Fresenius manufactures and distributes GranuFlo Acid Concentrate (GranuFlo), a powdered form of dry acid concentrate used to treat patients suffering from kidney failure. The product was designed to be diluted with purified water and combined with sodium bicarbonate, for delivery through hemodialysis machines to cleanse the patient's blood.
As many as 50% of dialysis patients have been treated with GranuFlo, or the liquid form of the product called NaturaLyte Liquid Acid Concentrate (NaturaLyte). Unfortunately, serious complications associated with the use of GranuFlo, including death, have been reported. As a result, hundreds of GranuFlo lawsuits have been filed against the company.
Problems Associated with GranuFlo Use
GranuFlo has been found to result in dangerously high serum bicarbonate levels in patients undergoing dialysis. This may contribute to the development of a condition called metabolic alkalosis - an elevation of pH levels in tissues beyond the normal range. Metabolic alkalosis can cause the following:
Fresenius owns and operates thousands of dialysis clinics in the U.S. In 2010 alone, 941 patients reportedly suffered sudden cardiac arrest during dialysis treatment at 667 of the company's clinics.
Recall of GranuFlo and NaturaLyte
In November 2011, Fresenius sent an internal memo to doctors at the company's dialysis centers, advising them about the incidents of sudden cardiac arrest that took place the prior year. The company warned that GranuFlo appeared to be causing unsafe bicarbonate levels in patients leading to metabolic alkalosis and advised the doctors to adjust dialysis settings to account for the higher than expected bicarbonate levels. Unfortunately, the company reportedly failed to issue warnings to doctors not associated with Fresenius clinics.
The U.S. Food and Drug Administration (FDA) received a copy of the internal memo from an anonymous source, and began an investigation. Under FDA pressure, Fresenius initiated a Class I recall of both GranuFlo and NaturaLyte on March 29, 2012. Class I recalls are the most serious type, and are reserved for situations where there is a reasonable probability that use of the recalled product could cause serious injury, or even death.
GranuFlo Lawsuit in Multi-District Litigation
As a result of the GranuFlo-related injuries, numerous lawsuits have been filed against Fresenius. On April 5, 2013, the Judicial Panel on Multidistrict Litigation ("MDL Panel") ordered 188 GranuFlo lawsuits that had been filed in various federal courts around the country to be consolidated in the U.S. District Court for the Districts of Massachusetts for pretrial proceedings. Additional cases are likely to be filed as well.
When a significant number of product liability cases have been filed against a manufacturer over the same product, it is common for the cases to be ordered into multidistrict litigation for discovery and other pretrial proceedings. The idea is to reduce costs to the litigants, as well as the risk of conflicting pretrial rulings from different judges. Once an MDL case is ready for trial, it is sent back to the court in which it was filed.
Strict Liability and Failure to Warn
Manufacturers, distributors, and sellers may be held liable if they place a defective product into the marketplace. Under the doctrine of strict liability, the focus is completely on the product, and no wrongdoing has to be established. This is called "strict liability." A product is considered "defective" if it is deemed unreasonably dangerous for its intended use. A product may be defective in its manufacture or in the way it was designed. A product may also be defective if the risks of its use were not adequately conveyed to the consumer. This is called a defect in warning.
In the GranuFlo lawsuits, plaintiffs contend the company knew of the risks associated with the drug, but allegedly concealed them from consumers. Although no fault has to be shown for defective warning liability to attach, if intentional concealment is proven against Fresenius, punitive damages may be awarded to the plaintiffs.
Pursuing a GranuFlo Lawsuit
Patients who suspect they've been injured by GranuFlo or NaturaLyte should contact an attorney for a case evaluation. This should be done as soon as possible, because each state has its own time limits for filing product liability cases.
Contact a qualified product liability attorney to make sure your rights are protected.