Medical Devices

Medical Devices

The challenges facing today’s companies in developing and commercializing cutting-edge medical devices and technologies are greater than ever. For companies to take promising technologies to market, they must protect those technologies from intellectual property, regulatory, and reputational risks within these unique regulatory and competitive demands. Amidst this backdrop of pricing and payor pressures, emerging innovations and challenging pipelines, patent expiration and generic challenges, research and development costs, and aggressive government enforcement action, it is critical that medical device and technologies companies receive sensible, comprehensive analysis and advice. 

Kendall PC leverages our vast experience garnered from guiding medical technology companies of all sizes through this intricate environment. Our team of medical devices attorneys employs a multi-disciplinary approach to address a broad range of matters for our medical device and technology clients, from commercialization and marketing matters, litigation and mass toxic torts defense, healthcare and clinical compliance, U.S. Food and Drug Administration (FDA) matters, competition and other regulatory matters, government and internal investigations, data protection and privacy support, to corporate governance and disclosure, licensing and strategic alliances, and mergers and acquisitions. We regularly advise manufacturers as well as distributors and other companies of all sizes and stages in the product life cycle.

Contact the experienced attorneys at Kendall PC today online or at (484) 414-4093. We serve clients throughout the United States and across the globe. 

Pharmaceutical, Biotechnology, and Medical Device Commercialization

The seasoned pharmaceutical, biotechnology, and medical device commercialization team of attorneys at Kendall PC maintains a deep knowledge and understanding of the scientific, market, and governmental components that lead to successful product development, approval, and commercialization. We routinely counsel clients on: 

  • Regulatory filings and communications 
  • Promotional review committees (medical, legal & regulatory review committee) 
  • Development, manufacturing, and supply agreements 
  • Sales and distribution contracting: PBM, wholesaler, and 3PL contracting 
  • Manufacturing, distribution, and wholesale licensure
  • Open Payments (Sunshine Act) compliance 

Litigation

When disputes arise, Kendall PC’s litigation team works to preserve our manufacturer, designer, and distributor clients’ interests, assets, and reputations quickly and efficiently. Our cross-practice litigation team provides comprehensive guidance in the most complex and high-stakes medical device and technology 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

Mass Tort and Toxic Tort Defense 

The mass tort and toxic tort defense team of attorneys at Kendall PC has significant experience managing mass tort litigation for medical device and technology companies. We have served as national coordinating counsel in state and federal courts throughout the country. Our team of attorneys has a demonstrated track record 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 our medical device and technologies companies through the evolving legal compliance requirements and governmental oversight of the U.S. FDA, U.S. Federal Trade Commission (FTC), U.S. Health and Human Services (HHS), and U.S. Department of Justice (DOJ), among other state, federal and international regulatory frameworks. We work 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 delivers complete, refined assistance to clients in all areas of medical device and technology product regulation. Our team of regulatory attorneys supports nearly every aspect of our clients regulated business activities including U.S. FDA regulatory strategies, clinical trials, inspections, promotion and advertising, fraud and abuse, pricing, contracting, coverage and reimbursement, compliance program support, transactional diligence, and post-transaction integration and various state and federal reporting obligations. We provide assistance to clients on: 

  • U.S. FDA compliance matters
  • Regulatory approval pathway strategies
  • Clinical trial design 
  • U.S. 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
  • Investigational device submissions 
  • 501(k) and premarket approval applications
  • Product modifications 
  • Medical device reporting 
  • 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 involving a range of law enforcement agencies, including the U.S. attorney’s offices, DOJ, and state attorneys general. We have extensive experience in defending medical device and technologies 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. We handle 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
  • Drug 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 a myriad of relationships and contracts that bind them to their suppliers, customers, licensors, distributors, and other strategic partners on a daily basis. These complexities are intensified by the regulatory obligations that impact every facet of operations within the medical device and technologies sector. Our team of attorneys has decades of experience advising medical device and technology companies on business-critical commercial transactions, including:

  • Manufacturing and supply
  • Product development
  • Sales and distribution
  • Logistics and warehousing
  • Master service
  • Software as a Service (SaaS)
  • Commercial lease
  • Intellectual property agreements

Data Protection and Privacy

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 represent medical device and technology clients in counseling, transactions, investigations, government relations, and responses to data breach and security incidents. We have extensive experience with data protection and privacy matters pertinent to manufacturers, distributors, and other entities 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

We conduct due diligence reviews for medical device and technologies companies engaging in acquisitions, mergers, licensing deals, and investments. Our business, startup, formation, and corporate governance and regulatory teams work together to identify and evaluate the myriad of issues, including those specific to proposed FDA-regulated entities and/or products, that may affect the proposed transactions. We are also able to provide business startup and formation services to emerging entities in the medical device and technology space.

Contact Kendall PC Today

To learn more about how our experienced legal team can help your medical device company, contact us today online or at (484) 414-4093. Kendall PC serves small, mid-sized, and emerging businesses throughout the United States and across the globe.

News & Articles

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