Wake Forest Law Review

By: Katherine Wenner & Holly Ingram

On February 6, 2018, the United States Court of Appeals for the Fourth Circuit published an opinion for Campbell v. Boston Scientific Corporation. The case affirmed a major products liability decision involving four plaintiffs, where each plaintiff received awards for over $4 million.

I. Facts and Procedural History

The case involved four plaintiffs who were each involved in a multidistrict litigation, which encompassed over 25,000 cases total. Defendant Boston Scientific Corporation (“BSC”) manufactured a transvaginal mesh prescription medical device, called Obtryx Transobturator Mid-Urethral Sling System (“Obtryx”) which was approved by the Food and Drug Administration (“FDA”) under its 510(k) approval process. That process approves products which are “substantially equivalent” to a device already approved on the market and does not require clinical trials. The problem with the device, according to the plaintiffs’ experts, was that it could degrade when implanted and cause the growth of scar tissue. Over the course of a few years, each of the plaintiffs experienced device dysfunction and brought separate lawsuits against BSC. Their claims were filed against BSC directly into a pre-existing Judicial Panel on Multidistrict Litigation, which is pending in the Southern District of West Virginia. The district court consolidated several cases before case-specific discovery began. BSC moved to conduct separate trials for the cases at issue today, but the motion was denied.

There were also two evidentiary motions that occurred prior to trial. In one motion, BSC moved to exclude evidence of the Marlex polypropylene’s MSDS, but this was denied. Additionally, plaintiffs moved to exclude evidence regarding the FDA’s 510(k) process and approval. This motion the district court granted.

Following an eleven-day trial, the jury returned verdicts in favor of plaintiffs, awarding $250,000 for past-compensatory damages, $1,000,000 for punitive damages, and future-compensatory damages ranging from $3–4.5 million dollars to each plaintiff.

BSC appealed the judgments on the grounds that the district court abused its discretion by (1) consolidating the four cases for trial; (2) permitting the MSDS evidence; and (3) excluding the 510(k) evidence. It also challenged the verdicts for lacking sufficient evidence and challenged the punitive damages awards, asserting there was an erroneous jury instruction.

II. The District Court did not abuse its discretion in consolidating the four cases, excluding the 510(k) evidence, or permitting the MSDS evidence.

The Fourth Circuit concluded that consolidating the independent cases did not render the decision unfair because the court first identified many common questions of law and fact across the trials. Additionally, the plaintiffs shared expert witnesses and presented much of the same evidence. Thus, the trials would have been largely repetitive and caused undue burdens, delays, and expenses. Moreover, the district court adequately endeavored throughout the trial to limit any potential jury confusion or prejudice. BSC lacked evidence to claim that the district court’s safeguards were inadequate. Further, although the four awards were similar, the damages were not identical. This evidenced that the merely similar values were because of the acute similarities between the injuries—which further justifies the consolidation. The Fourth Circuit ultimately notified that this illustrates the effectiveness of streamlining the judicial process, especially in cases such as this Multidistrict Litigation, which has over 25,000 cases involved.

Turning to the evidentiary dispute, the Fourth Circuit concluded that exclusion of the 510(k) evidence was not an abuse of discretion. BSC attempted to use this to argue that its conduct was reasonable. Yet, the court noted that although the 510(k) clearance may have said something about the safety of the product, it did not say anything very specific. Further, it would likely have only amplified the risk of confusion and wasted time. Thus, exclusion was not an abuse of discretion.

Next the Fourth Circuit concluded that including the MSDS was not inadmissible hearsay, as BSC so argued, because it was not admitted for the truth of the matter asserted. While it may have suggested that the company should have further investigated the safety of their product, it did not evince that the warning was actually correct. Thus, including the evidence was appropriate, and the district court did not abuse its discretion.

III. BSC was not entitled to judgment as a matter of law and the district court used the proper standard to instruct the jury on punitive damages.

Moving on to BSC’s contention that it was entitled to judgment as a matter of law, BSC argued that the plaintiffs did not have sufficient evidence for their claims. However, the Fourth Circuit noted that jury verdicts are only set aside in unusual circumstances, which were not present in this case. The plaintiffs identified several aspects of the Obtryx’s design that contributed to its danger and presented evidence of safer alternative designs that existed. BSC claimed that the jury should have been instructed that a safer alternative was an element of the plaintiffs’ claim, but the Fourth Circuit noted that this argument was made for the first time on appeal and was therefore inappropriate.

Under the failure to warn claims, BSC argued that the plaintiffs’ testimony was also inadequate. However, because the plaintiffs did provide testimony, then it was sufficient. The court agreed that expert testimony may have been helpful, but it was not required.

Finally BSC challenged that the district court’s jury instruction standards for punitive damages. However, the court concluded that the district court’s instruction was a correct statement of West Virginia law at the time. Since the time of trial, the West Virginia legislature has changed its statute regarding the award of punitive damages, but the new statute was not in effect at the time of the trial. Therefore, the punitive damages award was also affirmed.

IV. Conclusion

Because the district court did not abuse its discretion or use any improper legal standards, the judgments of the district court were affirmed.

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By Daniel Stratton

On December 29, 2015, the Fourth Circuit affirmed in part, and reversed in part, a district court’s dismissal of an inmate’s Federal Tort Claims Act (“FCTA”) claim, after he was stabbed and severely beaten by fellow inmates  in the published civil case Rich v. United States. The appellant, Joshua Rich, argued on appeal that the district court incorrectly dismissed his claim after determining that the FCTA’s discretionary function exception applied to the prison officials’ conduct. The Fourth Circuit, after reviewing Rich’s appeal, affirmed the district court’s determination that the prison officials’ decisions on prisoner placement were shielded by the discretionary function exception, but reversed the lower court’s decision regarding Rich’s opportunity to engage in discovery about the prison officials’ claims that they properly searched Rich’s attackers before placing them in proximity to Rich.

Rich is Sentenced to Fifty-Seven Years, Claims He was Targeted by Aryan Brotherhood While Incarcerated

In 2008, Rich was sentenced by the U.S. District Court for the District of Utah to fifty-seven years’ imprisonment, following his conviction for armed bank robbery, and for carrying a firearm in relation to the crime. He entered the U.S. Bureau of Prison (“BOP”)’s custody in September 2008.

Rich alleges that he was targeted by the white supremacist group, the Aryan Brotherhood, almost immediately after entering the BOP’s prison system for refusing to participate in the group’s criminal activities. Rich was transferred to several prisons over the course of 2008 to 2011 and required separation from the Aryan Brotherhood. In February 2011, Rich was moved to a U.S. penitentiary in West Virginia, USP Hazelton. While at USP Hazelton, Rich was attacked by five inmates on August 5, 2011, after they were put into the same recreation area, or “cage.”

Rich was severely beaten and stabbed multiple times. His injuries included laceration to his liver, among others, and he underwent several invasive surgeries as a result. A nine-inch homemade knife was recovered in the cage where the attack occurred.

Rich sued the federal government under the FCTA, claiming negligence on the part of the prison officials when they failed to protect him from harm. He argued that the prison’s correctional officers should have kept him separated from his attackers, and that those officers had failed to properly screen or search the other inmates before placing them in the same cage as Rich. The government moved to dismiss Rich’s claim, asserting that the discretionary function exception applied to both the prison officials’ decisions about separating Rich and his attackers and to the way in which the officers searched the attackers. The district court agreed with the government, and additionally found that Rich was not entitled to any discovery about whether the prison had any directives mandating a particular approach to performing pat downs and searches. As a result, the district court granted the government’s motion to dismiss for lack of subject matter jurisdiction.

The FCTA, the Discretionary Function Exception, and Their Application to Federal Prisons

The United States is generally immune from suit under the legal doctrine of sovereign immunity, however the FCTA provides an exception. Under the FCTA, sovereign immunity is waived when the federal government “would be liable to the claimant in accordance with the law of the place where the act or omission occurred” for torts like negligence when they are committed by federal employees acting within the scope of their employment.  The FCTA’s discretionary function exception limits this waiver, however, in situations where an employee must perform a discretionary function or duty.

To determine whether conduct fits within this exception, courts generally apply a two-pronged test. First, the court determines if the challenged conduct involves an element of judgment or choice. If a statute, regulation, or policy sets out a specific course of action to the degree that there is no exercise of discretion, then the exception does not apply. If the action does involve an element of judgment, the court must then tackle the second prong, which is to determine whether the judgment was based on considerations of public policy. If it was, then a government employee defendant can assert that the court lacks subject matter jurisdiction under the exception.

If a defendant disputes the allegations in a complaint that could establish subject matter jurisdiction, a court may engage in an evidentiary hearing to determine if there are facts that support the jurisdictional allegations. Generally, under these circumstances, a plaintiff’s allegations in his complaint are not afforded a presumption of truthfulness. However, if the jurisdictional facts are intertwined with merit facts central to the complaint, a presumption of truthfulness will attach to the plaintiff’s claims. While the application of the discretionary function exception to decisions about the separation of prisoners is an issue of first impression for the Fourth Circuit, other circuits have weighed in on this issue previously.

The Fourth Circuit Decides that the Discretionary Function Exception Applies to Decisions about Separating Prisoners

The Fourth Circuit began its analysis by determining if the discretionary function exception applied to the prison officers’ decision to place Rich and his attackers in the same cage. The first step in this analysis was to apply prong one of the two-pronged test. Noting that the BOP is tasked with protecting and caring for all persons in its custody, the Fourth Circuit explained that the BOP retained discretion in implementing those tasks. Prison officials must consider and balance several factors when determining if an individual inmate may require separation. This, the Court concluded, satisfied the first prong of the test.

The Court, noting the issue of first impression, drew on other circuits’ experiences in determining whether the second prong was met. Other circuits, including the Seventh, Ninth, Eleventh have previously held that prisoner placement and potential threats to prisoners against one another was a standard part of the public policy considerations of maintaining order and security in federal prisons. Those circuits viewed factors such as available resources, proper classification of inmates, and appropriate security levels as inherent in various policy questions. Following in the other circuits’ footsteps, the Fourth Circuit agreed that prison officials should be afforded discretion in determining prisoner placement and separation. This, the Court held, meant that the discretionary function exception shielded prison officials from liability regarding whether they should have kept Rich separated from his attackers.  The Fourth Circuit, in turn, affirmed the lower court’s refusal to grant discovery on this issue.

Turning to the question of whether Rich should be granted discovery as to his allegations that the prison did not properly search the attackers before putting them in his recreation cage, the Fourth Circuit diverged from the district court. On this claim, the Fourth Circuit found that the disputed jurisdictional facts were intertwined with the merits of Rich’s claim that the prison had not properly executed pat downs of the attackers. Citing the fact that the prison officials’ signed declarations that they had performed pat downs of the attackers stood in contrast to Rich’s allegations, the Fourth Circuit explained that the allegations applied to both the merits of Rich’s claim as well as the jurisdictional questions over his claim.

The Court argued that a period of discovery would give Rich the opportunity to challenge the prison officials’ declarations that they carried out the searches. The Court also explained that even if they accepted the declarations as fact, those did not resolve the question about whether the pat down searches were carried out correctly. The Fourth Circuit reasoned that because the pat downs were to be conducted as outlined in the Correctional Services Manual, this suggested the existence of specific directives which Rich should be permitted to find in discovery.

Because inmates who have a history of weapons possession are required to undergo visual searches, including a body cavity search, prior to entering a recreation area, discovery could reveal whether any of the attackers had such a history and if such a search was undertaken.

The Court finally noted that Rich could potentially establish jurisdiction under this claim if he could show that the discretionary conduct engaged in by the prison officers was marked by carelessness or laziness, because such conduct cannot be grounded in policy decisions.

The Fourth Circuit Vacates and Remands to Allow Discovery on the Prison Officials’ Pat downs

While the Fourth Circuit affirmed that the discretionary function exception shielded the decision to place Rich and his attackers in the same recreation cage, the Court vacated and remanded to allow Rich to engage in discovery on the issue of whether and how prison officials performed pat downs and searches.

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By Kayleigh Butterfield

On April 30, 2015, the Fourth Circuit issued a published opinion in the civil case Harris v. Norfolk Southern Railway Co. Norfolk Southern Railway Company (“Norfolk Southern”) appealed the district court’s grant of summary judgment against it on the issue of liability in a negligence action brought by Charles Harris, who sought compensation for injuries suffered from a train derailment. Harris cross-appealed the district court’s summary judgment grant against him on a claim for punitive damages. The Fourth Circuit reversed the grant of summary judgment on the issue of liability, affirmed the grant against punitive damages, and remanded the case for further proceedings.

Factual Background

On July 21, 2009, Harris was working at a coal-loading facility (“loadout”) in Mingo County, West Virginia. Norfolk Southern employees backed an empty train of freight rail cars over an area of the railroad track running underneath the loadout where Harris was working. Both the train and track were owned and operated by Norfolk Southern. A section of the rail about 35 feet from the loadout was heavily corroded between the ball and vertical part of the rail. When the rail cars passed over the damaged portion of the track, a part of the rail separated and the cars derailed. When one of the cars crashed into the loadout’s support beams, the loadout collapsed and Harris subsequently suffered severe physical and mental injuries. The evidence showed that most of the track damage occurred months or years prior to the derailment.

Standard of Review

Summary judgment is reviewed de novo, viewing all facts and reasonable inferences in the light most favorable to the nonmoving party. Summary judgment is appropriate so long as the movant shows there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.

Federal Rail Safety Act and Track Safety Standards

Under the Federal Rail Safety Act (“FRSA”), 49 U.S.C. § 20101, et seq. Norfolk Southern has a duty to inspect the rail in accordance with the comprehensive track safety standards (“TSS”) as set forth by the Secretary of Transportation. 49 C.F.R. Part 213. The TSS sets forth minimum requirements for how inspections must be conducted and how issues should be remedied.

Norfolk Southern Breached Its Duty to Inspect

Section 213.5 of the TSS states that a track owner “who knows or has notice that the track does not comply with the requirements of this part” is responsible for remedying the problem in accordance with the TSS. The Fourth Circuit examined the plain language of the Federal Railroad Administration’s (“FRA”) commentary to the 1998 TSS amendments, and found that their reading of the phrase “knows or has notice” was reasonably interpreted to include constructive notice.

The Fourth Circuit then determined the scope of Norfolk Southern’s duty to inspect the track. While the court rejected Harris’ contention that a visual inspection requires someone to look at every part of the track structure, the court concluded that a reasonable visual inspection must be made in light of the surrounding circumstances. In this case, evidence was brought showing that Norfolk Southern knew that the obstruction of coal and debris on the tracks could cause corrosion. Despite this knowledge, Norfolk Southern failed to examine any of the embedded portion of the track over a period of months and years. Thus, the Fourth Circuit determined that any reasonable jury would find that Norfolk Southern breached its duty to inspect.

Genuine Dispute as to Proximate Cause

The Fourth Circuit concluded that a genuine dispute of material fact existed as to proximate cause. Expert testimony revealed that corrosion could have been detected through ultrasonic testing or digging out coal debris from the damaged parts of the track. However, the court noted that the testimony did not provide that the damage was consistent along the track or that it would necessarily be discovered by digging out sample areas of coal debris. Because a jury could reasonably find that Norfolk Southern’s breach was not the proximate cause of Harris’s injuries, the Fourth Circuit reversed summary judgment on the issue of liability.

Harris Did Not Meet Standard for Punitive Damages

The Fourth Circuit did not find that Norfolk Southern’s conduct met the standard of severe negligence required for an award of punitive damages. The court noted that Norfolk Southern conducted ultrasonic rail testing and visual inspections on a regular basis. While the defect remained undiscovered, the court held that Norfolk Southern’s actions simply did not rise to the near-reckless level of negligence needed to award punitive damages.

Conclusion

For the above reasons, the Fourth Circuit reversed the grant of summary judgment on the issue of Norfolk Southern’s liability, affirmed the grant of summary judgment on Harris’s claim for punitive damages, and remanded to the district court for further proceedings.