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NaturaLyte Lawsuit

NaturaLyte, a liquid acid concentrate commonly used during dialysis treatment, is now the focus of a nationwide recall and federal investigation after researchers found it can cause heart attacks, strokes and death in renal-failure and kidney-disease patients.

Created and manufactured by Fresenius Medical Care (FMC), the nation’s largest provider of dialysis equipment, products and treatment facilities, NaturaLyte is supposed to aid in dialysis, which helps cleanse the blood of toxins. Instead, researchers have found it can create high levels of bicarbonate in the bloodstream, thus elevating the risk of heart attack. Unlike other acid concentration products, NaturaLyte contains an ingredient that converts into bicarbonate, giving the patient unsafe bicarbonate levels.

In March 2012, the U.S. Food and Drug Administration (FDA) issued a Class I recall for NaturaLyte and it’s sister product GranuFlo. A Class I recall is reserved for only th e most dangerous or defective products. In addition, the FDA is continuing its investigation into FMC to determine if the company violated federal regulations when it failed to inform all its customers about the risks.

NaturaLyte Recall

Introduced in 2007, NaturaLyte liquid concentrate was FDA approved under the controversial 510(k) approval process. This allows devices that are similar in nature to bypass any clinical testing or trials and go directly to the marketplace. NaturaLyte was a modified version of another FMC bicarbonate product.

In November 2011, FMC, which operates more than 1,800 dialysis clinics nationwide, sent an internal memo to its own researchers and physicians warning them of the risk related to NaturaLyte and elevated bicarbonate levels. The memo warned that NaturaLyte can produce higher than normal bicarbonate levels when compared to similar dialysis treatments and doctors may not take this into account when prescribing it. This could lead to serious injuries or death, FMC said. The company said that 941 FMC patients suffered cardiac arrests while undergoing dialysis with either NaturaLyte or GranuFlo. Through its own research, the company determined that patients with high bicarbonate blood levels had a six to eight times increased risk of cardiac arrest than those with lower levels.

Instead of making a public announcement about the dangers, the company only warned the medical personnel in its own clinics. The company did not warn the thousands of other dialysis centers that use NaturaLyte or GranuFlo about the dangers associated with the products. Company officials later said they had no way to communicate with non-company clinics and the findings were too preliminary to warrant publication in a medical journal.

It wasn’t until March 2012, after the FDA received an anonymous tip regarding the dangers of NaturaLyte and GranuFlo, that the brakes were put on the products. The FDA issued a recall and mandated the company to revise the product instructions and usage guidelines.

NaturaLyte Attorney

In addition to the nationwide NaturaLyte and GranuFlo recalls, the FDA also announced an investigation into FMC’s practices regarding the potentially lethal product. In June 2012, FDA officials announced they are determining if FMC violated federal regulations by failing to inform patients and doctors of the dangers.

Today, dozens of patients and their families have filed lawsuits against FMC for its NaturaLyte and GranuFlo products in courtrooms across the country. Already, a group has filed a petition to consolidate cases into a multidistrict litigation (MDL). Such a court proceeding can be helpful to individual complainants because it consolidates time-consuming and expensive work including pretrial hearings and discovery, but allows for cases to be heard on an individual basis. Unlike a class-action lawsuit, an MDL allows each case to be heard by a judge individually and awarded compensation based on individual circumstances. A judicial panel will decide on the motion to form the MDL in March 2013.

If you or a loved one was given NaturaLyte, please contact our attorneys. You may have the right to compensation for your medical expenses, pain, suffering and other difficulties that resulted from FMC’s negligence.