Philadelphia, PAIn the wake of concerns about the GranuFlo recall and NaturaLyte recall, GranuFlo lawsuits have been filed alleging patients were harmed by the use of Fresnius Medical Care's products. The lawsuits allege both GranuFlo and NaturaLyte did not carry adequate warnings to alert patients to the potential risks associated with the products.
According to Reuters (12/13/12), plaintiffs in the lawsuits have requested their wrongful death lawsuits be consolidated. Fresenius Medical Care has responded to the allegations saying the lawsuits are without merit and the products were cleared by the US Food and Drug Administration (FDA).
GranuFlo and Naturalyte are dialysates, used to treat acute and chronic kidney failure during hemodialysis. On May 25, 2012, the FDA issued a safety communication, warning that there had been complaints about dosing errors during hemodialysis, which could cause increased bicarbonate levels. Increased bicarbonate levels can cause metabolic alkalosis, which is associated with cardiopulmonary arrest, low blood pressure and cardiac arrhythmia.
"This potential exists for all currently marketed dialysate concentrate products containing acetate, acetic acid, or citrate," the FDA warned. It noted that a study published in the American Journal of Kidney Disease found that of 50 hemodialysis patients who were hospitalized in October 2010, 54 percent had serum bicarbonate of greater than 30 mEq/L. According to the agency, pre-dialysis serum bicarbonate levels of greater than or equal to 27 mEq/L is associated with a higher risk of death in hemodialysis patients.
In 2012 GranuFlo was recalled due to concerns about the increased risk of death in patients exposed to the product. Since that time, wrongful death lawsuits have been filed against Fresenius Medical Care. Among them is a lawsuit filed by Deborah Swigert, whose husband suffered cardiac arrest during kidney dialysis treatment. According to The Legal Examiner (11/28/12), Swigert's husband later died in hospital.
The lawsuit alleges Fresenius did not adequately disclose the cardiopulmonary risks associated with its dialysate products and, if it had given sufficient warnings, healthcare providers would not have used those particular products.
In addition to lawsuits, Fresenius also faces an investigation by the FDA into whether it failed to adequately warn customers about the risk of heart attacks. An internal memo was sent by Fresenius to its own medical clinics, warning about the risk of elevated serum bicarbonate levels, but that information was reportedly not shared with medical clinics that used the dialysate products but were not part of the Fresenius Medical Care chain, even though the memo warned, "This issue needs to be addressed urgently."
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