A three-year legal battle between Cavitat Medical Technologies and Aetna has spotlighted the activities of maverick dentists who tell patients they need surgery for “cavitations” in their jaw. Many of these dentists use a Cavitat device to diagnose “neuralgia-inducing cavitational osteonecrosis (NICO),” which is not a scientifially recognized condition. In 2002, Aetna issued a Clinical Policy Bulletin which explained why Aetna would not cover diagnostic or treatment procedures related to the “NICO” diagnosis. In 2004, Cavitat Medical Technologies and its president Robert J. Jones, accused Aetna of publication of injurious falsehoods, unlawful restraint of trade, and racketeering. As the case unfolded, the court dismissed the racketeering charge and nearly all of the other charges and Aetna filed a countersuit that attacked the organizers and funders of the suit.
In 2005, Aetna filed an amended complaint (shown below) which detailed how Cavitat and members of its scientific advisory board taught dentists how to miscode insurance claims in order to get paid for diagnosing and treating NICO. An attachment to the amended complaint identifies 22 dentists who filed 427 claims that Aetna paid because they were miscoded as medical procedures. The total amount paid was several million dollars. Of these, 185 were filed by Jerry Bouquot, D.D.S., who now chairs the Department of Diagnostic Sciences at the Dental Branch of the University of Texas. In May, the University of Texas announced that since Bouquot became director of its surgical pathology laboratory, the number of specimens the laboratory received had more than tripled:
In January 2006, the judge ruled on narrow legal grounds that Aetna did not have standing to sue Cavitat because the claims had been filed by individual providers and not the company. The underlying suit was settled a few months later. Although Aetna’s countersuit did not succeed, I believe that its allegations were well founded. Quackwatch has additional information about “NICO” and Cavitat’s lawsuit.
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLORADO
Civil Action No. 04-CV-1849-MSK-OES
CAVITAT MEDICAL TECHNOLOGIES, INC.,
Plaintiff and Counterclaim-Defendant,
AND ROBERT J. JONES,
Defendant and Counterclaim-Plaintiff.
DEFENDANT AETNA INC.’S FIRST AMENDED COUNTERCLAIM
Defendant Aetna Inc. (“Aetna”) asserts this counterclaim against Cavitat Medical Technologies, Inc. (“Cavitat”) and Robert J. Jones (“Jones”), collectively the “CounterclaimDefendants.” Aetna would show:
1. The Counterclaim-Defendants and their allies advocate removing all traditional fillings, removing all root-canalled teeth, extracting healthy teeth and sawing the jawbones on patients who have normal x-rays. They advocate these procedures not necessarily to treat dental complaints such as jaw pain, tooth decay or idiopathic facial pain; rather, they advocate and perform these procedures on patients who have no dental symptoms whatsoever. They promote tooth removal and oral surgery in order to treat non-dental conditions that exceed the scope of a dental license such as chronic fatigue, multiple sclerosis and Lou Gehrig’s disease.
1 Aetna is filing this First Amended Counterclaim prior to the time the Counterclaim-Defendants have filed a responsive pleading (answer). As such, leave of court is not required. FED. R. CIV. P. 15(a).
2. State dental regulators uniformly consider these radical practices to be improper or even unethical and dangerous to the patient. The Colorado Board of Dental Examiners has specifically found such medical claims to be false and deceptive in disciplinary proceedings brought against Hal Huggins, a guru for Cavitat and its customers. See infra ¶¶ 37-40. Like Hal Huggins, Cavitat customers and members of Cavitat’s “Scientific Board of Advisors” have been investigated, disciplined and de-licensed for advertising and performing the very same services advocated by the Counterclaim-Defendants and their allies. See infra ¶¶ 41-45. Nevertheless, the Counterclaim-Defendants and their allies continue to conspire to practice and promote this type of dentistry through false and deceptive claims. See infra, e.g., ¶¶ 21-30. Because their actions pose a danger to the public, and because Aetna has been injured in the course of its business as a result of said deceptive trade practices, Aetna is entitled to sue. Hall v. Walter, 969 P.2d 224, 235 (Colo. 1998); see also COLO. REV. STAT. § 6-1-113(2)(a) & (b) (West 2005).
3. The mass of scientific and regulatory forces arrayed against Cavitat and its allies should cause them to doubt their position. Instead, they claim that they are the victims of a massive conspiracy. Their conspiracy theory evolves to encompass the “bad actor” of the moment, whether it be the Food and Drug Administration (“FDA”) or its people, the American Dental Association (“ADA”), the various state dental boards, or Aetna. The theory, however, never had any basis in fact. Instead, the vituperative tenor of the communications among Cavitat and its allies, along with insupportable claims of wiretapping, racketeering and government malfeasance, exhibit that Cavitat and its allies are engaged in a vendetta. When they brought those types of grievances to the courthouse without the facts necessary to support the allegations, they crossed the line. Attorneys and their clients may not pursue claims for the purpose of conducting a “holy war.” See Mitchell v. Ryder, 104 P.3d 316, 321-22 (Colo. Ct. App. 2004). The original plaintiffs’ claims were not substantially justified under Colorado law, and Aetna is therefore entitled to recover the damages inflicted in defending against them.
JURISDICTION AND VENUE
4. This Court has jurisdiction over these counterclaims pursuant to 28 U.S.C. §§ 1331, 1332 or 1367. The action is between citizens of different states and the matter in controversy exceeds the value of $75,000, exclusive of interest and costs.
5. Aetna is a Pennsylvania corporation with a principal place of business at 980 Jolly Road, Blue Bell, Pennsylvania 19422.
6. Cavitat is a corporation incorporated in Colorado and was at one time based in Colorado, but is now based in Texas, at 150 CR 1558, Suite C, Alba, Texas 75410.
7. Jones is an individual resident of Texas, whose business address is 150 CR 1558, Suite C, Alba, Texas 75410. At all times material hereto, Jones personally directed the activities of Cavitat complained of herein.
Cavitat And Its Biologic Dentistry Allies
8. Cavitat manufactures the Cavitat device. Jones is the inventor of the Cavitat device and is the President and CEO of Cavitat. As alleged more particularly hereafter, Jones and Cavitat promote the sale and use of the Cavitat device, dangerous and deceptive dentistry, and the collection of funds from insurers for improper practices in a fashion that is false and misleading. Every action by Jones that is alleged herein was taken in the scope of his actual or apparent authority as an officer and/or agent of Cavitat, and/or was ratified by Cavitat, and/or was taken in furtherance of the conspiracy alleged herein.
9. Wesley Shankland (“Shankland”) is the owner of a Cavitat device, frequent lecturer at Cavitat conferences, and member of Cavitat’s “Scientific Board of Advisors.” As alleged more particularly hereafter, Shankland, at the direction of and on behalf of the Counterclaim-Defendants, promotes the sale and use of the Cavitat device, dangerous and deceptive dentistry, and the collection of funds from insurers for improper practices in a fashion that is false and misleading. Every action by Shankland that is alleged herein was taken in the scope of his actual or apparent authority as an officer and/or agent of Cavitat, and/or was ratified by Cavitat, and/or was taken in furtherance of the conspiracy alleged herein.
10. Michael Margolis (“Margolis”) is the owner of a Cavitat device, frequent lecturer at Cavitat conferences, and member of Cavitat’s “Scientific Board of Advisors.” As alleged more particularly hereafter, Margolis, at the direction of and on behalf of the Counterclaim-Defendants, promotes the sale and use of the Cavitat device, dangerous and deceptive dentistry, and the collection of funds from insurers for improper practices in a fashion that is false and misleading. Every action by Margolis that is alleged herein was taken in the scope of his actual or apparent authority as an officer and/or agent of Cavitat, and/or was ratified by Cavitat, and/or was taken in furtherance of the conspiracy alleged herein.
11. Hal Huggins (“Huggins”) formerly practiced dentistry in the state of Colorado. The medical and advertising practices of the Counterclaim-Defendants, Shankland and Margolis, and other so-called “biologic” or “holistic” dentists originated with Huggins. As alleged more particularly hereafter, the Colorado Board of Dental Examiners (“the Board”) has specifically found Huggins’ practices to be both dangerous and deceptive. The Counterclaim-Defendants and their allies, however, flaunt the Board’s determinations and have continued the very same ideas and practices for which Huggins was disciplined. As alleged more particularly hereafter, they use the Cavitat device and the debated condition “NICO” to do so. 12. Jerry Bouquot (“Bouquot”) is a member of Cavitat’s so-called “Scientific Board of Advisors.” Bouquot is a frequent lecturer at Cavitat conferences. Every action by Bouquot that is alleged herein was taken in the scope of his actual or apparent authority as an officer and/or agent of Cavitat, and/or was ratified by Cavitat, and/or was taken in furtherance of the conspiracy alleged herein. Bouquot, whose students have called him “Dr. NICO,” coined the terms “NICO” and “maxillofacial osteonecrosis.” Bouquot owned and operated a for-profit laboratory in West Virginia known as Head & Neck Diagnostics of America. As alleged with more particularity hereafter, Bouquot, at the direction of and on behalf of the Counterclaim-Defendants, promotes the sale and use of the Cavitat device, the practice of dangerous and deceptive dentistry, and the collection of funds from insurers for improper practices in a fashion that is false and misleading. The Counterclaim-Defendants represented to potential customers that an Investigational Review Board (“IRB”) had been established in conjunction with Bouquot and West Virginia University. This was false. There never was an IRB sponsored by the University of West Virginia concerning the Cavitat device. Nevertheless, the Cavitat device was used for clinical experiments on human subjects.
