Overview
Attorney Bob Hearn believes in making legal work count and never losing sight of every task’s value proposition.
Bob uses creative but practical strategies to resolve disputes, manage liabilities, and untangle regulatory and compliance challenges in an efficient yet durable manner. That’s why clients trust him when complex and potentially costly matters require attention.
Bob’s practice, while legally diverse—covering transactional support, litigation and enforcement, and regulatory and compliance counseling work—focuses on exclusively serving the health care and life sciences sector, with a heavy emphasis on representing clinical lab and lab-adjacent clients. For more than 20 years, Bob has dedicated a significant part of his practice to working with laboratories on a wide array of legal issues impacting lab operations. He spends a substantial amount of time serving as the subject-matter lead in complex lab transactions, structuring business and commercial relationships between labs and other providers that are compliant with state and federal fraud and abuse and billing laws, and counseling labs on CLIA and state law compliance, certification, and coding, coverage, reimbursement, and other related matters. Bob began representing the lab industry as a litigator and enforcement attorney and still represents labs in high-risk litigation and jury trial cases ranging from complex misdiagnosis liability claims to False Claims Act and whistleblower suits and client billing class action matters.
In addition to laboratories, Bob serves a broad range of other health care and life sciences clients. Clinical research entities, teleradiology providers, pharmaceutical companies, medical product manufacturers, specialty medical practices, and other health service providers turn to Bob to defend them in product liability and commercial litigation and billing disputes and to advise them on risk mitigation and regulatory and compliance concerns. He also has extensive experience with state and federal surprise billing statutes and the application of consumer protection laws, such as the Fair Debt Collection Practices Act and its state counterparts, as well as patient billing by health care providers. Bob advises clients in this area and defends claims based on alleged violations of these laws.
Geographically, Bob not only works in Florida but also advises clients on national issues and litigates in both state and federal courts in other jurisdictions across the country. Likewise, his regulatory work often engages him with state and local governments outside of Florida.
In court proceedings, Bob is known for investigating cases thoroughly, getting ahead of his opponents on the science and governing industry regulations, and distilling and presenting complex issues to courts and juries in an approachable way. His litigation experience allows him to bring sophisticated but practical regulatory counsel to his clients.
Before joining Epstein Becker Green, Bob was a health care attorney and commercial litigator at a regional law firm. Earlier in his career, he served as a law clerk in the Middle District of Florida before becoming an associate, then a partner, at a prominent white collar defense firm.
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Focus Areas
Services
- Class Actions
- Corporate and Securities Litigation
- Drug and Medical Device Litigation
- Fraud and Abuse Compliance Counseling and Defense
- General Counsel Services
- Health Care
- Health Care and Life Sciences Investigations and Enforcement
- Health Care Litigation
- Litigation & Business Disputes
- Medical Staff, Peer Review
- Opioids
- Product Marketing and Compliance
- Telehealth
- White Collar Defense and Internal Investigations
Industries
Trending Issues
Experience
- Represented a large academic hospital system in the sale of its outreach lab business to a national laboratory.
- Represented a regional hospital system in the sale of its outreach lab assets to a national laboratory.
- Served as health regulatory counsel for the purchaser in the acquisition of one of the largest privately owned clinical labs in the United States.
- Routinely advises clients on complex lab regulatory issues, such as complying with the evolving rules relating to laboratory-developed tests, marketing and commercializing new test offerings, and obtaining advanced diagnostic laboratory test status.
- Regularly advises clients on direct access lab testing and related issues.
- Defends a national laboratory in an array of litigation and enforcement matters, including claims arising from cytology and histology interpretations, prenatal genetic testing, result reporting and specimen management issues, blood coagulation studies, tissue transplant testing regulated by the Food and Drug Administration (FDA), microbiology cultures, and phlebotomy injuries. Bob’s casework focused extensively on defending misdiagnosis of cancer cases and the efficacy of laboratory screening tests.
