New York, New York (PRWEB) November 30, 2013
Hundreds of GranuFlo lawsuits (http://www.thegranuflolawsuit.com/) filed after the 2012 recall of GranuFlo and NaturaLyte dialysis drugs continue to move forward in a multidistrict litigation established in U.S. District Court, District of Massachusetts, Bernstein Liebhard LLP reports. On November 15th, the Court issued a new Case Management Order that established a mechanism by which the defendants will disclose certain medical records pertaining to plaintiffs’ dialysis treatments at clinics owned by Fresenius Medical Care. (In re Fresenius GranuFlo/Naturalyte Dialysate Litigation, MDL No. 2428)
“This Order will ensure that plaintiffs in GranuFlo lawsuits will have access to medical records that are important to their claims,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is currently offering free GranuFlo lawsuit evaluations to dialysis patients who suffered cardiac arrest, heart attacks, stroke, sudden cardiac death or other side effects allegedly related to the administration of GranuFlo and NaturaLyte during dialysis treatments.
According to court documents, Fresenius Medical Care faces nearly 400 lawsuits pending in the federal proceeding, all of which accuse the company of failing to provide adequate warnings regarding the use of GranuFlo and NaturaLyte. The lawsuits further allege that the company continued to aggressively market both products prior to the GranuFlo recall, even after their risks became apparent in order to protect their market share.
GranuFlo and NaturaLyte were both the subject of a March 2012 Urgent Product Notification issued by Fresenius Medical Care which warned of sudden, life-threatening heart problems that could occur due to inappropriate dosing of the drugs. The New York Times reported in June 2012 that, unbeknownst to many doctors who prescribed the products, GranuFlo and NaturaLyte contained more of an ingredient the body converts to bicarbonate than rival dialysis drugs. As such, certain dosages could result in metabolic alkalosis, a dangerous condition that is caused by excessive bicarbonate in the blood. This condition raises the risk that a dialysis patient will suffer a catastrophic heart event during or shortly after treatment.*
The U.S. Food & Drug Administration (FDA) ultimately granted Class I recall status to Fresenius Medical Care’s Urgent Product Notification, which indicates that a medical product poses a significant risk of serious injury or death. According to The Times, the agency also began investigating Fresenius Medical Care shortly after learning of a memo the company had issued in November 2011 to its own clinics that warned of the heart risks associated with GranuFlo and NaturaLyte. The agency is trying to determine if Fresenius violated federal regulations, as it chose not to inform any of the independent dialysis clinics it supplied with the products of these risks at that time.
Individuals who underwent a dialysis treatment with GranuFlo or NaturaLyte may be entitled to compensation if they experienced a catastrophic heart event within 72 hours of the treatment. To learn more about the GranuFlo recall, please visit Bernstein Liebhard LLP’s website, or visit the Firm’s Facebook page: https://www.facebook.com/granuflolawsuit. For additional information, and to arrange for a free case review, please call 800-511-5092.
*nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html; New York Times, June 14, 2012
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 11 consecutive years.
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Felecia L. Stern, Esq.
Bernstein Liebhard LLP