QuackeryWatch · Bad Devices
← Back to QuackeryWatchA South Dakota device seller is serving twelve years. A distributor from Ontario served fifteen months. Both were convicted over a machine sold on cancer claims — and neither case involved thermography. Breast thermography has been sold here for more than twenty years, and its own enforcement record runs to six warning letters, one surrendered licence, and nothing else.
The question this page was built to answer is a simple one: has anybody ever been prosecuted for selling breast thermography as a way to find cancer? Readers ask it because the harm is easy to state — a woman is told her scan looks normal, believes it, and comes back to the medical system later than she otherwise would have. That is not a subtle injury. It is the kind of thing the criminal law and the professional regulators exist to reach.
Start with the fact that the criminal law does reach this territory. In April 2018 a federal judge in Rapid City sentenced the seller of a bogus medical device to twelve years in prison, and sent two of his distributors — one of them a resident of Ontario — to prison as well. The machine in that case was sold on claims to cure cancer. That case is set out in full below, because a reader needs to know the statutes exist, the investigators exist, and the sentences can be severe.
It was not a thermography case, and the distinction is the reason this page exists. The device there was a low-level laser sold as a treatment. Thermography is an infrared camera sold as a test. Different machine, different claim, different way of hurting somebody — and, as it turns out, an entirely different enforcement history.
For breast thermography specifically, we could not find a prosecution at all. Searching the published enforcement records of the FDA, the US Department of Justice and the state licensing boards in July 2026, we located no criminal charge and no conviction arising from the marketing of breast thermography as a cancer screening or diagnostic tool.
That is a statement about what we searched, and its limits are worth putting plainly. There is no single index of every prosecution in every American state and county, still less in every province, and a negative finding of this kind is never more than the sum of the places looked. What we can say is that in the records that are published and indexed, the case is not there. If it exists somewhere we did not look, we would rather print it than keep the claim.
What we did find is one practitioner against whom a regulator filed a charging document that is almost entirely about breast thermography. He is named below, with a careful account of what that document is and what it is not.
Three separate searches, three empty results. Set out plainly, because the emptiness is the finding:
| Type of action | Found? | Detail |
|---|---|---|
| Criminal conviction | None located | None located for marketing breast thermography as a cancer screening or diagnostic tool. Sellers of other unapproved devices have drawn sentences of up to twelve years — so the absence here is not because the offence does not exist. |
| Criminal charge | None located | No prosecution appears ever to have been commenced. The absence of convictions is not a story about acquittals. |
| Financial penalty | None located | No fine against anyone selling, importing or operating a breast thermography device for cancer screening. This matches the finding already recorded in Table 4 of the regulation tables. |
| Federal regulatory letter | Yes — six letters | The US FDA wrote to six named businesses between January 2011 and February 2019, one of them to a well-known physician. Every one is correspondence, not a charge. The roster is below. |
| Professional regulator accusation | Yes — one, in California | One named licensee, one case number, resolved by surrender of the licence in March 2023. Set out in full below. |
| Canadian action of any kind | None located | No charge, no fine, no college discipline decision naming a member. See the note on scope at the foot of this page. |
The California Board of Chiropractic Examiners publishes its final disciplinary actions, with the licensee's name, location, case number and a summary of the basis for the action. One entry in that list concerns breast thermography, and it concerns almost nothing else.
Gregory Mark Melvin, chiropractic licence DC 11984, La Mesa, California. Case No. AC 2022-1367. Licence surrendered, effective 10 March 2023.
The Board's published summary sets out what it alleged. Paraphrasing its list, in its order: that he was grossly negligent in conducting an inadequate evaluation of a patient; that he endangered public health, safety and welfare by improperly providing thermography as a stand-alone diagnostic tool; that he failed to refer a patient to an appropriate healthcare professional after finding symptoms of breast cancer, a condition chiropractic methods cannot appropriately manage; that he rendered professional services without providing informed consent; that he failed to inform a patient of the limitations and material risks of thermographic imaging for detecting breast cancer; that he advertised thermography in a false and misleading way; that he exceeded the scope of chiropractic practice by using thermography to detect breast cancer, which is unreliable when used as the sole method
; and that he unlawfully used the title “doctor” without the qualifier the Chiropractic Act requires.
The provisions cited are section 15 of the Chiropractic Initiative Act, section 17500 of the Business and Professions Code — the state's false advertising statute — and a series of regulations in title 16 of the California Code of Regulations covering scope of practice, advertising, negligence, referral, records and informed consent.
This is where two records that the site has been treating separately turn out to be the same record.
