GranuFlo NaturaLyte Lawsuit Lawyers
For patients who receive dialysis treatment, the recent recall of GranuFlo has raised concerns about federal law violations. The company involved (Fresenius Medical Care or FMC) failed to inform the public about the risks associated with using its drugs. As a result, the FDA issued a warning to the public and healthcare professionals on May 25, 2012. Due to dosing errors, hemodialysis patients faced the risk of suffering heart attack, cardiac arrest, and cardiopulmonary arrest, and sudden cardiac death. Read on for all the details regarding GranuFlo lawsuit recall.
An Overview of GranduFlo and NaturaLyte
It is important to get a good grasp of both products before proceeding further. GranuFlo is the powder form variant while NaturaLyte is the liquid form. Although both products are similar, the dosage is slightly different. When a patient receives either of the products, it turns into bicarbonate and helps clean waste from the blood. Normally, the kidneys take care of cleaning waste chemicals found in blood. However, this is not possible if the kidneys fail. Doctors have to use dialysates to help the body clear these waste chemicals.
The Genesis of the Problem
According to an article published in the New York Times, Fresenius had prior knowledge of the risk posed by its drugs. However, the company only sent an internal memo outlining the risks to its own clinics. In the memo, Fresenius warned doctors that GranuFlo contained high levels of bicarbonates. As a result, 941 patients in its clinics suffered heart attacks in 2010. In addition, the memo had research estimates showing that GranuFlo increases the risk of heart attack by as much as six times. Instead of sharing this information with other clinics, Fresenius decided to limit this information to its own clinics. The FDA anonymously received this internal memo and started investigations. In late June 2012, the FDA issued a class I recall for both GranuFlo and NaturaLyte. This news led patients to seek GranuFlo lawsuit recall information. Data published by the dialysis information resource RenalWEB shows that at least 125,000 patients use GranuFlo.
NaturaLyte and GranuFlo Side Effects
During the dialysis procedure, healthcare professionals use a dialysate (such as GranuFlo) and a dialysis machine to remove waste from blood. The only problem with GranuFlo and NaturaLyte is the high levels of bicarbonate in both drugs. To be precise, NaturaLyte and GranuFlo contain 4.0 mEq/l and 8.0 mEq/l of acetate respectively. The body metabolizes these chemical components leading to elevated levels of bicarbonate. These high levels of bicarbonate in the body increase the risk of suffering the following complications:
• Sudden heart attack
• Cardiopulmonary arrest
• Low blood pressure
• Hypoxemia
• Hypokalemia
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Since many people were using GranuFlo and NaturaLyte at the time of the recall, litigation is the next logical step. Although the FDA recall does not direct clinics to stop using the dialysates, this does not mean that patients cannot proceed with lawsuits. If you or a loved one suffered after using GranuFlo or NaturaLyte, it is advisable to seek legal help. The company involved knew about the truth but chose to suppress the dissemination of this information. GranuFlo lawsuit recall information will help you demand compensation.
If you or a loved one were undergoing dialysis treatments and suffered a heart attack, contact Loncar and Associates today.
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