Robert W. Bradford Indicted (2008)

Stephen Barrett, M.D.


In 2008, Robert W. Bradford, C.R.B., Inc. (d/b/a American Biologics), C.R.B.'s chief operating officer Brigitte G. Bird, and John R. Toth, M.D. were charged with conspiring to violate federal food and drug laws and defraud individuals seeking medical care. The indictment (shown below) stated that Bradford, C.R.B., and Bird marketed bogus Lyme disease products and a microscope falsely claimed to diagnose the disease. Bradford, who founded CRB, claims to be a doctor and a professor but has no relevant degree from an accredited school. Toth is serving a prison sentence for manslaughter related to the death of a woman whom he falsely diagnosed with Lyme disease and treated with a dangerous intravenous product sold by American Biologics. Bradford has a long history of quackery-related activities. In 1977, he was convicted of conspiring to smuggle laetrile (a quack cancer remedy) into the United States.

In September 2009, a superseding indictment added Bradford's wife Carole to the list of defendants.


IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF KANSAS
(Kansas City Docket)

UNITED STATES OF AMERICA

Plaintiff,

vs.

C.R.B., INC.,
dba AMERICAN BIOLOGICS,

ROBERT W. BRADFORD,

BRIGITTE G. BYRD, and

JOHN R TOTH,

Defendants.


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Filed Dec 4, 2008

Case No. 08-20168

INDICTMENT

The Grand Jury charges:

At all material times:

INTRODUCTION

1. The defendants in this case,

C.R.B., INC. dba AMERICAN BIOLOGICS,
ROBERT W. BRADFORD,
BRIGITTE G. BYRD, and
JOHN R TOTH,

and others both known and unknown to the Grand Jury, engaged in a conspiracy and scheme to defraud and mislead the United States Food and Drug Administration ("FDA"), to defraud individuals seeking medical care, and to violate the Federal Food, Drug, and Cosmetic Act, Title 21, United States Code, Section 301, et seq., by marketing, distributing, receiving, and causing the manufacturing, marketing, distributing, and receiving of a medical device and drugs not approved by the FDA, which conspiracy and scheme resulted in serious bodily injury and death.

The Defendants and the Businesses

2. C.R.B., INC., DOING BUSINESS AS AMERICAN BIOLOGICS is a for-profit corporation organized under the laws of California, with its principal place of business at 1180 Walnut Avenue, Chula Vista, California.

3. Defendant ROBERT W. BRADFORD, is not a medical doctor, and has no medical or science degree from any accredited university, although he refers to himself as a "doctor" and as a "professor," and claims to be an innovative medical pioneer and inventor.

4. Defendant ROBERT W. BRADFORD, is associated with the following businesses, in the capacities indicated:

a. C.R.B., Inc., doing business as American Biologics. Defendant ROBERT W. BRADFORD claims to be C.R.B., Inc.'s Founder, Director of Research, and Scientific Director.

b. Robert Bradford Research Institute ("The Institute"). The Institute is a for-profit corporation organized under the laws of California, with its principal place of business at 1180 Walnut Avenue, Chula Vista, California. Defendant ROBERT W. BRADFORD, claims to be the Institute's Chief Executive Officer, Founder and Director of Research. The Institute claims it has researched and developed four proprietary compounds: Dioxychlor, ostensibly used for the management of infectious microbes; Sulfoxime, ostensibly a broad-based systemic anti-fungal agent; Bio-Rizin, ostensibly to limit histamine production; and Bismacine, ostensibly used to combat bacterial and spirochetal diseases. He also invented the Bradford Variable Projection Microscope ("Bradford Microscope") ostensibly used to identify pathologies and risk factors in health and disease.

c. RWB Compounds. RWB Compounds is a sole proprietorship, with its principal place of business at 1180 Walnut Avenue, Chula Vista, California. Defendant ROBERT W. BRADFORD, is the sole proprietor of RWB Compounds. This entity was created during the course of the conspiracy.

d. Hospital in Mexico. American Biologics and The Institute are affiliated with a hospital in Tijuana, Mexico. American Biologics provided information about, promotional services for, and admissions services for the hospital. Defendant ROBERT W. BRADFORD, claims to be the "scientific advisor" to the hospital.

5. Defendant ROBERT W. BRADFORD, and others conduct human intravenous drug experiments for, among other things, the treatment of Lyme disease at the hospital. Defendant BRIGITTE G. BYRD, is the Executive Vice President and Chief Operating Officer of C.R.B., INC. dba AMERICAN BIOLOGICS.

6. Defendant JOHN R TOTH, was a medical doctor, licensed in Kansas to practice internal medicine.

7. Defendant JOHN R TOTH, was the incorporator, director, and registered agent of The Luke Center for Integrative Health, Inc., a for-profit corporation organized under the laws of Kansas, with its principal place of business at 2115 S.W. 10th Street, Topeka, Kansas.

8. Because defendant JOHN R TOTH, knew that health care benefit programs would not pay for "alternative" therapies, he established the Alternative Therapies Health Association ("ATHA") as a separate entity from his licensed medical practice to bill patients for "alternative" therapies, and to receive payment from patients for those "alternative" therapies. Defendant JOHN R TOTH, operated ATHA out of The Luke Center of Integrative Health, Inc.