13. Timothy Bolen (“Bolen”) portrays himself as a “Crisis Management Consultant.” Bolen has been “hired,” “retained” or “consulted” in the past by attorneys and individuals accused of medical fraud, malpractice and quackery. As alleged more particularly hereafter, Bolen is among the persons who are providing support for Cavitat’s claim against Aetna. He has obtained a piece of the potential recovery and is involved in attempts to intimidate witnesses in this action and in giving false publicity to Cavitat’s claims so that they may be used to maximum effect in attempting to injure Aetna. Every action by Bolen or his company “JuriMed” that is alleged herein was taken in his actual or apparent authority as an agent or “partner” of the Counterclaim-Defendants, and/or was ratified by the Counterclaim-Defendants, and/or was undertaken in furtherance of the conspiracy as alleged herein.
NICO Is A Disputed Condition Whose Existence
Has Not Gained Acceptance In Mainstream Dentistry
14. Neuralgia-inducing cavitational osteonecrosis (“NICO”) or NICO-like conditions have been theoretically described over the years by a profusion of names including Roberts bone cavities, Ratner bone cavities, alveolar cavitational osteopathosis, maxillofacial osteonecrosis and cavitations. NICO has been alleged to be the cause of chronic, sometimes intense, pain in the upper and lower jaw or face.
15. The evidence-based scientific medical and dental communities do not recognize the clinical significance of a NICO diagnosis. The proposed cause-and-effect relationship between NICO cavitations and facial pain is speculative at best and has not been established or consistently defined by evidence-based scientific criteria.
16. According to the American Association of Endodontists,
Many etiologies for NICO have been suggested, but none have been substantiated through research. . . .
The recommended treatment for NICO is decorication and curettage of the bony tissues. While this practice has produced relief of pain in some cases, NICO has a strong tendency to recur and to develop in other jawbone sites.
. . . [S]ome patients with long, frustrating histories of pain associated with endodontically treated teeth have been presented the treatment option of tooth extraction followed by periapical curettage in an attempt to alleviate pain. The American Association of Endodontists cannot condone this practice when NICO is suspected. Because of the lack of clear etiological data, a NICO diagnosis should be considered only as a last resort when all possible local odontogenic causes for facial pain have been eliminated. . . .
In addition, the practice of recommending the extraction of endodontically treated teeth for the prevention of NICO, or any other disease, is unethical and should be reported immediately to the appropriate state board of dentistry.
17. Shankland has described the risk inherent in cavitation surgery in graphic terms:
Surgical management of osteomyelitis and/or osteonecrosis of the jaws is similar to, but at times, more risky than such surgery in other bones simply due to the presence of the inferior alveolar canal, the maxillary sinus and the nasal fossa, and potential damage to adjacent teeth.
In the mandible, frequently the inferior alveolar artery, vein and nerve are encountered and must be relocated within the body of the mandible. This procedure is risky due to a high potential for bleeding complications and damage to the inferior alveolar nerve which may produce temporary or even permanent parethesia throughout the mandible, lip and teeth.
Further, while surgical treatment of osteomyelitis of the maxilla presents an entirely different set of problems, most notable is the entrance into the maxillary sinus, which generally requires surgical repair of the defect after removal of the infected and/or necrotic bone.
Surgical management of osteomyelitis and/or osteonecrosis of the mandible and maxilla is complex and risky surgery, exposing both the patient and surgeon to many possible surgical complications and post-operative problems.
The Counterclaim-Defendants Claim The Cavitat Device
Detects The Presence Of This Debated Condition
18. Jones is a former airline pilot, believed to be an individual with an undergraduate degree in civil engineering, but having no medical background, no training in medicine, dentistry or any medical-related field and no license to practice any form of medicine. Jones nevertheless claims that “[a]s developer of the CAVITAT and a student of the alveolar bone I am always available for consultation. I, myself, although not a dentist or medical doctor, have several publications on the subject and am a noted lecturer on bone world wide and a visiting professor . . . in Washington DC.” (spelling and grammar corrected).
19. Similarly, in purporting to advise Patient C.G. concerning her medical care, Jones stated, “I am an engineer, scientist and CEO of the world’s only bone sonography imaging company. I hold all patents on sonography bone imaging. . . . The device that we manufacture for the medical profession is unique in that it images in 3-D color the diseases of the bone marrow of the alveolar bones. . . . I have . . . participated in the world’s largest peer reviewed published research on this disease factor and lecture monthly on this subject matter to medical conferences world-wide and am considered one of the world’s leading authorities on this disease.” (spelling and grammar corrected).
20. The clinical effectiveness of the Cavitat device, however, has not been sufficiently demonstrated in the evidence-based medical community or supported with appropriately-controlled studies, including follow-up studies, published in peer-reviewed medical journals. The ADA, for example, has noted:
Although the FDA may have approved a 510(k) for Cavitat, it is important to understand that the ADA Seal Program often has additional safety and/or efficacy criteria compared to the FDA. Specifically, one of the things that the Council wants to see are well designed, independently conducted, randomized clinical trials that follow patients from baseline diagnosis until a sufficient time following treatment to be able to demonstrate clinical effectiveness of Cavitat. Cavitat would be expected to follow the health status of diseased alveolar bone throughout the course of the study. To date, the studies you have submitted, including those in your original submission and those enclosed with your March 25, 2003 letter, have only dealt with identification of osteoporetic [sic] or ischemic bone and have not followed the clinical outcome.
Cavitat’s Customers Are Placing The Public At Risk By Performing
Cavitation Surgery To Treat Non-Dental Medical Conditions
21. Among NICO’s most vocal advocates are a minority of dentists and dental surgeons sometimes called biologic dentists who espouse, among other things, that systemic neuromuscular and neurological diseases spread from “focal infection points” in the mouth such as periodontal infections, viable teeth with amalgam fillings, NICO lesions and “dead” or root canal-treated teeth.
22. Advocates of the focal point theory purport to link septic foci to cancer, ALS, arthritis, diseases of the kidney, heart, nervous, gastrointestinal, endocrine and other systems, atherosclerosis, coronary thrombosis, ischemic heart disease and other disease processes. Jones, for example, believes that almost all strokes, heart attacks, type II diabetes and cancer can be attributed to these toxins from root canals. Jones claims to have discovered that the presence of such cavitations is a precursor to cancer, multiple sclerosis, heart attacks, stroke, Alzheimer’s, autism and other diseases. Jones has applied his theories to himself. Scott McAdoo, formerly licensed as a dentist in the State of Colorado, diagnosed and treated Jones, resulting in the removal of all or nearly all of Jones’ teeth purportedly to treat Jones’ non-dental, medical problems. Jones claims to have been cured of Lou Gehrig’s disease or similar major, debilitating medical conditions as a result.
23. The focal point theory and the treatment of non-dental conditions through oral surgery are inextricably tied to Cavitat, the Cavitat device, the practitioners who use it, and the manner in which they treat their patients. Adhering to the focal point theory, biologic dentists advocate the removal of amalgam fillings, root-canalled teeth, and traditional dental work and purport to treat non-dental conditions by removing healthy teeth and performing invasive cavitational surgeries on patients who frequently have no symptoms of maxillofacial pain—the “neuralgia” that NICO is purported to induce.
24. Margolis is but one example of this type of practitioner. Margolis has given lectures at “conferences” conducted by the Counterclaim-Defendants. Without limitation, Margolis lectured at the Second Cavitat Educational Conference held August 23-24, 2002 and the Fourth Cavitat Educational Conference held August 8-9, 2004. In promoting the sale and use of the Cavitat device at those conferences, Margolis presented case studies in which he performed oral surgery involving the excision of jaw bone material, the removal of teeth, and the insertion of purported bone-generating material in the jaws of patients who presented complaining of recurrent infection, “low metabolism,” “no energy,” “no sex drive,” allergies, gastrointestinal problems, chest pains, low blood pressure, “easily winded,” thyroid problems, severe fibromyalgia, chronic fatigue, hepatitis C, “frequently tired,” “overweight,” arthritis, and “no energy, no life.” Jones boasted that Margolis did this type of surgery “almost every day, if not every day.”
25. Margolis specifically recommended the extraction of five healthy teeth for a patient, “K.B.,” and was later disciplined by the Arizona State Board of Medical Examiners. Margolis claimed that he was referred this patient to coordinate treatment by a “heath food store operator.” K.B.’s top five medical complaints were completely non-dental: “Anemia, Kidneys (Don’t Break Down Animal Proteins), Hypothyroid, Allergies – Liver/overactive immune system, Hypoglycemia.” (spelling corrected). Ironically, Margolis advised providers at Cavitat seminars how to attempt to avoid discipline by dental boards by papering a patient’s record with aggressive and self-serving “informed consent” documentation, unlike those used by mainstream practitioners.
26. Key to Margolis’ brand of dentistry is the “preparation” of his patients, “not only physically, but emotionally and nutritionally.” Among the preparation is “hydrocolon therapy” or what he crudely calls “a tube up the booty, cleans things out. And some of my patients sit there and go, ‘Ooh.’ But, oh, if you’re going to put all these toxins in the body, you’ve got to make sure they come out . . . .” After surgery, he relies upon nutritional regimens and anodyne lights.
