The dates specifically are January 11 and February 16, 2016 for the trials slated for Massachusetts Federal Court (In re Fresenius GranuFlo/NaturaLyte Dialysate Litigation, MDL No. 2428). US District Judge Douglas P. Woodlock will be presiding over the two cases that will serve as a test, for lack of a better word, on behalf of over 2,000 similar cases consolidated in multidistrict litigation. As of October 15, those cases numbered 2,127 and climbing.
The Fresenius lawsuit centers on the alleged failure of Fresenius Medical Care Inc. to alert dialysis clinics outside its own cadre of branded Fresenius clinics of potential Alkali Dosing Errors inherent with its dialysis products GranuFlo and NaturaLyte. Fresenius is in the unique positon of manufacturing the two products that it uses in Fresenius-branded clinics, as well as competing clinics such as DaVita.
The problem is rooted in apparent errors, or confusion in the product labeling that could foster incorrect levels of bicarbonate in the bloodstream during dialysis that could, in turn, produce a GranuFlo heart attack or any number of other side effects. For some patients, the errors proved deadly. And because competing clinics were exposed to the potential problems with what eventually became a GranuFlo recall, DaVita heart attack was also an issue for some patients.
The recall of a product, or its label, is not new. However, what appears to set this case apart are the actions of Fresenius in the fall of 2011. To that end, a focus will be on deaths or injury that may have occurred either before or after November 4, 2011.
That’s the day when Fresenius issued an internal memo to health care professionals in its own facilities urging caution when using GranuFlo and NaturaLyte, and to carefully monitor bicarbonate levels. Fresenius, however, for reasons and positions understood only to them, decided against notifying other dialysis operators using GranuFlo and NaturaLyte. Thus, those facilities - and their patients - were in the dark with regard to the cautions, with dialysis patients at alleged risk for potentially serious health issues.
Fresenius eventually did issue a more widespread Fresenius Medical Care recall in March 2012 - four months after notifying its own clinics - but not before the internal Fresenius memo was leaked to the US Food and Drug Administration (FDA), which in turn launched its own investigation and subsequent Class I recall of GranuFlo and NaturaLyte in June of that year.
Plaintiffs charge Fresenius with failure to notify, and withholding important medical information vital to the health and safety of dialysis patients.
READ MORE GRANUFLO RECALL LEGAL NEWS
Even the state of Louisiana is getting into the fray, filing a lawsuit this past June against Fresenius (The State of Louisiana vs. Fresenius Medical Care, Case No. 631586, 19th Judicial District Court, Parish of East Baton Rouge). The latter operates nearly 100 clinics in the state. The state further charges Fresenius of fraud against Louisiana’s Medicaid program by failing to disclose the risk of GranuFlo heart attack inherent with the Alkali Dosing Errors.
There were some 1,500 non-Fresenius dialysis clinics that did not receive information about potential Alkali Dosing Errors, when Fresenius issued its initial internal memo on November 4, 2011. By the time other facilities were notified four months later, it may have been too late for some patients.
He told the attendants that he wasn't doing well. The last year of his life he had to wait for long time after each treatment because his blood pressure was too low and he could not leave the center. Yet they continue without discovering why. He suffered A fib first, then a stroke, then he passed away within hours of his treatment as my daughter was helping him walk into the bedroom. He died as he laid down on our bed. Something was terribly wrong and not only did the center ignore his complaints, they did not investigate any further than their fingertips. A lady died in her treatment bed, had a heart attack while on a treatment.
I am part of the lawsuit on behalf of my mother who had cardiac arrest at a Fresenius clinic and died on her way to the hospital which was only less than a mile away.
Dialysis is needed but the people in charge need to be accountable for their mistakes. When you are dealing with peoples lives you need to be held at a higher level.
We are all human and make mistakes but when you do not follow through and correct those mistakes in a timely manner so no one gets hurt then you SHOULD be held accountable!!
David W Moskowitz MD MA(Oxon.) FACP