The dialysis process was first invented in the 1940s, and the decades since have shown many advances in kidney care and treatment of acute and chronic conditions.

GranuFlo was first introduced to the U.S. market in 2003. It is manufactured by Fresenius Medical Care (FMC), a diversified health care company headquartered in Germany. The company is known for aggressive advertising, and both its GranuFlo and NaturaLyte products benefited from the exposure, becoming dominant treatment solutions within the dialysis industry.

During a seven-year period after its introduction, FMC observed a rise in serum pre-dialysis bicarbonate levels, which is very dangerous and can potentially result in cardiac arrest and stroke.

In 2010, FMC reported 941 cases of cardiac arrest resulting from the use of GranuFlo as well as NaturaLyte. Shortly thereafter, in 2011, FMC released a memo to its clinics warning of serious dangers related to the use of GranuFlo, including an increased risk of cardiac arrest resulting in death. That same year, the company provided 34.3 million dialysis treatments and had a net revenue of $12.8 billion.

With regard to the memo released by Fresenius, the company did not also alert other centers of the harmful effects of the product, thereby endangering significant portions of the customer base. The website RenalWEB estimated that 125,000 patients were treated with GranuFlo in non-Fresenius clinics.

The controversy surrounding the drug and reported cases of cardiac arrest was mainly concerned with the fact that GranuFlo automatically contributes extra bicarbonate to the body when being administered, with many doctors not taking this into account in prescribing separate doses of bicarbonate — resulting in an overdose.

In March 2012, the FDA ordered a Class 1 recall of GranuFlo and NaturaLyte. A Class 1 recall is the most serious recall level, defined as “a situation in which there is a reasonable probability that the use of or exposure to a volatile product will cause serious adverse health consequences or death.”

In a June 2012 article in the New York Times, it was estimated that Fresenius provides dialysis for more than one-third of the approximately 400,000 patients in the U.S. who require the treatment.

By the start of 2013, there were 37 cases involving GranuFlo and NaturaLyte pending in federal courts across the country, including the following states: Alabama, California, Florida, Louisiana, Massachusetts, Mississippi, New Jersey, New York, Ohio, and Pennsylvania. More than 1,500 people have filed suit against FMC under the assertion that the company did not provide proper warning about the dangers associated with the use of GranuFlo in dialysis treatment.