Pharmaceutical

Lawsuits against Fresenius dialysis product GranuFlo may be consolidated

dialysis Lawsuits against Fresenius dialysis product GranuFlo may be consolidatedA lawsuit filed against Fresenius Medical Care, the largest provider of dialysis products and services, by a Virginia woman has been removed to federal court and may be grouped with similar lawsuits against the dialysis company.

The lawsuit, filed by Linda Bryant, executor of the estate of Dalta Dixie Pauley, alleges that Pauley suffered a fatal heart attack two days after undergoing dialysis treatment during which she received GranuFlo. Granuflo is a Fresenius-made dry acid concentrate commonly used in dialysis patients to help balance the electrolytes in the blood.

“Dalta Dixie Pauley died as a result of receiving unreasonably dangerous dialysis chemicals that were unfit for the purpose they were designed and sold,” the lawsuit claims. The lawsuit also alleges that six months after Pauley died, the company sent an internal memo warning doctors in its clinics that instructions on the labels of GranuFlo, and a similar Fresenius product, NaturaLyte, may be confusing and as a result patients may erroneously be given toxic amounts of the concentrate. The company warned that this error may have caused incidences of sudden cardiac death in dialysis patients.

GranuFlo and NaturaLyte contain an ingredient that metabolizes into a substance known as bicarbonate. The Fresenius products contain more of this ingredient than competitor products. Elevated levels of bicarbonate in the blood have been associated with heart problems including cardiac arrest.

Fresenius issued this warning memo to doctors at its clinics, but the company failed to warn doctors at non-Fresenius-owned clinics of the risk. The company also didn’t warn patients or communicate this problem to the Food and Drug Administration (FDA). It wasn’t until someone leaked to the FDA a copy of the internal memo that the company was forced to come clean to other clinics and patients about the risk.

As a result, hundreds of wrongful death lawsuits have been filed against Fresenius.

Source: Virginia Record