Biote Lawsuit 2026: Claims, Risks & How to File

If you searched “Biote lawsuit,” you probably fall into one of three groups. You may have had hormone pellets placed and felt worse afterward. You may be worried about a family member. Or you may have seen headlines and want to know what is actually true.

This guide separates the real cases from the noise. It explains what has been alleged, what regulators and medical groups say about pellets, and what to do if you believe you were harmed. It was updated as of September 29, 2026.

One important point first. As far as public records show, there is no announced global settlement and no certified nationwide class action for patients who received Biote-associated hormone pellets. Individual cases exist, and some are moving through court. That difference matters for anyone thinking about filing.

What Is the Biote Lawsuit 2026?

There is not one single “Biote lawsuit.” The phrase covers several separate legal disputes involving Biote Corp. (Nasdaq: BTMD), its operating subsidiary Biote Medical, LLC, and the network of clinics certified in the Biote Method.

Here are the main categories:

1. Patient injury claims. People allege that hormone pellets or the dosing approach behind them caused physical harm.
2. Consumer product claims. In February 2026, a couple sued in Dallas County, alleging that a Biote sleep supplement damaged their livers.
3. Corporate and shareholder disputes. These involve the founder, his former spouse, and the 2022 SPAC merger.
4. Commercial and image-rights disputes. A commercial actress sued nearly two dozen Biote-affiliated providers over the use of her likeness.

Christopher and Mary Pat Sharon filed a lawsuit against Biote Medical in Dallas County court, saying they took the Deep Sleep supplement as directed and suffered serious liver damage. The complaint says Biote discontinued that product in late 2021 and introduced a reformulated version without public notice about safety concerns with the earlier one. These are allegations only. At the time of reporting, no formal response from Biote had appeared in the online court record.

If your question is “Can I join the Biote lawsuit?”, the honest answer depends on which claim you mean. The rest of this guide helps you sort that out.

Biote Class Action Lawsuit: What Is Being Alleged?

Many websites use the words “Biote class action” loosely. Here is what the record shows.

A class action lets one or a few plaintiffs sue on behalf of a large group with similar injuries. A judge must certify the class first. I found no public record that a court has certified a nationwide patient class against Biote.

What does exist is a putative class action filed in West Virginia. It was filed by plaintiff Timothy Koontz in Kanawha County and later moved to federal court. His complaint alleges Biote’s testosterone pellets caused blood clotting, abdominal vein thrombosis, and multiple surgeries for life-threatening conditions. It also alleges that Biote’s dosing approach frequently produced testosterone levels far above the normal range.

The federal docket shows the case was removed on September 17, 2024 to the Southern District of West Virginia, and Biote Medical filed a motion to dismiss in November 2024. I could not confirm a final ruling as of this writing, so treat the outcome as unresolved and check the court docket for current status.

Why the “class action” label can mislead

• Putative is not certified. A filing that asks for class treatment is not the same as an approved class.
• Injury cases are personal. Different pellets, doses, and health histories make it hard to certify a class in medical injury cases.
• Many patients end up with individual suits. That is common in pharmaceutical and medical device litigation.

Biote Medical Lawsuit: Who Is the Company?

Biote is an Irving, Texas company that describes itself as a preventive health care provider focused on personalized hormone optimization. It trades on Nasdaq under BTMD. Its operating arm, Biote Medical, was previously known as SottoPelle Texas LLC, according to an earlier Texas appeals court report.

Here is how the business works in plain terms:

• Biote trains and certifies practitioners in its dosing method.
• Independent clinics and physicians prescribe and insert the pellets.
• The pellets themselves are compounded, meaning they are made by pharmacies or outsourcing facilities, not approved as finished drugs.

The company’s own annual report addresses this structure. It warns that injury to a patient could result from quality issues, manufacturing or labeling flaws, or improper packaging or use of compounded products. It also says some contracted outsourcing facilities have faced civil suits alleging patient harm from improper formulation.

This structure explains why lawsuits often name several defendants at once: the company, the clinic, the clinician, and sometimes the compounding source.

