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Decker v. GE Healthcare Inc.

United States Court of Appeals, Sixth Circuit

October 20, 2014

PAUL DECKER; KAREN DECKER, Plaintiffs-Appellees,
v.
GE HEALTHCARE INC.; GE HEALTHCARE AS, Defendants-Appellants

Argued August 7, 2014.

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Appeal from the United States District Court for the Northern District of Ohio at Cleveland. Nos. 1:08-gd-50000; 1:12-gd-50004--Dan A. Polster, District Judge.

ARGUED:

Pierre H. Bergeron, SQUIRE SANDERS (U.S.) LLP, Cincinnati, Ohio, for Appellants.

Christopher V. Tisi, ASHCRAFT & GEREL, LLP, Alexandria, Virginia, for Appellees.

ON BRIEF:

Pierre H. Bergeron, SQUIRE SANDERS (U.S.) LLP, Cincinnati, Ohio, J. Philip Calabrese, SQUIRE SANDERS (U.S.) LLP, Cleveland, Ohio, Rebecca K. Wood, SIDLEY AUSTIN LLP, Washington, D.C., for Appellants.

Christopher V. Tisi, Michelle A. Parfitt, Peter T. Anderson, Stephanie L. Gardner, ASHCRAFT & GEREL, LLP, Alexandria, Virginia, William Hawal, Peter J. Brodhead, Peter H. Weinberger, SPANGENBERG SHIBLEY & LIBER LLP, Cleveland, Ohio, for Appellees.

Before: GIBBONS and McKEAGUE, Circuit Judges; LAWSON, District Judge.[*]

OPINION

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JULIA SMITH GIBBONS, Circuit Judge.

In 2005, in connection with a magnetic resonance imaging procedure (" MRI" ), Paul Decker received a dose of Omniscan, a gadolinium-based contrast agent manufactured by GE Healthcare Inc. and GE Healthcare AS (" GEHC" ). After taking Omniscan, Mr. Decker developed Nephrogenic Systemic Fibrosis (" NSF" ). In 2012, Karen and Paul Decker sued GEHC in the Northern District of Ohio, lodging a host of Ohio products liability claims and other tort claims. The Deckers' case forms a part of a multidistrict litigation (" MDL" ), managed by Judge Polster. Prior to the Deckers' case, hundreds of similar cases in the MDL involving GEHC had been settled. This case did not settle and was the first case in the MDL to go to trial. The jury returned a verdict in favor of the Deckers on their failure-to-warn claim, awarding $5 million in damages. GEHC moved for a new trial, which the district court denied. On appeal, GEHC makes a number of disparate arguments against rulings that the district court made applicable to all MDL cases as well as rulings specific to the instant case. GEHC alleges that a new trial is 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) erroneously failed to issue two proposed jury instructions. We affirm.

I.

Gadolinium-based contrast agents (" GBCA" ) are one type of contrast agent used to enhance the quality of images generated in MRIs. There are currently five different GBCAs approved by the FDA for use in MRI procedures in the United States. Omniscan, which is manufactured by GEHC, is one such GBCA. GBCAs, however, can be toxic to patients with impaired kidney function. The district court aptly summarized the background of GBCAs, their potentially adverse health effects, and the FDA's efforts to eradicate those adverse effects:

Gadolinium is a lanthanide element (rare earth metal) which exhibits high paramagnetism, a form of magnetism occurring only in the presence of an externally applied magnetic field. It is this characteristic that led research scientists to explore its use as a contrast agent in magnetic resonance scans.
It is undisputed that gadolinium, in its free state, is highly toxic to humans. In order to develop a safe gadolinium-based contrast agent for use in humans, researchers found it necessary to chelate the gadolinium (i.e., bind it to a ligand) in order to render it inert during its passage through the body prior to elimination. Of particular concern was its use in renally impaired patients, whose ability to quickly excrete toxic substances is inherently compromised. Because renally-impaired persons might retain the GBCA for longer periods of time than non-renally impaired persons,

