Internal Investigations

for the Drug & Device Industries

Tuesday, June 24, 2008

About

With Congress launching an array of inquiries and calling for even greater scrutiny and federal and state enforcement activity at an all-time high, drug and medical device companies are now faced with operating in an unprecedented, headline-oriented climate. At a time when multi-million dollar fines and settlements are fast becoming a way of life, it has never been more critical for companies to ensure that their protocols and guidelines for conducting internal investigations utilize the best available practices to contain the significant risks involved.

The true test for a company is whether it can identify problems and take necessary action before the government investigators appear at the doorstep. When an issue is presented, you must be able to assess what the potential liabilities are and the steps that your company can take to preserve its rights. As you evaluate and investigate findings, you must be prepared to navigate a dangerous minefield that includes potential whistleblowers and several critical federal statutes.

In addition, a significant degree of discretion must be exercised when conducting an investigation and it is essential to exercise that discretion wisely and effectively. Unique challenges must be overcome in the course of interviewing employees and collecting data. Determining whether or not to indemnify employees and preserving privilege during the course of the investigation are other key issues that need to be effectively tackled. Plus, with many companies operating globally and outsourcing significant parts of their operations, collecting data often requires a keen awareness to relevant international laws.

Whether it be accusations of off-label marketing, improper payments to consultants, failure to disclose clinical results, or any of the other types of conduct that are triggering escalated scrutiny, taking proper investigatory and remedial steps is the most critical way to contain damage and avoid or minimize government investigations and sanctions.

In response, ACI has specifically designed this publication from the 3rd National Conference on Internal Investigations for the Drug & Device Industries event where pharmaceutical and medical device companies to benchmark the nuances and intricacies of their internal investigatory processes and response mechanisms to government inquiries.

Contents & Contributors

About

With Congress launching an array of inquiries and calling for even greater scrutiny and federal and state enforcement activity at an all-time high, drug and medical device companies are now faced with operating in an unprecedented, headline-oriented climate. At a time when multi-million dollar fines and settlements are fast becoming a way of life, it has never been more critical for companies to ensure that their protocols and guidelines for conducting internal investigations utilize the best available practices to contain the significant risks involved.

The true test for a company is whether it can identify problems and take necessary action before the government investigators appear at the doorstep. When an issue is presented, you must be able to assess what the potential liabilities are and the steps that your company can take to preserve its rights. As you evaluate and investigate findings, you must be prepared to navigate a dangerous minefield that includes potential whistleblowers and several critical federal statutes.

In addition, a significant degree of discretion must be exercised when conducting an investigation and it is essential to exercise that discretion wisely and effectively. Unique challenges must be overcome in the course of interviewing employees and collecting data. Determining whether or not to indemnify employees and preserving privilege during the course of the investigation are other key issues that need to be effectively tackled. Plus, with many companies operating globally and outsourcing significant parts of their operations, collecting data often requires a keen awareness to relevant international laws.

Whether it be accusations of off-label marketing, improper payments to consultants, failure to disclose clinical results, or any of the other types of conduct that are triggering escalated scrutiny, taking proper investigatory and remedial steps is the most critical way to contain damage and avoid or minimize government investigations and sanctions.

In response, ACI has specifically designed this publication from the 3rd National Conference on Internal Investigations for the Drug & Device Industries event where pharmaceutical and medical device companies to benchmark the nuances and intricacies of their internal investigatory processes and response mechanisms to government inquiries.

Contents & Contributors

TOP TEN CONSIDERATIONS IN GOVERNMENT AND INTERNAL INVESTIGATIONS
Joel S. Goldberg, Millennium Pharmaceuticals, Inc. (Cambridge, MA)

EXERCISING DISCRETION FROM THE START: STRUCTURING AN APPROPRIATE SITUATION-SPECIFIC AND COMPANY-SPECIFIC INVESTIGATION
Lisa C. Dykstra, Morgan, Lewis & Bockius LLP (Philadelphia, PA)

BEST PRACTICES IN GOVERNMENT AND INTERNAL INVESTIGATIONS
Mark J. Stein, Simpson Thacher & Bartlett LLP (New York, NY)

PRESERVING PRIVILEGE IN INTERNAL INVESTIGATIONS
Brian K. French, Nixon Peabody LLP (Boston, MA)
Kathleen Meriwether, Ernst & Young, LLP (Philadelphia, PA)

CONDUCTING EFFECTIVE EMPLOYEE INTERVIEWS
Robin E. Abrams, Purdue Pharma L.P. (Stamford, CT)
M. Fabiana Lacerca, Mylan Inc. (Canonsburg, PA)
R. David Walk, Jr., Dechert LLP (Philadelphia, PA)

INDEMNIFICATION OF CORPORATE OFFICERS AND EMPLOYEES
Daniel S. Ruzumna, Patterson Belknap Webb & Tyler LLP (New York, NY)
Craig D. Margolis, Vinson & Elkins LLP (Washington, DC)

QUI TAMS: BEING PREPARED FOR WHISTLEBLOWERS
Stephen J. Immelt, Hogan & Hartson (Balitmore, MD)
Raymond G. Mullady, Jr., Orrick, Herrington & Sutcliffe LLP (Washington, DC)

RECENT DEVELOPMENTS IN RETALIATION ACTIONS UNDER § 3730 (H) OF THE FALSE CLAIMS ACT
Stephen J. Immelt, Hogan & Hartson (Balitmore, MD)
Alison J. Caplis, Hogan & Hartson (Balitmore, MD)

QUI TAMS: BEING PREPARED FOR WHISTLEBLOWERS
Raymond G. Mullady, Jr., Orrick, Herrington & Sutcliffe LLP (Washington, DC)
Christopher M. O’Connell, Orrick, Herrington & Sutcliffe LLP (Washington, DC)

INTEGRATING INVESTIGATION PREPAREDNESS INTO EXISTING COMPLIANCE PROGRAMS
Retta M. Riordan, Riordan Consulting LLC (Mountainside, NJ)
Trudy J. Seeley, sanofi-aventis (Bridgewater, NJ)
Keith M. Korenchuk, Covington & Burling LLP (Washington, DC)

CHALLENGES IN GLOBAL INVESTIGATIONS
Jeffrey L. Antoon, Johnson & Johnson (New Brunswick, NJ)
Jay T. Jorgensen, Sidley Austin LLP (Washington, DC)
SanDee Priser, Ernst & Young LLP (Chicago, IL)
John N. Joseph, Post & Schell, PC (Philadelphia, PA)

METICULOUSLY PREPARING FOR GOVERNMENT INVESTIGATIONS SARAH FRANKLIN, COVINGTON & BURLING LLP (WASHINGTON, DC)
Katayun I. Jaffari, Saul Ewing LLP (Philadelphia, PA)

INVESTIGATION AFTERMATH: TAKING PROPER REMEDIAL AND CORRECTIVE ACTION
B. Scott McBride, Baker & Hostetler LLP (Houston, TX)
Robert R. Stauffer, Jenner & Block LLP (Chicago, IL)

ENFORCEMENT TRENDS FOR THE DRUG & DEVICE INDUSTRIES
Daniel S. Reinberg, Foley & Lardner LLP (Chicago, IL)
Frederick Robinson, Fulbright & Jaworski LLP (Washington, DC)



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0