The attorney general of Louisiana is pursuing a lawsuit against Fresenius Medical Care over problems with GranuFlo and NaturaLyte dialysis solutions, alleging that the company defrauded the state’s Medicare program by not warning about the increased heart attack and cardiac arrest risks that eventually led to their recall.
The lawsuit was filed last week in the 19th Judicial District Court in Baton Rouge, claiming that Fresenius failed to warn nearly 100 clinics in Louisiana that used GranuFlo and NaturaLyte about the importance of monitoring patient bicarbonate levels during treatment.
The complaint comes amid a growing number of Fresenius dialysis lawsuits filed on behalf individuals nationwide who allege that serious and sometimes fatal injuries were caused by sudden cardiac arrest that occurred during or shortly after treatments involving the use of GranuFlo or NaturaLyte.
Fresenius Medical Care not only manufactures Granuflo, NaturaLyte and other dialysis products, but the company also owns and operates many of the dialysis treatment centers throughout the United States.
Concerns about the link between the Fresenius dialysis treatments and heart problems surfaced in early 2012, after an internal memo was leaked to the FDA.
In November 2011, Fresenius conducted an internal review of the use of the acid concentrates at their own clinics, identifying at least 941 instances where patients suffered sudden cardiac arrest during dialysis treatment in 2010. While the company issued the memo only to doctors at their own clinics, warning about the importance of monitoring bicarbonate levels during treatments, they failed to provide the same information other clinics that used the products.
After the internal memo was leaked to the FDA in March 2012, Fresenius finally provided a warning letter to all healthcare providers on March 29 of that year, which the FDA determined constituted a GranuFlo and NaturaLyte recall.
According to the Louisiana lawsuit, Fresenius knew about the risk of problems as early as 2004, and knew that it should be providing special instructions to medical providers using GranuFlo or NaturaLyte, which convert to bicarbonate at higher than expected rates, which may cause sudden cardiac arrest, heart attack or death.
The lawsuit claims that Fresenius voilated Louisiana Unfair Trade Practices and Consumer Protection Law, accusing the company of defrauding the state and its residents, doctors and dialysis clinics. The violations could carry fines of up to $5,000 per violation.
Fresenius GranuFlo Lawsuits
Fresenius Medical Care currently faces more than 1,800 product liability lawsuits pending in the federal court system over Granuflo or NaturaLyte dialysis treatments, which are centralized for pretrial proceedings as part of a multidistrict litigation (MDL) before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts. In addition, hundreds of additional cases are pending in various state courts nationwide.
All of the complaints involve similar claims that dialysis patients suffered sudden cardiac arrest or death following treatments involving Granuflo or NaturaLyte acid concentrates, alleging that Fresenius failed to provide adequate warnings about the importance of doctors monitoring bicarbonate levels during hemodialysis.
The cases are centralized to reduce duplicative discovery, avoid conflicting pretrial rulings and to serve the convenience of the parties, witnesses and courts.
As part of the coordinated pretrial proceedings, a small group of lawsuits are being prepared for early trial dates, known as “bellwether” cases, since they are designed to help the parties gauge how juries may respond to certain evidence and testimony that may be repeated throughout the litigation. The first trial dates are expected to begin in early 2016.