Fresenius Dialysis Products GranuFlo© and NaturaLyte© Linked to Cardiopulmonary Arrest and Sudden Cardiac Death

Use of the dialysis products, GranuFlo© and NaturaLyte© has been linked to an up to six-fold increase in the risk of cardiopulmonary arrest and sudden cardiac death. The manufacturer, Fresenius Medical Care (FMC), was aware of the injuries and dangers associated with their dialysis products but failed to warn patients and doctors until 2012. The result has placed more than half of all dialysis patients in the United States at risk and set the stage for imminent GranuFlo lawsuits

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900 Deaths Force Fresenius Recall

On March 29, 2012, the U.S. Food and Drug Administration (FDA) issued a Class 1 recall of GranuFlo and NaturaLyte, dialysis products manufactured by Fresenius Medical Care. The use of either product can result in high bicarbonate levels that can cause metabolic alkalosis, a significant risk associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia, which may culminate in cardiopulmonary arrest and death.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause adverse health consequences, or death. Read Safety Alert.

Research behind Serious Recall

Medical research links GranuFlo© and NaturaLyte© to high bicarbonate levels that can cause a variety of health problems including:

• Cardiopulmonary arrest
• Heart problems
• Metabolic alkalosis
• Low blood pressure
• Sudden MI or heart attack
• Stroke, and Death

The GranuFlo© and NaturaLyte© recall states that the company failed to disclose vital information to the FDA and health-care providers about the possible risk of high bicarbonate levels when administering these products.

Cardiac death is recognized as the number one cause of death for dialysis patients, accounting for 59% of those deaths. By 2010, the medical community had concluded that these cardiovascular-related deaths were not due primarily to atherosclerotic (plaques and arterial stiffening) disease, but rather uremic cardiomyopathy, characterized by left ventricular hypertrophy (LVH), LV dysfunction, and LV dilatation. This conclusion caused many in the medical community, including FMC, to research the issue, possibly a little too late to prevent GranuFlo© and NaturaLyte© related injuries. More on Complaints

Risks and Side-Effects

There are currently more than 5,700 dialysis centers providing service to approximately 400,000 dialysis patients in the United States. FMC, the largest dialysis services and products company in the U.S. and the world, not only owns thousands of dialysis clinics, it also manufactures nearly all the medical products used in dialysis care.

GranuFlo is an acid concentrate powder product that allows dialysis clinics to mix their own acid concentrate solutions, which helps lower shipping costs and storage space associated with traditional 55 gallon drums. Its formulations are the only marketed products to contain the "dry" powder form of acetic acid, sodium diacetate. Because GranuFlo uses sodium diacetate, it doubles the amount of acetate in dialysate compared to formulations made with acetic acid. FMC also sells traditional, pre-mixed, liquid acid concentrate formulations under the brand name NaturaLyte. Serial numbers for Naturalyte include:

08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8, 08-3201-4, 08-3231-1, 08-3251-9, 08-3301-2, 08-4123-1, 08-4223-7, 08-4225-1, 08-4230- 2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, 13-3231-1, 13-3251-9, 13-4123-1, 13-4220-1, 13-4225-1, 13-4325-1

Serial numbers for GranuFlo include:
OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-38, OFD2220-3B, OFD2223-3B, OFD2225-3B, OFD2231-3 B, OFD2251-3B, OFD2301-3B, OFD2323-3 B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B

Company Sat on Crucial Information

In response to the high rate of cardiac arrests that occurred in Fresenius Medical Care clinics in 2010, the company submitted an internal memo to its own dialysis clinics on November 4, 2011.

After the FDA received an anonymous copy of the November 4th internal memo, company executives were forced to issue an urgent public product warning and recall to its customers that GranuFlo and NaturaLyte were associated with elevated bicarbonate levels and an increased risk for cardiopulmonary arrest and sudden cardiac death.

Studies Show 941 Deaths

FMC conducted a case-control study that evaluated risk factors in hemodialysis patients who suffered from cardiopulmonary arrest in FMC facilities compared to other dialysis patients within the same facilities between January 1 and December 31, 2010. This study identified 941 patients in 667 FMC facilities who had cardiopulmonary (CP) arrests within the facilities. Looking at the data for these 941 patients, the study found that the patients' risk of cardiopulmonary arrest was up to six times higher if they had an elevated pre-dialysis bicarbonate level. See memo summarizing results.

According to the memo, FMC was aware that there was a significant increased risk of cardiac arrest and death during hemodialysis treatments associated with their GranuFlo and NaturaLyte dialysis concentrate products that contain sodium diacetate. The memo recommends action for patients with elevated pre-dialysis bicarbonate levels. However, FMC only provided this memo to FMC's doctors and dialysis facilities, and not to non-FMC physicians and clinics that were using products, despite the fact that over 100,000 dialysis patients were receiving products at non-FMC facilities.

FMC only decided to share its knowledge with the thousands of non-FMC physicians and clinics on March 29, 2012, after a copy of the November 4, 2011 internal memo was leaked to the FDA. Even then, FMC did not share all of its information. What was provided was a scientifically-ambiguous, two-page memo that lacked details and the urgency of the FMC internal memo. A key point: the March 29 memo did not mention patient blood levels or the most at-risk population of all, "acute" dialysis patients, and only included one of ten medical references that the FMC internal memo did.

Don�t Be a Victim: Know Your Rights

If you suspect that you or a loved one has been injured by one of these two dialysis drugs, contact Goza | Honnold, L.L.C. immediately. Our pharmaceutical injury attorneys can keep you advised on further investigations and the action to take in a lawsuit.

As industry leaders with decades of experience successfully prosecuting injury cases and recovering large financial awards, the partners at Goza | Honnold, L.L.C. have the expertise to provide just compensation for individuals who have suffered injuries as the result of GranuFlo© and NaturaLyte©. If you or a loved one has suffered from cardiac arrest, heart attack, or other illnesses following dialysis, we can help you assert your legal rights and will fight aggressively on your behalf.

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