Investigators Find No Link in Alabama Fresenius Dialysis Deaths, Infections

Following an investigation into a number of patient deaths and infections at a Fresenius dialysis center in Alabama, state health officials indicate that they have been unable to find any link between the cases.  

At least two patients died and five were hospitalized last month following dialysis treatment at the Bessemer Kidney Center in Bessemer, Alabama. However, investigators from the Alabama Department of Public Health have failed to find any common thread between the deaths and injuries.

The Bessemer Kidney Center is owned by Fresenius Medical Care, which is one of the largest providers of dialysis treatments in the United States. The clinic will now be allowed to re-open, after it was shut down on May 8.

State health inspectors previously cited the Fresenius dialysis center in March 2012, after a report cited one incident where a patient was hospitalized, and outlined problems at the 36-station dialysis center, including determinations that the facility failed to ensure that staff washed their hands and wore gloves during treatments. The center is one of 12 clinics owned by Fresenius in Alabama that have reportedly been cited for infection control problems.

It is unclear whether those problems had anything to do with the recent spate of infections and deaths. State health investigators said they were closing the investigation, but indicate that does not mean that there was no problem at the center, only that if there was a problem, they could not find it.

During the course of the investigations, inspectors found deficiencies with how the center was run, but a report of those issues has not yet been released.

Officials from the center said the deaths and illnesses were random events that just happened to occur in a short time span.

Fresenius GranuFlo and NaturaLyte Lawsuits

In addition to owning and operating thousands of dialysis centers throughout the United States, Fresenius Medical Care also manufactures dialysis products and machines used at other centers.

Fresenius currently faces hundreds of lawsuits over cardiac arrests and sudden deaths during dialysis treatments involving the company’s Granuflo or NaturaLyte dialysate solutions.

The complaints allege that Fresenius withheld important information from doctors at their own clinics and from the entire medical community about the risks associated with Granuflo and NaturaLyte, including the importance of monitoring bicarbonate levels for patients treated with the products. Both products contain sodium acetate that convert to bicarbonate at higher-than-expected levels for most doctors, according to allegations raised in the complaints.

Fresenius issued an internal memo to their own clinics in November 2011, indicating that an internal review of patients treated at 667 Fresenius dialysis clinics in 2010 and found at least 941 instances where individuals suffered cardiac arrest during dialysis treatment. The memo warned physicians at Fresenius clinics about the importance of monitoring bicarbonate levels, but the company failed to provide this information to other clinics that used Granuflo and NaturaLyte.

After the internal memo was leaked to the FDA in March 2012, Fresenius finally provided a warning letter to all healthcare providers, which the FDA has classified as a NaturaLyte and Granuflo recall.

In March, the U.S. Judicial Panel on Multidistrict Litigation issued an order consolidating the federal court Fresenius dialysis treatment litigation before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts, where the cases will be coordinated during pretrial proceedings as part of an MDL or multidistrict litigation. It is ultimately expected that hundreds, if not thousands, of cases are likely to be filed over problems with Granuflo or NaturaLyte.