Biote Hormone Pellet Lawsuit: What Are the Core Claims?

Across patient-side filings and legal explainers, the same handful of legal theories keep appearing. Here they are in plain language.

1. Failure to warn

Plaintiffs argue patients were not told enough about risks. One patient-facing explainer describes the central theme as misleading statements about safety, effectiveness, and regulatory status.

2. Informed consent problems

Informed consent means a patient understands the risks, the alternatives, and the fact that a product is not FDA approved. Plaintiffs may argue they were sold a lifestyle benefit without a real risk discussion.

3. Negligent dosing

Some claims focus on the dosing method itself. The allegation is that standardized or aggressive dosing pushed hormone levels too high for some patients.

4. Product liability

A pellet is a physical product placed in the body. Claims may allege a design defect, a manufacturing defect, or inadequate labeling.

5. Deceptive marketing

Plaintiffs may argue that “natural,” “bioidentical,” or “optimized” language created a false sense of safety.

6. Inadequate adverse event handling

The Koontz complaint alleges that Biote reported more than 3,500 adverse events between 2013 and 2018 but followed up on only a small fraction. That is an allegation, not a finding, and Biote has denied wrongdoing in related coverage.

A lawsuit is a set of claims, not proof. Courts decide which claims survive and which do not.

Biote Pellet Side Effects Lawsuit: What Injuries Are Patients Reporting?

Injury claims vary widely. Here are the categories that appear most often in complaints and medical literature.

Hormone-level effects

• Mood swings, anxiety, irritability
• Acne, oily skin, unwanted hair growth
• Hair thinning or loss
• Fluid retention and weight changes
• Breast tenderness
• Abnormal uterine bleeding

Serious medical events alleged in litigation

• Blood clots and venous thrombosis
• Cardiovascular complications
• Multiple corrective surgeries

Procedure-related problems

• Infection at the insertion site
• Pellet extrusion, where the pellet works its way out
• Scarring or cosmetic changes
• Pain or lumps where pellets were placed

Long-lasting hormone excess
Because pellets cannot be pulled back quickly the way a patch can be removed, patients sometimes report symptoms lasting for months.

Not every side effect means a lawsuit is possible. Legal claims generally require proof that the harm was caused by the treatment and by a legal failure, such as inadequate warning or negligent care. A physician can help you document what is medically related.

Biote Bioidentical Hormone Pellet Risks: What the Science Says

“Bioidentical” means a hormone has the same molecular structure as one your body makes. That word describes chemistry, not safety or regulatory status.

The distinction that trips people up: some FDA-approved products are bioidentical, such as estradiol patches and micronized progesterone. Compounded pellets are also called bioidentical, but they are not FDA approved.

What major medical sources say:

• ACOG says there is a lack of high-quality safety and efficacy data on custom-compounded bioidentical hormone therapy for menopause, and that it should not be prescribed routinely when FDA-approved options exist.
• ACOG also recommends preparations other than pellets for testosterone delivery, citing the lack of safety data and the inability to remove a pellet.
• One insurer’s medical policy classifies implanted estradiol pellets as investigational because they produce unpredictable and fluctuating serum estrogen levels.
• A study summarized in Contemporary OB/GYN reported side effects in 57.6% of a pellet group versus 14.8% for FDA-approved products. Readers should treat single-study numbers cautiously, but the direction matches other cautions.

A balanced view

Pellet supporters, including many practitioners, say patients feel better and prefer the convenience of dosing every few months. Those experiences are real. The scientific concern is that the evidence for long-term safety is thinner than for approved products, and that dosing is harder to adjust.

Biote Testosterone Pellet Lawsuit: What Men and Women Are Claiming

Testosterone pellets are the most common thread in injury filings.

