The issuance of this draft guidance comes as Tylenol lawsuits involving allegations of serious liver damage continue to mount in federal court.
New York, New York (PRWEB) October 08, 2014
As Tylenol lawsuits (http://www.tylenollawsuitcenter.com/) move forward in federal court, Bernstein Liebhard LLP notes that the U.S. Food & Drug Administration (FDA) has issued draft guidance regarding over-the-counter liquid pediatric medications that contain acetaminophen. According to the agency, the guidance is intended to address "ongoing concerns" about the potential for overdoses, which can result in serious adverse events including severe liver damage and death. The guidance includes voluntary labeling and formulation recommendations meant to "avoid confusion and the potential for dosing errors" in over-the-counter liquid acetaminophen products meant for children under 12-years-of age.*
“The issuance of this draft guidance comes as Tylenol lawsuits involving allegations of serious liver damage continue to mount in federal court. A number of these claims were filed on behalf of children who were allegedly harmed by the acetaminophen contained in pediatric Tylenol products,” 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
According to court documents, more than 150 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-induced 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)
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. ** In January, the agency 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.****
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. 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.
*fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM417568.pdf, FDA, October 2014
**http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM164897.pdf, FDA, 2009
***federalregister.gov/articles/2011/01/14/2011-709/prescription-drug-products-containing-acetaminophen-actions-to-reduce-liver-injury-from, Federal Register, January 2014
****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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Bernstein Liebhard LLP