This article was part of our April Fool’s edition. While it is completely factual (But no, our beloved Dr. D. did not go to jail), 30% of poll participants thought the story was fake. As Dr. D likes to say–Ouch!
Folks, you just cannot make this stuff up, or can you? Once upon a time, in an enchanted land called California, lived a doctor that appeared to love money more than his patients. Evidently, this doctor had no fear of King Obama’s terrifying agency, the knights of the FDA. Now the FDA just wanted to protect all of the subjects in the kingdom and did everything in its power to keep the subjects of King Obama’s kingdom safe from harm. Wanting to prevent a battle between the doctor and dreaded United States Department of Justice (DOJ), the FDA surprised the doctor on a warm August afternoon and inquired about his use of unapproved medical devices (IUDs) for implantation into his patients. The doctor begged for mercy and promised to change his evil ways. Feeling they were successful in their quest, the FDA returned to their castle. Fueled by dollar signs and the need for greed, the wayward doctor soon returned to his evil ways and once again, the king’s subjects suffered physically and fiscally. In fact, this evil doctor was so greedy he billed his patients and their insurance companies for approved devices while using inferior devices. No one in the kingdom reminded the doctor that using copper in most medical devices was a bad thing. Because of the fraudulent behavior, the FDA summoned the DOJ to join in the banishment proceedings for the wayward doc. Eventually, time in the dungeon was ruled to be the appropriate punishment. Dr. D thinks that off with his head would have been more appropriate. Is this story true or is it Dr. D’s way of entertaining the readers on April Fool’s Day?
Unfortunately, this story is no joke. It really happened and impacted the lives of patients and their families in Tehachapi, CA. For this offending medical practitioner, the only “epistemic” (look-it-up) certainty is a reserved cell in a federal penitentiary. Enjoy!
United States Department of Justice Press Release (March 7, 2016)
“FRESNO, Calif. — Dr. Paul S. Singh, 55, of Tehachapi, was sentenced today to six months in prison, to be followed by one year of home detention by United States District Judge Anthony W. Ishii, for a scheme to defraud patients and their insurers by implanting and billing for unapproved intrauterine devices (IUDs), United States Attorney Benjamin B. Wagner announced. A restitution hearing is set for May 9, 2016, at 10:00 a.m.
Singh, a medical doctor licensed to practice in California, had an office in Tehachapi. He provided obstetric and gynecological services to women, including providing forms of birth control. One form of birth control he provided were IUDs, which the Food and Drug Administration (FDA) regulates. The FDA has approved only one IUD that uses copper as its active ingredient, the ParaGard T-380A, which was sold only by its manufacturer and not available on third-party websites. Doctors who implant a non-FDA-approved copper IUD risk a patient’s safety. Such a device can result in an increased risk of pelvic inflammatory disease, ectopic pregnancy, hysterectomy, and other serious complications.
According to court documents, Singh bought unapproved IUDs on the Internet and implanted them in his patients. Rather than inform his patients or their insurers of using non-FDA approved IUDs, however, he fraudulently billed his patients and their insurers as if he had implanted FDA-approved IUDs, all without the permission or consent of his patients. Singh profited from the implanting unapproved IUDs by billing his patients and their insurers for the higher cost of approved IUDs, which was false and fraudulent.
According to court documents, Singh was sent multiple bulletins and newsletters warning against the use of unapproved IUDs. He was also warned that products sold by online pharmacies were not identical to the ParaGard T-380A and had not been approved as safe and effective by the FDA. In spite of the warnings, Singh purchased unapproved IUDs from online retailers and implanted them in numerous patients without their consent, between April 2008 and June 2012.
In August 2010, agents from the FDA confronted Singh about his history of implanting unapproved IUDs. During the meeting, Singh agreed to stop implanting them in his patients. In 2012, agents searched Singh’s office and learned that he had continued to implant unapproved IUDs in his patients.
According to the plea agreement, many of Singh’s patients later complained to him and other doctors about medical complications they associated with Singh’s insertion of the IUD. In multiple instances, Singh responded to such complaints by re-inserting the IUD rather than removing it. Some patients ultimately had to switch doctors in order to have the IUD removed.
U.S. Attorney Wagner stated: “Singh’s scheme risked the health of his patients and defrauded health care providers to benefit his bottom line. The investigation and prosecution of health care fraud is a priority for my office, particularly where that fraud endangers innocent patients.”
“Medical doctors have a special responsibility to make the best choices for their patients. When they ignore that responsibility and use unapproved medical devices, they put patients’ safety and health at risk,” said Special Agent in Charge Lisa L. Malinowski, FDA Office of Criminal Investigations’ Los Angeles Field Office. “Our office will continue its work to ensure that doctors and other healthcare professionals understand the consequences of using medical products that have not been approved by the FDA.”
This case was the product of an investigation by the Food and Drug Administration, Office of Criminal Investigations. Assistant United States Attorneys Patrick R. Delahunty and Kirk E. Sherriff prosecuted the case.”
Compliance for Dummies
The point Dr. D. wanted to make this week is that Chief Jailable Officers (CJOs) are not the only people that can spend time behind bars when bad judgment, with some serious intent to commit fraud occurs. Frankly, it is the doctor’s humble opinion that the sentence was far too light. Any physician willing to take liberties with their patients in order to improve their bottom line should spend some substantial time behind bars with a cell mate appropriately named Ben Dover. It is the doctor’s guess this fine upstanding example of how not to be an OB/GYN will eventually emerge from prison and wind up practicing medicine somewhere else in the world, either another state or another country. Too bad!
The bar is set high in the medtech industry, and rightfully so, because people’s lives are at stake every single day. Device establishments and healthcare providers are expected to beyond reproach as individuals tasked with designing, manufacturing, and employing finished medical devices must exhibit a high level of competency and professionalism in their work. One question Dr. D always asks his clients is, “Would you feel comfortable if you, a family member, or a close friend was on the receiving end of the device your establishment enters into commerce?” If the answer is no, the Houston, we have a problem.
Dr. D hopes the readers enjoyed some of the levity employed in the introduction of this week’s DG. All kidding aside, the behavior of the offending doctor is no joking matter. Bad behavior, resulting in money being more important than the patient is not acceptable. Trading the lives of patients and their families for dollars is worthy of a trip to hades, when it comes time to meet one’s maker. 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.
- Code of Federal Regulation. (April 2015). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
- FDA. (March 7, 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. “March 7, 2016: Tehachapi Doctor Sentenced to 6 Months in Prison for Defrauding Patients and Insurers by Implanting Unapproved IUDs”. Accessed March 29, 2016, Retrieved from http://www.fda.gov/ICECI/CriminalInvestigations/ucm489682.htm
The medical world and the public need your report and comment on the recent global recall of Nova T IUDs. This copper IUD has only 200 mm² surface (copper) whereas ISO 7439 describes a minimum of 300 mm² up to 380 maximum. The undersigned belonged to the ISO group which created the ISO Standard 7439.
Karl, Good morning. I will brush up on the recall this week and speak with my editor about writing a piece on this issue. Thank you for reading. Be Well, Dr. D