California Court Bans Unubstantiated
Claims for Pap-IMI Device

Stephen Barrett, M.D.


In 2005, Gerald Allen Anderson and his company, Bio-Energy Services (later called Biophotonix) were prohibited from marketing the PAP-IMI device or any other other product with false or misleading claims. They were also ordered to pay a $2,750 penalty plus $7, 000 for the cost of investigating what they had done. The full name of the device is the Pap Ion Magnetic Inductor. In 2003, Bio-Energy's Web site described it as an "advanced electrotherapeutic diathermy device that produces unique bio-energetic magnetic field pulses." The site further stated:

PEMF [pulsed electromagnetic field] is a method of applying a magnetic field to the cell which converts the magnetic field into a weak electrical signal, influencing the interaction of the ions, and the flow of nutrients in the cell. Enhanced circulation and nutrient exchange can speed the healing process and reduce down time.

The District Attorney's complaint (shown below) indicates that the defendants illegally promoted the PAP-IMI for treating immune system conditions, liver and prostate cancer, prostate gland disorders, bone or joint diseases, arthritis, lupus, heart disease, high blood pressure, and diabetes. The final judgment that ended the case included a penalty of $2,750 plus $7,000 for investigative costs.


STEVE COOLEY,
District Attorney
THOMAS A. PAPAGEORGE, State Bar No. 77690
Head Deputy District Attorney
MARY ANN KEYFAUVER, State Bar No. 125751
Deputy District Attorney
201 No. Figueroa Street, Suite 1200
Los Angeles, California 90012
Telephone: (213) 580-3369

Attorneys tor Plaintiff

IN THE SUPERIOR COURT OF THE STATE OF CALIFORNIA
FOR THE COUNTY OF LOS ANGELES

THE PEOPLE OF THE STATE OF CALIFORNIA.

Plaintiff,

v.

BIO-ENERGY SERVICES, INC,
BIOPHOTONIX. INC.; and
GERALD ALLEN ANDERSON. also known as
JERRY A. ANDERSON; and
DOES 1 through 10, inclusive.

Defendants.


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CASE NO. BC338072

COMPLAINT FOR
INJUNCTION AND
CIVIL PENALTIES
(Bus. &. Prof. Code
section 17200 et seq.)

Filed Aug 10, 2005

THE PEOPLE OF THE STATE OF CALIFORNIA, hy and through Steve Cooley, District Attorney for the County of Los Angeles. State of California. acting on information and belief, allege:

VENUE AND JURISDICTION

1. Steve Cooley, District Attorney for the County of Los Angeles, State of California, by Thomas A. Papageorge and Mary Ann Keyfauver. Deputy District Attorneys, acting to protect the general public from untrue or misleading representations and unlawful. unfair or fraudulent business practices. brings this suit in the public interest in the name of THE PEOPLE OF THE STATE OF CALIFORNIA.

2. Plaintiff, by this action and pursuant to Business and Professions Code sections 17203, 17204. 17206, 17535 and 17536, seeks to enjoin defendants from engaging in the unlawful business practices alleged herein and seeks to obtain civil penalties for defendants' unlawful business practices. including untrue or misleading representations.

3. Defendants at all times mentioned herein have transacted business within and from the County o£ Los Angeles. The violations of law described in this complaint have been committed within the County of Los Angeles and State of California. Pursuant to section 393 of the California Code of Civil Procedure. the County of Los Angeles is a proper and legal venue for this case.

DEFENDANTS

4. Defendant BIO-ENERGY SERVICES, INC. (hereinafter “Bio-Energy Services") is a California corporation. Its last known principal place of business was 18720 Oxnard Street, Tarzana, California.

5. Defendant BIOPHOTONIX, INC. (hereinafter "BioPhotonix") is a Nevada corporation which has a place of business at 5138 Zelzah Avenue, Suite 103. Encino, California. It has not qualified to do business in California as required by California. Corporations Code section 2105. Defendant BioPhotonix is a continuing enterprise of Bio-Energy Services and has the same officers and employees.

6. Defendant GERALD ALLEN ANDERSON also known as JERRY A. ANDERSON (hereinafter "Anderson") was the secretary of Bio-Energy Services between March 18, 2002, and October 14, 2003, and has been the president and director of BioPhotonix since its incorporation on December 16. 2004 until the present.