27. Indeed, the “Cavitation Surgery Protocol” calls for preparing a patient for surgery by:
- “Vegetable Juicing,”
- “Colon Cleansing,”
- “Supplementation” with cod liver oil, digestive enzymes, proteolytic enzymes, calcium, magnesium, B vitamins,
- “Exercise” such as rebounding on a mini-trampoline to increase circulation and enhance lymphatic drainage, as well as
- “Skin Brushing” to enhance lymph drainage.
28. Post-operatively, the “Protocol” advises oral surgery patients to swish with a cayenne pepper tincture, apply hot water bottles, receive lymphatic massage, take vitamin C supplementation, and follow a regimen involving daily application of progesterone cream “3 weeks out of the month” to the “umbilicus, inner thighs, thyroid area and breast,” purportedly to enhance bone regeneration in the jaw.
29. Shankland is yet another example of this type of practitioner. Shankland stopped using the standard amalgam filling for treating cavities in 1979, claiming he “realized it was wrong” upon hearing a presentation by the now de-licensed dentist Hal Huggins. He likewise believes that “root canals are dangerous, life-threatening and, in my not-so-humble opinion, immoral to do to anyone. No question.” Shankland has been doing “cavitation surgeries” since 1986.
30. Like Margolis, Shankland presented lectures at the conferences sponsored and conducted by Cavitat and Jones, including but not limited to the Second Cavitat Workshop and Educational Conference held August 23-24, 2002, and the Third Cavitat Educational Conference held January 16-18, 2003. In his lectures, Shankland presented cases of invasive oral surgery performed on patients who had presented complaining of non-dental conditions, including one pupil being larger than the other, extreme fatigue, phlebitis in the legs, and chronic fatigue. Using his definition of “success,” Shankland claimed that his surgical success rate had increased from 35% when first starting the surgeries to 90% at present as a result of the Cavitat, patient selection, therapy with vitamins B, C & E, anodyne lamps, and ginkgo biloba. Shankland claims to perform upwards of 15 such surgeries per week.
31. At his lectures, Shankland referenced veterinary medicine as purported scientific support for his theories. Shankland stated:
[Y]ou talk to a veterinary doctor. . . . They have no problem believing the focal theory of infection. Go into their offices. They always have these goofy little drawings . . . and they always show a dog and a cat with periodontal disease and an abscessed tooth and they’ve got arrows pointing to different organ systems, the body. These veterinarians—you talk to your vet. He will tell you—she will tell you—the focal theory of infection at least exists for dogs and cats. And if for those mammals, why not us?
32. The patients who are subjected to this type of medical practice are targeted and are easy prey for unscrupulous dentists and oral surgeons who use Cavitat sonography and NICO as a springboard for promoting unconventional and potentially dangerous treatments that are untested, unproven, unethical and harmful. Cavitat and Jones contribute to this problem for their own self-benefit. Jones routinely answers patients’ inquiries about their often complex medical conditions, the cause of their complaints, and how best to treat them. In so doing, he repeatedly steers or “drives” referrals to the preferred dentists on Cavitat’s “Scientific Board of Advisors” such as Shankland and Margolis, as well as to his own, now de-licensed dentist, Scott McAdoo.
33. For example, Jones purported to advise Patient L.M., who had been diagnosed with ALS (Lou Gehrig’s Disease). L.M. wrote to Jones, “I have been recently diagnosed with ALS . . and read in the book Beyond Amalgams that you had also been diagnosed with this insidious disease. I am desperately looking for some hope, as well as a testimony of someone, anyone at all, that has managed to turn this disease around.” (emphasis added).
34. Jones responded:
You are on the right track seeking alternative medical help. Your allopathic doctors just tell you to go home and die. A very poor attitude to say the least. Dental or oral toxicity triggers the disease. . . . All ALS patients have Lymes or they test positive for the Lymes borealis in the IGENEX urine test for borealis antibodies. THIS has to be addressed but not before complete dental revision. That consists of removing all amalgam fillings, removal of all root canalled teeth, removal of all avital teeth, complete removal of all cavitations from the jawbones which will result in losing most of the rest of the teeth. . . . REMEMBER YOU CANNOT USE YOUR TEETH IN A CASKET AND YOU CAN LIVE VERY WELL WITH FALSE TEETH. I CAN ATTEST TO THAT.
(all caps in original, bold italic emphasis added, spelling and grammar corrected).
35. Jones likewise gave advice to Patient L.D., who had just been told by her dentist that she had a severe case of osteonecrosis and needed to have all of her upper and almost all of her lower teeth removed. L.D. expressed concern about the fact that Dr. Meyer, also Jones’ personal dentist, proposed to leave a few teeth in her mouth, and Jones stumped in favor of having all the teeth removed. L.D. wrote, “I have difficulty understanding that if [osteonecrosis] is so serious that it needs to be treated aggressively, then why would he suggest leaving an area untreated?” “After all,” she reasoned, “because I’m told that this is such a serious issue is the only reason I’m considering having my teeth pulled in the first place.” (emphasis added).
36. Jones replied: “[A]ll of my lowers have been removed . . . . and I am scheduled to remove the rest of my remaining uppers over the next two weeks. Believe me, all my surgeries have been worth it. I could have saved a few teeth, but it just defers the additional surgery until later.”
State Regulators And Dental Boards Condemn This Type
Of Practice And Have Disciplined Cavitat’s Allies
37. State dental boards have found and continue to find this brand of dentistry to be a danger to the public. Dental boards have been independently investigating and disciplining practitioners who advocate the theories and share the practice habits of the Counterclaim-Defendants and Cavitat’s “Scientific Board of Advisors.”
38. For example, Hal Huggins was the self-proclaimed world leader in treatment of alleged mercury toxicity caused by amalgam fillings. He shared many of the same diagnostic and treatment theories as Shankland, Margolis, and other members of the Cavitat cadre. Although he was not a neurologist, the largest part of Huggins’ practice involved the targeting and exploitation of multiple sclerosis patients. That said, he also purported to treat disorders such as tremors, seizures, Lou Gehrig’s disease, Alzheimer’s disease, emotional disturbances, depression, anxiety, suicidal ideations, systemic lupus erythematosus, scleroderma, rheumatoid arthritis, heart pains, high (and low) blood pressure, tachycardia, irregular heartbeat, connective tissue disorders, osteoarthritis, chronic fatigue, “brainfog,” digestive problems and Crohn’s disease. 39. As widely varied as these disorders are, Huggins treated them by removing all dental amalgams, metallic crowns or bridges; extracting all teeth which had root canals; and performing the same cavitation surgery advocated by Cavitat, Jones, Margolis and Shankland. Like Shankland, Margolis and Cavitat’s other agents and allies, he provided this “treatment” to patients who were experiencing no problems with their teeth, amalgams, crowns, bridges or root canal teeth and who were dentally asymptomatic.
40. After soundly rejecting the hypotheses held in common by the Counterclaim-Defendants and biologic or holistic dentists (including members of the “Scientific Board of Advisors”), the Colorado Board of Dental Examiners found that Huggins had engaged in deceptive and misleading advertising for publishing the same pseudo-science theories advocated by the Counterclaim-Defendants and Cavitat’s “Scientific Board of Advisors.” Given Huggins’ steadfast and long-standing commitment to his theories in the face of substantial reasoned evidence to the contrary, the Board found that nothing short of revocation of his dental license would sufficiently punish Huggins or protect the public.
41. Scott McAdoo (“McAdoo”), formerly associated with Huggins’ clinic, owned a Cavitat device and practiced the same brand of dentistry formerly advocated by Huggins. The Counterclaim-Defendants endorsed McAdoo’s practice, frequently referring patients to his clinic for treatment of systemic diseases through removal of their amalgams, root canals, cavitations and the like. In fact, Jones claims that he presented himself at McAdoo’s clinic for treatment of his own chronic medical conditions. As with Huggins, the Colorado Board of Dental Examiners brought charges against McAdoo for advertising that mainstream dental practices cause cavitations and consequent systemic disease that were then treated with the removal of amalgam fillings, asymptomatic root-canalled teeth, intravenous vitamin C, and the like. McAdoo chose to enter into a “plea agreement” with the Board to cease and desist from the challenged practices, surrender his license, and sell his dental practice.
42. Similarly, Margolis was disciplined by the Arizona Board of Medical Examiners for overdiagnosing and recommending unnecessary surgery and the extraction of five healthy teeth in Patient K.B. after removing all her amalgams to avoid Huggins-like “toxicity.” In fact, the patient records reveal that Margolis initially recommended a Cavitat screening for lesions based upon the Huggins-like theory that they supposedly “can produce debilitating toxins and are often located in old extraction sites, under or near the roots of root-canalled teeth, dead and/or dying teeth and wisdom teeth. Sometimes the lesions spread extensively from these locations throughout the jawbone and have proven to be highly neurotoxic.”
43. Patient K.B. complained to the Board that, at her consultation visit, she was told that she had numerous areas of infection which needed to be treated, five teeth which should be extracted, possible sinus perforations which might need to be repaired, every crown she currently had would need to be replaced, and six fillings needed to be done. She asserted that Margolis told her that a biopsy of the infected areas was needed and that he thought she had osteomyelitis or some necrotic type of lesion that would need treatment and bone grafting. K.B. told the Board that she was “in shock.” She wrote, “I was stunned that I could have so much infection and problems in my mouth and not be suffering any symptoms or pain.” (emphasis added).
