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 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, claimed 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 2009, a superseding indictment added Bradford’s wife Carole to the list of defendants. In 2010 (as shown below), Bradford pleaded guilty to one count of engaging in a conspiracy to commit mail fraud, introduce misbranded drugs into interstate commerce, receive misbranded drugs in interstate commerce, and to defraud the FDA.
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF KANSAS
(Kansas City Docket)
ROBERT W. BRADFORD,
Case No. 08-20168-02-KHV
PLEA AGREEMENT PURSUANT TO FED. R. CRIM. P111(c)(l)(C)
The United States of America, by and through Trial Attorney John W. M. Claud, Department of Justice Office of Consumer Litigation and Scott C. Rask, Assistant United States Attorney, and Robert W. Bradford, the defendant, personally and by and through his attorney Michael L. Harris, enter into the following plea agreement pursuant to Rule 11 (c)(1 )(C) of the Federal Rules of Criminal Procedure:
1. Defendant’s Guilty Plea. If the Court permits, the defendant agrees to plead guilty to Count 1 of the Superseding Indictment, which charges a violation of Title 18, United States Code, Section 371, that is, engaging in a conspiracy to commit mail fraud, introduce misbranded drugs into interstate commerce, receive misbranded drugs in interstate commerce, and to defraud the Food & Drug Administration. By entering into this plea agreement, the defendant admits to knowingly committing this offense, and to being guilty of this offense. The defendant agrees to plead guilty by October 1, 2010. The defendant understands that the maximum sentence that may be imposed for Count 1 of the superseding indictment is not more than five years of imprisonment, a $250,000 fine, three years of supervised release, restitution as determined by the Court up to $40,372.08 to Sean Walby and Malgosia Cegelski, a $100 mandatory special assessment, and a money judgment in connection with the forfeiture allegation. The United States agrees that at the time of sentencing it will move for dismissal of the remaining counts of the indictment.
2. Forfeiture of Assets. The defendant also admits to the Forfeiture Allegation in the superseding indictment and agrees not to contest the criminal forfeiture allegation, and in so doing, he forfeits all right, title, and interest. The defendant acknowledges and agrees that the forfeiture of substitute assets as authorized herein and pursuant to Title 21, U.S.C. § 853(p) to satisfy the money judgment as will be agreed by the parties of approximately $400,000, shall not be deemed an alteration of defendant’s sentence or this agreement. The defendant acknowledges and agrees that the forfeiture of any personal property shall not be treated as satisfaction of any fine, restitution, cost of imprisonment, or any other penalty the Court may impose upon the defendant in addition to forfeiture. The defendant agrees to the immediate entry of the preliminary order of forfeiture. The defendant further agrees that he will truthfully and accurately complete a financial disclosure form, prior to signing this agreement and will list all his assets and financial interests, and allow U.S. Probation to disclose all financial information they obtain during the presentence investigation and supervision of him. The defendant agrees to sign any and all documents necessary to effectuate the forfeiture and transfer of his interest and possession in the property to the United States. The defendant freely, voluntarily, knowingly, and intelligently waives any right to collaterally attack any matter in connection with this prosecution and sentence, including the forfeiture of assets.
3. Factual Basis for the Guilty Plea. The parties agree the facts constituting the offense to which the defendant is pleading guilty are as follows:
The defendant is not a medical doctor, and has no medical or science degree from any accredited university in the United States. The defendant is the Founder, Director of Research, and Scientific Director of CRB, Inc., d.b.a. American Biologics. The defendant is the Chief Executive Officer, Founder, and Director of Research at the Robert Bradford Research Institute (“The Institute”). The Institute claims it has researched and developed four proprietary compounds:
Dioxychlor, Sulfoxime, Bio-Rizin, and Bismacine. Through The Institute, the defendant invented the Bradford Variable Projection Microscope (“Bradford Microscope”) ostensibly used to identify pathologies and risk factors in health and disease. The defendant also claims to be the sole proprietor of R WB Compounds, a sole proprietorship created during the course of the conspiracy. American Biologics and The Institute are affiliated with a hospital in Tijuana, Mexico. The defendant claims to be the “scientific advisor” to the hospital, where the defendant and others conduct human intravenous drug experiments for, among other things, the treatment of Lyme disease at that hospital.
Beginning in or about September 2001, the defendant along with coÂdefendants CRB, Inc., d.b.a. American Biologics, Brigitte Byrd, Carole Bradford, and others developed a strategy for marketing drugs as a means to ostensibly treat Lyme disease, which the defendants claimed was the underlying cause of many illnesses the medical community was not addressing, and could not address.
