With an FDA investigation underway the amount of Granuflo lawsuits being initiated continues to increase. Utilized to neutralize acid in the bloodstream during kidney dialysis, Fresnius’ acid concentrated powder is alleged to result in dangerous side effects for patients. The dry substance allows the body to create bicarbonate which is typically an opponent against other drugs common during dialysis treatment. Due to its elevated volume of bicarbonate the product can cause patients to suffer from alkalosis, cardiac arrest, or potentially cardiovascular death.
In 2011 Fresnius shared a memo with physicians working within their own treatment centers to communicate the possible side effects patients could suffer when not properly dispensed. Frequently an additional carbonate dose is prescribed, yet the combination could potentially lead to an overdose. While not distributed to non-Fresnius clinics, the memo was revealed to the Food and Drug Administration in early 2012. This leak led to a Class I recall as well as their ongoing investigation to determine whether or not the company is guilty of breaching federal regulations.
With about 125,000 dialysis patients seen in their own centers alone, the amount of customers placed in danger has been substantial. At least 30 Granuflo lawsuits were in the works in the federal court system as of January 2013. It is unknown if a large scale class action suit or multidistrict litigation will take place due to the disparities among patient side effects. Until that determination is made, individual legal action can continue. If a mass tort case is brought to life those pursuing their own damages can determine whether or not they choose to join, as both can take place simultaneously.
While Fresnius has opted to fight the allegations against their product and company actions, they are fully cooperating with legal officials.