Andy J. Miller

Andy Miller's practice focuses on the interplay between litigation and regulatory issues affecting the health care industry. He has over 13 years' experience litigating complex, multiparty, multidistrict cases and proficiency navigating various regulatory issues, including FDA, ACA, 340B and HIPAA compliance.

Before rejoining the Firm, Andy was an attorney in the National Complex Litigation and Investigations Division of the U.S. Department of Health & Human Services, Office of the General Counsel, overseeing HHS's largest, most complex and high-profile cases across its litigation and regulatory portfolio. He was appointed by the HHS Secretary as one of only six individuals to serve as a panel member on the newly formed 340B Administrative Dispute Resolution Board to adjudicate disputes between covered entities and manufacturers. Andy was also a Special Attorney for the Commercial Litigation Branch, Civil Division of the U.S. Department of Justice.

Andy has extensive experience in litigating complex, multiparty cases and is well-versed in all pre-trial, trial and post-trial phases of federal court litigation. He has litigated several large-scale patent-infringement actions under the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act for pharmaceutical products. He also counsels clients regarding regulatory compliance.

Andy also has represented clients in antitrust actions related to pharmaceutical products, including actions involving reverse payments, product hopping and REMS. During law school, he served as a research assistant for Professor Herbert Hovenkamp, a renowned expert in antitrust law.

Andy’s experience includes:

Government Experience

• Appointed by the Secretary of HHS to serve as one of six panelists on the Administrative Dispute Resolution Board to adjudicate disputes between covered entities and manufacturers regarding the 340B drug pricing program administered by the Health Resources & Services Administration
• Affordable Care Act Litigation: Coordinated HHS’s response to several cases filed near-contemporaneously in multiple district courts nationwide challenging regulations related to aspects of the Affordable Care Act
• HIPAA: Investigated and conducted enforcement actions related to HIPAA violations
• Breach of Contract: Served as in-house counsel for HHS, overseeing action in the Court of Federal Claims brought against the U.S. government alleging breach of material and clinical transfer agreements
• Oversight: Worked with other HHS personnel on oversight responsibilities for Congressional and FOIA requests related primarily to the Health Resources & Services Administration and the National Institute of Health

Patent Litigation

• Represented the United States in a patent infringement case brought by the United States against a pharmaceutical manufacturer for infringement of several U.S. patents related to the use of emtricitabine and tenofovir or a tenofovir prodrug for pre-exposure prophylaxis for the prevention of HIV
• Represented a generic drug company in a case involving patents related to delayed-release oral mesalamine. (Lialda®) Obtained a finding of non-infringement, which was affirmed by the Federal Circuit
• Represented a generic drug maker in a case involving a method patent related to an anti-spastic agent. (Zanaflex Capsules®) Obtained a finding of non-infringement and invalidity, which was affirmed by the Federal Circuit
• Represented a generic drug maker in a case involving a patent related to valganciclovir hydrochloride (Valcyte®). Matter resolved through settlement
• Represented generic company in a case involving patents related to an antidepressant (Paxil®). Matter resolved through settlement

Antitrust Litigation

• Represented a generic drug company in a case involving antitrust claims related to delayed-release oral mesalamine. (Asacol®) Obtained an order dismissing the company from the case
• Represented generic company in a case involving antitrust claims related to an antidepressant (Paxil®). Matter resolved through settlement