Tylenol Lawsuit News: FDA Issues New Draft Guidance Regarding OTC Acetaminophen Products, Dangerous Skin Reactions, Bernstein Liebhard LLP Reports

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The new guidance comes as scores of people are pursuing Tylenol lawsuits for injuries allegedly caused by the acetaminophen in Tylenol products.

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This new guidance comes as dozens of people are pursuing Tylenol lawsuits for liver injuries that were allegedly caused by acetaminophen, the active ingredient in these over-the -counter products.

As Tylenol lawsuits (http://www.tylenollawsuitcenter.com/) continue to move forward in courts around the country, Bernstein Liebhard LLP notes that the U.S. Food & Drug Administration (FDA) has issued draft guidance regarding the use of over-the-counter (OTC) acetaminophen products and serious skin reactions, including Stevens-Johnson Syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. Among other things, the agency is asking the manufacturers of such products to include warnings about the potential for these reactions, which the agency said can sometimes prove fatal.

“This new guidance comes as dozens of people are pursuing Tylenol lawsuits for liver injuries that were allegedly caused by acetaminophen, the active ingredient in these over-the -counter products. This warning just confirms that these types of medications can be associated with some very serious risks,” says Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices. The Firm is offering free legal reviews to consumers who were allegedly harmed by a Tylenol-brand over-the-counter medication.

Tylenol Liver Damage Litigation
According to court documents, at least 163 Tylenol liver damage claims are currently pending in a federal multidistrict litigation underway in the U.S. District Court, Eastern District of Pennsylvania. All of the complaints allege that Johnson & Johnson and McNeil Consumer Healthcare failed to provide consumers with adequate warnings regarding the risks associated with acetaminophen contained in Tylenol-brand medications. In many cases, plaintiffs claim that liver damage caused by Tylenol occurred even though the medication was used in accordance with label directions, and was severe enough to result in hospitalization, liver transplantation, or death. (In Re: Tylenol (Acetaminophen) Marketing, Sales Practices and Products Liability Litigation, MDL No. 2436)

Earlier this year, a Consumer Reports investigation revealed that acetaminophen-induced liver damage sends more than 80,000 people to the emergency room every year. Among other things, the report detailed one study which suggested that exceeding just 4,000 milligrams of acetaminophen for just a few days can result in serious liver problems and other complications. Yet the daily limits recommended for many over-the-counter acetaminophen products come very close to this threshold.*

The new guidance on skin reactions is not the first time the FDA has addressed the dangers potentially associated with acetaminophen. In January, the FDA finalized new guidance for the use of acetaminophen in prescription medications. However, these new guidelines do not apply to over-the-counter medications like Tylenol.** And in October the agency issued draft guidance regarding over-the-counter liquid pediatric medications that contain acetaminophen aimed at mitigating the risk of serious liver injury and death. ***

Individuals who sustained serious liver damage allegedly due to the acetaminophen in Tylenol products may be entitled to join the growing litigation involving these medications. To learn more about filing a Tylenol lawsuit, please visit Bernstein Liebhard LLP’s website. Free, confidential and no-obligation case reviews are available by calling 800-511-5092.

*newsnet5.com/money/consumer/consumer-specialist/warning-about-acetaminophen-consumer-reports-investigates, Consumer Reports (via 5 ABC News) October 29, 2014
**federalregister.gov/articles/2011/01/14/2011-709/prescription-drug-products-containing-acetaminophen-actions-to-reduce-liver-injury-from, Federal Register, January 2014
***fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM417568.pdf, FDA, October 2014

About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3 billion on behalf of our clients. The Firm has been named by The National Law Journal to the Plaintiffs’ Hot List, recognizing the top plaintiffs firms in the country, for the past 12 consecutive years. Bernstein Liebhard LLP is the only firm in the country to be named to this prestigious list every year since it was first published in 2003.

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ATTORNEY ADVERTISING. © 2014 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, 800-511-5092. Prior results do not guarantee or predict a similar outcome with respect to any future matter.

Contact Information:
Felecia L. Stern, Esq.
Bernstein Liebhard LLP

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