Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Orange Jumps Suits – Try One On!

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

The moral of this week’s guidance is: “Always do the right things!” However, for those of you with a moral compass that may not always point north, the moral of the story is; “Do not get caught!”

Dr. D continues to receive much email as to the potential of ever having to wear the infamous orange jump suits. In fact, some of the readers are skeptical that a Chief Jailable Officer (CJO) is ever afforded the opportunity to be fitted with a new orange jumpsuit and matching stainless steel bracelets. The doctor wants to ensure the readers that all-expense paid vacations to Fort Leavenworth (Kansas), while wearing the jump suit and shiny new bracelets, are very real. That being said, there have been many industry professionals that have been “incarcerated” (look-it-up) for their unscrupulous actions taken in the medical industry.

This week, the doctor is going to share with you the FDA’s Hall of Shame, by sharing the brief biographies of a few individuals that have run afoul of FDA and were rewarded appropriately in the US Federal Court System. On another note, if you do not find the jail time as an underlying driver to always do the right thing, then just maybe the fines might dissuade you from doing bad things. Enjoy.

The Hall of Shame The doctor would like to commence this section by stating that the names have not been changed to protect the innocent and those mentioned in this article were presumed to be innocent until proven guilty in a court of law. Each Hall of Shame Member has been convicted and sentenced in the Federal Courts and deemed to be guilty as charged. Please note, the doctor is only presenting the facts and remember, you just can’t make this stuff up.  

Ross A. Caputo and Robert M. Riley

Abbott had Costello and Laurel had Hardy, so it is only natural that Caputo had Riley. Seriously, in April of 2006, these former executives from AbTox were convicted of fraudulently selling a sterilizer that was not cleared by FDA. The sterilizers, primarily employed in the sterilization of products used in ophthalmic procedures, resulted in permanent injury and, in some cases, loss of sight in 18 patients. These rocket scientists were selling uncleared sterilization systems by showing healthcare providers a clearance letter for a smaller/cleared version of the system. As a result, Caputo and Riley were convicted of the following charges:

    • Three counts of wire fraud;
    • Four counts of mail fraud;
    • Seven counts of selling medical device that was not properly cleared by FDA; and
    • One count of conspiracy to defraud our friends from the agency.

As a result of their stupidity, Caputo was order to serve 10 years in the infamous orange jumpsuit; and Reilly was awarded 6 years in an orange jumpsuit. If the time doesn’t grab one’s attention, collectively the $17 million in restitution will.

Thomas Higgins, Michael Huggins, and John Walsh

These three gentlemen are former executives of Norian Corporation (a subsidiary of Synthes, Inc.) decided it was acceptable to run a clinical trial without prior approval of FDA. According to the FDA’s press release, these CJOs conspired to execute unauthorized clinical trials for bone cement. Norian XR and Norian SRS are employed as part of surgical procedures to treat compression factures of the spine. As a result, of their actions these former CJOs were awarded the privilege of wearing orange jumpsuits. Higgins and Huggins were awarded nine months in federal prison while Walsh was awarded five months in prison.

Michael Forrest

Michael Forrest was the president and founder of Jaguar Enterprises. Jaguar sold medical devices on the Intranet and claimed devices sold such as the Brain Synchronizer and Magnetic Pulsar reversed chronic disease states associated with AIDS, cancer, and hepatitis. FDA classified these devices as Class III; however, Jaguar forgot one minor detail, they never filed a PMA application with FDA. In August of 2001, a Consent Decree settlement resulted in no fines or jail time. All Forrest had to do was refund money to customers. Unfortunately, this individual thumbed his nose at the Federal Courts and continued to sell the products. In February of 2006, Forrest was awarded the privilege of wearing an orange jumpsuit for 24-months for the introduction of misbranded products into interstate commerce.

Takeaways

Hopefully, you enjoyed the three stories Dr. D shared as part of this week’s guidance. The moral of the story is: “Always do the right things!” However, for those of you with a moral compass that may not always point north, the moral of the story is; “Do not get caught!” That being said, the doctor will leave the readers with just one takeaway, it is not nice to attempt to fool FDA. Eventually, individuals and/or organizations that fail to properly submit Class I (some products), II, and III device applications to FDA for review and clearance/approval, FDA will eventually find out and they will not be pleased. This includes unapproved clinical trials. If orange is not your color, then that should be incentive enough to comply.

In closing, thank you, thank you, and 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. (2013, 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. Court decisions fiscal year 2008. (2008). FDA Website. Retrieved January 19, 2014, from http://www.fda.gov/downloads/iceci/enforcementactions/enforcementstory/ucm129820
  4. Food and Drug Administration Office of Criminal Investigations. (2011, November). FDA Website. Retrieved January 19, 2014, from http://www.fda.gov/iceci/criminalinvestigations/ucm280937.htm
  5. Office of Criminal Investigations – the enforcement story. (2006). FDA Website. Retrieved January 19, 2014, from http://www.fda.gov/downloads/iceci/enforcementactions/enforcementstory/enforcementst oryarchive/ucm090866.pdf.

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Dr. Christopher Joseph Devine, President, Devine Guidance International

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