Why Did the FDA Stop Mammograms at The Greenbrier Clinic?

Tabitha Martin had her mammogram at The Greenbrier Clinic on February 13, 2026. The report came back benign. It assured her the finding was dependable because high-resolution real-time ultrasound images had been obtained.

Five weeks later, a certified letter told her she could not rely on any of it.

The FDA ordered the clinic to stop performing mammography on February 26, 2026, after determining that the facility failed to meet the clinical image quality standards established by its accreditation body, the American College of Radiology. That finding reaches backward across every mammogram performed there between October 28, 2023, and February 26, 2026, more than two years of screenings and roughly 1,000 patients scattered across the country and overseas. Powell & Majestro P.L.L.C. filed a federal class action on their behalf in April 2026, and women screened during that window can call (304) 346-2889 for a free case review.

The distinction that matters most to those patients is a narrow one. Nobody has said their results were wrong. What the FDA said is that nobody can vouch for them.

What Prompted the FDA to Shut Down Mammography at the Clinic?

The FDA halted mammography at The Greenbrier Clinic because a review of the facility’s clinical images found they did not meet the quality standards its accreditation body requires. A facility that cannot satisfy those standards loses its authority to scan patients, and the loss takes effect immediately.

Every mammography provider in the United States operates under the Mammography Quality Standards Act of 1992, codified at 42 U.S.C. § 263b, with the operating rules at 21 C.F.R. Part 900. Congress passed it because screening quality varied so widely from one facility to the next that the value of a mammogram depended heavily on where a woman happened to get it.

To hold a certificate, a facility must:

• Hold FDA certification confirming it is capable of providing quality mammography
• Maintain accreditation through an FDA-approved body — the American College of Radiology, in this clinic’s case
• Submit clinical images for periodic review
• Complete an annual survey conducted by or under the supervision of a medical physicist
• Pass an annual inspection by a certified MQSA inspector
• Meet federal requirements for personnel qualifications, equipment, radiation dose, quality assurance, and recordkeeping

When the FDA suspects quality at a facility has degraded far enough to endanger patients, 21 C.F.R. § 900.12(j) governs what happens next. The agency can order an Additional Mammography Review, requiring the facility to turn over clinical images to its accreditation body for evaluation. If that review turns up serious image quality deficiencies, accreditation is revoked. Without accreditation, the FDA certificate lapses, and the facility must stop scanning.

What Does the March 23 Letter Actually Mean?

The March 23, 2026, letter was not a courtesy from the clinic. It was a federally mandated notification, and the FDA orders one only after determining that a facility’s mammography quality fell so far outside federal standards as to present a significant risk to human health.

That threshold is written into the regulation. Under § 900.12(j)(2), the agency may require a facility to notify every affected patient and every referring provider once it makes that finding. Routine paperwork lapses do not trigger it.

Staff radiologist Dr. Henry Setliff signed the letters, which went out by certified mail to everyone imaged during the affected period. They disclosed a “serious concern about the quality of the mammography” performed at the facility, explained that the FDA had required the clinic to stop, and told patients to speak with their health care provider as soon as possible. The clinic also acknowledged that most patients would need their prior images reviewed to determine whether a repeat mammogram elsewhere was necessary.

The letter is careful to say individual results are not necessarily incorrect. That is accurate, and it is also the heart of the problem. A screening mammogram is purchased for one reason: to replace uncertainty with an answer. These patients paid for an answer and were left holding a question.

Local reporting suggests some affected patients never received their certified letter. Anyone screened at the clinic between October 28, 2023, and February 26, 2026 should assume they fall inside the affected group regardless of what arrived in the mail.

What Should You Do If You Were Screened at The Greenbrier Clinic?

Patients imaged at the clinic during the affected period should have their prior images reviewed by another provider, preserve every document connected to the screening, and obtain a repeat mammogram if their physician recommends one. The clinical steps come first. The legal ones can follow.