44. Fortunately, Margolis was disciplined before this patient was harmed. K.B. wisely obtained a second opinion which alerted her to the risk, dangers and misdiagnosis of Margolis’s dangerous plans and prevented this unnecessary disfigurement. K.B. still has her teeth and they are causing her no problems. In fact, she appeared before the Board and stated that she had never complained of the symptoms attributed to her by Margolis in an effort to justify his treatment plan. After she complained to the Dental Board, Margolis punitively tried to bill her for the canceled appointment and for his attorneys’ fees in having to defend against her accusations.
45. Likewise, on information and belief, Shankland is under investigation by the Ohio Board of Dental Examiners, for the same type of practices that have been condemned in the Huggins case. On information and belief, Shankland operated on a patient from Pittsburgh and removed perfectly good teeth because a Cavitat scan suggested cavitations even though the patient’s x-ray was normal. The patient did not improve. Shankland’s records concerning his disciplinary investigations and his treatment of Aetna members have been subpoenaed and without just cause their production was delayed in a coordinated effort with Cavitat or its agents.
Use Of The Cavitat Device Purports To Legitimize The
Cavitation Surgeries And Increases The Danger To The Public
46. The Cavitat device, by generating purported “data” to justify a provider’s nonscientific diagnosis, encourages unnecessary and dangerous surgeries, exacerbating the danger to patients who are subjected to the theories of the biologic dentists. Cavitat representatives such as Jones, Margolis and Shankland specifically teach (contrary to the limitations imposed by the FDA) that the Cavitat should be used to detect alleged defects and cavitations that mainstream dentistry would consider normal as shown on a conventional radiograph. Consistent with that instruction, Margolis recommended surgery and the unnecessary extraction of five healthy teeth in patient K.B. who had normal radiographs.
47. Likewise, at the “Third Cavitat Educational Conference,” Shankland claimed, “I got a Cavitat in 2001. I’m more aggressive now in my diagnosis and surgical treatment than I ever was.” (emphasis added). Notwithstanding the FDA’s refusal to provide the aggressive overstated qualities and approval Cavitat sought, Shankland, who was aware of the FDA limitations, instructed conference participants to rely without question upon purported diagnostic readings from the device, stating, “When in doubt . . . trust the Cavitat. It’s never been wrong in my hands, that I have seen.”
48. Shankland likewise encourages seminar participants to remove otherwise healthy teeth based upon Cavitat readings. At the “Second Cavitat Workshop and Educational Conference,” for example, Shankland admitted:
“I’ve become more aggressive in diagnosis and surgical treatment. . . . The scoop on me was I was a good surgeon, but I was too conservative. . . . I would not take out teeth. I mean, my gosh. We’re taught to save teeth, bone structure, all we can. So, now I got a patient who, just like Mike was saying, I looked at. It’s a good tooth, but all the bone around it’s gone, dead. I’ve got a tooth in the middle of a dead sea of bone, I’d try to save that tooth. . . . So, I became far more aggressive. With any teeth, ischemic areas, they’re gone. Sayonara. Hit the road, Jack, you’re gone. There’s no doubt about it. And I’m now more extensive because I know where this crazy lesion goes. . . . So, now I’m a wild man when it comes to taking these things out.
49. Cavitat customers have been taught to “verify” or backfill their NICO diagnosis with biopsies only after performing invasive and potentially unnecessary surgical procedures. They do not, however, send bone samples and biopsies to a local, reputable, commercial or university pathology lab available to the medical community at large. Those labs cannot be depended on to “play ball” or recognize the diagnosis the dentists are attempting to support.
50. Apparently one of the only pathologists who can detect the condition is the pathologist that named it as a disorder, Jerry Bouquot. No matter where the Cavitat dentists are located, they send their samples to Bouquot, a member of Cavitat’s so-called “Scientific Board of Advisors.” Bouquot purports to grade the severity of NICO on a numeric scale that, not coincidentally, corresponds to the colors in a Cavitat reading. He uses this scale notwithstanding the FDA’s refusal to approve Cavitat as effective in the specific diagnosis of NICO or any other bone pathology and notwithstanding the existence of other conventional tools that are recognized as the “gold standard” for diagnostic imagery.
51. Almost without fail, Bouquot’s pathology reports confirm or support the questionable clinical diagnosis of the Cavitat practitioner. The practitioners use the pathology report as an after-the-fact justification for the already completed surgery to avoid a disciplinary charge of having performed experimental and unnecessary surgery, and to justify the extensive charges submitted for payment. Of course, Bouquot’s services nearly always get paid because real pathology analysis is something that insurance covers. A payor cannot tell that the pathology is for NICO-related services until after a NICO pathology report is created.
52. The risk of unnecessary surgery is exacerbated by the Counterclaim-Defendants’ choice to mis-market the machine and to appeal to the base avarice of its customers. Cavitat promotional literature promised that a practitioner could generate $115,200 in annual revenue from Cavitat scans for a 427% return on investment.
53. Jones himself represented to a prospective purchaser that “CAVITAT should be the largest most profitable center in your office. People come from everywhere just to be scanned and it should be and will soon be a necessary tool in every patient workup. The CAVITAT is CPT Coded as 76977 for sonograms of the oral facial bones. Each site has to be listed with a charge on each site along with the total. The least amount I have seen charged is $350 for a full mouth scan, and a high of $800. . . . most offices using the CAVITAT regularly report payout in 3-5 months and more than $125,000 a year in revenues from scans alone with surgery increases of more than $300,000 per year. Call Dr. Margolis in Mesa for more information on the revenues.” (spelling and grammar corrected).
54. Cavitat’s representatives echo this choreographed theme at the Cavitat conferences. At the Second Cavitat Workshop and Educational Conference, Shankland boasted that “Stevie Wonder could use those things and make money.” At the Third Cavitat Educational Conference, Shankland likewise lectured:
Now, we are in the business to help people, but we’re also in the business to make money. . . . [P]eople call and say, “You have a Cavitat?” “Yeah.” “Okay. We’ll come and see you.” I have people just because I have a Cavitat—they don’t care about—if I’m licensed. They don’t care if I know what I’m doing. “Do you have a Cavitat?” It’s like the Holy Grail, Cavitat and you take out the periodontal ligament, you’re okay.
55. Shankland went on to boast about the money he made with the machine, stating “Production from my examinations, $4,500 bucks, not counting x-rays or anesthetic blocks. Gross production per month alone for my Cavitat, $14,000, plus exams, about 18—$19,000. Now—now, that’s in one month. Add that up in 12 months. . . . [Y]ou can make money with these things.”
56. In the same fashion, at the Second Cavitat Workshop and Educational Conference, Margolis gave a presentation in his status as an agent of the Counterclaim-Defendants and one of their “Scientific Advisors” entitled “How to Use Cavitat for Diagnosis and Profit Center.” (emphasis added). Margolis instructed participants how to get paid by their patients up front, and how much one could charge for Cavitat examinations. According to Margolis, “We’ve been paid 90 percent on that. Now, we charge $25 a site, $200 a quadrant, $800 a mouth. Consultation, $98. So, for us to do a scan, full mouth scan is $898.” Margolis’ powerpoint presentation for this lecture specifically referenced the fact that Cavitat scanning leads to the profit because one can charge for more surgeries after the scan. He recommended training two staff members to sell the service and fee-splitting with non-licensed personnel by giving a percentage of the income generated and collected for the treatments. “Basic Human Nature,” he advised, was “Your staff wants to make more money.”
Cavitat Promotes The Sale Of Its Device Through Deception
57. The Counterclaim-Defendants promote the sale and use of the Cavitat device by organizing their own conferences. These conferences are false and deceptive.
58. In addition to the condemned practices previously alleged, Cavitat and Jones affirmatively, purposefully and persistently misrepresent the status and meaning of the limited marketing clearance they have received from the FDA. Cavitat claims that it began producing and selling its devices in the 1990s. It was not cleared for sale by the FDA at that time. On information and belief, various versions of the Cavitat devices were marketed and sold prior to FDA clearance and before any application was made by Cavitat to the FDA to clear the device for marketing.
59. In their presentation to the FDA on August 9, 2001, Counterclaim-Defendants claimed that the Cavitat device could “accurately portray and image necrosis, holes or demineralized area of the bone down to an area of less than 1/64th of a square inch” and that the color palette of the Cavitat device was “tuned to the vitality or ever increasing areas of necrosis changing from green (vital) to chartreuse (ischemic) to yellow (necrotic) to red (cavitational osteonecrosis).” The Counterclaim-Defendants advanced the focal point theory that NICO “lesions” are “increasingly being linked” to diseases such as type II diabetes, MS, Lou Gehrig’s disease, Parkinson’s disease, Chronic Fatigue Syndrome, fibromyalgia and Lupus. The members of Cavitat’s “Scientific Board of Advisors” then presented the results of their purported “research” to the FDA and argued in Cavitat’s favor for approval of its application.
60. The FDA expressly rejected Cavitat’s request to label and market its device as capable of diagnosing NICO or of distinguishing between normal and diseased bone. In disapproving Cavitat’s proposed labeling for the device, the FDA included a specific statement to the effect that the device had not been proven capable of distinguishing diseased bone from normal bone: “The clinical significance and correlation of the CAVITAT™ (Ultrasonograph) images, including column height and color grading, has not been established for specific osseous pathology, or normal bone. Positive images represent alveolar regions that attenuate ultrasound signals.” Moreover, the FDA also rejected Cavitat’s attempt to have the Cavitat device marketed as a stand-alone diagnostic tool, but instead tested it as the technical equivalent to an already marketed sonograph device that was only to be used as an adjunct to standard radiographic evaluation (x-rays) and clinical diagnostic procedures.
