GranuFlo Recall Judge OK’s Identification for Federal GranuFlo Dialysis Lawsuit Plaintiffs


Many of the plaintiffs who  filed federal dialysis lawsuit claims  in the wake of the GranuFlo and NaturaLyte recall will now be able to identify the type of acid concentrate used in the dialysis treatment they underwent just prior to sustaining their alleged injuries. According to an Order dated March 5, 2014, the judge overseeing the GranuFlo recall litigation underway in the U.S. District Court, District of Massachusetts, has approved protocols that will allow patients who received treatment at clinics owned by Fresenius Medical Care to obtain that vital information, which is often not included in standard medical records.

In addition to owning hundreds of dialysis clinics around the country, Fresenius Medical Care also manufactures GranuFlo and NaturaLyte. The two dialysis concentrates, which are used to remove acid from the blood during treatments, are used at Fresenius facilities, as well as thousands of other dialysis centers supplied by the company. In 2012, a Class I GranuFlo recall was announced for the drugs, after they were linked to dosage issues that had the potential to cause patients to suffer heart attack, strokes, and sudden cardiac death.

The March 5th Order issued in the District of Massachusetts will enable plaintiffs in GranuFlo lawsuits to request the sought-after information from a Fresenius “Data Warehouse.”  Within 14 business days, Fresenius must provide the plaintiff with the last “acetate value” or “concentrate identifier” associated with the dialysis treatment they underwent prior to their injury.

The Order only applies to cases where the last treatment was provided at a Fresenius-owned dialysis center.

GranuFlo Heart Attack, Stroke and Death Concerns

According to court documents, more than 500 dialysis lawsuits have been filed in the District of Massachusetts on behalf of alleged victims of potentially deadly heart problems, including GranuFlo heart attacks, strokes and cardiac death, associated with the use of GranuFlo or NaturaLyte. The lawsuits accuse Fresenius of failing to provide doctors with adequate instructions for use or warnings regarding the potential for the two dialysis concentrates to cause serious cardiovascular events.

In March 2012, Fresenius Medical Care issued an Urgent Product Notification to clinics nationwide advising doctors to adjust dosage of GranuFlo and NaturaLyte to avoid a dangerous elevation of bicarbonate in the blood of dialysis patients. This occurrence can lead to metabolic alkalosis, which increases the risk that a patient will experience a sudden and catastrophic heart event. In June of that year, the U.S. Food & Drug Administration (FDA) gave the notice its most serious classification, a Class I recall.

It has since come to light that Fresenius did issue a memo to its own dialysis clinics in 2011 to inform them of the dosage issues associated with GranuFlo and NaturaLyte. GranuFlo lawsuit plaintiffs cite that memo as evidence that the company was aware of the dangers posed by the two products well in advance of the GranuFlo and NaturaLyte recall.

Free Legal Reviews for GranuFlo Side Effect Victims

Alleged victims of GranuFlo heart attacks, strokes or other cardiovascular problems associated with the use of GranuFlo or NaturaLyte may be entitled to compensation for medical bills, lost wages, pain and suffering and more. To learn more about filing a dialysis lawsuit against Fresenius Medical Care, please call (888) 724-5009.