Claims from men

Men are often treated for fatigue, low libido, or low testosterone. Reported concerns in lawsuits include:

• Blood clots and circulatory problems (central to the West Virginia filing described above)
• Polycythemia, meaning the blood becomes too thick with red cells
• Elevated blood pressure
• Fertility and testicular effects
• Mood and sleep disruption

Regulators have also been active on testosterone generally. In February 2025, the FDA implemented class-wide labeling changes for testosterone products that replaced boxed cardiovascular language with TRAVERSE trial data and added a blood pressure warning. That was about approved products, not compounded pellets, but it shows how closely blood pressure and cardiovascular effects are watched.

Claims from women

As of 2026, there is no FDA-approved testosterone product made for women in the United States. That means any testosterone given to women is off label or compounded. Women describing harm often mention:

• Voice deepening
• Facial or body hair growth
• Acne and scalp hair loss
• Clitoral enlargement
• Aggression or mood changes

Some of these changes can be permanent. That is why dosing lawsuits and consent lawsuits matter most in this group.

Biote Estrogen Pellet Lawsuit: Specific Claims from Female Patients

Estradiol pellets raise their own set of concerns.

There are currently no FDA-approved implantable estradiol pellets available in the U.S. So any estradiol pellet is compounded by definition.

Claims and complaints from women often include:

• Prolonged high estrogen. Reviews note estradiol pellets have been associated with years of elevated estradiol and uterine bleeding.
• Ongoing bleeding or endometrial concerns. This is especially serious for women who still have a uterus and were not given adequate progesterone protection.
• Breast symptoms such as tenderness or lumps.
• Difficulty stopping treatment because the pellet cannot simply be discontinued.
• Unclear cancer counseling. Women with a history of hormone-sensitive cancer or strong family history may argue they were not properly screened.

Breast cancer risk with compounded pellet testosterone remains uncertain per ACOG guidance, and no one should assume a pellet caused or did not cause a cancer without medical review. That is a complex causation question that experts, not websites, must answer.

Biote Pellet Therapy Dangers: What Practitioners Are Saying

Clinicians are divided, and that split is worth understanding.

The cautious camp

Many gynecologists, endocrinologists, and menopause specialists prefer FDA-approved forms because:

• Doses can be lowered or stopped fast.
• Manufacturing follows federal standards.
• Insurance often covers them. Most plans classify compounded pellets as elective and do not cover them.

Some also argue that pellet doses can push testosterone far above the physiologic range in women. One physician’s 2026 patient guide says those who study testosterone therapy in women strongly advise against pellets because they deliver too much and lift levels far beyond normal.

The supportive camp

Certified practitioners say the Biote Method uses lab monitoring and follow-up, and that many patients report symptom relief. Biote has publicly denied wrongdoing in litigation coverage and says it provides risk information.

A supply-chain warning worth knowing

Quality of the compounded product matters separately from the brand. In January 2026, a Class II recall was initiated for Asteria Health testosterone pellets over potential metal particulate matter. That recall involved a different company, and I found no source linking it to Biote. But it shows why patients should ask exactly which pharmacy or outsourcing facility made their pellets.

Biote FDA Warning: What Regulators Have Said

Searchers often type “Biote FDA warning.” Here is what I could verify, and what I could not.

What I did not find: a public FDA warning letter or recall aimed specifically at Biote as of this update. Be careful with websites that claim one without linking a primary source.

What is documented:

• Compounded hormone pellets are not FDA approved as finished products for menopause. Compounding sits under a different legal framework than approved drugs.
• Biote’s own SEC filings describe regulatory risk. The company states that if the FDA acted on recommendations from the National Academies for compounded bioidentical hormones, it could substantially hurt outsourcing facilities’ ability to compound pellets and harm Biote’s revenue and operations.
• Broader hormone therapy policy shifted recently. In November 2025 the FDA announced it would begin removing long-standing boxed warnings across hormone therapy products, and in February 2026 it approved label changes for six systemic products removing warnings tied to cardiovascular disease, breast cancer, and dementia.

Why the label change matters for lawsuits

Some readers assume the FDA loosening warnings on approved products helps or hurts pellet claims. It does neither automatically. Those changes apply to approved products. Pellet cases turn on compounded products, dosing, and disclosure, so defendants and plaintiffs may both cite the changes in different ways.

