My dear readers, as Dr. D has said on multiple occasions; “You just cannot make this stuff up!” For this week’s guidance, the doctor came across another Chief Jailable Officer (CJO) who ran afoul of our dear friends at FDA. It appears that Mr. David Perez (former Carlsbad, CA resident) developed a magical black-box device capable of treating abdominal pain, AIDS, diabetes, stroke, ulcers, cancer, and worms. Worms, seriously? The doctor is going to go out on a limb here and guess that the only thing scarier than Mr. Perez’s blatant disregard for the sanctity of human life are the individuals that actually forked over the $1,200 to $1,500 to acquire one of these devices. To make a long story short, the FDA, the United States Attorney’s Office, and the United States Postal Inspection Service were not amused. However, the doctor believes that one Ben Dover, a long-time resident of the Federal Penitentiary located in beautiful Leavenworth, KS is delighted at the thought of having inmate Perez join him for the next 30 months. Dr. D guesses the unctuous (look-it-up) Mr. Perez wished that he had chosen another industry to work his unscrupulous magic, like selling used cars. Enjoy!

Department of Justice Press Release – April 4, 2016⁴

“Former Carlsbad resident David Perez was sentenced in federal court today to 30 months in custody for selling unapproved “Energy Wave” medical devices over the internet and mailing them to customers throughout the United States.”

“According to admissions in his plea agreement, Perez marketed the “Energy Wave” device using the website www.myenergywave.com. The Energy Wave device consists of a micro-current frequency generator with a digital readout, two stainless steel cylinders, two personal application plates with connectors and lead wire for the cylinders and plates.  Users were provided with an operating manual and a list of Auto Codes that set forth over 450 digital settings for the device, directed to treat specific conditions from abdominal pain, AIDS and diabetes to stroke, ulcer and worms.  The Auto Codes and Manuel advised users to connect the cylinders or plates to the machine, and touch them to the body for a recommended run time to treat each condition.”

“David Perez admitted selling each device for approximately $1,200-$1,500, and receiving gross proceeds of approximately $271,000.  He also acknowledged that he intended to defraud and mislead the Food and Drug Administration by attempting to evade the agency’s oversight of medical claims made regarding the Energy Wave device by maintaining a separate website (rifecodes.com) to which he referred customers who needed to obtain the auto codes that allegedly were used to treat the various medical conditions.  Perez admitted that he knew or should have known a number of his customers were vulnerable because they had purchased the device in an attempt to cure cancer, and that they were marketing the device without the proper FDA approvals.”

“It’s unconscionable to sell useless medical devices to critically ill people who are hoping for a miracle,” said U.S. Attorney Laura Duffy. “This sentence reflects the serious nature of this crime, and our commitment to protecting those who are most vulnerable to being preyed upon by heartless predators.”

“This investigation uncovered a serious public health threat and should serve as a warning to those who put consumers at risk for their own financial gain,” said Dave Shaw, special agent in charge for HSI San Diego. “HSI agents will continue to work with our law enforcement partners, both here and abroad, to investigate medical-related fraud over the Internet, especially when it involves an online marketing scam, such as this case in which unregulated medical devices were sold under false pretense.”

“The U.S. Postal Inspection Service will continue to work with our partners in law enforcement to ensure that the U.S. Postal Service isn’t used as a conduit for those criminals who seek to perpetrate medical quackery upon the American consumer,” said Robert Wemyss, Inspector in Charge of the U.S. Postal Inspection Service – Los Angeles Division.  “This type of crime takes advantage of the most vulnerable segment of the population to include the elderly and terminally ill.  The protection of our citizens remains the cornerstone of our mission.”

“Consumers rely on the FDA to ensure that the medical products they use, including medical devices, actually treat the diseases or conditions they claim to. When criminals sell misbranded devices not cleared by the FDA, they put users’ health at risk,” said Lisa L. Malinowski, Special Agent in Charge, FDA Office of Criminal Investigations’ Los Angeles Field Office.  “We will continue to devote our resources to removing such threats to the public’s health from the U.S. marketplace.”

Compliance for Dummies

There really is no compliance lesson to be learned here. Perez is just another bad actor that has earned a 30-month vacation in the custody of the federal authorities. The doctor struggles to fathom why someone would be so bold as to enter a bogus medical device into commerce in the United States. Offending parties will get caught and they will pay dearly for their transgressions, especially, when the offending party (CJO) willfully and blatantly disregards the Food, Drug, and Cosmetic Act, while intentionally hurting unsuspecting individuals in pursuit of the almighty dollar. As the doctor has said on many occasions, “There is a special place in hades for individuals like Mr. Perez.” I believe it is an eternity of shoveling the coal into the blast furnaces.

Takeaways

For this week’s guidance the doctor will leave the readers with just one takeaway: Please do not be that individual that is dragged into federal court to face the wrath of FDA and the U.S. Attorney’s office. Why? Because a 30-month date with Ben just does not sound like much fun. It is always best to walk the high road and remain in the good graces of our friends at FDA. In closing, thank you again for joining Dr. D, and I hope you find value in the guidance provided. Until the next installment of DG, cheers from Dr. D., and best wishes for continued professional success.

References

1. Code of Federal Regulation. (2015, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
2. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system   regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
3. Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
4. FDA (April 4, 2016). Inspections, Compliance, Enforcement, and Criminal Investigations.  Former Carlsbad Resident Jailed for Sale of Unapproved “Energy Wave” Medical Devices. Accessed April 19, 2016. Retrieved from http://www.fda.gov/ICECI/CriminalInvestigations/ucm494563.htm.