Were Fresenius Medical Care officials aware of the fact that nearly 1,000 dialysis patients had died in connection with treatment with the company’s GranuFlo and NaturaLyte products?
That possibility has been raised in court documents filed against Fresenius in a huge multidistrict litigation involving several hundred plaintiffs in the U.S. District Court of Massachusetts.
Allegations that an internal memo within Fresenius official circles was distributed containing data about 941 patient deaths occurring after use of GranuFlo and NaturaLyte have been filed.
In addition, the New York Times and other media have reported that when Fresenius executives decided to inform health care professionals about life-threatening risks linked to the products they initially only informed physicians at Fresenius-operated dialysis centers.
The Times reported that federal officials were investigating whether laws were broken by a notification process that put independent clinics at the back end of the notification process line.
The FDA wound up issuing a Class 1 Recall Notice in March of 2012, informing the public and health care professionals that Fresenius was recalling numerous lots of the GranuFlo and NaturaLyte acid concentrates.
In its Reason for Recall, the FDA wrote:
“The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.”
Class I recalls are described by the FDA as the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The U.S. District Court of Massachusetts website provides a link to the GranuFlo and NaturaLyte multidistrict litigation and detailed information about court filings and judicial orders.
This is the language describing the litigation which has been consolidated under U.S. District Court Judge Douglas Woodlock:
“These actions share factual issues arising from allegations that Plaintiffs suffered injury or death caused by the use of GranuFlo and/or NaturaLyte products during hemodialysis, which allegedly may cause metabolic alkalosis in patients resulting in low blood pressure, hypokalemia, hypoxemia, hypercapnia, cardiac arrhythmia, or cardiopulmonary arrest. All the actions involve factual questions relating to whether GranuFlo and NaturaLyte were defectively designed or manufactured, whether Fresenius, the manufacturer of these dialysate products, knew or should have known of the alleged propensity of these products to cause injury and whether it provided adequate instructions and warnings with these products. These cases have been assigned to Judge Douglas P Woodlock.”