Johnson & Johnson has successfully made Tylenol (acetaminophen) a household name. It has been a popular over-the-counter treatment for pain and fever-reduction for decades. But over the years, it’s also been associated with serious safety concerns, ranging from package tampering to bacterial contamination to inadequate labeling.
In addition to being used as an over-the-counter (OTC) treatment, acetaminophen is also used in a number of prescription drugs treatments such as Percocet and Oxycet. However, consumers taking these combination drugs don’t necessarily know that their prescriptions contain acetaminophen. Without this information, they risk acetaminophen overdose when they take Tylenol or other OTC acetaminophens in addition to their prescriptions. According to the FDA, research studies point to frequent acetaminophen overdoses.
The potential for overdose is a grave concern because acetaminophen overdose can cause severe liver damage. In fact, research has shown that acetaminophen has become a leading cause of liver damage in the United States.
In January 2011, the U.S. Food and Drug Administration (FDA) confirmed the link between Tylenol and liver damage. It directed prescription drugmakers to limit the amount of acetaminophen in their products to 325mg. It also directed them to strengthen warnings about the risk of liver damage by adding black-box warnings to their products.
However, the FDA’s action did not affect makers of OTC acetaminophen, including Tylenol. The agency’s rationale for not issuing the same directives to makers of OTC products was that labels for those products already contained warnings about liver damage. But according to the FDA, various studies have shown that consumers often take more than the recommended dose of acetaminophen when taking OTC drugs, prescription drugs, or both.
Knowledge about the extent of overdose risks suggests that makers of OTC acetaminophen products should, like prescription drugmakers, be held responsible and take appropriate safety measures. Indeed, when the FDA took its January 2011 action, it also announced it would continue evaluating ways to reduce the risk of liver injury from OTC products.
Meanwhile, many consumers continue to suffer liver injuries and even death after taking OTC acetaminophen products like Tylenol. Some filed lawsuits against Tylenol’s maker, McNeil-PPC, and its parent company, Johnson & Johnson.
Status of Tylenol Lawsuits
As of June 2013, 187 people had filed lawsuits across the country alleging Tylenol caused liver damage. This includes at least 14 cases filed in New Jersey, where Johnson & Johnson is headquartered. At least 74 cases have been filed in federal court and are now pending in the U.S. District Court for the Eastern District of Pennsylvania.
A federal judicial panel ordered the transfer of all federal cases to the Eastern District in April 2013. These cases are now collectively referred to as Multidistrict Litigation (MDL) No. 2436. Since the panel anticipates many more case filings with similar claims of Tylenol-related liver damage, these cases have been assigned to a single judge, the Honorable Lawrence F. Stengel, to streamline case processing.
Many more Tylenol cases are expected to be filed in New Jersey. In fact, an application is pending in New Jersey to transfer all cases in that state to a single county. If approved, Tylenol lawsuits filed in New Jersey would be processed under streamlined “multicounty litigation” procedures similar to the federal MDL.
How We Can Help
Finding out that you’ve sustained a life-threatening injury from a medication can be shocking. People usually associate drug dangers with prescription drugs, not with OTC drugs that are typically considered safe. So finding out that the injury resulted from an OTC drug that’s generally considered safe can be confusing.
The FDA has issued guidance advising consumers to read prescription and OTC product labels, ask their pharmacists if their medication contains acetaminophen, and follow recommended dosage instructions to avoid overdose.
Patient Advocates at Drugwatch.com are also available to provide more information on injuries associated with OTC Tylenol. If you or a loved one has been treated for liver damage after taking brand-name Tylenol, they can provide information on resources to help you cope with your injuries.
These resources include experienced drug injury attorneys who can explain your legal rights and how you may be able to obtain financial compensation. Although financial compensation cannot undo the injuries you may have suffered, it can help you pay for medical treatment and offset other financial losses such as lost income due to disability.
Why Should You File a Tylenol Lawsuit?
Acetaminophen is metabolized in the liver and broken down into small amounts of a toxin called N-acetyl-p-benzoquinoneimine (NAPQI). NAPQI is usually considered harmless because it combines with another compound in the liver known as glutathione. But if there is too much NAPQI (e.g., when the dosage is too high) or not enough glutathione (e.g., when a person hasn’t eaten enough), liver toxicity and damage can occur.
