After receiving an internal memo suggesting Fresenius knew there were serious dangers associated with the use of GranuFlo and Naturalyte, the FDA issued a Class 1 recall for both products, according to the New York Times. Prior to this Class 1 recall, which is reserved for products where there is a “reasonable probability…[of causing] serious adverse health consequences or death,” Fresenius had not warned doctors, potential patients, or the general public of the risks the products may pose, according to reports. They had, however, reportedly warned their own medical centers and doctors of the risks. The Times reports that a company using Fresenius products stated that “if the data was sufficient to warn their doctors, then the [public] should have been made aware of it.” Fresenius is currently being investigated for failing to warn customers of the risks associated with their dialysis concentrates and faces more than 200 lawsuits over these products.
GranuFlo and NaturaLyte are used in the dialysis process, along with other medications, and are administered to neutralize acid that builds up in the patient’s blood. GranuFlo and NaturaLyte, however, are reportedly different from rival medications because they contain a substantially greater amount of an ingredient that converts into bicarbonate in the kidneys. Bicarbonate happens to be one medication doctors prescribe separately in dialysis. If doctors are unaware of the amount of bicarbonate present in the body from the use of GranuFlo or NaturaLyte, they may overprescribe bicarbonate. An overdose of bicarbonate has reportedly been linked to serious health issues including heart attacks, cardiopulmonary arrest, and death.
If you or a loved one has suffered a sudden cardiac event during or shortly after dialysis, you may have legal recourse to seek compensation for your losses. Find out more today by visiting ClassAction.org.
About Class Action.org
Class Action.org is dedicated to protecting consumers and investors in class actions and complex litigation throughout the United States. Class Action.org keeps consumers informed about product alerts, recalls, and emerging litigation and helps them take action against the manufacturers of defective products, drugs, and medical devices. Information about consumer fraud issues and environmental hazards is also available on the site. Visit http://www.classaction.org today for a no cost, no obligation case evaluation and information about your consumer rights.
Accidents.com
Whitney Shields
8004491970
pressrelease@lawyercentral.com
Source: EmailWire.Com
