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An Alabama dialysis clinic owned and operated by Fresenius Medical Care has been shut down after at least two patients died from infections and several others fell ill.
The Bessemer Kidney Center was shut down on May 8, following an outbreak of infections following dialysis treatments.
Investigators have not found any common link between the infections and have not released details on the patients, but the Alabama state health department cited the center last year for problems with infection control measures.
According to a report by AL.com, the Fresenius dialysis center in Bessemer, Alabama was cited by state health inspectors on March 15, 2012. The inspection 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.
The Alabama Department of Public Health is investigating the outbreak of infections at the Fresenius dialysis center, but has yet to reveal any findings.
Lawsuits over Fresenius Dialysis Center Problems
Fresenius Medical Care is the largest provider of dialysis treatment and dialysis drugs in the United States, with thousands of centers nationwide. In addition to operating about half of all dialysis clinics in the U.S., Fresenius also manufactures and sells many of the products used at centers owned by other companies.
Over the past year, Fresenius has come under sharp criticism for failing to follow appropriate steps to ensure the safety of individuals receiving dialysis treatments involving their products. Specifically, the company reportedly failed to disclose information about a risk of sudden cardiac arrest and death that may be caused by side effects of their Granuflo and NaturaLyte acid concentrates, which were recalled early last year.
Several hundred Fresenius dialysis treatment lawsuits have been filed in courts throughout the United States on behalf of individuals who suffered sudden heart problems and wrongful death lawsuits for families of individuals who died during or shortly after treatment. 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.
NaturaLyte is a liquid acid concentrate and GranuFlo is a dry acid concentrate. 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.
A growing number of complaints allege that Fresenius placed their desire for profits before patient safety by failing to immediately warn about the risk of problems with Granuflo and NaturaLyte, continuing to market and sell the products to competing clinics even after they issued a warning to their own doctors about the number of dialysis treatment deaths that may be linked to the products.
In the federal court system, at least 161 lawsuits filed in U.S. District Courts throughout the country have been consolidated in the U.S. District Court for the District of Massachusetts as part of an MDL or multidistrict litigation. The cases have been centralized for consolidated pre-trial proceedings, where they will be managed in a manner similar to how a Fresenius dialysis center class action lawsuit would be handled during coordinated discovery. However, if a settlement agreement or other resolution for the Fresenius litigation is not reached following the MDL proceedings, each case may be remanded back to the U.S. District Court where it was originally filed for a separate trial.