Lisa C. Dykstra

パートナー

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 internal and government investigations, complex and parallel civil litigations, criminal investigations, and regulatory proceedings involving product marketing and promotional activities, compliance with FDA regulations, product liability claims, securities fraud, and antitrust violations, among others. Lisa 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 Food Drug and Cosmetic Act, the Anti-Kickback Statute, the Foreign Corrupt Practices Act, and the Medicaid Rebate Statute.

Extended Profile

Lisa also 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, Lisa manages strategy across product liability matters, government investigations, civil litigation, and patent litigation to ensure consistent advocacy and positions. In addition, Lisa represents individuals, including executives and board members, involved in white collar investigations and litigation. Lisa also advises on complex compliance issues, supervises compliance 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.

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

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

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. Lisa is also a frequent panelist at educational events.

selected representations

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 Protection Branch of the Department of Justice, 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 nonprosecution agreement and compliance program

Healthcare Fraud and Abuse

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
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