61. Nevertheless, having only received limited 510 k clearance to market the device with a specific limiting disclaimer, it misrepresented to potential customers that it had received full approval from the FDA to specifically market the device for its promoted uses. Indeed, they claimed that the FDA not only bought into their unproven medical/dental theories but endorsed their product as a government-granted monopoly. The Counterclaim-Defendants almost never include the disclaimer required by the FDA in their marketing materials.
a) Jones, for example, referred Patient A.G. to four dentists, among which was Margolis, claiming that the Cavitat was “a proven imaging system approved by EVERY FDA in the world, no other imaging system has met these requirements. . . . The CAVITAT is the best and only system to diagnostically image the Cavitational process, it not only has arrived but is essential for any dentist that really cares for the health of his patients.” (caps in original).
b) In his August 12, 2003 rant against a New York Times piece opining that amalgam fillings were safe and effective, Jones claimed that the Cavitat device was “approved by every FDA in the world including the USA.”
c) Similarly, at the Second Cavitat Workshop and Educational Conference, Shankland represented (among other things) that the non-existent FDA approval was a basis for defying the standards of the American Dental Association and state dental disciplinary boards. Shankland stated:
this is a recognized FDA standard of care. I don’t care what the ADA says. I don’t care what my state dental board says. This is a standard of care today. The FDA declared it. That’s United States government, a little bit higher than the ADA . . . .
62. Cavitat’s advertisements are directly contrary to the FDA’s limitation on how the Cavitat device could be marketed, and the requirement that it be used in conjunction with conventional radiographs. Cavitat specifically advertised, for example:
a) “Finally, an imaging device that absolutely performs a quantitative analysis of the alveolar process! The CAVITAT™ Ultrasonograph 3-D color image defines bone density with an accuracy rate that has never before been available (98.2%) and is revolutionizing the effectiveness of implantology.”
b) “The CAVITAT™ scan on the left indicates severe low bone density in the right mandibular molar region that is not readily visible on the radiograph. . . . It is better because it was designed to be better at what it does!” (emphasis in original).
63. The Cavitat device was mislabeled, misbranded and illegally being promoted for off-label uses and, therefore, was never actually allowed to be marketed, sold or used. On information and belief, Cavitat, its management, investors, “scientific advisors,” “researchers,” “investigators,” and users knew or should have known that since at least 1999, Cavitat was engaged in the illegal sale, marketing and use of the Cavitat in unlawful human clinical research involving an adulterated or misbranded medical device in violation of the Federal Food, Drug and Cosmetic Act (the “FDCA”). These violations of the FDCA include but are not limited to:
a) The manufacture, preparation, propagation, compounding, assembly, or processing of an unregistered medical device, FDCA §§ 510(a)–(j), 21 U.S.C. 360(a)-(j);
b) The failure and refusal to comply with the responsibilities of sponsoring an Investigational Device Exemption (“IDE”), 21 C.F.R. part 812, FDCA § 310(q)(1), 21 U.S.C. § 331(q)(1);
c) The sale, manufacture, promotion and use of the Cavitat without requisite FDA clearance or approval, FDCA §§ 501(f), 502(o), 21 U.S.C. §§ 351(f), 352(o);
d) The sale, manufacture, promotion and use of the Cavitat and introduction into interstate commerce the misbranded, adulterated Cavitat medical device, FDCA § 301(a), 21 U.S.C. § 331(a), FDCA 501(i), 21 U.S.C. 351(i);
e) The sale, manufacture, promotion and use of the Cavitat which was not manufactured in accordance with the required manufacturing standards, FDCA § 501(h), 21 U.S.C. § 351(h), FDCA § 520(f), 21 U.S.C. § 360j(f), 21 C.F. R., part 820;
f) The sale, manufacture, promotion and use of the Cavitat promising qualities it did not have, FDCA § 501(c), 21 U.S.C. § 351(c), 21 C.F.R. § 810.4;
g) The Misbranding of the Cavitat as a medical device including false and misleading claims, FDCA § 502(a), 21 U.S.C. § 352(a);
h) The failure to report significant changes or modifications to the Cavitat, 21 C.F. R. § 807.81(a)(3);
i) Failure to adhere to responsibilities under the alleged IRB review, 21 C.F.R. §§ 812.42, 812 43(a) and 812.46;
j) Failure to establish investigational plans and supervise investigators, 21 C.F.R. §§ 812.25, 812.45;
k) Failure to maintain records as required by 21 C.F.R. § 812.140;
l) Failure to report malfunctions of the Cavitat with required Medical Device Report (“MDRs”), FDCA § 519(a), 21 U.S.C. § 360i;
m) Failure to report and maintain records of adverse events or injuries involving the Cavitat, 21 C.F.R., part 803; and
n) The filing of false and misleading reports, FDCA § 301(q)(2), 21 U.S.C. § 331 (q)(2)(a).
64. Cavitat’s other advertising likewise continued to propagate Huggins’ medical theories, claiming, for example, that the “latest scientific studies” had proven that NICO lesions were “highly neurotoxic” or inhibit “protein and enzyme absorption essential for all cellular functions which contribute to, or induce, systemic, cellular disease.”
65. Likewise, long after the Colorado Board of Dental Examiners punished Huggins for advertising that NICO causes MS, cancer and the like, Cavitat claimed in its marketing materials that Cavitat screening was important because “CURRENT RESEARCH INDICATES COMPONENTS OF OSTEONECROTIC JAWBONE MAY CONTRIBUTE TO:
- HEART DISEASE
- CHRONIC FATIGUE
- ACCELERATED AGING
- TOOTH LOSS
- MS” ( All caps in original).
66. Cavitat’s efforts to hide the truth and misrepresent the facts are not limited to the FDA or to patients who unwittingly submitted to experimental dental procedures without informed consent. On information and belief, prior to filing an application with the United States Patent Office for a patent on the Cavitat device, Jones was aware of Patent No. 5,483,965 previously issued to Scott A. Wiener and Phillip J. Rossman for an ultrasonic densitometer device and method. Patent No. 5,483,965 is highly relevant and material to the claims of the Jones’ patent. Jones knowingly and intentionally deceived the Patent Office by failing to disclose this relevant prior art during the prosecution of his application as required by 37 C.F.R. § 1.56. When examining Jones’ patent application relating to the Cavitat device, the patent examiner did not have before him the previously-issued Patent No. 5,483,965. The patent on the Cavitat device is invalid, because had the examiner known of the prior art, the subsequent patent to Jones would not have been issued. Moreover, Jones’ violation of the duty of disclosure through his intentional misconduct constitutes inequitable conduct or fraud on the Patent Office which renders the subsequently-issued patent on the Cavitat device unenforceable.
Aetna Denies Coverage For Services And Supplies, Including NICO Services
And Supplies, That Are Experimental Or Not Generally Accepted
67. Aetna is a managed care company that provides various claims administrative services to benefit plans that are regulated by federal law although various state laws also affect or regulate certain aspects of plan administration. These benefit plans are established or maintained by employers for the purpose of providing health care coverage and other benefits to employees. Indeed, the vast majority of Americans with health care coverage receive their health benefits from such benefit plans.
68. Some benefit plans can be funded through the purchase of insurance or otherwise. Other benefit plans are self-funded such that the employer and employee directly or indirectly fund the available benefits. In all instances, the plan has a process for employees to submit claims for benefits pursuant to the terms of the various benefit plans. Aetna provides various claims administrative services to thousands of plans in the country and has millions of Aetna members nationwide who receive their health care coverage from Aetna or its affiliates.
69. Aetna typically serves as the claims administrator for the health benefit plans. In connection with this role, Aetna usually has fiduciary duties to the benefit plans, including determining which claims submitted by members are eligible for reimbursement or payment under the terms of the health benefit plan. In connection with this role, Aetna must follow federal and state statutes and regulations addressing plan administration which require it to provide a written basis for its benefit and coverage decisions in connection with claims for benefits submitted by its members or their health care providers.
70. While not all benefit plans are identical, the terms of the benefit plans to which Aetna provides administrative services typically contain an experimental or investigational exclusion. This exclusion typically defines a drug, device, procedure or treatment as investigational or experimental if there are insufficient outcomes data available from controlled scientific trials published in peer-reviewed literature to substantiate its safety or effectiveness for the disease or injury involved, or where a recognized national medical or dental society or regulatory agency has determined that it is investigational or experimental.
71. Aetna’s responsibilities are governed by numerous contractual relationships. Aetna has administrative services agreements with employers and plan sponsors in which Aetna agrees to provide claims administrative services in exchange for compensation. Aetna likewise provides insured products in which premiums are paid by members, sometimes in combination with their employers, in return for which Aetna pays covered benefits and is compensated for administering those benefits. Such contracts become more burdensome and less profitable if members, providers and others are involved in a concerted effort to attempt (and sometimes succeed) in subverting the limitations on coverage by continually submitting requests for benefits on claims that are known not to be covered.
72. Providers who treat Aetna members and/or take assignments of benefits from those members have a duty
- to act in good faith;
- to communicate honestly with Aetna;
- to act faithfully to the agreed common purpose of providing high quality covered services to Aetna members that are safe, medically effective and consistent with the ethical and professional requirements of licensed professionals;
- to act consistent with Aetna’s justified expectations of licensed professionals;
- to exercise diligence and proper standards of professional judgment;
- to refrain from violating community standards of decency, fairness or reasonableness;
- to refrain from subterfuges and evasions;
- to refrain from evading the spirit of the bargain;
- to refrain from willfully rendering imperfect performance;
- to refrain from abusing their power over patients; and
- to cooperate with Aetna’s performance of its responsibilities in accurately determining coverage and paying claims.
