Firm Experience

Life Sciences (FDA Law)


  • Provided FDA & FTC claims review for companies distributing dietary supplements from Omegas to pet supplements to traditional oriental medicine herbal products.
  • Navigated an overseas manufacturer of supplements on FDA rules governing foreign research and substantiation issues.
  • Gave FDA claims review to dietary supplement company targeted to athletes and patients with muscular and neurological issues.
  • Counseled a pharmacy on legal issues surrounding development of a dietary supplement line.


  • Advised an overseas manufacturer of a pain patch as to applicability of FDA medical device rules.
  • Counseled mobile medical app developers on how to structure healthcare apps as lifestyle-oriented, consumer products rather than as regulated mobile medical apps.
  • Advised healthcare fitness and medical app, software, and virtual reality developers as to their FDA obligations under FDA’s mobile medical app guidance.
  • Co-counseled a dispute among medical device executives regarding rights and obligations with respect to their medical device startup.
  • Guided health informatics company on FDA legal issues related to predictive analytics software intended for clinical decision-making.
  • Advised manufacturer on FDA and FTC regulatory issues relating to “brain scan” device.
  • Drafted response to a demand letter involving a commercial dispute relating to claims made in a medical device 510k.
  • Served as an FDA expert witness in a dispute between a manufacturer and developer of a CPAP device.
  • Counseled durable medical equipment manufacturers and distributors regarding the quality system regulations, 510k and premarket authorization processes.
  • FDA Inspections and FDA 483 responses


  • Advised a national cosmetics company on legal compliance strategy to create program for physician referrals.
  • Prepare response to FDA warning letter for cosmetics company under FDA fire.
  • Counseled manufacturer of an herbal slimming wrap on FDA and FTC compliance obligations.
  • Assisted manufacturer of cosmetics with response to FDA enforcement action involving alleged product misbranding.
  • Provided comprehensive legal guidance on labeling and advertising claims to ensure compliance with FDA and FTC regulations.
  • Conducted a regulatory audit for a cosmetics company to identify and rectify potential compliance risks across their product line.
  • Counseled a cosmetics company on risk management strategies related to product liability and consumer safety issues.
  • Negotiated and drafted licensing agreements for a cosmetics company to expand their brand through third-party manufacturers and retailers.
  • Assisted a cosmetics company in responding to consumer complaints and potential class-action lawsuits related to product efficacy and safety.
  • Offered strategic advice on corporate governance and compliance to the board of directors of a leading cosmetics company.
  • Advised on data privacy and protection laws relevant to a cosmetics company’s customer data management and marketing practices.


  • Evaluated OTC drug monograph requirements for manufacturer of an OTC drug with antibacterial properties.
  • Advised distributor regarding FDA issues involved in off-label promotion of Rx drugs.
  • Multi-regional clinical trials
  • Provide FDA consulting regarding registration and compliance requirements for manufacturers, distributors, and technology providers (including 510(k), Pre-Market Authorization, and New Drug Application processes).
  • New Drug Application to FDA
  • Abbreviated New Drug Application (ANDA) for generic drugs


  • Represented manufacturers and distributors of potential medical foods on FDA regulatory requirements for market entry as a medical food.
  • Reviewed claims regarding cardiovascular health for a nutritional support company.
  • Counseled publisher and blogger regarding FDA and FTC issues related to promotion of dental care products on website.
  • Advised maker of products containing “growth hormones” and “immune factors” on FDA compliance issues.
  • Drafted master manufacturing agreement, allocating FDA liability, between contract manufacturer and white-label branding company.


  • Drafted response to FDA warning letter received by pet nutritional company.
  • Performed a label review for the manufacturer of a testosterone support supplement.
  • Counseled a public company on FDA issues regarding marketing “mineral supplements.”
  • Performed a label review regarding a nutritional supplement targeted toward the diabetic market.
  • Advised an organic health food store on FDA issues relating to sales of devices and supplements.
  • Provide advice regarding FDA regulations, the False Claims Act, anti-kickback issues, and government contracting and pricing requirements.
  • Negotiated a Consent Decree with the FDA and led a cross-functional team charged with remediating quality issues and ensuring corporate-wide compliance during a Consent Decree.


  • Counseled a cord blood banking company on FDA and California biologics licensing issues.
  • Advised consultants to an international stem cell consortium regarding FDA biologics licensing, HCT/P Regulations, and California medical board rules regarding blood-based, stem cell injections.
  • Directed legal strategy for manufacturer of a novel probiotics product on FDA requirements.
  • Biologic and Device approval strategies

Healthcare Law


  • Set up MSO arrangements for numerous healthcare ventures, especially with review of fraud and abuse (Stark, self-referral, anti-kickback, and fee-splitting) and corporate practice of medicine issues.
  • Created MSO structure for entrepreneur setting up ventures with MDs and addiction counselors.
  • Established MSO structure and agreements for tele-dentistry startup.
  • Structured MSO arrangement for genetics counseling company.
  • Advised a naturopathic physician on expanding the business to include an MSO structure.
  • Counseled a psychiatrist-led MSO on multi-state expansion efforts.


