At least one dialysis patient has died and two more may have been injured by contaminated NaturaLyte liquid bicarbonate concentrate used during their treatment, according to federal drug regulators. Â
On May 28, the FDA provided an update on the recent NaturaLyte recall that includes new information about illnesses involving bacterial infections that appear to have been caused by the contaminated lots of the dialysis solution sold by Fresenius Medical Care.
Federal health regulators are aware of at least one death and two injuries that are likely caused by the bacterial contamination.
An initial NaturaLyte recall was announced in April, when Fresenius sent out a letter to health care professionals. On May 21, Fresenius announced that the recall was being expanded to include a total of 56 lots of of the liquid bicarbonate concentrate commonly used during hemodialysis treatments.
The NaturaLyte solution was contaminated with a bacteria called Halomonas. Early on Fresenius officials indicated that they believed that the dialysis filter, known as a dialyzer, and the use of the Diasafe filter created an effective barrier to prevent injuries or death from bacterial contamination. However, the FDA now says that the “use of the affected product may cause serious adverse health consequences, including sepsis, bacteremia, and death.”
The NaturaLyte recall affects NaturaLyte Bicarbonate Concentrate sold in 6.4 liter bottles, which were distributed between August 15, 2013 and April 7, 2014. The affected lots contain a product code of 08-4000-LB, with expiration dates of 6/30/2014, 7/31/2014, 8/31/2014, and 12/31/2014.
NaturaLyte Heart Attack Lawsuits
The recall comes a little more than two years after it was discovered that Fresenius withheld important safety information about the risk of cardiac arrest linked to the use of NaturaLyte and another dialysate solution known as Granuflo, a dry acid concentrate.
Fresenius Medical Care not only makes many of the products used during dialysis treatment, but also operates many of the clinics in the U.S.
In November 2011, the company sent an internal memo to their own clinics warning about the importance of doctors monitoring bicarbonate levels during treatments, since side effects of Naturlyte and Granuflo may cause higher than expected bicarbonate levels and cause dialysis patients to suffer a sudden cardiac arrest or death.
While Fresenius provided these warnings to their own clinics, the information was withheld from other dialysis clinics using the products. After the internal memo was leaked to the FDA, Fresenius finally provided warnings to the entire medical community in March 2012, which the FDA classified as a NaturaLyte and GranuFlo recall.
More than 1,500 Fresenius dialysis lawsuits are now being pursued by individuals throughout the United States who allege that sudden cardiac arrest or death following hemodialysis was caused by use of NaturaLyte or Granuflo.
In the federal court system, the litigation has been centralized before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts for coordinated handling during pretrial proceedings and a series of bellwether trials designed to gauge how juries are likely to respond to certain evidence and testimony that will be similar to what is offered in hundreds of other cases.