September 5, 2012 – Fresenius Medical Care (FMC), the largest dialysis provider in the United States, faces a wrongful death lawsuit filed on behalf of an Alabama man who died from a heart attack after being treated with the company’s GranuFlo product. According to the complaint, GranuFlo side effects caused the man’s heart attack because inadequate warnings were provided about the risks associated with the dialysis treatment. The lawsuit claims that FMC knew – or should have known – about GranuFlo’s potential to cause adverse health complications, but that it failed to warn the public and medical communities about these dangers.
July 2013 – Lawyer Michael Schmidt The Granuflo and Naturalyte Plaintiffs’ Steering Committee For Injury Lawsuits in All 50 States
GranuFlo Lawsuit Update 5/8/14: Lawyers involved in the nationwide GranuFlo litigation are expected to meet this week with a U.S. district judge to review proposals regarding preparation for the upcoming bellwether trials. Fresenius Medical Care (FMC), the company that manufactured GranuFlo, currently faces about 1,500 federal complaints from patients who allegedly suffered cardiac arrest or sudden death after undergoing dialysis treatment with the product. Click here to learn more.
GranuFlo Lawsuit Update 3/12/13: At least four separate GranuFlo and NaturaLyte class action lawsuits have been filed against DaVita Healthcare, alleging that the company should have known about the dialysis products’ potential to cause severe, potentially life-threatening side effects. The complaints seek class action status to include all patients who underwent hemodialysis treatment with GranuFlo or NaturaLyte at a DaVita clinic. Click here to learn more.
Free GranuFlo Lawsuit Evaluation: If you or a loved one has been injured by GranuFlo, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of GranuFlo and we can help.
What’s the problem?
On August 10th, Betty Lemmond, wife of the Alabama man who died of a sudden heart attack shortly after dialysis treatment with GranuFlo, filed a complaint with the U.S. District Court in Alabama naming Fresenius, its subsidiaries, as well as DaVita Inc.
According to Lemmonds’ lawsuit, her husband Dizzy Dean Lemmond’s heart attack and subsequent death were due to side effects of Granuflo and NaturaLyte. Both GranuFlo and NaturaLyte require sodium acetate as part of their prescription. During transfusion, the sodium acetate in dialysate products converts to bicarbonate, which causes an increase in pH, resulting in patients’ likeliness to become alkalotic. This alkalosis can cause severe myocardial depression, which may result in sudden heart attacks.
Lemmond’s suit claims that Fresenius, the manufacturer of both Granuflo and NaturaLyte, failed to provide adequate warnings about the rate at which the sodium acetate bicarbonate conversion occurs, placing patients receiving dialysis at risk for heart attacks if not closely monitored during and after dialysis treatment. In 2010 alone, 941 patients suffered heart attacks while receiving dialysis treatments at FMC clinics, raising alarms within the company.
Last November, Fresenius executives circulated an internal memo describing the risk of elevated bicarbonate levels to staff working in the company’s dialysis treatment centers. The memo reportedly discussed ‘troubling findings,’ and alerted staff that ‘this issue needs to be addressed urgently.’ However, the company did not pass this information along to the estimated 125,000 patients being treated with GranuFlo at clinics not operated by FMC. Instead, federal health regulators were not warned of GranuFlo’s dangers until early 2012, when the internal memo was leaked to the FDA. Only on March 29, 2012, over four months later, did Fresenius publish a public warning about GranuFlo.
The FDA subsequently issued a Class I Recall for GranuFlo and NaturaLyte on June 27, 2012. In its recall announcement, the administration stated that “Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.” According to an article published in the New York Times, the FDA is currently in the process of determining whether FMC’s failure to warn the public and medical communities about GranuFlo’s side effects violated federal laws.
Do I Have a GranuFlo Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in GranuFlo lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.
Free GranuFlo Lawsuit Evaluation: If you or a loved one has been injured by GranuFlo, you should contact our law firm immediately. You may be entitled to compensation by filing a GranuFlo injury suit and we can help.