The allegations in the Pacific Hospital of Long Beach criminal and civil litigation claims that fake hardware has been implanted in the spines of hundreds of victims. These allegations raise questions about surgeries in general. For example, it is now common to have hip or knee implants, or stents placed in an artery. Yet does anyone know who manufactured the surgical part, why that part was selected over any other part, what was the manufacturers warranty or if that was the best choice at the time it was made? Or, was it chosen because of kickbacks or other reasons? Consumers spend hours choosing the latest flat panel TV, but essentially zero time learning about a costly surgical part before it is implanted. Yet recent news continues to provoke questions about how surgeons select surgical products.

For example, the United States Attorney announced that Dr. Paul S. Singh, 55, of Tehachapi, pleaded guilty to mail fraud for a scheme to defraud his patients and their insurers by implanting and billing for unapproved intrauterine devices (IUDs). Singh had an office in Tehachapi. He provided obstetric and gynecological services to women. 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, 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.

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.

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.