Healthcare and Clinical Research
The healthcare industry is one of the more complex and important industries in the United States. Whether providing health care, paying for health care, developing information technology, researching and developing new medical drugs and devices through clinical research, or otherwise providing services or goods, entities in the healthcare sector are subject to complex regulatory and business risks at multiple levels. Companies in the healthcare industry require cost-effective and proactive approaches to ensure success in this competitive space. We provide clients with timely and practical counsel to not only help companies reach business objectives but also potentially avoid costly legal pitfalls. The team of attorneys at Kendall PC has a deep understanding of the industry sector, enabling us to work closely with clients to tackle tough issues and bridge the gap between industry challenges and desirable outcomes.
Additionally, our clinical trials team helps bring new pharmaceutical, medical device, and biotechnology products to market. Clinical research is an essential component of the healthcare industry and, as such, is subject to an intricate web of regulatory requirements and ethical and efficacy concerns. Our leading research specialists advise companies of all sizes on complying with applicable regulatory requirements and industry best practices across the board, from clinical contracting and Good Clinical Practice (GCP) to Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliance and reimbursement advice.
Contact Kendall PC today online or at (484) 414-4093. We serve healthcare and clinical research companies of all sizes and stages of development throughout the United States and across the globe.
Litigation
When disputes arise, Kendall PC’s litigation team works to preserve our clients’ interests, assets, and reputations quickly and efficiently. Our multidisciplinary team provides comprehensive counsel in the most complex and high-stakes disputes, including:
- Healthcare litigation
- Settlement discussions
- Anti-Kickback Statute litigation
- Healthcare Fraud Statute litigation
- Responsible Corporate Officer Doctrine disputes
- US False Claims Act litigation
- Physician Self-Referral (Stark) Law litigation
- Consumer class action and other consumer-related litigation
- Development, production, sale, and distribution disputes
- Breach of commercial contracts
- Licensing disputes
Mass Tort and Toxic Tort Defense
The mass tort and toxic tort defense team of attorneys at Kendall PC is comprised of experienced litigators who have defended cases on every level. We have served as national coordinating counsel in state and federal courts throughout the country. Kendall PC has demonstrated past performance including successful exclusions of general causation experts via Daubert hearings and trials, defending petitions to create Multidistrict Litigation (MDL) in nationwide products liability actions, conducting expert discovery and mapping strategies to obtain important early substantive motion victories for our clients.
Healthcare and Clinical Compliance
The healthcare and clinical compliance team of attorneys at Kendall PC advises on a wide range of compliance topics to guide healthcare and clinical research companies through the evolving legal compliance requirements and governmental oversight employed by the U.S. Food and Drug Administration (FDA), U.S. Federal Trade Commission (FTC), U.S. Health and Human Services (HHS), and Department of Justice (DOJ). We provide compliance guidance and fraud and abuse counseling to the full range of healthcare and clinical providers and suppliers, including:
- Hospitals and health systems
- Academic medical centers
- Pharmacies
- Hospices
- Specialty, post-acute, and long-term care providers
- Behavioral health providers
- Health plans
- Contract research organizations (CROs)
- Medical societies
- Physician practices
We provide practical, efficient solutions rooted in sophisticated knowledge of each client’s individual business gleaned through deep immersion in the industry and decades of first-hand experience. Our team works with our clients to implement effective and cost-efficient compliance strategies tailored to protect our clients’ interests.
Within these areas, our work typically encompasses:
- Policy development and implementation
- Compliance training
- Risk assessments, audits, and gap analysis
- Day-to-day “help desk” compliance support
- Industry benchmarking
- Due diligence and monitoring processes
Regulatory Counsel
Kendall PC’s regulatory practice has deep U.S. and global experience providing regulatory counseling and advice on all areas of healthcare and clinical research regulation. Healthcare remains one of the most highly regulated industries with rules governing relationships, revenue cycle, and organizational structure. Our regulatory team excels at providing advisory services to support the healthcare and clinical sectors. We bring experience to assist our clients in navigating the complex compliance and regulatory landscape. We provide specialized advice to healthcare systems, CROs, physician practices, and others to ensure that their operations are in compliance with the Physician Self-Referral (Stark) Law, Anti-Kickback Statute, False Claims Act, Civil Monetary Penalty, and GCP laws and regulations. Additionally, our cross-disciplinary team of attorneys supports clients in developing practical strategies throughout their entire journey, from nascent proof-of-concept studies and process development to clinical trial design to seeking regulatory approval to post-marketing.
We have extensive experience providing assistance to clients on matters relating to:
- Common Rule matters
- HIPAA and FTC data privacy matters
- US Food and Drug Administration (FDA) compliance matters
- Regulatory approval pathway strategies
- Clinical trial design
- Good Clinical Practice (GCP) matters
- FDA Advisory Committee matters and dispute resolution
- Government sales and contracting disputes
- Reimbursement strategies
- Availability market exclusivity assessments
- Promotional, reimbursement, marketing, distribution, and pricing strategies
- Labeling and advertising matters
- Manufacturing processes
- Recall, correction, removal, and supply chain Issues
- Comparative effectiveness research
- Export and import matters
- Product modifications
- Quality system regulation issues
- Medicare, Medicaid, and other federal health care program coverage and reimbursement
- Sunshine compliance
- State distribution compliance matters
- State license registration matters
- State price reporting matters
- 483 Observations and Warning Letters
Government Investigations
Kendall PC handles investigations across a range of law enforcement agencies, including the U.S. attorney’s offices, the DOJ, and state attorneys general. We have extensive experience in defending biotechnology companies in government investigations into alleged violations under the Federal Food, Drug and Cosmetic Act, the Anti-Kickback Statute and state and federal False Claims Acts, among others. Our government investigations team handles complex multiagency government investigations, including managing parallel investigations by federal and state government entities and settlement and corporate integrity agreement (CIA) discussions and negotiations.
