Study on Link Between Tylenol and Liver Failure at Recommended Dosage Allowed in MDL Trial

As parties prepare for the first bellwether trial involving allegations that side effects of Tylenol caused a user to suffer liver failure, the U.S. District Judge presiding over the litigation has determined that the plaintiff will be allowed to present findings from a crucial study that found the popular painkiller may pose serious liver risks when used at the maximum recommended daily dosage.

There are currently more than 200 Tylenol lawsuits pending throughout the federal court system, each involving similar allegations that Johnson & Johnson knew or should have known about the link between Tylenol and liver failure, yet failed to adequately warn consumers and the medical community.

Given the similar questions of law and fact raised in the claims, the federal litigation is centralized before U.S. District Judge Lawrence Stengel in the Eastern District of Pennsylvania, as part of an MDL, or multidistrict litigation.

As part of the coordinated pretrial proceedings, a bellwether trial is scheduled to begin later this year to help the parties gauge how juries may respond to certain evidence and testimony that will be presented in dozens of different trials involving claims that Tylenol caused individuals to suffer liver failure.

In a memorandum (PDF) issued last week, Judge Stengel denied a motion filed by Johnson & Johnson, which sought to block plaintiffs’ experts from relying on the findings of a 2005 study, which found that acute liver failure could occur even if a consumer stuck to the maximum daily recommended dose of 4 grams of acetaminophen, the active ingredient in Tylenol.

Johnson & Johnson argued that the Court should block plaintiffs’ experts from using the study and mentioning its findings to a jury, claiming it used flawed methodologies. However, Judge Stengel has decided to allow use of the study indicating that the drug makers can attack those methodologies during cross examination in the trial.

Judge Stengel noted that the Acute Liver Failure Study Group (ALFSG), which published the study, was a leading research organization in acetaminophen.

“Evidence from the plaintiff supports both the meticulousness of the ALFSG’s procedures and the reliability of the data,” wrote Judge Stengel in the memorandum explaining that the study’s methodology follows appropriate and reliable procedures under the requirements of the federal rules on admissibility of scientific evidence.

The first Tylenol liver failure trial is currently expected to begin in September 2016, involving a wrongful death lawsuit filed by Rana Terry, whose sister, Denice Hayes, died from acute liver failure in 2010 after using Extra Strength Tylenol.

While the outcome of this bellwether trial will not be binding on other cases, it will be closely watched by those involved in the litigation and may help facilitate potential Tylenol liver failure settlements to avoid the drug maker facing hundreds of individual jury trials.

Similar to other complaints pending in the Tylenol litigation, Terry alleges that Johnson & Johnson built a false reputation that Tylenol is a safe and effective medications by withholding important safety information about the risk of liver damage, which may have caused individuals throughout the United States to suffer severe liver failure, often resulting in death or the need for a liver transplant.

Tylenol is one of the most widely used painkiller medications in the United States, which has been used by millions of Americans. Federal health officials have previously suggested that Tylenol and other acetaminophen drugs may be responsible for more than 50,000 emergency room visits each year, including 25,000 hospitalizations and over 450 deaths annually due to liver failure.