9. C.R.B., INC. dba AMERICAN BIOLOGICS, the Bradford Research Institute, RWB Compounds, ROBERT W. BRADFORD, BRIGITTE G. BYRD, JOHN R TOTH, and CYNTHIA TOTH are not registered with the FDA in any capacity as a producer, manufacturer, preparer, propagator, compounder, or processor of either drugs or medical devices.

10. The Federal Food, Drug, and Cosmetic Act (the "FDCA"), Title 21, United States Code, Section 301 et seq., was enacted to ensure that drugs and medical devices sold for human use are safe and effective for their intended uses, and that the labeling of such drugs and medical devices contain true and accurate information.

11. The FDA is the agency of the United States responsible for enforcing the provisions of the FDCA. The FDA's responsibilities include, among other things, regulating the manufacturing, labeling, and distribution of drugs, drug components, and medical devices shipped and received in interstate commerce.

The Scheme to Defraud

12. Lyme disease is transmitted to humans from the bite of infected deer ticks. Typical symptoms include fever, headache, fatigue, and a characteristic skin rash called erythema migrans.

13. Beginning in or about April 2004, defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and others developed a strategy for marketing a medical device and drugs as a means to ostensibly diagnose and treat Lyme disease, which defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and others claimed was a disease that was under­diagnosed and was the underlying cause of many illnesses the medical community was not addressing, and could not address.

14. Beginning in or about April 2004, defendant ROBERT W. BRADFORD, and others wrote, and defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and others distributed through The Bradford Research Institute, a report or monograph entitled "Lyme Disease, Potential Plague of the Twenty-First Century - Detection Problems Resolved by imaging with the Bradford Variable Projection High Resolution Microscope."

15. In this monograph, defendant ROBERT W. BRADFORD, and others stated, among other things, that: (l) Lyme disease has the ability to mimic many other diseases, such as Amyotrophic Lateral Sclerosis and was usually associated with syphilis, depression and Alzheimer's disease, making diagnosis extremely difficult; (2) Lyme disease is estimated to be a contributing factor in more than 50% of chronically ill people; and (3) patients suffering from Chronic Fatigue Syndrome actually have Lyme disease. The monograph offered no published or peer reviewed clinical data in support of these assertions.

16. Defendants, C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and others created and executed a marketing plan through which they created a false "epidemic" of Lyme disease and created a demand for a microscope the defendants manufactured and claimed could diagnose the disease, and for drugs that defendants manufactured and claimed could cure the disease. In truth and in fact, however, there was no Lyme disease epidemic, the microscope could not diagnose Lyme disease, and the drugs could not cure Lyme disease.

17. Neither the medical device nor the drugs that the defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and others manufactured, marketed, and distributed had been approved by the FDA.

Medical Device - The Microscope

18. Defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD and BRIGITTE G. BYRD, under the auspices of the Bradford Research Institute, manufactured and sold a medical device called the Bradford High Resolution Variable Projection Microscope ("Bradford Microscope").

19. Defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD and BRIGITTE G. BYRD, the Bradford Research Institute, and others, represented to purchasers that the Bradford Microscope: (1) enabled practitioners to perform functional assessments of their patients' health status; (2) was ideal for both clinical and research applications; (3) allowed the clinician-practitioner within minutes to quickly, easily, and cost-effectively detect subtle biochemical shifts that occur in the body thereby opening the way for innovative treatments as well as therapeutic follow-up and management of diseases and metabolic imbalances; and (4) detected Lyme disease.

20. Defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD and BRIGITTE G. BYRD, and the Bradford Research Institute marketed the Bradford Microscope and various Bradford Peripheral Blood Assessments ("Bradford Assessments") as part of "The International Metabolic Research and Development Project" that defendant ROBERT W. BRADFORD, falsely claimed was "registered" with the FDA, and falsely held out as a method of diagnosing disease, including Lyme Disease.

21. The FDA did not approve or clear the Bradford Microscope or the Bradford Assessments for use or marketing in the United States for the assessment or diagnosis of Lyme Disease nor any other disease.

22. The FDA did not approve or clear any manufacturing nor marketing of the Bradford Microscope and the Bradford Assessments in the United States.

Drug - "Antimicrobial Treatment"

23. In conjunction with the Bradford Microscope and the Bradford Assessments, defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and others marketed a "protocol" of drugs that defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and others, manufactured in a make-shift laboratory located in C.R.B., INC. dba AMERICAN BIOLOGICS' office in Chula Vista, California.

24. To manufacture these drugs, defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and others, purchased several chemicals that were not certified or intended by their manufacturers for use in foods, drugs, or cosmetics for humans or animals.

25. Defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and others, received these chemicals in California in interstate commerce. Defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and others, manufactured various drugs with these chemicals, then shipped these drugs through interstate commerce to a pharmacy in Colorado Springs, Colorado, where the pharmacy dissolved the drugs into aqueous solutions, based on "protocols" or directions from American Biologics.

26. Defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and others, had the dissolving done by a pharmacy in an attempt to circumvent FDA's rules and regulations about the manufacturing of drugs, and in attempt to shield themselves from civil liability and criminal culpability.

27. Defendant ROBERT W. BRADFORD, developed what he termed an "Antimicrobial Treatment" for diseases, including Lyme Disease. As part of the "Antimicrobial Treatment" defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and others manufactured the drugs Bismacine, Dioxychlor, Bio-Rizin, and Sulfoxime. This "Antimicrobial Treatment" involved the intravenous injection of these drugs.

28. Defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, made available "Antimicrobial Kits" containing Dioxychlor, Bio-Rizin, and Sulfoxime. Users purchased these drugs individually as well. The monograph directed that users take varying doses of these drugs in five interval states, and combined the use of these drugs with several other nutrients and vitamins.

29. Bismacine is the trademark for an intravenous drug invented by defendant ROBERT W. BRADFORD, manufactured by defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and others at C.R.B., INC. dba AMERICAN BIOLOGICS. Bismacine is sometimes further dissolved into an aqueous solution by a pharmacy in Colorado, and marketed and distributed by defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, JOHN R TOTH, and others.

30. The active ingredient in Bismacine is Bismuth Citrate. Bismuth is a heavy metal. Examples of other heavy metals are mercury and arsenic.

31. Defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, JOHN R TOTH, and others marketed and distributed Bismacine as a treatment for a variety of medical conditions, including Lyme Disease.

32. The FDA gave no approval to any company or individual to manufacture, market, and distribute in the United States the drug Bismacine or any intravenous drug containing Bismuth Citrate.

33. The FDA has not approved for use in the United States either the drug Bismacine or any intravenous drug containing Bismuth Citrate treat any disease, including Lyme Disease.

34. Dioxychlor is the trademark of an intravenous drug invented by defendant ROBERT W. BRADFORD, manufactured by defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and others at C.R.B., INC. dba AMERICAN BIOLOGICS. It is further dissolved into an aqueous solution by a pharmacy in Colorado, and marketed and distributed by defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, JOHN R TOTH, and others.

35. Defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, JOHN R TOTH, and others marketed and distributed Dioxychlor to treat a variety of medical conditions, including Lyme Disease.

36. The FDA gave no approval to any company or individual to manufacture, market, and distribute in the United States the drug Dioxychlor.

37. The FDA has not approved for use in the United States the intravenous drug Dioxychlor to treat any disease, including Lyme Disease.

38. Sulfoxime is the trademark of an intravenous drug invented by defendant ROBERT W. BRADFORD, manufactured by defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and others at C.R.B., INC. dba AMERICAN BIOLOGICS. It is further dissolved into an aqueous solution by a pharmacy in Colorado, and marketed and distributed by defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, JOHN R TOTH, and others.

39. Defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, JOHN R TOTH, and others marketed and distributed Sulfoxime to treat a variety of medical conditions, including Lyme Disease.

40. The FDA gave no approval to any company or individual to manufacture, market, and distribute in the United States the drug Sulfoxime.

41. The FDA has not approved for use in the United States the drug Sulfoxime to treat any disease, including Lyme Disease.

42. Bio-Rizin is an intravenous drug invented by defendant ROBERT W. BRADFORD. It is dissolved into an aqueous solution by a pharmacy in Colorado, and marketed and distributed by defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, JOHN R TOTH, and others.

43. Defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, JOHN R TOTH, and others marketed and distributed Bio-Rizin to treat a variety of medical conditions, including Lyme Disease.

44. The FDA gave no approval to any company or individual to manufacture, market, and distribute in the United States the drug Bio-Rizin.

45. The FDA has not approved for use in the United States the drug Bio-Rizin to treat any disease, including Lyme Disease.

46. Defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and others profited from the sale of both the medical device and the drugs described herein. For example, for the period April 2004 to August 2006, defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD,

BRIGITTE G. BYRD, and others, received over $400,000.00 for the Bradford Microscope and the drugs described herein.

47. Defendant JOHN R TOTH, profited by charging defendant JOHN R TOTH's patients for the use of the Bradford Microscope and the intravenous injection of the drugs described herein. For example, defendant JOHN R TOTH, through A THA, charged patients approximately $100 for each use of the Bradford Microscope, and approximately $320 for each intravenous "Antimicrobial Treatment."

COUNT 1 - CONSPIRACY

48. The Grand Jury incorporates by reference Paragraphs 1-48 as though fully restated and re-alleged herein.

49. Beginning in or about April 2004, and continuing through December 2008, the exact dates being unknown to the Grand Jury, in the District of Kansas and elsewhere, the defendants,

C.R.B., INC. dba AMERICAN BIOLOGICS,
ROBERT W. BRADFORD
,
BRIGITTE G. BYRD
, and
JOHN R TOTH
,

knowingly and willfully combined, conspired, confederated, and agreed with each other and with other persons, both known and unknown to the Grand Jury:

a. to commit offenses as set forth in Counts 2-25 against the United States, that is:

(1) mail fraud, in violation of Title 18, United States Code, Section 1341;

(2) introducing unapproved new drugs into interstate commerce, in violation of Title 21, United States Code, Sections 331(d), 333(a)(2), and 355(a);

(3) introducing misbranded drugs into interstate commerce, in violation of Title 21, United States Code, Sections 331(a), 333(a)(2), 352(a), 352(f)(1), and 352(0);

(4) receiving misbranded drugs in interstate commerce, and delivering them for pay or otherwise, in violation of Title 21, United States Code, Sections 331(c), 333(a)(2), 352(a), 352(f)(1), and 352(0);

(5) introducing an adulterated and misbranded medical device into interstate commerce, in violation of Title 21, United States Code, Sections 331 (a), 351 (f)(1)(B), 352(0), and 333(a)(2); and to defraud the United States and departments and agencies thereof, namely, the FDA, by impairing, impeding, and obstructing by craft, trickery, deceit, and dishonest means, the FDA's lawful and legitimate functions of regulating drugs and medical devices.

