Fresenius Center Closed in Alabama After Deaths

A dialysis center run and owned by Fresenius Medical Care has been closed down after two renal patients died from infections. The Bessemer Kidney Center in Alabama is one of twelve Fresenius clinics in the state that were featured in a 2012 health department report citing multiple deficiencies.

The center closed on May 8th following a brace of deaths, and several hospitalizations. The Center for Disease Control and Prevention is investigating instances of Fresenius dialysis injury in the state, in conjunction with the Alabama Department of Public Health.

The inspection report from March 2012 asserted that the Bessemer Kidney Center did not meet minimum standards in numerous areas, including infection control and disinfection of surfaces. The report also stated:

“Based on the observation, facility policy review and staff interview, it was determined the facility failed to ensure the patient care staff wore gloves and washed hands appropriately during patient care.”

The report cited seven specific standard-of-care deficiencies observed by inspectors. In one instance, a patient received a new catheter and dressing from a nurse who failed to change gloves after removing the old catheter. The man had to be hospitalized and given antibiotics.

By the time of the follow-up inspection on April 26, 2012, the center had corrected the deficiencies, and was allowed to continue operating until the recent closure.

Eleven other Fresenius centers judged “deficient”

Health department surveys found deficiencies in eleven other Fresenius dialysis centers over a two year period. In some cases, no follow-up reports were conducted. In others, the centers improved conditions and were judged to be compliant.

Fresenius dialysis injury prompts legal action

Fresenius runs thousands of centers in Canada, Mexico, and the U.S. The company also distributes equipment and dialysates to other clinics. Their most widely-used dialysate – the chemical agent used to screen blood during hemodialysis – is GranuFlo. The product has been at the center of numerous allegations of Fresenius dialysis injury.

A commonly-cited Fresenius dialysis injury is cardiopulmonary arrest. In GranuFlo lawsuits filed up and down the country, plaintiffs allege that the product converts to sodium bicarbonate at an unusually high level, causing patients to overdose. Fresenius is accused of knowing the risk of cardiovascular problems, and concealing it from consumers. An in-house study in 2012 found that 941 patients had died in a single year after being treated with GranuFlo.

Memo warned of Fresenius dialysis injury

In November 2011, Fresenius issued a memo to their own clinics which stated that using GranuFlo increased the risk of cardiopulmonary arrest by up to 8 times. The memo was not sent to any non-Fresenius clinics that use GranuFlo.

GranuFlo generates around $80 million annually for Fresenius. It’s estimated that 3,300 dialysis clinics in the U.S. have used GranuFlo – more than half the total number of centers in the country. More than a quarter of a million patients have been treated with the product.

There are at least eleven GranuFlo lawsuits pending against Fresenius, spread over eight different District Courts. The number of patients pursuing legal action is expected to rise significantly.

On December 12th, 2012, a motion was filed with the US Judicial Panel on Multidistrict Litigation, requesting consolidation of GranuFlo lawsuits filed in federal courts. The petition, calling for centralization to the District of Massachusetts, was signed by Fresenius on January 3rd 2013.