C.R. Bard, Inc.’s Request to Depose Troy A. Brenes Denied
September 22, 2017
In July 2015, the FDA found that C.R. Bard and Davol (“Bard”), the manufacturers of the Recovery, G2, Eclipse, Meridian and Denali inferior vena cava (“IVC”) filters, had violated minimum safety regulations regarding its IVC filters. Among other failures, the FDA found that Bard repeatedly failed to report and/or downplayed patient injuries or product malfunctions associated with its IVC filter devices to the MAUDE database. Such failures were critical for several reasons.
First, the MAUDE database is designed to reveal evidence of unsafe devices by providing safety signals of unexpected failure modes or injuries, or unexpectedly high failure rates. However, this safety system operates almost entirely on the honor system. If a manufacturer fails to report patient injuries or device complications, safety problems can be concealed from the FDA and public. Second, Bard often marketed its IVC filters to physicians or defended their safety track record by claiming their reported failure rates were the same as all other companies, as evidenced by the MAUDE data. While these claims were untrue even based on the under-reported data, these claims are rendered even more questionable given Bard’s massive under-reporting of adverse events.
In 2017, Bard requested to take the deposition of Troy A. Brenes, of Brenes Law Group, P.C., in connection with the FDA’s findings. Bard claimed the FDA only discovered its safety violations because of conversations Mr. Brenes and another lawyer had with representatives from the FDA. Plaintiffs opposed the request by arguing, among other things, that any such conversations, even if they had occurred, were irrelevant. Plaintiffs noted that even if these claims could be established, it seemed extremely unlikely that Bard would argue to a jury that, but for Mr. Brenes having brought Bard’s safety violations to light, Bard would never have been caught. Bard’s request to depose Mr. Brenes was denied.