Among Our Projects

 FDA & FTC Law

Biologics Companies

  • 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.

Cosmetics Companies

  • 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.

Healthcare Law

Healthcare Facilities

  • 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.

Medical Groups & 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.

Medical Spas

  • 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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