NEW YORK – As GranuFlo lawsuits (http://www.thegranuflolawsuit.com/) stemming from the 2012 recall of GranuFlo and NaturaLyte dialysis concentrates continue to move forward in the U.S., Bernstein Liebhard LLP notes that Fresenius Medical Care has announced a new NaturaLyte recall in Canada. According to a notification issued by HealthCanada on April 5, 2014, the NaturaLyte recall involves several specific lots of “NaturaLyte Sodium Bicarbonate Liquid Concentrate” that may be contaminated with bacteria. The affected NaturaLyte products were distributed to hospital and home settings in Canada between August 8, 2013 andOctober 28, 2013. So far, no adverse events have been linked to this issue.
“Our Firm is actively filing GranuFlo lawsuits on behalf of individuals who were harmed by products included in the 2012 GranuFlo and NaturaLyte recall, so this issue is of great interest to us,” says Bernstein Liebhard LLP, a nationwide law firm representing individuals harmed by defective medical devices and drugs. Currently, the Firm is offering free and confidential case evaluations to individuals who may have experienced side effects within 72 hours of receiving GranuFlo or NaturaLyte.
2012 GranuFlo Recall
GranuFlo and NaturaLyte are used during hemodialysis to remove toxins from the blood in patients whose kidneys are no longer able to perform this function. The 2012 GranuFlo and NaturaLyte recall was announced after it became apparent that dosage issues were causing patients to suffer serious and catastrophic heart events, including heart attacks, strokes and sudden cardiac death. According to a June 2012 report from The New York Times, many doctors were not aware prior to the GranuFlo recall that in comparison to other dialysis concentrates, GranuFlo and NaturaLyte contained higher amounts of an ingredient the body converts to bicarbonate. Failure to account for this difference can cause patients to develop metabolic alkalosis, a condition related to a dangerous elevation of bicarbonate in the blood that can result in life-threatening heart events.
The U.S. Food & Drug Administration (FDA) ultimately granted Class I status to the 2012 GranuFlo recall, which indicates the products posed a serious risk of injury and death.
According to court documents, more than 650 GranuFlo lawsuits have been filed in a multidistrict litigation underway in U.S. District Court, District of Massachusetts on behalf of individuals who allegedly suffered injuries related to the 2012 GranuFlo recall. Among other things, these lawsuits claim that Fresenius was aware of problems long before the recall was announced, but failed to notify the public in order to protect sales of GranuFlo and NaturaLyte. Among other things, plaintiffs point out that Fresenius issued an internal memo to its own dialysis clinics in November 2011 to advise doctors practicing at those facilities about the dosage issues associated with GranuFlo and NaturaLyte. The lawsuits question why a similar notification was not issued to dialysis clinics outside the company’s network at that time. (In re Fresenius GranuFlo/Naturalyte Dialysate Litigation, MDL No. 2428)
Dialysis patients who may have suffered cardiovascular side effects within 72 hours of receiving GranuFlo or NaturaLyte may be eligible to file a lawsuit against Fresenius Medical Care. Learn more about the GranuFlo recall by visiting Bernstein Liebhard LLP’s website, or by speaking with one of the Firm’s lawyers directly. To arrange for a free case review, please call 800-511-5092.