Lawyers Encourage Patients and Their Loved Ones to File Against GranuFlo and Naturalyte
In November 2011, an internal memo at Fresenius, the manufacturers of GranuFlo and Naturalyte, warned it’s clinic doctors and medical directors that the products could create a higher risk of cardiopulmonary arrest or sudden cardiac death in certain patients. The internal memo stated that “[t]his issue needs to be addressed urgently.”
However, while the information was widely spread in the company, Fresenius did not notify the FDA of the problem.
Steve Silverman, director of compliance for the FD’s medical device division, stated that he “was troubled by the fact Fresenius on its own initiate didn’t notify its entire customer base of its concerns.”
The FDA Recalls GranuFlo and Naturalyte Because of Personal Injury and Wrongful Death
According to the FDA’s website, “The Naturalyte and Granuflo Dry Acid Concentrate are used in the treatment of acute and chronic renal failure during hemodialysis.”
In March 2012, the FDA officially recalled the product under a Class I recall, the strongest recall possible. An anonymous tip described the complications related to GranuFlo and Naturalyte.Their stated reason for the Class I recall: “The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.
FDA has issued a general safety communication related to inappropriate prescription and resultant alkali dosing errors in the dialysate concentrates used in hemodialysis.”
The FDA is currently investigating Fresenius to determine if the manufacturer violated federal law by failing to warn patients and doctors at non-Fresenius clinics of the serious, sometimes deadly, risks of using GranuFlo and Naturalyte concentrates.
Patients who have been treated with GranuFlo and Naturalyte report the following complications:
- Cardiac arrhythmia (irregular heartbeat)
- Cardiopulmonary arrest
- Hypercapnia (high levels of carbon dioxide in the blood)
- Hypokalemia (low levels of potassium in the blood)
- Hypoxemia (low levels of oxygen in the blood)
- Metabolic Alkalosis
- Sudden cardiac death
The Attorneys at the Strom Law Firm Can Help With Your Personal Injury Suit Against GranuFlo and Naturalyte
Fresenius is also the world’s largest supplier of dialysis machines, and operates over 2,700 dialysis centers worldwide. They manage several dozen kidney clinics, and have treated more than 130,000 patients.
Estimates suggest another 100,000 patients have been treated with GranuFlo and Naturalyte outside of Fresenius’s clinics.
If you are one of these patients, or the loved one of a patient who has received dialysis with GranuFlo and Naturalyte, you may be entitled to compensation. Cardiac conditions are very serious, and can change your life forever. You may be unable to return to work, or you may be unable to enjoy activities you previously enjoyed. It is important to hold manufacturers responsible for faulty products, but there is a short window of time in which you can file a personal injury lawsuit against the manufacturer of a defective medical product.
The attorneys at the Strom Law Firm can help. We fight aggressively to get the compensation you deserve to pay your medical bills and recover some lost wages. We offer free, confidential consultations to discuss the facts of your case, so do not hesitate to contact us.803.252.4800.