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.
Dietary Supplement Companies
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.
Medical Foods & Other Nutritional Products
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 manufacturerand white-label branding company.
Combination Products; Other FDA-Related Issues
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.
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.
Medical Device Companies
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 amedical device 510k.
Rx & OTC Drug Companies
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.
Homeopathic Drug Companies
Advised European manufacturer of homeopathic products on FDA pathways to U.S. homeopathic, OTC drug, and dietary supplements markets.
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.
Physicians & Medical Centers
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.
Law Firms & Attorneys representing Healthcare Clients
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.
Management Service Organizations (MSOs)
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.
Non-MD Healthcare Practitioners
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.
Physicians & Physician Practices
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.
Telemedicine Startups & Other Healthcare Companies
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.
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.
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