Kidney dialysis patients who fell victim to cardiopulmonary arrest, cardiac arrhythmia, and sudden heart attack may want to speak to a NaturaLyte lawyer.
Recent reports have linked the use of GranuFlo and NaturaLyte acid concentrates during hemodialysis to cardiac side effects. As a result, the FDA released a warning to physicians on May 25, 2012. Fresenius Medical Care, a major provider of dialysis centers in the U.S. and the manufacturer of these products, may be responsible for failing to warn doctors and patients of potentially serious NaturaLyte side effects.
Fresenius was Aware of Serious NaturaLyte Side Effects
During a hemodialysis procedure, in which a machine helps cleanse the blood of waste, doctors use concentrates like GranuFlo and NaturaLyte to reduce acid buildup in the blood. In early 2012, the FDA anonymously received a Fresenius internal memo linking the use of these products with cardiac arrest. The memo was distributed only to company run dialysis centers.
According to the memo, dated November 4, 2011, Fresenius examined data from 941 patients who died of cardiac arrest in Fresenius dialysis centers in 2010. The company determined that an elevated level of bicarbonate in the blood was a significant risk factor in these deaths, and that the use of GranuFlo and NaturaLyte could contribute to high bicarbonate levels.
Both of these products are designed differently than competeing concentrates, and can cause a bicarbonate overdose in patients if used incorrectly. Apparently doctors were unaware of the difference, and failed to adjust the dosage accordingly, putting patients at risk of serious NaturaLyte side effects.
NaturaLyte Lawyer Likely to Argue that Fresenius Delayed Warnings
Other dialysis centers not run by Fresenius also used GranuFlo and NaturaLyte, but Fresenius failed to warn them until the FDA investigated. On March 29, 2012, nearly five months after they released the internal memo, Fresenius issued a broader warning to outside medical centers and nursing homes. A Fresenius lawyer is likely to argue that the company put thousands of patients at risk in delaying the second warning.
A high level of bicarbonate in the blood can contribute to a condition called metabolic alkalosis, which is a significant risk factor for heart problems. The May 25, 2012 FDA warning to doctors noted that the condition can contribute to low blood pressure, low blood oxygen, high blood carbon dioxide, cardiac arrhythmia, and cardiopulmonary arrest.
FDA Issues Class I Recall
On June 27, 2012, the FDA issued a Class I recall notice for both NaturaLyte and GranuFlo, nothing that use of these products could lead to high serum bicarbonate levels in patients undergoing hemodialysis. They added that this could contribute to metabolic alkalosis, a significant risk factor associated with heart rhythm problems and even cardiac death.
Free Consultation with a NaturaLyte Lawyer
If you or a loved one suffered a serious cardiovascular injury after going through dialysis with NaturaLyte, you may benefit from speaking with a NaturaLyte lawyer. A thorough review of your case may reveal claims that can be made against the manufacturer in a NaturaLyte lawsuit. Contact Chaffin Luhana LLP for a free and confidential case evaluation at 1-888-480-1123.