On January 14, 2016, in Cisson v. C.R. Bard, Inc., the United States Court of Appeals for the Fourth Circuit affirmed a jury’s decision in favor of the plaintiff in a case from the United States District Court for the Southern District of West Virginia. The ruling is an important step in the fight against medical device makers that endanger patients.
On August 15, 2013, a jury awarded plaintiffs Donna and Dan Cisson $250,000 dollars in compensatory damages for a design defect and failure to warn claim against C.R. Bard, Inc. The jury also awarded $1.75 million in punitive damages. The case, along with tens of thousands of similar claims, involves harmful transvaginal mesh devices that are used to treat pelvic organ prolapse. Cisson v. C.R. Bard, Inc., was the first jury verdict stemming from multi-district litigation that includes more than 70,000 cases.
On appeal, C.R. Bard claimed that because the company complied with the United States Food and Drug Administration’s (FDA) section 510(k) medical device process, the transvaginal mesh product was technically to be considered “safe.” Bard also argued that it was not permitted to provide evidence of this fact to the jury, as the District Court concluded that “the § 510(k) process is not concerned with the device’s safety or effectiveness.”
In affirming the jury’s verdict and the lower court’s decisions, the Fourth Circuit Court held that the FDA clearance established under section 510(k) does not assess the safety of products, but only establishes that products are significantly comparable in nature to other devices. This ruling is significant for victims of defective and dangerous products, and negligent manufacturers, because medical device manufacturers cannot claim their products are “safe” solely based on gaining FDA approval through the expedited 510(k) clearance process.