Tylenol Liver Damage Concerns Eroding Consumer Loyalty: Report

According to a new report by market analysts, the risk of liver damage from Tylenol is increasingly being appreciated by consumers, eroding trust in the safety of one of the best selling pain medications on the market. 

For decades Tylenol has been perceived as a safe and effective over-the-counter medication, while the active ingredient acetaminophen has been causing thousands of individuals nationwide to suffer severe and potentially life-threatening liver damage.

Due to the serious liver risks associated with acetaminophen overdoses, either from taking too much Tylenol or combining multiple pain medications that contains the same active ingredient, the FDA and health experts have been working in recent years to raise awareness among consumers.

A report published this week by the financial website The Motley Fool highlights the recent impact of these efforts, suggesting that Tylenol has the least brand loyalty by consumers of any other major over-the-counter pain reliever on the market. That means that consumers feel little need to stick with the pain killer or buy it over other available competitors.

The marketing research firm Brand Keys released a Customer Loyalty Engagement Index earlier this year, which placed brand loyalty for Tylenol behind Advil, Aleve, Bayer, Excedrin and Motrin. Aleve led the pack with the most loyal customers.

According to The Motley Fool analysis, the weakness in Tylenol brand loyalty stems from concerns in recent years over quality control issues at Johnson & Johnson, which led to massive recalls starting in 2009. The report says that consumers are also being scared away from Tylenol and all drugs containing acetaminophen as regulators continue to warn about the risks of liver damage and liver failure.

Acetaminophen Liver Damage Concerns

Tylenol has been aggressively marketed for decades, building a reputation that the drug carries little risk for consumers. However, serious questions have been raised in recent years over the warnings provided for users of the medication about the risk of liver failure or other liver damage.

Acetaminophen contained in Tylenol has been identified as a leading cause of liver injury in the United States.

The FDA has suggested that acetaminophen may be responsible for more than 50,000 emergency room visits each year, including 25,000 hospitalizations and over 450 deaths annually.

Since Tylenol was first introduced, acetaminophen has also been used in a number of different prescription and over-the-counter medications commonly used to treat a cold or other illness. Due to a lack of sufficient warnings about the risks associated with acetaminophen, many consumers have not realized the risks associated with using too much Tylenol or combining multiple medications containing acetaminophen.

In late May, the FDA issued a consumer update, warning that there is no tried and true method of determining who may experience liver damage caused by a Tylenol overdose.

“Acetaminophen when used as labeled is generally considered to be safe. But overdoses of acetaminophen are the most common cause of drug-related liver injury, whether these occur accidentally or otherwise,” Dr. Mark Avigan, an FDA medical reviewer, said in the update. “With acetaminophen overdoses, some people get a more severe reaction than others.”

In 2011, Johnson & Johnson lowered the maximum recommended dosage on Tylenol and other acetaminophen-based products from 4,000 mg per day to 3,000 mg per day, after the FDA announced the new limits on acetaminophen levels in prescription painkillers like Vicodin and Percocet. However, the drug maker continues to market Extra Strength Tylenol, containing 500 mg in each pill, providing a narrow window between the recommended dose and potentially life-threatening liver injury if more than six pills are taken within 24 hours.

Tylenol Liver Failure Lawsuits

Johnson & Johnson currently faces a number of Tylenol lawsuits filed in state and federal courts throughout the country on behalf of former users who suffered liver damage, liver failure or death.

The complaints allege that Johnson & Johnson has built the global impression that Tylenol is safe by withholding information about the potential risks associated with acetaminophen for decades. Many of the complaints suggest that the FDA would never approve Tylenol as an over-the-counter medication if it were first introduced today.

Since April 2013, the cases have been centralized before U.S. District Judge Lawrence F. Stengel in the Eastern District of Pennsylvania as part of an MDL, or multidistrict litigation, to reduce duplicative discovery in the cases, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

As part of the coordinated Tylenol litigation, a small group of cases are going through case-specific discovery to prepare them for early trial dates, known as “bellwether” cases.

Although the outcomes of these early trials are not binding in other cases, they are designed to help the parties gauge how juries may respond to certain evidence and testimony that may be introduced, promoting potential Tylenol settlement agreements that may avoid the need to schedule dozens of cases for individual trial dates.