Fresenius Medical Care North America has recalled 58 lots of its 6.4-liter NaturaLyte Liquid Bicarbonate Concentrate used in dialysis. There were 49 lots in the April 10 recall and another nine in the May 1 expanded recall. The U.S. Food and Drug Administration, which issued its own safety communication on the Fresenius action, elevated the recall May 28 to its most serious level.
"The affected lots are being recalled," the FDA wrote, "because they may develop higher bacteria levels than is allowed by the company's internal specification during their shelf life." The agency said that laboratory testing identified the Halomonas (species 1, 2, 3) bacteria, which typically is found in water bearing a high salt concentration. "Bacterial contamination of the dialysate may lead to bacteremia or systemic infection," according to the FDA.
The concentrate is used with a three-stream hemodialysis machine calibrated for acid and bicarbonate concentrates.
The FDA ratcheted up the recall to a Class I status after the Memorial Day weekend. As the agency explained in its recall notice, "Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death." Federal regulators reported that they had received one report of death and two reports of injury that may be related to use of this product.
If any of this rings of déjà vu, there is a good reason.
As of May 15, the U.S. Judicial Panel on Multidistrict Litigation had consolidated 1,717 pending federal cases classified as Fresenius GranuFlo/NaturaLyte Dialysate products liability litigation. Those actions are centralized before one judge for uniform pretrial management.
"All of the actions ...," the panel wrote in February, "involve similar allegations that plaintiffs or their decedents suffered metabolic alkalosis as a result of the use of GranuFlo and/or NaturaLyte. These actions also likewise involve factual questions relating to whether these products were defectively designed or manufactured, whether Fresenius, the manufacturer of these dialysate products, knew or should have known of the alleged propensity of these products to cause injury, and whether it provided adequate instructions and warnings with these products."
The U.S. Food and Drug Administration announced in March 2012 a Class I recall of the dialysis "medical device" known as the NaturaLyte and GranuFlo Dry Acid Concentrate.
The agency explained that Fresenius Medical Care at the time was "cautioning clinicians" that "[i]nappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis," which may trigger risk factors culminating in "cardiopulmonary arrest." There were patients experiencing CP during treatment.
With 30 years of experience trying product liability cases against pharmaceutical corporations, the skilled attorneys at Reich & Binstock can be an effective ally that GranuFlo and NaturaLyte victims, or their grieving family members, want on their side.