Tylenol Lawsuits Mount, as FDA Launches Review of Regulations Governing Over-the-Counter Medications, Bernstein Liebhard LLP Reports

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The Firm is investigating Tylenol lawsuits on behalf of individuals who allegedly suffered liver damage from acetaminophen, the active ingredient in Tylenol-brand over-the-counter medications.

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We continue to receive inquiries about Tylenol lawsuits on a regular basis, and will be closely monitoring any FDA action relevant to this issue.

As Tylenol lawsuits (http://www.tylenollawsuitcenter.com/) continue to mount in federal court, Bernstein Liebhard LLP notes that the U.S. Food & Drug Administration (FDA) has launched a review of the regulations governing over-the-counter medications, including Tylenol-brand products. According to the FDA’s announcement, the agency will convene a public hearing on the matter on March 25 and 26, 2014, in order to obtain input on how to improve or alter the current OTC Monograph Process for reviewing nonprescription drugs. Written or electronic comments regarding this matter will be accepted until May 12, 2014, the agency said.*

“This review comes as the litigation involving Tylenol liver damage claims is growing. We continue to receive inquiries about Tylenol lawsuits on a regular basis, and will be closely monitoring any FDA action relevant to this issue,” 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 and Liver Damage
In 2009, the FDA reported that acetaminophen, the active ingredient in Tylenol products, was the leading cause of acute liver failure in the U.S. between 1998 and 2009.** According to a recent report from ProPublica, the FDA has been working on new rules governing the safe use of acetaminophen for over 40 years, but has yet to finalize any regulations due, in part, to the cumbersome system used to regulate nonprescription medications. ***

In January, the FDA did finalize new guidance for the use of acetaminophen in prescription medications. However, these new guidelines do not apply to over-the-counter medications like Tylenol. In August 2013, Bloomberg.com reported that over-the-counter Extra Strength Tylenol caplets each contain 500 mg of acetaminophen, well over the new limits of 325 mg per tablet mandated by the FDA for prescription medications.****

According to court documents, at least 125 Tylenol lawsuits are now pending in a federal multidistrict litigation underway in U.S. District Court, Eastern District of Pennsylvania. All of the complaints were filed on behalf of individuals who allegedly suffered acetaminophen- liver injuries resulting in hospitalization, liver transplantation or death, due to a Tylenol-brand product. The lawsuits further allege that severe liver injuries can occur with Tylenol use, even when the medications are used in accordance with package directions. (In Re: Tylenol (Acetaminophen) Marketing, Sales Practices and Products Liability Litigation, MDL No. 2436)

Individuals who suffered liver damage allegedly related to the use of a Tylenol-brand over-the-counter medication may be entitled to compensation for their medical bills, lost wages, pain and suffering, and more. 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.

*federalregister.gov/articles/2014/02/24/2014-03884/over-the-counter-drug-monograph-system-past-present-and-future-public-hearing#page-10170; Federal Register, February 24, 2014
**propublica.org/article/fda-opens-review-of-rules-for-over-counter-drugs-including-acetaminophen, February 27, 2014
***http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM164897.pdf, FDA, 2009
****bloomberg.com/news/2013-08-29/j-j-adds-warning-to-tylenol-caps-on-acetaminophen-risk.html, Bloomberg.com, August 29, 2013

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, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. 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 the list 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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