As most large pharmaceutical companies face dozens of lawsuits at any given time, the rapid growth of electronic documents and e-mail has opened up the new legal frontier of electronic document discovery (EDD).
Recent cases have made plain that plaintiffs’ attorneys will attempt any legal maneuver to gain access to drug companies’ internal electronic documents during the discovery part of litigation — and that many judges are granting access.
“The e-discovery landscape is changing rapidly, and pharmaceutical companies face exploding costs attempting to manage oceans of electronic data,” says Robert Owen, a partner with the law firm Fulbright & Jaworski, headquartered in Houston, who launched his firm’s e-discovery group in 2003. “Many firms are struggling with this transition from paper to electronics.”
At stake is the vast trove of data related to drug safety and communications between management, marketing and research. Generally speaking, EDD entails gathering and organizing electronic documents on databases that can be easily searched and accessed. Legal teams can enter search words, such as “cardiovascular risk,” to identify all relevant documents.
But EDD programs aren’t simply means to satisfy judges and regulators. Drug firms that do not maintain electronic document retention programs and store relevant electronic communications run the risk that key documents may be unavailable for their defense in litigation.
“Pharmaceutical companies need to put their e-discovery houses in order,” Owen says. “Litigation is a huge risk factor for them. The whole idea of preparedness is to avoid becoming the next poster child for bad e-discovery practices.”
In litigation, having the right electronic data at your fingertips can make all the difference in a case, Owen says. The absence of such electronic evidence in court can make a drug company look like it’s hiding something, and “turn a losing case into a winner,” he says.
Drug companies also must take into account sanctions and other penalties. Companies are often subject to sanctions when they do not or cannot produce evidence upon demand, according to Todd Nunn, a partner in the Seattle law firm of Preston Gates & Ellis.
“Companies can really get into trouble for not having adequate policies in place for the retention of electronic documents,” says Nunn. “It really affects their ability to respond effectively to litigation.”
Dr. Saul Helman, an Indianapolis-based director of pharmaceuticals for KPMG, says that despite the many difficulties in building an EDD program, there are drug companies that need to make a better commitment to the process. It is a vast and forbidding process that entails storing e-mail, voice mail messages, wireless communications, and documents on computer hard drives, which often amount to terabytes of data.
“The use of e-discovery technology is extremely helpful in the discovery process and document management process in response to litigation,” Helman says. “There is value in centralizing this process when in litigation, increasing efficiencies in discovery and cost containment.”
The use of effective document retention and EDD before the launch of high-risk drugs may help identify risks, according to Helman; that, in turn, enables drug firms to develop a risk-minimization action plan and incorporate it into FDA submissions.
Such a plan includes efforts to document adverse events, track the writing of prescriptions, educate physicians about the risks involved, and conduct post-marketing studies.
“It may [slow] down the efforts to bring the drug to market,” Helman says. “But sometimes it is wise to err on the side of caution.”
That caution has lead companies like Roche to develop records retention and management procedures. At Roche, each department has a person designated to maintain electronic records and make sure that they are accessible for review by a central records retention committee, according to Kim Cayz, a Roche spokeswoman in Nutley, N.J.
“Our company takes the process of electronic document management very seriously,” Cayz says, who adds that the company’s legal department has mandated the process. “We’ve made a major commitment in terms of technology and resources.”
However, managing such an enormous volume of electronic data also poses a burden for pharmaceutical companies. That’s why companies establish strict records retentions policies and schedules.
Roche retains official records of electronic communications for a period established by its records retention schedule, but also purges records immediately following the end of their active, useful value, according to Cayz.
If documents are considered to be essential to any potential litigation, the company’s legal department can place a hold order on them, meaning that they should be retained.
GlaxoSmithKline (GSK), the world’s second-largest drug firm, maintains an electronic document management system “spanning everything from FDA submissions to documents involved in litigation,” according to Robert Sutton, a spokesman for GSK in Research Triangle Park, N.C.
By Richard Merli, Managing Editor, Pharmaceutical Insider
Source : http://www.kpmginsiders.com/
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