1. Call your physician. Bring the date of your mammogram and the clinic’s letter if you have it. Your provider decides whether the prior images are usable for comparison or whether you need fresh imaging.
2. Request your original images and report. Patients have a right to their mammography records. Ask in writing and have them routed to whichever facility handles your follow-up.
3. Do not wait on the clinic. The FDA has not restored the facility’s authority to perform mammography, and no date has been announced for its return. Your follow-up needs to happen somewhere else.
4. Keep the paper. The letter, the envelope, your bill, your explanation of benefits, receipts for out-of-pocket costs, and every invoice generated by repeat screening. These establish both class membership and damages.
5. Write down the timeline. When you were screened, what you were told, when the letter arrived, and what it cost you to sort out. Memory fades faster than litigation moves.

Who Pays for the Repeat Mammogram?

No patient has been reimbursed. The clinic billed for the original screenings, collected from patients and their insurers, and as of the filing of the federal complaint had issued no refund, rebate, or credit for imaging the FDA determined was unreliable.

The cost lands in two places. Insurers commonly cover one screening mammogram per plan year, so a second scan inside the same twelve months can be denied outright or applied to a deductible. And every patient who paid coinsurance or a deductible on the first mammogram paid it for a service she did not receive.

That is the economic core of the litigation. The claims are not built on a misread scan. They are built on money changing hands for a diagnostic service that did not meet the standard it was sold as meeting.

What Lawsuits Have Been Filed Against The Greenbrier Clinic?

Three proposed class actions were filed within roughly six weeks of the notification letters — two in federal court and one in state court.

The first, Martin v. The Greenbrier Clinic, Inc., No. 5:26-cv-00252, was filed April 7, 2026 in the United States District Court for the Southern District of West Virginia, Beckley Division, and assigned to Judge Frank Volk. It advances five causes of action:

• Unfair and deceptive acts and practices under the West Virginia Consumer Credit and Protection Act
• Unjust enrichment
• Breach of contract
• Fraudulent, deceptive, or misleading representations
• Negligent infliction of emotional distress

The proposed class covers everyone who received mammography services at the clinic between October 28, 2023, and February 26, 2026 and received the March 23 letter. The complaint estimates the class at roughly 1,000 patients and invokes federal jurisdiction under the Class Action Fairness Act, 28 U.S.C. § 1332(d).

A second suit followed on April 8 in Greenbrier County Circuit Court on behalf of a patient identified as E.H., screened around May 2024, pressing breach of contract and unjust enrichment theories.

A third federal complaint arrived in May on behalf of April Wilson of White Sulphur Springs and Erin Dotson of Ronceverte, screened in October 2024 and March 2025. It proposes a nationwide class raising consumer protection, unjust enrichment, contract, and emotional distress claims.

Residency in West Virginia is not a requirement. The clinic serves resort guests from across the country and abroad, and the proposed classes reach patients wherever they live.

Which West Virginia Laws Apply to These Claims?

The claims run primarily through the West Virginia Consumer Credit and Protection Act, which makes it unlawful to use unfair or deceptive acts or practices while engaged in trade or commerce. W. Va. Code § 46A-6-104.

Several provisions map onto these facts:

• 46A-6-102(7)(B) — causing confusion or misunderstanding about the approval or certification of goods or services. The complaint alleges the clinic held itself out as operating under FDA-approved standards while its imaging did not comply.
• 46A-6-102(7)(E) — representing that services carry approval, characteristics, or benefits they do not have.
• 46A-6-102(7)(G) — misrepresenting that services are of a particular standard, quality, or grade.
• 46A-6-102(7)(M) — deception or concealment of a material fact intended to be relied upon in connection with the sale of services.

The clinic’s own marketing supplies the comparison. Its website advertised “state-of-the-art diagnostic technologies” and described its 3D mammography as one of the latest innovations in women’s health care, capable of detecting breast cancer earlier and allowing treatment sooner.

Section 46A-6-106 gives consumers a private right of action. Sections 46A-5-104 and 46A-5-106 shift attorney’s fees and costs onto a defendant that violates the Act — which matters in a case where individual economic losses are measured in hundreds of dollars rather than thousands.

How Long Do Patients Have to File a Claim in West Virginia?

Filing deadlines vary by claim, and the shortest one that applies to your situation controls your planning.