7. Defendants. DOES I through 10, are officers, directors, managers or employees of defendants Bio-Energy Services or BioPhotonix who, at all times herein mentioned, caused or engaged in the violations of law hereinafter alleged.

NATURE OF BUSINESS INVOLVED

8. Defendants are engaged in the business of the importation, sales and repairs of an unapproved device called the Pap Ion Magnetic Inductor (hereinafter "PAP-IMI device").

9. The PAP-IMI devices are plant and seed germinators manufactured in Greece, imported into the United States by air freight. and routed through Los Angeles International Airport (LAX) for purposes of sales and/or leases to the general public. including sales and/or leases to the public within Los Angeles County.

10. Defendants transport the PAP-IMI devices from LAX to another location within Los Angeles County and remove the "Plant and Seed Germinator" label and replace it with their own PAP-IMI device label.

11. The PAP-IMI devices are represented by defendants to the public as being medical devices to be used in the treatment or cure of many serious illnesses, conditions. disorders or diseases, including cancer, and administer treatments by use of the PAP-IMI devices to the public as a cure for various medical conditions.

12. Defendants conduct sales seminars and operator training courses to the public in the use of the PAP-IMI devices to treat and cure illnesses, conditions, disorders or diseases in violation of the California Health and Safety Code.

13. Defendants offer repair services for the PAP-IMI devices to owners and lessees of the devices.

14, These claims. representations and services have not been approved for PAP-IMI devices by the U. S. Food and Drug Administration (hereinafter "FDA") nor by the State of California Department of Health Services. Food and Drug Branch (hereinafter "FOB'') nor can they be substantiated by competent and reliable scientific evidence.

FIRST CAUSE OF ACTION
Violations of Business and Professional Code
Section 17500 (Untrue or Misleading Statements)
Alleged by the People Against All Defendants

15. Plaintiff incorporates paragraphs [ through 14 of this complaint as though they were set forth a( length herein.

16. Beginning at an exact date that is unknown to plaintiff.. but within three years prior to the filing of this complaint, defendants with intent directly or indirectly to dispose of personal property or to perform services, or to induce the public to enter into any obligation relating thereto, made or disseminated or caused to be made or disseminated before the public in this state by any means whatsoever, representations concerning such property or services or concerning any circumstance or disposition thereof, which were untrue Or misleading, and which were known, or which by the exercise of reasonable care should have been known to have been untrue or misleading. These representations include but are not limited to the following:

a. The PAP-IMI device is effective in the treatment of tumors. immune system conditions, liver and prostate cancer, prostate gland disorders, bone or joint diseases, arthritis, lupus, heart and vascular disease, high blood pressure and diabetes.

b. The PAP-IMI device energizes water which transfers the energy to seeds, plants, animals or humans with observable positive effects.

c. The PAP-IMI device can be used for a “Cosmetic Magnetic Face-Lift.”

d. Defendants distribute literature to the public bearing representations the PAP-IMI device is approved as a medical device in Canada by the Medical Devices Bureau of Health Protection Branch Canada. when in fact it is not.

e. Defendants distribute literature to the public representing that the PAP-IMI device produces a magnetic field which penetrates deep tissue and can provide sustainable biological results without proof of scientific investigation or substantiation.

f. Defendants distribute literature to the public representing that European studies on the PAP-IMI device have been performed on inflammation, edema and pain relief with an 89% success rate for the relief of pelvic pain without proof of scientific investigation or substantiation.

g. Defendants distribute literature to the public representing that at least one woman in Greece responded to treatments by use of the PAP-IMI device with complete regression of massive ovarian cancer.

17. The representations and medical claims made by defendants as set forth in Paragraph 16 above were untrue or misleading when made. and were known, or by the exercise of reasonable care should have been known, to be untrue or misleading.

