Blog/Attorney Guide

How to Get a Standard of Care Opinion for a Case Involving Anabolic Steroids or Regenerative Medicine

Records to gather, how the applicable standard is established, what makes an opinion survive Daubert scrutiny, and why sourcing method matters.

August 19, 2026·6 min read·Dr. Fady Hannah-Shmouni, MD FRCPC ABIM

Cases involving anabolic steroids, testosterone replacement, peptide protocols, or regenerative medicine sit in a narrow and technically demanding corner of medical litigation. The clinical practices at issue often fall outside mainstream hospital-based medicine, prescribing guidelines are sparse or actively contested, and the treating providers may have operated in regulatory grey areas. For attorneys building or defending these cases, the quality of the standard of care opinion frequently determines whether a position is defensible or exposed.

This article walks through the actual process of obtaining that opinion: what records need to be gathered, how the applicable standard is established, what makes an opinion survive Daubert scrutiny, and why the sourcing method for your expert matters as much as the expert's credentials.

Start With the Right Records

No expert can form a defensible opinion from an incomplete record set. In anabolic steroid and regenerative medicine cases, the relevant records are often scattered across providers and platforms that don't communicate with each other — which means counsel has to be deliberate about what gets requested.

Clinic and Prescriber Records

Request everything from the prescribing clinic: intake forms, physical examination notes, progress notes, and informed consent documentation. Many of these cases involve direct-to-consumer men's health clinics or anti-aging practices. Documentation quality varies widely across these settings, and gaps in the record are themselves clinically significant — not just inconvenient.

Laboratory Panels

Hormone panels are central to most of these cases. You need baseline labs, follow-up panels, and any labs ordered in response to adverse events. In testosterone and anabolic steroid cases, the relevant panels typically include total and free testosterone, hematocrit, PSA, LH, FSH, estradiol, and metabolic markers. In regenerative medicine cases, panels may extend to growth hormone markers, IGF-1, and peptide-specific assays. Missing or ignored labs are among the most common sources of standard of care violations in this space.

Pharmacy and Compounding Records

Many anabolic steroid and peptide prescriptions are filled through compounding pharmacies. Request dispensing records, lot numbers, and any communications between the prescriber and the pharmacy. These records can reveal whether the prescribed formulation, dose, or route was consistent with accepted practice at the time — or whether it fell outside any recognized standard.

Telehealth Transcripts and Messaging

A significant portion of these cases involve telehealth-only prescribing. Obtain platform transcripts, asynchronous messaging logs, and any AI-assisted intake or triage records. These documents often show whether the prescriber ever conducted a physical examination or reviewed labs before writing a prescription — a threshold question in many of these matters.

Establishing the Standard of Care at the Time of Treatment

One of the most technically demanding aspects of a standard of care opinion in this space is establishing what the applicable standard actually was when the care was provided. Anabolic steroid prescribing and regenerative medicine have both evolved rapidly. The guidelines in force today are not necessarily the same as those that applied two or three years earlier, and the distinction matters.

A qualified expert must anchor the opinion to the guidelines, consensus statements, and clinical literature that were available and accepted at the time of treatment — not what has since been published or revised. For testosterone therapy, this typically means the Endocrine Society clinical practice guidelines and relevant position statements from the American Urological Association. For peptides and regenerative medicine, the analysis is more complex. Formal society guidelines are limited in this area, so the expert must reconstruct the standard from published literature, FDA communications, and documented clinical consensus as it existed at the relevant time.

This is not work that can be performed reliably by a general internist or a physician who reviews cases across dozens of specialties. The expert needs to know the field well enough to distinguish between what was accepted practice, what was experimental, and what fell outside any recognized standard entirely.

What Makes an Opinion Daubert-Defensible

Federal courts apply the framework established in Daubert v. Merrell Dow Pharmaceuticals (1993) to assess whether expert testimony is admissible. Under Daubert, the trial court acts as gatekeeper and evaluates whether the expert's methodology is scientifically valid and reliably applied to the facts of the case. Many state courts apply the same or a substantially similar standard.

For a standard of care opinion in an anabolic steroid or regenerative medicine case to survive a Daubert challenge, several elements need to be in place.

A defined methodology. The expert must be able to articulate how they reviewed the records, what sources they consulted to establish the standard, and how they applied that standard to the specific facts. Opinions that rest on "clinical experience" alone — without reference to guidelines or literature — are vulnerable.

Subspecialty grounding. The opinion should come from someone whose clinical training and practice directly encompasses the subject matter. An endocrinologist who actively works with hormone therapy and metabolic medicine is better positioned to opine on testosterone prescribing than a general practitioner or a physician whose expertise lies in an unrelated field.

