Some dangerous dialysis medications have prompted lawsuits by many patients, with claims that the drugs were responsible for serious health concerns, including fatal heart failure. Specifically, Fresnius Medical Care’s Granuflo and Naturalyte are responsible for serious adverse effects and have been recalled by the FDA as a result. This recall, which started in March 2012, was done because the administration believed there was a reasonable chance the drugs could cause major complications or death. The FDA is also investigating whether or not Fresnius was in violation of federal regulations in how they handled research that showed the dangers of its products.
Fresnius is a leader in the administration of dialysis, but many lawsuits are now challenging its safety procedures. These medications deliver bicarbonate during blood filtering, which is a necessary part of the process. However, these substances contain an abundance of bicarbonate, and other ingredients in the drugs are processed into bicarbonate by the body. Doctors have regularly overdosed their patients on bicarbonate because they are unaware of the extra bicarbonate being produced by the patient. The result is dangerous levels of bicarbonate, which can result in elevated tissue pH, potentially leading to metabolic alkalosis and dialysis-linked heart attacks. If not addressed immediately, metabolic alkalosis can cause fatal heart failure.
An internal memo circulated by the company on November 4, 2011, showed that Fresnius was aware of this risk and sought to alert its physicians with the memo. However, the company failed to alert other physicians and medical facilities using Granuflo and Naturalyte, nor did Fresnius alert patients to its risks. Because of this, many physicians and their patients believe the company was acting negligently.
Anyone who has taken Granuflo or Naturalyte and suffered serious health effects should consider speaking to a drug injury attorney for guidance on how to pursue restitution.