You can verify current FDA actions yourself at FDA.gov by searching for the drug name, compounding pharmacy, or outsourcing facility.

Biote Hormone Therapy Lawsuit: How These Cases Are Being Built

Understanding how attorneys assemble a case helps you know what evidence matters.

Who gets named

Plaintiff lawyers often sue more than one party:

• The clinic or medical practice
• The prescribing practitioner
• Biote Medical or related corporate entities
• The compounding pharmacy or outsourcing facility, if there is evidence of a product problem

A federal court in West Virginia addressed this. In a March 2022 order, Judge Irene C. Berger remanded a hormone pellet case to state court and allowed the plaintiff to join the non-diverse medical practitioner defendants, reasoning that one set of facts and damages should be handled together to avoid inconsistent rulings. The case was Jeffries v. BioTE Medical.

Core proof lawyers look for

1. Diagnosis and baseline. What were your labs and symptoms before treatment?
2. Dose records. Which hormones, at what strength, and when?
3. Monitoring. Were blood levels checked and acted on?
4. Consent paperwork. What did you sign, and what did you actually hear?
5. Injury timeline. When did symptoms start, and what did doctors find?
6. Expert opinion. A physician usually must link the injury to the treatment.

Why these cases are hard

• Hormone symptoms overlap with menopause, aging, and stress.
• Defendants may argue patients accepted known risks.
• Preemption and regulatory arguments can complicate the picture.
• Damages must be documented, not just described.

Biote Lawsuit Who Qualifies: Eligibility Criteria

No court has published a universal eligibility checklist for a single Biote claim, so qualification is case by case. Attorneys generally look at the following.

You may have a stronger claim if

• You received Biote-associated pellets from a certified provider
• You have records proving the treatment and dates
• A doctor diagnosed a specific injury after treatment
• You have medical bills, lost income, or corrective procedures
• You can show you were not properly warned
• You are still within the filing deadline

Claims that are usually weaker

• Symptoms that were mild, brief, and undocumented
• Injuries that started long before treatment
• No medical records or no proof of which product was used
• A missed deadline

A note on the statute of limitations

Personal injury deadlines vary by state and are often around one to three years, sometimes measured from when you discovered the harm. Do not guess. Ask an attorney early, because a late claim can be barred no matter how strong it is.

Who does not qualify through this path

If you own Biote stock and want to recover investment losses, that is a securities claim, not a patient claim. Likewise, a former employee’s retaliation or whistleblower claim is separate from patient injury.

Biote Practitioner Lawsuit: Can You Sue the Doctor Too?

Yes, in many situations you can. Practitioners are often named in the same case as the company.

Why practitioners get sued

• They decide the dose and place the pellets.
• They obtain your consent.
• They are responsible for follow-up testing.
• They may have local malpractice exposure that a national company does not.

Two kinds of claims to understand

• Medical malpractice. This focuses on whether the clinician met the standard of care. Many states require expert affidavits or pre-suit notice, which adds steps and deadlines.
• Product or corporate liability. This targets the company’s practices and messaging.

Practical cautions

• Malpractice rules differ sharply by state. Some cap damages or require review panels.
• Arbitration clauses in patient paperwork may limit where and how you can sue.
• A clinic that closes or lacks insurance can complicate recovery.

Bring your intake forms, consent documents, and billing statements to the attorney consultation. Those papers often decide who can be sued and where.

There is also a related but separate example of practitioners being sued. A commercial actress sued nearly two dozen Biote-affiliated providers, saying they kept using her likeness in marketing after her contracts expired, with a Dallas County trial scheduled in the 101st Judicial District Court. That case is about image rights, not patient injury, but it shows affiliated clinics can face claims independent of the parent company.

Biote Lawsuit Settlement: Is There a Settlement Yet?

For patient injury claims, I could not find a public, court-approved settlement as of September 29, 2026.

That said, Biote has settled other disputes, and mixing them up is where confusion starts.