Manner and Means

50. Defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, JOHN R TOTH, and others used the following manner and means in furtherance of the conspiracy and scheme. In so doing, defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, JOHN R TOTH, and others, at times, used and perverted otherwise lawful conduct to further the conspiracy and scheme.

51. During the course of and in furtherance of the conspiracy and scheme, defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and others manufactured and caused the manufacture of the Bradford Microscope for sale in interstate commerce, and marketed it as, and falsely represented it to be a medical device for the diagnosis of diseases, including Lyme Disease.

52. During the course of and in furtherance of the conspiracy and scheme, defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and others manufactured and caused the manufacture of unapproved new drugs and misbranded drugs, including Bismacine, Dioxychlor, Bio-Rizin, and Sulfoxime, and shipped and sold these unapproved new drugs and misbranded drugs in interstate commerce.

53. During the course of and in furtherance of the conspiracy and scheme, defendants C.R.B., INC. dba AMERICAN BIOLOGICS ROBERT W. BRADFORD, BRIGITTE G. BYRD, JOHN R TOTH, and others distributed and caused the distribution in interstate commerce, unapproved new drugs and misbranded drugs, including Bismacine, Dioxychlor, Bio­Rizin, and Sulfoxime, some of which were intravenously injected into individuals seeking medical treatment.

54. During the course of and in furtherance of the conspiracy and scheme, defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, JOHN R TOTH, and others received and caused the receipt in interstate commerce, and thereafter delivered for pay or otherwise, misbranded drugs, including Bismacine, Dioxychlor, Bio-Rizin, and Sulfoxime.

55. During the course of and in furtherance of the conspiracy and scheme, defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and others failed to register with the FDA in any capacity as a producer, manufacturer, preparer, propagator, compounder, and processor of either drugs or medical devices, knowing they were required to do so.

56. During the course of and in furtherance of the conspiracy and scheme, defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, JOHN R TOTH, and others falsely diagnosed, and caused the false diagnosis of, Lyme Disease in individuals seeking medical treatment.

57. During the course of and in furtherance of the conspiracy and scheme, defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, JOHN R TOTH, and others falsely claimed and represented to individuals seeking medical treatment that intravenous injections of Bismacine, Dioxychlor, Bio-Rizin, and Sulfoxime would successfully treat disease, including Lyme Disease.

58. During the course of and in furtherance of the conspiracy and scheme, defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, JOHN R TOTH, and others intravenously injected, and caused the intravenous injection of, Bismacine, which resulted in one individual in Kansas (B. G.) experiencing renal failure, and one individual in Kansas (B. W.) lapsing into a coma and eventually dying.

Overt Acts

59. In furtherance of the conspiracy and scheme, and to accomplish their purposes and objectives, one or more coconspirators committed in the District of Kansas and elsewhere the following overt acts, among others:

a. Each of the factual allegations set forth in Counts 2-25 is incorporated and re­alleged as though restated herein, as an individual overt act done in furtherance of the conspiracy.

b. On or about October 27 through October 30, 2004, defendant JOHN R TOTH, attended a symposium and met with defendants ROBERT W. BRADFORD, and BRIGITTE G. BYRD, in Hilton Head, South Carolina.

c. On or about October 29 through October 30, 2004, in Hilton Head, South Carolina, defendant ROBERT W. BRADFORD, gave to defendant JOHN R TOTH, a vial of BISMACINE, which defendant BRADFORD brought with him from California to South Carolina.

d. On or about November 3, 2004, defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, and BRIGITTE G. BYRD, mailed and caused to be shipped from California to defendant JOHN R TOTH, in Kansas monographs from the Bradford Research Institute entitled "Lyme Disease, Potential Plague of the Twenty-First Century."

e. On or about November 3, 2004, defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, and BRIGITTE G. BYRD, mailed a letter, and caused a letter to be mailed to defendant JOHN R TOTH, regarding the Bradford Microscope.

f. On or about November 16, 2004, defendant JOHN R TOTH, entered into a contract with C.R.B., INC. dba AMERICAN BIOLOGICS to purchase a Bradford Microscope.

g. On or about November 16, 2004, defendant BRIGITTE G. BYRD, signed a Microscope System Work Order for customer JOHN R TOTH,.

h. On or about November 29, 2004, defendant JOHN R TOTH, received in interstate commerce a Bradford Microscope.

i. On or about December 2, 2004, defendant JOHN R TOTH, signed a Confidential Participation Agreement for Training in the International Metabolic Research and Development Project with Bradford Research Institute.

j. On or about December 2 through December 4, 2004, defendant ROBERT W. BRADFORD traveled to Topeka to train defendant JOHN R TOTH, and others in the use of the Bradford Microscope to diagnose Lyme Disease and other diseases, and about his protocol for treating Lyme Disease, which protocol included the intravenous injection of Bismacine, Dioxychlor, Sulfoxime, Bio­Rizin.

k. On or about December 16, 2004, defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and others entered into an Agreement and Addendum with a pharmacy in Colorado for the exclusive processing rights for Bismacine. This Agreement and Addendum added to the Agreement C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and others entered into on or about September 4, 2001, with a pharmacy in Colorado for the exclusive processing rights for Bismacine, Dioxychlor, Bio-Rizin, and Sulfoxime.

