Granuflo Side Effects Blamed for Alabama Man’s Death

On February 25, 2013, Tanzella Leary, individually, and on behalf of the estate of Darian Leary – her deceased husband – filed a Granuflo lawsuit in U.S. District Court, Northern District of Alabama. The case of Leary v. Fresenius Medical Care mirrors that of hundreds of other claims filed in court rooms across the nation, in which plaintiffs allege use of Naturalyte and/or Granuflo during dialysis caused the wrongful death of their loved ones.

As detailed in court documents, Darian Leary suffered severe injuries and damages including adverse cardiovascular events and cardiovascular death on February 28, 2011. The Alabama wife claims that defendant Fresenius Medical Care and its subsidiaries manufactured and sold dangerous acid concentrate products known as Naturalyte and Granuflo, causing her husband to experience metabolic alkalosis and die after receiving the dialysates during hemodialysis treatment.

Granuflo lawyer alleges Fresenius failed to warn of risks

According to the recently filed Granuflo lawsuit, the defendants exercised negligent, intentional, willful, wanton and fraudulent conduct by failing to warn of the severe health risks associated with its dialysis products. The plaintiff alleges that neither she nor her deceased husband’s treating physicians had reason to suspect the decedent’s injuries were related to use of Naturalyte or Granuflo until the products were recalled in 2012. The FDA issued its Class I Granuflo recall on March 29, 2012, in the wake of increasing reports of adverse events.

The FDA website states the following as grounds for its most stringent recall for both Granuflo and Naturalyte, “Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.”

Fresenius had prior knowledge about deadly Granuflo side effects

Among the many allegations raised in Mrs. Leary’s Granuflo lawsuit is that Fresenius had prior knowledge concerning the dangers of Granuflo and Naturalyte in regards to improper dosages – information that was revealed in a 2011 internal memo that was later leaked to the FDA. According to Fresenius’ memo, “[i]n light of these troubling findings, we strongly recommend that physicians adjust dialysate bicarbonate prescriptions monthly for individual patients, with immediate attention to patients with serum pre-dialysis bicarbonate levels of >24 mEq/L.” The memo was not distributed to outside dialysis centers such as the one where the Alabama decedent received treatment, and was only made public after the FDA product recall.

Alabama widow seeks compensatory and punitive damages

Both Naturalyte (liquid concentrate) and Granuflo (dry powder concentrate) have been linked to a slew of injuries and complications including cardiopulmonary arrest, electrolyte imbalances, cardiac arrhythmias, stroke, coma, hypotension and sudden death. For the wrongful death of her husband, Mrs. Leary is requesting all costs and expenses associated with the decedent’s death, burial, and funeral; compensatory damages for medical expenses; and compensation for emotional distress, loss of enjoyment of life, pain and suffering – in addition to punitive damages as the court deems proper.

The plaintiff’s Granuflo lawyer adopts multiple counts against the defendant including fraudulent concealment, misrepresentation, breach of implied and express warranties and other charges. Like other grieving parties who have filed a Granuflo lawsuit, the claimant is demanding a trial by jury.