Based in the Firm’s Washington, D.C. office, Vanessa represents clients in healthcare regulatory matters, including those involving the Food and Drug Administration (FDA). Vanessa has advised pharmaceutical and medical device manufacturers, healthcare and technology companies, hospitals and other providers in connection with regulatory and compliance needs, as well as in connection with M&A and capital-raising transactions. Vanessa has extensive experience counseling clients with respect to FDA enforcement matters, health privacy, security and breach issues, healthcare fraud and abuse matters and cannabis and hemp laws.
Previously, Vanessa held several government positions focused on healthcare regulation. Her experience includes serving as HIPAA Privacy Officer and Attorney for the Department of Public Health for the City of Chicago. Vanessa also advised Members of Congress and their staff on FDA matters as a Legislative Attorney with the Congressional Research Service, including laws that expanded FDA’s regulatory and enforcement authorities (FDAAA, TCA, FSMA, and FDASIA). She handled healthcare law, administrative law and constitutional law matters during the creation and passage of the Patient Protection and Affordable Care Act (ACA) and the 2009 H1N1 pandemic.
Vanessa’s experience includes the representation of:
- Microsoft in its $19.7 billion acquisition of Nuance, a leading provider of conversational AI and cloud-based ambient clinical intelligence for healthcare providers
- Karuna Therapeutics in its announced acquisition by Bristol-Myers Squibb Company
- Change Healthcare in its $13.8 billion acquisition by UnitedHealth Group and the $2.2 billion divestiture of Change’s ClaimsXten business unit
- CSL Behring in the formation of the CoVIg-19 Plasma Alliance, and its acquisitions of Vitaeris, Vifor Pharma and the exclusive global license rights to commercialize an adeno-associated virus (AAV) gene therapy program
- Initial purchasers in $5.5 billion notes offering by Roche
- Underwriters in a $1.35 billion public offering by Humana Inc.
- PPD in its $1.863 billion IPO and in its $17.4 billion acquisition by Thermo Fisher Scientific
- Underwriters in the IPOs of Signify Health, Sotera Heath, Bioventus, Nuvalent and Frequency Therapeutics
- JPMorgan Chase Bank, N.A. in the $1.75 billion committed financing for Bausch + Lomb Corporation in Bausch + Lomb’s acquisition of XIIDRA®
- Evercore Group and Morgan Stanley, as representatives of the underwriters, in the $1.95 billion public offering of 25,000,000 common stock of GE HealthCare Technologies
- Underwriters/initial purchasers in the $6 billion debt offering by CVS Health, $5.25 billion debt offering by Philip Morris International, $5 billion notes offering by Roche, $2.25 billion debt offering by AstraZeneca, $1.25 billion debt offering by Humana and follow-on equity offerings by Nuvalent, Inc.