73. Aetna members and health care providers with whom Aetna has actual and prospective contractual and commercial relationships have an interest in knowing in advance of contemplated surgery whether a procedure or device is or is not a covered benefit under the terms of the relevant insurance plan.
74. One way in which Aetna provides the basis for its claims determinations to members and their health care providers is the development and publishing of Clinical Policy Bulletins (“CPBs”). Aetna has hundreds of CPBs. Generally, CPBs provide information to Aetna’s members, prospective members and their respective health care providers and others regarding various medical conditions and treatments.
75. The CPBs provide Aetna’s coverage position and the basis for its coverage position. In this fashion, Aetna members and health care providers are supplied information (often in advance of a contemplated surgery or treatment) as to whether a procedure or device is covered or not under the terms of their employee benefit plan. This is one way in which Aetna fulfills its duties to the employee benefit plans to which it provides services.
76. CPB 642 advises members and their health care providers that Aetna considers treatment by the Cavitat device to detect NICO in jawbones to be experimental and investigational because there is no adequate scientific evidence to support its clinical value. Additionally, CPB 642 advises members and their health care providers that surgery for NICO, including the scraping of “infected cavities” and removal of vital or root canal-treated teeth, is considered experimental and investigational because the clinical significance of NICO is in question.
77. The basis for Aetna’s coverage determination regarding the Cavitat device and NICO surgery being investigational and experimental is contained in CPB 642, which is reviewed periodically, and updated in the event that additional information regarding the subject matter is obtained, provided or discovered. As a matter of law and public policy, the value of CPBs and other statements regarding coverage such as Explanations of Benefits (“EOBs”) are of such a value to members, providers and the public that they are privileged from claims of disparagement. Aetna is privileged to publish CPBs for the protection of the interests of third persons and the public, in addition to its own interests. Aetna is also privileged to share coverage information with others having a common interest in the subject matter of the CPBs.
78. There is no doubt that a review of CPB 642 provides Aetna’s members and their health care providers notice that NICO-related treatment is not covered under health plans to which Aetna provides claims administrative services. Nonetheless, aided and abetted by Cavitat and Jones, certain providers have utilized various means to defraud Aetna by misrepresenting, concealing or otherwise mischaracterizing the services rendered to patients for the purpose of obtaining payment for non-covered services.
Cavitat Has Long Known That Aetna Does Not
Cover NICO-Related Services And Supplies
79. Cavitat has never operated under any illusion that Aetna covers NICO-related services and supplies. To the contrary, it knows now and has long known of Aetna’s coverage position. Indeed, it knew Aetna’s position even before Aetna published CPB 642. CPB 642 reflects Aetna’s long-standing policy concerning the non-coverage of NICO and NICO-related claims.
80. Before CPB 642 was published, Jones, individually and as an agent for Cavitat, communicated extensively with an Aetna insured, identified herein as Patient F., whose NICO and Cavitat device claims had been denied. Jones coached Patient F. on how to respond to Aetna’s claim-related communications. Based on this correspondence, there is now no doubt that Jones and Cavitat knew that NICO-related treatment, including Cavitat scans, were not covered under health plans to which Aetna provides claims administrative services.
81. For example, in a series of e-mails in 2002, the Counterclaim-Defendants were called upon to assist Patient F. in the attempt to secure payment from Aetna. In July 2002, Jones responded to the inquiry misrepresenting that “The CAVITAT is FDA ‘approved’ for imaging the Alveolar process both in the mandible and maxillas [Ref. #K011147]. The CAVITAT is also AMA CPT coded as 76977. If Aetna is refusing to pay and they pay for all correctly coded CPT procedures you have legal ground for recovery.”
Cavitat Instructs Its Customers On How To Obtain Payment Through Deception
82. Counterclaim-Defendants know that Aetna does not cover NICO-related services. Counterclaim-Defendants likewise know that Aetna does not cover the treatment of non-dental conditions through dental surgery based upon the toxicity and focal point theories shared by the Counterclaim-Defendants and their customers. Counterclaim-Defendants know that if a claim is submitted to Aetna that truthfully and prominently disclosed that NICO was the condition being treated or that oral surgical procedures were being undertaken to treat non-dental conditions, the claim would not be paid.
83. At its “conferences,” Cavitat had its speakers preach the value of charging the patient cash “up front” for surgery and diagnosis followed by the submission of claims for dental services sometimes disguised as medical codes on a fee-for-service basis. Cavitat offered “assistance” on how to create invoices that disguised that the diagnosis, surgery and treatment was for NICO and also furnished boilerplate operative notes to induce the patient to apply for reimbursements from the payor that Cavitat and the speakers knew or should have known were not reimbursable services. Cavitat also provided advice at these conferences on price-fixing as well as form “treatment plans” designed to maximize the profitability of the Cavitat for its owner at the expense of the patient and the payor.
84. Counterclaim-Defendants provide their customers and attendees with a laundry list of American Medical Association (“AMA”) Current Procedure Terminology (“CPT”) codes and ADA codes. Nowhere in the AMA or ADA CPT Codes is there a descriptive term or procedure for the treatment of NICO. Likewise, the World Health Organization has not recognized NICO as a pathologic condition in its publication, “International Classification of Diseases, Ninth Revision” (“ICD-9”), which serves as the generally-accepted standard for describing recognized diseases and illnesses. These codes generically apply to conditions and procedures that are not related to NICO. Counterclaim-Defendants teach customers how to use the codes when billing insurance companies for the diagnosis and treatment of NICO, NICOrelated conditions, or oral surgery performed to treat non-dental maladies.
85. Large insurers like Aetna handle tens of millions of claims in any given year. In order to do so, Aetna must depend upon the essential honesty of providers who seek payment through a system of auto-adjudication in which a computerized claims system automatically authorizes payments and issues checks based upon procedure codes entered by providers, largely without the intervention of a human being with respect to each claim. The Counterclaim-Defendants and their customers know that this is the case. The majority of medical providers act honorably and in good faith to accurately disclose and bill for the services they render to Aetna members and their patients. Aetna is required to promptly adjudicate those claims under applicable regulatory requirements.
86. Use of these descriptive codes for Cavitat screening and cavitation surgery, with the knowledge that Aetna does not cover NICO and does not cover oral surgery to treat nondental conditions, is intended to secure payment for services and supplies through concealment and deception that the Counterclaim-Defendants and their customers know are not covered. Cavitat practitioners do not disclose that they are performing cavitation surgery primarily, if not exclusively, to treat non-dental and systemic diseases according to the theories shared in common by Huggins, McAdoo, Jones, Margolis, and Shankland. The Counterclaim-Defendants and their customers know that if Aetna knew this information, the claims would not be paid. The Counterclaim-Defendants and their customers intended and still intend to deceive Aetna into paying non-covered claims in reliance on the code information supplied by the Counterclaim-Defendants to their providers and in ignorance of the true nature and/or purpose of the services being provided. Margolis, and on information and belief other providers as well, disguise the fact that they have performed a Cavitat scan and that they are performing cavitation surgery by increasing the surgical charge rather than billing separately for surgery and diagnostic imagery.
87. Aetna has been deceived into paying for care that is not only excluded under the terms of the plans it administers, but is also dangerous to its members and to the general public. Aetna is still investigating the full extent to which it has been deceived, but some such claims have been identified to date. Margolis, for example, claimed before the Arizona Board of Dental Examiners and to the Counterclaim-Defendants that he had a receipt from Aetna in the amount of $4300 for cavitation surgery and Cavitat screening. On information and belief, the providers who have engaged in the improper billing and treatment practices described herein include, but are not necessarily limited to, William Glaros, Stephen Evans, James Shen, Vincent DiLorenzo, Wesley Shankland II, Tony Roeder, Tony Lim, Blanche Grube, Thomas Thomasson, Thomas Colpitts, Mark A Breiner, Nicholas Meyer, Lowell Weiner, Marilyn Jones, Michael Baylin, Scott McAdoo and Thomas Boc.
88. Ex. A to this amended complaint is a non-exclusive listing of improper claims submitted to and paid by Aetna. At the Counterclaim-Defendants’ instruction or encouragement, the claims were submitted in such a way as to disguise that they involved NICO-related services or supplies and/or oral surgery undertaken to treat non-dental systemic diseases. The materials submitted in connection with the claims identified in Ex.A. were false and deceptive. The Counterclaim-Defendants and their customers knew that the materials were false and/or acted recklessly with regard to their truth or falsity. The Counterclaim-Defendants and their customers intended Aetna to rely upon those materials, Aetna did rely upon those materials, and as a result suffered injury. Aetna incorporates Ex. A by reference as if set out in full.
