According to reports by the New York Times, Fresenius Medical Care (world’s largest provider of Dialysis products and services) has agreed to "pay $250 million to settle thousands of lawsuits from Dialysis patients and their relatives claiming that the company’s products [dialysate brands GranuFlo and NaturaLyte] had caused heart problems and deaths." The Large Dialysis Organization agreed on the settlement out of court, and if accepted will conclude a very troubling chapter in the Chronic Kidney Disease Community's history.
Reports by Law Firms such as Saiontz & Kirk, P.A., have suggested that hundreds of Hemodialysis patients suffered Heart Attacks, Cardiopulmonary (Cardiac) Arrest, Stroke, Sudden Death, and Catastrophic Heart Injury as a result of problems with the warnings and instructions provided with the Fresenius Medical Care products, GranuFlo and NaturaLyte. "Although Fresenius Medical Care knew or should have known about the potentially life-threatening side effects from NaturaLyte and Granuflo Dialysis treatments, they failed to provide proper instructions and warnings about important steps that must be taken to reduce the risk of individuals suffering a heart attack or sudden cardiac death during Dialysis," noted Saiontz & Kirk, P.A.
The Law Firm continued with even more scathing assertions, citing an internal review conducted at Fresenius Dialysis Clinics, revealing that within a close time period at least 941 patients suffered a cardiac arrest during their Dialysis Treatment. "Even after the company became aware of the shocking number of Dialysis Treatment heart problems, they failed to notify the FDA or issue a warning to clinics that were using their products." Saiontz & Kirk, P.A. claimed. The Attorney General for Louisiana elaborated, “The Defendants purposefully advised their own clinics, practitioners, and physicians of the dangers of the product, but did not advise non-Fresenius clinics, practitioners, and physicians of the increased risk of (Cardiopulmonary Arrest) associated with the use of their products.”
While both GranuFlo and NaturaLyte were approved by the Food and Drug Administration (FDA), "The company conducted a recall, which was actually a change in the label, not the removal of the product from the market," reported the New York Times. Steven Silverman (Director of compliance for the FDA’s medical devices division) called the action, "bad for business." “Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern...[it's] not in the interest of public health to sit on information about risks.”
Youhavealawyer.com speculated, "According to lawsuits over Fresenius Dialysis treatments, it is alleged that the company was attempting to hide, mislead and obscure information about the risks in an attempt to maintain market share, placing their desire for profits ahead of the safety of Dialysis patients." Kent Jarrell (Spokesman for Fresenius) disagreed and stated, "The initial internal memo was actually incorrect and contradicted by further careful analysis."
While Fresenius was not ordered to pay damages in the first of the 10,000 lawsuits which went to trial, Mr. Jarrell suggested that the company decided to settle for $250 million in order to put the
"lawsuits behind it," reported the New York Times. “Fresenius deeply regrets the confusion and concern temporarily generated by the November 2011 memorandum,” Kent said in an emailed statement.
While available damages will vary between cases, below are common damages which have been pursued:
- Pain and suffering
- Mental anguish
- Medical bills
- Lost wages
- Loss of life’s enjoyment
- Loss of earning capacity
- Funeral expenses.
Have you ever used GranuFlo or NaturaLyte dialysate brands? Do you think that it was simply an unfortunate mistake that Fresenius did not disclose findings or do you think it was a means to hide the truth about their products? Share your response with the over 36,000 KidneyBuzz.com Facebook Friends (click here). While you are there, click the "like" button to get KidneyBuzz.com updates in your Facebook News Feed. Also, follow the over 115,000 individual monthly viewers to KidneyBuzz.com every day for up to date news, information, inspiration, Impact Meals, Freebies, products and services which teach those with Chronic Kidney Disease, Dialysis, Diabetes, Kidney Transplant, and High Blood Pressure how to better manage and improve their lives.