New NaturaLyte Recall Expands Over Contamination Concerns

The latest Fresenius recall over a contaminated batch of NaturaLyte has been expanded. The new recall goes above and beyond the earlier recall, and comes as the company is facing legal action over a previous recall-generating issue.

NaturaLyte and GranuFlo are two similar dialysis products produced by Fresenius. They are used to create dialysis fluid. Dialysis is a process that purifies the blood of patients whose kidneys have failed. In this process, dialysis fluid is used to create an osmotic gradient and draw waste out of the blood. However, both NaturaLyte and GranuFlo have been involved in recalls and dialysis treatment lawsuits over alleged problems with the formulations.

The current recall concerns NaturaLyte. The recall came after several lots of NaturaLyte tested positive for bacterial contamination. Specifically, the batches in question have tested positive for a bacteria called Halomonas. Halomonas can thrive in salt-rich liquids, like those of the human body and dialysis fluid. If it gets into the blood stream, this bacterium can cause systemic body-wide infections, which can be fatal.

The recall initially went out for 49 lots of NaturaLyte. Top Class Actions reported on the recall when it was first issued. However, Fresenius recently added to the NaturaLyte recall. The voluntary recall was coordinated between the FDA and Fresenius. It was a Class I recall, the highest level of recall the FDA can issue. Class I recalls are reserved for cases where there is “reasonable probability that use or exposure to a violative product will cause serious adverse health consequences or death.”

Fresenius has faced previous recalls for GranuFlo and NaturaLyte, in which the recalls led to GranuFlo lawsuits. The previous recall was related to an increased risk of developing alkalosis, a condition in which the blood’s pH rises dangerously. Alkalosis can increase a person’s risk of developing sudden cardiac arrest. In this case, an internal memo dated to late 2011 allegedly indicated that Fresenius was aware of this risk. However, it was not until 2012, when the memo was leaked to the FDA, that a recall was initiated.

The action against Fresenius over this earlier recall has taken the form of a multidistrict litigation (MDL) or mass tort. MDLs are a type of group litigation, wherein a group of similar lawsuits are coordinated together. In some ways, MDLs are similar to the more familiar class action lawsuit. Both MDLs and class action lawsuits allow a group of plaintiffs to allege that they have suffered similar harms at the hands of the same defendants in a court of law. Both class action lawsuits and MDLs are designed to streamline the legal system, by combining dozens, hundreds, or even thousands of individual lawsuits, into a single legal proceeding. MDLs are more common than class action lawsuits for drug and medical supply lawsuits, since these lawsuit are harder to coordinate into a class action lawsuit from the beginning. However, they are often similar enough to be included in a single MDL.

The GranuFlo/NaturaLyte MDL is In re Fresenius GranuFlo/NaturaLyte Dialysate Products Liability Litigation, MDL No. 2428 in the District Court of Massachusetts.

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