l. On or about December 29, 2004, defendant ROBERT W. BRADFORD, shipped and caused to be shipped from California to Kansas a monograph from the Bradford Research Institute entitled "Lyme Disease, Potential Plague of the Twenty-First Century."

m. On or about January 1, 2005, defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and others had the monograph "Lyme Disease, Potential Plague of the Twenty-First Century" published in the Townsend Letter, a publication about alternative medicine.

n. On or about January 3, 2005, defendant JOHN R TOTH, and others, held a meeting with patients at The Luke Center to discuss diagnosing Lyme disease with the Bradford Microscope and to discuss treating Lyme disease with the Bradford protocol of intravenous injections of Bismacine, Dioxychlor, Bio-Rizin, and Sulfoxime.

o. On or about January 3, 2005, defendant JOHN R TOTH, sold to B.W. a copy of the monograph from the Bradford Research Institute entitled "Lyme Disease, Potential Plague of the Twenty-First Century."

p. On or about January 7, 2005, defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, and BRIGITTE G. BYRD, transmitted and caused to be transmitted to a pharmacy in Colorado the first shipment of raw Bismacine. The Bismacine was shipped in what was described as a peanut butter jar with a large brown chunk still in it.

q. On or about January 6, 2005, defendant BRIGITTE G. BYRD, sent to a pharmacy in Colorado via facsimile an altered chemical Certificate of Analysis regarding bismuth.

r. On or about March 23, 2005, defendant ROBERT W. BRADFORD, mailed and caused to be mailed from California to defendant JOHN R TOTH, in Kansas monographs from the Bradford Research Institute entitled "Lyme Disease, Potential Plague of the Twenty-First Century."

s. On or about April 11, 2005, defendant JOHN R TOTH, infused B.G. with Bismacine.

t. On or about April 18, 2005, defendant JOHN R TOTH, infused B.W. with Bismacine causing her to suffer cardiac arrest and lapse into a coma.

u. On or about April 19, 2005, defendant JOHN R TOTH, admits B.G. into the hospital for renal failure.

v. On or about May 2, 2005, and on or about May 13, 2005, and following the injuries to B.W. and B.G., defendant JOHN R TOTH, ordered Bismacine from a pharmacy in Colorado, which the pharmacy shipped to defendant JOHN R TOTH, through interstate commerce.

w. Beginning on or about May 10, 2005, defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, and BRIGITTE G. BYRD, updated the written information about Bismacine by eliminating references to American Biologics and adding contraindications and warnings.

x. On or about May 17, 2005, defendant BRIGITTE G. BYRD, wrote a letter to defendant JOHN R TOTH, responding to his request for defendant ROBERT W. BRADFORD's curriculum vitae, stating in pertinent part: "while [Dr. Bradford] personally offered you some Bismacine from his own therapeutic supply from the hospital he is involved with in Mexico, including his C.V. in your endeavors would directly involve American Biologics. Please understand we, 'American Biologics,' must walk a very defined straight line as a nutritional supplement company and the manufacturer of the BVPM Microscope System."

y. On or about May 31, 2005, RWB Compounds invoiced a pharmacy in Colorado for Bismuth Citrate.

z. On or about the following dates, defendant JOHN R TOTH, ordered from a pharmacy in Colorado the Antimicrobial Kit, which contained unapproved new drugs and misbranded drugs, manufactured by defendants C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and others at American Biologics, and caused their introduction into interstate commerce, each order being an overt act in furtherance of the conspiracy:

Shipped On
or About Date

Location Shipped/
Location Received

Dec. 10, 2004 Colorado/Kansas
Jan. 27, 2005 Colorado/Kansas
Jan. 28, 2005 Colorado/Kansas
Feb. 4, 2005 Colorado/Kansas
Feb. 10, 2005 Colorado/Kansas
Feb. 25, 2005 Colorado/Kansas
March 7, 2005 Colorado/Kansas
March 15, 2005 Colorado/Kansas
March 18, 2005 Colorado/Kansas
April 11, 2005 Colorado/Kansas

The foregoing is in violation of Title 18, United States Code, Sections 2 and 371

COUNTS 2-9
MAIL FRAUD

61. The Grand Jury incorporates by reference Paragraphs 1-60 as though fully restated :md re-alleged herein.

62. Having devised the above-described scheme and artifice to defraud, on or about the dates set forth below, within the District of Kansas and elsewhere, defendants,

C.R.B., INC. dba AMERICAN BIOLOGICS,
ROBERT W. BRADFORD,
BRIGITTE G. BYRD, and
JOHN R. TOTH,

for the purpose of executing the aforesaid scheme and artifice to defraud, and attempting to do so, knowingly deposited and caused to be deposited, the things and matters described below, to be sent and delivered, by the U.S. Postal Service and private and commercial interstate carrier, according to the instructions thereon, and took and received therefrom, such things and matters as described below:

Count

On or About
Date Deposited

Thing or Matter

Location Shipped/
Location Received

2

November 3, 2004 Lyme Disease Monographs California/Kansas

3

November 29, 2004 Bradford Microscope California/Kansas

4

December 29, 2004 Lyme Disease Monographs California/Kansas

5

January 27, 2005 Dioxychlor California/Kansas

6

March 23, 2005 Lyme Disease Monographs California/Kansas

7

April 11, 2005 Dioxychlor California/Kansas

8

May 2, 2005 Bismacine California/Kansas

9

May 13, 2005 Bismacine California/Kansas

63. The foregoing is in violation of Title 18, United States Code, Sections 2 and l34l.

FOOD, DRUG. & COSMETIC ACT VIOLATIONS

The Food, Drug and Cosmetic Act

64. The FDCA defines "interstate commerce" as (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any territory not organized with a legislative body. Title 21, United States Code, Section 321(b).

