I am at the Masters Conference, a leading e-discovery conference. This a real-time report on the session Challenges Faced by Inhouse Counsel in the Pharmaceutical & Healthcare Industry

– Bernard Ford, Navigant [moderator]
– Peter S. Spivack, Hogan & Hartson
– David Z. Seide, WilmerHale
– Geoffrey R. Kaiser, Navigant

[Notes on this session: (1) the one in-house counsel schedule for this panel could not be present; (2) most of this session focuses more on regulatory and litigation issues than EDD so I have limited my reporting to elements of particular interest to EDD community.]

Q: What are the top three challenges inhouse counsel fact today?
Kaiser: (1) The cost of managing discovery, including outside counsel review fees, data collection costs, and integrating records in acquisitions. This will continue to be – and the trend has been – to rely less on outside counsel to review docs that were over-collected in the first instance. They will invest a bit more upfront to scoping the collection, the GC can control costs. (2) Dealing with strict liability, including criminal liability, for arguably ordinary corporate actions. Cites Oxycontin case as example of execs pleading guilty to a mis-branding charge [ed. note – stemming from what is frequently called off-label use]. Thinks the misbranding issue net will expand to medical device makers.
Spivack: (1) Agrees that misbranding liability is a huge issue.
Seide: (1) Risk management and assessment is the biggest challenge. GCs have to figure out “what the hell happened”. It’s often to figure out what happened given the numbers of custodians and volume of data. Need to manage the story over the course of what may be year+ investigation as understanding the data evolves. (2) Cost is another big issue. It’s very expensive to figure out what’s in the mountain of data and documents. There is no magic way to understand data and docs – someone has to read the documents and data. (3) GCs want closure; they don’t want multi-year investigations. But EDD is very hard to do quickly and efficiently.

Q: I ask: what are GCs doing to address, other than whining?
A: Review counsel bills. Compliance systems. Active monitoring and internal audit program that goes beyond the finances (e.g., audit against procedures). Need to recognize the challenge of managing risks in globally diverse companies with so many employees. There is a lot of fear among GC of off-label use. Sales team has to be trained for this but company needs an active monitoring program to control this. Selling prevention internally is not easy.