  • Provided strategic legal guidance to telemedicine, mobile health, digital health, and connected health startups.
  • Analyzed regulatory issues for a veterinary telemedicine startup.
  • Provided advice on Stark and anti-kickback issues to a “hydration therapy” startup.
  • Counseled online distributor of HCG products regarding FDA, FTC and state law issues.
  • Provided strategic advice for telemedicine company involving medical cannabis recommendations.
  • Guided ND telemedicine startup on legal and regulatory issues.
  • Advised independent film project on intellectual property issues relating to clinical research partners.
  • Drafted contracts with joint venture and alliance partners for healthcare startup focusing on reducing medication among diabetics.
  • Worked on agreements between telemedicine hospitalist client and hospital customers.
  • Set up legal structure for online provider of medical marijuana doctor referrals.
  • Negotiated procurement, Software as a Service (SaaS), healthcare information technology, and digital health agreements for payers, distributors, and providers.
  • Drafted and negotiated regulated SaMD (software as a medical device) agreements, including enterprise SaaS, software development, data privacy, business associate, and quality agreements, terms of use, and a wide range of agreements such as consulting and other professional services, vendor and outsourcing services, marketing, confidentiality, etc.
  • Managed response to investigation of telemedicine provider by State Board of Medicine regarding the use of an asynchronous store and forward telemedicine model to deliver treatment for common medical conditions.
  • Advise providers on telehealth regulations and compliance (50 State compliance).


  • Counseled a physician on legal relationship and contracts with a weight-loss oriented medical spa.
  • Navigated medical spa legal rules for a physician serving as medical director for a medical spa.
  • Assisted physician with legal advice to establish her own, branded medical spa and wellness center.
  • Advised medical spa physician on compliance obligations relating to physician supervision of mid-levels, good faith exam, bonuses, and other legal issues.
  • Provided comprehensive legal guidance to physicians and medical spa owners on navigating the complex regulatory landscape, ensuring adherence to state and federal health care laws and regulations.
  • Drafted, reviewed, and negotiated contracts for medical spa professionals, including employment agreements, vendor contracts, and partnership agreements to protect client interests and promote business growth.
  • Advised on the structuring and implementation of compliant medical spa operations, focusing on risk management strategies and operational efficiencies.
  • Counseled clients on the legalities of advertising and marketing within the medical spa industry, ensuring compliance with FDA guidelines and consumer protection laws.
  • Assisted in the development of privacy policies and procedures in accordance with HIPAA regulations, safeguarding patient information and confidentiality.
  • Guided medical spa clients through the process of intellectual property protection, including trademark registration for brands and services.
  • Represented medical spa clients in negotiations and disputes, providing legal support to resolve issues efficiently and maintain business continuity.
  • Conducted legal workshops and training sessions for medical spa staff on compliance, ethical practices, and legal responsibilities to foster a culture of compliance and integrity.


  • Reviewed and drafted radiation oncologist’s employment contract with multi-disciplinary cancer center.
  • Created concierge medicine program for physician breaking into a VIP practice focused on anti-aging and longevity medicine.
  • Advised psychiatry practice on concierge medicine, telemedicine, and other care models.
  • Drafted a stock purchase agreement and other legal documents as part of physician’s exit strategy from physician partner.
  • Created a concierge medicine program for a physician breaking into a VIP practice focused on anti-aging and longevity medicine, providing guidance on FDA regulations pertaining to anti-aging treatments and supplements.
  • Provided comprehensive legal guidance on labeling and advertising claims to ensure compliance with FDA regulations for a range of medical products and treatments used within physician practices.
  • Conducted regulatory audits for medical practices to identify and rectify potential compliance risks with FDA regulations, ensuring safe and effective patient care.
  • Counseled medical practices on risk management strategies related to product liability and consumer safety issues, maintaining adherence to FDA guidelines.
  • Advised on data privacy and protection laws relevant to medical practice’s customer data management and marketing practices, ensuring compliance with FDA regulations concerning patient data and health information.


  • Counseled chiropractor regarding fee-splitting issues arising out of DC’s collaboration with MD.
  • Advised chiropractor opening a functional medicine practice.
  • Reviewed scope of practice issues for a licensed mental health counselor practicing neurofeedback.
  • Discussed website claims made by practitioner of traditional oriental medicine offering cancer support.
  • Drafted SB577 disclosure for non-licensed health coach and Reiki practitioner.
  • Created informed consent and other legal forms for multidisciplinary wellness center led by physical therapist.


