Fresenius USA, the maker of GranuFlo and NaturaLyte, is the largest provider of dialysis products and services in the country, so it’s not surprising the litigation surrounding the GranuFlo recall is growing.
New York, New York (PRWEB) May 04, 2013
GranuFlo lawsuits filed in the wake of last year’s recall for GranuFlo and NaturaLyte dialysis concentrates continue to mount in state and federal courts throughout the country, Bernstein Liebhard LLP reports. Most recently, a pair of sisters filed a complaint in the U.S. District Court, Northern District of California, following the alleged wrongful death of their mother due to GranuFlo side effects (Case no. 3:2013cv01403). An additional GranuFlo recall lawsuit was also filed in the Northern District of Alabama by a widow who claims her husband’s cardiovascular death was the result of a dialysis treatment with GranuFlo. (Case no. 2:2013cv00371)
“Fresenius USA, the maker of GranuFlo and NaturaLyte, is the largest provider of dialysis products and services in the country, so it’s not surprising the litigation surrounding the GranuFlo recall is growing. Our firm continues to hear from individuals who allegedly suffered serious GranuFlo side effects associated with the use of these drugs,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is currently offering free GranuFlo lawsuit evaluations to dialysis patients who suffered cardiac arrest, heart attacks, stroke, sudden cardiac death or other side effects allegedly related to the GranuFlo recall.
GranuFlo and NaturaLyte are used during dialysis to reduce the amount of acid in the blood. According to a New York Times report published last summer, both drugs were used in dialysis clinics owned by Fresenius, as well an estimated 125,000 customer clinics outside of the company’s network. Compared to rival products, GranuFlo and NaturaLyte contain more of an ingredient that is converted by the body into bicarbonate. If doctors do not account for this difference when prescribing dosage of the products, patients may develop a condition known as metabolic alkalosis, which has been linked to catastrophic GranuFlo side effects, including cardiac arrest and sudden cardiac death, in dialysis patients, according to the Times.*
In March 2012, Fresenius issued an “Urgent Product Notification” to its customer clinics warning of possible heart risks associated with the products, which would later be deemed a Class I GranuFlo recall by the U.S. Food & Drug Administration (FDA). Class I recalls are the agency’s most serious type, and are issued when a medical product poses a significant risk of serious injury or death.** Months before the announcement of the GranuFlo recall, however, Fresenius had issued a memo to dialysis clinics within its own network warning doctors practicing at those facilities that GranuFlo had been associated with serious heart side effects, and advised the physicians to adjust dosages in order to avoid excessive levels of bicarbonate in the blood. According to the New York Times, the FDA has since launched an investigation to determine if Fresenius Medical Care’s failure to issue an earlier warning to its customer clinics regarding the significant dangers associated with GranuFlo and NaturaLyte may have violated the law.**
On March 29th, 2013, the U.S. Judicial Panel on Multidistrict Litigation ordered that all federally-filed GranuFlo lawsuits be transferred to the U.S. District Court, District of Massachusetts for pretrial proceedings. Court filings show that plaintiffs in GranuFlo lawsuits allege Fresenius Medical Care was aware of the heart risks associated with GranuFlo and NaturaLyte, but failed to provide adequate warnings regarding those risks. (In re Fresenius GranuFlo/Naturalyte Dialysate Litigation, MDL No. 2428)
Dialysis patients who suffered heart attacks, sudden cardiac death, and other catastrophic heart side effects within 48 hours of a dialysis treatment with GranuFlo and NaturaLyte may be entitled to file a Granuflo lawsuit to obtain compensation for medical expenses, lost wages, pain and suffering, and more. Learn more about the GranuFlo recall by visiting Bernstein Liebhard LLP’s website. For additional information, contact a lawyer at Bernstein Liebhard LLP today by calling (877) 779-1414.
*New York Times, June 15, 2013; nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html
**FDA, March 29, 2012; fda.gov/MedicalDevices/Safety/ListofRecalls/ucm309990.htm
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 10 consecutive years.
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ATTORNEY ADVERTISING. © 2013 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
Felecia L. Stern, Esq.
Bernstein Liebhard LLP