These cases are still around since the Copper T-380A is one of the world's most used IUDs and it is essentially identical to ParaGard's version but it is the only one authorized by the Food and Drug Administration (FDA) to distribute in the United States. The price in the U.S. for this product is over $200 while in other countries the identical product can be obtained for $20 to $60. In Canada, for example, suppliers were buying them there and distributing in the U.S.
Internet pharmacies are selling these devices from Canada and Australia in the United States. This is not allowed and even if the product is identical it is not an FDA approved device. This means that when government or insurance programs are billed for IUDs that are not FDA approved, it is not an approved claim or is a false claim.
A physician has learned the hard way what can happen if one is not careful in using devices that are not FDA approved - even if they seem identical. According to court documents, Dr. Singh bought unapproved IUDs on the Internet and implanted them in his patients after he was warned by the FDA.
On March 7, 2016, Dr. Paul S. Singh of Tehachapi, California was sentenced to six months in prison for one count of mail fraud, to be followed by one year of home detention, by United States District Judge Anthony W. Ishii, for an alleged scheme to defraud patients and their insurers by implanting and billing for unapproved intrauterine devices (IUDs). A restitution hearing is set for May 9, 2016, at 10:00 a.m. to determine how much he will be ordered to repay Medi-Cal and private insurers.
According to the plea agreement, the facts were that Dr. 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 FDA regulates. After the Dalkon Shield litigation in the 1980s, there are only two FDA IUD devices and ParaGard's device is one of them.
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 in the U.S. According to court documents, Dr. Singh bought unapproved IUDs on the Internet and implanted them in his patients.
The government alleged that 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. The Medi-Cal billing form for IUD specifically mentioned "ParaGard" which some physicians do not realize. Some physicians think "Copper T-380" and do not focus on the licensee or manufacturer. It was alleged that Dr. Singh profited from the implanting unapproved IUDs by billing his patients and their insurers for the higher cost of approved IUDs.
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 in the U.S. According to court documents, Dr. Singh bought unapproved IUDs on the Internet and implanted them in his patients.
The government alleged that 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. The Medi-Cal billing form for IUD specifically mentioned "ParaGard" which some physicians do not realize. Some physicians think "Copper T-380" and do not focus on the licensee or manufacturer. It was alleged that Dr. Singh profited from the implanting unapproved IUDs by billing his patients and their insurers for the higher cost of approved IUDs.
According to court documents, Dr. 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, Dr. Singh allegedly purchased unapproved IUDs from online retailers and implanted them in numerous patients without their consent, between April 2008 and June 2012.
Attorney Commentary:
What made this case turn criminal instead of simply an audit for overpayment? In
August 2010, agents from the FDA allegedly confronted Dr. Singh about his history of
implanting unapproved IUDs. During the meeting, Dr. 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 Dr. Singh’s
insertion of the IUD. In multiple instances, Dr. Singh allegedly 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. Thus, the government also had an argument that Dr. Singh by implanting a non-FDA-approved copper IUD was risking a patient’s safety. Such a device can result in an increased risk of pelvic inflammatory disease, ectopic pregnancy, hysterectomy, and other serious complications.
