Tampa, Florida (PRWEB) October 18, 2012
The Granuflo recall lawyers at Morgan and Morgan are investigating potential claims on behalf of patients who underwent dialysis and suffered cardiac arrest during treatment or shortly thereafter.
In June 2012, the FDA declared Fresenius Medical Care’s decision to change labeling on two of its hemodialysis concentrates to be a Class I recall, indicating that the products could cause serious adverse health effects or death. When inappropriately prescribed, Fresenius’ Naturalyte and Granuflo Acid Concentrates can lead to excessive bicarbonate levels and potentially contribute to a metabolic condition which is a significant risk factor associated with cardiac arrest, the FDA said. The FDA action does not involve the removal of the products from the market.
In November 2011, Fresenius sent an internal memo to the company’s dialysis centers, warning them that improper use of Granuflo may be linked to an increase in the risk of death from cardiac arrest, according to a June 15 New York Times article. The company failed to immediately warn other centers that used the product and only did so in March 2012 after the FDA was leaked a copy of the memo, which revealed that more than 940 patients had suffered cardiac arrest in the company’s own clinics during the previous year, the Times reports. According to the article, the FDA has launched an investigation to determine whether Fresenius violated federal law when it failed to warn customers about the potentially fatal risk of cardiac arrest.
During dialysis, bicarbonate will be administered to neutralize the build-up of acid which is often seen in kidney failure patients. Granuflo and similar products contain an ingredient which the body turns into bicarbonate; however, the Times reports that Granuflo contains a greater amount of this ingredient than its competitors’ products. When determining how much bicarbonate to administer separately, some physicians may not be taking into account the additional bicarbonate contributed by Granuflo, according to the Times.
In light of these reports, the GranuFlo recall lawyers at Morgan and Morgan are currently offering a free, no obligation online case review for those who underwent dialysis and suffered a cardiac arrest, as well as loved ones acting on their behalf. For more information on Morgan and Morgan and to fill out a free case review, please visit http://www.forthepeople.com/granuflo-naturalyte-recall--11-4643.html today.
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Morgan & Morgan is one of the largest exclusively plaintiffs’ law firms in the country with 15 offices throughout Florida, Georgia, Mississippi, Tennessee, and New York. The firm handles cases nationally involving personal injury, medical malpractice, consumer class action, and securities fraud, as well as complex litigation against drug and medical device manufacturers. Visit Morgan & Morgan online at http://www.forthepeople.com/ for a free case evaluation and information about your legal rights.