A man with end-stage renal disease (ESRD) underwent an MRI. In connection with the procedure he received a dose of a Gadolinium-based contrast agent (GBCA). After taking the GBCA, the man developed nephrogenic systemic fibrosis (NSF) (a disease of fibrosis of the skin and internal organs).
GBCAs are one type of contrast agent used to enhance the quality of images generated in MRIs. GBCAs, however, can be toxic to patients with impaired kidney function, whose ability to quickly excrete toxic substances is inherently compromised. Because renally-impaired persons might retain the GBCA for longer periods of time than nonrenally impaired persons, 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 the 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.
The man and his wife sued the manufacturer of the GBCA lodging a host of Ohio product liability claims and other tort claims. The couple’s case forms a part of a multidistrict litigation. Prior to their case, hundreds of similar cases in the multidistrict litigation involving this manufacturer had been settled. This case did not settle and was the first case in the multidistrict litigation to go to trial. The jury returned a verdict in favor of the couple on the failure to warn claim, awarding $5 million in damages.
Following the verdict, the couple sought prejudgment interest. The manufacturer moved for a new trial, to alter or amend the judgment, and for remittitur. The United States District Court for the Northern District of Ohio at Cleveland denied the manufacturer’s motion for a new trial. The judge declined to rule on the couple’s motion for prejudgment interest, which required a showing of the prevailing party’s good faith effort to settle and the nonprevailing party’s lack of such an effort. Because the judge was so heavily involved in mediating a resolution of this case that he likely would have been a witness to a litigated dispute involving the parties’ settlement efforts and because the judge was not allowed to act as both a judge and a witness, he held that any ruling on the couple’s motion would have been improper.
The Sixth Circuit United States Court of Appeals affirmed. The court held that the trial judge’s sua sponte recusal from ruling on the couple’s motion for prejudgment interest did not require vacatur of the judgment and a new trial, nor did the judge’s recusal from ruling on the prejudgment interest motion indicate he should have also recused himself from ruling on other motions; the trial court did not err with regard to several evidentiary rulings, thus, those rulings did not warrant a new trial; the trial court correctly concluded that the couple produced sufficient evidence to support the jury’s verdict and did not abuse its discretion in concluding that a reasonable juror could find that the manufacturer’s failure to warn caused the man’s NSF; and the trial court did not err when it declined to give two jury instructions proposed by the manufacturer.
The trial judge’s sua sponte recusal from ruling on the couple’s motion for prejudgment interest did not require vacatur of the judgment and a new trial. Nor did the judge’s recusal from ruling on the prejudgment interest motion indicate he should have also recused himself from ruling on other motions. First, the judge’s recusal was not from the entire case but only from the couple’s motion for prejudgment interest. Second, the judge gave motion-specific reasons for recusal, citing his firsthand knowledge of the parties' settlement efforts and his concern that ruling on the couple’s motion would undermine his ability to mediate other settlements in the multidistrict litigation. Third, he avowed that his limited recusal was not due to any financial conflict or to any actual or perceived bias toward either party. The court found that the reasons for the judge’s recusal from the couple’s prejudgment interest motion were specific to that motion, did not impugn his impartiality or the appearance thereof with respect to the jury trial or any other proceeding, and simply did not count in favor of his disqualification from the entire case. Vacatur and a new trial were not required to ensure the appearance of impartiality and public confidence in the judiciary. Accordingly, the trial judge did not abuse his discretion in holding that recusal from the couple’s motion for prejudgment interest did not require a new trial.
