The Timeline of the Tylenol® Lawsuit

Early Research and Marketing of Acetaminophen and Tylenol®

McNeil Laboratories began studying and researching acetaminophen in 1949 as an alternative to aspirin. McNeil discovered acetaminophen was not associated with some of the dangerous side effects of aspirin, including stomach irritation, gastrointestinal bleeding, and reduced blood clotting. The drug was approved by the FDA in 1951 and McNeil began marketing Tylenol® for children in 1955. At the time, it was available by prescription only. In response to the great success McNeil had seen with the medication, the manufacturer began developing new formulations of Tylenol®. Johnson & Johnson acquired McNeil in 1959. Several popular children’s formulations were launched in the years that followed, before Johnson & Johnson developed a formulation for adults in 1961.

New Strengths and Dosages of Tylenol®

The first Tylenol® formulation for adults was a 325-milligram tablet. By 1975, Johnson & Johnson launched Extra Strength Tylenol®, which contained 500 milligrams of acetaminophen per tablet. The original recommended maximum daily dose was 4,000 milligrams. However, the directions on the packaging instructed consumers to take two tablets, four to six times a day, resulting in a potential intake of 6,000 milligrams of acetaminophen.

In addition to the dosages of the various Tylenol® options, acetaminophen is also in countless other over-the-counter and prescription medications. Acetaminophen is also commonly used in cold and flu medications, such as DayQuil® and NyQuil®. The drug can also be found in prescription pain medications, including Vicodin® and Percocet®. Consumers who do not pay careful attention to the amount of acetaminophen in each medication they are taking can easily exceed the recommended daily dosage. Accidentally overdosing on Tylenol® can cause liver toxicity, acute liver failure, and even death.

FDA Warnings and Requirements

A United States Food and Drug Administration (FDA) Advisory Committee was formed to review the dangers of Tylenol®. Testimony at a hearing in 1977 revealed several cases of fatal acetaminophen overdoses occurred in 1966. The committee made the recommendation that all Tylenol® products include a clear warning about exceeding the maximum daily dosages and the risk of liver damage. This recommendation was ignored until 1994, when Johnson & Johnson was sued by a patient who needed a liver transplant after taking Tylenol® and consuming alcohol.

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The FDA issued new guidelines in 2009 that required additional warnings regarding the risk of overdose to all products containing acetaminophen. The guidelines require the use of specific language stating the risk of severe liver damage if the consumer exceeds the recommended maximum dosage of 4,000 milligrams, including when taken with other products containing acetaminophen. Warnings about consuming three or more alcoholic beverages while taking acetaminophen were also included in these guidelines.

Just two years later, in 2011, the FDA requested that all manufacturers of acetaminophen or acetaminophen-containing products limit their medications to 325 milligrams per tablet, capsule, or overall dose. The FDA also required the addition of a “Black Box” warning to prescription medications containing acetaminophen to warn of the increased risks of liver damage.  

Despite the FDA’s 4,000-milligram dosage recommendations, Johnson & Johnson voluntarily reduced the maximum daily dosage to 3,000 milligrams in 2011. In 2013, Johnson & Johnson added another voluntary warning to the packaging, stating “Contains Acetaminophen” and “Always Read the Label” on Tylenol® bottle caps.

Tylenol® Recalls

Over the span of just three years, Tylenol® was recalled several times. The first recall of Tylenol® was in 2009, after it was discovered that a wood-treating chemical had contaminated the medication. This chemical caused nausea, vomiting, and diarrhea for those who took the contaminated pills. By 2011, this recall was expanded to include additional lots of medication that were suspected to have been contaminated. This recall alone resulted in huge losses for Johnson & Johnson, pulling tens of thousands of Tylenol® products off the market and forcing the closure of one of their manufacturing plants. The FDA even had to intervene, taking over the supervision of three of Johnson & Johnson’s manufacturing plants.

Another recall occurred in 2012, pulling over 600,000 bottles of infant Tylenol® off the shelves. It was discovered that the dosages were off, which could result in an infant receiving too much or too little of the medication.

Tylenol® Lawsuits

Since the initial lawsuit in 1994, countless claims have been filed against Johnson & Johnson. A 2007 lawsuit resulted in a $5 million verdict for the parents of a one-year-old who died from liver failure after consuming infant Tylenol®. Another lawsuit in 2012 was filed by a woman who took Tylenol® as directed for several days but still suffered from acetaminophen poisoning and liver failure.

Many Tylenol® lawsuits have been consolidated into multidistrict litigation (MDL). An MDL collects a group of similar cases against a single defendant for review by one judge to create more efficient pretrial processing and conserve the resources of everyone involved. Although similar to a class action, an MDL allows each plaintiff to receive an individual verdict or settlement based on their individual case. Many of the lawsuits against Tylenol® and Johnson & Johnson allege different types of wrongdoing, including:

• The drug is dangerous and defective
• Risk of acetaminophen-related liver failure was known by Johnson & Johnson
• The drug lacked clear and concise warnings regarding the increased risks of dangerous side effects
• Health care providers were not properly trained in the use of Tylenol®
• Johnson & Johnson falsely marketed Tylenol® as safe and effective
• Johnson & Johnson failed to perform adequate testing on the drug

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The claims against Tylenol® and Johnson & Johnson are ongoing. If you or a loved one has suffered an overdose, liver toxicity, or acute liver failure after taking Tylenol®, please contact an experienced pharmaceutical attorney for a complimentary case evaluation.