65. The FDCA requires producers of drugs and medical devices to register with the FDA. New producers, upon first manufacturing, preparing, propagating, compounding, or processing drugs or medical devices, must immediately register their name and place of business. Title 21, United States Code, Section 360(c).

Drugs and New Drugs

66. Under the FDCA, a "drug" is defined, in relevant part, as any article intended for use in the diagnosis, cure, mitigation, treatment, and prevention of disease in man or other animals; and articles (other than food) intended to affect the structure or any function of the body of man or other animals; and articles intended for use as components of other drugs. Title 21, United States Code, Section 321(g)(l)(B), (C), and (D).

67. The FDCA defines a "new drug" to mean any drug, the composition of which is such that the drug is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended or so suggested in its labeling. Title 21, United States Code, Section 321 (p)(1).

68. The FDCA prohibits the shipment of a "new drug" in interstate commerce, unless the manufacturer of the new drug first obtains FDA approval of a New Drug Application ("NDA"), an Abbreviated New Drug Application ("ANDA"), or a notice of claimed exemption for an investigational new drug ("IND") for that drug. Title 21, United States Code, Sections 331(d), 355(a), 355(i).

Labeling and Misbranding

69. Under the FDCA, the term "label" means a display of written, printed, or graphic matter upon the immediate container of any article. Title 21, United States Code, Section 321 (k). The term "labeling" means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers of wrappers, or (2) accompanying such article. Title 21, United States Code, Section 321 (m).

70. Under the FDCA, a drug is misbranded if its labeling (1) is false or misleading in any particular; (2) does not bear adequate directions for use; and (3) is manufactured, prepared, propagated, and processed in an establishment not duly registered pursuant to Title 21, United States Code, Section 360. Title 21, United States Code, Sections 352(a), 352(f)(1), and 352(0).

71. The FDCA makes unlawful the introduction or delivery for introduction into interstate commerce, or the causing thereof, of any drug that is adulterated or misbranded. Title 21, United States Code, Section 331(a).

72. The FDCA makes unlawful the receipt in interstate commerce, or the causing thereof, of any drug that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise. Title 21, United States Code, Section 331(c).

Medical Devices

73. Under the FDCA, a "device" includes an instrument, apparatus, implant, machine, or other similar or related article, which is intended for use in the treatment or prevention of disease in man, which does not achieve its primary intended purposes through chemical action within or on the body of man and which is not dependent upon being metabolized for the achievement of its primary intended purposes. Title 21, United States Code, Section 321(h).

74. Pursuant to the FDCA, every manufacturer of a new medical device must obtain "clearance" or "approval" from the FDA prior to marketing its medical device. Title 21, United States Code, Sections 360(c), 360e.

75. All medical devices marketed in interstate commerce in the United States fall into one of three regulatory classes under the FDCA: Class I which are medical devices subject to the least stringent regulatory requirements; Class II; and Class III which are medical devices subject to the most stringent regulatory requirements. The classification assigned to each medical device is determined by the degree of regulatory control necessary to provide reasonable assurance of the safety and effectiveness of the medical device in its intended use. Title 21, United States Code, Section 360c.

76. The Medical Device Amendments to the FDCA became effective on May 28, 1976. If a medical device was not in commercial distribution before May 28, 1976, it is automatically a Class III medical device by operation of law.

77. Class III medical devices cannot be legally marketed in the United States until the manufacturer submits to the FDA a Pre-Market Approval Application and the FDA approves the application. The FDA does not approve a Pre-Market Approval Application unless the information in the Pre-Market Approval Application provides the FDA with reasonable assurance that a medical device is safe and effective when used according to its labeling. Title 21, United States Code, Sections 360c(f)(l), 360e(a).

78. As an alternative to submitting a Pre-Market Approval Application, the manufacturer of a new Class III medical device can seek to demonstrate to the FDA that its medical device should be classified as a Class I or Class II medical device, or that it is "substantially equivalent" to a legally marketed medical device for which pre-market approval was not required. Title 21, United States Code, Section 360c( a).

79. A manufacturer seeking a determination of "substantial equivalence" can submit to the FDA a "Pre-Market Notification" no later than ninety days before the manufacturer intends to introduce the medical device into interstate commerce. If the FDA makes a finding of "substantial equivalence," the medical device is then cleared for marketing in a manner consistent with the Pre-Market Notification approved by the FDA. Title 21, United States Code, Section 360c(a).

80. The Pre-Market Approval Application and a Pre-Market Notification are separate methods for obtaining the FDA's permission to market a medical device. Until a medical device is approved for marketing under either the Pre-Market Approval Application process or cleared under the Pre-Market Notification process, whichever process is applicable, the medical device cannot be legally marketed.

81. A Class III medical device is adulterated if it is required to have an approved Pre- Market Approval Application and did not have one in effect. Title 21, United States Code, Section 351(f)(1)(B).

82. A medical device is misbranded if the manufacturer of a medical device fails to provide the FDA with the necessary Pre-Market Notification. Title 21, United States Code, Sections 360(k), 3 52( 0).