SECOND CAUSE OF ACTION
Violations of Business and Professions Code
Section 17200 (Unfair Competition)
Alleged by the People Against All Defendants

18. Plaintiff incorporates paragraphs 1 through 17 of this complaint as though they were set forth at length herein.

19. Beginning at an exact date that is unknown to plaintiff but within four years prior to filing this complaint, defendants have engaged in a course of conduct constituting unfair competition within the meaning Business and Professions Code section 17200, which defines unfair competition to include any unlawful. unfair or fraudulent business act or practice and unfair, deceptive, untrue or misleading advertising. Defendants' acts and practices of unfair competition include, but ate not limited to the following:

a. Defendants have violated Section 17500 of the Business and Professions Code as more particularly described in paragraph 16 of this complaint, which is re-alleged and incorporated herein by this reference as though set forth fully herein.

b. Defendants have engaged in the sale or delivery of an unapproved new device; to wit: PAP-IMI device, without receiving prior written approval from the FDB, in violation of California Health & Safety Code section 111550.

c. Defendants have engaged in the sale or delivery of an unapproved new device, to wit PAP·IMI device. without receiving from the FDA either ( 1) a written determination, pursuant to Section 510(k) of the federal Food. Drug and Cosmetic Act, certifying that the device is substantially equivalent to legally marketed predicate devices, or (2) written approval of a premarketing application, pursuant to Section 515 of the Federal Food, Drug and Cosmetic Act.

d. Defendants have sold, delivered or given away an unapproved MW drug. to wit: pulsed or energized water. without receiving prior written approval from. the FDB in violation of California Health &. Safety Code section 111550.

e. .Defendants have sold. delivered or given away an unapproved new drug. to wit: pulsed or energized water. without filing a New Drug Application with the FDA. as defined in section 201 (p) and pursuant to sections 355 and 505 of the Federal Food, Drug, and Cosmetic Act.

f. Defendants have engaged in the sale or leasing of PAP-IMI devices to lay persons without obtaining a prescription from a licensed practitioner, in violation of Health and Safety Code sections 111470(b) or 111470(c).

g. Defendants have engaged in selling. delivering, holding or offering for sale I misbranded drugs or devices, in violation of California Health & Safety Code section 111440.

h. Defendants have engaged in conduct involving misbranding a drug or device in violation of California Health & Safety Code section 111445.

20. Defendants' acts of unfair competition as described in paragraph 19 above constitute patterns and practices central to the operation of defendants~ business. Unless enjoined by order of this Court, defendant is likely to continue to engage in such acts of unfair competition.

PRAYER FOR RELIEF

WHEREFORE, plaintiff prays for judgment as follows:

1. Defendants. their successors, assigns, agents, representatives, employees and all persons who act in concert with them be permanently enjoined from making any untrue or misleading statements in violation of Business and Professions Code section 17500 including, but not limited to, the untrue or misleading statements alleged in the First Cause of Action.

2. Defendants. their successors. assigns, agents, representatives, employees and all persons who act in concert with them be permanently enjoined from engaging in unfair competition as defined in Business and Professions Code section 17200 including, but not limited to, the acts or practices alleged in the Second Cause of Action.

3. Pursuant to Business and Professions Code section 17536. the court assess a civil penalty of two thousand five hundred dollars ($21500) against each defendant for each violation of Business and Professions Code section 17500 alleged in the First Cause of Action. Plaintiff requests that a civil penalty of no less than two hundred thousand dollars ($200,000) be imposed against each defendant.

4. Pursuant to Business and Professions Code section 17206, the court assess a civil penalty of two thousand five hundred dollars {$2,500) against each defendant for each violation of Business and professions Code section 17200 alleged in the Second Cause of Action. Plaintiff requests that a civil penalty of no less than two hundred thousand dollars ($200,000) be imposed against each defendant.

5. Defendants he ordered to make full restitution of all money or other property that may have been acquired by their violations of Business and Professions Code sections 17200 and 17500.

6. Plaintiff recovers it costs of suit, including costs of investigation.

7. Plaintiff have such other and further relief as the nature of the case may require and the court deems appropriate to fully and successfully dissipate the effects of the untrue and misleading statements and unlawful and unfair business acts complained of herein.

DATED: 8-10-05

STEVE COOLEY
District Attorney
THOMAS A. PAPAGEORGE
Head Deputy District Attorney

By: _______________________
MARY ANN KEYFAUVER
Deputy District Attorney

This page was posted on October 1, 2007.

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