Overview

Attorney Bob Hearn believes in making legal work count and never losing sight of every task’s value proposition.

He 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 both litigation and regulatory, compliance, and business counseling work—focuses on the health care and life sciences sector. Over the last 20 years, Bob has dedicated a significant part of his practice to working with clinical laboratories on a wide array of legal issues impacting lab operations. He has represented labs in high-risk litigation and jury trial cases ranging from complex misdiagnosis liability claims to False Claims Act and whistleblower suits, and with regard to facility and personnel licensure and certification, billing, fraud and abuse compliance, regulatory, and payor-oriented matters that span the full spectrum of lab operations and relationships with patients, clinicians, and commercial and government health plans. Bob routinely assists with structuring business relationships between laboratories and hospitals and physician practices that comply with federal and state anti-kickback, self-referral, anti-markup, and direct billing laws and policies; advises early lifecycle labs on developing and commercializing lab-developed tests; and helps labs draft standard operating procedures, compliance plans, and document retention protocols. Clients purchasing companies with lab operations rely on Bob to handle their due diligence investigations and post-closing regulatory obligations. And he regularly manages survey and inspection processes and any enforcement fallout from them.

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In addition to his deep experience with laboratories, Bob serves a broad range of other health care and life sciences clients. Clinical research entities, pharmaceutical companies, medical product manufacturers, specialty medical practices, and other health service providers turn to Bob to defend them in products liability and commercial litigation and billing disputes and to advise them on risk mitigation and regulatory and compliance concerns. Bob also possesses extensive experience with state and federal surprise billing statutes and the application of consumer protection laws, such as the FDCPA and its state counterparts, to patient billing by health care providers. Bob both advises clients in this area and defends claims based on alleged violations of these laws.

Geographically, Bob litigates throughout Florida and 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 in the laboratory, clinical trial, pharmaceutical, and medical products industries. Before joining Epstein Becker Green, Bob was a health care attorney and commercial litigator at a regional law firm. Earlier in his career, he was an associate, then a partner, at a nationally prominent white collar defense firm and a law clerk to U.S. Magistrate Judge Mark A. Pizzo of the U.S. District Court for the Middle District of Florida.

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Focus Areas

Experience

  • Defends a national laboratory in an array of litigation matters, including claims arising from cytology and histology interpretations, prenatal genetic testing, result reporting and specimen management issues, blood coagulation studies, FDA-regulated tissue transplant testing, microbiology cultures, and phlebotomy and specimen collection injuries. Bob’s casework focused extensively on defending misdiagnosis of cancer cases and the efficacy of laboratory screening tests.
  • 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 (“Act”) compliance infrastructure for multiple clinical laboratories, and advised numerous ancillary services provides on complying with the Act.
  • Advises genetic counseling operations and maternal health care providers on mitigating risks posed by evolving state abortion laws.
  • Represented a global pharmaceutical manufacturer in state opioid litigation.
  • Assists with due diligence investigations of lab-oriented businesses on behalf of private equity clients.
  • Helped a professional football franchise determine whether its training facility was subject to state health care licensure relative to its on-site training operations.
  • Routinely helps corporate health care providers renew facility licenses and maintain compliance with the agency standards.
  • Assists clients with transitioning health care licenses and certifications to new ownership.
  • 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

Credentials

Education

  • Tulane University School of Law (J.D., cum laude, 1995)
  • Vanderbilt University (B.A., 1990)

Bar Admissions

Court Admissions

Professional & Community Involvement

  • The Florida Bar
  • Gasparilla Distance Classic Association, Organizing Committee Member
  • Hillsborough County Bar Association

Media

Events

Past Events

Insights

Insights

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