• Consumer protection claims — four years. Va. Code § 46A-5-101 sets a four-year limitations period running from the date the violation occurred, for actions filed on or after September 1, 2015. The West Virginia Supreme Court of Appeals applied that framework in Harper v. Jackson Hewitt, Inc., 706 S.E.2d 63 (W. Va. 2010).
• Negligent infliction of emotional distress — two years. Va. Code § 55-2-12.
• Breach of a written contract — ten years. Va. Code § 55-2-6. Oral contracts carry five.

For patients screened in late 2023, the two-year window on emotional distress claims is the one to watch. Waiting carries a practical cost unrelated to the calendar as well: billing records get purged, imaging archives get overwritten, and the memory of what a technologist said in the exam room stops being reliable evidence.

What Mistakes Do Patients Make After a Notification Like This?

• Reading “not necessarily incorrect” as “probably fine.” The phrase describes uncertainty, not reassurance.
• Throwing the letter away. It is the cleanest single proof of class membership.
• Waiting for a refund that has not been offered. No reimbursement has been issued.
• Skipping the repeat scan over cost. The cost is recoverable. A delayed diagnosis is not.
• Assuming distance disqualifies them. Patients who traveled to the resort from other states are inside the proposed classes.

What the Shutdown Means for Screening in the Greenbrier Valley

The gap left behind is wider than the patient count suggests, because southern West Virginia was already losing ground on breast cancer.

The state data tells an uncomfortable story. West Virginia women are diagnosed with breast cancer at a lower rate than the national average — 126.8 cases per 100,000 against 131.3 nationally — yet they die of it at a higher rate, 20.8 per 100,000 against 19.2. Fewer diagnoses and more deaths point in one direction: cancers found later, when they are harder to treat. Roughly 32 percent of West Virginia breast cancer cases are caught at a late stage.

Two years of screening that cannot be relied on, in a rural corner of that state, sits badly against those numbers.

Geography compounds the problem. For women in Greenbrier, Monroe, Summers, and Pocahontas counties, follow-up imaging means a drive. CAMC Greenbrier Valley Medical Center in Ronceverte is the nearest hospital to White Sulphur Springs. Beyond that, patients look west along I-64 toward Raleigh General Hospital and Beckley ARH, or further to CAMC in Charleston and WVU Medicine in Morgantown for subspecialty follow-up. A repeat mammogram is not an errand in this part of the state. It is a half-day.

For the clinic’s out-of-state patients — many of whom booked a screening as part of a resort stay — the logistics differ but are no simpler. Records have to be requested from a facility hundreds of miles away and routed to a provider back home.

Frequently Asked Questions (FAQs)

Does the letter mean I have breast cancer?

No. The letter says nothing about your health. It says the imaging used to assess your health did not meet federal quality standards, which is why your provider needs to determine whether a repeat scan is warranted.

I live in another state. Can I still be part of the class?

Yes. The proposed classes cover everyone who received mammography at the clinic during the affected window and received the notification, regardless of where they live. Many of the clinic’s patients came through the resort from other states and other countries.

I was screened during that period but never received a letter. What now?

Contact the clinic to confirm your status and update your address, and speak with your physician about follow-up imaging. Some patients reportedly did not receive their certified letter. The date of your screening, not the arrival of an envelope, determines whether you were affected.

Is this a medical malpractice case?

No. These are consumer protection and contract claims. They rest on what patients were sold and what they paid for, not on an allegation that a radiologist misread a particular film. A patient later diagnosed with breast cancer that earlier imaging should have caught has a different and separate claim, and should have it reviewed individually.

What does it cost to have my situation reviewed?

Nothing. These matters are handled on a contingency fee basis, and the initial consultation is free.

 

Talk With a West Virginia Class Action Attorney

Powell & Majestro P.L.L.C. filed the first federal class action arising from the mammography failures at The Greenbrier Clinic and represents patients affected by the FDA’s determination. The firm has handled complex consumer class actions in West Virginia and nationwide for more than two decades, including litigation involving contaminated water supplies, defective products, and deceptive business practices.

If you were screened at The Greenbrier Clinic between October 28, 2023, and February 26, 2026, we can review your situation at no cost and explain your options.

Call (304) 346-2889 or reach us through our online contact form. You can also read more about the case on our Greenbrier Clinic mammography lawsuit page. There are no fees unless we recover compensation on your behalf.