Barry H. Boise
Barry H. Boise is a partner in the Litigation and Dispute Resolution Department of Pepper Hamilton LLP. He is a member of the firm’s Health Effects Litigation and Life Sciences practice groups.
Mr. Boise provides litigation and regulatory counseling to medical device manufacturers, pharmaceutical manufacturers, hospitals and physician practice groups.
Clients that Mr. Boise has assisted include:
- national and trial counsel for pharmaceutical companies defending products liability, consumer fraud, class action, and medical monitoring claims
- trial counsel defending actions brought by State Attorneys General
- pharmaceutical manufacturers responding to federal and state investigations concerning manufacturing and promotional practices, including multistate Attorney General investigations, state Medicaid fraud unit investigations and congressional inquiries
- represent major pharmaceutical company in resolving a multistate Attorneys General investigation brought by 33 states under each state's consumer protection laws regarding the company's promotional practices, dissemination of scientific information and payments to physicians
- represent major pharmaceutical company in resolving a multistate Attorneys General investigation brought by 38 states under each state’s consumer protection laws regarding the company’s promotional practices and dissemination of scientific information
- represent major pharmaceutical company in resolving state health care payor claims brought under common law and state consumer protection laws
- represent major pharmaceutical company in resolving a multistate Attorneys General investigation brought by 38 states under each state’s consumer protection laws regarding the company’s manufacturing processes
- companies negotiating and implementing in-licensing, co-promotion and contract research organization arrangements
- pharmaceutical and medical device companies regarding regulatory and litigation risks presented by pharmacogenomics, the launch of new products and emerging technologies
- businesses performing corporate due diligence in mergers, acquisitions and other transactions involving life sciences businesses
- medical device and pharmaceutical companies requesting counseling on product labeling, warnings and instructions
- medical device manufacturers defending product liability claims for devices that include catheters, atherectomy devices, guidewires, stents, mitral heart valves and surgical sutures
- a large hospital and physician network as lead litigation counsel in payment disputes with Medicaid and commercial payors
- physician practice group responding to an OIG and Department of Justice Medicare billing investigation, defending False Claims Act litigation, negotiating a settlement and corporate integrity agreement and managing press relations.
Mr. Boise is a frequent writer and speaker on matters affecting the life science industry including litigation prevention, regulatory compliance and settlement strategies. He contributed a chapter on "Recognizing (and Avoiding) Traps for the Unwary" in Winning Legal Strategies for Life Sciences Settlements and Negotiations, published by Aspatore Books (2006).
Recent presentations by Mr. Boise include:
- “Impact of EHRs on the Medical-Legal-Regulatory Framework and the ‘Duty-to-Warn’ Landscape,” PDR Network’s PharmaEHR Summit (March 20-21, 2012)
- “Responding to State Attorneys General Investigations,” 12th Annual Pharmaceutical Regulatory & Compliance Congress & Best Practice Forum (November 2-4, 2011)
- “Listen to a Podcast: Lessons for Life Sciences Companies Developing or Marketing Medicines or Medical Devices,” Pepper Hamilton LLP Life Sciences Speaker Series (January 28, 2011)
- “Recent State and Federal Enforcement Activities – Lessons for Life Science Companies Developing or Marketing Medicines or Medical Devices,” Pepper Hamilton LLP Life Sciences Speaker Series (September 30, 2010 and October 19, 2011)
- “Off-Label Communications: Evaluating and Revamping Compliance Protocols in the Wake of Unprecedented Settlements,” American Conference Institute’s 7th National Forum (July 2010)
- “Compliance Issues Facing Bioscience Companies,” 2010 Association of Bioscience Financial Officers Annual Conference (May 2010)
- “Square Pegs & Round Holes: Update on State Attorney General Litigation Against Manufacturers of Atypical Antipsychotic Medications,” HB Litigation Conference on Defense Perspective on Attorney General Pharmaceutical Claims (February 2009)
- "Picking up Where the Federal Government Left Off: The States’ Growing Interest in Regulating Drug Promotion," ACI’s 7th Annual Corporate Counsel Forum on Advertising and Promotions for the Pharmaceutical Industry (November 2008)
- “Defense Perspectives on Attorney General Pharmaceutical Claims,” LexisNexis Teleconference (June 2008)
- “Factoring New State Enforcement Priorities into the Fraud and Abuse Analysis,” ACI’s 8th National Forum on Fraud & Abuse in the Sale and Marketing of Drugs (April 2008)
- “Understanding the Legal Implications of Disclosing Clinical Trial Information and Claims of Off-Label Promotion,” Clinical Compliance and Good Clinical Practices Conference (November 2005)
- “Factoring FDA Review into Project Characterization and Planning,” Chief Scientific Officer Boot Camp, BIO (2005).
Mr. Boise joined Pepper in 1995. Before joining the firm, Mr. Boise was a law clerk to the Honorable Frank J. Montemuro, Jr. of the Pennsylvania Superior and Supreme Courts and practiced at the law firm of Cohen, Shapiro. His civic activities included mentoring a local high school student through the Philadelphia Futures organization, and coaching youth soccer and baseball. He also is a member of the Fellows of the American Bar Foundation.
B.A. 1988, cum laude, University of Delaware
J.D. 1991, cum laude, Dickinson School of Law; associate editor, Dickinson Law Review
1991-93 Law Clerk to Hon. Frank J. Montemuro, Jr., Pennsylvania Superior and Supreme Courts
Admitted to practice in Pennsylvania and New Jersey