NY Times Warns of FDA Investigation into Dialysis Dosing Errors

New York, NY – On June 14, 2012, the New York Times published an article concerning dialysis provider Fresenius Medical Care and their products, GranuFlo and NaturaLyte. Both GranuFlo and NaturaLyte have been linked with potential cardiac arrest.

According to the article, the FDA investigated the German-based company to determine whether they violated federal regulations concerning the risks of their products. Thousands of patients may have been put at risk, which opens the door for injured patients to file GranuFlo lawsuits.

Fresenius Products Linked with Serious GranuFlo Side Effects

Fresenius Medical Care operates thousands of dialysis centers in the U.S., and also manufactures and distributes products used during hemodialysis in its own centers and other centers around the world.

GranuFlo and NaturaLyte are acid concentrates used during hemodialysis to help control acid buildup in the blood. These products are designed differently than other concentrates and can potentially raise bicarbonate levels in the blood. Bicarbonate is a natural alkaline substance, but too much of it can lead to a condition called metabolic alkalosis, a pH imbalance in the body that increases the risk of serious GranuFlo side effects.

Internal Memo Details Cardiac Risk

In November 2011, Fresenius sent an internal memo to doctors in its own dialysis centers warning them of the risks associated with GranuFlo and NaturaLyte. The memo noted that improper use of these products may be leading to an increase in patients dying from cardiac arrest. But it was not until the FDA investigated that Fresenius notified medical centers other than those run by the company.

Fresenius analyzed 941 patients that died of cardiac arrest in company run dialysis centers in 2010, and found that a high bicarbonate level, potentially related to GranuFlo and NaturaLyte, was an independent risk factor in these deaths.

Fresenius Waited to Warn Outside Centers

The New York Times notes that experts were troubled that Fresenius waited to warn other centers of the risks. It was not until March 29, 2012, nearly five months after Fresenius circulated the internal memo, that the company issued another warning to outside medical centers and nursing homes.

Fresenius countered with a statement noting that their analysis was preliminary, and not ready for publication in scientific journals. Other than publicizing study results, the company asserted it had no way to warn outside centers of the risks.

GranuFlo Lawyer Likely to Note FDA Warning

On May 25, 2012, the FDA warned doctors and other healthcare professionals to be cautious when using certain dialysis concentrates. The agency received complaints about dosing errors that contributed to cardiopulmonary arrest.

Doctors failed to adjust the dosage of GranuFlo and NaturaLyte, because they were not aware of the potential for excess bicarbonate in the blood when using the products. When metabolized, these concentrates can raise bicarbonate levels, leading to metabolic alkalosis, which the FDA explained can contribute to low blood pressure, low blood oxygen, high blood carbon dioxide, cardiac arrhythmia, and cardiopulmonary arrest.

Dialysis centers are now armed with better information, and are likely to check bicarbonate levels prior to hemodialysis procedures. Before the March 2012 warning, however, thousands of patients may have been put at unnecessary risk, and may now be eligible to file a GranuFlo lawsuit.

Injured Patients May be Eligible for GranuFlo Lawsuit

If you or a loved one suffered a serious cardiovascular injury after going through dialysis with GranuFlo or NaturaLyte, you may benefit from speaking with a GranuFlo lawyer. A thorough review of your case may reveal claims that can be made against the manufacturer in a GranuFlo lawsuit. Contact Chaffin Luhana LLP for a free and confidential case evaluation at 1-888-480-1123.