Unfortunately, this means that people who use Tylenol for common purposes may be at risk of serious side effects. According to recent studies, the people who are most at risk for Tylenol-related liver damage are those who have depression, chronic pain, or who take a combination of acetaminophen-containing products at once. These people are at risk for unintentional overdose, which can result in severe liver necrosis and acute liver failure. People who use Tylenol to treat stomach flu or hangover are at risk, too, because they may not have enough glutathione present to absorb the NAPQI.
Specifically, people who are injured by OTC Tylenol may experience acute or sudden liver failure. These conditions can lead to hospitalization, liver transplant and death. An antidote is available to reduce toxicity, but it’s most effective when administered quickly (e.g., within 8-10 hours of ingestion) and may not be well tolerated due to vomiting. Liver transplant could also be required in as little as 48 hours.
This is not the type of fast action consumers usually think of when it comes to Tylenol. For years, the drug’s makers have profited from the drug’s reputation as a fast-acting remedy that’s safe to administer at home without a prescription. Although Johnson & Johnson and McNeil-PPC contend that their product comes with warnings about liver damage, consumers and other critics allege the warnings are not strong enough and do not adequately reflect the full extent of the risk.
People Who Filed Tylenol Lawsuits
Plaintiffs who file Tylenol liver damage lawsuits include people who have experienced liver damage and loved ones or representatives of people who have died from liver failure. These plaintiffs claim that the drug’s makers failed in their duties to produce a safe product and adequately warn consumers about risks associated with Tylenol. They also state they would not have taken Tylenol had they been adequately informed about the hazards.
Plaintiffs include people like Charlotte Thompson, a Florida woman who sued McNeil-PPC and Johnson & Johnson in state court in February 2012. Thompson took Tylenol for several days before she was taken to the emergency room in February 2008. She experienced severe liver damage and was hospitalized for several days. In addition to severe physical injuries, she has also experienced emotional injury, loss of earning capacity, and significant medical expenses. Her case is pending in federal court.
|Some other people who filed lawsuits include:|
|A Kentucky woman, Patricia Burdin, suffered severe injury, including acute liver failure, after taking Extra Strength Tylenol and Lortab. She took the drugs in the dosages directed by her physician, but was admitted to the emergency room with fulminant liver failure in May 2011. She and her husband filed a lawsuit in the Philadelphia Court of Common Pleas in January 2013. Their lawsuit includes her allegations of physical and emotional injuries and economic losses and her husband’s loss of consortium claim. The lawsuit is pending in the federal MDL.|
|After taking Tylenol, Tonja Rash was taken to Park Ridge Medical Center’s emergency room in Chattanooga, Tenn., on or about April 20, 2010. She experienced acute liver failure and was transferred to Vanderbilt University Medical Center on April 22. She died that day. Her husband and her father, as executor of her estate, filed a lawsuit against McNeil-PPC and Johnson & Johnson in the Philadelphia Court of Common Pleas in January 2013. The lawsuit was later transferred to the federal MDL.|
|People injured by Tylenol claim McNeil and J&J:|
|Negligently designed, manufactured and marketed Tylenol.|
|Inadequately labeled their product and made a “conscious decision” not to re-label or otherwise inform the “unsuspecting consumer public” of its hazards.|
|Misrepresented and over-promoted the safety and effectiveness of Tylenol to fraudulently induce consumers to buy the product.|
|Hid information about the product’s hazards from consumers.|
|“Recklessly disregarded the fact that Tylenol causes debilitating and potentially lethal side effects.”|
|Marketed Tylenol “without disclosing these side effects where there were safer alternative methods for pain relief.”|
What to Ask Your Tylenol Lawyer
It is best to contact an experienced drug injury attorney before filing a Tylenol lawsuit. An attorney can help you determine whether you are eligible to file a claim and explain the case process.
You should feel free to ask your attorney questions. One of the first things you should ask is how long you have to file a claim. This is because each state limits the amount of time a plaintiff has to file a lawsuit after being injured.
You should also ask your attorney what type of medical evidence you will be expected to provide. For instance, your attorney will want to know:
- When you ingested Tylenol
- Which brand name you used
- The dosage taken
- Prescriptions you have taken
- When you were hospitalized and what treatment you received
- What type of liver damage you were diagnosed with
If you decide to file a Tylenol liver damage lawsuit on behalf of yourself or a loved one, Drugwatch’s Patient Advocates can provide more information on what to expect when contacting an attorney and questions you should consider asking.