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Fresenius Allegedly Failed to Warn, Say GranuFlo Lawsuits

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Washington, DCConsidering the growing number of plaintiffs who are filing a GranuFlo lawsuit, it’s no surprise that GranuFlo actions have been consolidated, as requested, into multi-district litigation. In recent weeks, the Judicial Panel on Multi-District Litigation (MDL) consolidated GranuFlo lawsuits to MDL 2428 (In re: Fresenius GranuFlo/NaturaLyte Dialysate Products Liability Litigation) in the US District Court for the District of Massachusetts.

Given the fact that Fresenius, the German manufacturer of GranuFlo, serves up to one-third of Americans requiring dialysis, it’s reasonable to assume that lawsuits will keep coming. To an individual who has lost a loved one, or having suffered serious health complications, a Fresenius lawsuit is the only logical recourse.

Health care advocates were disappointed in Fresenius last year, when it was revealed the manufacturer of GranuFlo and NaturaLyte - and the operator of a collection of dialysis clinics under the Fresenius banner - discovered the potential for alkali dosing errors inherent with GranuFlo and NaturaLyte, and duly alerted physicians at clinics within its own network.

However, Fresenius apparently didn’t bother to report the findings to customer clinics that utilized the Fresenius products until the internal Fresenius memo was leaked to the US Food and Drug Administration (FDA) in March of last year. The FDA, in turn, is reportedly investigating as to whether the inaction by Fresenius constituted a criminal act.

According to a story in The New York Times (6/14/12) appearing last year, a representative with Fresenius claimed that in the company’s view the observations that caused them concern were too preliminary to warrant publication, which in Fresenius’ view was the only way they could communicate with non-Fresenius clinics.

However, there is little doubt the dosing issue nonetheless caused Fresenius grave concern, describing their findings in the Fresenius-only memo as “troubling.”

“This issue needs to be addressed urgently,” the memo stated.

The problem centered on alkali dosing errors and the potential for an over-abundance of bicarbonate, levels of which could trigger sudden cardiac arrest. Once the FDA intervened, a Fresenius Medical Care recall of the troubled products quickly followed, but it proved too late for some patients.

Recent lawsuits involve those of two sisters who filed a wrongful death GranuFlo lawsuit on behalf of their late mother. The lawsuit is Case no. 3:2013cv01403, and was filed in US District Court, Northern District of California. In another lawsuit (Case no. 2:2013cv00371), a widow claims that in her Fresenius lawsuit the cardiovascular death of her husband was tied to the GranuFlo used during dialysis.

The crux of the problem surrounding GranuFlo and NaturaLyte involves increased levels of an ingredient converted by the body into bicarbonate. Doctors unaware of this have been found to commit alkali dosing errors, inadvertently raising bicarbonate to dangerous levels. Should metabolic alkalosis ensue, the result can be - and has proven to be - dire for some patients.

Hence the Naturalyte GranuFlo recall, and the resulting lawsuits.


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