A Georgia man has filed a GranuFlo lawsuit against Fresenius Medical Care (FMC) over the death of his mother, who suffered a fatal cardiovascular event after receiving dialysis treatment that involved FMC’s GranuFlo or NaturaLyte acid concentrates. The complaint was filed by Waddell Bishop on September 14, 2012, in the U.S. District Court for the Southern District of Georgia, and seeks compensation from Fresenius USA, Inc. and its various subsidiaries for the wrongful death of his mother, Frances Carol Bishop. If you have suffered a serious side effect that you believe to be linked to the dialysis product GranuFlo, consult our knowledgeable GranuFlo lawyers at Atkins & Markoff as soon as possible. Our GranuFlo attorneys have extensive experience in drug injury litigation, and can help you seek fair and timely reimbursement for your injuries allegedly related to FMC’s dialysis drug, GranuFlo.
GRANUFLO AND POTENTIAL SIDE EFFECTS
Fresenius Medical Care operates about one-third of all dialysis clinics in the United States, and is also the leading provider of dialysis drugs, like GranuFlo, to clinics in the U.S. and Europe. According to Bishop’s complaint, about 79,600 dialysis patients receive treatment in 1,080 Fresenius-run dialysis clinics across the country. Frances Carol Bishop reportedly received dialysis treatment that allegedly included the use of GranuFlo or NaturaLyte, and then suffered a cardiovascular event that led to her death on September 16, 2010. The lawsuit alleges that Bishop’s dialysis-related death was caused by complications associated with the FMC products, and claims that the company failed to provide patients and healthcare professionals with adequate warnings about the risk of cardiac arrest for dialysis patients using GranuFlo.
FMC UNDER INVESTIGATION FOR FAILURE TO WARN
GranuFlo is a dry acid concentrate used as part of the dialysate solution that many patients receive during dialysis treatment. According to recent side effect complaints, both GranuFlo and FMC’s NaturaLyte dialysis product contain sodium acetate that allegedly converts to bicarbonate at a higher-than-expected level, which requires close monitoring of dialysis patients to reduce the risk of potentially deadly cardiovascular complications. FMC was apparently aware of this potential risk in November 2011, when the company issued an internal memo to FMC-run clinics warning doctors that as many as 941 GranuFlo patients had suffered sudden cardiac arrest due to improper administration of the dialysis drug in 2010. Unfortunately, FMC failed to alert non-FMC clinics about this risk, putting thousands of GranuFlo patients at risk for life-threatening cardiovascular problems.
FDA ISSUES CLASS I GRANUFLO RECALL
“Fresenius is responsible for ensuring (through adequate training, instructions, monitoring and hiring principles) that its clinicians, nurses, contractors, employees and physicians know how to properly use all hemodialysis products in a manner that is safe and effective for the recipients,” alleges Bishop in the lawsuit. However, Bishop claims, neither the product label, nor the packaging or instructions contained adequate warnings or instructions regarding the importance of monitoring patients when GranuFlo and/or NaturaLyte products were used during Frances Carol Bishop’s dialysis treatment. It was more than a year after Bishop’s death that FMC issued the detailed internal memo regarding the risk of fatal cardiovascular events with GranuFlo use, and it wasn’t until March 2012 that the FDA became aware of these side effect risks and issued a Class I NaturaLyte and GranuFlo recall.
GRANUFLO ATTORNEYS FOR SIDE EFFECT CLAIMS
Bishop’s case joins a growing number of lawsuits filed against FMC on behalf of patients across the country who have died or suffered catastrophic injury as a result of cardiac arrest, stroke or heart attack occurring during or shortly after dialysis treatment involving GranuFlo or NaturaLyte. Bishop’s lawsuit is seeking compensatory damages, as well as punitive damages intended to punish FMC for its allegedly reckless actions, which exposed Frances Carol Bishop and other GranuFlo patients to life-threatening side effects. If you received GranuFlo during your dialysis treatment and have since experienced a serious side effect like heart attack or stroke, contact our skilled GranuFlo attorneys at Atkins & Markoff today. Our drug injury lawyers have years of experience protecting the rights of side effect victims, and can help you pursue the compensation you deserve for your injuries.