Beginning in or about April 2004, the defendant and others wrote and distributed through The 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.” In this monograph, the defendants and others stated, among other things, that: (1) “Lyme disease has the ability to mimic many other diseases,” and is commonly “associated” with a number of diseases as well, including depression and Alzheimer’s disease; (2) “it is estimated that Lyme disease may be a contributing factor in more than 50% of chronically ill people;” and, (3) most patients diagnosed as suffering from Chronic Fatigue Syndrome actually have Lyme disease.
The defendant and others created and executed a marketing plan through which they promoted an epidemic of Lyme disease and created a demand for a microscope the defendants manufactured and claimed could diagnose the disease, and for drugs the defendants manufactured and claimed could cure the disease. The monograph made factual statements and cited sources as authority for those statements in order to convey credibility to the reader, when in truth and in fact those sources were false or misleading. The drugs that the defendants and others manufactured, marketed, and distributed had not been reviewed, cleared, or approved by the FDA for any reason, nor were they exempt from such review by FDA.
In conjunction with the Bradford Microscope and the Bradford Assessments, the defendants and others marketed a “protocol” of drugs, which they manufactured in a make-shift laboratory located in American Biologics’ office in Chula Vista, California. To manufacture these drugs, the defendants 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. The defendants and others received these chemicals in California in interstate commerce, and then manufactured various drugs with these chemicals by shipping these drugs through interstate commerce to a pharmacy in Colorado Springs, Colorado, where the pharmacy dissolved the drugs into aqueous solutions, based on “protocols” that were specific directions issued by the defendants.
The defendant developed what he termed an “Antimicrobial Treatment” for diseases, including Lyme disease. As part of the “Antimicrobial Treatment” the defendants and others manufactured the drugs Bismacine, Dioxychlor, BioÂRizin, and Sulfoxime. This “Antimicrobial Treatment” involved the intravenous injection of these drugs. Users purchased these drugs individually as well. The monograph directed that users take varying doses of these drugs in interval stages, and combined the use of these drugs with other nutrients and vitamins.
Bismacine is the trademarked name for an intravenous drug invented by the defendant, manufactured by the defendants and others at CRB, Inc. Bismacine is sometimes further dissolved into an aqueous solution and marketed and distributed by the defendants and others. The active ingredient in Bismacine is Bismuth Citrate. Bismuth is a heavy metal that may cause renal complications, as the kidneys have difficulty filtering heavy metals from the bloodstream. The defendants and others marketed and distributed Bismacine as a treatment for Lyme disease.
Dioxychlor is the trademark of an intravenous drug invented by the defendant, manufactured by the defendants and others at CRB, Inc. It is further dissolved into an aqueous solution and marketed and distributed by the defendants and others. The defendants and others marketed and distributed Dioxychlor to treat a variety of medical conditions, including Lyme disease.
Sulfoxime is the trademark of an intravenous drug invented by the defendant, manufactured by the defendants and others at CRB, Inc. It is further dissolved into an aqueous solution and marketed and distributed by the defendants and others. The defendants and others marketed and distributed Sulfoxime to treat a variety of medical conditions, including Lyme disease.
Bio-Rizin is the trademark of an intravenous drug invented by the defendant, manufactured by the defendants and others at CRB, Inc. It is further dissolved into an aqueous solution and marketed and distributed by the defendants and others. The defendants and others marketed and distributed Bio-Rizin to treat a variety of medical conditions, including Lyme Disease.
The defendants and others profited from the sale of the drugs listed above. For example, for the period October 2001 through July 2006, the defendants received more than $400,000.00 from these sales. The sales of the drugs were often accomplished with shipments through the U.S. Postal Service or other commercial interstate carriers. Several of these shipments were from California to co-defendant John Toth in Kansas, which also included the literature with claims or omissions concerning the diagnosis of Lyme disease.
The Institute, RWB Compounds, and the defendants are not registered with the FDA in any capacity as producers, manufacturers, preparers, propagators, compounders, or processors of either drugs or medical devices.
