$250 Million Settlement Reached in Granuflo Litigation

A $250 million settlement has been reached between Fresenius Medical Care and the patients that claimed the company’s dialysis products led to serious and deadly side effects.

The settlement is “in principle,” which means the company agreed to the settlement without admitting to any defect in their product or negligence on their part in sharing potential risks with the medical community or general public.

Fresenius sets aside settlement money

Fresenius Medical Care, one of the largest providers of dialysis products in the world, has agreed to set aside $250 million to settle more than 10,000 lawsuits filed by dialysis patients and family members. The plaintiffs in those lawsuits allege use of Granuflo and Naturalyte during hemodialysis treatments led to heart problems and sudden death for some patients. The complaints further alleged Fresenius did not provide adequate instructions or warnings for their products, increasing the potential risk for patients.

The lawsuits began to be filed after it was discovered an internal memo was circulated within Fresenius dialysis centers voicing concerns about the potential dangers of those products. The memo, which was dated November 2011, urged personnel inside the Fresenius clinics to use increased caution when mixing Granuflo and Naturalyte for dialysis treatments. However, that memo never made it to the hundreds of non-Fresenius dialysis clinics that also used the products, leaving those patients vulnerable to possible mixing errors.

Unique formulations lead to Granuflo complications

The concern with the Fresenius products arose from the unique formulations that required different mixing instructions than other types of dialysis products. If the concentrates are mixed improperly, they could increase levels of bicarbonate in the blood which could lead to a potentially dangerous condition known as metabolic alkalosis. Metabolic alkalosis increases a patient’s risk for decreased blood pressure, heart arrhythmias and heart attack. The complications can be deadly for some patients, particularly if metabolic alkalosis is not detected and treated quickly.

The internal memo was brought to the attention of the FDA in March 2012, which prompted an inquiry and resulted in a class I recall of Granuflo and Naturalyte. A class I recall means the drug in question could have serious and even deadly consequences. While the products were not removed from circulation, stricter warnings and instructions were included with the concentrates in an effort to prevent serious side effects.

Litigation concerning dialysis injuries

Patients who were injured after using Granuflo or Naturalyte, or family members of patients that died after using the products, began filing lawsuits against Fresenius. As the lawsuit number continued to grow, coordination of cases, known as multidistrict litigation, was established in U.S. District Court for the District of Massachusetts. Multidistrict litigation is used when there are a growing number of complaints with common statements of fact for the purpose of streamlining early trial proceedings and making the legal process more efficient and convenient.

To date, more than 10,000 Naturalyte and Granuflo lawsuits been filed against Fresenius. The first case went to trial earlier this year and resulted in a decision that Fresenius was negligent in not distributing their internal memo to other clinics using their products. However, the jury stopped short of deciding the death of the patient in this case could be directly attributed to Granuflo, which meant no damages were awarded to the plaintiffs in the case.

Now, Fresenius has decided to settle the majority of the cases remaining in litigation, to “put the lawsuits behind,” according to a report at the New York Times. The settlement will only go into effect if at least 97 percent of the plaintiffs with cases currently filed in Massachusetts agreed to the settlement terms. The deadline for accepting the settlement is July 2016.

If the Granuflo settlement moves forward, the monies would be dispersed in August 2016.

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