83. A medical device of any class is misbranded if it was manufactured by an establishment in any State and not duly registered under Title 21, United States Code, Section 360, or if it was not included in a list required by Title 21, United States Code, Section 360(j). Title 21, United States Code, Section 352(0).

84. The introduction and delivery for introduction into interstate commerce any adulterated or misbranded medical device or the causing thereof violates the FDCA. Title 21, United States Code, Section 331(a).

85. The receipt in interstate commerce of any medical device that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise, and the causing thereof, violates the FDCA. Title 21, United States Code, Section 331(c).

COUNT 10
INTRODUCTION OF UNAPPROVED NEW DRUG (BISMACINE)
INTO INTERSTATE COMMERCE

86. The Grand Jury incorporates by reference Paragraphs 1-85 as though fully restated and re-alleged herein.

87. On or about October 29-30, 2004, in the District of Kansas and elsewhere, the defendants,

ROBERT W. BRADFORD, and
JOHN R TOTH,

with the intent to defraud and mislead the FDA and individuals seeking medical care, introduced, and caused the introduction into interstate commerce of, Bismacine, an unapproved new drug, as defined by Title 21, United States Code, Section 321 (p)(1), when, as defendants well knew, the drug was not approved for use in the United States, did not have a New Drug Application, Abbreviated New Drug Application, or Investigational New Drug Application in effect with the FDA, as required by Title 21, United States Code, Section 355(a).

88. The foregoing is in violation of Title 21, United States Code, Sections 331 (d), 333(a)(2), 355(a); and Title 18, United States Code, Section 2.

COUNTS 11-14
INTRODUCTION OF UNAPPROVED NEW DRUGS
INTO INTERSTATE COMMERCE

89. The Grand Jury incorporates by reference Paragraphs 1-88 as though fully restated and re-alleged herein.

90. On or about the dates below, in the District of Kansas and elsewhere, the defendants,

C.R.B., INC. dba AMERICAN BIOLOGICS,
ROBERT W. BRADFORD
, and
BRIGITTE G. BYRD
,

with the intent to defraud and mislead the FDA and individuals seeking medical care, introduced, and caused the introduction into interstate commerce of, the following unapproved new drugs, as defined by Title 21, United States Code, Section 321 (p)(1), when, as defendants well knew, the drugs listed were not approved for use in the United States, did not have a New Drug Application, Abbreviated New Drug Application, or Investigational New Drug Application in effect with the FDA, as required by Title 21, United States Code, Section 355(a):

Count

On or About Date

Unapproved New Drug

Location Shipped/
Location Received

11

January 27, 2005 Dioxychlor Colorado/Kansas

12

April 11, 2005 Dioxychlor Colorado/Kansas

13

May 2, 2005 Bismacine Colorado/Kansas

14

May 13, 2005 Bismacine Colorado/Kansas

91. The foregoing is in violation of Title 21, United States Code, Sections 331(d), 333(a)(2), 355(a); and Title 18, United States Code, Section 2.

COUNT 15
INTRODUCTION OF A MISBRANDED DRUG (BISMACINE)
INTO INTERSTATE COMMERCE

92. The Grand Jury incorporates by reference Paragraphs 1-91 as though fully restated and re-alleged herein.

93. On or about October 29-30, 2004, in the District of Kansas and elsewhere, the defendants,

ROBERT W. BRADFORD, and
JOHN R TOTH
,

with the intent to defraud and mislead the FDA and individuals seeking medical care, introduced, and caused the introduction into interstate commerce of, Bismacine, a misbranded drug, in that its labeling failed to bear adequate directions for use, was false and misleading in any particular, and the drugs came from an unregistered establishment as required by Title 21, United States Code, Section 352(a), 352(f)(1), and 352(0).

94. The foregoing is in violation of Title 21, United States Code, Sections 331(a), 333(a)(2), 352(f); and Title 18, United States Code, Section 2.

COUNTS 16-19
INTRODUCTION OF A MISBRANDED DRUG
INTO INTERSTATE COMMERCE

95. The Grand Jury incorporates by reference Paragraphs 1-94 as though fully restated and re-alleged herein.

96. On or about the dates below, in the District of Kansas and elsewhere, the defendants,

C.R.B., INC. dba AMERICAN BIOLOGICS,
ROBERT W. BRADFORD
, and
BRIGITTE G. BYRD
,

with the intent to defraud and mislead the FDA and individuals seeking medical care, introduced, and caused the introduction into interstate commerce of the following misbranded drugs, in that their labeling failed to bear adequate directions for use, was false and misleading in any particular, and the drugs came from an unregistered establishment as required by Title 21, United States Code, Section 352(a), 352(f)(1), and 352(0):

Count

On or About Date

Misbranded Drugs

Location Shipped/
Location Received

16

January 27, 2005 Dioxychlor Colorado/Kansas

17

April 11, 2005 Dioxychlor Colorado/Kansas

18

May 2, 2005 Bismacine Colorado/Kansas

19

May 13, 2005 Bismacine Colorado/Kansas

97. The foregoing is in violation of Title 21, United States Code, Sections 331(a), 333(a)(2), 352(f); and Title 18, United States Code, Section 2.

