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From Products Liability Law Daily, October 21, 2014

$5-million verdict for kidney-damaged man further harmed by Omniscan withstands drug-maker’s challenges

By Kathleen Bianco, J.D.

A new trial was not warranted in a drug-maker’s challenge to an Ohio jury’s $5-million verdict for a man whose already impaired kidneys were further damaged after he received an MRI utilizing the gadolinium-based contrast dye Omniscan, the Sixth Circuit Court of Appeals determined (Decker v. GE Healthcare Inc., October 20, 2014, Gibbons, J.). Omniscan’s manufacturer, GE Healthcare Inc., challenged a lower court’s findings relating to causation, jury instructions, and the admissibility of expert testimony—all of which were summarily rejected.

Background. As part of a magnetic resonance imaging procedure, Paul Decker was injected with Omniscan, a gadolinium-based contrast dye developed and sold by GE Healthcare, Inc. (GEHC). Gadolinium dyes can be extremely toxic to individuals with impaired kidney functions, as was Decker’s condition at the time that he received the Omniscan injection. Sometime later, Decker developed Nephregenic Systemic Fibrosis (NSF), a debilitating disease that hardens the skin/internal organs and stiffens the joints. Decker and his wife subsequently sued GEHC under Ohio law, asserting claims for failure to warn, design defect, and nonconformance to representation.

In the first case in the multidistrict litigation (MDL) involving Omniscan to go to trial, the jury returned a verdict in favor of the plaintiffs, unanimously concluding that GEHC knew or should have known about the risks of Omniscan to patients with renal impairment but failed to adequately warn the medical community—including the radiologist who administered the drug to Decker—about those risks. The jury awarded Decker $4.5 million in compensatory damages ($1 million for economic loss and $3.5 million for noneconomic loss), and his wife was awarded $500,000 for loss of consortium.

After receiving the jury’s verdict, GEHC filed a motion for a new trial which the district court rejected. GEHC appealed the denial, arguing that a new trial was warranted because the district court judge (1) should have recused himself from the trial and its motion for a new trial, (2) made several erroneous evidentiary rulings, which were applicable to all MDL cases, (3) erroneously denied GEHC’s motion for a new trial because insufficient evidence supported the jury’s verdict regarding the causation element of the Deckers’ failure-to-warn claim, and (4) wrongly failed to issue two proposed jury instructions.

Causation. Contrary to the drug-maker’s assertion, the court did not err in finding that the plaintiffs had produced sufficient evidence to support the jury’s verdict, the appellate panel ruled, noting that it was the jury’s prerogative to determine which experts to credit and how to resolve conflicting testimony. In order to support their failure-to-warn claim, the plaintiffs had presented to the jury the scientific evidence that, at the time Mr. Decker was injected with Omniscan, the drug-maker was aware that the drug was toxic to renally-impaired patients, the court said, remarking that this information had included chemistry, toxicology, and human studies—some of which had been conducted internally by the drug-maker’s employees/consultants and were left unpublished/undisclosed to regulatory authorities.

Jury instructions. As for the drug-maker’s contention that a new trial was warranted based upon the district court’s failure to give a limiting instruction to the jury on Adverse Event Reports, the appellate panel disagreed, finding the notion that the jury would consider those reports for an improper purpose (i.e., as proof of causation) absent the requested limitation was improbable. The plaintiffs presented no evidence, nor did they argue, that the four AERs proved that Omniscan causes NSF generally or that it had caused Mr. Decker’s NSF specifically, the appellate court noted. Additionally, the drug-maker presented no evidence challenging the fact that Mr. Decker had NSF or the fact that his NSF had been caused by the single dose of Omniscan he had received. As such, the district court’s determination that the limiting instruction would not have been helpful and would have caused more confusion was reasonable, the appellate court concluded.

Expert witness admissibility. Finally, the drug-maker asserted several challenges involving the inclusion/exclusion of certain expert testimony. Under the applicable standard for determining the admissibility of such evidence, the party offering the expert testimony must show by a “preponderance of proof” that the expert whose testimony is being offered is qualified and will testify to scientific knowledge that will assist the trier of fact to understand the relevant issues. The district court has discretion to determine whether an expert is qualified and if the proffered testimony is relevant and reliable.

Upon review of the facts, the appellate panel concluded that the district court had not abused its discretion when it (1) determined that the testimony regarding the speculated cause of the injury, the so-called “free” gadolinium theory of NSF, was admissible under Daubert; (2) allowed the AER testimony of a pharmacovigilance expert who was not a medical doctor but excluded the related testimony of a medical doctor who was not a pharmacovigilance expert; and (3) rejected evidence regarding reports of cases of NSF not related to gadolinium exposure because the studies were methodologically flawed based on the failure to confirm the lack of exposure to a gadolinium-based contrast agent. Based on the totality of the circumstances, the appellate court affirmed the lower court’s judgment and denied the drug-maker’s motion for a new trial.

The case number is 13-4002.

Attorneys: Christopher Vincent Tisi (Ashcraft & Gerel) for Paul Decker. J. Philip Calabrese (Porter Wright Morris & Arthur) for GE Healthcare Inc. and GE Healthcare AS.

Companies: GE Healthcare Inc.; GE Healthcare AS

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