Couple Prosecuted for Use of a "VIBE Machine"
Stephen Barrett, M.D.
In 2008, Donald Brandt and his wife Sharon Brandt pled guilty to a misdemeanor charge of "causing the introduction into interstate commerce of an adulterated medical device" called a Vibrational Integrated Bio-photonic Energizer (VIBE) Machine. They also agreed to forfeit the device and six others. Their indictment (shown below) states that they used the devices to treat patients at their clinic even though neither was licensed as a health professional. In 2006, the State of Washington's Unlicensed Practice Program ordered Donald to stop. At that time, the authorities had noted that he referred to himself as a doctor, offered to cure a prospective patient of lung cancer, and treated many other patients for health problems. Sentencing in the criminal case is scheduled for September 2008. The VIBE machine is falsely claimed to cure disease by "the vibrational level of your body back to its natural state of being." The FDA has notified the distributor (VIBE Technologies, of Greeley, Colorado) that the device cannot be legally marketed in interstate commerce.
IN THE UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF WASHINGTON AT SEATTLE
UNITED STATES OF AMERICA,
DONALD BRANDT and
The Grand Jury charges that:
Conspiracy to Cause the Introduction Into Interstate Commerce,
with Intent to Defraud or Mislead,
One or More Misbranded Medical Devices
and One or More Adulterated Medical Devices
1. Beginning at a date unknown but believed to be by at least 2002 and continuing through at least 2005, within the Western District of Washington and elsewhere, defendants DONALD BRANDT and SHARON BRANDT (collectively "the BRANDTS"), knowingly conspired, confederated and agreed with each other to commit the following offenses against the United States: to cause, with the intent to defraud or mislead, the shipment in interstate commerce of misbranded and adulterated medical devices, in violation of Title 21, United States Code, Sections 331(a) and 333(a)(2).
A. The Brandts.
At all times relevant to this Indictment:
2. The BRANDTS were husband and wife.
3. The BRANDTS operated a "clinic" on Blodgett Road in Mt. Vernon, Washington, within the Western District of Washington. The purpose of the business was to provide purported medical treatments and to sell supplements.
4. Among SHARON BRANDT's duties at the "clinic" were scheduling appointments and interacting with patients and families of patients on the phone and in the clinic's waiting area.
5. Among DONALD BRANDT'S duties in the operation of the "clinic" was purported treatment of patients for various conditions and diseases. DONALD BRANDT used various medical devices in such treatments.
6. DONALD BRANDT was not a licensed medical doctor and had not received any kind of medical degree ..
B. The Food and Drug Administration and Medical Devices
At all times relevant to this Indictment:
7. The Food and Drug Administration (hereafter "FDA") regulates, among other things, medical devices. Title 21, United Stated Code, Section 321(h) defines a medical device, in pertinent part, as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, incIuding any component, part, or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, treatment, or prevention of a disease, in man or in animals, or intended to affect the structure or any function of the body of man or other animals.
8. The introduction into interstate commerce and the receipt through interstate commerce of a device that is misbranded or adulterated is prohibited.
9. A device is adulterated if it is classified under FDA regulations as a Class III device, it has not received FDA approval and is not exempt from the requirement of FDA approval.
10. The device known as the Vibe Machine was a Class III device. It had not received FDA approval, and was not exempt from the requirement that it receive FDA approval.
11. The devices known as Multi-Function Wave Form Generators were Class III devices. They had not received FDA approval, and they were not exempt from the requirement that they receive FDA approval.
12. A device is misbranded if its labeling lacks adequate directions for use.
13. A prescription device is a device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary t6 its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which "adequate directions for use" cannot be prepared.
14. Adequate directions for use means directions under which the layman can use a device safely and for the purposes for which it is intended.
15. A prescription device may be exempt from the labeling requirements that it have adequate directions for use only if the device is: (a) In the possession of a person, or his agents or employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device; or (b) In the possession of a practitioner, such as a physician, dentist, or veterinarian, licensed by law to use or order the use of such device; and is to be sold only to or on the prescription or other order of a licensed practitioner for use in the course of the licensed practitioner's professional practice.
16. The device known as the Electro-Acuscope Model 70C was an FDA approved, Class II, prescription device.
17. The device known as the Electro-Acuscope Model 70C lacked adequate directions for use by a layman. When held by someone other than a licensed practitioner or without a prescription from a licensed practitioner, the Electro-Acuscope Model" 70C was not exempt from the requirement that it have adequate directions for use.
18. A prescription device that lacks adequate directions for use by a layman that is in the possession of a layman is misbranded.
II. The Object of the Conspiracy
19. The object of the conspiracy was to purchase and cause the shipment through interstate commerce of medical devices that were adulterated or misbranded. The defendants also acted with the intent to defraud and mislead, by concealing their purchase for and use of such devices in their "clinic."
III. Manner and Means of the Conspiracy
20. Beginning at a date unknown but believed to be by at least 2002 and continuing through at least April 2005, the BRANDTS ordered, paid for and caused to be shipped in interstate commerce, various adulterated and misbranded medical devices.
21. Among these devices were five Multi-Function Wave Form Generators, an Electro-Acuscope Model 70-C, and a Vibe Machine.
