Doctors who treat dialysis patients should be very concerned about the dialysis product GranuFlo. Many doctors had no idea that an ingredient found in this common dialysis solution had been linked by its manufacturer, Fresnius Medical Care, a German company, to a sharp increase in patient heart attacks.
The patients who had received dialysis using GranuFlo or its sister product, NaturaLyte, should be concerned, as well. These patients remain at risk for heart problems related to these products for up to two years. Family members of anyone who suffered a serious or fatal heart attack while being treated for dialysis should contact an attorney for guidance immediately.
Last year Fresnius confirmed a sharp increase in heart attacks at its clinics and linked them to an ingredient in GranuFlo. It notified its own clinics about the problem and how to alter dosing formulas to prevent the problem. However, it did not notify its other customers, the non-Fresnius clinics that treat approximately 125,000 patients each year. The company kept the information to themselves. They knew that if they informed the other doctors, it would inevitably lead to recalls or new labeling requirements which would cut into its profits.
The company never came forward alerting the doctors or the public. They were exposed when the U.S. Food and Drug Administration (FDA) received an anonymous tip in March, forcing the company to alert ALL of their customers about the problem and how to prevent it. In the meantime, how many dialysis patients suffered heart attacks? How many patients have increased risk of heart attacks in the future? Do you think the doctors are losing sleep knowing they never came forward with this knowledge?
Fresnius Medical care is being sued on behalf of victim’s experiencing life-threatening cardiovascular injuries caused by the use of GranuFlo and NaturaLyte in kidney dialysis.
GranuFlo and NaturaLyte have been associated with an increase in death, sudden cardiac, cardiopulmonary arrest, heart attack, and other catastrophic cardiovascular injuries. In fact, on March 29, 2012, Fresnius issued an “urgent product notification” highlighting the increased health risk associated with its dialysis product. GranuFlo and NaturaLyte cause alkalosis, which “is a significant risk factor associated with cardiopulmonary (CP) arrest in the dialysis unit, independent of an additive to the risk of CP arrest associated with pre-dialysis hypokalemia.”
The FDA is investigating Fresnius for possible regulatory violations. Fresnius is currently under investigation based on allegations that the company withheld information of its own internal analysis confirming that increased health risks are associated with its dialysis products GranuFlo and NaturaLyte.
Fresnius should be investigated for criminal violations. Once again, the big pharma’s are putting profits ahead of patient’s safety.
Fresnius is the largest dialysis service and products company in the world. Fresnius treats more than one third of the estimated 400,000 (dialysis) patients in the United States. Fresnius operates over 2,700 dialysis clinics including 1,800 clinics in the U.S. Fresnius Medical Care reported record second-quarter profits this year.
Patients who seek dialysis treatment are in poor health and place trust in their health care professionals to provide treatment that is safe. It is unethical and immoral for a physician to knowingly administer a treatment, with increased risks of causing heart attacks, which can be fatal, without advising the patient of the potential risks.
For more information, contact a Gacovino Lake attorney at 1-800-246-HURT (4878).