People who took Tylenol and suffered liver damage sued Johnson & Johnson and its subsidiary, McNeil Consumer Healthcare, accusing the companies of failing to properly warn consumers of the risk for liver damage.
If your child was diagnosed with ADHD or autism spectrum disorder (ASD) after you took Tylenol while pregnant, you may be entitled to compensation.
For a few days in 1993, Antonio Benedi took the recommended dose of Extra-Strength Tylenol to ward off flu symptoms while continuing his daily ritual of drinking wine with dinner.
In less than a weeks’ time, Benedi’s liver was destroyed, and he went into a coma. A last-minute liver transplant saved his life.
In 1994, Benedi became the first person to win a lawsuit against the drug’s maker, McNeil Consumer Healthcare, over allegations that the company failed to warn that mixing alcohol with acetaminophen, the active ingredient in Tylenol, could cause liver damage.
A federal court jury awarded Benedi $8.8 million: $7.855 million in compensatory damages and $1 million in punitive damages. A federal appeals court rejected the appeal of McNeil’s parent company, Johnson & Johnson.
The company denied that its drug damaged Benedi’s liver. It said during the trial that Benedi’s liver was destroyed by a herpes infection, but federal judges said Benedi tested negative for herpes before receiving blood transfusions after his liver transplant.
Since the 1994 verdict, hundreds have filed complaints alleging that Tylenol use caused their liver damage. By June 2013, lawsuits had been filed by some 187 people across the country, including at least 14 cases filed in New Jersey, where Johnson & Johnson is headquartered, and 74 cases filed in federal court. As of April 2019, plaintiffs had filed 233 federal lawsuits, and 13 were still pending in a federal MDL.
For years, the drug’s makers have profited from the drug’s reputation as a fast-acting remedy that’s safe to administer at home without a prescription. Although Johnson & Johnson and McNeil-PPC contend that their product comes with warnings about liver damage, consumers and other critics allege the warnings are not strong enough and do not adequately reflect the full extent of the risk.
In a 2017 interview with the American Council on Science and Health, Dr. Aric Hausknecht, a New York neurologist and pain management specialist who calls Tylenol “by far the most dangerous drug ever made,” said acetaminophen-associated overdoses result in 50,000 emergency room visits every year.
And according to the National Institutes of Health, acetaminophen overdose is the nation’s leading cause of acute liver failure.
People injured by Tylenol claim McNeil and J&J:
Lawsuits filed against the companies seek damage for:
At the time of Benedi’s injury, the recommended daily dose of Extra Strength Tylenol was 4,000 milligrams. In 2011, McNeil announced that it was lowering the recommended dose to 3,000 mg per day in accordance with the FDA’s recommendations.
But two years later, an investigative piece in ProPublica accused McNeil of resisting the FDA and the FDA itself of failing to complete its decades-old review of acetaminophen, stating that roughly 150 Americans were dying every year from accidental acetaminophen poisoning.
In an article in Medical News Today Edwin Kuffner, vice president of OTC medical affairs and clinical research at McNeil Consumer Healthcare acknowledged the dangers of its drug, saying “Acetaminophen is safe when used as directed. But, when too much is taken (overdose), it can cause liver damage. … McNeil is revising its labels for products containing acetaminophen in an attempt to decrease the likelihood of accidental overdosing in those instances.”
To streamline pre-trial proceedings, the U.S. Judicial Panel on Multidistrict Litigation transferred all federal liver damage lawsuits filed against McNeil to the U.S. District Court for the Eastern District of Pennsylvania in April 2013. U.S. District Judge Lawrence F. Stengel oversaw the multidistrict litigation.
According to the April 1, 2013, transfer order, the actions “involve allegations that over-the-counter (“OTC”) acetaminophen-containing products that are marked and sold under its TYLENOL® brand-name caused liver damage, including liver failure, even when taken as directed.”
The panel noted that “centralization will eliminate duplicate discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel and the judiciary.”
Thirteen actions were pending in the MDL as of April 2019.
Judge Stengel selected the case of Rana Terry v. McNeil-PPC, Inc., et al. as the first bellwether case, or test case, to proceed to trial.
Rana Terry filed the lawsuit in 2012, claiming Tylenol caused the death of her sister, Denice Hayes, in 2010. Hayes had acute liver failure and died at age 51 after taking two different formulas of the drug “at appropriate times and in appropriate amounts,” according to the lawsuit.
The Lawsuit Claims:
The trial was initially set for October 26, 2015. It was put on hold following several days of settlement talks.
Pretrial battles ended in Terry’s favor. In February 2017, McNeil agreed to pay a confidential amount to settle more than 200 liver injury lawsuits under the MDL.
McNeil and the Plaintiffs’ Steering Committee (PSC) of the MDL signed a master settlement agreement on Feb. 10 that reportedly created a global private settlement program to resolve claims, both filed and unfiled.
In October 2015, a liver damage case went to trial and resulted in a win for Johnson & Johnson. A New Jersey jury decided that Regina Jackson, 55, couldn’t prove that she had actually taken Extra Strength Tylenol before she spent a week in the hospital.
Jackson argued that she had inadvertently overdosed on the pain medication, resulting in her hospitalization. Her lawsuit claimed Johnson & Johnson improperly designed the drug and that the recommended dosage doesn’t provide enough of a safety margin to protect users from overdose. The jury didn’t rule on the merits of Jackson’s claim of defective design, only that she couldn’t prove she took the drug.
During Jackson’s trial, it was revealed that McNeil was lobbying for lawmakers to disregard the FDA’s urging to make Extra Strength Tylenol available by prescription only — a recommendation that threatened the $400 million revenue from the company’s extra strength line of medication.
People have successfully sued for injuries other than liver damage. These settlements include:
McNeil settled a lawsuit in March 2017 filed by a woman who says she developed the serious skin reaction Stevens-Johnson Syndrome (SJS) after taking Tylenol and Motrin together. The settlement came just a few hours after the jury began deliberating.
The FDA has warned about Tylenol’s link to rare, dangerous skin reactions, including SJS, and in 2013, it required manufacturers to include a warning in labels of acetaminophen drug products.
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