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GranuFlo Lawsuit Filed over Dialysis Patient’s Heart Attack

dialysis machineA Texas resident has filed a GranuFlo lawsuit over a heart attack that he suffered allegedly as the result of the dialysis product during his dialysis treatment at a Fresenius medical facility in California. The complaint was filed in the US District Court, District of Massachusetts on April 1, 2015. The lawsuit was filed as a short form complaint which will be incorporated directly as part of the multidistrict litigation (MDL No. 2428-DPW) currently taking place under Judge Douglas P. Woodlock in the Massachusetts court.

According to Lee Greeneagle v. Fresenius Medical Care Holdings, Inc. et al (Case 1:15-cv-11491), Lee Greeneagle suffered cardiac arrest while undergoing dialysis at the Fresenius Medical Care center located in Eureka, CA. The complaint alleges that the heart attack was caused by the GranuFlo dialysis product used during his treatment.

Over 2,500 complaints similar to Greeneagle v. Fresenius have been incorporated as part of the Granuflo MDL.

Granuflo lawsuit one of hundreds of cases

As lawsuits continue to be added to the MDL taking place in Boston, participating parties are now looking toward the next major milestone in the litigation process: two preliminary (or “bellwether”) trials to be held in 2016. (The first is slated to take place on January 11 and the second on February 16.)

The two bellwether cases are designed to “test the waters” with jurors to see how they will react to evidence presented during the trials. If, for instance, the jurors find overwhelmingly for the plaintiffs, the defendants may consider negotiating a large scale settlement to resolve the hundreds of other cases pending in the court. MDLs are structured in order to efficiently process large numbers of similar cases, with a shared discovery process and the representative bellwether cases designed to bring unwieldy number of legal battles to an end in a reasonable amount of time.

The master form complaint to which all short form complaints in the MDL refer asserts that Fresenius Medical Care, a company based in Germany but with a significant number of dialysis centers in the US, had knowledge that their product was defective and dangerous as dispensed. Although Fresenius clinics associated with the company were warned of the problem, clinics outside of the Fresenius network who nevertheless used GranuFlo and NaturaLyte, the two products named in lawsuits, were given no information about the risks.

An internal memo circulated in 2011 made note of the fact that 941 patients in settings where the two Fresenius products were used had died of heart attacks; this number represented an increase six times the expected rate and raised alarm.

The memo is clear that the deaths are linked to the high level of bicarbonate that the dialysis process produced when GranuFlo and NaturaLyte were employed in the proportions directed.   A recall of the products was only announced in 2012 when the memo was leaked to the FDA.

  1. US District Court, District of Mass, MDL2428: In Re: Fresenius Granuflo/Naturalyte Dialysate Products Liability Litigation
  2. NY Times, Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry