What in the Products Manufacturing Liability is Happening?

What in the Products Manufacturing Liability is Happening?

Product manufacturers and the insurance companies that defend and indemnify them should pay close attention to a recent Eleventh Circuit decision, Taylor v. Mentor Worldwide, LLC. This case is intriguing for a few reasons. First, it raises questions about the admissibility of a plaintiff’s expert witness’s testimony when such testimony falls outside the scope of his Rule 26 report. Second, it teaches defense attorneys a valuable lesson about refraining from asking for alternative relief that could be injurious to one’s case without having received an answer from the court as to one’s first request for relief that would be more favorable. Finally, and as a reminder, this case teaches defense attorneys the importance of preserving issues at trial for appeal.

FACTUAL BACKGROUND

In Taylor, Teresa Taylor sued Mentor Worldwide, LLC and Mentor Corporation for compensatory and punitive damages associated with injuries she sustained from a polypropylene mesh sling, manufactured by Mentor, which was implanted in Taylor to treat her stress urinary incontinence. Mentor named the mesh sling ObTape. Taylor contended that ObTape caused her urethral wall to thin and chronic bladder inflammation.

Taylor endeavored to prove at trial that her injuries resulted from design defects in that ObTape’s small pore size did not allow adequate tissue ingrowth and had a propensity to degrade and shed polypropylene particles in the body. Taylor relied on several expert witnesses to establish both general causation—that is, that ObTape was capable of causing the type of injuries from which she suffered—and specific causation—that is, the ObTape implant caused her injuries.

The jury awarded Taylor $400,000 in compensatory damages and $4 million in punitive damages. Mentor moved for judgment as a matter of law or, alternatively, for a new trial or to reduce the punitive damages award. The district court upheld the jury’s verdict as to liability and compensatory damages, but concluded that the punitive damages award exceeded Florida’s statutory cap because the trial evidence was insufficient to support that Mentor had “specific intent” to cause Taylor’s injuries. The district court reduced the punitive award to $2 million. Both Taylor and Mentor appealed the district court’s judgment.

APPELLATE ISSUES

There were four issues on appeal. The first two issues were whether the district court erred in receiving certain expert testimony on the issue of specific causation and applying an incorrect causation standard to Taylor’s failure to warn claims. The third issue was whether Mentor was entitled to a new trial because of several evidentiary rulings or to an amended judgment eliminating or further reducing the punitive damages award. The fourth issue was whether the district court erred in reducing the jury’s punitive damages award. The 11th Circuit found no error in the district court’s judgment and affirmed.

RULES AND ANALYSIS

1. Motion for Judgment as a Matter of Law

Mentor argued that it was entitled to judgment as a matter of law or, alternatively, to a new trial because the district court failed to strike Dr. Porter’s testimony to the extent he offered trial opinions that were not disclosed in his Rule 26 report. The 11th Circuit reasoned that the district court did not err in denying Mentor’s motion to strike Dr. Porter’s testimony because the only true inconsistency between Dr. Porter’s Rule 26 report and his trial testimony was regarding “urethral erosion,” and Dr. Porter’s trial testimony as to causation was not inconsistent with his Rule 26 report, which was the basis of Mentor’s motion to strike. The 11th Circuit explained that the district court had discretion under Rule 37 to fashion an appropriate sanction regarding Taylor’s failure to supplement Dr. Porter’s Rule 26 report on the topic of “urethral erosion,” and that it did so by allowing Mentor a twenty-four-hour window to prepare Dr. Porter’s cross-examination in light of his conflicting testimony. Finally, the 11th Circuit reasoned that “any unfair surprise as to . . . [the ‘urethral erosion’] issue was minimal because ‘erosion’” was extensively covered in pretrial discovery. Dr. Porter disclosed his belief that ObTape could cause “‘erosion of mesh into tissues or organs’” in his Rule 26 report.

2. Motion for a New Trial

Mentor argued that the district court erred in admitting the general causation testimony of Dr. El-Ghannam as to degradation and shedding of the ObTape because his testimony did not address the “dose-response relationship”—that is, how much of the ObTape was necessary to create a risk of harm to Taylor. Mentor relied on McClain v. Metabolife International, Inc. in which plaintiff’s expert was required to opine as to the “dose-response relationship.” In McClain, plaintiff sued defendant for products liability after suffering from illnesses, such as strokes and heart attacks, after using the defendant’s products. The 11th Circuit contrasted this case from McClain by stating that the “dose-response relationship” was not implicated here. In McClain, “the missing piece – among others – was how much ephedrine and caffeine were required to start a chain reaction leading to a stroke or heart attack.” “That piece was important because there evidently was a level of ephedrine and caffeine that a person could consume safely.” The 11th Circuit analyzed that Dr. El-Ghannam’s testimony was that all ObTape degrades and that the body’s immune system responds to any polypropylene particles it sheds. ObTape’s degradation and shedding caused inflammation and erosion. There was no suggestion in this case that there was a level of degradation that would not cause these harmful effects. Thus, the “dose-response relationship” was not implicated, and there was no abuse of discretion in admitting the testimony.

