Tag Archives: Liebhard

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


New York, NY (PRWEB) February 16, 2013

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 LLPs website, http://www.consumerinjurylawyers.com/. For additional information, contact a lawyer at Bernstein Liebhard LLP today at (877) 779-1414.

*newsandinsight.thomsonreuters.com/Legal/News/ViewNews.aspx?id=68509&terms=%40ReutersTopicCodes+CONTAINS+%27ANV%27

**justice.org/cps/rde/xbcr/justice/Fact_Sheet_Post-Mensing.pdf

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.

Generic Drug Lawsuit News: Bernstein Liebhard LLP Commends FDA Plan to Alter Generic Drug Labeling Rules


New York, New York (PRWEB) July 07, 2013

The nationwide law firm of Bernstein Liebhard LLP reports that a recent decision from the U.S. Food & Drug Administration (FDA) could pave the way in the future for individuals allegedly injured by generic versions of popular medications, including Fosamax, to pursue product liability lawsuits against their manufacturers. According to a July 3rd notice posted on the website of the federal Office of Management and Budget, the FDA is planning to allow generic manufacturers to make changes to their drugs labels when they become aware of new information about potential risks associated with their products. At the present time, generic medications are required to carry the same label warnings as their name-brand counterparts, and generic drug makers are barred from altering labels on their own.*

This is wonderful news for future victims of generic drug side effects, as the new rule could finally eliminate the current pre-emption on failure-to-warn claims against generic-drug manufacturers, says Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices.

Generic Drug Preemption

Even though generic drugs pose the same risks as their brand name counterparts, consumers have been barred from bringing state law failure to warn claims against generic drug manufacturers since 2011. That year, the U.S. Supreme Court determined that such lawsuits were barred because generic drug makers had no control over their products labels. (Pliva v. Mensing, 131 S. Ct. 2567 (2011)) Just last week, the High Court reaffirmed that ruling by a 5-4 margin. (Mutual Pharmaceutical Co. v. Bartlett, 12-142.)

According to the American Association for Justice, numerous generic drug failure-to-warn lawsuits have been dismissed in the wake of the Supreme Courts Mensing decision. 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 Wednesdays notice, the FDA could publish its new generic drug labeling ruling as early as September, after which the agency would accept public comments on the issue.

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 LLPs website, http://www.consumerinjurylawyers.com/. For additional information, contact a lawyer at Bernstein Liebhard LLP by calling 800-511-5092.

*reginfo.gov/public/servlet/ForwardServlet?SearchTarget=Agenda&textfield=0910-AG94

**justice.org/cps/rde/xbcr/justice/Fact_Sheet_Post-Mensing.pdf

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

800-511-5092

ATTORNEY ADVERTISING.