Consider the Source
By Crystal Conde Texas Medicine January 2011

Physicians Sued for Using Unapproved IUDs

Law Feature – January 2011

Tex Med. 2010;107(1):49-52.

By Crystal Conde
Associate Editor

Six Grapevine physicians find themselves embroiled in a lawsuit [PDF] with Texas Attorney General Greg Abbott for selling patients birth control devices the U.S. Food and Drug Administration (FDA) has not approved for distribution in this country. The clinic, along with other medical practices in several states, is under fire for using a Canadian Mirena intrauterine device (IUD). (See "Unapproved IUDs Used in Other States.")

The Texas lawsuit lists Women's Integrated Healthcare and Angela L. Cope, MD; Barbara Coulter-Smith, DO; Katrina E. Allen, MD; Courtney Walters, MD; Monica E. Lopez, MD; and Wendy A. Kendrick, DO, as defendants. It says a Texas Department of State Health Services (DSHS) inspection revealed that the clinic sold 490 of the unauthorized Mirena IUDs. The suit seeks up to $20,000 in civil penalties for each violation and a court order requiring the clinic to sell only FDA-approved IUDs. The agency also wants the clinic to ensure that the IUDs it sells are labeled in English.

Bayer Healthcare Pharmaceuticals produces different versions of the Mirena IUD, but the FDA says only one version meets its standards for use in the United States. It is distributed by TheraCom. All the IUDs are made at Bayer's plant in Finland.

According to the lawsuit, Women's Integrated Healthcare began implanting the unapproved IUDs in April 2008 and voluntarily stopped using them in December 2009.

Dr. Coulter-Smith, one of the defendants, says she and her partners acquired the Canadian IUDs to offer more affordable forms of birth control to uninsured patients and those with high insurance deductibles.

She says that after consulting with colleagues and learning of the less expensive, unapproved Canadian IUD available online, the clinic's physicians began using it in April 2008. She adds that the clinic's legal counsel assured them that importing the unapproved Canadian IUDs would comply with all state and federal laws and regulations governing the practice of medicine.

She said multiple price increases in a short period of time made the approved version of the IUD "cost prohibitive for many of our patients. Because of the high cost of the U.S. product, our practice would often lose money when it utilized the Mirena IUD."

Dr. Coulter-Smith says the FDA-approved version of the Mirena IUD purchased in the United States can cost up to three times more than the unapproved version purchased through Bayer's Canadian distributors. Canada imposes price controls on most drug sales, making them cheaper than the same or similar products sold in the United States.

She adds that the clinic's physicians carefully monitor women using the imported IUD. She says from April 2008 to December 2009, patients reported only the usual side effects of IUDs, such as headache, weight gain, and irregular bleeding.

"The negative publicity around this issue has created a lot of unnecessary concern, and we are addressing those issues individually with patients," Dr. Coulter-Smith said.

For patients who want the unapproved IUD removed, Women's Integrated Healthcare is accommodating them at no cost.

Health care attorney Rick Robinson, JD, who does not represent the clinic, says cases dealing with importing unapproved medical devices normally are brought by the FDA, not the state. The Federal Food, Drug, and Cosmetic Act prohibits importing an unapproved drug or medical device.

"The case of Women's Integrated Healthcare shows a state's attorney general will step in if he or she doesn't think the feds are taking appropriate action," he said.

He adds that physicians could face substantial legal penalties if they give patients unapproved medical devices or drugs from another country. The government could seize the drugs or devices, he says, and the physicians could be subject to criminal, civil, and administrative penalties. Furthermore, any physician who bills government payers, such as Medicare or Medicaid, or health care payment plans for unapproved drugs or devices might face fraud charges and could be excluded from participating in those programs.

Health care professionals nationwide received warnings about the unapproved Mirena IUD. The FDA mailed letters in July 2010 reminding physicians that using unapproved IUDs raises concerns about effectiveness and safety, as well as the potential for fraud and counterfeiting. Bayer sent a letter in 2008 with the same message.

