GranuFlo               

Fresenius Medical Care is a German company that operates thousands of kidney dialysis centers in North America. According to recent reports, two of the products made by the company and used during dialysis – NaturaLyte Liquid Acid Concentrate and GranuFlo Dry Acid Concentrate – have been linked with serious cardiovascular side effects, including heart arrhythmia and sudden cardiac arrest. An internal company memo outlined these concerns in November 2011, but Fresenius did not issue a public warning until March 2012. Patients who were injured by GranuFlo side effects may be eligible to file a GranuFlo lawsuit.  

Company Memo Details GranuFlo Side Effects 

Hemodialysis is a procedure that helps clear waste from the blood in patients with kidney malfunction. Doctors typically administer products to neutralize acid buildup in the blood, and according to the Fresenius web site, GranuFlo is the most widely prescribed dry acid product in the dialysis industry today. It is also marketed as being safer than liquid acid concentrates.            

On November 4, 2011, the company circulated an internal memo to doctors operating at Fresenius clinics. According to the memo, improper use of GranuFlo contributed to a sharp increase in patients suffering from serious GranuFlo side effects, including cardiac arrest.  

In the memo, Fresenius explains that their case-control study evaluated risk factors in hemodialysis patients who suffered cardiac arrest didn't between January 1 and December 31, 2010. They determined that patients with high bicarbonate levels were most at risk for cardiac problems. Since kidney patients often have outside prescriptions of bicarbonate – and GranuFlo also increases bicarbonate levels – these patients were at risk for metabolic alkalosis, which can lead to a heart attack.  

Doctors Unaware of Issues that Could Lead to GranuFlo Side Effects

The Fresenius memo notes “there are instances whereby the physicians' bicarbonate prescriptions were kept the same when shifting to powder concentrate [GranuFlo]…thus exposing patients to a higher total buffer load than intended.”. In other words, doctors were apparently unaware that GranuFlo could raise bicarbonate levels more than other products, and failed to adjust patients' prescriptions to accommodate for the difference.  Increased bicarbonate levels may lead to a higher risk of GranuFlo side effects.

Though the company sent this memo to its own doctors, it failed to warn other centers that used GranuFlo. It was not until the FDA anonymously received a copy of the memo, and questioned Fresenius about it, that they released a public notice about the concerns in March 2012.

GranuFlo Lawyer Likely to Blame Company

A GranuFlo lawyer is likely to blame Fresenius for dragging their feet on notifying outside dialysis centers, physicians, and the public to concerns about GranuFlo side effects. When  Fresenius finally released a public statement in March 29, 2012, they noted that, “previous reports have identified an association between elevated pre-dialysis bicarbonate levels and an increased mortality risk.”

The memo did not detail the company's internal case-control study, however, and advised clinicians only to ”exercise their best clinical judgment” regarding the bicarbonate prescriptions for each patient.

In May 2012, the FDA issued a safety communication regarding dialysis dosing errors, warning doctors about the potential for bicarbonate overdose, metabolic alkalosis, and cardiac arrest. On June 27, 2012, the FDA issued a Class I recall for both NaturaLyte liquid and GranuFlo powder acid concentrates, noting that these products may cause serious adverse health consequences, including death.

A GranuFlo Lawyer Can Help

If you suffered a serious cardiovascular injury after going through dialysis, and your doctor used GranuFlo, you may benefit from a consultation with a GranuFlo lawyer. A thorough review of the case may reveal claims against the manufacturer. If successful, a GranuFlo lawsuit could result in monetary compensation. Contact Chaffin Luhana LLP for a free and confidential case evaluation at 1-888-480-1123.