HPM assists companies and individuals in responding to enforcement actions and threatened enforcement actions by state and federal prosecutors and regulators.  Our attorneys have experience responding to a range of enforcement actions including:

  • Import Detentions
  • Warning Letters
  • Consent Decrees
  • Debarment proceedings initiated by FDA
  • Exclusion proceedings initiated by HHS
  • Clinical investigator disqualification proceedings
  • Administrative Subpoenas
  • Grand Jury Subpoenas
  • Search Warrants
  • Seizures
  • Civil Investigative Demands
  • Congressional Investigations

We use our in-depth understanding of laws and regulations enforced by FDA, DEA, FTC, CMS, HHS, OIG, and state and federal prosecutors to advise our clients on how to address potential enforcement actions, and to respond to and resolve them.  Our related Internal Investigations and Government Investigations Practice Areas complement our Enforcement Practice.


HPM represents clients in arbitration and administrative, civil and criminal litigation.

We regularly defend our clients against allegations of violations of law by state and federal regulators and prosecutors.  Examples of our defensive litigation include:

  • Litigating DEA immediate suspension orders and orders to show cause
  • Defending Federal False Claims Act cases
  • Defending federal criminal charges
  • Litigating seizure actions
  • Representing witnesses in depositions, hearings, and trials
  • Defending State Attorney General actions

We also sue the government when it violates our clients’ rights.  Our affirmative government litigation includes suits against agencies for:

  • Unlawful FDA decisions regarding market exclusivity under the FDC Act
  • Unreasonable delay in agency action
  • Unlawful product classification
  • Arbitrary and capricious or otherwise unlawful agency action, such as
    • Actionable FDA Warning Letters
    • Unlawful FDA approval of competitors’ products
    • Failure to approve our clients’ products
    • Improper imposition of import detentions

In addition, we represent our clients in litigation between private parties.  We have experience as both a plaintiff and defendant in unfair competition cases under the federal Lanham Act and related state laws.