QuackeryWatch has cited, on the thermography overview and in the regulation tables, an FDA warning letter of February 2019 to a California imaging centre over marketing an unapproved device as a sole breast screening method. That letter went to Total Thermal Imaging, Inc. of La Mesa, California, and to its president and co-owner, Linda Hayes. Melvin co-founded that company. The clinic and the licence are the same operation, and the two documents are four years apart.
| Date | What happened | Character of the action |
|---|---|---|
| Jul–Aug 2018 | FDA inspects the firm. | Investigation |
| 13 Feb 2019 | A US network television investigation broadcasts, filmed at the clinic the previous July. | Journalism |
| 22 Feb 2019 | FDA warning letter issued to the company and its president, over a package of proprietary software and infrared cameras marketed as a sole screening device for breast cancer and other diseases. Announced publicly on 25 February with a safety communication. | Correspondence alleging violations |
| 2019–2022 | No seizure, no injunction, no civil money penalty, no prosecution located, although the letter named all of those as possibilities. | Nothing on record |
| 10 Mar 2023 | California chiropractic licence surrendered under Case No. AC 2022-1367. | State accusation, resolved by settlement |
The FDA's letter pleaded the product as a device under the Federal Food, Drug, and Cosmetic Act, because it was intended for use in diagnosing disease. The agency's position was that a thermography system marketed as a sole screening tool requires premarket approval, which this one did not have. It asked the firm to stop distributing the package within fifteen working days and set out what could follow if the violations were not corrected: seizure, injunction, civil money penalties.
So far as the public record shows, none of it followed.
This next part is our reading, not the record.
The two documents on this page are usually cited as evidence that the system works — a federal agency wrote a letter, a state board took a licence. We think the sequence shows something closer to the opposite. The FDA identified conduct it described as illegal in February 2019 and listed three escalations available to it. It appears to have used none of them. The state board's accusation, when it came, arrived four years later and was resolved by an agreement that required no admission of anything.
Between those two dates the clinic was the subject of a national television investigation. The regulator that acted was the one that could reach a person's licence, not the one that could reach the machine — and the machine, unlike the licence, is still perfectly legal to own, sell and operate as an adjunct. Nobody has ever been fined a dollar or charged with an offence over any of it.
The La Mesa letter was not the first. When the FDA published its February 2019 safety communication it listed the five it had already sent. Set out together, they are the entire federal enforcement record on breast thermography.
| Date | Recipient | Location | What followed |
|---|---|---|---|
| January 2011 | Central Coast Thermography | San Luis Obispo, CA | No escalation located |
| 22 March 2011 | Dr Mercola's Natural Health Center — Joseph Mercola, D.O. | Hoffman Estates, IL | No escalation located |
| April 2011 | Meditherm | Parkland, FL | No escalation located |
| November 2016 | Thermogram Assessment Services | Palos Verdes, CA | No escalation located |
| April 2017 | Nature's Treasures, Inc. | Glendale, CA | No escalation located |
| 22 February 2019 | Total Thermal Imaging, Inc. — Linda Hayes, president | La Mesa, CA | Business partner's licence surrendered, March 2023 |
Every one of those letters set out the same three possible consequences: seizure, injunction, civil money penalties. In eight years and six letters, we can find no instance of the agency using any of them on a thermography case.
The March 2011 letter went to Joseph Mercola, an osteopathic physician — a D.O., not an M.D., a detail at least one trade outlet got wrong at the time — and one of the largest alternative health publishers on the internet. It concerned the Meditherm Med2000 telethermographic camera used at his Hoffman Estates centre and endorsed by him for thermography centres in other states.
The FDA's objection was specific. His website presented the camera as a stand-alone device for diagnosing or screening breast conditions, in language promising early diagnosis of cancer and describing it as a safe new cancer screening tool. The agency also read the site as representing that the camera was more sensitive than the machines used for mammography. That mattered because the camera's own 510(k) clearance, granted in February 2001, covered viewing and digitally storing thermal patterns generated by the human body in a healthcare setting. It did not authorise any of what the site claimed.
Why this letter earns its place on a page about charges. It is the clearest illustration on the record of the gap between what the FDA says and what the FDA does. The agency told a publisher with an audience in the millions to stop, and named seizure, injunction and civil monetary penalties as what could follow. Fifteen years later, no such action against him over thermography appears anywhere in the public record, and thermography remains a subject he promotes. Reporting at the time noted it was not his first FDA letter.
A reader might reasonably conclude from all of the above that American prosecutors do not bring cases over fraudulent medical devices. That is emphatically not true, and the counter-example matters because it is a device case — the same category of thing this whole section documents — and because it runs the escalation ladder all the way to the end.
