Rights of Those Suffering Side Effects Caused by Granuflo® and NaturaLyte® during Dialysis
While dialysis is an essential and lifesaving procedure for many people suffering from kidney failure and disease, there has been a wave of lawsuits filed by those who suffered severe adverse effects like stroke, heart attack, cardiac arrest and other dangerous medical conditions after receiving dialysis treatment with GranuFlo® and NaturaLyte®. These dialysis products have been recalled because they have been linked to a sudden and unsafe increase in bicarbonate levels in the blood that can cause serious cardiopulmonary arrest and even death according to the FDA. In recognizing the risk associated with GranuFlo® and NaturaLyte®, the FDA issued its most serious Class I recall designation covering these medical products effective March 29, 2012.
The New York Times reported in an article following the recall last year that the FDA had launched an investigation into the implementation of the recall by Fresenius Medical Care, which manufactures the medical products. The article indicates that the FDA’s investigation was prompted by the discovery that Fresenius had issued a letter warning about the risk of severe cardiac incidents to its own dialysis clinics in November 2011. The memo warned clinics within the Fresenius network that 900 people had suffered heart attacks during the prior year after dialysis treatments using Granuflo® and NaturaLyte® according to the New York Times article.
Despite the company’s apparent knowledge of the potential for life-threatening side effects, Fresenius did not warn dialysis clinics outside its own network according to the article. This information was not provided even though the company’s memo indicated that the elevated levels of bicarbonate linked to the use of the products resulted in a six-fold increase in the risk of cardiac arrest as compared to a patient with bicarbonate levels within the normal range.
According to Renal WEB, a website that provides information on the dialysis industry, the composition of these Fresenius dialysis products differs from those manufactured by other companies because they utilize sodium diacetate rather than sodium monoacetate, which is used in similar products manufactured by other companies. This difference in the composition promotes higher levels of bicarbonate when administered in dosages equal to traditional sodium monoacetate according to the website.
There are hundreds of cases pending against the manufacturer of GranuFlo® and NaturaLyte® alleging severe personal injuries and wrongful death. The lawsuits generally allege that Fresenius failed to provide adequate warnings regarding the potential medical risks associated with these dialysis medical products. The lawsuits also indicate that the medical product company continued to engage in an aggressive marketing campaign to promote GranuFlo® and NaturaLyte® despite awareness by representatives of the company that the medical products could cause cardio-pulmonary arrest and other serious medical conditions including death.
Put Our Law Firm's Over 35 Years Experience to Work For You
If you or someone close to you suffered severe side effects like a heart attack within 48 hours of a dialysis treatment, our Atlanta personal injury attorneys at Montlick and Associates are available for a free consultation and to provide legal representation to those throughout all of Georgia and the Southeast, including but not limited to Albany, Athens, Atlanta, Augusta, Columbus, Gainesville, Macon, Marietta, Rome, Roswell, Savannah, Smyrna, Valdosta, Warner Robins and all smaller cities and rural areas in the state. No matter where you are located our attorneys are just a phone call away, and we will even come to you. Call us 24 hours a day/7 days a week for your Free Consultation at 1-800-LAW-NEED (1-800-529-6333). You can also visit us online at www.montlick.com and use our Free Case Evaluation Form or 24-hour Live Online Chat.