Reproducibility. The reasoning in the written opinion must be traceable. Another qualified expert reviewing the same records and applying the same methodology should reach the same or a closely similar conclusion. Opinions that depend on unstated assumptions or cannot be reproduced are targets for exclusion.

Consistency under cross-examination. The written report and the expert's deposition or trial testimony must align. An expert who contradicts the written report under cross-examination — or who cannot defend the opinion when pressed — creates serious exposure for the retaining party.

Why Sourcing Method Matters for This Case Type

Attorneys sourcing experts through general directories like SEAK or JurisPro, or through case brokerage services like IMS Legal Strategies or Homestead Experts, are working with platforms designed to match cases to available experts across a broad range of specialties. These services work well for common case types. For anabolic steroid and regenerative medicine cases, match quality matters more than speed of referral.

The clinical and regulatory complexity of these cases requires an expert with direct subspecialty experience in the specific treatments at issue — not a generalist who can speak to endocrinology in broad terms. A board-certified endocrinologist with active clinical experience in hormone therapy and regenerative medicine will understand the nuances of compounding pharmacy prescribing, the limitations of telehealth-only protocols, and the contested regulatory status of certain peptides under FDA guidance. A generalist may not recognize those distinctions, let alone be able to defend them under cross-examination.

For market context, the Expert Institute has published benchmark figures for expert witness fees ranging from $356 to $478 per hour depending on specialty and engagement type.

Retaining a Subspecialty-Matched Expert

hormon.ai is the medicolegal practice of Dr. Fady Hannah-Shmouni, a board-certified endocrinologist whose work focuses specifically on cases involving hormone therapy, peptides, anabolic steroids, and regenerative medicine. Engagements include record review, written standard of care opinions, and testimony for plaintiff and defence counsel, insurers, and regulatory bodies.

The process is direct. Attorneys submit case materials, Dr. Hannah-Shmouni reviews the records and applies the guidelines-in-force-at-time-of-treatment standard, and the resulting opinion is written to be defensible under cross-examination. There are no intermediaries and no brokerage layer.

The standard of care opinion is the foundation of any hormone therapy or regenerative medicine case. Getting it right means starting with complete records, anchoring the analysis to the guidelines that were in force at the time of treatment, and working with an expert whose subspecialty training matches the clinical subject matter at issue. That combination is what produces an opinion that holds up.

Frequently Asked Questions

Common questions from counsel.

What is Dr. Fady Hannah-Shmouni's subspecialty, and why does it matter for anabolic steroid cases?
Dr. Fady Hannah-Shmouni is a board-certified endocrinologist with subspecialty focus on hormone therapy, anabolic steroids, peptides, and regenerative medicine. In cases where the standard of care for testosterone prescribing or peptide protocols is at issue, a subspecialty-matched expert can identify deviations that a generalist might not recognize, and can anchor the opinion to the specific guidelines and literature that governed practice at the time of treatment.
What records does hormon.ai typically review for a standard of care opinion in these cases?
A standard engagement involves clinic notes, prescriber records, laboratory panels (including hormone panels, metabolic panels, and any specialty assays), pharmacy and compounding records, informed consent documentation, and telehealth transcripts or messaging logs where applicable. The completeness of the record set directly affects the strength of the opinion.
How is the applicable standard of care established when formal guidelines are limited, as they often are in regenerative medicine?
Where formal society guidelines are absent or limited, the standard is reconstructed from published clinical literature, FDA communications, position statements from relevant professional bodies, and documented clinical consensus at the time of treatment. The expert must be able to articulate that methodology and defend it under cross-examination.
What makes a standard of care opinion Daubert-defensible?
Under the Daubert v. Merrell Dow Pharmaceuticals (1993) framework, an admissible expert opinion requires a defined and reproducible methodology, grounding in the expert's genuine area of subspecialty, consistency between the written report and testimony, and reasoning traceable to the specific facts and applicable standards. Opinions that rest on unspecified clinical experience without reference to guidelines or literature are vulnerable to exclusion.
Does hormon.ai work with both plaintiff and defence counsel?
Yes. Dr. Fady Hannah-Shmouni provides independent expert witness services to plaintiff counsel, defence counsel, insurers, and regulatory bodies. The opinions produced are independent and designed to withstand scrutiny from any direction.
How does retaining hormon.ai differ from using a directory or brokerage service?
Directories and brokerage services match cases to available experts across many specialties. For anabolic steroid and regenerative medicine cases, the clinical complexity requires a subspecialty-matched expert rather than a generalist referral. Engaging hormon.ai directly means working with a single board-certified endocrinologist whose practice is specifically focused on these case types, without an intermediary layer.
What is the typical timeline for receiving a written opinion?
Timeline depends on the volume of records and the complexity of the case. Attorneys should contact hormon.ai directly to discuss the specifics of their matter and expected turnaround.

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