Lisa C. Dykstra

A former Assistant United States Attorney, Lisa’s representation of pharmaceutical manufacturers and other healthcare and technology organizations most frequently involve issues relating to global product marketing and promotional activities, FDA regulations, global bribery and corruption charges, federal and state pricing regulations, securities fraud, antitrust violations and commercial bribery. She also represents individuals, including executives and board members, involved in white-collar investigations and litigation. Lisa has negotiated and monitored compliance agreements with the US Department of Health and Human Services Office of Inspector General and the State Attorneys General.

In addition, Lisa serves as the National Discovery Counsel to a major pharmaceutical client managing and counseling on complex discovery strategy across their portfolio of litigation and investigations. In this role, she manages the strategy across products liability matters, government investigations, civil litigation and patent litigation to ensure consistent advocacy and positions. As part of this role, Lisa oversees an ediscovery team responsible for end-to-end document discovery.

Lisa handles a variety of pro bono matters, 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 Vetri Community Partnership Board of Directors and the WXPN 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.

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 Act, 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 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.
• Represented a major pharmaceutical company in a federal investigation related to compliance with Poison Prevention Packaging Act.
• Conducted numerous internal investigations related to potential fraud and abuse, off-label marketing, improper pricing practices, 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, 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 federal investigation and settlement of fraud and abuse allegations and negotiated corporate integrity agreement.
• Represented a major pharmacy benefit manager (PBM) in a federal investigation and resulting litigation relating to drug pricing and intervention programs.

False Claim Act/ Qui Tam Litigation

• Lead defense counsel in numerous False Claims Act and qui tam matters throughout the United States.
• In healthcare matters, defended major pharmaceutical manufacturers, pharmacies chains, a national dental practice, home health care agencies, medical device companies, and individuals in civil and criminal matters involving allegations of improper marketing practices, pricing practices, misbranding, and the distribution of adulterated products.
• Defended a major technology company in multiple federal 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 to successful conclusions.
• Conducted internal investigations for pharmaceutical and medical device manufacturers relating to whistleblower allegations and conducted negotiations with DOJ 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.