GranuFlo is a product used in the treatment of acute and chronic renal failure, specifically during hemodialysis. GranuFlo is made by Fresenius Medical Care North America, an offshoot of a larger, billion-dollar German medical supplier.
To be clear, renal failure is when the kidneys lose their ability to remove waste and balance fluids, and hemodialysis is kidney dialysis, or the purification of blood through a medical procedure designed to replicate kidney function.
According to the website of Fresenius, GranuFlo is the most widely prescribed dry-acid product in the dialysis industry today. Its website also assures doctors that the product is “safe for your patients and your staff.”
GranuFlo is put into a concentrate, which is then fed into a three-steam hemodialysis machine, specifically designed to handle acid, and bicarbonate concentrates. GranuFlo uses acetic acid and sodium acetate, which can have the unintended side effect of increasing sodium acetate in the dialysate, which then leads to higher levels of bicarbonate in the bloodstream.
High levels of bicarbonate in the bloodstream are problematic and can cause cardiac arrest, metabolic alkalosis, stroke, low blood pressure and even death.
Internal Fresenius memos circa 2001 have been revealed and indicate that the company was aware that GranuFlo could increase the risk of heart attack and other cardiac problems.
“In light of these troubling findings,” the memo said, doctors should take corrective action. “This issue needs to be addressed urgently,” the memo added later.
The memo was leaked to the Food and Drug Administration earlier this year, but until then had only been made available to a few doctors using the product, with only limited bits of information revealed. Most importantly, the only clinics that had been informed of the problem were Fresenius-owned clinics, not competitor clinics.
As a result, more patients survived dialysis at Fresenius clinics than at other clinics. Whether this was the company’s motivation behind not releasing the information sooner is unclear.
After the memo was leaked, the FDA issued a Class I recall of the product, the most serious type of recall, which is launched when a product can cause death. Fresenius notified other providers.“Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern,” Steven Silverman, director of compliance for the F.D.A.’s medical devices division, said
Multidistrict Litigation Will Begin Next Year
Two trials in the multidistrict litigation of GranuFlo and another Fresenius product—NaturaLyte—begin in early 2016. The two trial dates are January 11 and February 16. They will both take place in Massachusetts Federal Court, labeled In re Fresenius GranuFlo/NaturaLyte Dialysate Litigation, MDL No. 2428, and will be presided over by US District Judge Douglas P. Woodlock.
Many consider these two cases as key to determining how the rest of the GranuFlo litigation—at the time, there are 2,127 cases pending—will turn out.The basic issue in these cases is that Fresenius did not tell clinics outside of its own network about the products’ problems, particularly those related to alkali dosing errors that could cause heart problems.
One state has gotten into GranuFlo litigation. Louisiana, which is home to almost 100 Fresenius clinics, filed The State of Louisiana vs. Fresenius Medical Care, Case No. 631586, 19th Judicial District Court, Parish of East Baton Rouge this past June. Louisiana alleges that Fresenius defrauded the state’s Medicaid program by failing to warn about alkali dosing errors.
The possible effects of this problem with GranuFlo are legion, and include:
- Metabolic alkalosis
- Cardiac arrest
- Cardiac arrhythmia
- Low blood pressure