GranuFlo® or NaturaLyte®


Have You or Someone You Love Suffered Adverse Reactions from Utilizing GranuFlo® or NaturaLyte® for Dialysis?GranuFlo® and NaturaLyte® Products Are Frequently Administered in Dialysis Treatments

Today, there are nearly 400,000 Americans undergoing dialysis treatment in the United States. Dialysis is, unfortunately, a necessary treatment for those suffering from stage 5 chronic kidney disease (CKD) (also referred to as end stage renal disease (ESRD)), or an acute kidney injury (AKI), in which the kidneys have completely failed.

The kidneys are essential components of the urinary system. They filter out wastes from the blood, and divert this waste to the urinary bladder to be eliminated. When the kidneys fail to function properly, wastes build up in the blood, causing other health problems to arise. Renal dysfunction can lead to cardiovascular disease, anemia, bone disease, and other problems which, if left untreated, can be ultimately fatal.

Kidneys also regulate the blood in other ways, in particular by making sure that the blood maintains the right balance of salt and water (and thereby regulating blood pressure), and blood acidity, as well as performing other functions.

When there is complete kidney failure, renal patients have few options: dialysis or a kidney transplant. And while there has been considerable success with transplants, there are not enough donor kidneys for the kidney patients who might benefit from a transplant, and not all patients with kidney failure are appropriate candidates for transplants. Consequently, dialysis treatments have become a way of life for many patients with ESRD or AKI.

Dialysis is not a treatment in the sense that it is a cure. Instead, it is essentially an attempt to replicate the function of the kidneys by artificially filtering the blood, and thereby allowing patients with kidney failure to prolong their lives. As with all such processes, however, it is far from perfect in that dialysis cannot completely replicate a normal functioning kidney. In addition, dialysis is a cumbersome process for patients. A typical hemodialysis regimen consists of three treatments per week at a dialysis clinic, with sessions ranging from three to five hours. (For peritoneal dialysis, the process is longer, although it need not be carried out in a clinic.)

In hemodialysis, blood is pumped from the patient’s body to a dialyzer. In very simple terms, within the dialysis machine, the patient’s blood and a solution of dialysate flow through a membrane in opposite directions. The dialysate is low in certain solutes, which it essentially absorbs from the blood, while it is higher in other solutes, which it transfers to the blood. Once blood is “cleansed” through dialysis, it is pumped back into the body.

One of the key components of the dialysis process is dosing the patient with the correct level of bicarbonate—or acetate, which the liver converts into bicarbonate—which is intended to reduce the acidity of the blood. When the kidneys fail to remove enough acids from the blood, this can result in low blood pH, or metabolic acidosis, which is not uncommon in dialysis patients, and this condition can lead to coma or even death. Conversely, however, studies show that blood that has too high a pH, or alkalosis, can lead to cardiopulmonary arrest.

GranuFlo® and NaturaLyte® Solutions Are the Subject of a Class 1 FDA Recall Due to High Levels of Acetate/Bicarbonate

Fresenius Medical Care (Fresenius) is one of the world’s leading providers of dialysis services and products. It is based in Germany, but has its North American headquarters in Waltham, Massachusetts; its revenues are over $10 billion annually. Worldwide, it operates over 2,700 kidney dialysis clinics, which serve over 215,000 ESRD patients. In the United States alone, Fresenius Medical Care operates over 1,800 dialysis clinics, serving nearly one-third, or over 130,000, of all dialysis patients in the country. In addition, Fresenius provides hemodialysis machines, dialyzers, dialysate, and other solutions, including producing GranuFlo® and NaturaLyte®, not only to its own clinics, but to dialysis clinics operated by other concerns.

In November of 2011, Fresenius circulated a memo to its own clinics warning that, in 2010, 941 hemodialysis patients suffered cardiac arrest in 667 different facilities operated by the company. After analyzing the blood data on these patients, Fresenius concluded that these patients had experienced alkalosis episodes which led to cardiac arrest. Consequently, it warned these clinics to be more vigilant in monitoring the blood acidity of patients in providing supplemental or separate doses of bicarbonate before undergoing dialysis, especially in administering its GranuFlo® and NaturaLyte® products, which had relatively high levels of acetate relative to other products manufactured by other suppliers.