- Bright Health Group in its $924.3 million IPO and sale of its California Medicare Advantage business to Molina Healthcare, Inc. for $600 million
- Laborie Medical Technologies in its strategic equity investment in Bright Uro; its multi-faceted, strategic partnership with Urotronic, Inc.; its acquisition of GI Supply in partnership with Signet Healthcare Partners; and its acquisitions of Pelvalon and Novonate
- Avantor, a leading global provider of mission-critical products and services to customers in the life sciences, advanced technologies and applied materials industries, in its $2.9 billion acquisition of the Masterflex bioprocessing business and related assets of Antylia Scientific
- Heartland Dental’s amendment and extension of $1.38 billion credit facility and $535 million senior secured notes offering
- New Mountain Capital in its acquisition of PerkinElmer’s Applied, Food and Enterprise Services businesses
- Transaction Data Systems in the merger of the Outcomes business of Cardinal Health into TDS
- BlackRock Long Term Private Capital in its acquisition of a minority interest in Transaction Data Systems
- Waystar in its acquisitions of eSolutions, Patientco and HealthPay24
- Patricia Industries and Sarnova in Sarnova’s acquisition and simultaneous combination of Digitech and the R1 RCM Inc. EMS business
- WW International, Inc. in its acquisition of Weekend Health, Inc., d/b/a Sequence
- EQT IX fund and funds affiliated with the private equity business within Goldman Sachs Asset Management in their $8.5 billion acquisition of Parexel from Pamplona Capital Management LP
- Certara in its $768.5 million IPO
- Silver Lake in its investment in Root Inc., closed concurrently with Root Inc.’s IPO
Experience prior to joining the Firm includes advising:
- Medical device manufacturers on FDA inspections, warning letters, import alerts and detentions, clinical trial regulations, communications regarding investigational and marketed devices, and product development, labeling and claims
- Pharmaceutical manufacturers on off-label promotion, codes of conduct, gift and entertainment policies, drug shortages and patient assistance programs
- Investors, advisors, consultants, hospital and health systems, and manufacturers on FDA, DOJ, DEA, USDA, and state laws, regulations and guidance on hemp, cannabidiol (CBD) and cannabis products
- A multinational technology company and applicable manufacturers on the Open Payments provisions of the Patient Protection and Affordable Care Act, implementing federal regulations and state transparency and disclosure laws
- Compounding pharmacies in connection with FDA and state inspections and laws related to dispensing and distribution
- Clients on anti-kickback, compliance, and scope of practice issues identified in the course of regulatory due diligence
- Healthcare company and health plan on change of control notices and requirements for state licenses
- Academic medical centers on federal controlled substances research
- Health plans, providers, business associates, and subcontractors on breaches, federal and state investigations, audits, risk assessments and requests for information
- Investors, asset managers, insurers, health plans and providers on HIPAA/Health Information Technology for Economic and Clinical Health Act (HITECH) regulations and guidance related to workforce members, business associate agreements, training, minors, marketing, data use agreements, data security and ransomware
- Pharmaceutical, medical device, health information technology (HIT) companies on regulatory due diligence
Vanessa has spoken at events including the Food and Drug Law Institute (FDLI)’s Introduction to Drug Law and Regulation, the American Health Law Association (AHLA) Fundamentals of Health Law Program, Academic Medical Centers and Teaching Hospitals Law Institute, AHLA webinars on specialty drugs, HIPAA, and telehealth, the National HIPAA Summit, Seton Hall Legislative Journal Spring 2022 symposium, and the Hispanic National Bar Association’s Annual Convention. In June of 2023, Vanessa was featured on an AHLA podcast titled “Assessing HIPAA Risks During the M&A Due Diligence Process.” Vanessa also moderated an FDLI panel discussion regarding “Recent Rulings Surrounding Mifepristone Access.” She served as a panelist at the Practicing Law Institute’s “Hot Topics in Health Care Law” 2022 program.
Vanessa also writes for industry publications and authored an article in Journal of Health Care Law and Policy in 2021 titled, “Cannabis Considerations for Health Care Entities.” She also co-authored an article titled, “2 Bills Reflect Gov’t Interest In Health PE Investments,” which was published by Law360.
Vanessa currently serves on the Food and Drug Law Institute’s Publications Peer Review Committee and is a member of the American University Washington College of Law (AUWCL) Health Law and Policy Program Alumni Advisory Council. She serves as a Leader on the AHLA Fundamentals of Health Law Program Planning Committee. She was a member of Law360’s 2022 Health Care Editorial Advisory Board and served as a judge for the AUWCL’s National Health Law Writing Competition in 2021 and 2022. Vanessa has also served on the FDLI’s Webinar Committee and as the Vice Chair of Member Engagement for the AHLA’s Women’s Leadership Council.
Vanessa received her J.D., cum laude, from American University, Washington College of Law, an M.A., with honors, from Queen’s University Belfast, and a B.A., magna cum laude, from Valparaiso University. She is admitted to practice in the District of Columbia and Illinois.