Two victims of what has been called “one of the biggest U.S. mass torts in history”
will finally get some justice, thanks to a ruling issued yesterday by the U.S. Court of Appeals for the Fourth Circuit in Cisson v. C.R. Bard, Inc. Over 70,000 more cases are waiting in the wings.
The appeal involves transvaginal mesh medical devices, used to treat pelvic organ prolapse in women. The devices are supposed to help women but, all too often, it leaves them scarred for life, in chronic pain, and with ongoing loss of sexual feeling.
In yesterday’s decision, the Fourth Circuit affirmed the first jury verdict arising from multi-district litigation involving more than 70,000 cases against the proprietors of transvaginal mesh medical devices, which awarded the plaintiffs—Donna Cisson and her husband Don—$250,000 in compensatory damages and $1,750,000 in punitive damages against device manufacturer C.R. Bard Inc.
The decision is important news for the Cissons. Their emotional and physical pain can never be cured by money, of course, but at least they will know that the corporation that caused their injuries has not gotten off scot free.
But the Fourth Circuit’s ruling is important for a broader reason as well, because it rejected a defense that could have spelled disaster for injury victims in a wide-range of cases. One of C.R. Bard’s key arguments in the appeal was that, because it complied with the U.S. Food and Drug Administration’s Section 510(k) medical-device process, its product was necessarily “safe”—and, argued Bard, it should have been allowed to tell that fact to the jury.
Supporting this argument as amici curiae, the U.S. Chamber of Commerce and other pro-corporate amici groups argued that “evidence of § 510(k) clearance is relevant under Georgia law and easily passes muster under Federal Rule of Evidence 401, as it bears on the safety, efficacy, and reasonableness of the product’s design.” They further argued that “the District Court erred in concluding that the § 510(k) process is not concerned with the device’s safety or effectiveness.”
This argument was just plain wrong—not to mention legally dangerous. As we explained in an amicus brief to the court, the FDA’s 510(k) process doesn’t actually establish that a product is safe. Instead, the FDA’s clearance under that process merely establishes a device is “substantially equivalent” to another device. It does not, contrary to Bard’s and its amici’s claim, evaluate a product’s safety. Nor does it impose any new regulatory requirements on devices. Thus, we argued, the district court was plainly correct in refusing to allow Bard to introduce evidence of its 501(k) compliance to prove its “reasonableness” under Georgia law.
The Fourth Circuit agreed with our position, noting that “[w]hile some courts have found evidence of compliance with the 510(k) equivalence procedure admissible in product liability cases, the clear weight of persuasive and controlling authority favors a finding that the 510(k) procedure is of little or no evidentiary value.” Thus, the Court concluded, “it is clear that the court did not abuse its discretion by excluding Bard’s evidence of 510(k) clearance.”
Everyone should breathe a huge sigh of relief that the Fourth Circuit has rejected Bard’s efforts to hide behind FDA’s Section 510(k) process. If Bard’s argument had succeeded, then device manufacturers in a huge range of cases would undoubtedly have jumped to introduce evidence of their compliance with 510(k) process to prove their “reasonableness” under state tort law. And, faced with such evidence, some juries would undoubtedly have proven reluctant to side with the injury victim.
But today we don’t have to go there. Because yesterday, the Fourth Circuit did the right thing.
(This post was written by Public Justice Senior Attorney Leslie Brueckner.)