Non-FDA-Approved Intrauterine Devices

It has come to our attention that some physicians have been purchasing and using intrauterine devices (IUDs) from sources outside of the United States. These IUDs may be nearly identical to those marketed in the United States; however, they have not been approved by the Food and Drug Administration (FDA) and are, consequently, illegal and may subject physicians to regulatory sanctions and additional liability. Although using foreign IUDs may represent a substantial saving for physicians and patients alike, physicians who continue using these products risk civil and criminal penalties.

The United States Federal Food, Drug, and Cosmetic Act prohibits the interstate shipment (which includes importation) of unapproved new drugs. Thus, the importation of drugs (including levonorgestrel IUDs) that lack FDA approval violates the act. At least one state has taken direct action to discontinue use of these foreign IUDs, while another state has brought criminal actions against physicians who use them. The American College of Obstetricians and Gynecologists (ACOG) has issued a bulletin concerning the illegality of these products. The bulletin is on ACOG's Web site.

Physicians who continue to use these products risk suspension by their state’s medical board, civil liability, and criminal punishments. In addition, using foreign IUDs may subject physicians to unforeseen liability. In the event of an unwanted pregnancy due to the alleged failure of one of these devices, the treating physician may be subject to wrongful-life actions founded upon the use of an illegal product. While the medical risks may be identical to domestic IUDs, defending legal claims arising from the use of foreign IUDs could be considerably more difficult due to their illegality.

Finally, because these foreign IUDs are non-FDA-approved devices, using them may preclude The Doctors Company from defending and/or indemnifying any physician who continues to purchase and use these products.

If you have questions or concerns about the risks associated with using foreign IUDs, consider consulting a local attorney for more information about possible regulatory and legal sanctions in your jurisdiction.