Tehachapi Doctor Pleads Guilty to Defrauding Patients and Insurers by Implanting IUDs That Were Not Approved by the FDA
FRESNO, Calif. — Dr. Paul S. Singh, 55, of Tehachapi, pleaded guilty today to mail fraud for a scheme to defraud his patients and their insurers by implanting and billing for unapproved intrauterine devices (IUDs), United States Attorney Benjamin B. Wagner announced.
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. The insertion of a non-FDA-approved copper IUD risks a patient’s safety. It 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 but fraudulently billed his patients and their insurers as if he had inserted FDA-approved IUDs, all without the permission or consent of his patients,
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. Agents later conducted a search warrant of Singh’s office in 2012 and learned that he had continued to implant unapproved IUDs in his patients.
Singh failed to advise his patients of the risks of unapproved IUDs or of the fact that one had been implanted in them. 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.
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.
United States Attorney Wagner stated: “Doctors who take shortcuts by utilizing unapproved medical devices willingly put their own financial interests ahead of their obligation to care for the health of their patients. My office is increasing its focus on health care fraud cases, and those who benefit while disregarding the health of patients will be first in line for investigation and prosecution.”
“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 is 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 are prosecuting the case.
Singh is scheduled to be sentenced by United States District Judge Anthony W. Ishii on November 23, 2015. Singh faces a maximum statutory penalty of 20 years in prison and a $250,000 fine. The actual sentence, however, will be determined at the discretion of the court after consideration of any applicable statutory factors and the Federal Sentencing Guidelines, which take into account a number of variables.