Our government investigations team of attorneys counsel clients on the following government investigation matters:
- Suspensions and debarments
- Anti-Kickback Statute
- FDA Form 483 and Warning Letter Responses
- Foreign Corrupt Practices Act, UK Bribery Act, and other fraud and corruption matters investigations
- False Claims Act investigations
- Deferred prosecution agreements
- US federal and state government civil investigative demands and administrative subpoenas
- Corporate Integrity Agreement (CIA) negotiations
- Billing and coding practices
- Biologics price reporting practices, including discounting and rebate practices
- Medicare, Medicaid, and other US healthcare program matters
Internal Investigations
The seasoned internal investigations attorneys at Kendall PC have wide-ranging experience in conducting internal investigations for an array of publicly traded and private organizations and entities. Our internal investigations team possesses cross-disciplinary regulatory, corporate, commercial compliance, and litigation know-how to assist clients with these sensitive and highly complex matters. We work with our clients to assess potential exposure, reduce costs and damages, and resolve issues expediently to bring the investigation to an acceptable end. Our attorneys also guide entities post-investigation to successfully maintain reputation and goodwill and retain business.
Our internal investigations team has experience in investigations concerning:
- Audit committee inquiries into illegal or improper conduct
- Corporate governance, risk management practices, and compliance programs
- Diligence in connection with M&A transactions
- Export compliance
- The False Claims Act, qui tam actions, and government contract billing
- The Foreign Corrupt Practices Act
- Restatements
- Section 10A
- Shareholder and other derivative demands
- Special litigation committees
- Whistleblower and other investigations under Sarbanes-Oxley
- Healthcare fraud
- FDA violations
Commercial Contracting
Kendall PC’s commercial contracting practice combines legal knowledge with deep sector experience to cover the full spectrum of commercial and business law issues companies must address on a daily basis with a myriad of relationships and contracts that bind them to their suppliers, customers, licensors, distributors, and other strategic partners. These complexities are intensified by the regulatory obligations that impact every facet of operations within the healthcare and clinical sectors.
We provide support to business entities in their commercial contracting needs, including:
- Provider and managed care contracts and exclusive contracts
- Real estate transactions
- Clinical trial agreements
- License agreements
- Arrangements of sale between exempt and for-profit organizations
- Clinical research collaboration agreements with government bodies, industry partners, and academic institutions
- Manufacturing and supply
- Master service agreements
- Software as a service (SaaS)
- Product development
- Sales and distribution
- Logistics and Warehousing
- Intellectual Property Agreements
- Logistics and warehousing
Data Protection and Privacy
Data protection and privacy requirements have become central to the success of healthcare and clinical research sectors. Kendall PC lawyers advise clients across virtually all healthcare sectors on privacy and security compliance matters. The data protection and privacy team at Kendall PC focuses on the evolving business technological and legal issues relating to the security and privacy of networks and data. We counsel on the development of privacy and data security policies and procedures, structuring healthcare information technology ventures, and training employees on the disclosure of information and ongoing compliance monitoring. We represent healthcare and clinical research clients in counseling, transactions, investigations, government relations, and responses to data breach and security incidents. Additionally, we provide clients with acute analysis of and timely guidance on rapidly developing federal rules and regulations, congressional legislation, and other federal policies issued by healthcare oversight agencies critical to their healthcare and clinical research business objectives.
Our team has extensive experience in data protection and privacy matters including the application of:
- EU General Data Protection Regulation (GDPR)
- California Consumer Privacy Act (CCPA) / California Privacy Rights Act (CRPA)
- Health Insurance Portability and Accountability Act (HIPAA)
- Health Information Technology for Economic and Clinical Health (HITECH) Act
- Federal Trade Commission (FTC) Act
- Children’s Online Privacy Protection Act (COPPAA)
- CAN-SPAM Act
- US state security breach notification law compliance
- Medical privacy law matters
- Information disclosure and compliance training
Business Startup, Formation, and Corporate Governance
Starting or expanding a business is a complicated endeavor that must be done correctly to ensure future growth. This complexity is exacerbated by the introduction of the regulatory requirements in the healthcare and clinical research industry. Our team reviews your healthcare startup or expansion with both industry trends and your business goals in mind.
The team of attorneys at Kendall PC represents all sectors of the healthcare and clinical research industry in their business startup, formation, and corporate governance needs, including:
- Corporate formation and structure, addressing complexities resulting from state-specific statutes and the conflict between federal and state law
- Public companies and filings with Securities and Exchange Commission (SEC) and other agencies
- Capital formation activities
- Mergers and acquisitions
- Affiliation structure, legal due diligence, and state and federal approval processes
- Joint venture and strategic alliances, including those involving for-profit and nonprofit entities
- Physician alignment strategies
- Partnership and operating agreements
Contact Kendall PC Today
To learn more about how our team of healthcare and clinical research attorneys can help your company, contact Kendall PC today online or at (484) 414-4093. We serve companies of all sizes throughout the United States and across the globe.
