Counseled a Pharmaceutical Company on Compliance Program Development and Implementation
Advised a clinical-stage pharmaceutical company regarding its transition to commercial stage, including the development and implementation of a corporate compliance program. This included training company executives on compliance and regulatory matters, drafting and reviewing compliance policies and procedures, reviewing promotional materials, advising on implementation of a transparency tracking/reporting program consistent with federal and state laws, and advising on compliance and regulatory matters.
Internal Investigation Conducted on Behalf of Pharmaceutical Company
Conducted an internal investigation on behalf of a commercial pharmaceutical company arising from an employee whistleblower complaint. Allegations included inappropriate promotional activities, false claims, HIPAA violations, and kickbacks. The investigation included interviewing multiple employees, reviewing relevant documents, and preparing a findings memorandum with corrective action recommendations.
Mr. Jernigan has served as principle West Virginia counsel for Purdue Pharma, LP in the defense of claims based upon the marketing of its prescription pain relief medication, OxyContin. In the course of that defense, Mr. Jernigan was successful in obtaining one of the first judgments in favor of the company based upon the defense of misuse of the product. Mr. Jernigan was also able to obtain the dismissal of a significant number of individual claims and negotiate a resolution of one of the first actions instituted by a state attorney general against the company.
Conducted a Compliance Review and Assessment of a Biotechnology Company’s Corporate Compliance Program
Assessed the implementation and effectiveness of a biotechnology company’s corporate compliance program, including review of company policies, procedures, guidelines, training materials, risk assessment processes, internal investigation reporting mechanisms and follow-up, and auditing and monitoring activities. Also made recommendations for enhancing the program and assisted with implementation of such recommendations.
Defense of Clinical Laboratory in False Claims Act Investigation
Defended a clinical laboratory in civil and criminal investigations by the Department of Justice, U.S. Attorney’s Office for the Northern District of California, Office of Inspector General, Federal Bureau of Investigation, and the California Department of Insurance related to inappropriate sales and marketing activities, phlebotomy payments, and other kickbacks. Civil and criminal investigators declined to intervene in the matter against the company.
Internal Investigation Conducted on Behalf of Medical Device Company
Conducted an internal investigation on behalf of a medical device company arising from two employee whistleblower complaints alleging health regulatory and compliance violations. Allegations included pre-approval promotion, inappropriate promotional activities, and a detrimental lack of a corporate compliance program. The investigation included interviewing multiple employees, reviewing relevant documents, preparing a findings memorandum with corrective action recommendations, and assisting the company in implementing several corrective action recommendations.
Represented Electronic Health Records Company During Health Care Fraud Investigation
Represented an electronic health records and billing vendor in a government investigation by the U.S. Attorney’s Office for the Eastern District of Pennsylvania related to false claims submitted by and on behalf of a client health care professional. The matter was successfully resolved for the client.
Defense of Pharmaceutical Company in False Claims Act Lawsuit
Defended a global pharmaceutical company in a False Claims Act investigation involving five qui tam complaints related to the sales, marketing, and promotional activities for several drugs in the company’s product portfolio. Criminal and civil investigators from multiple federal agencies were involved in the investigation, including the U.S. Attorney’s Office for the District of Massachusetts, U.S. Food and Drug Administration (FDA), Veterans Administration (VA), and Federal Bureau of Investigation (FBI). The matter included document collection from more than 1,800 employees, witness interviews, and presentations to investigators. I negotiated a civil settlement agreement with the Department of Justice, settlement agreement and release with the lead qui tam relator, civil settlement agreements with the National Medicaid Fraud Control Unit team and individual states, and a corporate integrity agreement (CIA) with the U.S. Department of Health and Human Services Office of Inspector General (OIG).
Diet Drug Litigation
In re Bendectin Product Liability Litigation
Defense of Merrell Dow in several thousand suits alleging that birth defects were caused by the prescription anti-nausea medication, Bendectin. Numerous summary judgments and jury verdicts obtained in favor of Merrell Dow.
Represented Medical Device Company in Connection with Internal Investigation and Self-Disclosure to Government Regulators
Conducted an internal investigation for a medical device manufacturer of a compliance matter reported to the company and its board of directors. Further represented the company in a self-disclosure of the matter to the U.S. Department of Health and Human Services Office of Inspector General (OIG).
Acquisition of Two Affiliated Swiss Companies
Represented Global Pharmaceutical Manufacturer During Health Care Fraud Investigation
Defended a foreign-based global pharmaceutical manufacturer in a multi-jurisdiction (federal and state) government investigation of sales, marketing, and research activities. Client was dismissed from the False Claims Act qui tam action, and intervention proceeded against their co-promote partner only.