Files Can Come Back to Haunt Drug and Device Companies

Reams of emails have become evidence against managers at Davol, a unit of C.R. Bard, allegedly showing it used a resin-based plastic unit to produce hernia repair mesh even though the supplier warned it shouldn’t be permanently implanted in people. As reported by Bloomberg, a U.S. District Judge just ruled that the e-mails raised “a genuine issue of material fact about whether Bard was aware its conduct was practically certain to cause injuries.” Lawyers for a woman suing the company will use the e-mails in next month’s trial. The case highlights the importance of smart recordkeeping for life sciences and device companies, says John Avellanet, managing director and principal at Cerulean Associates LLC. He’ll lead an FDAnews workshop, FDA Recordkeeping: How to Prove Compliance and Avoid Dangerous Documents, July 17-18 in Boston, along with Nancy Singer, founder of Compliance-Alliance LLC. “Companies that don’t understand ‘dangerous documents’ do so at their peril,” Singer says. Avellanet agrees. “Your records are your proof of FDA compliance, or lack thereof.”