GranuFlo Manufacturer Hid its Serious Health Risks, According to Class Action

GranuFlo and NaturaLyte lawyers at Pintas & Mullins Law Firm report that Fresenius USA, which manufactures the dialysis drugs, was recently hit with a proposed class action claiming it knowingly concealed the health risks of GranuFlo. Plaintiffs allege the company promoted the dialysis drug, despite its risk of cardiac episodes, to increase sales.

Plaintiffs claim that Fresenius initiated a comprehensive and carefully-orchestrated scheme in the early 2000s to promote the safety and effectiveness of GranuFlo and conceal its health risks. They believe the promotional campaign was deceptive, fraudulent, and led to the injury and death of patients throughout the country.

GranuFlo is a dry acid concentrate to help clean and filtrate the bloodstream during dialysis, which patients with kidney failure undergo to remove toxins and waste from the blood. Fresenius is among the world’s largest providers of dialysis products and services, with over 3,200 dialysis clinics globally.

The class action case alleges violations of California’s false advertising laws; Fresenius is currently facing similar allegations in Pennsylvania. In June 2013, the family of a deceased man filed a wrongful death lawsuit against Fresenius after he died from GranuFlo treatment during dialysis. That suit also claims the company knowingly hid the product’s risks from patients, physicians, and the public.

In March 2013, an internal memo from Fresenius was anonymously submitted to the FDA. The letter, written in November 2011, informed its medical directors of the severe health risks associated with GranuFlo and NaturaLyte. The memo was never shared with the general medical community or with the FDA. In light of this, the FDA launched an investigation into the issue, which resulted in a Class I recall of GranuFlo over the risk of heart attack and stroke. Class I recalls are the most serious recalls and are only used when products pose a direct risk of adverse health effects or death.

The Pennsylvania plaintiff contends that GranuFlo creates an unreasonably dangerous level of bicarbonate in the bloodstream, which can cause metabolic alkalosis (a pH imbalance) and ultimately lead to cardiac arrest. There were nearly 950 deaths in 2010 alone due to GranuFlo side effects. This was revealed in a study conducted by Fresenius, which concluded that GranuFlo patients had a six times higher risk of cardiac arrest if their pre-dialysis bicarbonate levels were elevated.

This study was never released to the public, however, and Fresenius continued to manufacture and distribute the drug, without cardiac warnings, through June 2012. Cardiac death causes about 59% of fatalities in dialysis patients, so any additional cardiac risks should have been made public immediately. As one lawsuit put it, the failure to inform the public demonstrates Fresenius’ “callous, reckless, depraved, willful indifference to the health, safety and welfare of [patients].”

As part of its fraudulent marketing scheme, Fresenius developed a new acid concentrate for dialysis, Citrasate, which it promoted in order to justify the discontinuation of GranuFlo. This was done to evade concerns that GranuFlo and NaturaLyte were being taken off market due to safety issues.

Compounding Fresenius’ problems, in March 2013, the FDA sent the company a warning letter concerning its artificial kidneys, also known as dialyzers. The products are used during dialysis to filter patient blood, however, the FDA claims Fresenius did not complete adequate pre-market studies to verify that the dialyzer matched its initial designs. The FDA specifically mentioned dialyzers manufactured in Ogden, Utah.

GranuFlo and NaturaLyte attorneys at Pintas & Mullins Law Firm are currently investigating and accepting cases related to Fresenius dialysis drug injuries. If you or a loved one suffered a cardiac arrest or stroke after dialysis treatment using GranuFlo or NaturaLyte, you may be entitled to significant compensation for your injuries and medical bills, and should contact a qualified attorney as soon as possible.