Lawsuit Over Tylenol Liver Failure Risk to be Identified for Early Trial in MDL

Lawyers involved in the federal Tylenol liver failure lawsuits are scheduled to meet tomorrow with the U.S. District Judge presiding over the litigation, at which time the parties are expected to provide an update on the status of discovery in a small group of “bellwether” cases, and the time-frame for selecting one claim to go forward as the first trial.

There are currently at least 163 federal product liability lawsuits against Johnson & Johnson’ and their McNeil Healthcare subsidiary, which all involve similar allegations that the drug maker has withheld information from consumers and the medical community for decades about the risk of liver damage from Tylenol side effects.

The federal complaints are centralized before U.S. District Judge Lawrence F. Stengel in the Eastern District of Pennsylvania as part of an MDL, or multidistrict litigation, to reduce duplicative discovery into common issues in the cases, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

As part of the coordinated management of the Tylenol litigation, the parties have been preparing a group of six cases for early trial dates. Known as “bellwether” claims, the process is designed to help the parties gauge the relative strengths and weaknesses of their cases and to potentially facilitate Tylenol settlement agreements that may avoid the need for dozens of trials to be scheduled throughout the country.

According to a joint status report (PDF) submitted by the parties in advance of Thursday’s conference, case-specific discovery in the six “Eligible Trial Pool” cases is nearly complete and the parties appear to be “on schedule” to designate one candidate as the first bellwether trial by December 1, pursuant to a previous order issued by Judge Stengel.

Attorneys for Johnson & Johnson and McNeil did indicate that they may request a brief delay in nominating the bellwether cases, due to the need to complete additional depositions of doctors involved in the cases and due to potential motions that the drug makers may file in advance of the selection. The Defendants indicated that they will be prepared to discuss any such requests to revise the prior time-table during the status conference.

If Judge Stengel agrees to the delay in selecting the first trial case, it would be the second time the bellwether selection process has been pushed back. In August 2014, all Tylenol bellwether trial deadlines were pushed back 90 days due to discovery delays.

The first trial is not expected to go before a jury until at least 2016.

Tylenol Liver Failure Risks

Tylenol is one of the most widely used painkiller medications in the United States, which has been used by millions of Americans.

The medication contains acetaminophen as the active pharmaceutical ingredient, which has been identified in recent years as a leading cause for liver injury in the United States.

The FDA has indicated 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.

In recent years, efforts have been ramped up to bring the risk of acetaminophen overdose to the public’s attention and to reduce the amount of liver injury cases linked to the popular analgesic, which is also found in other pain killers and a number of cold medications.

In 2011, Johnson & Johnson lowered the maximum recommended dosage on Tylenol and other acetaminophen-based products from 4,000 mg per day to 3,000 mg per day. However, the lawsuits allege that the drug maker has withheld important safety information from the public for decades, ignoring the narrow window between the recommended dosage for Extra Strength Tylenol and the risk of liver injury.

All of the Tylenol lawsuits raise similar allegations that Johnson & Johnson built a reputation that acetaminophen was 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 the need for a liver transplant.