One of Dr. D’s favorite sayings is quickly becoming; “You can’t make this stuff up!” The doctor cannot fathom why someone would risk the possibility of sharing a prison cell with old Ben Dover versus doing the right thing when it comes to finished medical devices. In this week’s Devine Guidance (DG), Dr. D will tell the readers a story about how a salesman and his side kick managed to embrace evil (no, not Evil Knievel) and sell misbranded adjustable gastric banding systems to unsuspecting physicians. You see my readers, our dear friends from the United States Department of Justice (DOJ) and the FDA frown down upon criminals who are willing to risk the health and well being of patients and healthcare providers in pursuit of the almighty dollar. Please keep in mind, one does not have to be an exulted Chief Jailable Officer (CJO) to face the wrath of the legal system and an extended stay at fine facilities such as the federal penitentiary located Fort Leavenworth, Kansas. Trips to the big house, the pen, the hoosegow, jail, prison, etc. and an opportunity to spend some quality time (or not so much) with Big Ben Dover and his friendly band of convicts can be the prize awarded to anyone willing to tempt face and place profit above product safety and efficacy in the med-tech industry. There is no doubt in Dr. D’s twisted mind that the individuals target in this investigation imprecated (look-it-up) the FDA and DOJ for their relentless pursuit of a conviction. Enjoy!

Department of Justice Press Release – January 17, 2017

“A Tampa-area medical device salesman pleaded guilty on Friday, January 13, 2017, to conspiracy to commit wire fraud in connection with the sale of expired LAP-BAND Adjustable Gastric Banding Systems to physicians in South Florida.”

The Real Story

Two account executives (and by now former employees of Apollo Endosurgery) developed a scheme for purchasing Lap-Bands that were expired or nearing their end-of-life and then re-creating product labeling with fraudulent serial numbers and new expiration dates. This now grossly misbranded product was then reintroduced into commerce through the sale to unsuspecting physicians. According to court records, Gregory Charles Grimm conspired with Peter Lawrence Kafka in this scheme to profit from the sale of intentionally misbranded products. In fact at least seven of these systems found their way into patients. It appears Kafka would acquire expired or nearly expired adjustable gastric banding systems and supply them to Grimm (giving new meaning to Tales from the Grimm). Grimm would create the fraudulent labeling, resulting in the misbranding of finished medical devices and ship them back to his co-conspirator Kafta, who in turn sold them to unsuspecting physicians. The doctor guesses that Kafka’s and Grimm’s employer did not appreciate the competition and made that fateful call to FDA (a.k.a., blowing the whistle), and the rest is soon to be history. Nicely done, Apollo Endosurgery! Your actions clearly deserve applause from industry as they may have resulted in the saving of patient lives and the anguish of their loved ones.

Severe Penalties

As of this article, Mr. Grimm has pleaded guilty to a single count of wire fraud. However, the statutory maximum sentence could be up to 20 years in the heavily protected sin bin. That sure sounds like a lot of quality time with old Ben. Personally, the doctor hopes the judge hurls the proverbial book at this individual so others contemplating doing bad things in industry, in an attempt make a quick buck will be able to learn a lesson from Mr. Grimm’s bad behavior. There was no mention of Mr. Kafka’s fate in the DOJ article, but premised on the DOJ press release, his time will surely come. That being said, Mr. Kafka has been indicted. However, an indictment is only an allegation of wrongdoing, and a defendant is presumed innocent until proven guilty in a court of law.

Takeaways

For this week’s guidance, the doctor will leave the readers with just one takeaway: Always do the right thing in industry. You never know when you, a family member, or a friend may find themselves on the receiving end of a medical procedure resulting in the use of a medical device. The expectation is that the treatment provided will save or enhance life. In pursuit of successful patient outcomes, the expectation is that finished medical devices are always safe and effective in their intended use. In closing, thank you again for joining Dr. D, and I hope you found value (and some humor) 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. (April 2016). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
2. Code of Federal Regulation. (April 2016). Title 21 Part 803: Medical device reporting. Washington, D.C.: U.S. Government Printing Office.
3. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system   regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
4. Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality         management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
5. FDA. (January 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. Tampa-Area Medical Device Salesman Guilty of Selling Expired Lap-Band Devices. Accessed February 4, 2017. Retrieved from http://www.fda.gov/ICECI/CriminalInvestigations/ucm537660.htm