  • Drafted lease and associated loan documents for an $8 million nursing facility purchase and provided lender’s opinion regarding same.
  • Drafted and negotiated $5 million asset purchase agreement allowing for the expansion of the company’s clinical solutions footprint in the long-term care market (negative pressure wound therapy and therapeutic support surfaces).
  • Led the internal due diligence effort and was a key member of the negotiating team for a $55 million stock purchase of a large durable medical equipment dealer.


  • Represented physician in asset acquisition of home healthcare company.
  • Counseled addiction treatment center on anti-kickback issues related to handling of marketing leads.
  • Advised a hospital chain on its legal and compliance obligations in establishing a nationally branded, off-site wellness center.
  • Rendered fraud and abuse advice to a national dietary supplement company in joint venture with clinical lab chain.
  • Drafted consent forms and contracts for medical clinics, addiction centers, sleep medicine centers, integrative medicine clinics, aesthetic medicine practices, diagnostic laboratories, medical spas, and other healthcare entities.
  • Advised hospital on legal rules related to conditions of hospital admission and insurance assignment.
  • Counseled a school on legal requirements applicable to educational institutions for acupuncture and traditional oriental medicine, and Ayurvedic medicine.
  • Informed hospital legal counsel on legal strategy to establish a national anti-aging part of the hospital brand.


  • Structured joint ventures and strategic alliances between healthcare providers and technology companies to innovate patient care and operational efficiencies.
  • Structured complex debt and equity financing transactions for healthcare companies to support growth and operational needs.


  • Provided start-up financing and fundraising counsel for emerging biomedical and pharmaceutical investment firms and companies, including all aspects of capital raising, corporate formation, partnerships/collaborations, and complex transactional agreements.
  • Led contract negotiations with managed care organizations/health plans/insurance organizations on behalf of a host of different providers, including physicians, hospitals, hospice care providers, home care providers, and durable medical equipment providers.
  • Led a request for proposal, selection process, and contract negotiations with major retail pharmacies for pharmacy benefits for public sector entities including the negotiation of market access rates, rebates, formularies, specialty drugs, and distribution channels.
  • Facilitated mergers and acquisitions for healthcare companies, including due diligence, regulatory compliance, and integration strategies.
  • Negotiated and drafted commercial leases for medical office spaces, ensuring compliance with healthcare-specific regulatory requirements.
  • Coordinated with venture capital and private equity firms to secure investment funding for healthcare technology and pharmaceutical startups.
  • Provided legal guidance on international expansion for healthcare companies, including compliance with foreign healthcare regulations and market entry strategies.
  • Developed corporate governance frameworks for healthcare organizations, ensuring alignment with industry best practices and regulatory standards.
  • Assisted healthcare providers in transitioning to value-based care models, including contract negotiation and compliance with federal and state healthcare regulations.
  • Managed the legal aspects of divestitures and spin-offs for large healthcare conglomerates, ensuring seamless transitions and compliance with antitrust laws.
  • Assisted in the development and implementation of compliance programs for healthcare organizations to mitigate legal risks and enhance operational integrity.


  • Digital Health Platform licensing
  • IP licensing for Pharma/medical devices
  • New Chemical entity development and clinical trials (U.S. and Intl)
  • Patent prosecution to grant (with outside counsel)
  • Patent licensing
  • Copyright protection
  • Work product protection
  • Trademark prosecution and protection (with outside counsel)
  • Identification and protection of IP through M&A process


  • Counseled physician plaintiff in medical partnership dispute against medical group.
  • Created HIPAA compliance program for small medical practice.
  • Advised healthcare company on self-referral and kickback issues in ownership of a clinical laboratory.
  • Counseled numerous medical groups and physicians regarding Medicare, insurance regulatory, and anti-kickback issues in establishing a concierge medicine practice.
  • Counseled a medical doctor on extricating a physician assistant shareholder of physician’s professional medical corporation.
  • Created legal structure for high-end, regenerative medicine clinic.
  • Co-counseled successful resolution of an employment agreement dispute for physician client.


  • Provided healthcare regulatory expertise to international law firm on M&A due diligence issues, with respect to buyer client’s acquisition of medical spas.
  • Advised law firm on legal structure and compliance for a California medical spa.
  • Co-counseled with law firm for physician weight loss practice reviewing anti-kickback constraints.
  • Advised national law firm on legal issues relating to online referral service for healthcare services.
  • Counseled a business law firm on legal issues governing client’s establishment of a mental health counseling practice.

Disclaimer: the above defined the experience of the firm along with its attorneys in their various representations.

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