Womens Integrated Healthcare cited for purchasing selling unapproved IUDs
Texas Insider Report: FORT WORTH Texas Texas Attorney General Greg Abbott today took legal action against a Grapevine womens health clinic for purchasing and selling intrauterine devices (IUDs) that were not approved for sale in the United States.
The States legal action stems from a referral by the Texas Department of State Health Services (DSHS). It names Womens Integrated Healthcare P.A. and six of its physicians as defendants:
- Angela L. Cope M.D.
- Barbara Coulter-Smith D.O.
- Katrina E. Allen M.D.
- Courtney Walters M.D.
- Monica E. Lopez M.D.; and
- Wendy A. Kendrick D.O.
According to court documents filed by the State Womens Integrated Healthcare first obtained unapproved IUDs in April 2008. The IUDs were ordered from an online Canadian pharmacy called Medisave.
Although the manufacturer Bayer produces Mirena® IUDs that are approved for use in the U.S. by the Food and Drug Administration (FDA) the defendants sought to reduce acquisition costs and thus purchased unapproved IUDs.
All Mirena® IUDs are manufactured in Finland by Bayer Schering Pharma OY. However only one version of the Mirena® IUD has been approved by the FDA for use in the U.S. To obtain federal approval Bayer filed a required new drug application" in late 2000.
The approved version of the IUD contains a birth control drug called levonorgestrel" which prompted the manufacturers new drug application with the FDA. After FDA approval was granted licensed drug distributor
TheraCom began distributing the Mirena® IUD in the U.S.
According to DSHS Bayer indicated to state authorities that the IUD approved in the U.S. differs from those sold in other countries. Among the disparities between the approved and unapproved IUDs are design differences lower cost alternate package labeling and non-English medical warnings.
Additionally because the IUDs were procured from a Canadian pharmacy rather than a licensed drug distributor the products were not stored or transported through licensed distribution channels.
The States enforcement action indicates that Bayer issued a warning to U.S. health care professionals in 2008. The manufacturers warning informed physicians who had previously purchased the FDA-approved Mirena® IUD including the defendants that purchasing distributing possessing and selling the unapproved IUDs to U.S. patients was unlawful.
Court documents filed by the State also indicate that the unapproved IUDs packaging contained health advisory information and physician instructions that were printed in Scandinavian languages not in English. Under federal law all information on the labels and inserts must be printed in English.
The defendants attempted to resolve the situation by removing the foreign labeling and inserting an English language warning downloaded from Bayers website. However because the packaging itself was not in English the prescription products are misbranded and therefore could not be lawfully distributed in the U.S.
In December 2009 the defendants voluntarily stopped selling and administering the unapproved IUDs. To ensure future compliance with the law the Office of the Attorney General is seeking a court order requiring that the defendants only purchase and sell FDA-approved IUDs. The State is also seeking to ensure that such products purchased by the defendants are properly labeled in English.
Additionally the State is seeking civil penalties for violations of the Texas Deceptive Trade Practices Act and the Texas Health and Safety Code.
