in which plaintiffs plan to pursue unlimited punitive damages, is scheduled for Oct. 26, 2015.
Ms. Jackson’s attorneys argued that the current recommended dose of Extra Strength Tylenol is eight pills per day, but studies have shown as few as two pills per day for longer periods can cause liver damage. Attorneys argued McNeil knew of this risk for years. They said more stringent warnings would prevent consumers like Ms. Jackson from taking too much.
J&J, McNeil: Tylenol is Safe
McNeil attorneys argued that Extra Strength Tylenol is safe. They argued that Ms. Jackson failed to prove she actually took Tylenol. They also suggested that she also took cold medicine and Aleve, another over the counter painkiller, prior to being hospitalized with elevated liver enzymes in 2011.
J&J spokeswoman Jodie Wertheim emailed CVN a statement: “Tylenol has more than 50 years of use and over 150 studies to support its safety and efficacy, and, when used as directed, it has one of the most favorable safety profiles among over-the-counter pain relievers.”
Tylenol Leading cause of Liver Failure
The trial laid bare McNeil and J&J’s fight against increased FDA regulation of acetaminophen, the main ingredient in Tylenol. Studies show Tylenol to be the leading cause of acute liver failure in the United States, but FDA has not issued regulations for the safe use of it since Tylenol hearings began 38 years ago.
Tylenol Profits $400 Million per Year
The FDA in 2009 began to consider a reduction in the daily recommended dose of acetaminophen, and also to require a prescription for extra strength versions. Tylenol is an over-the-counter (OTC) medication. Ms. Jackson’s attorneys claim McNeil resisted these measures, which would have significantly reduced the company’s profits. Tylenol sales generate more than $400 million per year, Ms. Jackson’s attorneys said.
Ms. Jackson’s attorney told CVN that the jury determined only that Ms. Jackson didn’t prove she took Extra Strength Tylenol. The verdict doesn’t tackle the issue of what McNeil knew about the alleged risks. The attorney said he is considering an appeal.
Ten Years of resisting FDA Pleas
“For over a decade the FDA and the medical community have been urging McNeil to take action to reduce the deaths, transplants and hospitalizations every year from this drug,” Ms. Jackson’s attorney said.
The case is Regina Jackson v. McNeil Consumer Healthcare, et al., case number ATL-L-880-13, in the Superior Court of New Jersey in Atlantic County.
• Tylenol Trial won by J&J