Lisa C. Dykstra

Lisa also provides guidance on complex compliance issues, oversees compliance audits, and has negotiated and monitored compliance agreements with the US Department of Health and Human Services Office of Inspector General (HHS-OIG) and state attorneys general.

In addition, 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, Lisa manages strategy across product liability matters, government investigations, civil litigation, and patent 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 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 co-chairs 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. Lisa is also a frequent panelist at educational events.

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
• Conducted investigations on behalf of companies involved in government contracts and managed resolution of debarment issues.

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

Results may vary depending on your particular facts and legal circumstances.