- Successfully handled liability claims arising from the performance of FDA-regulated clinical trials for a global contract research organization and worked with sponsors to manage such claims.
- Designed No Surprises Act compliance infrastructure for multiple clinical laboratories and advised numerous ancillary service providers on complying with the statute.
- Advises genetic counseling operations and maternal health care providers on mitigating risks posed by evolving state abortion laws.
- Represented a global pharmaceutical manufacturer in regional state attorneys general opioid litigation.
- Assists with due diligence investigations of lab-oriented businesses on behalf of private equity clients.
- Routinely helps labs’ corporate health care providers renew facility licenses and maintain compliance with agency standards.
- Successfully represented corporate and individual clients in federal criminal prosecutions and pre-indictment investigations arising from the alleged violation of health care fraud and abuse, securities fraud, public corruption, environmental, and telemarketing fraud laws and rules.
Recognition
- The Best Lawyers in America, Commercial Litigation (2021)
Credentials
Education
- Tulane University School of Law (J.D., cum laude, 1995)
- Vanderbilt University (B.A., 1990)
Bar Admissions
- Florida
Court Admissions
- U.S. District Court, Middle District of Florida
- U.S. District Court, Northern District of Florida
- U.S. District Court, Southern District of Florida
Professional & Community Involvement
- The Florida Bar
- Gasparilla Distance Classic Association, Organizing Committee Member
Media
Events
Past Events
- November 9, 2021
- The Florida Bar Health Law Section: Representing the Physician Program: Representing Radiologists and Physician Practices with Radiology Operations
- Association of Corporate Counsel - Research Triangle Area Chapter: Answers to Common Employee Questions About COVID-19 Vaccines
- ACC Tampa Bay CLE: Potential Claims and Liabilities Associated with COVID-19 Pandemic
- The Florida Bar Health Law Section CLE: Master Class on Telemedicine
Insights
Insights
- Media CoverageMandated Coverage of Biomarker Testing: Q&A with Robert Hearn4 minute read
- BlogsBioMarin Subpoena Potentially Signals Continued Investigations into Sponsored Testing Programs4 minute read
- Media CoverageBob Hearn Quoted in “Concerns Mount as More States Adopt Biomarker Laws”2 minute read
- PublicationsSponsored Genetic Testing Programs: Compliance Considerations Following DOJ False Claims Act Settlement13 minute read
- PublicationsWhat’s on the Agenda? Laboratory Developed Tests Added to the Unified Regulatory Agenda Signals FDA Movement Toward New ...26 minute read
- Media CoverageRobert Hearn Quoted in “Surveying Laboratory Tests from a Health IT Perspective”3 minute read
- PublicationsNo Surprises Act: HHS Extends Enforcement Moratorium on Co-Provider & Co-Facility Good Faith Estimates5 minute read
- PublicationsAt Nine Months, No Surprises Act Can Barely Crawl2 minute read
- BlogsCMS Issues Guidance on COVID-19 Testing in the Workplace4 minute read
- BlogsNew Guidance Clarifies Requirements for Onsite Workplace COVID-19 Testing4 minute read
- BlogsFlorida Joins a Growing Number of States Requiring Licensure of Genetic Counselors6 minute read
- PublicationsThe No Surprises Act: New and Surprising Challenges for Clinical Laboratories3 minute read
- PublicationsThe No Surprises Act: A Look at the First Round of Federal Regulations on Surprise Billing3 minute read
- BlogsFlorida Legislature Provides COVID-19 Liability Protection for Health Care Providers4 minute read
- Media Coverage
Bob Hearn Featured in Law360 Pulse Article on Recent Health Care Litigator Hires in Florida
2 minute read - Media CoverageBob Hearn Featured in “Epstein Becker Adds Health Care Atty from Phelps Dunbar”3 minute read
- Firm AnnouncementsHealth Care Attorney & Commercial Litigator Robert R. Hearn Joins Epstein Becker Green3 minute read