Gary F. GiampetruzziGary F.Giampetruzzi

Represented a small pharmaceutical company in connection with FDA and government investigations across multiple prosecutor offices into drug registry, off-label promotion, and patient-support program issues. Resolved the first manufacturer opioid case for US$7.55 million on a civil-only basis.

Represented a mid-sized pharmaceutical company in connection with a multi-year, federal civil and criminal investigation into patient support program, pricing, and specialty pharmacy issues. No action taken by the federal prosecutors.

Represented a mid-sized pharmaceutical company in connection with a federal civil investigation into Pharmaceutical Benefits Manager (PBM) related pricing and kickback issues. No action taken by the federal prosecutors.

Represented a mid-sized pharmaceutical company in connection with a State AG inquiry into patient support program and related pricing issues, as related to PBM relationships.

As in-house counsel, oversaw the negotiations, finalization of terms, and preparations for the announcement of the landmark US$2.3 billion Bextra civil and criminal, off-label promotion and kickback investigations with the Boston, Philadelphia, and other U.S. Attorney’s Offices, Main Justice, HHS OIG, and State Medicaid Fraud Control Units (largest criminal case in history at the time), and associated CIA negotiations.

As in-house counsel, oversaw the US$491 million Rapamune civil and criminal, off-label promotion investigation with the Western District of Oklahoma U.S. Attorney’s Office, Main Justice, HHS OIG, and State Medicaid Fraud Control Units, and associated CIA negotiations.

As in-house counsel, oversaw the negotiation and resolution of the grand jury investigation into the promotion of the drug Protonix—which saw US$10 billion in sales—by the Boston U.S. Attorney’s Office, achieving a civil-only resolution entailing US$55 million in disgorgement under the Food, Drug, & Cosmetics Act.

Represented a leading rare disease company as compliance counsel before the U.S. Department of Justice and SEC in connection with an ongoing FCPA matter, the first rare disease enforcement case of its kind.

Represented a leading ex-U.S. medical device company before the U.S. Department of Justice in connection with an ongoing FCPA matter, involving one of the first voluntary disclosures out of this critical market.

Represented a leading multinational pharmaceutical company as strategic counsel in connection with various government-facing FCPA matters, including board-facing counsel regarding overall matter oversight.

As in-house counsel, oversaw internal investigations and associated voluntary disclosures under the FCPA involving numerous markets around the world to the U.S. Department of Justice and SEC, and certain foreign authorities, beginning in 2004 and concluding in 2012. Secured a full declination for the parent company, a deferred prosecution agreement for the relevant corporate subsidiary, no imposition of an independent monitor, and explicit government recognition of the company’s compliance efforts.

As in-house counsel, oversaw the acquisition due diligence, resultant internal investigations in numerous markets, and associated voluntary disclosures to the U.S. Department of Justice and SEC, which resulted in a full declination for the parent company and subsidiaries, and a purely civil resolution.

As in-house counsel, defended a pharmaceutical company against government inquiries and investigations by the Chinese Administration of Industry and Commerce (“AIC”) in Beijing, Shanghai, and other cities and provinces across China, as well as related inquiries.

As in-house counsel, oversaw the successful resolution of several individual State AG and multi-state AG coalition matters, including the US$33 million consumer protection settlement with a coalition of 44 states around the promotion of Geodon, and the US$45 million consumer protection settlement with a coalition of 34 states around the promotion of Zyvox and Lyrica.

Represented one multinational rare disease company in connection with its global anti-corruption/FCPA due diligence associated with its landmark US$32 billion acquisition of another leading rare disease company.

Conducted a gap assessment of the integration of the compliance program and systems of one medical device company acquired by another leading medical device company against industry and regulator standards.

Represented a multinational pharmaceutical company in connection with its global anti-corruption/FCPA due diligence associated with its US$16 billion acquisition of another pharmaceutical and medical device company.

Represented a multinational pharmaceutical company in connection with its global anti-corruption/FCPA due diligence associated with its US$16 billion acquisition of the vaccines business of another pharmaceutical company, divestiture of its oncology business, and a consumer healthcare joint venture.

Developed enhanced online anti-corruption training curriculum and revised global anti-corruption policies and procedures for a global private equity firm, and provided counsel on portfolio company management.

Conducted transactional compliance, AML, and sanctions diligence for a leading private equity firm in connection with higher-risk healthcare investments, including in hospitals, in emerging growth markets, including China.

Acted as de facto independent monitor for a leading private equity firm to provide monitor oversight of higher-risk investments in emerging markets.