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the chelate's stability was considered crucial since retained GBCA might well dechelate, exposing the kidney patient to the toxic effects of gadolinium. Research shows that renally impaired persons do in fact retain GBCAs for a significantly longer period of time than non-renally impaired persons, renally impaired persons retain a significant portion of the gadolinium that is injected into them, and dialysis is not very effective in ridding the body of the unrecovered gadolinium.
Nephrogenic systemic fibrosis, or NSF, was first described in the medical literature in 2000, with the first reported cases going back to 1997. NSF causes fibrosis of the skin, connective tissue and organs throughout the body. It is a painful, progressive and debilitating disease. While the precise pathogenesis of NSF is unknown, it has been reported only in patients who have severe kidney disease and, with the exception of a few reported cases with inconclusive medical histories, has been found exclusively in kidney patients who have had one or more exposures to GBCAs.
In June 2006, the FDA issued a Public Health Advisory notifying healthcare professionals and the public about the risk of NSF following the administration of GBCAs; and in May 2007, the FDA asked GBCA license holders to issue a boxed warning about the risk of NSF in patients with renal failure. The issuance of the " blackbox warning," along with policies and procedures adopted by healthcare facilities and notice to healthcare providers, have all but led to the eradication of new NSF cases.

In September 2005, Paul Decker, a patient with end-stage renal disease (" ESRD" ), underwent an MRI at Riverside Radiology Associates. In connection with the procedure, Mr. Decker received a single dose of Omniscan. Mr. Decker's kidneys were impaired when he received the dose of Omniscan, and sometime thereafter he developed NSF.

In February 2012, Paul and Karen Decker sued GEHC in the United States District Court for the Northern District of Ohio, alleging claims under the Ohio Products Liability Act, section 2307.71 et seq. of the Ohio Revised Code, for manufacturing defect, design defect, failure to warn, nonconformance with representations, negligence, breach of express warranty, breach of implied warranty, misrepresentation, fraud, and loss of consortium. The Deckers' case forms part of an MDL established in 2008-- In re Gadolinium Based Contrast Agents Product Liability Litigation, (MDL No. 1909) (N.D. Ohio)--which was assigned to Judge Dan Polster, who has managed the MDL since 2008. Hundreds of similar cases in the MDL involving GEHC had been settled, including a block of 25 cases involving the same attorneys as in the instant case. Despite multiple attempts at mediation and the active involvement of Judge Polster, the parties in this case did not reach a settlement.

This case was the first in the MDL to go to trial. Before the Deckers filed this action, however, the district court made certain rulings that were applicable to all MDL cases, some of which are the subject to GEHC's appeal in this case. One set of rulings concerned the admissibility of the testimony of certain " generic" experts--that is, testimony that did not relate specifically to an individual plaintiff. The plaintiffs' steering committee (" PSC" ) and GEHC designated nineteen generic experts to testify about three issues: (1) the likely causal mechanism of NSF; (2) the existence of gadolinium-naï ve cases, meaning purported cases of NSF occurring without GBCA exposure; and (3) the presence of gadolinium toxicity signals and

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whether additional warnings should have been added to the Omniscan label in light of those putative signals. The parties argued over the admissibility of expert testimony on these issues, and the district court addressed those arguments for all MDL cases in two extensive rulings.

First, it was undisputed that Omniscan triggered NSF in ESRD patients; however, the causal mechanism by which Omniscan triggered NSF was disputed. The PSC sought to introduce expert testimony " that Omniscan most likely causes NSF in renally impaired patients when, due to various processes (for example, transmetalation), the gadolinium becomes dechelated, dissociated, released or freed from the ligand to which it is bound . . . [and that t]his dechelation exposes tissue to labile, toxic gadolinium which rapidly bonds elsewhere in the body and begins the fibrotic process leading to NSF." In short, the PSC proffered expert testimony on the " free gadolinium theory" of the likely causal mechanism of NSF, which is the prevailing theory of NSF causation in the scientific community. By contrast, GEHC sought to introduce the testimony of Benjamin Newton that chelated GBCAs may trigger the fibrotic process leading to NSF. The implication of Newton's hypothesis was that the chelated gadolinium in Omniscan and other GBCAs causes NSF and, thus, Omniscan was no more likely to cause NSF than any other GBCA. Proof of the causal mechanism was disputed because, while adverse health effects from " free gadolinium" were foreseeable, adverse health effects from chelated gadolinium were not.