Robert “Larry” Lytle of Rapid City, South Dakota, sold the QLaser System, a family of roughly a dozen low-level laser devices for home use, priced from around $4,000 to $13,000. The labelling claimed they treated a long list of serious conditions — cancer, HIV and AIDS, heart disease, diabetes, emphysema, autism, paralysis. Reporting on the indictment put the claimed range at more than two hundred conditions. No published clinical evidence supported any of it, and the FDA had never approved the devices for those uses. Buyers were told “Dr. Lytle” was a retired dentist and laser expert. They were not told his dental licence had been revoked in 1998; the Justice Department's account is that it was permanently revoked over fraud and material deception.
What makes the case instructive is the sequence, because at every stage the agencies did the thing that never happened in any thermography matter.
| Stage | What happened |
|---|---|
| From 2002 | FDA told Lytle, verbally and in writing across roughly eleven years of inspections, that selling the devices without clearance broke federal law. |
| Late 2014 | The United States filed a civil complaint for injunctive relief against Lytle and 2035 Inc., trading as private membership associations. |
| 2015 | Federal court injunctions ordered the selling stopped and every purchaser refunded. |
| 2015–2017 | The order was defied: false statements to the court and to FDA investigators, collection letters sent to purchasers instead of refunds, roughly 600 devices moved out of Rapid City to upstate New York to keep them from seizure, and an attempt to open a bank account in Belize. |
| 2017 | Postal Inspectors arrested three people after a federal grand jury indictment in Rapid City. Charges included mail fraud, wire fraud, conspiracy, contempt and obstruction. |
| 20 April 2018 | Sentences imposed by US District Judge Roberto A. Lange. |
| Defendant | Role | Outcome |
|---|---|---|
| Robert “Larry” Lytle, 83, Rapid City | Leader and organiser | 12 years in prison, 2 years supervised release. Admitted obtaining at least $16,669,015. Paid $637,000 toward restitution and surrendered gold and silver coins. |
| Ronald D. Weir Jr., 39, Sioux Falls | Distributor | 24 months in prison, 3 years supervised release. |
| Irina Kossovskaia, 63, Ontario, Canada | Distributor | 15 months in prison, 2 years supervised release. |
| Fredretta Eason, Rapid City | Charged with criminal contempt | Charges dismissed |
The third name on that list is the reason this case belongs on a Canadian website.
Irina Kossovskaia was a resident of Ontario. She pleaded guilty in the District of South Dakota to conspiracy to introduce misbranded medical devices into interstate commerce with intent to defraud and mislead. She admitted making false claims about the devices' curative powers, admitted helping move hundreds of units out of Rapid City to a facility in upstate New York after the court had ordered sales stopped, kept selling until 2017, and funnelled tens of thousands of dollars back to Lytle while he was under a court order to refund every buyer. She was arrested in New York and served a US prison sentence.
We can find no Canadian action of any kind. No Health Canada advisory, recall or prosecution naming Lytle, Kossovskaia, 2035 Inc. or the QLaser has been located, and no Canadian professional body appears to have made any public statement about her. Searches of Health Canada's laser material return only the general regulatory framework for laser products.
An Ontario resident was investigated, indicted, convicted and imprisoned over an unapproved medical device — by another country. This is the same shape as the finding on the Hulda Clark page, where a Saskatchewan-born practitioner's devices drew US federal enforcement and nothing at all from her own country's regulator. If a Canadian document exists that we have missed, we would like to see it.
The state has one more. John Martin of Spearfish, then 74, was sentenced on 25 November 2013 to nine years in federal prison, with restitution of at least $209,300, after pleading guilty to mail fraud and misbranding of a drug. Martin was not a physician. He had people mail him money and samples of blood, saliva and hair, told them the samples showed cancer, called them to Spearfish, sold them herbal supplements and then pronounced them cured. The FDA's Office of Criminal Investigations and the Postal Inspection Service ran the case.
The regulator's accusation refers to a patient. Independently, the February 2019 network television investigation reported the accounts of two Californian women whose cancers were not caught after they relied on thermography. According to a trade-press summary of the broadcast, one of the two later died, having been told her scan was clear.
The woman whose account concerned this clinic went in after finding a lump. She was reported as having been given a baseline report describing a mild to moderate risk, and advised to take up some self-care measures and return in three months for a comparison scan. Uninsured and out of work, she took months to obtain a mammogram, then a biopsy, and was then diagnosed with stage 3 breast cancer. Melvin's response to the broadcaster, by email, was that she had not followed his recommendations, had not returned at three months, and that the intake form told her the report would not tell her whether she had a disease or condition.
This is the reason the page belongs in Bad Devices rather than in a section about practitioners.