Bayer's letter informed physicians who had previously purchased the FDA-approved Mirena IUD that purchasing, distributing, possessing, and selling the unapproved IUDs to U.S. patients was illegal and raises "important patient care and legal considerations."

The letter outlines concerns with the Canadian version of the IUDs, including differences in thread lengths, inserters, patient support materials, and product packaging. Bayer also says the products may have passed through a number of countries before being shipped to the United States, and it cannot guarantee that IUDs imported from Canada are genuine, contain the correct active ingredient, and meet standards of quality, purity, and potency. It also said there are product differences from country to country that can affect insertion and "appropriate post-insertion monitoring and patient care."

The FDA letter outlines the following concerns with the use of unapproved IUDs:  

• The potential lack of safety and efficacy, especially the risk of reduced ability to prevent pregnancy;
• The negative public health impact from importing and using unapproved IUDs that can be from unknown sources or foreign locations and may not have been manufactured, transported, or stored under conditions required as part of the FDA approval process; and
• The use of and subsequent billing for unapproved medical products, which raises the possibility of insurance fraud, particularly Medicaid fraud.  

The FDA advises physicians to make medical product Internet purchases from state-licensed distributors or pharmacies located in the United States to avoid breaking federal law and to reduce their risk of receiving unapproved or adulterated devices.

Licensed Internet pharmacies display a Verified Internet Pharmacy Practice Sites (VIPPS) seal. To access a list of VIPPS pharmacies, click here.

Dr. Coulter-Smith says she never received the Bayer letter and learned of the FDA's letter through a notice on the American Congress of Obstetricians and Gynecologists (ACOG) website. She says Women's Integrated Healthcare had stopped using the unapproved IUD by the time the FDA issued its letter.

DSHS spokesperson Christine Mann says a complaint prompted the health department's investigation of Women's Integrated Healthcare. She would not identify who made the complaint.

DSHS licenses distributors and manufacturers of drugs and medical devices in Texas. The department inspects its licensees and investigates complaints it receives about the potential use of unapproved medical products in commerce.

"In this case, DSHS chose to seek civil relief through the attorney general's office," Ms. Mann said.

The Texas Food, Drug, and Cosmetic Act grants DSHS enforcement options, including the authority to seek civil, administrative, and criminal remedies. When seeking civil remedies, the department examines a variety of factors, including the seriousness of the violation, previous violations, and hazards to the health and safety of the public.

Upon procuring the Canadian IUDs, Dr. Coulter-Smith says the clinic's physicians contacted Bayer's manufacturing plant in Finland to confirm that only one factory produced the device and that all IUDs originated from there. The physicians also checked the Bayer website, which made no distinction between IUDs shipped to different countries, according to Dr. Coulter-Smith.

"We consulted with our health care attorney and were assured of the legality of the issue," she said. "We were told that the FDA had approved the design and the medication, and because it was the same IUD, we could import them without legal complications."

She adds that Women's Integrated Healthcare gave all patients written materials in English before inserting the Canadian Mirena IUD. She says the materials came from the Bayer website. In addition, she says the clinic didn't insert the unapproved IUD in any Medicare or Medicaid patients.

The clinic stopped importing Mirena IUDs from Canada on Dec. 29, 2009, following the DSHS inspection.

Women's Integrated Healthcare now sells only the FDA-approved Mirena IUDs to patients willing to pay the cash price of more than $800 or to those whose insurance will cover it.

Dr. Coulter-Smith says physicians who wish to provide their patients with more affordable drugs and medical choices face "the difficult choice of serving patients or facing sanctions from people who are more interested in protecting the profit margins of a drug company."

Women's Integrated Healthcare will continue to answer patients' questions about the Mirena IUD imported from Canada.

