Because of FDA regulations governing generic drug labels, they are pre-empted from bringing certain types of legal claims based on a failure-to-warn theory of liability.
New York, New York (PRWEB) July 01, 2015
The federal court overseeing a generic drug injury lawsuit filed against the manufacturers of Levaquin (http://www.injurybeacon.com/levaquin/lawsuit/) has granted the Defendants’ Motion for Summary Judgment. According to an Order issued in the U.S. District Court, Southern District of West Virginia on June 26th, the Court rejected the Plaintiff’s assertion that one manufacturer can be held liable for injuries stemming from another manufacturer's product. Among other things, Plaintiffs had argued that because generic manufacturers merely copied the label warnings for Levaquin, the manufacturers of the name-brand product should be held responsible for the allegedly inadequate warnings. (Case No. No. 2:14-1746)
“This lawsuit highlights all too well the challenges faced by the alleged victims of generic drug injuries. Because of FDA regulations governing generic drug labels, they are pre-empted from bringing certain types of legal claims based on a failure-to-warn theory of liability. And, as this decision illustrates, those who take a generic version of a medication are often left without recourse,” says Sandy A. Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is currently investigating potential legal claims on behalf of individuals who allegedly developed peripheral neuropathy due to Levaquin.
Generic Drug Lawsuits
The U.S. Food & Drug Administration (FDA) currently requires generic medications to carry the same label warnings as their name-brand counterparts, and generic drug makers are barred from altering labels on their own. In 2011, the U.S. Supreme Court ruled in Pliva vs. Mensing that generic manufacturers could not be sued for failing to warn patients about their drugs´ risks, since they have no control over the content of their labels. (Pliva v. Mensing, 131 S. Ct. 2567 (2011))*
In 2013, the FDA proposed new regulations that would allow generic manufacturers to make changes to their drugs’ labels when they become aware of new information about potential risks associated with their products. The period for the public to submit comments on the proposed rule changes closed in April, but the agency has yet to make a final decision.*
“The ability to hold drug makers accountable in court is an important incentive to ensure that patients are provided with adequate warnings regarding safety risks. The changes being considered by the FDA could finally eliminate the current pre-emption on failure-to-warn claims against generic drug manufacturers,” says Sandy A. Liebhard.
Bernstein Liebhard LLP is currently investigating potential legal claims on behalf of individuals who were diagnosed with permanent peripheral neuropathy allegedly related to the use of Levaquin. To learn more about filing a Levaquin lawsuit, please visit Bernstein Liebhard LLP's website. Free, no-obligation legal consultations can be obtained by calling 800-511-5092.
*nytimes.com/2015/03/28/science/makers-of-generic-drugs-challenge-fda-plan-for-updated-warnings.html, The New York Times, March 28, 2015
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 National Law Journal has recognized Bernstein Liebhard for twelve consecutive years as one of the top plaintiffs' firms in the country. 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. © 2015 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.
Sandy A. Liebhard, Esq.
Bernstein Liebhard LLP
info (at) consumerinjurylawyers (dot) com