COUNT 20
RECEIPT OF A MISBRANDED DRUG (BISMACINE)
INTO INTERSTATE COMMERCE and THE DELIVERY
THEREOF FOR PAY OR OTHERWISE

98. The Grand Jury incorporates by reference Paragraphs 1-97 as though fully restated and re-alleged herein.

99. On or about October 29 through October 30, 2004, in the District of Kansas and elsewhere, the defendants,

ROBERT W. BRADFORD,
and JOHN R TOTH,

with the intent to defraud and mislead the FDA and individuals seeking medical care, received, and caused the receipt in interstate commerce of Bismacine, a drug as defined by Title 21, United States Code, Section 321 (g)(1), and delivered and caused to be delivered the drug for pay and otherwise, while the drug was misbranded in that its labeling failed to bear adequate directions for use was false and misleading in any particular, and the drugs came from an unregistered establishment as required by Title 21, United States Code, Section 352(a), 352(£)(1), and 352(0). 100. The foregoing is in violation of Title 21, United States Code, Sections 331(c), 333(a)(2); and Title 18, United States Code, Section 2.

COUNTS 21-24
RECEIPT OF A MISBRANDED DRUG IN INTERSTATE COMMERCE and
THE DELIVERY THEREOF FOR PAY OR OTHERWISE

101. The Grand Jury incorporates by reference Paragraphs 1-100 as though fully restated and re-alleged herein.

102. On or about the following dates, in the District of Kansas and elsewhere, the defendants,

C.R.B., INC. dba AMERICAN BIOLOGICS,
ROBERT W. BRADFORD
, and
BRIGITTE G. BYRD
,

with the intent to defraud and mislead the FDA and individuals seeking medical care, received, and caused the receipt in interstate commerce of the following drugs as defined by Title 21, United States Code, Section 321 (g)(1), and delivered the drugs for pay and otherwise, while the drugs were misbranded, in that their labeling failed to bear adequate directions for use was false and misleading in any particular, and the drugs came from an unregistered establishment as required by Title 21, United States Code, Section 352(a), 352(£)(1), and 352(0):

Count

On or About Date

Misbranded Drugs

Location Shipped/
Location Received

21

January 27, 2005 Dioxychlor Colorado/Kansas

22

April 11, 2005 Dioxychlor Colorado/Kansas

23

May 2, 2005 Bismacine Colorado/Kansas

24

May 13, 2005 Bismacine Colorado/Kansas

103. The foregoing is in violation of Title 21, United States Code, Sections 331 (c), 333(a)(2); and Title 18, United States Code, Section 2.

COUNT 25
INTRODUCTION OF ADULTERATED & MISBRANDED MEDICAL
DEVICE INTO INTERSTATE COMMERCE

104. The Grand Jury incorporates by reference Paragraphs 1-103 as though fully restated and re-alleged herein.

105. From in or about October 2004, through in or about November 28, 2004, within the District of Kansas and elsewhere, defendants,

C.R.B., INC. dba AMERICAN BIOLOGICS,
ROBERT W. BRADFORD
,
BRIGITTE G. BYRD
, and
JOHN R TOTH
,

with the intent to defraud and mislead the FDA and patients, introduced, delivered for introduction, and caused to be introduced and delivered for introduction into interstate commerce, namely from California to Kansas, an adulterated and misbranded medical device, namely the Bradford Variable Projection Microscope, a Class III medical device not approved by the FDA.

106. The foregoing is in violation of Title 21, United States Code, Sections 331(a), 351(t)(l)(B), 333(a)(2); and Title 18, United States Code, Section 2.

FORFEITURE ALLEGATIONS
FORFEITURE-MAIL FRAUD AND
CONSPIRACY TO COMMIT MAIL FRAUD

107. The Grand Jury incorporates by reference Paragraphs 1-106 as though fully restated and re-alleged herein.

108. Upon conviction of one or more of the mail fraud offenses alleged in Counts I through 9 of this Indictment, defendants, C.R.B., INC. dba AMERICAN BIOLOGICS, ROBERT W. BRADFORD, BRIGITTE G. BYRD, and JOHN R TOTH, shall forfeit to the United States of America, pursuant to Title 18, United States Code, Section 981 (a)(1)(C), and Title 28, United States Code, Section 2461 (c), any and all property, real or personal, that constitutes or is derived, directly or indirectly, from proceeds traceable to the offenses. The property to be forfeited includes, but is not limited to, the following:

A. MONEY JUDGMENT

A sum of money equal to the amount of proceeds obtained as a result of the mail fraud offenses set out in Counts 1 through 9, for which the defendants are jointly and severally liable; and

FORFEITURE ALLEGATION
SUBSTITUTE PROPERTY

109. If any of the above-described forfeitable property, as a result of any act or omission of the defendants:

(a) cannot be located upon the exercise of due diligence;

(b) has been transferred or sold to, or deposited with, a third party;

(c) has been placed beyond the jurisdiction of the court;

(d) has been substantially diminished in value; or

(e) has been commingled with other property which cannot be divided without difficulty;

it is the intent of the United States, pursuant to 21 U.S.C. § 853(p), to seek forfeiture of any other property of said defendants up to the value of the forfeitable property described above.

All pursuant to 18 U.S.C. § 981 (a)(1)(C) and 28 U.S.C. § 2461(c).

A TRUE BILL.

DATE

MARIETTA PARKER
United States Attorney
District of Kansas
500 State Avenue, Suite 360
Kansas City, Kansas 66101
(913) 551-6730 (phone)
(913) 551-6541
Ks. District. Ct. No. 77807
Marietta.Parker@usdoj .gov

[It is requested that trial be held in Kansas City, Kansas.]

This page was revised on January 19, 2010.

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