Tylenol (acetaminophen) is an over-the-counter (OTC) painkiller and fever reducer that has generated tens of billions of dollars for McNeil Consumer Healthcare and parent company Johnson & Johnson (J&J) over the past 60 years. Approved by the U.S. Food and Drug Administration (FDA) in 1955, it is consistently one of the bestselling painkillers in North America, at times accounting for over a third of the market.
Unfortunately, Tylenol also accounts for hundreds of deaths every year. It has been linked to acute liver failure, especially when taken in excess (usually a combination of prescription medication) or by patients who are malnourished or fasting.
Because the FDA and J&J took several decades to even acknowledge these risks, let alone warn consumers about them, hundreds of plaintiffs have filed lawsuits against the drug maker. Lawsuits allege that Johnson & Johnson knew about the risk of acute liver failure due to toxicity and/or overdose, but failed to warn the public promptly and adequately.
A Brief History of Tylenol
In 1955, the FDA approved acetaminophen as a painkiller and fever reducer. McNeil Laboratories initially billed Tylenol as Tylenol Elixir for Children.
In 1959, Johnson & Johnson purchased McNeil Laboratories (now McNeil Consumer Healthcare), a Pennsylvania-based company that manufactures Tylenol products.
In 1960, Tylenol became an over-the-counter medication. Over the next 50 years, it would become one of the bestselling and most recognizable pain medications in the world.
In 1966, the first documented case of acetaminophen-related liver failure occurred.
In the fall of 1982, when someone in the Chicago area laced several bottles of Extra Strength Tylenol with cyanide. Seven people died, and Johnson & Johnson recalled all of the Tylenol on American shelves. The crisis cost J&J $100 million, and the killer was never found.
In the late 1990s, scientists finally began to establish the link between Tylenol and acute liver failure (ALF). But the public remained largely in the dark. By 2003, Tylenol products accounted for 35% of the painkiller sales in North America.
In 2009, the FDA added a warning to Tylenol products about the risk of acetaminophen overdose. (Many people taking prescription drugs do not realize that their medications also contain acetaminophen.)
From 2009 to 2010, Johnson & Johnson carried out four major recalls due to product contamination and other manufacturing issues. The largest of these recalls was the 2010 recall of 43 children’s medicines, which the company said had become contaminated. In the wake of these recalls, The House Committee on Oversight and Government Reform launched an investigation into J&J’s production practices.
In January 2011 – more than 50 years after the drug’s initial approval – the FDA finally confirmed the link between acetaminophen and severe liver damage. In doing so, the agency also asked manufacturers to limit the amount of acetaminophen in prescription drugs to 325mg.
In 2013, “This American Life” (along with ProPublica) reported that 150 Americans die every year from acetaminophen poisoning (see below: “Tylenol and Liver Failure”).
In May 2016, the Ottawa Citizen reported that Health Canada was considering significantly reducing the maximum recommended dosage of acetaminophen due to concerns over liver damage and overdoses.
Tylenol and Liver Failure
One of the main functions of the liver is to purify and clear waste products, toxins, and drugs. When someone takes Tylenol, the liver metabolizes the drug and breaks it down into other chemicals.
Unfortunately, some of the drug will be metabolized into a harmful toxin known as NAPQI. If the patient’s body is producing an adequate amount of glutathione, the liver will quickly break down NAPQI into a non-toxic chemical. But for some patients, an excessive amount of this toxic byproduct may accumulate, resulting in liver failure.
Countless studies have demonstrated this link between Tylenol and liver failure. A 2004 study by Hepatology found:
Acetaminophen overdose is the leading cause for calls to Poison Control Centers (>100,000/year) and accounts for more than 56,000 emergency room visits, 2,600 hospitalizations, and an estimated 458 deaths due to acute liver failure each year. Data from the U.S. Acute Liver Failure Study Group registry of more than 700 patients with acute liver failure across the United States implicates acetaminophen poisoning in nearly 50% of all acute liver failure in this country.
In 2013, “This American Life” teamed with ProPublica to investigate and illuminate the acetaminophen crisis in America. The story’s introduction states:
One of the country’s most popular over-the-counter painkillers – acetaminophen, the active ingredient in Tylenol – also kills the most people, according to data from the federal government. Over 150 Americans die each year on average after accidentally taking too much. And it requires a lot less to endanger you than you may know.
Finally, in January 2016, the American Gastroenterological Association (AGA) released some disturbing findings from a study of 1,015 American consumers (479 of them with chronic pain) and 251 gastroenterologists. The AGA determined that 43% of individuals with chronic pain intentionally exceeded the recommended daily dosage of OTC pain medications, while 38% were “unaware that combining multiple acetaminophen products increases their risk for complications.”
Patients at Greater Risk
Patients who are malnourished, fasting, or restricting their caloric intake to less than 500 calories per day may be at the greatest risk of acetaminophen-related liver failure, as they may have more difficulty processing the drug than healthy Tylenol users.
Additionally, patients taking prescription drugs containing acetaminophen—in combination with OTC acetaminophen products such as Tylenol—put themselves at risk for an overdose, and potentially acetaminophen-related liver failure.
FDA Warnings About Liver Disease
Many people taking prescription drugs do not even realize that their medications also contain acetaminophen.
To remedy this problem, in 2011 the FDA required that all prescription medications containing acetaminophen update their labels to contain boxed warnings highlighting the risk of liver injury. The agency also imposed a 325mg limit on the amount of acetaminophen prescription drugs may contain per dose, to minimize the risk of liver damage in patients taking these medications.
But many consider these actions to be too little, too late. The FDA approved acetaminophen in 1955; it became an over-the-counter drug a year later. For over 50 years, then, Tylenol did not have these boxed warnings or the 325mg maximum dosage in prescription medications.
This 50-year failure to warn consumers has spawned hundreds of lawsuits.
Roughly 220 plaintiffs have filed lawsuits against J&J, alleging that use of over-the-counter Tylenol products can cause serious liver damage, including liver failure, even when taken as directed.
In April 2013, for logistical reasons the bulk of these lawsuits were consolidated into a multi-district litigation (MDL).
In October 2015, a New Jersey jury ruled against plaintiff Regina Jackson, 55, but only because Ms. Jackson couldn’t prove that she had taken Extra Strength Tylenol. Bloomberg noted, “The verdict gives hope to plaintiffs pursuing about 220 lawsuits against J&J and its McNeil Consumer Healthcare unit in state and federal court in New Jersey and Pennsylvania.”
Ms. Jackson’s attorney, Clay Milling, told Bloomberg, “The important health issue that the Food & Drug Administration and the medical community has put on the table about Tylenol was not answered by this jury verdict.”
For more information on the types of lawsuits people have filed over Tylenol, and the damages for which they seek compensation, please see our Tylenol Lawsuit page.
If you or a loved one suffered liver failure after using a Tylenol product, there is still time to join this growing litigation. Contact us for a free, no-obligation case review.