GranuFlo

GranuFlo and/or NaturaLyte are used in the treatment of acute and chronic renal failure during dialysis. According to Fresenius’ website, “GranuFlo is the most-widely prescribed dry acid product in the dialysis industry today.”

Dialysis is a method of treatment designed to replace the function of kidneys by filtering toxic waste from the blood through an external bicarbonate filtration system – a system that helps the body to maintain an acid-base balance, otherwise referred to as a pH balance. Bicarbonate in the blood stream acts as a pH buffer to neutralize metabolic acidosis (the over-production of acid), which is often associated with dialysis patients.

There are two types of dialysis: peritoneal dialysis and hemodialysis. Hemodialysis is the most common way to treat advanced and acute kidney failure. During hemodialysis, the blood is pumped through the dialyzer in one direction and the dialysate is pumped in the opposite direction. The dialysate used is a mixture of a bicarbonate concentrate and an acid concentrate (such as GranuFlo and/or NaturaLyte). The solution flows through the dialyzer and interacts with the patient’s blood.

GranuFlo and/or NaturaLyte, as the acid concentrate, contain acetic acid and sodium acetate. Because sodium acetate is a bicarbonate precursor and does not consume an equal amount of bicarbonate, it enters the bloodstream and metabolizes quickly, which can result in metabolic alkalosis, a condition in which the pH of tissue is elevated beyond the normal range. Metabolic alkalosis is correlated with an increased risk of cardiopulmonary arrest and sudden cardiac death during or after dialysis treatment.

In 2003, the FDA approved “the New Fresenius Naturalyte Granuflo Dry Acid Concentrate” for marketing pursuant to Section 510(k) of the Food, Drug and Cosmetic Act. A Section 510(k) application is a premarketing submission made to the FDA to demonstrate that a device is substantially equivalent to a device already placed on the market. Fresenius claimed GranuFlo was “substantially equivalent” to its dialysates that were approved in 1991 (when Fresenius first began using sodium diacetate) and in 1994 (when Fresenius increased the amount of sodium diacetate). Notably, these other dialysates were also approved under the FDA’s 510(k) process.

On November 4, 2011, Fresenius issued an internal memo to doctors practicing in the company’s dialysis centers. The memo warned doctors that failure to properly use GranuFlo and/or NaturaLyte appeared to be contributing to sharp increase in the risk of patients dying suddenly from cardiac arrest. The basis for the memo was a study conducted by Fresenius of patients in its dialysis centers. According to the case-control study, over 25% of the patients showed high bicarbonate levels, which could lead to cardiac arrest. Accordingly, the study identified 941 patients in 667 Fresenius facilities between January 1, 2010 and December 31, 2010 that had suffered from cardiac arrest. The company’s medical staff concluded that patients with high levels of bicarbonate in their blood had from 4.7 to 6.3 times higher risk of cardiopulmonary arrest (depending on their pre-dialysis bicarbonate or potassium levels).

On March 29, 2012, the FDA issued a Class I recall of GranuFlo and/or NaturaLyte due to the possibility that use of the drugs could contribute to metabolic alkalosis. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that the product will cause serious adverse heath consequences or death. According to the FDA, Fresenius failed to disclose vital information to the FDA and health-care providers about the possible risk of high bicarbonate levels when administering these products.

Plaintiffs in the litigation claim that Defendants knew, or should have known, as early as 2005 that the concentration of acetic acid or sodium diacetate contained in GranuFlo and/or NaturaLyte, was leading to a dangerous increase in bicarbonate levels in patients undergoing hemodialysis, causing Plaintiffs damages and harm. Such damages and harm include death, serious permanent physical injury, life-altering pain and suffering, loss of income, loss of opportunity, loss of family and social relationships, and other economic harm.

Causes of action for this litigation include strict liability, negligent failure to warn, negligent design, negligence, negligent misrepresentation, breach of implied warranty of merchantability, breach of implied warranty of fitness for particular purpose, breach of express warranty, fraud, violation of consumer protection laws, loss of consortium, wrongful death, and survival actions.