The federal Food and Drug Administration (FDA) was alerted anonymously to this memo. As a result, the FDA conducted an investigation into the incidents and, in March of 2012, issued a Class 1 recall of GranuFlo® and NaturaLyte®. A Class 1 recall is the most serious type of recall issued by the FDA, and is issued only where “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”

Although the data supplied with both the GranuFlo® and NaturaLyte® products provided information on the acetate concentrate of these solutions, these products also had a higher concentration of acetate than other products used in the same process. As a result, many of the physicians and clinics utilizing these solutions had failed to adequately account for the specific level of acetate in these solutions when deciding how much bicarbonate to prescribe to its ESRD patients undergoing dialysis. As a result of the oversight, the risk of a bicarbonate overdose—and consequent alkalosis—was appreciably increased—so much so that the risk of cardiopulmonary arrest or sudden cardiac arrest and death was increased by an estimated six times.

While it remains to be seen whether Fresenius or administering physicians can be held legally liable for the injuries caused by the utilization of GranuFlo® or NaturaLyte®, some issues seem clear. Even though Fresenius did not specifically identify its own products as the cause of the adverse reactions to dialysis, by issuing the memo, Fresenius manifestly recognized that there was an inherent problem with the acetate-concentration disparity between its own products and competing products. Indeed, the memo urged doctors to take corrective action, and characterized the matter as “urgent.”

The memo essentially served as special warning notice for the firm’s own facilities, bringing needed and special attention to the problem of acetate concentration in order to protect the health of patients. But by failing to provide the same level of attention for this issue to product users outside of Fresenius-operated facilities—particularly given the statistics compiled on cardiopulmonary arrest—Fresenius exposed itself to the question of whether the company operated negligently in marketing and selling its dialysis products, in that it did not recognize a moral and legal responsibility, obligation, and duty to warn of an inherent danger connected with its products when confronted with compelling safety information.

As a result of the recall, the FDA has issued a general warning to all dialysis centers to be more acutely conscious of monitoring bicarbonate levels in dialysis patients in order to minimize the possibility of alkalosis.

If You or Someone Close to You Are a Dialysis Patient and Have Suffered an Adverse Event Related to a Dialysis Treatment, Grimes Teich Anderson May Be Able to Help You Recover

The potential problems and cases involving GranuFlo® and NaturaLyte® are by no means limited to dialysis facilities owned or operated by Fresenius Medical Care. According to estimates by RenalWEB, a website that focuses on renal issues and dialysis, approximately 125,000 patients are treated with GranuFlo® at clinics or dialysis facilities operated by firms other than Fresenius. Consequently, if you are a dialysis patient, chances are that you may have used a Fresenius Medical Care product, even if you do not know for certain at this time.

As noted above, because the events relating to the recall are very recent, it remains to be seen whether Fresenius can be held liable for any injuries caused by a bicarbonate overdose administered during a dialysis treatment. Moreover, the medical facilities and physicians involved in the administering of dialysis may share some portion of the blame for any adverse incidents that involve improper dosing. In either case, however, these product and service providers owed a grave duty of care to their dialysis patients to safeguard them from known risks, particularly given the critical and sensitive nature of dialysis treatments to individuals suffering from kidney failure.

If you believe you have suffered an injury that may be related to the use of one or both of these Fresenius Medical Care products, the product liability and medical malpractice attorneys at Grimes Teich Anderson in North Carolina and South Carolina can help you to evaluate whether you may have a case against Fresenius or any other parties involved in your treatment.* We experienced in assisting clients in recovering from injuries or wrongful death caused by defective drugs or defective medical devices. Contact Grimes Teich Anderson toll-free at (800) 533-6845, or complete our online confidential case evaluation form if you would like a free, no-obligation consultation regarding your case with one of our attorneys.

We have offices conveniently located in Asheville, Rutherfordton, Waynesville, and Spruce Pine, North Carolina, as well as in Greenville and Gaffney, South Carolina. If you have been harmed through the negligence of others, call us today.

*Grimes Teich Anderson LLP works on these cases with Henson & Fuerst PA, Raleigh NC but these claims will be handled primarily by associated co-counsel with offices in other state(s).

Naturalyte, and Granuflo are trademarks of Fresenius Medical Care Holdings, Inc.

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