New York, NY (PRWEB) August 14, 2014
A U.S. Food and Drug Administration (FDA) initiative that allows public access to product recall information reveals that actions similar to one that has since prompted thousands of GranuFlo lawsuits (http://www.thegranuflolawsuit.com/) have increased dramatically over the past few years, Bernstein Liebhard LLP reports.
According to a recent report from the Regulatory Affairs Professionals Society, a total of 499 drug recalls were issued by the FDA in 2012; the same year a Class I recall of GranuFlo and NaturaLyte, two acid concentrates used in dialysis, was announced. The FDA issued more than 1,220 recalls in 2013, and another 836 have already been announced in 2014, according to an article published on August 11th.*
Following the GranuFlo recall of 2012, court documents show thousands of lawsuits now filed on behalf of individuals who received the dialysis medications, which are distributed by Fresenius Medical Care. (In re Fresenius GranuFlo/Naturalyte Dialysate Litigation, MDL No. 2428)
“As product recalls continue to be announced by the FDA, our Firm continues to hear from individuals who suffered injuries allegedly caused by dialysis medications affected by the 2012 GranuFlo recall,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is currently offering free and confidential case reviews to individuals who were allegedly injured by products affected by the 2012 GranuFlo and NaturaLyte recall, as well as others involved in similar recalls.
In June 2012, the FDA granted a Class I recall of GranuFlo and NaturaLyte after determining that use of the dialysis drugs may pose a risk of serious injury or death. This action followed an Urgent Product Notification issued by Fresenius two months earlier that noted its products’ potential to cause serious cardiovascular problems. Since then, thousands of GranuFlo and NaturaLyte lawsuits were filed on behalf of individuals who allegedly suffered cardiac arrest, heart attacks, strokes, sudden cardiac death and other side effects caused by the dialysis medications. The majority of claims have now been centralized in the U.S. District Court, District of Massachusetts, where a multidistrict litigation has been established.
GranuFlo recall lawsuits now filed in Massachusetts accuse Fresenius of failing to adequately warn dialysis patients about the potential for its products to cause serious heart problems that may turn fatal. Plaintiffs further allege that the company continued to aggressively market GranuFlo and NaturaLyte even after it became aware of its potential to cause harm to patients.
In addition to Fresenius lawsuits now filed in the District of Massachusetts, court records indicate that nearly 4,000 claims have been consolidated at the state court level in Middlesex County Superior Court. (In re: Consolidated Fresenius Cases, No. MICV2013-03400-O).
Individuals who were allegedly harmed by GranuFlo or NaturaLyte may be eligible to file their own lawsuit against Fresenius. Learn more (http://www.thegranuflolawsuit.com/granuflo-dialysis-recall/) about the FDA’s GranuFlo recall of 2012 by visiting Bernstein Liebhard LLP’s website, or call 800-511-5092 to arrange for a free, no-obligation case review.
*raps.org/Regulatory-Focus/News/2014/08/11/20005/Number-of-Drug-Recalls-Surges-at-FDA-Led-by-Mid-Level-Concerns/; Regulatory Affairs Professional Society, August 11, 2014.
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 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 it was first published in 2003.
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