A wrongful death lawsuit has been filed against the manufacturer of GranuFlo, Fresenius Medical Care North America in Boston federal court on February 27, 2013 by Bettye Alexander. Mrs. Alexander’s late husband, Gary Alexander, suffered a heart attack and died following hemodialysis treatment using GranuFlo. Mrs. Alexander alleges that Fresenius failed to warn that GranuFlo, which has been used as part of a dialysate prescription at thousands of dialysis clinics over the last decade, puts patients at a substantially higher risk of cardiac arrest, stroke, and sudden cardiac death.
Fresenius Medical Care, based in Germany, is the largest operator of dialysis centers in the U.S., treating as many as one third of the country’s 400,000 dialysis patients. Fresenius is also the leading supplier of dialysis machines and dialysis products in the U.S. and is the manufacturer of dialysis medications, NaturaLyte and GranuFlo. Fresenius provides its dialysis machines and medications to many medical clinics, nursing homes, as well as to its own dialysis centers nationwide.
These medications are used in the treatment of acute and chronic renal failure during hemodialysis. These concentrations help reduce acid build-up in the blood during dialysis. NaturaLyte is the liquid form of the concentration and GranuFlo is the powder form.
The lawsuit alleges that Fresenius was aware of the risk for years, long before Alexander underwent his hemodialysis treatment. As we reported to you many months ago, Fresenius sent an internal memo in November 2011 warning that the use of GranuFlo was associated with a 6-8 fold greater increase of cardiopulmonary arrest and sudden cardiac death in the dialysis facility. The internal memo, which covered only a single year and about one third of Fresenius’ clinics, identified 941 cardiac deaths. Fresenius only sent the internal memo within its own network of dialysis clinics, not to any of the facilities they supply. Fresenius sells GranuFlo to thousands of other dialysis clinics, nursing homes and medical centers, as well. Why Fresenius took four months to share this important information with the facilities they supply is not understood. The only reason the FDA found out about the link to adverse cardiac effects is that the internal memo was anonymously leaked in March 2012, prompting an immediate recall of GranuFlo, as well as their liquid product, NaturaLyte.
In the memo, it stated that GranuFlo and NaturaLyte have the potential to raise bicarbonate levels in patient’s blood, more so than other dialysis concentrates. Since doctors outside of Fresenius clinics were not made aware of this risk, they were not adjusting the dosages of these concentrates properly, raising the risk of bicarbonate overdose, which could lead to “metabolic alkalosis,” a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, and other conditions, including arrhythmias and heart attack. The memo called these findings “troubling” and warned that “this issue needs to be addressed urgently.”
How could Fresenius Medical Care have known about the dosing errors, directly linked to the elevated levels of bicarbonate in all 941 patients with cardiac deaths, and not immediately have issued a warning to the rest of their customers, including nursing homes, medical centers and on-site dialysis providers, for four months? It was not until the FDA put pressure on them that they finally spoke up. How many deaths could have been prevented had Fresenius warned the providers sooner?
Mrs. Alexander is seeking compensatory and punitive damages for the unnecessary and unfortunate death of her husband.
Plaintiffs with cases against Fresenius have filed with the Judicial Panel of Multidistrict Litigation (JPML), seeking to consolidate all GranuFlo lawsuits in a single federal court in order to coordinate pretrial proceedings and efficiently manage the litigation.
For more information on the recall, visit http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm309990.htm
Not only did Fresenius’ GranuFlo and NaturaLyte products turn out to be very dangerous since they significantly increase the risk of the dialysis patient suffering cardiac death or stroke, they should be held liable for not warning their customers immediately. If they had knowledge that their product was defective and dangerous, it was their obligation to warn the public.
If you or a loved one feels that you have been hurt by Fresenius, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).