{{slotProps.result.Title}} {{slotProps.result.Title}} {{slotProps.result.Title}} {{slotProps.result.Title}}

Lisa C. Dykstra

Partner

Lisa C. Dykstra is a seasoned litigator and trial lawyer who represents pharmaceutical manufacturers, medical device manufacturers, and other healthcare and technology organizations. Lisa’s practice focuses on civil and criminal government investigations, internal investigations, complex and parallel civil litigations, and regulatory proceedings involving compliance with FDA regulations, product marketing and promotional activities, product liability issues, securities fraud, and antitrust violations, among others. She routinely develops and executes strategies to address and exit large-scale, high-profile crisis situations in cases arising under the False Claims Act (FCA), the Federal Food, Drug, and Cosmetic Act (FDCA), the Anti-Kickback Statute, the Foreign Corrupt Practices Act, and the Medicaid Rebate Statute. Lisa serves as a core member of the firm’s crisis management team.

In addition, Lisa represents individuals, including executives and board members, involved in white collar investigations and litigation. Lisa advises on complex compliance issues, supervises compliance and ethics audits, and has negotiated and monitored compliance agreements with the US Department of Health and Human Services Office of Inspector General and state attorneys general. Separately, Lisa serves as national discovery counsel to a major pharmaceutical client, managing and counseling on complex discovery strategies across its portfolio of litigation and investigations. In this role, she manages strategy across product liability matters, government investigations, and civil litigation to ensure consistent advocacy and positions.

Lisa served as an assistant US attorney in the District of New Jersey Criminal Division.

Lisa has an active pro bono practice. She is a participant in the Pennsylvania Innocence Project and has served on the Criminal Justice Act Panel for the US District Court for the Eastern District of Pennsylvania.. In addition, Lisa is the co-chair of the Vetri Community Partnership’s board of directors, and serves on the USC Shoah Foundation’s leadership council and The Wistar Institute’s leadership council.

Lisa regularly lectures on FCA litigation, compliance issues, white collar crime, ethics, and internal investigations. She frequently participates in seminars and advises in-house counsel on managing internal investigations, creating and implementing compliance programs, and decision-making around indemnifying employees.

Pharmaceutical Manufacturers

  • Obtained declination from the US Department of Justice (DOJ) followed by a full dismissal of Merck & Co. Inc in the FCA case United States ex rel. Krahling v. Merck & Co. Inc.
  • Defends pharmaceutical industry cases involving a broad array of issues, including off-label promotion, marketing practices, clinical trials and disclosures, regulatory submissions, pharmaceutical pricing (average manufacturer price/best price), Anti-Kickback Statute, drug switching, and drug packaging
  • Represents major pharmaceutical manufacturers in internal investigations, civil and criminal federal and state investigations, and civil litigation involving allegations of improper promotional practices and off-label marketing
  • Represented a major pharmaceutical company in a federal investigation related to compliance with the Poison Prevention Packaging Act to declination and dismissal of FCA allegations

Medical Devices

  • Serves as lead counsel in the federal multidistrict litigation (MDL) In re: Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Liability Litigation
  • Serves as lead counsel in the representation of multiple medical device companies under investigation by various federal government agencies including the FDA, the Consumer rotection Branch of the DOJ, and the DOJ Criminal and Civil Divisions
  • Represented a major medical device manufacturer in a criminal investigation involving allegations of the sale and distribution of adulterated products and negotiated non-prosecution agreement and compliance program

General Healthcare Fraud and Abuse

  • Conducted numerous internal investigations related to potential fraud and abuse, off-label marketing, improper pricing practices, and clinical study programs, and advised on voluntary disclosures of potential healthcare fraud and abuse issues
  • Negotiated a $399 million global federal and state settlement for a major pharmaceutical manufacturer arising from allegations of improper promotional and pricing practices
  • Negotiated a $250 million global federal and state settlement for a major pharmaceutical manufacturer arising from allegations of improper pricing practices and best price violations
  • Obtained declinations of prosecution in civil healthcare fraud investigations for major pharmaceutical manufacturers involving allegations of improper pricing and promotional and marketing practices
  • Negotiated corporate integrity agreements for a major pharmaceutical manufacturer and implemented extensive compliance programs
  • Represented a home health agency in connection with a federal investigation and settlement of fraud and abuse allegations and negotiated corporate integrity agreement
  • Represented a major pharmacy benefit manager in a federal investigation and resulting litigation related to drug pricing and intervention programs

False Claims Act/Qui Tam Litigation

  • Served as lead defense counsel in numerous FCA and qui tam matters throughout the United States
  • Defended major pharmaceutical manufacturers, pharmacy chains, a national dental practice, home health care agencies, medical device companies, and individuals in civil and criminal healthcare matters involving allegations of improper marketing practices, pricing practices, misbranding, and the distribution of adulterated products
  • Defended a major technology company in multiple FCA investigations resolved through declinations and settlements related to government contracting and pricing
  • Represented a major pharmaceutical company in qui tam litigation related to compliance with federal packaging provisions
  • Litigated non-intervened qui tam cases involving major pharmaceutical manufacturers
  • Conducted internal investigations for pharmaceutical and medical device manufacturers related to whistleblower allegations and conducted negotiations with US Department of Justice to resolve claims through declination

Antitrust

  • Defends leading pharmaceutical manufacturer against putative class action allegations alleging Sherman Act Section 2 violations and related state law claims
  • Defending generic pharmaceutical supplier in multidistrict price-fixing cases and related government criminal investigations
  • Defending generic pharmaceutical supplier in FCA investigation related to price fixing

Discovery Strategy

  • Serves as national discovery counsel for a major pharmaceutical manufacturer across a portfolio of litigation and investigations
  • Advises pharmaceutical manufacturers on global discovery strategy in white collar investigations, product liability litigation, and commercial litigation

Government Contract Fraud

  • Represented a major technology company in multiple federal government contract investigations and litigation, resolved through settlements and declinations

Compliance

  • Negotiated corporate integrity agreements and compliance programs for major pharmaceutical manufacturers
  • Conducts compliance training and oversight for corporate integrity agreements, reportable events, and global compliance programs
  • Developed and conducted annual audit programs for sales and marketing activities
  • Provided guidance on implementation of routine compliance monitoring and investigation protocols

Miscellaneous

  • Represents pharmaceutical and device manufacturers in connection with federal and state grand jury subpoenas
  • Villanova University School of Law, 1992, J.D.
  • New York University, 1989, B.A.
  • Pennsylvania
  • New Jersey
  • US Court of Appeals for the Third Circuit
  • US District Court for the Eastern District of Pennsylvania
  • US District Court for the District of New Jersey

Co-chair, Board of Directors, Vetri Community Partnership

Leadership Council, The Shoah Foundation

Listed, The Best Lawyers in America, Criminal Defense: White-Collar, Philadelphia (2022–2025)

Listed, The Philadelphia Inquirer, Influencer of Law, White Collar (2019)

Listed, Benchmark Litigation, Future Star, Pennsylvania (2010–2014, 2017, 2018)

Member, The Legal Intelligencer, Pennsylvania Product Liability, Department of the Year (2014)

Member, The Wistar Institute Leadership Council

Board Co-Chair, Vetri Community Partnership

Former Member, Board of Directors, The Miquon School

Member, American Bar Association, Criminal Justice Section White Collar Crime Committee

Served on Criminal Justice Act Panel

Member, Villanova Law Review

No aspect of this advertisement has been approved by the Supreme Court of New Jersey. A description of the selection methodology for the above awards can be found here.