TAMPA, Fla. — A federal appeals court upheld a $6.7 million jury award to a Florida woman injured by the Pinnacle transvaginal mesh device, manufactured by Boston Scientific Corporation. BSC voluntarily recalled the Pinnacle device in 2011.
The case was brought to the appeals court because BSC argued against consolidation of plaintiffs’ suits and the exclusion of certain evidence, as well as the sufficiency of presented evidence and the timeliness of the claims.
Florida residents Amal Eghnayem, Margarita Dortes, Maria Nunez and Juana Betancourt were implanted with the Pinnacle Floor Repair Kit between 2008 and 2011 and allegedly suffered severe injuries. Such injuries included infection, scarring, nerve damage, and organ perforation. Their cases were consolidated on the grounds that they all claimed design defect in regards to the Pinnacle system.
Prior to trial, all evidence relating to the Pinnacle’s 510(k) clearance granted by the FDA was excluded. Receiving 510(k) clearance means that the FDA found the new device to be “substantially equivalent” to a device that has previously been on the market.
BSC argued that the court abused its discretion in consolidating the suits because the cases were predominantly concerned with individual issues, and the consolidation yielded prejudice. BSC also contended that the evidence concerning the Pinnacle’s 510(k) clearance should not have been excluded, as it represented information relevant to the device’s safety.
The appellate court upheld the original verdict and found that the trial court did not abuse its discretion in consolidating the cases and excluding the evidence.
“The plaintiffs all brought the same claims based largely on the same facts: BSC’s Pinnacle device was unreasonably dangerous by design, and BSC failed to include sufficient warnings,” the appellate court explained, according to Harris Martin Publishing.
The court also stated that any prejudice had been reduced because the court had explained the consolidated nature of the trial to the jury and instructed it to consider each of the claims separately.
In regards to the exclusion of evidence, the appellate court found that the 510(k) clearance was not in fact relevant to the product’s safety and therefore was properly excluded. The FDA’s 510(k) clearance is focused on equivalence, not safety, according to the court.
“Because 510(k) is not a safety regulation, approval under that process cannot show that BSC performed sufficient testing or complied with applicable safety regulations,” the court held, according to Harris Martin.
BSC further appealed that Eghnayem did not present sufficient evidence to prove her claims that the Pinnacle device was defectively designed and lacked adequate warnings. The court, however, disagreed.
Eghnayem presented expert testimony on two specific defects of the Pinnacle: the polypropylene material may lose its physical and mechanical properties in a way that causes injury, and the crosshatched design of the mesh makes it very difficult, if not impossible, to remove should a complication arise.
The appellate court upheld that the expert testimony presented by Eghnayem provided sufficient evidence for the jury to conclude that the Pinnacle’s design increased the potential for degradation and the difficulty of removal. Furhermore, the court found that the evidence supported the failure-to-warn claims, as BSC did not warn doctors about the difficulty, and in some cases impossibility, of removal.
“Indeed, the repeated warnings that removal might be necessary suggest just the opposite,” the court stated, according to Harris Martin.
The court also noted that BSC failed to warn physicians that removal of the mesh might require removal of healthy tissue as well.
Eghnayem’s own doctor testified that had he known of the risks associated with the Pinnacle, he would have had concerns about using the device and would have discussed such concerns with Eghnayem.
Lastly, the appellate court confirmed that the plaintiffs’ claims were not time-barred under Florida’s four-year statute of limitations.
The evidence showed that Eghnayem’s claims accrued after April 11, 2009, which was the cut-off point. Although Eghnayem did experience urinary incontinence in 2008 that could have been associated with a defect in the Pinnacle, the court conluded that it was not “patently clear” or “obvious” that the incontinence was “a sufficiently distinct symptom from what might be expected after vaginal surgery to put her on notice of her cause of action against BSC.”
The four plaintiffs were awarded compensatory damages on their claims of strict liability, negligent design, and negligent failure to warn. Eghnayem and Betancourt were awarded $6,722,222 each, Dotres was awarded $6,766,666, and Nunez was awarded $6,533,333.
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