A California doctor could serve up to 20 years in prison for treating patients with an unapproved intrauterine device that he purchased over the Internet.
In a case filed in the U.S. District Court for the Eastern District of California, the federal government accused Paul S. Singh, 55, of buying unapproved IUDs sold by online pharmacies and implanting them in women from April 2008 through June 2012. Patients were unaware they were being treated by an unapproved device, and several later experienced complications.
These devices were not identical to the ParaGard T-380A, the only approved IUD that uses copper as an active ingredient. Using unapproved copper-containing IUDs puts patients at increased risk for pelvic inflammatory disease, ectopic pregnancy and hysterectomy.
FDA representatives confronted Singh over his scheme in August 2010, and he agreed to stop using the unapproved devices. Despite this promise, he continued to implant women with the products purchased over the Internet, billing them and their insurers for the approved IUDs.
When patients complained of complications, Singh reinserted the IUD instead of removing it. Some patients ultimately went to other doctors to have the devices removed.
“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,” says Special Agent in Charge Lisa Malinowski, FDA Office of Criminal Investigations’ Los Angeles Field Office, in a statement. “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.”
Singh is scheduled to be sentenced Nov. 23. In addition to prison time, he could face a $250,000 fine. — Elizabeth Hollis