A federal jury in Virginia on Thursday awarded $8.9 million to a former White House aide who said his liver was destroyed by taking the pain-reliever Tylenol in combination with his regular consumption of wine with dinner.
In his suit, Antonio Benedi, of Springfield, Va., who was appointments and scheduling secretary to President George Bush, said he took Tylenol for the flu in February 1993, but was otherwise in good health.After several days of taking Tylenol in the usual, recommended doses for flu, he said he fell into a coma and was taken to Fairfax Hospital in Virginia suffering from liver failure. He received a liver transplant several days later.
Although the case is unusual, it has been known for some time among doctors that drinking alcohol regularly and taking Tylenol, the brand name of the relieving drug acetaminophenin, can cause liver damage.
Jeff Leebau, assistant director of corporate communications for Johnson & Johnson, the parent company to McNeil Consumer Products, which makes Tylenol, said that the company planned to appeal the verdict.
"We believe the injuries sustained by the plaintiff were caused by a pre-existing viral infection and not by Tylenol," Leebau said.
Lawyers for Benedi said on Thursday that they found evidence in company records that 16 deaths and an unknown number of serious liver injuries have been caused by acetaminophen in combination with alcohol. Leebau said that he did not know if that figure was correct, but that the reaction between alcohol and acetaminophen is "very, very rare."
About 55 million people in the United States take Tylenol, the country's most popular pain reliever, each year, for a total of about 7 billion doses, Leebau said.
In June 1993, an advisory committee to the Food and Drug Administration had recommended that the agency require a warning on painkillers containing acetaminophen saying that heavy drinking while taking the drug could cause serious liver damage. At that time, the company fought the warning, saying it would unecessarily alarm consumers.
The FDA has not yet issued any such warning.
Testimony at that hearing also was presented by independent liver experts who said that anyone who takes two or three drinks or more a day should not take more than two grams of acetaminophen in a day - half the recommended maximum on the label - because even though the reaction with alcohol is rare, it can be fatal.
Leebau said: "Liver damage is not caused by taking regular amounts of Tylenol and regular amounts of alcohol. We have only seen this kind of damage when there is extensive drug and alcohol abuse at the same time - overdoses of Tylenol and chronic alcoholism."
But he said the company was not saying Benedi abused either alcohol or Tylenol.