Expert Witness Services: Favorable Outcomes in High-Stakes Regulatory and Medico-Legal Cases

Overview:

Restore Health Consulting provides expert witness services for 503A pharmacies, 503B outsourcing facilities, and compounding professionals involved in litigation or disciplinary proceedings. Our experts bring clinical, operational, and regulatory experience rooted in real-world compounding practice and quality leadership.

Why Legal Teams Trust Restore Health

Our team includes seasoned professionals with deep, specialized experience:

  • Director level and above leaders with specific industry experience

  • Board-Certified Sterile Compounding Pharmacists (BCSCP)

  • Authors and presenters of ACPE-accredited CE on USP <797>, <795>, <800>, CGMP, and sterile compounding quality systems

  • Consultants to 503A and 503B facilities nationwide, including facilities on probation with State Boards of Pharmacy

  • Expertise with USP, CGMP, 21 CFR 210/211, and both federal and state-level enforcement standards

  • Experienced in drafting reports, testifying in depositions, and supporting litigation strategy

Representative Case Highlights

Licensure Defense (Ruling in Favor of Pharmacy)

  • 503A pharmacy on probation accused of multiple compounding violations

  • Judge ruled in the pharmacy’s favor

Adulteration Allegations (Favorable Ruling)

  • Large 503A pharmacy accused of compounding adulterated CSPs

  • Judge ruled in favor of the pharmacy; although later overturned by the Board, our testimony stood

Controlled Substance Mismanagement Allegation

  • Large LTC/503A pharmacy accused of narcotics mismanagement and sterile compounding violations

  • Case resolved with settlement

Essential Copy Rule Violation

  • 503A pharmacy accused of violating federal compounding limits for essential copies

  • Settlement reached with Board

503B Outsourcing Facility License Case

  • National outsourcing facility accused of compounding adulterated CSPs and operating without a license

  • Matter settled favorably

Adverse Patient Outcome Case

  • Compounded irrigation product allegedly caused serious adverse event during surgery

  • Parties reached settlement

Summary Judgment Granted in Favor of Pharmacy

  • 503A pharmacy sued by manufacturer for alleged adulterated compounded product

  • Summary judgment granted in pharmacy’s favor

Our Role in These Cases

  • Expert witness reports for civil, administrative, and Board proceedings

  • Support for hearings, depositions, and testimony

  • Interpretation of compounding regulations and application to specific case facts

  • Opinions regarding standard of care, regulatory compliance, insanitary conditions, adulteration allegations, and more

Trusted by Industry Leading Attorneys Nationwide

Restore Health Consulting is proud to support patients, pharmacies, physicians, and their counsel with reliable, credible expert insight rooted in real compounding practice. Our goal: protect patients & licensees, clarify the regulatory landscape, and contribute to fair and accurate outcomes.

Need an expert for an upcoming case?

Reach out to Restore Health Consulting to request CVs, discuss engagement terms, or explore how our expertise aligns with your legal strategy.