A Grapevine women's clinic and six of its physicians have been accused of offering their patients unauthorized birth-control products from Canada.
In a lawsuit, Attorney General Greg Abbott said Women's Integrated Healthcare obtained intrauterine devices from an online Canadian pharmacy even though Bayer, their manufacturer, offers a U.S. version. Neither the attorney general's office nor Bayer has claimed that the device is unsafe.
Doctors at Women's Integrated Healthcare said that they turned to Canada because they were desperate to provide a safe but less expensive IUD for patients who were uninsured and could not afford the U.S. version. The Mirena IUD costs about $200 in Canada and $700 in the United States.
"I, as a physician, always thought it was a physician's duty to go to bat for my patients and that's what I tried to do," said Dr. Angela Cope, an obstetrician-gynecologist at Women's Integrated Healthcare. "We're surprised to be in this situation for a device that is exactly the same worldwide."
According to the Texas Department of State Health Services, Bayer told authorities that the Canadian Mirena IUD differs from the one approved in the U.S. because it has lower-cost, alternative package labeling and foreign-language medical warnings. Health advisory information and physician instructions were printed in Scandinavian languages.
The physicians attempted to address the differences by removing the foreign labeling and inserting an English warning downloaded from a website, according to the statement from the attorney general's office.
All Mirena IUDs are made by an American company in Finland. Cope said that only after thoroughly researching the devices did the group conclude that the two versions are not medically different.
"Whether the Mirena IUD gets on an airplane in Finland and comes to Canada or America, the product is exactly the same," Cope said.
The Mirena IUD is a small T-shaped device which delivers a small amount of progestin, a hormone, to the inner wall of the uterus over five years. It is one of the most effective and safest forms of contraceptive and was recently approved for use as a menstrual cycle treatment.
A while back, Bayer raised the price, making it more costly for physicians to use, said Dr. Sealy Massengill, a Fort Worth OB-GYN who is not associated with the Grapevine group.
"Medicaid specifically was a big problem for this," he said. "You couldn't bill Medicaid and be reimbursed for as much as it cost."
Consequently, some physicians looked for alternatives.
"Undoubtedly these people were trying to provide for their patients," he said.
Women's Integrated Healthcare, which opened in 2002 with two physicians and one nurse practitioner, has grown to six physicians and three nurse practitioners. The practice has about 33,000 patients, of which 380 received the IUDs.
Cope said that before importing the IUDs from Canada, the practice consulted with legal counsel and was assured that the purchase complied with all state and federal laws and regulations.
The attorney general went ahead with the lawsuit, even though the clinic voluntarily stopped selling and administering the unapproved IUDs in December. In a statement, the attorney general's office said it took the action to ensure future compliance with the law and to ensure that the products purchased by the clinic were properly labeled.
The state is seeking civil penalties of up to $20,000 for each violation of the Texas Deceptive Trade Practices Act. It asks to be awarded investigative costs and other fees for violations of the Texas Health and Safety Code.
The health department discovered the unauthorized IUDs during an inspection of the clinic, according to the lawsuit.
This summer, physicians in Rhode Island also came under fire for importing the devices from Canada.
The FDA and Bayer have issued warnings to physicians about selling the unapproved devices.
Cope said that the Grapevine practice had already stopped using the devices by the time the FDA warning went out and that they never received a letter from the manufacturer.
She said the physicians have been cooperating with authorities, but she believes that her large all-female practice was singled out. She also questioned the timing.
"If we were wrong, we were wrong," Cope said. "We received bad advice, and now we'll go from there."
Jan Jarvis, 817-390-7664