Experience

European Union GDPR—Institution

Counseled a preeminent health system and academic medical center on its compliance with the European Union General Data Protection Regulation (GDPR) in relation to its clinical and research activities, including its international research studies.

Conflicts of Interest

Reviewed medical center's systems, policies and procedures for identifying, assessing, and managing investigator and institutional conflicts of interest.

Multi-Site Global Research

Developed and negotiated site and coordinating center agreements in connection with a multi-site, international, National Institutes of Health (NIH)-funded study, and advised on regulatory issues related to the conduct of the study and subsequent government review of NIH funding activities.

Common Rule

Guided multiple clients through the implementation of the revised HHS regulations (the "Common Rule"), including reviewing and revising policies and procedures, and assisting with institutional approaches to implementation.

FDA Advertising/Promotion

Presented to senior executives and other management of a start-up pharmaceutical company on complying with the FDA advertising and promotion requirements pre- and post-launch.

On-Site Counsel

Served as on-site, long-term legal counsel for various clients, including pharmaceutical and device companies during times of staffing shortage at the clients.

Informed Consent Form Templates

Developed 23 different types of global research informed consent templates for a major pharmaceutical company along with detailed negotiation guidelines for compliance with applicable laws and best practices.

European Union GDPR—Pharmaceutical Company

Advised pharmaceutical company on all aspects of compliance with the GDPR, including gap analysis, policy and procedure development, and vendor and other third party contract revisions.

Government Enforcement

Obtained a jury verdict in federal court for a qui tam whistleblower against a medical device company that had retaliated against our client for filing a qui tam lawsuit under the False Claims Act, which resulted in the federal Medicare and California Medicaid programs recovering in excess of $25 million.

Medicaid Appeal

Developed and prosecuted coordinated Medicaid appeals and litigation on behalf of a group of hospitals that resulted in a landmark settlement of approximately $95 million with the State.

Health Information Exchange

Worked on behalf of a client to effect statutory changes to a state law that would allow for the creation of one of the nation's first state-wide health information exchanges.

Health System Affiliation

Acted as corporate counsel to a large health system during a major affiliation, negotiating deal documents and advising on structural and various legal issues, which ultimately lead to the creation of the second largest non-profit health system in New England.

Payor-Provider Joint Venture

Worked with an insurance company and a network of primary care practices to create a joint venture, providing patients with access to high-quality, personalized health care in a community setting.

Sale of Teaching/Community Hospital

Assisted with the sale of a 500-bed teaching and community hospital to the teaching hospital of a major university, making this hospital system one of the largest in the country.

Appellate Tax Board Decision Appeal

Represented a trade association, on behalf of a health insurer, before the state Supreme Judicial Court in a successful appeal of an Appellate Tax Board decision.

Sale of Nursing College

Worked with a hospital in the sale of its nursing college to a nearby university, including negotiation of a management agreement to allow the university to operate the college pending regulatory approvals.

Acquisition of Urgent Care Centers

Represented a private equity group in acquiring the stock of two entities which owned 13 urgent care centers.

Corporate Governance

Assisted a tax-exempt health care organization to draft new bylaws following extensive discussions with board committees and the full board to assure that both the mission and governance structure of the organization were fully captured in the new bylaws.

Firm Highlights

Publication/Podcast

EU-U.S. Privacy Shield Invalidated: Does Your Company Have a Plan B?

On Thursday, July 16, 2020, the Court of Justice of the European Union (“CJEU”) invalidated the EU-U.S. Privacy Shield (“Privacy Shield”) in Data Protection Commissioner v. Facebook Ireland and Maximillian Schrems (Case C-311/18...

Publication/Podcast

FDA Updates its Guidance on Conducting Clinical Trials During COVID-19 Public Health Emergency

On April 16, 2020, the U.S. Food & Drug Administration (“FDA”) again updated its guidance on the “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency,” adding seven new questions and...

News

Nearly 80 Verrill Attorneys Recognized by Best Lawyers® 2021, Including a Dozen Named Lawyers of the Year

(August 24, 2020) – Nearly 80 Verrill attorneys were recognized as "Best Lawyers" by Best Lawyers® 2021 , including 12 attorneys named “Lawyer of the Year,” a distinguished recognition for only a single lawyer...

News

Michael K. Fee to Lead Verrill’s Nationally-Recognized Health Care and Life Sciences Practice Amidst Recent Changes

(August 31, 2020) – Verrill is pleased to announce Michael K. Fee as the new leader of Verrill’s nationally-recognized Health Care & Life Sciences Group. The Group has a long history of representing a...

Matter

Conflicts of Interest

Reviewed medical center's systems, policies and procedures for identifying, assessing, and managing investigator and institutional conflicts of interest.

Publication/Podcast

News Flash: HHS Issues Statement Removing Premarket Review Requirements for Laboratory Developed Tests (“LDTs”), Including COVID-19 LDTs

What happened? On August 19, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a single paragraph statement rescinding U.S. Food and Drug Administration (“FDA”) guidance documents concerning premarket review of Laboratory...

Matter

Common Rule

Guided multiple clients through the implementation of the revised HHS regulations (the "Common Rule"), including reviewing and revising policies and procedures, and assisting with institutional approaches to implementation.

Matter

Multi-Site Global Research

Developed and negotiated site and coordinating center agreements in connection with a multi-site, international, National Institutes of Health (NIH)-funded study, and advised on regulatory issues related to the conduct of the study and subsequent...

Matter

European Union GDPR—Institution

Counseled a preeminent health system and academic medical center on its compliance with the European Union General Data Protection Regulation (GDPR) in relation to its clinical and research activities, including its international research studies...

Publication/Podcast

FDA Issues Guidance on IRB Review of Non-Emergency Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products to Treat COVID-19

Prompted by a substantial increase in requests for individual patient access to investigational drugs and biologics to treat COVID-19, the U.S. Food & Drug Administration (“FDA”) issued guidance on June 2, 2020 that outlines...