GranuFlo Dialysis Recall

Published on September 13, 2013 by Sandy Liebhard

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The GranuFlo recall for GranuFlo and NaturaLyte dialysis concentrates was announced in March 2012, after the two products were linked to sudden, serious, and even life-threatening heart side effects in patients who were administered the drugs during dialysis. Just months after Fresenius Medical Care issued an Urgent Product Notification to warn the public of the dangers associated with Granuflo and NaturaLyte, the U.S. Food & Drug Administration granted a Class I designation to the GranuFlo recall, the agency’s most serious type. The FDA has warned that use of the products may place patients at risk of serious injury or death, as they could lead to a number of dangerous heart complications, including:

  • sudden cardiac death
  • dangerously low blood pressure
  • cardiopulmonary arrest
  • heart attack
  • stroke

Since the announcement of the GranuFlo and NaturaLyte dialysis recall, hundreds of patients who were allegedly injured by these products have filed GranuFlo lawsuits against Fresenius seeking compensation for their physical, financial and emotional damages. Bernstein Liebhard LLP is now offering free and confidential lawsuit evaluations to victims of serious and deadly heart injuries that may be associated with the Granuflo recall. If you or a loved one suffered a heart attack, stroke, cardiac death or any other sudden and dangerous heart problem within 48 hours of undergoing a dialysis treatment with either GranuFlo or NaturaLyte, please contact our Firm today to discuss your case with one of our experienced dialysis recall attorneys.

GranuFlo and NaturaLyte Dialysis Recall

granuflo class action lawsuitGranuFlo and NaturaLyte have been marketed by Fresenius Medical Care since 2003, and both are used during dialysis to reduce acid in the blood of patients whose kidneys do not function properly. Prior to the GranuFlo recall, both products were used in 1,800 U.S. dialysis clinics operated by Fresenius, as well as thousands of independent facilities that purchased the drugs from the company. Unlike rival products that perform the same function, both GranuFlo and NaturaLyte contain more of an ingredient that the body converts to bicarbonate. Apparently, many doctors were not taking this difference into account when they prescribed GranuFlo and NaturaLyte to their patients.

According to dialysis recall lawsuits filed against Fresenius, both GranuFlo and NaturaLyte can elevate  the amount of bicarbonate in the body to dangerous levels if they are not dosed properly, placing patients at risk for catastrophic heart problems, including cardiac arrest and sudden cardiac death. Plaintiffs in these lawsuits also allege that Fresenius was aware of this problem before the GranuFlo recall was announced. In November 2011, the company issued an internal memo its own dialysis clinics, warning them that inappropriate administration of GranuFlo and NaturaLyte could contribute to sudden cardiac death. Among other things, the memo revealed that more than 900 people treated with GranuFlo had died from cardiac arrest at Fresenius clinics in 2010, and doctors were advised to adjust dosage of both drugs to ensure patient safety.

GranuFlo recall plaintiffs claim that none of this vital safety information was relayed to the thousands of independent dialysis facilities that also used GranuFlo and NaturaLyte until the issuance of the Urgent Product Notification in March 2012. According to a report that appeared in The New York Times in June 2012, the company only issued that notice after the FDA became aware of the November 2011 memo, and started questioning Fresenius about it. The same article also revealed that the FDA had launched an investigation of Fresenius’ handling of the dialysis recall, to determine if the company had violated any regulations in not sending an earlier warning to its customers.

Lawsuits Mount in Wake of GranuFlo Recall

As of August 2013, more than 300 GranuFlo recall claims had been filed in courts around the country on behalf of dialysis patients allegedly injured by GranuFlo or NaturaLyte. Most of the lawsuits are now pending in a federal multidistrict litigation underway in U.S. District Court, District of Massachusetts. All of these lawsuits seek damages for either wrongful death or personal injuries, and accuse Fresenius Medical Care of failing to provide adequate warnings to patients or medical centers about the drugs’ heart risks.

There is still time for individuals affected by the GranuFlo and NaturaLyte dialysis recall to file their own lawsuit against Fresenius. The GranuFlo attorneys at Bernstein Liebhard LLP will take the time to discuss your legal options with you and answer all of your questions. To get in touch with our legal staff today, please call .