As GranuFlo Lawsuits Keep Flowing, Fresenius Dialysis Center Cited for Deficiencies

Bessemer, ALAs the GranuFlo lawsuit parade continues unabated, GranuFlo manufacturer and dialysis operator Fresenius Medical Care was recently cited for deficiencies in one of its facilities.

In a report carried by the Birmingham News (6/19/13), it was revealed that two deaths occurred during dialysis treatment at the Bessemer Kidney Center at Bessemer, Alabama. Five others were hospitalized. The Bessemer Kidney Center is owned by Fresenius, the German-based company that remains one of the largest operators of dialysis centers in the US. The company has been under a cloud stemming from a Fresenius Medical Care recall last year of GranuFlo and NaturaLyte.

State records show the same facility was cited in 2012 for failure to meet standards associated with infection control, glove use and disinfection of surfaces. The deficiencies were corrected. However, following the recent deaths and hospitalizations, the facility was shut down pending further investigation.

As of June 19, investigators were not able to find a link between the seven cases. “From the investigation, we didn’t find anything to correlate with the blood cultures,” said Dr. Tom Geary, director of the Bureau of Health Provider Standards at the Alabama Department of Public Health. “This is not to say that there couldn’t possibly have been one, but we could not find one. Not in the water system. Not in any one particular dialysis machine. Not in any particular dialysis technician.”

The facility was shuttered May 8, after two dialysis patients died and five others were hospitalized within several days of one another. While there was no link found amongst the seven cases, state inspectors did find deficiencies related to staffing levels and training. The facility, one of several Fresenius operates in the state of Alabama, will not be allowed to reopen until the deficiencies are addressed.

Meanwhile, Fresenius lawsuits continue to be filed over alleged alkali dosing errors related to GranuFlo and NaturaLyte. The two products are used as part of kidney dialysis, and are effective when dosing remains at optimum levels and are closely monitored for bicarbonate in the blood. Incorrect levels of bicarbonate can foster cardiac events. One of the most recent GranuFlo lawsuits was filed on June 3 in Iowa Southern District Court (case no. 3:2013cv00073). The plaintiff, who survived, claims in his Fresenius lawsuit that he suffered a heart attack while driving to work following dialysis treatment, lost consciousness and was involved in an automobile accident that resulted in a fatality. It is alleged that GranuFlo was employed during his dialysis treatment.

In a separate Fresenius lawsuit, the daughter of a woman who died following dialysis treatment alleged her mother suffered a fatal heart attack caused by the use of GranuFlo and NaturaLyte during Fresenius dialysis. The lawsuit, filed May 17 in Massachusetts District Court, is case no. 1:2013cv11215.

Fresenius, by way of an internal memo to Fresenius-operated dialysis facilities, warned of potential alkali dosing errors leading to incorrect levels of bicarbonate on the blood, further endangering patients and especially those with heart conditions.

However, Fresenius drew the ire of Dr. Tom Geary (director of the Bureau of Health Provider Standards at the Alabama Department of Public Health) and non-Fresenius dialysis patients when it was revealed that Fresenius issued the warning exclusively to Fresenius-operated facilities, and not to other operators using Fresenius products.

The memo, which reflected serious concern on the part of Fresenius, was leaked to the FDA in March of last year. It led to a NaturaLyte GranuFlo recall, together with an ongoing parade of litigation.