Johnson & Johnson Opposes MDL for Tylenol Lawsuits

Johnson & Johnson indicates that it is opposing the proposed consolidation of all federal Tylenol lawsuits, maintaining that it has appropriately warned for years about the potential risk of liver damage from acetaminophen and that any product liability cases pending against the drug maker will depend largely on the facts in individual cases. 

Johnson & Johnson currently faces at least 33 lawsuits over Tylenol in the federal court system, involving allegations that users suffered severe liver damage or liver failure from acetaminophen contained in the popular pain killer.

On January 17, a group of plaintiffs filed a motion to centralize the Tylenol litigation as part of an MDL, or multidistrict litigation, which would transfer cases pending in U.S. District Courts throughout the country to one judge for coordinated handling during pretrial proceedings in a manner similar to how a Tylenol class action lawsuit would be managed.

Plaintiffs have maintained that consolidation is appropriate, as all of the complaints involve common allegations, suggesting that Johnson & Johnson, and its subsidiary, McNeil Healthcare, failed to adequately warn doctors and the medical community about the risk of liver damage from Tylenol.

In a response (PDF) filed on February 8, Johnson & Johnson indicates that it opposes the formation of a Tylenol MDL and suggests that the process is not warranted or justified.

The drug maker indicates that the Tylenol warning label has provided information about the potential risk of liver damage caused by acetaminophen overdose since at least 2005, and argues that consolidating the Tylenol lawsuits is inappropriate because the cases will center on the individual facts of each case, such as whether the plaintiffs took Tylenol, how much they took, and whether they had other problems that could have caused liver failure.

Lawsuits Allege Tylenol Warnings Were Adequate

According to many of the complaints, Plaintiffs allege that Johnson & Johnson provided misleading and inaccurate warnings about the risk of liver damage from Tylenol. In addition, many plaintiffs contend that they overdosed on Tylenol and suffered liver damage or liver failure after using the recommended daily dose of the medication.

In July 2011, Johnson & Johnson’s McNeil subsidiary announced that it was lowering the maximum recommended dosage on Tylenol and other acetaminophen-based products from 4,000 mg per day to 3,000 mg per day. The decision came after the FDA announced new limits on acetaminophen levels in prescription painkillers like Vicodin and Percocet. However, over-the-counter painkillers and drugs with acetaminophen went unaffected.

A number of studies have shown links between Tylenol and liver failure.

In 1986, acetaminophen was found to be amplified in people with depleted levels of an enzyme known as glutathione, increasing the risk of liver failure. Then, in 1993, studies indicated that acetaminophen liver failure risk was dose dependent and could also be increased by fasting. This was followed by a 1994 label warning indicating that alcohol use also increased the risks of liver failure.

The FDA has indicated that acetaminophen overdose is a leading cause of liver failure in the U.S., resulting in more than 50,000 emergency room visits, 25,000 hospitalizations and over 450 deaths annually.  In a 2002 FDA advisory committee meeting, experts found that there were between 1,000 and 2,000 acetaminophen-induced liver failures each year.

Consolidation of Tylenol Litigation

The original motion to consolidate the Tylenol litigation asked that the U.S. Judicia Panel on Multidistrict Litigation (JPML) centralize the cases in the U.S. District Court for the Eastern District Pennsylvania, which is where most of the currently filed cases are already pending. However, there are also a number of cases pending before different judges in other districts, and it is expected that the size of the litigation will continue to increase as Tylenol injury lawyers continue to evaluate and file new cases for individuals who experienced liver problems after using acetaminophen.

A number of responses have been filed by other plaintiffs in the litigation supporting the centralization of the cases to reduce duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

At least one plaintiff, Tommie Jean Coleman, has filed a response opposing the formation of a Tylenol MDL (PDF). Coleman filed her complaint in the U.S. District Court for the Southern District of Mississippi following the death of her husband, Robert Coleman, who died from liver and kidney damage after using Tylenol after knee surgery in 2009. The response indicates that it would be unduly expensive for Coleman to travel to Pennsylvania and to transport witnesses there as well, asking that the U.S. JPML deny the motion or exclude her case from any MDL that is established.

In another response filed by Novartis Consumer Healthcare (PDF), who is a co-defendant in at least one of the cases involving a plaintiff who took Theraflu together with Tylenol and other drugs, the drug maker has also filed asked that the Tylenol MDL request be denied or that their case be excluded.

It is expected that oral arguments on the motion will be considered during the next hearing session for the U.S. JPML, which is scheduled in San Diego on March 21, 2013.