GranuFlo Wrongful Death Lawsuit Filed in Massachusetts Superior Court

On June 24, 2013, an estate administrator filed a GranuFlo wrongful death lawsuit against Fresenius in Suffolk Superior Civil Court. The plaintiff represents the estate of a deceased Alabama woman who allegedly died as a direct result of receiving NaturaLyte and/or GranuFlo during her dialysis treatment. The lawsuit contends that Fresenius failed to disclose the defects and safety hazards associated with the products to all of the patients and medical providers. The plaintiff is attempting to recover damages for the injuries and death of the decedent as well as the damages incurred by the beneficiaries of the estate.

GranuFlo and NaturaLyte linked to dangerous side effects

NaturaLyte and GranuFlo are acid concentrates used during hemodialysis – a procedure that filters waste from the bloodstream of patients who are suffering from kidney failure. Fresenius is one of the largest manufacturers and distributors of dialysis equipment and dialysis-related services. It also owns dialysis clinics throughout the country that provide treatment to patients. Fresenius used NaturaLyte and GranuFlo in its dialysis clinics and distributed the products to healthcare facilities owned by competitors.

The sodium acetate used in GranuFlo and NaturaLyte increases the serum bicarbonate levels in dialysis patients. Patients with high bicarbonate levels are at risk of developing metabolic alkalosis – a medical condition that may lead to sudden cardiac death, cardiopulmonary arrest, and other life-threatening injuries. The GranuFlo lawsuit states that Fresenius knew or should have known about the adverse side effects associated with the acid concentrates, but the manufacturer allegedly chose to conceal this information in order to maintain its profits and minimize liability.

According to a November 4, 2011 internal memo Fresenius distributed to its executives and medical facilities, the manufacturer indicated that administering GranuFlo and NaturaLyte during dialysis treatments heightened the risk of patients suffering from cardiac problems. The memo stated that analyses performed by Fresenius concluded that elevated bicarbonate levels were associated with a 6 to 8 fold increase in the risk of patients having cardiopulmonary arrest and sudden cardiac death. Physicians were advised to adjust the dialysate bicarbonate prescriptions for patients immediately in order to address this dangerous health issue.

FDA recall of GranuFlo and NaturaLyte

Even though Fresenius was aware of the dangers GranuFlo and NaturaLyte posed to dialysis patients, it failed to inform the medical facilities owned by its competitors. The FDA anonymously received a copy of the internal memo in March 2012. Shortly thereafter, the FDA contacted Fresenius about the health risks linked to GranuFlo and NaturaLyte. On March 29, 2012, Fresenius issued a 2-page memo to the clinics owned by their competitors to advise them of the safety risks the acid concentrates posed to dialysis patients. On April 27, 2012, the FDA advised Fresenius to modify the product warning labels to accurately reflect the side effects.

The FDA issued a Class I recall of GranuFlo and NaturaLyte since there is a reasonable probability that patients exposed to the acid concentrates could suffer from serious adverse side effects, including death. If the prescriptions for the products aren’t properly adjusted for patients, there is the risk of low blood pressure, hypoxemia, GranuFlo heart attack, cardiac arrhythmia, cardiopulmonary arrest, and other injuries. The FDA also initiated an investigation to determine if Fresenius’s failure to inform the public and the agency about the products’ safety risks violated federal regulations.

Decedent suffered from fatal heart injuries

The decedent in the GranuFlo wrongful death lawsuit received NaturaLyte or GranuFlo during her regular hemodialysis treatments at a dialysis facility located in Alabama. On February 14, 2010, the decedent suffered from a severe cardiovascular injury and died shortly after the completion of a hemodialysis treatment.

According to the lawsuit, the decedent and her healthcare providers relied upon Fresenius’s misrepresentation that GranuFlo and NaturaLyte were safe and effective products. Since Fresenius didn’t disclose the defects and safety risks linked to NaturaLyte or GranuFlo at that time, it prevented the decedent and healthcare providers from making an informed decision regarding her medical treatment.

The court documents filed in the Granuflo wrongful death lawsuit state that the decedent and plaintiff sustained injuries and damages as a direct result of Fresenius’s wrongful conduct. The plaintiff seeks compensation for the decedent’s medical expenses, pain and suffering, loss of earnings, and funeral expenses. The lawsuit is also requesting compensation for the loss of decedent’s future support, services, care, guidance, and instruction to the wrongful death beneficiaries.