Multidistrict litigation continues against Fresenius Medical Care, a German-based pharmaceutical company that manufactures the dialysis drug GranuFlo. The GranuFlo MDL was established in the US District Court for the District of Massachusetts in April of this year.
Discovery for the GranuFlo lawsuit is currently in process, and Bellwether trials are set to begin in January. Plaintiffs who have taken GranuFlo allege that Fresenius failed to warn anyone, other than their own dialysis centers, of the dangerous findings related to their product.
In November 2011, Fresenius sent an internal memo warning its dialysis centers that the failure to account for an excess of bicarbonate resulting from an ingredient in their GranuFlo product, was associated with “Six to eight-fold greater risk of CP arrest and sudden cardiac death.”
Though the company knew of the possibility for GranuFlo to potentially cause heart problems and even death, they did not inform other dialysis centers or patients of this urgent issue. The FDA only learned of Fresnius’ findings a year later, when it received a copy of the internal memo anonymously.
Since then, the FDA has issued two warnings to the company, stating that the practices at two of its subsidiaries, located in India and Puerto Rico, do not meet safety standards. The most recent warning concerns marketing issues related to the mislabeling of a product.
Since entering the market in 2003, GranuFlo had steadily increased in market share and is now used by approximately 40,000 kidney dialysis patients in the US. In 2010, 941 patients suffered cardiac arrest inside Fresenius clinics, as a result of taking GranuFlo.
The drug, used in the treatment of acute and chronic renal failure during hemodialysis, was recalled in March 2012.
“Fresenius covered up the dangers of their GranuFlo product for years, possibly decades,” said attorney Ben Gordon, a shareholder with the Levin, Papantonio law firm who practices in the areas of personal injury and bad drug and medical device litigation.
“This company, with 55,000 US employees, gobbling up other companies of this type in the United States, has done everything they can to simply their procedure and cut costs in a way that they can save themselves money and boost their bottom line without protecting patient safety,” he added.
Pharmaceutical manufacturer Fresenius Medical Care is the nation’s largest supplier of dialysis machines and disposable products. Their dialysis centers treat more than one-third of all American receiving dialysis.