GranuFlo and sister drug NaturaLyte are used in dialysis treatments for patients with kidney failure or disease. Evidence shows that frequent dosing errors took place in medical facilities. These dosing errors led to an increased level of bicarbonate in the blood. As a result, a number of GranuFlo and NaturaLyte patients suffered metabolic alkalosis from the heightened bicarbonate levels. Metabolic alkalosis can cause conditions such as low blood pressure and cardiac arrhythmia.
In 2012, the U.S. Food and Drug Administration (FDA) issued a Class I recall of the drugs. The recall was a reaction to the evidence of severe cardiovascular side effects from dosing errors. Many patients suffered severe side effects including cardiac arrest or death. A number of GranuFlo lawsuits have been filed against the manufacturer, Fresenius Medical Care North America. It is expected that the number of GranuFlo lawsuits will significantly increase.
Before GranuFlo and NaturaLyte were recalled, the drugs were administered through dialysis treatments in thousands of medical facilities. These facilities included third-party hospitals and clinics, as well as clinics owned and operated by Fresenius. In November 2011, Fresenius issued an urgent internal company memo to Fresenius clinics administering GranuFlo and NaturaLyte. The memo reported that nearly 950 Fresenius clinic patients suffered heart attacks.
The memos concluded that an excess level of blood bicarbonate significantly increased the risk of cardiac arrest. Additionally, the memo linked GranuFlo treatment with increased bicarbonate levels and consequent heart attacks. However, Fresenius did not notify the FDA or distribute the memo to medical professionals outside of the Fresenius corporation.
In March 2012, the memo was anonymously leaked to the FDA. The FDA immediately investigated the claims and eventually issued a recall of the drugs. When asked why Fresenius failed to warn others, the company stated that the evidence was too preliminary for public release. The FDA, medical professionals, and consumers alike are troubled by Fresenius’s decision not to share this potentially life-saving information with the public.
GranuFlo Lawsuit Claims
Several GranuFlo lawsuits have been filed against Fresenius. These lawsuits claim that patients suffered serious health complications as a direct result of using GranuFlo. GranuFlo use can cause conditions such as hypoxemia, hypokalemia, hypercapnia, and cardiac arrhythmia. Many GranuFlo lawsuits have also been filed by families of those who died after GranuFlo treatment. The plaintiffs of these cases allege that Fresenius was fully aware of the risks of using GranuFlo.
GranuFlo lawsuits allege that despite this side effect knowledge, Fresenius continued to market and sell the drug without properly warning doctors and patients of the risks. Additionally, plaintiffs allege that Fresenius deliberately misled consumers regarding the safety of GranuFlo. Fresenius is accused of displaying a “conscious disregard” for the public’s safety in favor of sales and revenue.
GranuFlo Lawsuit Status
As of January 2013, Fresenius is facing 37 federal GranuFlo lawsuits claiming that patients suffered severe cardiopulmonary complications. These federal cases were consolidated into a multidistrict litigation (MDL). The pretrial process of these GranuFlo lawsuits will be heard in the U.S. District Court, District of Massachusetts. Once the pretrial phase is complete, the cases will be returned to their respective districts. The MDL was deemed appropriate since a number of additional GranuFlo lawsuit claims are expected to be filed.
Filing a GranuFlo Lawsuit
Those who have suffered a serious injury such as cardiac arrest may be eligible to file a GranuFlo lawsuit. Additionally, GranuFlo lawsuits may also be filed by those who lost a loved one from treatment. Those who wish to file a GranuFlo lawsuit against Fresenius should speak to an attorney immediately. An experienced attorney can discuss each plaintiff’s case details and legal options.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.