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Lawyers Bid for Leadership Roles in Fresenius Dialysis Litigation

On June 21, a group of six lawyers representing plaintiffs involved in Granuflo litigation filed a motion to request appointment to a variety of leadership roles in the recently-established federal multidistrict litigation (MDL 2428). The MDL, which is to be heard in Massachusetts District Court, was established earlier this year. The presiding Judge is Douglas P. Woodlock.

Fresenius dialysis lawsuits filed all over the United Stated were consolidated into the MDL in order to reduce duplicative discovery, serve the convenience of witnesses, parties and the court system, and to avoid conflicting pretrial rulings from different judges. Each lawsuit makes similar allegations against Fresenius, claiming that the company’s dialysate GranuFlo, used to treat renal patients, can cause cardiopulmonary arrest and other fatal side effects.

The six attorneys who filed the motion have requested that Judge Woodlock schedule an Initial Case Management Conference to determine the structure of the MDL and assign leadership positions to help lawyers coordinate their efforts. It is suggested that Judge Woodlock should appoint lawyers to a Plaintiffs’ Executive Committee, a Plaintiffs’ Steering Committee, and a Liaison Counsel, which will be responsible for coordinating activities in the federal MDL with state-level litigation from all over the country.

This type of coordination is not uncommon in MDL proceedings, which are typically comprised of vast amounts of evidence and witness testimonies. In their request, the six lawyers have asked Judge Woodlock to ascertain all the necessary leadership positions before the first MDL hearing takes place.

Hundreds of Fresenius dialysis lawsuits pending

Thus far, more than 300 plaintiffs have filed a Granuflo injury lawsuit against Fresenius in the U.S. Each one alleges that serious side effects of the dialysate caused cardiac arrest, heart attack or death either during or shortly after treatment.

Granuflo is a dry acid concentrate that counteracts acid in the body by promoting diffusion with alkaline. It requires careful management to ensure a stable pH balance in the body. Granuflo works by converting acetate to bicarbonate. According to Fresenius dialysis lawsuits, the product converts acetate to bicarbonate at an unusually high rate, creating dangerous levels of sodium in the blood.

Thousands of patients are suspected to have been unwittingly exposed to potentially fatal Granuflo side effects after visiting one of the 3,300 clinics that use the products in the U.S. Around a third of these clinics are directly operated by Fresenius, with the rest being supplied GranuFlo, Naturalyte and other dialysis technologies by the company.

Internal memo implicates Fresenius

Plaintiffs currently involved in Fresenius dialysis lawsuits accuse the firm of having prior knowledge of the risk of heart attacks associated with GranuFlo. Furthermore, Fresenius allegedly withheld this information from doctors and clinics who utilized their products.

In a memo sent to their own clinics in November 2011, Fresenius issued details of an internal review of patients treated at 667 clinics in 2010. The results showed at least 941 instances of cardiac arrest during hemodialysis treatment.  The memo warned Fresenius’ physicians regarding the importance of closely monitoring bicarbonate levels. But the company failed to disperse this information to other clinics that used Granuflo. The memo – which indicated the risk of cardiac arrest was as much as eight times higher compared to other dialysates – was leaked to the FDA in March 2012, prompting Fresenius to provide all clinics that used GranuFlo with a warning letter. In June 2012, the FDA implemented a Class I recall of both Granuflo and Naturalyte.

While the organizational structure of the MDL is being established, and as publicity surrounding the litigation grows, lawyers are expecting thousands of Fresenius dialysis lawsuits to emerge. It’s estimated that a quarter of a million people have been treated with GranuFlo.