The Texas dialysis injury attorneys at Denena & Points remark that GranuFlo is a concentrated powder product that gets mixed with water. The resulting acid solution combines with a bicarbonate solution in the dialysis machine to create “dialysate.” The dialysate passes through the machine’s artificial kidney to cleanse the patient’s blood.
Our Texas dialysis injury attorneys point out that GranuFlo has been linked to 941 sudden cardiac deaths in 2010 at 670 dialysis centers in North America that are owned by Fresenius, the maker of GranuFlo. Fresenius, based in Germany, owns 50 dialysis centers in New Jersey alone. The company provides dialysis services to more than 2 million patients across the globe and also sells dialysis machines and other products to its own dialysis facilities and others.
The FDA recall of GranuFlo for cardiac death risks said of the dialysis product that “[t]here is a reasonable probability that use of these products will cause serious adverse health consequences or death.” The FDA issued its highest level of recall, a Class 1, against the product, but did not require that GranuFlo be removed from the market. The reason is a shortage of available alternative products that could be used t help the millions of patients worldwide in need of dialysis.
Our Texas dialysis injury attorneys note that the need for dialysis services has burgeoned along with the obesity epidemic. Obesity leads to diabetes, high blood pressure, and kidney failure. Kidney failure requires dialysis treatments to compensate for the loss of the kidneys’ services as blood cleansers. Patients usually need dialysis treatments 3 times a week for several hours each session. Medicare (your tax dollars) pays for most of these treatments in the 400,000 U.S. dialysis patients at a cost of around $20 million annually.
Instead of yanking the product from the market, the FDA has required that Fresenius re-label GranuFlo and update its operating manuals for the dialysis machines that use the product. The cardiac death risk related to GranuFlo seems to stem from the increase in bicarbonate levels that the product causes in the blood stream. Where patients already had higher levels of bicarbonate in their blood prior to dialysis, the GranuFlo treatment apparently heightened the risk of cardiopulmonary arrest and sudden cardiac death by 6 to 8 times. Sudden cardiac death presents a leading cause of death to U.S. dialysis patients.
Fresenius has strongly recommended to physicians at its centers that they test their patients’ blood chemistries, particularly for bicarbonate levels, monthly, and tailor their individual prescriptions for dialysis chemicals to appropriate levels. Our Texas dialysis injury attorneys emphasize that Fresenius did not send similar warnings to non-Fresenius owned centers that use GranuFlo until some 5 months after it had warned its own centers of the danger. The FDA is investigating this troubling delay that could have endangered other patients’ lives.
Fresenius is the largest for-profit dialysis treatment center chain in the United States. But ownership of dialysis treatment centers is becoming increasingly consolidated among a few for-profit chains. The 2nd largest for-profit dialysis chain is Davita.
The growing concentration of dialysis services into a few hands is raising questions about safety and accountability. The concern is particularly strong where one of the chain operators also makes the products that it and other centers use. As recently as May, more than a quarter million dialysis patients, slightly more than half of whom received treatment in Fresenius facilities, were using GranuFlo as part of their treatments. Sales of the product reached more than $80 million per year. (Source: Lindy Washburn, The Record, NorthJersey.com, 7/22/2012.)
If you or your loved ones require dialysis treatments to clean your blood following kidney failure, you might not have any alternative to use of the GranuFlo product until other alternative products become more widely available. Your treating physician should be testing your blood chemistry regularly for elevated bicarbonate levels and adjusting your treatment dosage as needed in order to minimize your risk of cardiopulmonary arrest and sudden cardiac death from your dialysis treatments.
If you or a family suffered a cardiac incident or injury from your dialysis treatment, the adverse consequences could be catastrophic for your family. Our dedicated Texas dialysis injury attorneys could help you make a full financial recovery for your harm from those responsible for your injury.
Contact us for a free and confidential legal consultation regarding your options and eligibility for financial compensation stemming from the recalled dialysis product. Our Texas dialysis injury attorneys have almost 15 years of reliable experience holding negligent companies accountable for the suffering they and their products have caused to innocent victims.
Let us help you too. Call us toll free at 877-307-9500 or use our online contact forms at your convenience. Get the full financial recovery you deserve when a dangerous product or company delay regarding known risks has endangered your life or the life of a family member.