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Managing Parallel Legal Matters in Medical Device Industry

Learn how to handle subpoenas, assemble legal teams, and manage document collection in parallel legal matters. Explore strategies for employee interviews and tips to resolve matters efficiently.

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Managing Parallel Legal Matters in Medical Device Industry

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  1. Medical Device Congress: What to do When the Subpoena Arrives Michael J. Harrington Deputy General Counsel Eli Lilly and Company March 26, 2008

  2. Overview • Parallel Matters • Assembling and Managing the Team • Document Retention and Collection • Employee Interviews

  3. Parallel Matters • Government investigations spawn parallel litigation • The opposite also is true • Litigation/investigations go 0-60 in record speed • Critical to quickly identify broadest possible scope • Drives team • Drives strategy • Avoids subsequent surprises • Requires rapid understanding of the facts

  4. Parallel Matters • Likely parallel matters • Product liability • State consumer fraud actions • Public and private third party payer actions • Securities fraud actions • Derivative actions • HR disputes, including qui tam • Insurance coverage litigation (p/l, D&O) • Congress • None of these will wait while you resolve matters with USAO

  5. Parallel Matters • Each additional parallel matter makes any resolution more difficult. So important to resolve what you can. • What matters can you control? Influence? • Model for “global resolution” seems still be with DOJ/FDA at the “hub”

  6. Assembling and Managing the Team • External Team • White collar • E-discovery • Product liability • Securities/Derivative • Insurance • Structure: how many firms? • Counsel for board?

  7. Assembling and Managing the Team • Internal Team • Single point of contact (“Field Marshall”) • Substantive in house experts (securities, e-discovery, product liability) • Document retention/collection group • Secondary Team • Compliance • Audit • IR • Corporate communication

  8. Document Collection and Retention • Need to be ready in advance • Processes for Collection—Important • Speed • Efficiency • Reliability • Processes for Retention—Critical • Spoliation • Obstruction • Poor retention becomes an independent crisis

  9. Document Collection and Retention • Retain at first sign of trouble • Don’t wait for subpoena • Don’t take comfort is clever legal arguments that failure to retain in defensible • Retain broadly, then add specificity and narrow when possible • Document, document, document • Communicate retention methodology to USAO in transparent way

  10. Document Collection and Retention • Collection • Begin early • Needed for investigation • Better for lawyers to have control of key documents • Target key people first • Don’t rely on file owners alone to produce documents • Document, document, document • Communicate collection methodology to USAO in transparent way • Production

  11. Employee Interviews • Trap for the unwary—take legal advice before beginning interviews. Standardize protocol and script. • Led by outside counsel • Who do you represent? If you represent company and the witness, what happens if a conflict occurs? • Is this privileged? Who owns the privilege? • Criticality of honesty. Explain consequences of dishonesty including termination and potential obstruction charges. • Issues related to separate counsel for employees

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