"It was never our intention to break any regulatory law, and we have always tried to uphold the highest standards in our practice," Dr. Coulter-Smith said. "We have to save our practice from the adverse publicity we have received. We have to defend the lawsuit filed by the attorney general."

Non-FDA-approved drugs and medical devices acquired from outside the United States raise many patient safety considerations, Mr. Robinson says. In some cases, product information isn't available in English, leaving the patient in the dark about the product's side effects and instructions for proper use.

"I also can see a lot of the potential quality-control issues if people are getting products from Internet pharmacies overseas. The drugs could be counterfeit, could be missing the active ingredient, or could contain harmful ingredients," he said.

While some physicians may think they're doing their patients a service by giving them a cheaper alternative, Mr. Robinson says that may be shortsighted.

"You don't know what you're getting; therein lies the danger. That's why the FDA doesn't allow importation of unapproved drugs and medical devices. The FDA can't ensure the safety of medical products that come from unapproved sources," he said.

Mr. Robinson recommends that physicians who have distributed non-FDA-approved drugs or devices not manufactured in the United States speak to an attorney about what they need to tell their patients and possibly the government.

He also suggests physicians look into affordable drug programs set up by pharmaceutical companies as a legal avenue of providing less expensive medical products to patients. (See "Drug Assistance Programs for Patients in Need.")

The Texas attorney general has tackled the issue of Canadian drug importation before. Gay Dodson, RPh, executive director of the Texas State Board of Pharmacy, says that in 2005 Attorney General Abbott issued an opinion [PDF] regarding whether federal law preempted a portion of Senate Bill 410.

SB 410 authorized the importation of Canadian pharmaceuticals to Texas and required the Texas State Board of Pharmacy to assist Canadian pharmacies in importation. The attorney general's opinion said portions of SB 410 "directly conflict with federal law, namely the Federal Food, Drug, and Cosmetic Act. …" The opinion added that by "expressly permitting Texas consumers to import prescription drugs that cannot be imported under federal law, the Texas State Board of Pharmacy would violate the Federal Food, Drug, and Cosmetic Act, as will Texas consumers and those Texas pharmacies that take part in such transactions."

With the proliferation of Internet-based pharmacies, Ms. Dodson suggests physicians be cautious when ordering drugs and medical devices online.

"I'd encourage doctors and pharmacists to suggest patients look for generic versions of drugs they can obtain legally in the United States," she said.

The Texas Medical Association, DSHS, and other health care organizations have guidance related to drug importation.

The American Medical Association supports drug importation, but only if all the drugs are FDA-approved, can be tracked electronically and traced back to their original source, and the FDA receives additional funding to monitor drug imports.

ACOG has received inquiries about the use of IUDs imported from other countries. ACOG and the FDA continue to recommend approved IUDs as a safe and effective method of contraception.

For practical assistance in helping physicians make these options available to patients, physicians can visit ACOG's Long Acting Reversible Contraception webpage.

DSHS has guidance for physicians and other practitioners regarding importation of non-FDA-approved medical devices or drugs. DSHS warns against the following:  

• Purchasing, possessing, or administering drugs or devices in the United States not approved by the FDA and that do not have English labeling (these products are considered misbranded);
• Making a personal determination of the safety or effectiveness of a drug or device that is not approved by the FDA to justify using it in the United States;
• Purchasing drugs from manufacturers or distributors not licensed with DSHS; and
• Purchasing devices from unlicensed manufacturers or distributors in Texas. Those who purchase devices from manufacturers or distributors outside Texas should verify that the supplier is lawfully engaged in the wholesale or retail distribution of such devices in the United States.  

Crystal Conde can be reached by telephone at (800) 880-1300, ext. 1385, or (512) 370-1385; by fax at (512) 370-1629; or by e-mail at crystal.conde[at]texmed[dot]org.

