Decker v. GE Healthcare, Inc.

956 F. Supp. 2d 809, 2013 WL 3853406, 2013 U.S. Dist. LEXIS 104273
CourtDistrict Court, N.D. Ohio
DecidedJuly 25, 2013
DocketCase Nos. 1:08 GD 50000, 1:12 GD 50004; MDL No. 1909
StatusPublished
Cited by1 cases

This text of 956 F. Supp. 2d 809 (Decker v. GE Healthcare, Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. Ohio primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Decker v. GE Healthcare, Inc., 956 F. Supp. 2d 809, 2013 WL 3853406, 2013 U.S. Dist. LEXIS 104273 (N.D. Ohio 2013).

Opinion

MEMORANDUM OF OPINION AND ORDER

DAN AARON POLSTER, District Judge.

Pending before the Court is Defendant GE Healthcare’s motion for a new trial, to [811]*811alter or amend the judgment, and for remittitur (Doc. #: 271). For the reasons to follow, the motion is DENIED.

I. Background

On September 2, 2005, Plaintiff Paul Decker was injected with a gadolinium-based contrast dye developed and sold by GE Healthcare, Inc. (“GEHC”). Such dyes are used in conjunction with magnetic-resonance-imaging procedures. The dyes enhance the quality of the images, but they can be extremely toxic to patients with impaired kidney functions. Mr. Decker’s kidneys were impaired when he received the dose of GEHC’s contrast dye, Omniscan, and some time later he developed Nephrogenic Systemic Fibrosis (“NSF”), a debilitating disease that hardens the skin and internal organs and stiffens the joints. Mr. Decker and his wife, Karen, thereafter sued GEHC under Ohio law.

On March 22, 2013, after twelve days of testimony and two days of deliberation, a jury returned a verdict in favor of Mr. and Mrs. Decker. The jury unanimously determined 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 Mr. Decker’s radiologist, who administered the drug — about those risks.1 The jury awarded Mr. Decker $4,500,000 in compensatory damages: $1,000,000 for economic loss; and $3,500,000 for noneconomic loss. The jury awarded Mrs. Decker $500,000 for loss of consortium.

The Court must now rule on GEHC’s motion, which seeks a new trial, to alter or amend the judgment, and remittitur (i.e., to reduce the jury’s award). (Doc. #: 271.) GEHC advances six arguments:

• Plaintiffs failed to prove the element of causation
• The Court’s decision not to give a jury instruction about “Adverse Event Reports” unfairly prejudiced GEHC
• Admitting evidence that a Danish governmental agency had determined that Omniscan caused the injuries reported in a 2003 Adverse Event Report unfairly prejudiced GEHC
• The Court wrongly excluded from evidence Mr. Decker’s past medical bills
• Plaintiff failed to provide evidence to support an award based on mental distress
• Because I recused myself from ruling on Plaintiffs’ post-trial motion for prejudgment interest, I should never have presided over the trial

The Court has already ruled on—and rejected—GEHC’s last argument, (see Doc. #: 272), so this opinion will focus on the other five.

II. Standard of Review

A court “may grant a new trial under Rule 59 if the verdict is against the weight of the evidence, if the damages award is excessive, or if the trial was influenced by prejudice or bias, or [was] otherwise unfair to the moving party.” Rush v. Ill. Cent. R.R., 399 F.3d 705, 727 (6th Cir.2005).

At the same time, “[t]he importance of Rule 61 in its application to motions for a new trial cannot be overlooked.” 11 Charles Alan Wright et al., Federal [812]*812Practice and Procedure § 2805 (3d ed.2012). Rule 61 is the harmless error rule: “Unless justice requires otherwise, no error ... is ground for granting a new trial.... At every stage of the proceeding, the court must disregard all errors and defects that do not affect any party’s substantial rights.” Fed.R.Civ.P. 61.

III. Causation

To support their failure-to-warn claim, Plaintiffs presented to the jury the scientific evidence GEHC was aware of in September 2005—when Mr. Decker received a dose of Omniscan—that indicated the drug was toxic to renally impaired patients. This information included chemistry, toxicology, and human studies, some of which were conducted internally by GEHC employees and consultants but left unpublished and undisclosed to regulatory authorities. The information also included four Adverse Event Reports. An Adverse Event Report is a report sent to a drug company. The report tells the company that a patient experienced a harmful event after taking its drug.

Plaintiffs also offered the testimony of Cheryl Blume, Ph.D., an expert in the field of pharmaeovigilance. She analyzed the label that was on the Omniscan packaging in 2005. She pointed out the ways in which the label failed to capture what GEHC knew about the risk of gadolinium toxicity. The label did not “reflect the data [GEHC] generated in multiple studies with patients with impaired renal function”; these studies showed that renally impaired patients retained abnormally high levels of gadolinium in their system for weeks after receiving a dose of the drug. (Doc. # : 197 at 194, Trial Tr. Mar. 12, 2013, at 1578.) The label did not tell doctors that the retained gadolinium might be in an “unchelated” state, meaning that it was no longer bound to the chemical that helped ensure its safe passage through the body and out via the kidneys. (Id. at 195, 1579. ) The label did not inform doctors of the “laboratory experiments, preclinical experiments, and pharmacokinetics studies in renally-impaired patients ... that suggest ] that there can be ... an exaggerated period of time that the product stays in the body [during which] it can have serious consequences to various organ systems.” (Id. at 198, 1582.) Moreover, according to Dr. Blume, the label should have mentioned the four Adverse Event Reports and the debilitating symptoms the patients in those reports suffered. (Id. at 196, 1580. )

To be sure, the 2005 label did contain a precaution for patients with renal disease. But that was the same precaution found on the labels of all classes of contrast dyes, including iodine-based contrast agents. As Dr. Blume told the jury, that precaution informs doctors of acute, short-term effects of contrast dyes; it does not reflect the debilitating, long-term harmful effects of gadolinium. (Id. at 197, 1581.)

Finally, and perhaps most significantly, Dr. Blume testified that GEHC should have put a contraindication on the label for patients with severe renal failure, telling doctors not to administer the drug to such patients. (Id. at 195, 1579.)

GEHC vigorously cross-examined Dr. Blume. GEHC also offered its own pharmacovigilanee expert, Dr. David Feigal. It was ultimately up to the jury to decide whose testimony to credit.

Still, GEHC argues that Plaintiffs failed to prove the element of causation. It argues that even if it had improved its warnings, Mr. Decker’s doctor would have gone ahead and administered Omniscan anyway. The argument is, in other words, that the allegedly inadequate warning was not a but-for cause of Mr. Decker’s NSF.

[813]*813GEHC bases its argument on the testimony of Dr. Geoffrey Wiot. Dr. Wiot was a partner in the radiology practice where Mr. Decker received Omniscan. Dr. Wiot was the one who decided which gadolinium-based dyes the clinic would use and what procedures the doctors in the clinic should follow in administering those dyes. Dr.

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956 F. Supp. 2d 809, 2013 WL 3853406, 2013 U.S. Dist. LEXIS 104273, Counsel Stack Legal Research, https://law.counselstack.com/opinion/decker-v-ge-healthcare-inc-ohnd-2013.