During the course of and in furtherance of the conspiracy and scheme, the defendants manufactured and caused the manufacture of misbranded drugs, including Bismacine, Dioxychlor, Bio-Rizin, and Sulfoxime, and shipped and sold these misbranded drugs in interstate commerce; the defendants distributed or caused the distribution in interstate commerce, misbranded drugs, including Bismacine, Dioxychlor, Bio-Rizin, and Sulfoxime, some of which were intravenously injected into individuals seeking medical treatment; the defendants received or caused the receipt in interstate commerce, and thereafter delivered for payor otherwise, misbranded drugs, including Bismacine, Dioxychlor, Bio-Rizin, and Sulfoxime; the course of and in furtherance of the conspiracy and scheme, the defendants failed to register with the FDA in any capacity as producers, manufacturers, preparers, propagators, compounders, or processors of drugs, knowing they were required to do so; the defendants made material misrepresentations or omitted material facts to diagnose, or caused the diagnosis of, Lyme disease in individuals; the defendants made material misrepresentations or omitted material facts to promote the use of intravenous injections of Bismacine, Dioxychlor, Bio-Rizin, and Sulfoxime to treat disease, including Lyme disease; and the defendants intravenously injected or caused the intravenous injection of Bismacine, which resulted in one individual in Kansas experiencing renal failure, and another individual in Kansas lapsing into a coma and eventually dying.
4. Proposed (c)(1)(C) Sentence. The parties propose, as an appropriate disposition of the case, a sentence of five years probation; all conditions of probation determined to be appropriate by U.S. Probation after completing its presentence investigation, to include a period of home confinement with electronic monitoring of at least twelve months; no fine; restitution as determined by the Court up to $40,372.08 to Sean Walby and Malgosia Cegelski; a forfeiture money judgment as agreed upon by the parties of approximately $400,000; and the mandatory special assessment of $100. The parties seek this binding plea agreement as an appropriate disposition of the case because it brings certainty to the sentencing process and assures that the defendant and the government will benefit from the bargain they have struck if the Court permits itself to be bound by the proposed sentence; the interests of justice are served by the sentence, thereby assuring that the sentence is consistent with the sentencing factors of 18 U.S.C. § 3553(a); and ifthe Court does not agree with the sentence, the parties may be restored to the positions they maintained prior to reaching this plea agreement. This agreement centers on the defendant’s agreement to enter his guilty plea as soon as the Court’s schedule permits, thereby preserving valuable Court, prosecution, public defender, probation office, U.S. Marshals Service and other law enforcement resources.
5. Application of the Sentencing Guidelines.The parties are of the belief that the proposed sentence does not offend the now advisory sentencing guidelines, but because this proposed sentence is sought pursuant to Fed. R. Crim. P. II(c)(1)(C), the parties are not requesting imposition of an advisory guideline sentence.
6. Government’s Additional Agreement. In return for the defendant’s plea of guilty as set forth herein, the United States Attorney for the District of Kansas also agrees to not file any additional charges against him arising out ofthe facts forming the basis for the Indictment.
7. Whether to accept the Proposed Plea Agreement and Sentence is up to the Court. The Court has no obligation to accept the proposed plea agreement and sentence. It is solely within the Court’s discretion whether to accept the proposed binding plea agreement as an appropriate disposition of the case.
8. Withdrawal of Plea Permitted Only if the Court Does Not Accept the Plea Agreement and Proposed Sentence. On the other hand, if the Court agrees to be bound by the proposed plea agreement and accepts the defendant’s plea of guilty, the defendant will not be permitted to withdraw it. Only if the Court rejects the proposed plea agreement will the defendant be permitted to withdraw his guilty plea.
9. Identification of Assets & Agreement Concerning Monetary Penalties.
- The defendant agrees to disclose to law enforcement officials the existence and status of all monies, property or assets, of any kind in which he has sole, joint, or partial ownership or control OR was derived from or acquired as a result of, or used to facilitate the commission of the crimes charges. Furthermore, the defendant agrees to provide all of his financial information to the United States Attorney’s Office at the same time that he provides such to the United States Probation Office as part of the presentence investigation procedure. The defendant consents to the release of the information from the United States Probation Office to the United States Attorney’s Office should he neglect to separately provide such information to the United States Attorney’s Office or the United States Probation Office, to participate in a pre-sentencing debtor’s examination, which may include the taking of information from the defendant under oath.
- The defendant further agrees to prevent the disbursement of any monies, property, or assets derived from the crimes charged, or otherwise under his custody or control. If the defendant fails to comply with this provision, then the United States is relieved of it obligation to recommend a sentencing reduction for Acceptance of Responsibility pursuant to U.S.S.O. § 3E1.1, to file a motion under U.S.S.O. § 5K1.1, or to make any other sentencing recommendations contained in this agreement.
