LAW
Physician-buyer beware AG targets doctors for illegal drug, device purchases BY CRYSTAL CONDE Texas Attorney General Greg Abbott is
cracking down on physicians who purchase medical products and drugs deemed illegal to use in the United States. In some instances, the physicians purchased misbranded products or medical devices from outside the United States not approved by the U.S. Food and Drug Administration (FDA). And some physicians unknowingly bought products from a distributor not licensed and not authorized to do business in Texas or the United States. Last year, six Grapevine physi- cians found themselves embroiled in a lawsuit with the attorney general for selling patients a ver- sion of the Mirena intrauterine device (IUD) the FDA has not approved for distribution in this country. Women’s Integrated Healthcare settled with the attor- ney general in March, agreeing to pay penalties.
And in 2009, the Texas Depart- ment of State Health Services (DSHS) inspected a Harlingen physician’s medical practice as a result of its investigation of Elite Med, LLC, a distributor operat- ing in New Braunfels. Authorities said Elite Med didn’t have a li- cense to do business in Texas and was selling physicians medical products not approved for sale in the United States. The physician reached an agreement with the attorney general last November. The physician, who asked not to be named, describes the experience as “really painful.” In fact, the doctor closed the Harlingen medical practice earlier this year and is looking for a position in other states due in large part to the ordeal. “I totally cooperated throughout the entire process of the in- vestigation,” the physician said. “I’ve practiced for decades in an impoverished region of Texas, where it’s difficult to recruit doctors. For none of this to be taken into consideration by the attorney general is a slap in the face.”
“Physicians shouldn’t try to deal with the problem themselves or
ignore it. That’s not a good approach.”
Earlier this year, the Texas Medical Liability Trust (TMLT) alerted its policyholders to the attorney general’s action against physicians who purchase products from unlicensed distributors and to the presence of misbranded drugs on the market. To view TMLT’s Physician Alert, visit
www.tmlt.org/ newscenter/features/
physician-alert-unapproved-drugs.html. The DSHS Drug and Medical Devices Group licenses dis- tributors of drugs and medical devices in Texas. According to Kerrville attorney Jay Henderson, DSHS may learn of the distribu- tion or purchase of unauthorized drugs or devices by Texas physi- cians from any source. These re- ports may be made directly to the agency or anonymously. He says DSHS doesn’t divulge anonymous sources. Mr. Henderson has represent- ed physicians sued by the attor- ney general for using unapproved or misbranded drugs and medical devices. He says once DSHS de- cides to investigate, the depart- ment has authority to inspect the distributors and report them to the attorney general’s office for prosecution. If physicians find themselves in a situation in which they’ve
been distributing non-FDA-approved drugs or devices to pa- tients, Mr. Henderson suggests they call their professional li- ability insurer or a lawyer familiar with drugs and devices. “Physicians shouldn’t try to deal with the problem them- selves or ignore it. That’s not a good approach,” he said.
Ignorance no excuse According to Mr. Henderson, the attorney general’s office gen- erally alleges that receiving and using unapproved drugs or devices violate the Texas Deceptive Trade Practices Act (DTPA). To read the statute, visit
www.statutes.legis.state.tx.us/SOT WDocs/BC/htm/
BC.17.htm.
August 2011 TEXAS MEDICINE 49
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