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Ring the Bell – Another Defense Verdict For Fresenius in Dialysis Treatment Bellwether Trial

Posted in Massachusetts Courts, Pharmaceutical and Medical Devices, Products Liability, Professional Liability

blood-pressure-1573037_1920On March 3, 2017, after less than four hours of deliberations, a Massachusetts federal jury found that Fresenius Medical Care was not liable for the 2012 death of one of their patients. The verdict drew to a close a four-week long bellwether trial, the second for plaintiffs who opted out of a $250 million settlement offered by Fresenius relating to dialysis products, NaturaLyte and GranuFlo.

The matter arose out of the death of fifty-seven year old North Carolina man, Carley Dial. The decedent’s wife and representative of the estate, Florella Dial, alleged that Mr. Dial suffered from cardiac arrest as a result of the misuse of NaturaLyte, a dialysis product manufactured and sold by Fresenius. Lead trial counsel, Robert Carey of Hagens Berman Sobol Shapiro, argued in his closing that Fresenius did not adequately warn about their products, nor did they have an understanding of their products to ensure they were safe.

Over the course of the fourteen day trial, several Fresenius staff members, from Mr. Dial’s treating nurse at the Pembroke, North Carolina clinic, to the current Chief Medical Officer of Fresenius, headquartered in Waltham, Massachusetts, testified before the jury to evidence the methods that were used to educate, train, and instruct dialysis clinics on their product, NaturaLyte. Plaintiff challenged this testimony by offering Mr. Dial’s treating physician assistant and staff member of Carolina Kidney Care, and PowerPoint presentations created by Fresenius in her attempt to evidence the alleged confusion regarding NaturaLyte.

Plaintiff expert, Dr. G.M. Samaras, a professional engineer and an expert in the field of industry accepted standards and risk management, testified that Fresenius was aware that the information and training they provided regarding NaturaLyte was confusing. Plaintiff also offered nephrologist, Dr. Borkan, who opined that Mr. Dial died from cardiac arrest as a result of metabolic alkalosis, caused by the mismanagement and overuse of NaturaLyte in Mr. Dial’s dialysis treatment. Ultimately, the jury disagreed and found that the use of NaturaLyte in Mr. Dial’s dialysis treatment was not the proximate cause of Mr. Dial’s death.

During his closing, lead trial counsel for Fresenius, James Bennett of Dowd Bennett LLP, argued that Mr. Dial did not die from cardiac arrest, but suffered a heart attack at home, hours after the conclusion of his dialysis treatment. He referred to Mr. Dial’s medical history which evidenced heart blockages and an undetected prior heart attack. Attorney Bennett argued that Mr. Dial’s blockages had been developing for several decades and Mr. Dial did nothing to correct them. Attorney Bennett highlighted that NaturaLyte has been on the market for more than three decades, contains the same amount of acid concentrates as competitors, and more than 305 million gallons of NaturaLyte were sold between 2000 and 2012.

Dr. William Buchanan, Mr. Dial’s treating nephrologist responsible for prescribing NaturaLyte, testified that he received appropriate training by Fresenius regarding the use of their products and that he had a clear understanding of the acid/base balance and conversions of NaturaLyte. Dr. Buchanan believed he provided individualized care for Mr. Dial based on guidelines set by the clinic’s standard order. As Mr. Dial’s treating physician, Dr. Buchanan was responsible for signing the death certificate. Upon Dr. Buchanan’s review of the ambulance notes indicating Mr. Dial suddenly collapsed and Mr. Dial’s previous diagnosis of coronary artery disease, he concluded that the patient had a major heart attack. No autopsy of Mr. Dial was requested or performed.

Defense expert and cardiologist, Dr. Peter McCullough, reviewed Mr. Dial’s medical records before the jury for over two hours. He agreed with Dr. Buchanan and opined that based on the decedent’s history of untreated heart blockages and comorbidities, Mr. Dial suffered from a heart attack unrelated to his dialysis treatment. During closing arguments, Attorney Bennett argued that Dr. McCullough was the only cardiologist to review Mr. Dial’s medical records and was 100% correct in his testimony. Indeed, the jury concluded, to a fair preponderance of the evidence, that the use of NaturaLyte was not the proximate cause of Mr. Dial’s death.

This is the second defense verdict for Fresenius. In December of 2015, a separate bellwether trial also resulted in a defense verdict before Judge Kirpalani in Massachusetts state court. Although another defense verdict is good news for Fresenius, thousands of other claims remain. Judge Woodlock expressed his intention to schedule the next Fresenius bellwether trial soon.