3. Punitive Damages

1. Availability of Punitive Damages

Both parties disputed the propriety of the punitive damages award. The 11th Circuit agreed with the district court’s findings that Taylor proved by clear and convincing evidence that Mentor was grossly negligent regarding ObTape’s risks—both its porosity and propensity to degrade. The jury heard evidence that Mentor: (1) did not conduct sufficient product testing, including tests as to degradation, despite it being well known that heat and pressure cause polypropylene to degrade; (2) knew of the relatively high rate of complications associated with ObTape but nonetheless concealed or materially understated those risks; and (3) ignored warnings from both Mentor employees and physicians outside of the company. Therefore, the record was sufficient to authorize punitive damages under Florida law.

2. Unreasonable Financial Gain and Actual Knowledge

Mentor argued that the punitive damages award should have been remitted to $1.2 million (three times the compensatory damages award) because the district court did and could not identify any evidence that the alleged flaws in Mentor’s manufacturing process were motived purely by unreasonable financial gain. The 11th Circuit noted that the district court had no opportunity to do so because Mentor raised this issue for the first time on appeal and thus, waived the issue. The 11th Circuit explained, however, that even if Mentor had not waived the issue, there was substantial trial evidence that Mentor employees and executives knew that ObTape was associated with serious risks of complications and actively attempted to conceal or understate those risks.

3. Specific Intent

The final issue on appeal was whether Mentor had “specific intent to harm the claimant,” in which case Florida law would permit uncapped punitive damages. The district court concluded that the record was insufficient to support a finding of specific intent and reduced the punitive award to $2 million pursuant to Fla. Stat. § 768.73(1)(b). The 11th Circuit agreed, differentiating “between situations in which ‘the unreasonably dangerous nature of the conduct, together with the high likelihood of injury resulting from the conduct, was actually known by . . . [a] person responsible for making policy decisions on behalf of the defendant’ and those in which ‘at the time of injury the defendant had a specific intent to harm the claimant and . . . defendant’s conduct did in fact harm the claimant.’” If this distinction is to have any meaning, the evidence that Taylor relied on to support uncapped punitive damages only evinced that Mentor knew there was a high likelihood of injury. To be substantially certain that someone will be harmed because of wrongful conduct required a belief much closer to total certainty that anyone who used ObTape would be harmed. Evidence that Mentor knew of a high incidence of injury did not satisfy this threshold.

CONCURRING AND DISSENTING OPINIONS

1. Judge Julie Carnes, Circuit Judge, Concurring Specially

Judge Carnes concurred with the majority’s conclusion and explained that the tie-breaker as to the exclusion of conflicting expert testimony was that Mentor moved to strike Dr. Porter’s testimony, but before receiving a ruling from the district court, proposed an alternative remedy. Mentor requested a twenty-four-hour window in which to prepare Dr. Porter’s cross-examination in light of his conflicting testimony. Not only did Mentor seek alternative relief aside from its motion to strike, but it failed to move for a new trial. Based upon these facts and because the district court has broad discretion under Rule 37 to fashion an appropriate remedy, Judge Carnes concurred that the district court did not abuse its discretion by granting Mentor’s alternative request for relief.

2. Gerald Bard Tjoflat, Circuit Judge, Dissenting

Judge Tjoflat opined that the majority’s opinion contained two legal errors: (1) it applied the wrong legal standard to determine whether Dr. Porter’s trial testimony should have been excluded under Rule 37(c)(1); and that (2) even if the majority applied the correct legal standard, it still botched the analysis in concluding that Taylor’s Rule 26 violation was not prejudicial. Judge Tjoflat concluded that the majority’s opinion gave “the green light to Taylor’s ‘ambush tactics . . .’” (citing Licciardi v. TIG Ins. Grp.).

CONCLUSION AND HOLDINGS

Key takeaways from this case are that Rule 37 gives broad discretion to a trial court to fashion an appropriate remedy concerning an expert’s conflicting deposition and trial testimony. A trial court’s failure to strike an expert’s testimony altogether is not grounds for appeal. This conclusion is especially true when a products manufacturer requests an alternative remedy, which the trial court grants, to rectify the conduct of a patient that failed to comply with Rule 26.

Furthermore, when the issue of whether an amount of a product that a patient can withstand before her safety is risked is not implicated, neither is an expert’s testimony as to the “dose-response relationship.” The threshold to bust the punitive damages statutory cap is exceptionally difficult to satisfy unless a patient presents trial evidence that a products manufacturer acted with specific intent to harm her when its wrongful conduct did in fact cause her injuries—that is, the products manufacturer is totally certain that the consequences that flowed from its wrongful conduct would occur.

Finally, all similarly situated parties should be cognizant of a circuit split regarding the issue of whether Rule 37 requires an automatic exclusion of conflicting expert testimony regardless of the presence of substantial justification or harmlessness. See Pitts v. HP Pelzer Auto. Sys., Inc., 2019 WL 2448821, at *5 n.7, 331 F.R.D. 688 (S.D. Ga. June 20, 2019) (Hall, C.J.).