Granuflo Recall Lawsuits Move Forward, as Parties Submit Bellwether Trial Proposals for Federal Litigation

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The Firm is representing numerous GranuFlo lawsuit clients who allegedly suffered sudden and catastrophic heart problems following the administration of GranuFlo or NaturaLyte Dialysis Concentrates.

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Our Firm is representing numerous clients in GranuFlo lawsuits. We are pleased to see that the federal Granuflo recall litigation is moving closer to its first trials, which may provide insight into how juries would rule in similar claims.

Hundreds of GranuFlo lawsuits ( filed in the wake of the 2012 recall of GranuFlo and NaturaLyte dialysis concentrates continue to move forward in courts throughout the country, Bernstein Liebhard LLP reports. According to court documents, the parties have submitted proposals for a bellwether trial program in the federal GranuFlo recall litigation currently underway in U.S. District Court, District of Massachusetts. According to their proposals, both sides have agreed that a bellwether trial pool should be established that consists of 20 representative cases, with each side selecting 10 cases for the pool. Once case-specific discovery is completed, the number of potential bellwether cases will be reduced to 10, from which cases will be selected for the litigation’s first trials. (In re Fresenius GranuFlo/Naturalyte Dialysate Litigation, MDL No. 2428)

Court records indicate that the federal GranuFlo recall litigation will convene a Status Conference on March 28, 2014, at which time the bellwether trial proposals will be reviewed.

“Our Firm is representing numerous clients in GranuFlo lawsuits. We are pleased to see that the federal Granuflo recall litigation is moving closer to its first trials, which may provide insight into how juries would rule in similar claims,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is now offering free legal reviews to dialysis patients who were allegedly harmed by GranuFlo or NaturaLyte.

GranuFlo Recall
Both GranuFlo and NaturaLyte are dialysis concentrates manufactured by Fresenius Medical Care that are used to remove toxins from the blood during treatments. In March 2012, Fresenius Medical Care issued an Urgent Product Notification for both products that warned of dosage issues that could cause dialysis patients to suffer serious and catastrophic heart side effects. The U.S. Food & Drug Administration (FDA) ultimately granted Class I recall status to the Urgent Product Notification, which indicates GranuFlo and NaturaLyte posed a risk of serious injury and death.

According to a New York Times report from June 2012, many doctors were not aware that GranuFlo and NaturaLyte were formulated differently than rival dialysis drugs. If dosage was not adjusted to account for this difference, a dialysis patient could experience a dangerous elevation of bicarbonate in their blood known as metabolic alkalosis. This condition increases the risk that an individual will suffer a heart attack, stroke, sudden cardiac death, or other serious heart problems during or shortly after undergoing dialysis.*

The Times also reported that the FDA had launched an investigation of Fresenius Medical Care, after learning that the company had circulated an internal memo to its in-network dialysis clinics in November 2011 that detailed the dosage issues associated with GranuFlo and NaturaLyte. The agency is trying to determine if Fresenius’ decision not to issue a similar notification to facilities outside of its network at that time violated any federal regulations.*

Since the GranuFlo recall was announced, court documents indicate that more than 600 claims have been filed in the proceeding underway in the District of Massachusetts. All of the lawsuits similarly allege that Fresenius failed to provide adequate warnings regarding the risks associated with GranuFlo and NaturaLyte, and that the company continued to aggressively market the products even once it became aware of those risks.

In additional to the federal litigation, a number of GranuFlo lawsuits filed on the state level have been consolidated in Massachusetts’ Middlesex County Superior Court. (In re: Consolidated Fresenius Cases, No. MICV2013-03400-O).

Dialysis patients who suffered serious and catastrophic heart problems allegedly related to the use of GranuFlo and NaturaLyte may be eligible to file their own GranuFlo lawsuit against Fresenius Medical Care. To find out more about the litigation stemming from the GranuFlo recall, please visit Bernstein Liebhard LLP’s website, or the Firm’s Facebook page: For additional information, and to arrange for a free case review, please call 800-511-5092.

*; 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 12 consecutive years. Bernstein Liebhard LLP is the only firm in the country to be named to this prestigious list every year since the list was first published in 2003.

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