$5 millionVerdict

Nation's First NSF Trial: Ohio Jury Awards $5 Million Against GE Healthcare Over Omniscan Gadolinium Contrast Dye

Verdict · N.D. Ohio (Cleveland), aff'd 6th Cir. 2014 · 2013

Won by Ashcraft & Gerel, LLP.

A federal jury in Cleveland awarded $5 million to Paul Decker and his wife after finding that GE Healthcare failed to adequately warn patients about the risk of nephrogenic systemic fibrosis from its Omniscan MRI contrast agent, making Decker the first gadolinium NSF case in the country to reach a jury verdict.

What happened

Paul Decker had end-stage renal disease when he received an injection of Omniscan during an MRI procedure in 2005. Omniscan is a gadolinium-based contrast agent manufactured by GE Healthcare and used to improve image clarity in MRI scans. In patients with severely impaired kidneys, gadolinium can escape its chemical binding agent and accumulate in tissue, triggering a condition called nephrogenic systemic fibrosis, or NSF.

NSF causes progressive hardening and thickening of the skin, connective tissue, and internal organs. It has no known cure. Decker developed the condition after his 2005 imaging procedure, and the disease locked his arms at the elbows and contracted his hands, wrists, and fingers. Evidence presented at trial showed that GE Healthcare had internal data on gadolinium retention risks dating to the late 1980s, years before NSF was first described in the medical literature in 2000 and long before the company added warnings to Omniscan's label in 2007.

Hundreds of similar lawsuits were consolidated in multidistrict litigation in federal court. The Decker case was selected as the first to go to a jury. Trial took place in the Northern District of Ohio in Cleveland. Ashcraft and Gerel attorneys Michelle Parfitt and Christopher Tisi, along with co-counsel from Spangenberg Shibley and Liber LLP, argued that GE's failure to warn prescribing radiologists of the elevated NSF risk in renally impaired patients was the cause of Decker's injuries. The jury agreed on the failure-to-warn claim, finding that Omniscan itself was not defective but that GE did not provide adequate warning.

On March 26, 2013, the jury awarded Paul Decker $4.5 million in compensatory damages and his wife Karen Decker $500,000 for loss of consortium, for a total of $5 million. GE Healthcare moved for a new trial and remittitur; the trial court denied both. GE appealed to the Sixth Circuit. Paul Decker died before the appellate decision was issued.

On October 20, 2014, a three-judge Sixth Circuit panel unanimously affirmed the verdict. The court rejected GE's challenges to the expert testimony, jury instructions, and the trial judge's partial recusal, finding no abuse of discretion on any ground. The $5 million award stood in full, with no reduction.

Sources

This account is drawn from contemporaneous public reporting and the court record.