GranuFlo Lawsuit Update: Fresenius Medical Care Under Investigation for Handling of GranuFlo and NaturaLyte Recall

Bernstein Liebhard LLP continues to investigate GranuFlo lawsuits on behalf of dialysis patients who suffered cardiac arrest, heart attacks, sudden cardiac death or other catastrophic health problems following the administration of GranuFlo or NaturaLyte acid concentrates during dialysis.

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Bernstein Liebhard LLP | Consumer Injury Lawyers
Prior to the GranuFlo recall, both drugs were used by thousands of dialysis clinics throughout the U.S. Tens of thousands of patients may have been placed in danger by Fresenius’ actions.

New York, NY (PRWEB) November 25, 2012

Potential GranuFlo lawsuits continue to be evaluated by Bernstein Liebhard LLP. According to a recent report from The New York Times, Fresenius Medical Care is already the subject of a U.S. Food & Drug Administration (FDA) investigation stemming from the company’s handling of the GranuFlo and NaturaLyte recall announced earlier this year. The agency is trying to determine if Fresenius Medical Care’s failure to warn its customers about serious heart side effects associated with the improper dosing of GranuFlo and NaturaLyte may have violated federal law.*

“Prior to the GranuFlo recall, both drugs were used by thousands of dialysis clinics throughout the U.S. Tens of thousands of patients may have been placed in danger by Fresenius’ actions,” says Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices. The firm is currently offering free lawsuit evaluations to dialysis patients allegedly injured by GranuFlo or NaturaLyte.

GranuFlo and NaturaLyte Recall
GranuFlo and NaturaLyte are acid concentrates used during dialysis to reduce the amount of acid in the blood. On March 29, 2012, Fresenius Medical Care issued an Urgent Product Notification to its customer clinics warning of possible heart risks associated with GranuFlo and NaturaLyte. Compared to rival products, GranuFlo and NaturaLyte contain higher levels of an ingredient that the body converts to bicarbonate. If a doctor fails to account for this when prescribing the dosage for the drugs, patients may experience a condition called alkalosis, which has been associated with cardiovascular death and catastrophic heart injuries in patients undergoing dialysis treatment. The notification would later be deemed a Class I recall by the U.S. Food & Drug Administration (FDA).**    

According to The New York Times, Fresenius had issued a similar warning to dialysis clinics it owned months earlier, in November 2011. The document reported that 941 patients had suffered cardiac arrest inside Fresenius clinics in 2010. Fresenius’ own medical staff had determined that patients with high levels of bicarbonate in their blood had about six times the risk of cardiac arrest as those with lower levels, according to the document. Yet while the internal memo characterized the problem as one that “needs to be addressed urgently,” Fresenius did not send a similar warning to the thousands of customer clinics it supplied with GranuFlo and NaturaLyte at that time. The March 2012 warning to customers was issued only after the FDA learned of the November 2011 memo and began questioning Fresenius about it, the Times said.

Dialysis patients who suffered heart attacks, sudden cardiac death, and other catastrophic heart side effects within 48 hours of a dialysis treatment with GranuFlo or NaturaLyte may be entitled to compensation for medical expenses, lost wages, pain and suffering, and more. Learn more about filing a GranuFlo or NaturaLyte lawsuit by visiting Bernstein Liebhard LLP’s website, http://www.consumerinjurylawyers.com. For additional information, contact a lawyer at Bernstein Liebhard LLP today at (877) 779-1414.

*nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html
**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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