The district court denied GEHC's motion to exclude the PSC's experts who advanced the " free gadolinium theory" of the likely causal mechanism of NSF. The district court also reaffirmed this ruling after GEHC's motion for reconsideration, explaining that " it would allow Plaintiffs' experts to testify regarding the free (or dechelated) gadolinium theory, a theory that reasonably attempts to explain what happens to the not-insignificant amount of chelated gadolinium (here, Omniscan) that is injected into severely renally impaired persons, is never excreted, and is later found in one form or another in the biopsies of NSF patients." The district court noted that " most researchers (including research scientists employed or retained by GEHC) believe that the gadolinium becomes unbound from its ligand during its prolonged retention time in renal patients where it, either alone or newly bound to other substances, may trigger the process leading to NSF." The district court also allowed Newton to testify about his alternative hypothesis that NSF is caused by chelated gadolinium. The district court concluded that since there was no definitively proven mechanism for NSF causation, both parties could present their respective theories to the jury.

Second, the district court did not permit GEHC experts, including Newton, Sushrut Waikar, and Anthony Gaspari to testify about reports of gadolinium-naï ve cases of NSF-- i.e., cases of NSF that allegedly occurred in the absence of GBCA exposure. The district court found that proffered expert testimony about gadolinium-naï ve cases was based on methodologically flawed studies that did not sufficiently demonstrate the subjects' lack of gadolinium exposure. For example, the " Collidge study" [1] " did not examine whether the one NSF patient who had not received a GBCA while undergoing an MRI had undergone

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any non-MRI procedures in which a GBCA was used." And the " Wahba study," [2] " which concluded that two patients developed NSF without exposure to a GBCA, did not confirm its findings by testing these patients' tissue for the presence of gadolinium." For the same reason, the district court barred expert testimony as to gadolinium-naï ve cases of NSF based on the " Deng study." [3]

Third, the district court made several evidentiary rulings on proffered expert testimony concerning pharmacovigilance, the science relating to the collection, detection, and prevention of adverse effects of pharmaceutical products. For example, GEHC moved to exclude the testimony of the PSC's generic experts--including the testimony of Cheryl Blume--who testified regarding the significance of four adverse event reports (AERs) concerning Omniscan. AERs are reports sent to drug companies that inform the company that a patient experienced a harmful event after taking the company's drug. Specifically, GEHC argued that Blume's opinion that four specific AERs constituted a " safety signal" was inadmissible. The district court denied that motion.

The district court also reviewed the PSC's motion to exclude testimony of Gaspari concerning his medical analysis of the four AERs. Gaspari submitted an expert report, " the primary purpose of which was to review the four AERs and determine whether there was any consistency in [these] reports to suggest that exposures to gadolinium based contrast agents (GBCA) resulted in NFD/NSF." The report included preliminary information about the history of NSF and the difficulties associated with diagnosing it, and " [t]his information formed the basis for his conclusion that the AERs did not support a clinical diagnosis of NSF." The district court excluded Gaspari's testimony because his " conclusions are based on incomplete information and therefore do not satisfy the . . . requirement that expert testimony be based on sufficient facts or data." Upon GEHC's motion for reconsideration, the district court reaffirmed this ruling because (1) whether the four AERs supported a clinical diagnosis of NSF was irrelevant to the question of whether the AERs constituted a safety signal; (2) Gaspari was not an expert in pharmacovigilance; and (3) Gaspari arrived at his safety-signal conclusion without reviewing all of the information GEHC had available to it at the time.

Consistent with its free gadolinium theory of NSF causation, the PSC focused its early discovery efforts on demonstrating that GEHC knew that Omniscan was capable of releasing free gadolinium once ingested. The PSC deposed Robert Muller, a Belgian chemist and GEHC consultant. At his 2010 deposition, Muller produced a copy of an unpublished 1995 GEHC study that suggested that Omniscan did release significant amounts of free gadolinium. The PSC subsequently learned that GEHC had this 1995 study but did not disclose it. The PSC filed a motion for sanctions under Federal Rule of Civil Procedure 37(b) and (c). After a sanctions proceeding, it was ...


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