Unapproved IUDs Used in Other States  

Women's Integrated Healthcare in Grapevine isn't the only practice under fire for using unapproved intrauterine devices (IUDs) from foreign countries. According to the State of Rhode Island Department of Health, 10 obstetric and gynecologic practices there had been purchasing or implanting Mirena and ParaGard IUDs from international sources not approved by the U.S. Food and Drug Administration (FDA).

The department issued compliance orders for the practices that stipulate, in part, they must surrender all non-FDA-approved IUDs, notify patients who received unapproved IUDs, and give the health department the names and medical records of patients who had an unapproved IUD implanted. The Rhode Island health department website, www.health.state.ri.us/news/nonfdaapprovediuds, has links to compliance orders for practices that have been identified as having purchased or used non-FDA-approved IUDs. It also provides guidance for women who possibly received the non-FDA-approved version of the IUD and outlines the action the health department is taking.

A group of Rhode Island patients who received a non-FDA-approved IUD filed a class-action lawsuit against four group medical practices identified by the Rhode Island state health department, as well as 34 physicians and 16 nurse midwives and nurse practitioners. The plaintiffs allege they suffered inconvenience, embarrassment, emotional distress, and battery because they had an unapproved IUD implanted in their bodies without their informed consent.

The FDA's July 2010 letter [PDF] to health professionals cites the Rhode Island case as an example of the "unacceptable risk patients may be exposed to when a product's identity, purity, source, handling, and storage cannot be verified."

Pine Bluff, Ark., obstetrician-gynecologist Kelly Dean Shrum, DO, faces criminal and civil charges triggered by a 2009 FDA investigation of his practice. The feds found him in possession of unapproved Mirena IUDs imported from Canada.

In October 2009, a federal grand jury indicted Dr. Shrum on one count of misbranding in violation of the Federal Food, Drug, and Cosmetic Act, one count of health care fraud, and three counts of money laundering. As the basis for the health care fraud charge, the indictment alleges Dr. Shrum billed the Arkansas Medicaid program for the more expensive, FDA-approved version of Mirena when he was giving Medicaid beneficiaries a significantly cheaper, non-FDA approved version.

According to federal prosecutors, the maximum penalty for misbranding is three years imprisonment and a $10,000 fine. The maximum penalty for health care fraud and for each count of money laundering is 10 years imprisonment and a $250,000 fine.

On top of the civil and criminal case, Dr. Shrum was sued by former patients in state court. Due to implantation of the unapproved IUDs, the class-action plaintiffs allege Dr. Shrum is liable for medical negligence, violation of Arkansas' deceptive trade practices law, and breach of fiduciary duty.

And, Dr. Shrum's medical liability insurer, Volunteer Mutual Insurance, filed a lawsuit against him and the class action plaintiffs in Arkansas federal court. The company wants the court to declare it isn't responsible for defending Dr. Shrum or paying his damages due to the nature of the case.

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Drug Assistance Programs for Patients in Need

The Partnership for Prescription Assistance (PPA), a nationwide effort sponsored by America's pharmaceutical research and biotechnology companies, has helped 467,485 uninsured and financially struggling Texans receive help from programs that provide prescription medicines free of charge or for little cost. PPA provides access to more than 475 patient assistance programs, including nearly 200 offered by pharmaceutical companies.

Doctors and pharmacists may log on to the PPA website to answer questions on behalf of the patients and identify an assistance program that can best serve them.

Applications also can be downloaded online for patients. Or patients may call toll-free (888) 477-2669 for guidance with the application process.

Additionally, assistance is available specifically for seniors through Together Rx Access. Those who meet all of the following requirements are eligible for a card:   

• Ineligible for Medicare,
• No prescription drug coverage of any kind, and
• Household income equal to or less than $45,000 for a single person, $60,000 for a family of two, $75,000 for a family of three, $90,000 for a family of four, or $105,000 for a family of five.  

Physicians who have elderly patients who may qualify can refer them to the Together Rx Access website. Patients may enroll online, print an application and mail it, or call (800) 444-4106.

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