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From Products Liability Law Daily, March 3, 2017

Jury did not find that NaturaLyte® caused patient’s death in Fresenius bellwether win

By Susan Lasser, J.D.

Without reaching the question of the adequacy of the drug’s warnings, a federal jury in Massachusetts has rendered a defense verdict for Fresenius Medical Care in a bellwether trial in the multi-district litigation concerning the drug maker’s dialysis drug, NaturaLyte®. The jury found that the evidence in the patient’s case did establish that his use of the product in his dialysis treatments was a producing cause of his death (In re: Fresenius Granuflo/Naturalyte Dialysate Products Liability Litigation (Dial v. Fresenius Medical Care Holdings, Inc.), March 3, 2017, Woodlock, D.).

Multi-district litigation and patient’s complaint. The multi-district litigation arose out of allegations that patients suffered injury or death as a result of the use of Fresenius’s GranuFlo® and/or NaturaLyte products during hemodialysis. All of the actions involve factual questions relating to whether GranuFlo and NaturaLyte were defectively designed or manufactured, whether Fresenius, the manufacturer of the dialysate products, knew or should have known of the alleged propensity of the products to cause injury and whether it provided adequate instructions and warnings with the drugs.

Among the claims alleged in the short-form complaint filed by the deceased patient’s wife against the Fresenius defendants were claims for strict liability, negligent failure to warn, negligent design, negligence, and wrongful death.

About a year ago, Fresenius Medical Care AG & Co. KGaA told investors that it reached an agreement in principle with a plaintiffs committee in the multi-district litigation involving its dialysis products to settle the patient claims. The terms of the agreement in principle provided that a settlement amount of $250 million would be made available, provided that 97 percent of all plaintiffs agreed to the settlement terms. The patient’s wife did not opt to settle.

Jury verdict. The jury was asked whether the patient’s wife had established that the use of NaturaLyte in the patient’s hemodialysis treatments after the patient received results of his January 23, 2012 tests was the proximate cause of his death. The question further explained that this meant that it was a cause which in natural and continuous sequence unbroken by any new and independent cause produced his death and without which his death would not have occurred. The jury answered, no, thereby ending its work. The jury never reached the next question on the jury form asking whether the wife had established that the drug maker acted unreasonably in failing to provide prescribers or health care providers "who were in a position to reduce the risks of harm in accordance with instructions or warnings, adequate warnings or instructions for use of Naturalyte" in the patient’s dialysis treatments, "thereby creating an unreasonably dangerous condition that Fresenius knew, or in the exercise of ordinary care, should have known posed a substantial risk of harm to him."

The case is No. 14-11101-DPW (MDL 2428).

Attorneys: Brian D. Ketterer (Janet, Jenner & Suggs, LLC) for Florella Dial. James F. Bennett (Dowd Bennett LLP), Roger A. Denning (Fish & Richardson P.C.) and Maria R. Durant (Collora LLP) for Fresenius Medical Care Holdings, Inc. d/b/a Fresenius Medical Care North America, Fresenius USA, Inc. and Fresenius USA Manufacturing, Inc.

Companies: Fresenius Medical Care Holdings, Inc. d/b/a Fresenius Medical Care North America; Fresenius USA, Inc.; Fresenius USA Manufacturing, Inc.

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