- The defendant understands and agrees that pursuant to Title 18, United States Code, Section 3613, whatever monetary penalties are imposed by the court will be due and payable immediately and subject to immediate enforcement by the United States. If the Court imposes a schedule of payments, the defendant understands that the schedule of payments is merely a minimum schedule of payments and not the only method, nor limitation on the methods, available to the United States to enforce the judgment. If the defendant is incarcerated, he agrees to participate in the Bureau of Prisons Inmate Financial Responsibility Program, regardless of whether the Court specifically directs participation or imposes a schedule of payments.
- The further agrees to pay restitution as determined by the Court not more than $40,372.08 to Sean Walby and Malgosia Cegelski.
10. Payment of Special Assessment. The defendant understands that a mandatory special assessment of $100 will be entered against the defendant at the time of sentencing.
11. Waiver of Appeal and Collateral Attack. If the Court agrees to the proposed plea agreement, the defendant knowingly and voluntarily waives any right to appeal or collaterally attack any matter in connection with this prosecution, conviction, or the components of the sentence to be imposed herein (including the length and conditions of supervised release, as well as any sentence imposed upon a revocation of supervised release). The defendant is aware that Title 18, U.S.C.. § 3742 affords a defendant the right to appeal the conviction and sentence imposed. By entering into this agreement, the defendant knowingly waives any right to appeal if the Court imposes the sentence requested by the parties. The defendant also waives any right to challenge a sentence or otherwise attempt to modify or change his sentence or manner in which it was determined in any collateral attack, including, but not limited to, a motion brought under Title 28, U.S.C.. § 2255 [except as limited by United States v. Cockerham, 237 F.3d 1179, 1187 (10th Cir. 2001)], a motion brought under Title 18, U.S.C.. § 3582(c)(2), and a motion brought under Fed. Rule of Civ. Pro. 60(b). However, if the United States exercises its right to appeal the sentence imposed as authorized by Title 18, U.S.C.. § 3742(c), the defendant is released from this waiver and may appeal the sentence received as authorized by Title 18, U.S.C.. § 3742(c).
12. Waiver of FOIA Request. The defendant waives all rights, whether asserted directly or by a representative, to request or receive from any department or agency of the United States any records pertaining to the investigation or prosecution of this case including, without limitation, any records that may be sought under the Freedom of Information Act, Title 5, U.S.C.. § 552, or the Privacy Act of 1974, Title 5, U.S.C.. § 552a.
13. Full Disclosure by United States. The defendant understands the United States will provide to the court and the United States Probation Office all information it deems relevant to determining the appropriate sentence in this case. This may include information concerning the background, character, and conduct of the defendant including the entirety of the defendant’s criminal activities. The defendant understands these disclosures are not limited to the count to which the defendant has pled guilty. The United States may respond to comments made or positions taken by the defendant or defendant’s counsel and to correct any misstatements or inaccuracies. The United States further reserves its right to make any recommendations it deems appropriate regarding the disposition of this case, subject only to any limitations set forth in this plea agreement. The defendant also has the right to provide information concerning the offense and to make recommendations to the court and the United States Probation Office.
14. Parties to the Agreement. The defendant understands this plea agreement binds only the defendant and the United States Attorney for the District of Kansas, and that it does not bind any other federal, state, or local prosecution authority.
15. No Other Agreements. The defendant has had sufficient time to discuss this case, the evidence, and this agreement with the defendant’s attorney and defendant is fully satisfied with the advice and representation provided by defendant’s counsel. Further, the defendant acknowledges that he has had the plea agreement read to him, understands it and agrees it is true and accurate and not the result of any threats, duress or coercion. The defendant further understands that this plea agreement supersedes any and all other agreements or negotiations between the parties, and that this agreement embodies each and every term of the agreement between the parties. The defendant acknowledges that the defendant is entering into this agreement and is pleading guilty because the defendant is guilty and is doing so freely and voluntarily.
Office of Consumer Litigation
Liberty Square Building, 6th Floor
450 5th Street NW
Washington, D.C. 20001
(202) 514-8742 (fax)
District of Columbia Bar No. 497900
Scott C. Rask
Assistant United States Attorney
500 State Avenue, Suite 36
Kansas City, Kansas 66101
(913) 551-6541 (facsimile)
Kan. Sup. Ct. No. 15643
Robert W. Bradford
Michael L. Harris
Assistant Federal Public Defender
500 State Avenue, Suite 201
Kansas City, Kansas 66101
913) 551-6943 (fax)
Attorney for Defendant
Date: Sept. 17, 2010.
This page was posted on December 9, 2010.