Texas physicians should be aware that the Texas attorney general and the federal government are taking actions against physicians arising from the purchase and use of medical products and drugs that are allegedly not legal for use in the United States. Most of these cases arise when physicians attempt, for honorable reasons, to save money for their patients by buying drugs and devices from Internet sites or distributors who offer product discounts.
The typical scenarios that give rise to these actions include:
- Physicians purchase medical products over the Internet believing the goods are approved for use in the U.S., but the products are not "FDA approved" or labeled for domestic distribution. This renders the products "misbranded."
- Physicians may unknowingly purchase a medical product from a distributor unlicensed or unauthorized to do business in Texas or the U.S.
Either of these actions may give rise to a charge of numerous "laundry list" acts that violate Texas law, most prominently the Texas Deceptive Trade Practices Act (DTPA). The DTPA has been interpreted by some as essentially a strict liability statute, so that fines may be pursued even if the doctor had no intent to violate the law.
Under Texas law, each proven violation may result in a civil penalty of not more than $20,000 per violation, with additional penalties if the consumer was over the age of 65. Each individual use of the product may be deemed a distinct statutory violation by the attorney general, so the fines can be very large.
A recent example of an enforcement action involved a treatment for arthritis using a product known as Synvisc injections. Numerous Texas physicians unknowingly purchased this product from a supplier who was reportedly not licensed to distribute the products in Texas. The Texas attorney general alleged the supplier obtained products labeled for use in Turkey and then imported the products through Canada. Accordingly, the products were deemed by the attorney general to be "misbranded" and not legal for sale in the U.S
News stories indicate an escalation in enforcement proceedings. The Texas attorney general has also pursued claims against health care professionals who use other medical products claimed to be either "misbranded" or otherwise not legal for sale or use in the U.S. Examples include certain intrauterine devices and cosmetic injections (e.g., Botox).
The federal government may also investigate physicians who use these allegedly non-FDA-approved drugs and devices. A physician who is found guilty of certain statutory violations may face criminal punishment, fines, and civil restitution. Further, if the physician bills for unapproved drugs or devices, he or she may be in violation of federal laws that govern health care reimbursement programs.
RISK MANAGEMENT CONSIDERATIONS
To reduce the risk of purchasing or using an unapproved or misbranded drug or device, physicians should use care in the methods by which they obtain these products and the steps that may be taken to verify the legitimacy of these drugs and devices. While there is no guaranteed course to verify the authenticity of a medical product, the following are measures that you may wish to consider in an effort to avoid this problem.
- Contact the Texas Department of State Health Services to verify that the entity from whom you purchased your drugs and medical products is licensed to distribute the products in Texas. You may also request that the distributor provide you with a copy of their license; and
- Take steps to verify that the product is FDA approved and branded for use in the U.S. There is no established method to ensure that products are what they purport to be. In prior cases, the medical products were reported to be labeled in a language other than English and did not have the FDA-approved labeling that is familiar to most health care professionals. There are also resources you may consult to attempt to establish the authenticity of the product:
- Drugs@FDA — can be used to search for any FDA-approved drug and its label.
- Daily Med — a source of official FDA-approved labels for drugs marketed in the U.S.
- Health care professionals may also consult the web site for the particular product or manufacturer. These sites customarily contain links to all marketed products and their labels.
The FDA has created a guide for consumers who buy drugs over the Internet. There is no such guide for physicians. Purchasing medical products from international web sites is generally discouraged by the FDA and this practice may be considered illegal.