The Counterclaim-Defendants Sued Aetna Because They Blame
Medicine’s Refusal To Accept Their Bizarre Practices On A Conspiracy
89. The Counterclaim-Defendants have brought this litigation out of their conviction that the FDA, the ADA, and Aetna are involved in a conspiracy to destroy them. As a result of their conspiracy theory, Counterclaim-Defendants have subjected their perceived “enemies” to threats and rants of a type not tolerated in civil society. For example, in an e-mail dated January 14, 2002 to numerous providers, Jones ranted:
A little input from my side [long known in the ADA as the far side or fringe element]. Mercury amalgam, the ADA’s crown jewel, long known to be hazardous to recipients will never be eliminated as long as the NATIONAL COUNCIL AGAINST HEALTH CARE FRAUD is allowed to operate unchallenged. This is public enemy #1 in my opinion. DR. ROBERT BARATZ, MD, PHD, DDS [self appointed President after the ouster of Steven Barrett] IS A PAID GUN FOR THE STATE DENTAL BOARDS, EVEN THOUGH IN MY OPINION IS AN IDIOT BUT HAS QUALIFIED HIMSELF AS AN EXPERT WITNESS BY HIS CREDENTIALS EVEN THOUGH HE HAS PERJURED HIMSELF SEVERAL TIMES. THE JUDGES LET HIM OFF THE HOOK AS IN ADMINISTRATIVE HEARINGS THERE IS NO LAW ENFORCING AGAINST PERJURY! Dr. Baratz knows this so he just lies. The motive, POWER, EGO AND PROBABLE PAYOFFS from the ADA sister organizations as high as $25,000 a day for his testimony against dentist charged by the board [taxpayer money authorized by the State Attorney General. . . . .Dr. Baratz also has an inside line to the dental division at the FDA thru apparently Dr. Susan Runner, Director and Dr. Robert Betz vice Director of Dental apparatus in the FDA. Betz had inside knowledge and has conspired with Runner and Baratz to hold up clearance on the CAVITAT even though all of the FDA except Betz and Runner say we have met all the requirements including SAFE and EFFECTIVE.
(All caps in original, grammar corrected).
90. The Counterclaim-Defendants’ attacks include actual and threatened litigation that has no basis in fact or in law, but instead is designed and intended to use the litigation process and its related expenses as a weapon to bully compliance to their point of view. For example, in a September 18, 2004 e-mail to a third party, Jones claimed that:
In January 2004 the ADA started covertly directing Dental Board here in the US to go after dentists using the CAVITAT so as to intimidate other dentists from purchasing a unit from us . . . On August 12th this year we filed a legal action alleging that the Aetna Insurance Company , National Council Against Health Care Fraud, each of their officers . . . and two dentists of this group acting as paid consultants to Aetna misrepresenting the facts about what the CAVITAT does and is. We have alleged that they have been racketeering under both the State of Colorado RICO Statutes and the USA RICO Act. We have them in writing. . . 157 violations of these laws . . . .
(grammar and spelling corrected). Similarly, Margolis threatened that if any penalty were imposed on him by the Arizona Board of Dental Examiners, he would “file along with Bob Jones for Racketeering (RICO) which would carry a mandatory 3 year jail sentence! This would be done in Federal Court, which takes these fish out of their pond and puts them into a big ocean with the real sharks.” (spelling and grammar corrected).
91. Jones also brought his conspiracy theories to bear on Margolis’ dispute with Board members from Arizona. For example, on February 23, 2004, he threatened a Board member:
Your reference to NICO or cavitational osteopathosis is very disturbing for a dentist that is politically motivated as a member of the Arizona Dental Board. Since there are 2011 peer reviewed science papers that have been published in honorable science journals and zero  publications of papers siding with your opinion, can I ask what science you are basing your opinion on? . . . It is advised that you educate yourself or have you committed intellectual suicide as so many self-professed leaders in dentistry have done. What I see is a conspiracy by ADA dentists to commit acts of criminal negligence against the American Public by prosecuting and persecuting dentists who act responsibly in informing patients of a very serious progression of a disease . . . An undereducated dentist like yourself that takes actions against dentists that are properly educated is committing RICO and should be held accountable as should the Directors of the ADA and the National Board of Dental Examiners. . . . The ADA and its member Quacks are the only people who do not endorse the [Cavitat] system. Since I invented the technology and asked the ADA to grant a seal of Acceptance to this technology there has been an organized boycott of the product occurring because of intimidation of the dentists who have purchased the system by the force of the NBE, ADA and State Dental Boards exerts. RICO is a very serious charge, [and] I suggest you rethink your actions and educate yourself properly. . . . See you in Court SOON!
(allcaps in original, spelling and grammar corrected).
92. The real-time business records relating to Cavitat’s business show that it was not a conspiracy, but rather Cavitat’s own defects and shortcomings that caused its business reverses. The limited nature of the FDA approval and the ADA’s refusal to endorse the Cavitat device negatively impacted the prospects of the company, which had always been chronically undercapitalized and probably insolvent from the first moment of its existence. Most importantly, the market for the Cavitat device is limited by Jones’ choice to associate it with the debated condition of NICO, and the fringe elements of biologic dentistry.
93. Right from the start, the Counterclaim-Defendants promoted the sale of the Cavitat device by attending conventions and conferences for biologic dentists, holistic medical practitioners and naturopaths. In addition, the Counterclaim-Defendants specifically advertised to and held their own seminars for biologic dentists, holistic medical practitioners and naturopaths. Presenters at these seminars included Boyd Haley, Bouquot and Margolis, known proponents of medical theories that are not accepted by the Colorado Board of Dental Examiners or mainstream medicine. The testimonials in Cavitat’s advertisements were provided by the likes of Christopher J. Hussar, the now de-licensed McAdoo, and Boyd Haley, known proponents of medical theories that are not accepted by the Colorado Board of Dental Examiners or mainstream medicine.
94. The Counterclaim-Defendants specifically advertised the Cavitat device as a way to generate information to combat the dental boards who were enforcing traditional practice standards. For example, in a “Dear Doctor” letter dated July 17, 2002, Jones wrote:
It’s time to go on the offensive in protecting your right to practice correct dental medicine when predatory dental regulatory boards are challenging your treatment of patients by removing infected endo treated teeth and resulting cavitations.
(Bold print in original).
95. Likewise, in directions concerning “How to Utilize” the Cavitat device, Cavitat represented that the device had an “ADDITIONAL LEGAL BENEFIT.” (All caps and bold in original). Cavitat stated:
DOES YOUR STATE DENTAL BOARD FROWN ON YOU MAKING A DIAGNOSIS OF CAVITATIONAL OSTEONECROSIS BASED SOLELY ON X-RAY BECAUSE X-RAY SHOWS ONLY 40% OF THE LESIONS? IF SO, ADD THE CAVITAT TO YOUR DIAGNOSTIC WORKUP TO ADD THE REMAINING 60% OF DATA NEEDED TO INSURE (sic) A 98-100% ACCURATE CLINICAL DIAGNOSIS.”
(All caps in original)
96. The Counterclaim-Defendants also refused to accept that the FDA’s decision might have been based upon the state of existing science. Rather, they continued to advance their conspiracy theory and misinformed their investors that the FDA’s decision was improperly engineered by FDA personnel with political agendas. Among other things, the Counterclaim-Defendants claimed that FDA approval was stymied by Dr. Runner at the FDA because of her association with the ADA. Jones claimed that Runner “receive[d] her marching orders direct from Chicago [the ADA’s headquarters] even though she is on the taxpayer’s payroll.” (spelling and grammar corrected). Jones also claimed, “I think it is recognized by her superiors at the FDA she was unethical and negligent in handling CAVITAT, but have you ever tried to ‘fire’ a Federal Employee . . . .”
97. Cavitat was also unable to get the ADA’s “seal of approval.” Like the FDA, the ADA questioned NICO as a scientifically-recognized malady, and questioned the documentation that supposedly supported the clinical effectiveness of the Cavitat device in detecting NICO. Just as it had done with the FDA, Cavitat refused to accept an opinion based upon science that disagreed with its position, blaming a conspiracy instead. As a result, the Counterclaim-Defendants directed specious threats of litigation against the ADA for its refusal to approve the device. In 2001, Jones expressly communicated his intent to “go after” the dentist who testified against his position “along with the ADA puppets at the FDA. He has conspired to delay our approval with the FDA . . . .”
98. The Counterclaim-Defendants reiterated their conspiracy theory in an e-mail dated July 1, 2004 with the subject line: “FDA Criminals” In the e-mail, Jones stated,
[W]hen you challenge the FDA, the combined forces of the ADA will economically destroy you with unwarranted inspections, charges and boycotts of the device. These are the two most powerful agencies in the whole world, the FDA and ADA. The FDA, under the guidance of Al Gore when he was VP, seized control over every product manufactured in the USA and the world in the name of safety. From tongue depressors to bed pans, a 510k or PMA has to pass through the device testing and approval at an unwarranted cost to the company and taxpayer. . . . Susan Runner, as a retired military officer . . . knows how to play the power/force like a fiddle but she is corrupt and that is the break we need to prevail. A full Congressional Investigation and overhaul is needed today . . . Look into her finances; she owns a lot of expensive resort property up on the East Coast. A federal employee would be more than hard pressed to qualify [for] this type of vacation home. Look at her connections to [National Council Against Healthcare Fraud]. She was, until about two years ago, listed as one of their dental advisors, which is in itself [an] illegal act as a conflict of interest for a federal employee. Find the money trail. Follow the greed. Get down and dirty!!! There seems to be no one in the Federal Government, including the majority of elected officials, that is not on the take.
(spelling and grammar corrected).
99. Nevertheless, having blamed the FDA, the ADA and even September 11th for their lack of business success, the Counterclaim-Defendants sued Aetna little more than a month after the “FDA Criminals” rant. Their only complaint is that Aetna’s own opinion of the science agrees with the mainstream, which includes the FDA and the ADA.