22. The BRANDTS made efforts to keep their purchase, receipt, possession and use of these devices secret from regulatory authorities and law enforcement. They also obtained and attempted to obtain some of these devices through misrepresentations to the businesses selling the devices.
IV. Overt Acts in Furtherance of the Conspiracy
During and in furtherance of the conspiracy, the BRANDTS committed, and caused to be committed, one or more of the following overt acts, among others.
23. On or about late January, 2004, DONALD BRANDT ordered a Electro-Acuscope Model 70C from Pacific Biomedical Systems Inc'} in Huntington Beach, CA. When ordering the device, DONALD BRANDT falsely represented himself to the seller as a medical doctor.
24. DONALD BRANDT paid a total of approximately $4,355.00, including shipping charges, for the Electro-Acuscope Model 70C, a standard accessories package and a set of earclip electrodes.
25. On or about January 30, 2004, DONALD BRANDT caused an Electro-Acuscope Model 70C to be sent from Huntington Beach, California via Federal Express to the BRANDTS' address on Blodgett Road in Mt. Vernon, Washington.
26. On or about January 31, 2004, the BRANDTS received into their "clinic" on Blodgett Road in Mt. Vernon, Washington an Electro-Acuscope Model 70C.
27. On or about December 29, 2004, DONALD BRANDT ordered a Vibe Machine from a business called The Vibe Machine Company in Greeley, Colorado. When ordering the device, DONALD BRANDT falsely represented himself to be a medical doctor.
28. On or about December 29, 2004, DONALD BRANDT authorized $17,800.00 to be charged to a credit card in payment for the Vibe Machine.
29. On or about January 3, 2005, DONALD BRANDT caused a Vibe Machine to be sent from Greeley, Colorado via UPS to BRANDTS' address on Blodgett Road in Mt. Vernon, WA.
30. On or about December 29, 2004, when advised by the owner of The Vibe Machine Company that he often places the name of customers on the company's website, DONALD BRANDT advised that under no circumstances did he want the company to identify him as a purchaser of the device.
31. On or about January 4, 2005, the BRANDTS received into their "clinic" on Blodgett Road in Mt. Vernon, Washington, a Vibe Machine.
32. At various times relevant to this Indictment, SHARON BRANDT told patients, prospective patients, and their family members that they should keep quiet about the treatments provided at the "clinic," indicating that the BRANDTS could get in trouble if the FDA discovered that the BRANDTS were providing medical treatments at their "clinic."
33. At various times relevant to this Indictment, SHARON BRANDT told patients, prospective patients, and their family members that the "clinic" was secret or clandestine, or words to that effect, in order to keep the FDA from learning what they were doing.
34. On or about March 9, 2005, SHARON BRANDT told a woman she believed to be the wife of a prospective patient of the "clinic" (but who was in fact an investigator for the State of Washington Department of Health) that the woman should not tell anyone about the treatments at the BRANDTS' clinic," and that the BRANDTS' work was unapproved and clandestine.
35. On or about late 2003, DONALD BRANDT falsely told a law enforcement officer who had inquired about the '·clinic" on behalf of a prospective patient, that they were not treating patients.
All in violation of Title 18, United States Code, Section 371.
Causing the Introduction of a Misbranded Medical Device
in Interstate Commerce
with Intent to Defraud or Mislead
36. Paragraphs 1 - 8, 12 - 26, and 32 - 35 of this Indictment are hereby incorporated by reference.
37. On or about January 30, 2004, DONALD BRANDT and SHARON BRANDT,' with intent to defraud and mislead, caused the shipment of in interstate commerce, from Huntington Beach, California to their "clinic" in Mt. Vernon, Washington, an Electro-Acuscope Model 70C, a prescription device, which was misbranded as defined at Title 21, United States Code, Section 352(t)(1), in that it lacked adequate direction for use by a layperson, which such device had been ordered and purchased by DONALD BRANDT, and which had been shipped at the request of DONALD BRANDT.
All in violation of Title 21, United States Code, Sections 331(a), 333(a)(2) and Title 18 United States Code, Section 2.
Causing the Introduction of an Adulterated Medical Device
in Interstate Commerce,
with Intent to Defraud or Mislead
38. Paragraphs 1 - 11, 19 - 22, and 27 - 35 of this Indictment are hereby incorporated by reference.
39. On or about January 3, 2005, DONALD BRANDT and SHARON BRANDT, with intent to defraud and mislead, caused the shipment of in interstate commerce, from Greeley, Colorado to their "clinic" in Mt. Vernon, Washington, a Vibe Machine, which was adulterated as defined at Title 21, United States Code., Section 351(t)(1), in that it was a Class III device lacking the required pre-market approval, which such device had been ordered and purchased by DONALD BRANDT, and which had been shipped at the request of DONALD BRANDT.
All in violation of Title 21, United States Code, Sections 331 (a), 333(a)(2) and Title 18 United States Code, Section 2.
A TRUE BILL:
Signature of the foreperson redacted
pursuant to the policy of the Judicial
Conference of the United States
JEFFREY C. SULLIVAN
United States Attorney
Assistant United States Attorney
Assistant United States Attorney
This page was posted on June 3, 2008.