SCRANTON, Pa. (CN) - A widow claims in court that her husband died because of faulty dialysis products from Fresenius USA, the largest maker of dialysis products and services in the world.
Hope Schultz claims that her 50-year-old husband, Michael Schultz, died the day he received his last dialysis treatment, Dec. 17, 2010.
"After receiving defendants' defective product, he became ill during and after treatment, and went home. He suffered at home in pain and tremendous weakness until he died later that same day," the complaint states.
Fresenius, based in Waltham, Mass., has been sued dozens of times this year by people or survivors who claim their loved ones were killed or injured by its GranuFlo or NaturalLyte products.
Fresenius and its affiliate defendants treat 79,600 patients in its 1.080 dialysis clinics in the United States, according to the federal complaint.
Schultz claims Fresenius ignored repeated warnings.
"By at least January 2010, defendants had analyzed data and found that 941 patients from 667 facilities had cardiopulmonary arrests, a figure that was over six times higher than of competing products. Defendants knew that the high bicarbonate levels related to their product was an independent risk factor in these deaths," the complaint states.
Schultz claims that her husband's "injury and death, like those striking thousands of similarly situated across the country, were avoidable tragedies. This preventable loss of life resulted directly from defendants' refusal to conduct proper safety studies; defective product design; suppression of information revealing life-threatening risks; wanton failure to provide adequate instructions; willful misrepresentation concerning the nature and safety of their product; and defendants' flagrant disregard for safety by failing to disclose the risks to health care providers.
"Despite being aware of research and clinical reports that foretold of these risks and evidenced that defendants' product formulation was flawed and that their warning instructions were inadequate, defendants disregarded, and even suppressed, the risks to the detriment of thousands of dialysis patients, including the decedent."
Fresenius introduced its product NaturaLyte/GranuFlo Dry Acid Concentrate products in 2004. They contain sodium diacetate, Schultz says.
She claims that Fresenius knew that its products "significantly increased patients' total buffer and thus bicarbonate levels. Despite the risks of causing alkalosis and therefore sudden cardiac arrest, and without conducting proper testing and research studies, defendants aggressively promoted their product across the county."
The complaint continues: "For nearly a decade while doing so, defendants actively misled everyone about the product's safety and characteristics. Defendants willfully misrepresented the high bicarbonate levels their product produced and the increased buffer levels associated with its use in the information they provided to physicians, nurses, dialysis clinic staff and patients. Lacking this critical information and effective product labeling, warning and instruction, [this] caused these individuals to provide and receive dialysis treatments in an unsafe and ineffective manner. Defendants could have prevented this had they addressed the risks of which they were aware."
Schultz adds: "Without sufficient testing and while disregarding various safety signals, defendants introduced a new product to the market as a Class II medical device by gaining clearance from FDA through its 510(k) process. ... When one accounts for the additional bicarbonate from this acetate after the body converts it, Defendants' formulation increases the total buffer ultimately delivered by the dialysate nearly twice as much as any other marketed product."
Schultz seeks damages for wrongful death, negligence, negligent misrepresentation, fraud, and other charges.
She is represented by Carrie Capouellez, with Lopez McHugh, of Philadelphia.