The trial court did not err with regard to evidentiary rulings; thus, those rulings did not warrant a new trial. Testimony about the free gadolinium theory of NSF was admissible under Daubert and its progeny. Accordingly, the district court did not abuse its discretion when it refused to exclude plaintiffs' experts' testimony that free (dechelated) gadolinium is a cause of NSF. Because the couple’s expert was a pharmacovigilance expert, irrespective of whether she was a medical doctor, she was qualified to reliably testify as to the significance of the adverse event reports (AERs) concerning the contrast agent. Conversely, the trial court concluded that because the manufacturer’s expert was not a pharmacovigilance expert, even though he was a medical doctor, he was not qualified to testify reliably regarding the significance of the AERs. The district court did not abuse its discretion in reaching either conclusion. The trial court excluded the manufacturer’s proffered expert testimony regarding reports of gadolinium naïve cases of NSF as unreliable. The trial court analyzed the studies on which the proffered testimony was based and concluded that these studies were methodologically flawed because they did not definitively confirm the lack of exposure to GBCA. Accordingly, the trial court determined that expert testimony regarding gadolinium naïve cases of NSF was unreliable. The trial court did not abuse its discretion in rulings concerning the manufacturer’s proffered expert testimony about gadolinium naïve cases of NSF. Nor did the trial court abused its discretion when it refused to admit expert testimony about one patient in one study unless the expert had examined both that patient and the man and had determined that the conditions of the two of them were so similar that it was probable that the man’s NSF was not caused by his contrast dosage. The study, which concerned a potential gadolinium naïve case of NSF, was published after the FDA safety warning regarding use of GBCAs in renally impaired patients. Therefore, it was not clear how the specific case of that patient in that study was relevant to the manufacturer’s ability to foresee the risk their GBCA presented to renally impaired patients.
The trial court correctly concluded that the couple produced sufficient evidence to support the jury’s verdict and did not abuse its discretion in concluding that a reasonable juror could find that the manufacturer’s failure to warn caused the man’s NSF. During trial, the couple presented evidence of what the manufacturer knew at the time the man received the dose of contrast. This evidence indicated that the manufacturer new the drug was harmful to patients with impaired renal function. This evidence included chemistry, toxicology, and human studies, some of which were conducted by the manufacturer’s staff and consultants but left unpublished and undisclosed to regulatory agencies. The evidence also included four AERs. The radiologist in charge of the man’s MRI testified that had the manufacturer issued a more informative warning he would not have used the contrast. A pharmacovigilance expert testified that the earlier contrast label failed to capture the manufacturer’s knowledge of the risk of gadolinium toxicity to renally impaired patients. This expert also testified that the label did not inform doctors that gadolinium had the risk of being retained in an unchelated state, meaning that it was no longer bound to the ligand that helped ensure safe passage through the patient’s body. According to this expert, the label should have also mentioned the four AERs and the symptoms suffered by the patients in those reports. This expert testified that the manufacturer should have placed a contraindication on the label for patients with severe renal impairment, which would have warned doctors against administering this contrast to these patients. The court concluded that this testimony was sufficient to support a reasonable juror’s verdict as to the couple’s failure to warn claim.
The trial court did not err when it declined to give two jury instructions proposed by the manufacturer. The trial court's refusal to give a limiting instruction with respect to the AERs—namely, that the AERs did not prove that the negative reaction described in the AER was actually a side effect or caused by the drug administration—did not unfairly prejudice the manufacturer’s defense. The testimony regarding AERs concerned the notice the manufacturer had regarding the risks of the contrast agent, not the causal relationship between the contrast agent and an SF. The couples’ expert relied on the AERs to prove notice of a safety signal. The couples’ experts did not rely on the AERs to conclude that NSF is gadolinium poisoning. Because the trial court correctly found that the manufacturer’s proposed AER instruction would have been confusing, the trial court did not abuse its discretion in refusing to give it. The trial court also did not err when it refused to issue an instruction regarding the lost or discarded documents. In admitting limited testimony as to the missing or destroyed documents, the district court noted that it was curtailing the testimony so as to permit the relevant fact that there were potential gaps in the evidence without prejudicing the manufacturer. The court noted that the trial court was careful not to over emphasize the importance of the fact that the manufacturer lost or destroyed documents relating to an expert’s study, declining to give the manufacturer’s proposed instruction because it would be giving the issue of the lost or discarded documents a lot more importance than it had in the trial.
The Sixth Circuit United States Court of Appeals affirmed the trial court’s judgment entry and denial of the manufacturer’s motion for a new trial.
See: Decker v. GE Healthcare Inc., 2014 WL 5315079 (C.A.6 (Ohio), October 20, 2014) (not designated for publication).
See also Medical Law Perspectives, June 2012 Report: Too Much, Too Little, Too Late: Injuries from Delays and Failures to Perform CT Scans or Overexposure to Radiation
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication