Tylenol Liver Damage Warnings Decades Overdue: ProPublica Report

Years of inaction on the risk of liver damage from Tylenol may have led to hundreds of deaths and thousands of injuries, according to a new report by an independent, non-profit journalism group.  

ProPublica and This American Life have published an investigative report on the health risks associated with Tylenol and its active ingredient, acetaminophen, revealing how the Johnson & Johnson’s McNeil Healthcare division worked for decades to avoid warnings or other safety measures that could have protected users from the risk of liver injury.

The report outlines how the FDA dragged its feet for decades on the risks of acetaminophen overdose and how McNeil Healthcare, a subsidiary of Johnson & Johnson, sometimes dodged safety warnings and at other times was ahead of the FDA in warning about Tylenol side effects.

The report highlights Tylenol liver damage concerns and echos many of the allegations raised in recent product liability lawsuits, which indicate that the drug maker failed to provide adequate information about the potential side effects of acetaminophen and that millions of users nationwide do not realize that they are walking a virtual tightrope between the drug’s effectiveness and an acetaminophen overdose that could destroy their liver in just a few doses.

About 150 American die every year due to acetaminophen overdose, resulting in about 1,567 deaths between 2001 and 2010. However, the drug generated more than $1.5 billion in worldwide sales a year in 2010 and 2011, with the manufacturer regularly spending more than $100 million on advertising that promotes Tylenol as the drug hospitals and doctors trust most, implying that the drug is safe.

Tylenol and acetaminophen have been identified as the leading cause of liver failure in the country, spurring federal regulators to come up with plans in recent years to raise awareness about the risk of liver damage and to make Tylenol and other medications containing acetaminophen safer. However, the ProPublica report reveals that information about the acetaminophen liver damage risks has been known to the FDA for more than 30 years, with an expert panel in 1977 determining that there needs to be a “severe liver damage” warning label on Tylenol. However, amid opposition from Johnson & Johnson’s McNeil division, the language was not added to the medication for more than three decades.

McNeil Has Opposed Many Tylenol Warnings

Tylenol advertising efforts market the medication as trustworthy, which is one of the few reasons it has survived against 40 years of competition from generic equivalents that are widely available.

Due to the potential risk that liver failure warnings would damage the brand reputation, McNeil has repeatedly opposed safety warnings, restrictions and other measures that would have increased safety. According to ProPublica, the company has even opposed informational campaigns designed to warn people of the risks of acetaminophen liver damage. However, in cases where the company recognized that label warnings or new safety precautions were inevitable, it often beat out the FDA, implementing them voluntarily before they could be required by the federal regulators.

This report comes just a couple weeks after Johnson & Johnson agreed to put a new “red cap warning” on Extra Strength Tylenol that will warn users that it contains acetaminophen and to read the label directions and warnings.

In addition to Tylenol, the medication is found in more than 600 other products, including NyQuil, Excedrin, Sudafed and other common cold medications.

Due to the widespread use of acetaminophen, federal health officials have been focusing in recent years on raising awareness about the risk of overdosing on acetaminophen, including the risk of taking multiple medications that contain the pain killer.

While Johnson & Johnson did agree to revise the recommended daily dose of Tylenol in 2011, reducing it from 4,000 mg per day to 3,000 mg, the drug maker has faced substantial criticism for continuing to sell Extra Strength Tylenol, which contains 500 mg in each tablet and poses a serious risk of liver failure if consumers take more than two tablets every six hours.

Some estimates have suggested that nearly a quarter of users take more than the recommended dose, which could result in small, accidental Tylenol overdoses that may go untreated, increasing the risk of liver failure or death.

Tylenol Liver Injury Lawsuits

Johnson & Johnson currently faces a growing number of Tylenol liver injury lawsuits filed in courts throughout the United States on behalf of users who claim that Johnson & Johnson failed to adequately warn the public about Tylenol liver risks for years.

Earlier this year, the Tylenol litigation in the federal court system was centralized before one judge as part of an MDL, or Multidistrict Litigation. There are currently at least 80 lawsuits pending nationwide, and as Tylenol injury lawyers continue to review cases for individuals who suffered liver damage or liver failure, it is ultimately expected that hundreds, if not thousands of complaints will be filed.