Baker Donelson is among the nation's most experienced law firms representing pharmaceutical companies, medical device manufacturers, health technology and biomedical enterprises, clinical research organizations (CROs), durable medical equipment (DME) suppliers, wholesalers, pharmacies, and hospital systems on the full range of legal issues that arise in the drug, device, and life sciences industry.
We advise and counsel life sciences companies on complex transactions, Food and Drug Administration (FDA) regulatory guidance, clinical trial contracting, HIPAA, GDPR, and state privacy obligations. When disputes arise, we defend them in product liability litigation, mass tort proceedings, government investigations, and enforcement actions. We combine regulatory depth, transactional sophistication, and courtroom firepower that few firms can match.
Many of our attorneys have served as in-house counsel at leading pharmaceutical and life sciences companies or held positions at federal agencies, including the FDA, U.S. Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), Federal Trade Commission (FTC), and U.S. Patent and Trademark Office (USPTO). This combination of private-sector business acumen and government-side regulatory experience allows us to anticipate enforcement trends, navigate complex regulatory frameworks, and structure transactions that keep our clients competitive while fully compliant with the law.
From company formation and clinical trials to product launch, post-market commercialization, and courtroom defense, we deliver an integrated legal strategy across every phase of the product lifecycle.
FDA Regulatory Compliance and Product Launch
Launching a drug or medical device is an extraordinarily complicated process, requiring companies to navigate a labyrinth of laws and FDA regulations as they conduct clinical trials, protect intellectual property, and negotiate vendor agreements. We guide pharmaceutical and medical device companies through every stage of bringing a product to market:
- Pre-market approval (PMA) and 510(k) submissions to the FDA
- Clinical trial regulatory compliance (Phases I – IV)
- Product labeling, promotional materials, and marketing compliance review
- FDA warning letter and deficiency notice responses, including corrective action plans
- Product recalls and adverse event management
- Regulatory training and compliance programs for sales and marketing teams
- Laboratory-developed test (LDT) regulatory guidance
Clinical Trials and Medical Research
We represent sponsors, CROs, SMOs, CMOs, institutions, investigators, and consultants across the clinical research ecosystem:
- Drafting and negotiating clinical trial agreements, master service agreements, and informed consent forms
- Formation and growth of clinical research enterprises, including dedicated sites, CROs, SMOs, and CMOs
- HIPAA, GDPR, and state privacy law compliance for research data
- Ethical and compliant AI implementation in clinical research
- Template agreements and playbooks for efficient site activation
- Post-market studies and real-world evidence programs
- Streamlining site engagement and accelerating participant enrollment
Life Sciences Transactions and Corporate Counsel
We provide full-service transactional and corporate advisory capabilities tailored to the life sciences industry:
- Mergers, acquisitions, and strategic partnerships, including regulatory due diligence
- Initial public offerings and private placements of debt and equity securities
- Joint venture structuring, including biotech and academic medical center collaborations
- Licensing agreements, research collaborations, and vendor contracts
- Business formation, corporate governance, and entity structuring
- Fraud and abuse risk assessment for proposed transactions (Anti-Kickback Statute and Stark Law)
- Specialty pharmacy transactions, including sales, acquisitions, and regulatory structuring
Product Liability, Mass Tort, and Class Action Defense
Our trial attorneys have defended manufacturers, distributors, and retailers in high-stakes product liability litigation:
- Pharmaceutical and medical device defective design and manufacturing claims
- Multidistrict litigation (MDL) and consolidated proceedings involving thousands of plaintiffs
- National and regional coordinating counsel roles in mass tort cases
- Class actions involving hundreds of millions of dollars at stake
- Consumer protection and false labeling defense
- Opioid litigation and state attorney general enforcement actions
Regulatory Compliance and Government Investigations
We help life sciences companies navigate the complex web of federal and state health care regulations and defend against government investigations and enforcement:
- Anti-Kickback Statute and Stark Law compliance and restructuring
- False Claims Act defense, including qui tam (whistleblower) matters
- DOJ and OIG investigations and self-disclosure
- Coverage, payment, and coding guidance for new product launches (CMS)
- Compliance program development, review, and implementation
- 340B Drug Pricing Program counsel
- Average wholesale price (AWP) issues and self-reporting to CMS and OIG
- Medicare enrollment and DMERC coordination
Data Privacy, Cybersecurity, and AI Governance
Our team includes CIPP/US, CIPP/E, and AIGP-certified professionals with experience at the intersection of data privacy, AI governance, and life sciences regulation – critical capabilities as the industry increasingly relies on data-driven innovation. Our AI, Data Protection, Privacy and Cybersecurity Team provides counsel for the drug, device, and life sciences sector:
- HIPAA compliance for covered entities and business associates
- GDPR compliance for international clinical trials and data transfers
- U.S. state privacy laws (CCPA/CPRA and emerging state frameworks)
- Cybersecurity incident response and breach notification
- AI governance programs for health care and life sciences applications
- Technology contract negotiation (i.e., MSAs, SaaS, EHR, HIE agreements)
- Biometric data privacy compliance
Intellectual Property and Patent Litigation
We protect the innovations that drive the life sciences industry forward:
- Patent prosecution for pharmaceutical, biotech, and medical device inventions
- Patent infringement litigation in U.S. courts and the International Trade Commission
- Trade secret protection and licensing
- University technology transfer and commercialization
- IP due diligence for life sciences transactions
Commercial Disputes and Antitrust
We resolve the complex commercial disputes that life sciences companies confront:
- Contract disputes with suppliers, distributors, and commercial partners
- Antitrust litigation and FTC enforcement
- Average wholesale price (AWP) litigation
- Labor and employment matters specific to the pharmaceutical and device industry
- Alternative dispute resolution (mediation and arbitration)
International Trade, Tariffs and Supply Chain
We advise pharmaceutical and medical device companies navigating the evolving international trade landscape:
- Section 232 tariff analysis and compliance for pharmaceutical and medical device imports
- Customs and trade regulation for life sciences supply chains
- Reshoring and domestic manufacturing strategies for critical medicines
- Export controls and sanctions compliance for life sciences products