Perham Gorji

Pair-Um Gore-JeePartner
About

With more than 20 years of federal service, including nearly a decade as the Deputy Chief Counsel for Litigation at the US Food and Drug Administration (FDA) and a dozen years combined as a Department of Justice (DOJ), Consumer Protection Branch (CPB) trial attorney and Assistant U.S. Attorney, Perham Gorji has extensive litigation experience and a deep understanding of the FDA's regulatory goals and methods of enforcement.

With his unique level and breadth of experience at FDA and DOJ, Perham has the judgment and skills necessary to guide clients through significant litigation and investigations and manage the reputation risks they present. In addition to overseeing a firm's response to an enforcement action, his administrative and regulatory experience at the FDA enables him to help clients properly respond to and resolve warning letters, import alerts, and other regulatory actions. Perham is able to advise clients as they navigate the FDA inspection process, including product application inspections, routine inspections, for cause inspections and supervision inspections pursuant to an FDA consent decree or other government compliance agreements, and clients benefit from his insider's understanding of the factors that inform agency decisions to move matters from the regulatory inspection phase, to warning letters and/or enforcement.

Perham's work has involved the full gamut of FDA regulated medical products, and he has the experience and skills necessary to evaluate these product offerings and manufacturing processes for compliance with the statutes and regulations that govern them. He is able to assist clients to establish and maintain robust compliance programs and attain a long-term culture of adhering to the US Department of Health and Human Services (HHS) and FDA regulatory requirements.

Perham's practice focuses on the following areas central to legal disputes, compliance, and transactional matters, and engagement with federal regulatory agencies:

• FDA/DOJ civil enforcement litigation, related investigations, and criminal prosecutions
• Challenges to FDA agency action: e.g., application denials, product classification, clinical holds, rulemaking
• Agency citizen petition process and comments on proposed rulemaking and guidance
• Product liability litigation concerning FDA-regulated products
• Competitor litigation
• FDA Inspectional Violations (Form 483) or Warning Letter responses
• Recalls and marketing withdrawals
• Product and Manufacturing Quality
• Labeling & Disclosures, Advertising & Promotion
• Government Compliance Agreements and Orders: DOJ; FDA; FTC; HHS, OIG
• Compliance Program Development: FDA; HHS; FTC; CPSC
• Risk Assessment
• Distribution, Licensing, and Supply Agreements
• Clinical Trial Agreements
• DOJ's Voluntary Self-Disclosure Program

Bar admissionsDistrict of ColumbiaDelaware
CourtsUnited States District Court for the District of Delaware
Education
  • J.D., Harvard Law School
    Associate editor, International Law Journal

  • B.A., Duke University
    magna cum laude

AWARDS

The Legal 500 United States

  • Recommended, Cannabis (2024)
Additional Awards
  • Investigation of the Year Award, National Health Care Anti-Fraud Association (2014)
  • Investigation Award for Excellence, Council of Inspectors General (2014)
  • Special Achievement Award, US Attorney’s Office's Felony Trial, Grand Jury and Federal Major Crimes sections (2004-2007)

Seminars

  • Panelist, "A Comprehensive Guide to Consent Decree Negotiation and Compliance," FDLI Enforcement, Litigation and Compliance Conference, December 2023
  • Panelist, "Managing Risks and Avoiding Pitfalls in Criminal Enforcement Against Corporations," FDLI Annual Conference, May 2023
  • Panelist, "Protecting Consumers: Federal Enforcement Priorities and Recent Highlights," ABA 38th National Institute on White Collar Crime, March 2023
  • Panelist, "Protecting Consumers: Federal Enforcement Priorities and Recent Highlights," American Bar Association 8th Annual Southeastern White Collar Crime Institute, September 2022
  • Panelist, "CIAs and Compliance Programs," Federal Bar Association, Qui Tam Section Annual Conference, March 2019
  • Panelist, "Cell and Gene Therapy Compliance and Enforcement," FDLI Enforcement, Litigation and Compliance Conference, December 2019
  • Panelist, "Criminal Prosecutions Under the Food, Drug & Cosmetic Act," FDLI Annual Conference: Criminal Prosecutions Panel, May 2017

Prior Experience

Prior to joining DLA Piper, Perham Gorji worked at the US Food & Drug Administration (FDA) in the Office of Chief Counsel (OCC) as the Deputy Chief Counsel for Litigation. He also served as a trial attorney for the Department of Justice, Consumer Protection Branch (CPB); an assistant US Attorney in the US Attorney's Office for the District of Columbia; a law clerk to the Honorable R. Barclay Surrick of the US District Court in the Eastern District of Pennsylvania; and as an associate for a highly regarded, national law firm.

At CPB, Perham was the lead attorney for numerous civil and criminal matters in federal courts nationwide, representing the FDA, Federal Trade Commission (FTC) and Consumer Product Safety Commission (CPSC). He investigated and prosecuted violations of federal fraud-related statutes, with specific emphasis on health care fraud, off-label promotion of medical products and false advertising. He defended client agencies from lawsuits challenging agency action and rulemaking. Perham litigated several significant matters against drug manufacturers for failing to comply with good manufacturing practices and to ensure data integrity in product applications and testing. He was the Department of Justice's (DOJ) lead attorney in matters involving regulation of biological medical products and related enforcement.

As Deputy Chief Counsel for Litigation at the FDA, Perham directly supervised the FDA's civil and criminal matters, including seizures, injunctions, administrative actions, civil money penalties, subpoena responses, judicial defensive matters and criminal investigations related to violations of the Federal Food, Drug and Cosmetic Act (FDCA), the Public Health Service Act (PHSA) and related federal statutes. Perham oversaw and managed more than 40 litigation attorneys who provide legal guidance to the FDA's civil inspection officials and criminal agents, as well as supported the DOJ in litigating civil matters and criminal prosecutions in federal courts. He directly supervised FDA attorneys on over 100 enforcement actions, both civil and criminal, and dozens of lawsuits against the agency. These matters have spanned the range of products FDA regulates, including food, drugs, medical devices, biological medical products, tobacco products and animal-related products. His most significant matters included securing consent decrees, injunctions and seizures on behalf of the FDA; criminal prosecutions; representing the FDA's interests in False Claims Act (FCA), qui tam matters; advising the FDA on numerous warning letters and other regulatory notices; and defending lawsuits against the agency.

Connect