Known corporate settlements (not patient compensation):

• In April 2024, Biote announced a definitive settlement with founder Dr. Gary Donovitz, agreeing to repurchase his 18.4 million shares for about $76.9 million.
• A Brewer law firm update says Biote reportedly reached a $60 million settlement in July 2024 with shareholder Marci Donovitz. That figure comes from the plaintiff-side firm, so treat it as reported rather than independently confirmed.

Neither settlement pays injured patients. Any article claiming “Biote settlement checks are available” without naming a court and a claims administrator deserves suspicion.

How to spot a settlement scam

• A website asks for your Social Security number before naming a case
• It promises guaranteed payouts
• There is no case name, court, or docket number
• It pushes you to sign quickly with an unknown law firm

Real settlements are posted by the court or a named claims administrator and include deadlines, claim forms, and contact details.

Biote Settlement Amount: What Could Plaintiffs Receive?

Nobody can honestly promise a number. There is no public patient settlement fund to quote.

What can be explained is how compensation is usually measured in injury cases.

Common categories of damages

1. Medical expenses. Past and future treatment, surgery, and monitoring.
2. Lost income. Time off work or reduced earning capacity.
3. Pain and suffering. Physical pain and emotional distress.
4. Permanent changes. For example, lasting voice or body changes.
5. Punitive damages. Rare, and only if a court finds especially bad conduct.

What shapes a payout

• Severity and permanence of the injury
• Strength of medical causation evidence
• Which defendants are named and how much insurance they carry
• Your state’s damage rules
• Attorney fees, which are typically a percentage collected only if you win, plus case costs

Realistic expectations

• A minor, short-lived reaction may have limited value.
• A serious clotting event with surgeries may be valued much higher.
• Cases can take years.
• Losing at trial or on a dispositive motion means no payment.

Be skeptical of any site that lists a dollar range for “Biote plaintiffs.” A range without a source is guesswork.

Biote Lawsuit How to File a Claim: Step-by-Step Guide

Here is a practical path. Follow it in order.

Step 1: Get medical care first

Your health comes before any legal claim. See a physician, tell them about the pellets, and ask for blood work. If you are considering removal or other treatment, discuss it with your doctor.

Step 2: Preserve evidence

Start a folder now. Include:

• Consent forms and intake questionnaires
• Lab results before and after treatment
• Pellet dose and lot information, if provided
• Receipts and insurance statements
• Photos of symptoms, scars, or extrusion sites
• A dated symptom diary
• Emails, texts, and portal messages with the clinic
• Any marketing materials you relied on

Do not delete social media posts or messages, and avoid posting about the case publicly.

Step 3: Request your complete medical records

Ask the clinic and any treating physician for full records in writing. Include procedure notes and pharmacy or compounding details.

Step 4: Identify the timeline and deadline

Write down when treatment began, when symptoms started, and when a doctor connected them. Ask an attorney about your state’s limitation period immediately.

Step 5: Consult an experienced attorney

Look for a lawyer with pharmaceutical, medical device, or medical malpractice experience. Most personal injury firms offer free consultations and take cases on contingency. Ask:

• Have you handled hormone or compounded drug cases?
• Which defendants would you name?
• What is your fee and who pays case costs?
• What is the likely timeline?

Step 6: Have the case evaluated

The lawyer will review records and often consult a medical expert on causation before filing.

Step 7: Follow pre-suit rules

Some states require notice letters or expert certificates for malpractice claims. Your attorney handles these.

Step 8: File the complaint

The case is filed in state or federal court. Then defendants respond, often with motions to dismiss or requests to move the case.

Step 9: Discovery and negotiation

Both sides exchange documents, take depositions, and may mediate. Most civil cases resolve before trial, but that is not guaranteed.

Step 10: Resolution

The case ends by settlement, dismissal, or verdict. If there is ever a class settlement, you would follow the claim instructions posted by the court or claims administrator.

If you already have an arbitration agreement

Do not assume it blocks everything. Some agreements are contested, and your attorney can tell you whether it applies.

Biote Lawsuit Updates 2026: What Is Happening Right Now?

