Fresenius Hit with GranuFlo Class Action Lawsuit

Fresenius Medical Care may soon be facing a Granuflo class action lawsuit in Pennsylvania, if the court certifies the action. The case was brought by Carmen Brysten, who lost her husband to heart failure shortly after he was treated with Granuflo in November 2011. Brysten filed the complaint in the Philadelphia Court of Common Pleas on June 14, and is requesting class action status to include individuals and their beneficiaries who have been treated with Granuflo during dialysis and suffered heart problems including sudden cardiac arrest. If the court approves the Fresenius dialysis class action lawsuit, hundreds if not thousands of Pennsylvania residents are likely to join, all claiming the defendant failed to warn of serious risks and side effects posed by Granuflo.

Plaintiff files Granuflo class action following husband’s death

Court documents show that shortly before his death in November 2011, Brysten’s husband was administered Granuflo as part of his dialysis treatment at Langhorne Health Center. That same month, Fresenius Medical Care circulated an internal memo to its own clinics warning about potentially fatal cardiac events linked to Granuflo dosage errors and its unique formulation that raise bicarbonate levels, leaving patients at risk for heart attacks, cardiopulmonary arrest and sudden death.

In the complaint Brysten contends that “GranuFlo is defective and unreasonably dangerous for its use because it creates an unreasonably dangerous level of bicarbonate in the blood stream during dialysis causing metabolic alkalosis and a corresponding substantial increase in the risk of cardiopulmonary arrest during dialysis treatment.”

The lawsuit further alleges, “Despite this knowledge, Fresenius failed to inform physicians that GranuFlo increases the level of bicarbonate in patients, thus preventing physicians and/or clinicians from learning of the need to reduce the bicarbonate prescribed to patients undergoing dialysis with GranuFlo.”

While Fresenius alerted its own dialysis centers about adverse Granuflo side effects in 2011, the company did nothing to caution outside clinics or health care providers using the dialysate, leaving thousands of patients at risk. The public wasn’t informed about Fresenius dialysis injuries until an anonymous source leaked the memo to the FDA. Based on the disturbing data and reports of over 900 GranuFlo-related deaths, federal regulators ordered a Class I recall for Granuflo and its liquid version, Naturalyte, in March 2012.

Litigation against Fresenius consolidated as MDL

On top of the pending Granuflo class action lawsuit in Pennsylvania, Fresenius is already being sued by more than 160 plaintiffs alleging heart attacks, cardiac arrest, disability or dialysis death from its products. Since the majority of Naturalyte and Granuflo lawsuits all contained common issues of fact and allegations, to preserve judicial resources and streamline pre-trial proceedings, all federal cases were transferred to Massachusetts district court under the guidance of Judge Douglas P. Woodlock.

The products liability MDL No. 2428 may help injured patients and family members who lost a loved one from Granuflo to reach a timely resolution to their claims, as MDL helps prevent duplicative discovery and avoid differing judicial rulings if all claims were handled in separate courts. While still in the early stages, the consolidated litigation may encourage mediation talks for potential Granuflo lawsuit settlements.

If the Pennsylvania court fails to certify the Fresenius dialysis class action lawsuit filed by Brysten, the complaint may be eligible for transfer to MDL for pre-trial coordination.