We are investigating a number of legal claims stemming from the GranuFlo recall, and are monitoring this proceeding very closely. We are looking forward to additional progress next year, as the Court embarks on the bellwether trial process.
New York, New Yor (PRWEB) December 18, 2013
The federal multidistrict litigation established for GranuFlo lawsuits (http://www.thegranuflolawsuit.com/ ) in U.S. District Court, District of Massachusetts, will begin preparing for bellwether trials next year, Bernstein Liebhard LLP reports. According to court documents, the parties have been directed to submit a proposed Case Management Order by January 6, 2014 that addresses the bellwether trial process, as well as case specific discovery. (In re Fresenius GranuFlo/Naturalyte Dialysate Litigation, MDL No. 2428)
“We are investigating a number of legal claims stemming from the GranuFlo recall, and are monitoring this proceeding very closely. We are looking forward to additional progress next year, as the Court embarks on the bellwether trial process,” 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.
GranuFlo and NaturaLyte, dialysis concentrates manufactured by Fresenius Medical care, were named in a March 2012 Urgent Product Notification that advised dialysis centers nationwide that inappropriate dosing of the drugs could cause patients to suffer sudden, life-threatening heart problems. The New York Times reported in June 2012 that prior to the notification, many were unaware that GranuFlo and NaturaLyte contained more of an ingredient the body converts to bicarbonate than rival dialysis drugs. If this difference is not accounted for when dosage is determined, a patient may develop metabolic alkalosis, a dangerous condition that is caused by excessive bicarbonate in the blood. Metabolic alkalosis raises the risk that a dialysis patient will suffer a catastrophic heart event during or shortly after treatment.*
Several months after it was issued, the U.S. Food & Drug Administration 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 after it became aware of a memo the company had issued in November 2011 to its own clinics that advised doctors of the dosage issues 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.
According to court documents, hundreds of dialysis lawsuits have been filed in Massachusetts federal court since the GranuFlo recall was announced. Others have been filed in a consolidated litigation established in Massachusetts’ Middlesex County Superior Court. (In re: Consolidated Fresenius Cases, No. MICV2013-03400-O) Consolidated proceedings like these are designed to preserve the resources of the court, parties and witnesses when there exists a large number of lawsuits involving the same product and similar allegations of fact. Bellwether trials are intended to gauge the strength of plaintiffs’ claims in such large, complex litigations.
Individuals who suffered a serious heart event within 72 hours of a dialysis treatment with GranuFlo or NaturaLyte may be entitled to compensation for their injury-related damages. To learn more about the GranuFlo recall, please visit Bernstein Liebhard LLP’s website, or 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