Here is a verified snapshot as of September 29, 2026.

Matter	What is known	Status to watch
Sharon v. Biote Medical (supplement liver injury)	Filed in Dallas County in February 2026 by a former employee and his wife	Biote’s formal response and any motion practice
Latch image-rights case	Trial against affiliated providers scheduled in Dallas County	Trial outcome and any appeal
Koontz v. Biote Corp. (testosterone pellets, West Virginia)	Removed to federal court in 2024, motion to dismiss filed	Ruling on the pleadings and class issues
Founder and SPAC shareholder disputes	Founder and one shareholder resolved in 2024, further Delaware claims filed	Delaware court developments
Patient class settlement	None found	Court dockets and claims administrators
FDA policy	Boxed warning removals for approved hormone products in late 2025 to 2026	Any action on compounding

How to track updates reliably

• Search the PACER system for federal dockets and your state court’s public case search.
• Read Biote’s SEC filings on EDGAR (10-K, 10-Q, 8-K) for legal proceedings disclosures.
• Watch FDA.gov for compounding and drug safety communications.
• Consult a lawyer, because unreported motions and rulings can change the picture.

This story may have changed since this article was published. Always confirm on a primary source before acting.

Frequently Asked Questions

Is there a Biote class action lawsuit?

A putative class action was filed in West Virginia in 2024, but I found no certified nationwide patient class as of September 2026.

Is there a Biote settlement for patients?

No public, court-approved patient settlement was found. Known settlements involved the founder and a shareholder, not injured patients.

What are Biote pellets?

They are small implants placed under the skin that release testosterone, estradiol, or both over several months, and most are compounded rather than FDA approved.

Are Biote hormone pellets FDA approved?

No. Compounded pellets are not FDA approved for menopause, and there are no FDA-approved estradiol pellets available in the U.S.

Did the FDA issue a warning against Biote?

I could not verify a public FDA warning letter or recall naming Biote. Check FDA.gov for the latest notices.

What side effects are people suing over?

Claims include blood clots, high hormone levels, mood changes, hair and skin changes, abnormal bleeding, extrusion, infection, and surgical complications.

Can women sue over testosterone pellets?

Yes, women can bring claims. No FDA-approved testosterone product exists for women, so consent and dosing are common issues.

Can I sue my doctor or clinic?

Often yes. Practitioners are commonly named alongside the company, subject to state malpractice and arbitration rules.

How long do I have to file?

Deadlines vary by state, often one to three years, and may depend on when you discovered the injury. Ask an attorney right away.

How much does it cost to hire a lawyer?

Many injury lawyers work on contingency, meaning they are paid a percentage only if you recover money, plus case costs.

What evidence do I need?

Medical records, consent forms, lab results, pellet dosing details, receipts, photos, and a symptom timeline.

Is the Biote sleep supplement lawsuit about pellets?

No. It is a separate Dallas County case alleging a supplement caused liver injury.

Are hormone pellets safe?

Safety varies by person, but ACOG advises against routine use of compounded pellets when approved options exist, citing limited data and inability to remove the pellet.

Where can I check current case status?

Use PACER, your state’s court search, Biote’s SEC filings, and a licensed attorney.

Conclusion

The “Biote lawsuit” is really a cluster of cases. Patient injury claims focus on failure to warn, informed consent, dosing, and product liability, with a West Virginia filing alleging serious clotting events. A separate Dallas County suit targets a sleep supplement. Corporate disputes over the founder and the SPAC deal have largely been about money between insiders, not patient compensation.

The facts most readers need are these:

• No patient settlement is public yet. Be careful with anyone promising payouts.
• Pellets are compounded. They are not FDA approved for menopause, and major medical groups urge caution.
• Practitioners can be defendants too. Your paperwork decides much of your strategy.
• Deadlines are strict. Speak to an attorney soon if you believe you were harmed.

If you have symptoms now, see a doctor first. Then gather your records, write your timeline, and book a consultation with a lawyer who handles hormone or compounded drug cases. Careful documentation is the most valuable thing you can do today.