Thomas H. Lee II focuses his practice on representing companies and individuals involved in criminal and other government investigations and related civil litigation, including investigations and litigation under the federal False Claims Act and state counterparts, the federal Food, Drug and Cosmetic Act, the Medicare/Medicaid Anti-Kickback Statute, the Bank Secrecy Act, the Financial Institutions Reform, Recovery and Enforcement Act (FIRREA) and state consumer fraud statutes.
In recent years, Mr. Lee has represented pharmaceutical companies, medical device and equipment manufacturers, clinical laboratories, nursing homes, and other health care providers in government health care fraud investigations and related civil litigation, including litigation under the False Claims Act, RICO, and state consumer fraud statutes. He also represents defense contractors and other companies and individuals outside the health care industry that are accused of defrauding the government. In addition, Mr. Lee frequently conducts internal investigations for corporate clients and advises companies on matters related to those investigations. He also regularly advises corporate clients on the design, implementation, and administration of corporate compliance programs.
Mr. Lee has been consistently ranked as a leading lawyer for white-collar crime and government investigations by Chambers USA and described by clients and peers as "careful and thoughtful" and a "superb lawyer" who "brings credibility to every conversation he has" and "the legal community has a lot of trust in him." The Legal 500 United States 2013 also recognized Mr. Lee for his government investigations practice within the life sciences industry. He was named a "Life Sciences Star" by LMG Life Sciences 2012-2014 and was recognized as a "Securities Litigation Star" by the 2012 edition of Benchmark Litigation. He has been listed numerous times in The Best Lawyers in America for white-collar criminal defense, and by Practical Law Company’s Which Lawyer? as a nationally recommended lawyer for government enforcement and investigations in life sciences. In 2013, Mr. Lee was also recognized by The International Who’s Who of Business Crime Defence Lawyers for his "'deep understanding' of the health-care sector, the federal Food, Drug and Cosmetic Act and the Medicare/Medicaid Anti-Kickback Statute." Mr. Lee has also been named to Global Investigations Review’s list of “Who’s Who Legal Investigations 2015.”
Mr. Lee formerly served as Chief of the Major Crimes Section, Chief of the Criminal Division, and First Assistant United States attorney for the U.S. Attorney’s Office for the Eastern District of Pennsylvania. A member of that office from 1981 to 1990, he was responsible for many of its most significant prosecutions, including major police and political corruption cases and government contracting fraud prosecutions. He has lectured on a number of topics, including issues involving sales and marketing practices in the pharmaceutical industry, health care fraud, securities enforcement, corporate criminal liability, criminal enforcement of environmental laws, and corporate compliance programs.
- Sales and Marketing and Nominal Price Investigations: Mr. Lee represented a major pharmaceutical manufacturer in two government investigations that were part of a recent global settlement with the federal government and numerous states and included a payment of US$3 billion by the company to resolve various criminal charges and civil liability arising from these investigations. One of the investigations concerned the company's sales and marketing practices and allegations of off-label promotion and violations of the Anti-kickback Statute. The other investigation involved allegations that the company improperly used the nominal price exception and thus understated its rebates under the Medicaid Rebate Statute.
- Bank Investigation: Mr. Lee recently represented a bank in an investigation by the U.S. Department of Justice, the Federal Deposit Insurance Corporation (FDIC) and the Financial Crimes Enforcement Network (FinCEN) of the U.S. Department of Treasury of the bank's e-payments programs, including its compliance with the anti-money laundering provisions of the Bank Secrecy Act. The investigation was resolved with all three agencies with the bank's payment of a US$15 million civil monetary penalty and an agreement to set aside an additional amount for restitution.
- Average Wholesale Price Litigation: Mr. Lee represented a major pharmaceutical company in a government investigation involving allegations that the company set an inflated "average wholesale price" (AWP) for certain of its products and then promoted those products to its physician customers based on the "spread" between the AWP-based Medicare and Medicaid reimbursement and the actual selling price to the physicians. The investigation and two related False Claims Act cases were resolved in a civil settlement for US$149 million with no criminal charges against the company. Mr. Lee continues to represent the company in ongoing AWP litigation, including civil cases brought by state attorneys general and others alleging the fraudulent use of AWP.