Melvin's promotional biographies described him as a teacher and certifier of other doctors and technicians in thermal imaging, and listed a long training history: a 1991 clinical thermology course, further certification in 2004, a claimed period of training in 2005, and a count of several hundred scans read. After the surrender, that biography did not disappear. It remained visible on the team page of a thermography business in New York and in the “about” section of another thermal imaging company, on pages crawled in 2025 and 2026.
We make no claim that he practises at either business, or that either has done anything improper — a stale web page is often just a stale web page. The point is structural, and it is the one this whole section was built on. A regulator can take a licence. It cannot take back the training a person gave to everyone else, and it has no reach at all over the machine, which remains lawful, remains for sale, and does not need a licensee to keep working.
Elsewhere on this site we have reported that no regulated health college, in any profession, has published a discipline decision naming a member over breast thermography. That finding was searched across Canadian colleges, and for Canada it still stands. It does not hold in North America generally. California's chiropractic board published exactly such a record, with a name, a case number and an allegation list, and it has been publicly available since 2023.
Any statement of the null on this site should be read as scoped to Canada. We have corrected the phrasing here and flag it so that a reader who found the broader claim elsewhere on the site knows which version is right.
California Board of Chiropractic Examiners, Final Disciplinary Actions, published at chiro.ca.gov, page updated 30 March 2026. Entry for MELVIN, GREGORY MARK, licence DC 11984, La Mesa, Case No. AC 2022-1367, action type Surrender, effective 10 March 2023. The Board's definitions of probation, public reproval, revocation, surrender and suspension appear at the head of the same page, and the description of surrender used above is taken from it.
US Food and Drug Administration, warning letter to Total Thermal Imaging, Inc. and Linda Hayes, reference 567742, dated 22 February 2019; FDA news release and safety communication, 25 February 2019. The safety communication records five earlier warning letters to firms over unapproved thermographic devices or misleading thermography claims, the earliest June 2011 and the most recent October 2017; we have not yet identified those five firms individually.
FDA warning-letter roster: the five letters preceding the La Mesa one are listed in the FDA's safety communication of 25 February 2019 and were reported in the radiology trade press with dates and locations — Central Coast Thermography (January 2011), Dr Mercola's Natural Health Center (March 2011), Meditherm (April 2011), Thermogram Assessment Services (November 2016) and Nature's Treasures (April 2017). Accounts differ slightly on the date of the last of these, some referring to an October 2017 letter; we give the dates as the trade press listed them and flag the discrepancy rather than resolve it.
Mercola letter: warning letter to Dr Joseph Mercola, dated 22 March 2011, concerning the Meditherm Med2000 telethermographic camera, reproduced by Quackwatch and summarised in the Consumer Health Digest of 28 April 2011 and in the radiology and consumer-health trade press. The Med2000's 510(k) clearance of 21 February 2001 is quoted in that reporting.
South Dakota — QLaser: US Attorney's Office, District of South Dakota and DOJ Office of Public Affairs — press releases on the civil enforcement action against 2035 Inc. and Robert L. Lytle, on the arrests and indictment, on the guilty pleas of Ronald D. Weir Jr. and Irina Kossovskaia, and on the sentencing of all three on 20 April 2018 before US District Judge Roberto A. Lange. Investigated by the US Postal Inspection Service; prosecuted by Trial Attorney Ross S. Goldstein of the DOJ Consumer Protection Branch with Assistant US Attorney Kevin Koliner and former Assistant US Attorney Ted McBride. Contemporaneous reporting in the Rapid City Journal supplied the 1998 licence-revocation date and the price range; accounts differ on the stated grounds for revocation and on whether the claimed condition count was two hundred or three hundred, so we give the Justice Department's characterisation and the lower figure. Quackwatch also maintains a page on the case.
South Dakota — Martin: US Attorney's Office, District of South Dakota — press releases on the indictment of John Martin (23 March 2012), his guilty plea (9 May 2013) and his sentencing (25 November 2013, Chief Judge Jeffrey L. Viken). Investigated by the US Postal Inspection Service, FDA Office of Criminal Investigations, South Dakota Division of Criminal Investigation, Spearfish and Belle Fourche police and the Butte County Sheriff's Office; prosecuted by Assistant US Attorney Eric Kelderman.
Television investigation: ABC News / Good Morning America, broadcast 13 February 2019, filmed at the clinic in July 2018; and a contemporaneous trade-press summary of that broadcast. Patient accounts in this page are drawn from that reporting and are reported allegations, not findings.
Also consulted: Science-Based Medicine's coverage of the February 2019 FDA action; the companies' own published biographies and team pages.
QuackeryWatch corrects errors on the record rather than quietly. If any statement here is wrong, or if you hold a document that settles one of the open questions — the identity of the five earlier FDA letter recipients, or any charge or penalty anywhere over breast thermography — please write. A Canadian enforcement document would be particularly welcome, since we have found none.