Fresenius did not address the issue 'urgently'
(PRWEB) May 28, 2014
Dialysis injury lawsuits involving Granuflo and NaturaLyte are currently being filed on behalf of injured individuals, and families of lost loved ones, by the law firm McSweeney / Langevin. (See In Re: Consolidated Fresenius Cases: MICV2014-03015-O and MICV2014-03014-O).
According to Fresenius Medical Care, GranuFlo and NaturaLyte are chemicals used in dialysis machines to help clean blood. Granuflo and NaturaLyte contain a substance called bicarbonate. Bicarbonate is used to prevent a buildup of acid in the blood.
Fresenius, the German based manufacturer of Granuflo and NaturaLyte, conducted an internal study of the safety of Granuflo and NaturaLyte. The internal study revealed an up to eight-fold increase in the risk of cardiopulmonary arrest and sudden cardiac death. This information was detailed in a November 4, 2011 Fresenius Internal Memo sent only to to medical directors and physicians. This internal memo was later published by The New York Times on June 15, 2012. The internal memo warned a small number of doctors of the sharp increase of patients dying suddenly from cardiac arrest. The internal memo states "[t]his issue needs to be addressed urgently."
In attorney David Langevin's opinion, Fresenius did not address the issue "urgently." In fact, Fresenius failed to inform the Food and Drug Administration of dangers associated with Granuflo and NaturaLyte. According to the New York Times June 14, 2012 article "Dialysis Company's Failure to Warn of Product Risk Draws Inquiry," Fresenius only warned the public of the safety risks and dangers of Granuflo and NaturaLyte after an individual sent an anonymous copy of the internal memo to the FDA.
On March 29, 2012, The FDA Issued a Class I recall of Granufo and NaturaLyte shortly after the anonymous tip. A Class I recall is the most serious recall due to the risk of serious injury and death.
According to the FDA's Class I Recall, side effects of Granuflo and NaturaLyte include cardiopulmonary arrest, heart problems, metabolic alkalosis, low blood pressure, sudden MI or heart attack, stroke and even death. These side effects are usually seen during, or shortly after, the dialysis treatment.
About the personal injury law firm of McSweeney / Langevin
With the sole purpose of helping the injured, the personal injury law firm McSweeney / Langevin ensures victims and victims’ families are adequately compensated for wage loss, medical expenses and pain and suffering. While most firms have you speak with an “investigator” or “case manager,” McSweeney / Langevin connects people with one if its attorneys who will be handling your case. The firm handles personal injury cases related to dangerous/defective pharmaceutical drugs, dangerous/defective medical devices, and serious/catastrophic injury claims. For more information, visit http://www.westrikeback.com or call 1-800-888-4425.