In re Fresenius GranuFlo/NaturaLyte Dialysate Products Liability Litigation Lawsuit

In re Fresenius GranuFlo/NaturaLyte Dialysate Products Liability Litigation

Product and manufacturer

Patients with kidney failure depend on dialysis, a treatment in which a machine filters their blood on the machine's behalf. Central to the process is the dialysate: the electrolyte solution that the blood is exchanged against, whose precise concentrations of sodium, potassium, magnesium, and other ions must track the body's own balance closely. Two of the solutions used to prepare dialysate were GranuFlo and NaturaLyte, dialysate concentrate products made by Fresenius, part of the Fresenius Medical Care group, with the North American operations run through Fresenius Medical Care North America. The concentrates are shipped in concentrated form and diluted at the dialysis facility before use, following the manufacturer's mixing instructions. The products at issue here were therefore not implanted in patients but passed through their blood treatment every dialysis session, which is why a defect in their composition could reach a large patient population at once.

Alleged harm

The allegations in this litigation concerned the electrolyte content of the two solutions. Plaintiffs alleged that GranuFlo and NaturaLyte were manufactured with electrolyte concentrations that fell short of what the products' own labeling and the manufacturer's specifications called for, an error in the products' composition rather than in their use. When dialysis patients received dialysate prepared from the affected concentrates, their blood sodium and other ion levels could be drawn down over repeated treatments. The claimed consequences were the clinical syndromes that follow from low electrolyte levels — disorientation, muscle weakness, seizures, and cardiac complications — and, in the cases that gave rise to this litigation, deaths and serious illness among dialysis patients. The products were subsequently withdrawn from sale.

Litigation

As the deaths and illnesses came to light, patients and their families filed product liability suits in federal and state courts across the country. Those cases were centralized as Multi-District Litigation No. 2428, docket 1:13-md-02428, in the United States District Court for the District of Massachusetts, before Judge Douglas P. Woodlock. Centralization brought the federal and state cases together for coordinated discovery and pretrial proceedings, which in a case involving a dialysis product used in facilities nationwide also meant a single forum for the common questions about how the concentrates were formulated, tested, and labeled.

Outcome

The matter resolved by settlement. On February 17, 2016, Fresenius Medical Care North America agreed in principle to settle the litigation, with the company's insurers funding the bulk of the arrangement. The agreement was structured as a claims program: it was subject to claimant approval by a 97 percent threshold, with the approval deadline set for July 2016 and funding of the program expected in August 2016. The case data records the outcome as a 2016 settlement and the MDL as terminated. No financial terms are stated in this entry.

This is an archived encyclopedia record; intake for new claims is closed and the entry is provided for historical reference only.