Generic Drug Lawsuits: Bernstein Liebhard LLP Comments on Possible FDA Rule Change that Could Eliminate Pre-emption

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Bernstein Liebhard LLP investigating lawsuits on behalf of individuals injured as a result of drug side effects.

Bernstein Liebhard LLP | Consumer Injury Lawyers
Generic drugs pose the same risks as their name-brand counterparts. Yet, under the current state of the law, individuals allegedly injured by generic medications are denied legal recourse.

The U.S. Food & Drug Administration (FDA) is considering a rule change that could pave the the way for individuals allegedly injured by generic versions of popular medications, including Fosamax, to pursue generic drugs lawsuits against their manufacturers, Bernstein Liebhard LLP reports. The agency recently confirmed to Reuters that it is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances. The proposed change could eliminate pre-emption of failure-to-warn claims against generic-drug manufacturers.*

“Generic drugs pose the same risks as their name-brand counterparts. Yet, under the current state of the law, individuals allegedly injured by generic medications are denied legal recourse,” says Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices.

Generic Drug Lawsuits
Under existing FDA regulations, generic drugs are required to carry the same label warnings as their name-brand counterparts. However, generic drug manufacturers are currently barred from altering their 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))

According to the American Association for Justice, numerous generic drug failure-to-warn claims have since been dismissed by courts citing Mensing. In November 2011, for example, the Judge overseeing Fosamax lawsuits in the U.S. District Court, District of New Jersey, granted a motion filed by generic manufacturers to dismiss claims against them that were based on failure to warn. (In re: Fosamax (Aledronate Sodium) Products Liability Litigation (No. II) – MDL 2243). **

According to the Reuters report, the U.S. Department of Justice recently filed an Amicus Brief in Mutual Pharmaceutical v. Barret, a lawsuit involving a generic heartburn medication. One footnote in that brief suggested that if the FDA adopts the new generic drug labeling rule, generic drug makers won't be able to use pre-emption as a defense to failure-to warn claims.

Victims of defective drugs may be entitled to compensation for medical bills, lost wages, pain and suffering and other damages. Bernstein Liebhard LLP offers free legal consultations to individuals injured as a result of drug side effects, including those allegedly caused by Fosamax, Actos and Pradaxa. Learn more by visiting Bernstein Liebhard LLP’s website, For additional information, contact a lawyer at Bernstein Liebhard LLP today at (877) 779-1414.


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 10 consecutive years.

Bernstein Liebhard LLP
10 East 40th Street
New York, New York 10016
(877) 779-1414

ATTORNEY ADVERTISING. © 2013 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414. 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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