GranuFlo Lawsuits

Dialysis, a process by which the blood is rid of toxins when the kidneys in a patient are no longer functioning properly, is required by over 500,000 Americans. Dialysis centers are located across the country, and patients typically use this service on a regular basis, depending upon both the extent of the renal damage and the type of dialysis they receive. GranuFlo, for many of these patients, was a key aspect of the less-than-enjoyable process. Granuflo lawsuit attorneys are working with these patients to protect their legal rights.

However, when patients go to dialysis centers, they often do so with full confidence in the staff at these locations; patients trust that their physicians are properly supervising both the operation of the equipment and the dosage of the medication. However, it has recently come to light that Fresenius Medical Care Company, a corporation that is in charge of one-third of all dialysis centers in the United States, created a product, GranuFlo, that put its patients at an unnecessary risk. Additionally, plaintiffs who are filing lawsuits against Fresenius maintain that the company demonstrated an extreme disregard for their well-being while undergoing treatment at other dialysis locations.

What is GranuFlo?

Administering dialysis includes providing bicarbonate to the patients, a medication that helps to reduce the acid in the blood. Additionally, physicians may also use GranuFlo in dialysis—some components of the drug are converted into bicarbonate in the blood. However, because the drug contains more of this ingredient than other similar products, patients allege that using GranuFlo could potentially create unnecessarily high levels of bicarbonate within the body, leading to heart attacks, among other serious or fatal complications.

Not only are these dangers a concern as they specifically relate to the product, but when Fresenius was contacted about the adverse effects, they only notified the dialysis centers which they owned directly and failed to warn other dialysis locations across the country that had originally purchased their products; while patients who were being treated at their centers were aware of the risks, others had no idea and were left vulnerable to serious complications.

Although Fresenius only serves one-third of the country’s dialysis patients, hundreds of patients have passed away after taking GranuFlo. It was only after the U.S. Food and Drug Administration (FDA) called to attention the dangers of the medication that Fresenius acted responsibly and let dialysis centers know of the potential dangers associated with the drug.

Dangers of GranuFlo

Plaintiffs allege that physicians who were directly working for Fresenius first realized that the medication was fatally affecting patients; these individuals claimed to have sent out a letter warning other staff members and advising them to be certain that they use GranuFlo carefully and as instructed. However, they neglected to share that same memo with other centers using the medication, putting nearly 125,000 other dialysis patients at risk for:

Heart attacks
Low blood sugar
Stroke
Irregular heartbeat
Decreased oxygen levels in the blood stream
Increased bicarbonate levels in the blood stream
Increased carbon dioxide in the blood stream
Sudden death

Not only did Fresenius have a responsibility to address and recall the product due to adverse side effects, but they also had a moral and legal obligation to notify their customers of the potential risks associated with the medication. Plaintiffs allege that their failure to do so was merely driven by profit, demonstrating a complete disregard to the welfare of their patients.

FDA Finally Recalls GranuFlo

Once the FDA was made aware of the increasing number of heart attacks occurring as the result of the medication, they issued a Class 1 recall in June 2012 for the product; a Class 1 FDA recall, the most urgent recall issued by the administration, is typically issued only when there is a serious threat of injury or death linked to a product that is regulated by the agency.

The product recall was unusual in that it did not require the manufacturer to recover the current supply of the medication already located in various centers across the country; instead, Fresenius was instructed to notify the clinics of the risk of heart attacks related to the product. The process has taken longer than normal, leaving many physicians and patients to wonder just how long dialysis centers continued to administer the product even after the recall was issued. In some instances, dialysis centers may have continued to use GranuFlo after the recall simply because they did not have a similar product in stock to administer as an alternative.