In June 2012, the U.S. Food and Drug Administration (FDA) requested that Fresenius Medical Care issue a recall for its dialysis products Naturalyte Liquid Acid Concentrate and Naturalyte Granuflo. Reported problems with these products include heart attack, stroke or even death. The FDA is investigating Fresenius for failing to inform the public in a timely way about the risks of these drugs.
Dialysis Products Put Patients at Risk of Cardiac Problems
According to the FDA, the possibility of serious harm results from the potential for high levels of serum bicarbonate in patients undergoing hemodialysis for chronic or acute kidney failure. These high bicarbonate levels can lead to metabolic alkalosis, a serious risk factor for low blood pressure, hypokalemia, hypoxemia, hypercapria and cardiac arrhythmia. Each of these conditions, if not identified and properly treated, can lead to cardiac arrest. Patients whose serum bicarbonate levels were already elevated and who were treated using Granuflo or Liquid Acid Concentrate were especially at risk.
Fresenius Responds to Lawsuits Over Granuflo Risks
Numerous lawsuits have been filed against Fresenius alleging that the manufacturer continued to distribute the products without altering its warnings after it learned of the potential dangers.
Fresenius has denied the plaintiffs’ allegations. In January 2013, Fresenius asserted, “The plaintiff’s claims will fail on their merits because the plaintiffs cannot show that Fresenius’ products are unreasonably dangerous or that Fresenius failed to provide adequate warnings and instructions to the intermediaries who used GranuFlo and NaturaLyte to treat dialysis patients.”
Manufacturer Only Issued Internal Warnings About Dangers of Dialysis Products
Unfortunately for Fresenius, its own actions suggest that it was aware of the danger. In 2011, the company took steps to warn its own network of dialysis clinics about the potential dangers of the products and the need to identify patients at high risk of complications. According to a memo leaked to the FDA, the internal memo stated, “[i]n light of these troubling findings, we strongly recommend that physicians adjust dialysate bicarbonate prescriptions monthly for individual patients, with immediate attention to patients with serum pre-dialysis bicarbonate levels of >24 mEq/L.”
It did not, however, send the same information to doctors and to dialysis centers operated by others. As the largest operator of dialysis centers in the U.S., Fresenius treats one-third of all dialysis patients, yet it did not notify the places where the other two-thirds receive treatment.
Lawsuits Will Probably Be Consolidated in Multidistrict Litigation
Fresenius is located in Waltham, Massachusetts, and the company would like the lawsuits to be consolidated in the U.S. District Court for the District of Massachusetts. However, a large number of plaintiffs are in the southern states, so federal courts in Alabama and Mississippi are being considered as possible venues for the consolidated lawsuits.