Failure to Warn of GranuFlo Dangers

Most of us take our kidneys for granted while their working normally. But because they act as a filter to remove toxins and waste materials from the blood, it can be fatal when it does not do what it is supposed to. In essence, the body is being poisoned from inside out. In order to clean the blood when renal failure occurs, the patient has to undergo dialysis regularly. A dialysis machine is designed to take the place of the kidneys with the use of a neutralizing substance.

GranuFlo (and its liquid counterpart NaturaLyte) is a product developed and marketed by Frenesius Medical Care (FMC) to help in the neutralization process. It increases the capacity of the bicarbonate agent to deactivate the acid that naturally accumulates in the blood. It makes the process more efficient and less bothersome for the patient.

It is expected that those administering the process of dialysis will have to be sufficiently trained and conscientious about the dosages of the cleaning agents as this will have a direct effect on the patient. An over-dosage of any pharmaceutical product is always undesirable, although there are typically margins for error. With GranuFlo, the margin for error was very narrow, especially for patients with a history of cardiac problems.

It seems strange then that FMC would emphasize potential GranuFlo dangers to dialysis centers in their network but neglect to issue the same warnings to other centers that use their product. It was an inexplicable failure, and one that is turning out to be a legal quagmire of liability for the company. Currently, in excess of 500 cases have been filed in multidistrict litigation (MDL No. 2428 In re Fresenius GranuFlo/Naturalyte Dialysate Litigation) after a Class 1 recall by  the Food and Drug Administration made public a suspected pharmaceutical defect in the product. It is alleged that personal injury caused stroke, cardiac problems, and death of patients.

If you or a family member has suffered injury from using Granuflo, you may be eligible for compensation. Contact a product liability lawyer in the area who is experienced in handling defective drug cases to assess your case and discuss legal options with you.

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