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Judge Stengel Establishes Deadlines in Tylenol MDL

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In April 2013, the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued an order centralizing all Tylenol personal injury lawsuits into one court in the Eastern District of Pennsylvania. The panel noted that they chose this location because McNeil Consumer Healthcare, the division of McNeil-PPC, Inc.—alleged to be primarily responsible for the design, manufacturer, and distribution of Tylenol—is headquartered in that district. Judge Lawrence F. Stengel was chosen to oversee the proceedings.

Now, in a recent case management order, Judge Stengel established some deadlines, including the date by when the parties must select those cases to be considered for bellwether trials.

Acetaminophen and Risk of Liver Injury

In January 2011, the FDA published a safety communication alerting the public and healthcare professionals of the potential danger of a Tylenol (acetaminophen) overdose. It asked drug makers to limit the strength of the drug in prescription products to 325 mg per tablet to make them safer for patients. A boxed warning highlighting the potential for severe liver injury was added as well.

Because of cases of liver injury, Johnson & Johnson and other manufacturers have also reduced the maximum recommended daily dose of Tylenol in over-the-counter products from 4,000 milligrams to 3,000 mg in a 24-hour period.

Currently, about 100 lawsuits have been filed against the manufacturer at the federal level, and are now part of the MDL in the Eastern District of Pennsylvania. Plaintiffs allege that the company failed to provide adequate warnings about the risk of liver damage, and should have done more to protect the public.

Upcoming Deadlines in the Tylenol MDL

In the October 2013 case management order, Judge Stengel outlined the selection process for bellwether trials, to be chosen in 2014. He set the following deadlines:

  • April 1, 2014: The parties shall each designate three cases, for a total of six, to be put into the eligible trial pool, from which the bellwether trials will be chosen. The judge emphasized that trials involving over-the-counter Tylenol products must be included.
  • May 1, 2014: Once the six cases are selected, the parties may engage in core case-specific discovery in those cases.
  • August 1, 2014: All case-specific discovery shall be completed.
  • September 1, 2014: Each party shall present to the court its suggestion for one designated case from the eligible trial pool as the candidate for the first bellwether trial. The court will then select the first bellwether case within 15 days of its receipt of the parties’ reasons as to which case should be the first to be tried.
  • October 1, 2014: Alternative proposals will be submitted to the court, if the parties are unable to agree on a pretrial schedule for the first bellwether trial.
  • Second bellwether trial: Following the first bellwether trial, the court will confer with the parties about subsequent bellwether trials.

According to the FDA, acetaminophen is “one of the most commonly used medicine in the United States,” but an overdose “can be toxic and lead to acute liver failure.”