100. To fund this baseless litigation, Cavitat solicited funds from third parties who had invested in the company, some of whom had a monetary stake in its survival, as well as others whose livelihoods derived from the use of the Cavitat device, and created the Cavitat Legal Fund. In exchange for money to fund the litigation, Cavitat promised each of these individuals a share of the anticipated recovery in this case. The individuals who contributed money to this improper and frivolous litigation effort included Margolis, Darrel and Patricia Hershey of Parker, Colorado, Dr. Glaros of Houston, Texas, Dr. James Medlock of West Palm Beach, Florida and Drs. John Tate and Robert Jones of Spartanburg, South Carolina.
101. Cavitat also promised a percentage of the anticipated recovery to Timothy Bolen, the so-called “Crisis Management Consultant.” Jones contacted Bolen in connection with the disciplinary prosecution of McAdoo in an effort to find material to humiliate and discredit the expert witnesses for the state. Cavitat employed a similarly ruthless tactic designed to intimidate and obstruct the testimony of Dr. Robert S. Baratz who was a third-party witness under subpoena in this action.
102. Cavitat and Jones attempted to hide from Aetna and the Court the fact that Bolen was a partner with Cavitat in the Cavitat Legal Fund and had a known and demonstrable economic self-interest in improperly influencing this litigation until the Court ordered production of documents reflecting this fact. In open Court, Cavitat and Jones described Bolen as a “loose cannon” and described his accusations as often false and wrong, and yet failed to admit that Bolen was the press agent, consultant and agent-in-fact for the Cavitat Legal Fund, Cavitat and Jones.
103. Cavitat frivolously named Dr. Baratz and other third parties as purported “RICO” racketeers. When given an opportunity to depose Dr. Baratz, Cavitat spent about 40 seconds regarding these groundless accusations and when given full opportunity to plead the facts supporting their preposterous racketeering claims, the Counterclaim-Defendants had no claim to plead. Beyond the absence of any conspiracy involving Dr. Baratz, the Counterclaim-Defendants made threats of additional litigation against Dr. Baratz for the improper purpose of attempting to procure Dr. Baratz’s agreement not to testify against Cavitat owners in proceedings brought by state dental boards and in malpractice lawsuits. This secret gag deal was promptly rejected by Dr. Baratz and his counsel.
104. Cavitat, Jones, Bolen and others have engaged in a campaign to intimidate and obstruct testimony of witnesses under subpoena in this case by various means including the posting of false representations on the Internet and boasting that the witnesses in this case should fear Bolen when he arrives unannounced in hearings where they testify. Without limitation:
a) The Counterclaim-Defendants, through Bolen, republished the criminal enterprise allegation, for which the Plaintiffs did not have the facts.
b) The Counterclaim-Defendants, through Bolen, called the physicians in the supposed conspiracy “testifying whores” from a “subversive organization” or the “king of rats” and the “village idiot.”
c) The Counterclaim-Defendants, through Bolen, portrayed Aetna and the members of the non-existent conspiracy as criminals that would one day be “taken away in shackles by the Federal Marshalls (sic).”
d) The Counterclaim-Defendants, through Bolen, repeated the false claims that the Cavitat device had been FDA approved and that a root canal “can, will, and does, literally stop the human heart from beating.”
e) The Counterclaim-Defendants and their counsel were directly involved in funneling misinformation from this lawsuit for Bolen to use in his campaign.
f) In return, Bolen, as agent for the Counterclaim-Defendants, publicized a presentation in which Plaintiffs’ counsel could solicit clients to bring more RICO claims like the one that was dismissed in this case.
g) Bolen, as agent for the Counterclaim-Defendants and a non-lawyer “case runner” for their counsel gave a similar presentation.
105. Consistent with Bolen’s abusive practices as promised to and expected by Cavitat, the Counterclaim-Defendants have routinely publicized the frivolous and pretextual allegations of this lawsuit that were dismissed for failure to state a claim in an effort to use the lawsuit as a weapon to injure those who legitimately disagree with them, not as a vehicle to address legitimate grievances.
COUNT I: COLORADO CONSUMER PROTECTION ACT
106. Aetna hereby incorporates the allegations of paragraphs 1 through 105 as if fully set forth herein at length.
107. Counterclaim-Defendants engaged in these deceptive trade practices during the course of their business.
108. Counterclaim-Defendants have engaged in and/or have caused others to engage in deceptive trade practices as defined by COLO. REV. STAT. § 6-1-105 (West 2005), including but not necessarily limited to
a) knowingly making false representations as to the source, sponsorship, approval, or certification of goods, services, or property;
b) knowingly making false representations as to the characteristics, ingredients, uses, benefits, alterations or quantities of goods, services or property or a false representation as to the sponsorship, approval, status, affiliation, or connection of a person therewith;
c) representing that goods, services or property are of a particular, standard, quality, or grade, or that goods are of a particular style or model, knowing that they are of another;
d) disparaging the goods, services, property, or business of another by false or misleading representation of fact;
e) refusing or failing to obtain all governmental licenses or permits required to perform the services or to sell the goods, services, or property as agreed to or contracted for with a consumer.
109. Counterclaim-Defendants engaged in this conduct in bad faith.
110. Counterclaim-Defendants’ deceptive trade practices significantly impact the public as actual or potential consumers of their product.
111. Aetna has been injured in the course of its business as a result of said deceptive trade practices.
112. Aetna has incurred actual damages as a result of Counterclaim-Defendants’ deceptive trade practices.
113. Aetna is therefore entitled to general and special damages, treble damages, and attorneys’ fees as provided by COLO. REV. STAT. § 6-1-113(2)(a) & (b) (West 2005).
COUNT II: FRAUD
114. Aetna hereby incorporates the allegations of paragraphs 1 through 113 as if fully set forth herein at length.
115. Counterclaim-Defendants made misrepresentations of material fact and made partial disclosures under circumstances that those disclosures conveyed a false impression.
116. They knew that the misrepresentations were false.
117. Aetna did not know the misrepresentations were false.
118. Aetna was within the class of persons intended to be influenced by those misrepresentations and/or Counterclaim-Defendants intended that Aetna act upon the misrepresentations.
119. As a direct and proximate result, Aetna suffered damages, both general and special, as alleged hereafter.
COUNT III: CONSPIRACY
120. Aetna hereby incorporates the allegations of paragraphs 1 through 119 as if fully set forth herein at length.
121. Cavitat and Jones, along with other persons such as Sarah Jones, Robert Y. Jones, Bouquot, Shankland, Margolis, Haley, Bolen and others, came to a meeting of the minds and committed or caused to be committed the aforementioned wrongful acts which constitute, at a minimum and without limitation, tortious interference, disparagement, insurance fraud and violations of the Consumer Protection Act.
122. As a direct and proximate result, Aetna suffered damages, both general and special, as alleged hereafter.
COUNT V: ATTORNEYS’ FEES UNDER COLORADO LAW
123. Aetna hereby incorporates the allegations of paragraphs 1 through 123 as if fully set forth herein at length.
124. The claims against Aetna lacked substantial justification, were interposed for delay and harassment, or have unnecessarily expanded this proceeding by improper conduct.
125. Additionally, all of Jones’ claims against Aetna, and all of the racketeering claims and other of Cavitat’s claims against Aetna, have now been dismissed.
126. Aetna is, therefore, entitled to its reasonable attorneys’ fees under COL. REV. STAT. ANN. §§ 13-17-103 & 201 (West 2005).
127. Aetna hereby incorporates the allegations of paragraphs 1 through 126 as if set out in full.
128. As a direct and proximate result of that conduct, Aetna has suffered both general and special damages within the jurisdictional limits of this Court. Without limitation, Aetna is entitled to recover and seeks recovery for:
- claims improperly submitted and paid as a result of that conduct;
- ther expenses incurred as a result of that conduct, including but not limited to costs of court, litigation expenses; and
- attorneys’ fees and pre- and post-judgment interest in the maximum amount allowed by law.
129. Aetna hereby incorporates the allegations of paragraphs 1 through 128 as if set out in full.
130. The conduct of Jones and Cavitat as well as Bolen and their other agents was intentional, willful, wanton, malicious, reckless, grossly negligent and deserving of punishment.
131. Aetna is therefore entitled to exemplary or punitive damages in the maximum amount allowed by law to punish Jones and Cavitat and to deter other similarly-situated persons from engaging in like conduct.
WHEREFORE, Aetna respectfully prays that Cavitat take nothing by its claims, that Aetna be granted judgment against Jones and Cavitat, and for such other and further relief to which Aetna shall show itself entitled.
DATED this the 27th day of September, 2005.
John B. Shely
ANDREWS KURTH LLP
600 Travis, Suite 4200
Houston, Texas 77002
John M. Palmeri
WHITE AND STEELE, P.C.
950 17th Street, Suite 2100
Denver, Colorado 80202
(303) 296-2828 (303)
John M. Elliott
James C. Crumlish III
Mark J. Schwemler
ELLIOTT GREENLEAF & SIEDZIKOWSKI, P.C.
925 Harvest Drive
P.O . Box 3010
Blue Bell, Pennsylvania 19422
Telephone: (215) 977-1000
ATTORNEYS FOR DEFENDANT AND
COUNTERCLAIM-PLAINTIFF AETNA INC.
CERTIFICATION OF SERVICE
I hereby certify that on September, 2005, I electronically filed the foregoing with the Clerk of Court using the CM/ECF system which will send notification of such filing to the following e-mail addresses:
John B. Shely
Attorney for Defendant
Andrews Kurth LLP
600 Travis, Suite 4200
Houston, Texas 77002
This article was revised on February 13, 2008.