Fresenius Faces New NaturaLyte Recall

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Fresenius has recently issued a recall for their dialysis product, NaturaLyte. This NaturaLyte recall comes after a much larger 2012 recall over different reasons.

NaturaLyte, and a smilar product called GranuFlo, are two dialysis mixes produced by Fresenius. GranuFlo and NaturaLyte are used to create dialysis fluid, a liquid used to draw biological waste out of the blood during dialysis.

The current urgent medical device recall from Fresenius was issued in April for 49 lots of NaturaLyte, for lots of NaturaLyte distributed between Aug. 15, 2013 and April 7, 2014. Fresenius’s website lists the specific dates and batch numbers.

The NaturaLyte recall is over the possibility of bacterial contamination. According to the recall notice, the exact species of bacterium is unknown, but there is sufficient concern to recall the NaturaLyte. According to Fresenius, bacterial endotoxins can cause a host of serious medical problems, including fever, chills, and trouble breathing. The recall says that the effects should be temporary, but may be severe, and even life-threatening. Fresenius recommends that any dialysis equipment that used the tainted batched of NaturaLyte be sterilized with heat-disinfectants.

This NaturaLyte recall is much smaller than a previous recall involving Fresenius dialysis products. In November 2011, an internal memo revealed that Fresenius was aware of the risk of alkalosis and serious heart problems associated with their dialysis products.

Dialysis fluid can alter blood chemistry. Theoretically, dialysis fluid can raise the blood’s pH by increasing serum levels of bicarbonate. Alkalosis, or high blood pH, can create a situation where a person is more likely to suffer from sudden heart attack, since high pH levels can interfere with the ions that regulate the heart muscle.

The GranuFlo and NaturaLyte lawsuits against Fresenius has centered on the fact that the internal Fresenius memo about the problem was issued in November 2011, but only distributed to Fresenius-affiliated dialysis centers. It was not until an anonymous whistleblower leaked the memo to the U.S. Food and Drug Administration that Fresenius released the same information to non-Fresenius dialysis centers, culminating in a 2012 recall of GranuFlo and NaturaLyte over alkalosis concerns. This has lead to GranuFlo lawsuits, alleging that Fresenius did not do enough to protect dialysis patients from sudden cardiac arrest.

The GranuFlo lawsuits against Fresenius have taken the form of a Multidistrict Litigation (MDL) or Mass Tort. Mass Torts are a type of group lawsuit, similar to the more familiar class action lawsuit. In both Mass Torts and class action lawsuits, a group of plaintiffs allege that they have suffered similar harm at the hands of the same defendant. The main difference is that class action lawsuits start out as group lawsuits, while MDLs start as individual suits which are later consolidated together to take advantage of the same legal resources. Mass Torts are more common in drug and medical supply lawsuits, since drugs and medical injuries can vary, making a single Granuflo class action lawsuit unrealistic.

The NaturaLyte lawsuit is In Re: Fresenius Granuflo/Naturalyte Dialysate Product Liability Litigation, MDL No. 2428, filed in the U.S. District Court for the District of Massachusetts.

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