- False Claims Act Case: Mr. Lee represented a pharmaceutical manufacturer in an FCA case in the United States District Court for the Eastern District of Pennsylvania alleging that the company paid illegal kickbacks to physicians to induce those physicians to prescribe the company’s products and thus caused those physicians to submit false claims for the company’s products to Medicare and Medicaid. After the company filed its motion to dismiss, the plaintiff voluntarily agreed to dismiss his complaint with prejudice.
- U.S. ex rel. King v. Alcon Labs et al.: Mr. Lee represented a major international pharmaceutical company in an FCA case brought against 25 major pharmaceutical manufacturers alleging that they defrauded the United States by selling the government pharmaceutical products that were "adulterated" because they allegedly were not manufactured in accordance with good manufacturing practices. The court dismissed the amended complaint with prejudice as to all defendants for failure to comply with Rule 9(b). Reported decision: 2005 WL 20372 (N.D.Tex. Jan. 4, 2005).
- U.S. ex rel. Atkinson v. Pennsylvania Shipbuilding Company et al.: Mr. Lee represented the defendant Pennsylvania Shipbuilding Company in an FCA case alleging that Penn Ship fraudulently obtained a government contract to build oil tanker ships for the Navy. The court dismissed most of the case on pre-trial motions and then granted summary judgment to Penn Ship and its co-defendant on the remaining claim. On January 12, 2007, the Third Circuit affirmed the judgment of the district court and dismissed the case in its entirety. Reported decisions: 2004 WL 1686958 (E.D.Pa. July 28, 2004); 255 F.Supp.2d 351 (E.D.Pa. 2002); 2000 WL 1207162 (E.D.Pa. Aug. 24, 2000); 473 F.3d 506 (3rd Cir. 2007).
- Confidential Client: Mr. Lee currently represents an individual executive of a pharmaceutical manufacturer in a federal investigation of the manufacturer’s compliance with Good Manufacturing Practices.
- Confidential Client: Mr. Lee currently represents an executive of a major international pharmaceutical company in a government investigation of the company's sales and marketing practices with respect to one of its products.
- Confidential Client: Mr. Lee currently represents an employee of an international pharmaceutical company in an FCPA investigation in Latin America.
- Confidential Client: Mr. Lee represented a pharmaceutical manufacturer in a government investigation into its alleged failure to report as its "best price" under the Medicaid Rebate Program the price of certain products sold to a health maintenance organization that repackaged and relabeled the products under its own NDC numbers. The case was resolved by civil settlement in April 2003 for approximately US$89 million with no criminal charges against the company.
- Anti-Kickback and Stark Case: Mr. Lee represented a large clinical laboratory company in an FCA case which alleged that the company paid kickbacks to physicians and otherwise violated the Stark law in providing various goods and services to physicians. The court dismissed the case on summary judgment in favor of the company. Reported decisions: 2005 WL 78931 (E.D.Pa. Jan. 12, 2005); 2003 WL 22795324 (E.D.Pa. Nov. 21, 2003).
- Clinical Laboratory Billing Litigation: Mr. Lee represented a major clinical laboratory company in a federal government investigation and related FCA litigation in the Eastern District of Pennsylvania alleging that the company fraudulently billed the government for unnecessary laboratory testing. The company settled with the government and three groups of relators but litigated with three other groups of relators who sought a share of the settlement. The court dismissed the claims of the other relators. In a related case in Louisiana, the court dismissed several of the claims before that case also settled. Mr. Lee also represented the company in related litigation with consumers and private insurers that ultimately settled. Reported decisions: 149 F.3d 227 (3rd Cir. 1998); 2000 WL 17838 (E.D.La. Jan. 10, 2000); 2000 WL 222843 (E.D.La. Feb. 23, 2000); 1999 WL 639683 (E.D.La. Aug. 19, 1999).
Williams College, B.A., 1973, magna cum laude, Phi Beta Kappa
Harvard Law School, J.D., 1976, cum laude
United States Court of Appeals for the First Circuit
United States Court of Appeals for the Third Circuit
United States Court of Appeals for the Ninth Circuit
United States District Court for the Eastern District of Pennsylvania
United States District Court for the District of Massachusetts
United States Court of Federal Claims