Attorneys for Fresenius, makers of the blood cleaning product GranuFlo, insist that the spate of lawsuits facing the company will fall flat, as plaintiffs have “no merit” to bring suit against the company.
GranuFlo is used in dialysis operations to help cleanse the blood of toxins. Evidence shows us that the drug has been linked to an abnormal increase in the risk of cardiac events, including a six times greater likelihood of death from cardiopulmonary arrest. The drug has also been linked to increases in the risk of heart attacks and strokes in patients.
In spite of the documented risks, associated with GranuFlo, their attorneys issued this statement earlier in January in a court filing (courtesy of LawyersAndSettlements.com):
The plaintiff’s claims will fail on their merits because the plaintiffs cannot show that Fresenius’s products are unreasonably dangerous or that Fresenius failed to provide adequate warnings and instructions to the intermediaries who used GranuFlo and NaturaLyte to treat dialysis patients.
The company would have us believe that not only did they not fail to warn patients about the risks of GranuFlo, but that those risks don’t even exist. However, the available evidence does not support the company’s claims. As we reported earlier this week:
On November 4, 2011 Fresenius sent out an internal memo warning that failure to account for an excess of bicarbonate resulting from an ingredient contained in their product, GranuFlo, was associated with “… 6 to 8 fold greater risk of CP arrest and sudden cardiac death in the dialysis facility.”
Though Fresenius stated in the internal memo to its own dialysis centers that “this issue needs to be addressed urgently;” they apparently did not see the need to warn other centers of the dangerous findings on their product. The FDA is currently investigating just why Fresenius Medical Care chose not to share their findings with their customers and other centers that use their product, and whether their failure to inform others of the potentially lethal risk of one of their products is a violation of federal regulations…
The memo stated the findings that 941 patients suffered cardiac arrest inside Fresenius clinics in 2010. Dr. Franklin W. Maddux, chief medical officer for Fresenius North America stated that his office had no way of communicating with non-company clinics other than through medical journals saying that he did not feel the memo was “… in a condition for general consumption.”
But the attorneys for the plaintiffs in the case aren’t afraid of Fresenius’s claims about “merit,” as Levin Papantonio associate attorney Chris Paulos told us, “”We believe that we have a very strong case with regards to a dialysate product. The facts will show that Fresenius chose to design and utilize a product that puts patients at an increased risk yet provides no increase in efficacy or benefit to those patients. Additionally, Fresenius has all but conceded the inadequacy of their warnings by changing the instruction manual to their dialysis machines but failing to change the label on their products.”
Fresenius is talking a big game, but the evidence is against them in this case. And the most damning piece of evidence of all is from their own internal memos.
Farron Cousins is the executive editor of The Trial Lawyer Magazine, a contributing writer for DeSmogBlog.com, and a producer of Ring of Fire.