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Shezad Malik MD JD
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Tylenol Liver Damage Injury Lawsuits Heading to MDL

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Tylenol (acetaminophen) liver damage and liver transplant injury cases begin to heat up. Johnson & Johnson, Tylenol's manufacturer opposes the consolidation of all federal Tylenol lawsuits. Johnson & Johnson argues that they have provided proper label warnings about the risk of liver damage from acetaminophen.

Johnson & Johnson faces at least 33 Tylenol liver injury lawsuits involving claims that users suffered severe liver damage or liver failure from acetaminophen contained in the popular pain medication. Recently in January, plaintiffs filed a motion to centralize the Tylenol litigation as part of an MDL, or multidistrict litigation. In a MDL, there would be transfer of cases pending in U.S. District Courts to one court for coordinated handling during pretrial proceedings.

Plaintiffs claim that Johnson & Johnson, and its subsidiary, McNeil Healthcare, failed to adequately warn doctors and the doctors about the risk of liver damage from Tylenol. According to Johnson & Johnson, the Tylenol warning label is adequate about the potential risk of liver damage caused by acetaminophen overdose since at least 2005.

Tylenol Warnings Were Inadequate

Plaintiffs allege that Johnson & Johnson provided misleading and inaccurate warnings about the risk of liver damage from Tylenol. Furthermore to compound the allegations, plaintiffs contend that they suffered liver damage or liver failure after using the recommended daily dose of the medication.

FDA Tylenol Dosage Limitations

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 FDA announced new limits on acetaminophen levels in prescription painkillers like Vicodin and Percocet. Over-the-counter painkillers and drugs with acetaminophen went unaffected.

Medical Studies: Tylenol and Liver Failure

In 1986, acetaminophen toxity was increased in patients with depleted or reduced levels of glutathione liver enzyme, leading to increasing the risk of liver failure. In 1993, it was determined that acetaminophen liver failure risk was dose dependent and could also be increased by fasting. In 1994, label warning indicating that alcohol use also increased the risks of liver failure.

According to the FDA, 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.

Benefits of Tylenol Litigation Consolidation

Centralization and consolidation of the Tylenol is beneficial to both plaintiffs and defendants, and reduces duplicative discovery, avoids conflicting rulings from different judges. 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.