Waltham, MAIt has been almost three years since an internal memo regarding alkali dosing errors was sent to Fresenius medical care centers and almost two-and-a-half years since the FDA announced a Class I recall of the products. GranuFlo lawsuits continue to mount, with patients and their loved ones alleging harm as a result of the use of GranuFlo and NaturaLyte dialysis products.
According to the Boston Herald (7/17/14), approximately 5,500 lawsuits have been filed against Fresenius Medical Care, alleging the company failed to properly warn about the risks of the dialysate solutions. Those lawsuits have been consolidated for multidistrict litigation (MDL number 2428, US District Court, District of Massachusetts).
The problems began in November 2011 when Fresenius sent an internal memo to doctors in its own dialysis clinics warning those doctors about the risks associated with errors in using the company’s dialysis solutions. The memo called the company’s findings concerning an increased risk of cardiac arrest and death “troubling” and noted that the issue needed to be addressed “urgently.”
Although that memo was sent to Fresenius clinics, it was not sent to outside dialysis clinics until the FDA found out through an anonymous source about the memo. The memo was more widely distributed in March 2012. In other words, doctors who worked at Fresenius clinics knew four months before doctors at other clinics about a possible increased risk of death when improperly administering the dialysis products.
In June 2012, a spokesperson for Fresenius told the New York Times that the company could not communicate with outside clinics except through medical journals and did not think the findings were conclusive enough to be published in a journal.
Lawsuits filed against Fresenius include wrongful death allegations involving patients who suffered cardiac arrest following dialysis treatment. They allege that Fresenius knew or should have known about the risks associated with the dialysis solutions and properly warned patients and physicians about those risks.
According to court documents filed in the case, "Plaintiffs contend that GranuFlo causes a rapid and unsafe elevation of bicarbonate, which creates a 6 to 8 fold increased risk of cardiopulmonary arrest and death that is unique to GranuFlo.” They further argue that Fresenius’ own study found that 941 patients treated with GranuFlo suffered cardiopulmonary arrest and sudden cardiac death.
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