FDA, Plaintiffs Warn Against Unapproved IUDs

FDA, Plaintiffs Warn Against Unapproved IUDs | Pintas & Mullins Law Firm

Mirena attorneys at Pintas & Mullins Law Firm remind women implanted with an IUD contraceptive or thinking of having one implanted of the still-present problems over unapproved, or “black market” IUDs. This issue was first raised in 2010, when the FDA issued letters to health professionals stating that using unapproved IUDs could constitute fraud and counterfeiting lawsuits.

Inevitably, that is exactly what happened. In September 2010 the Rhode Island Department of Health opened an investigation after a class action lawsuit was filed on behalf of women who received unapproved IUDs. The lawsuit named over 50 health care providers as defendants, all of whom worked for group practices targeted by FDA investigations – Bayside OB/GYN, Center for Obstetrics and Gynecology, and OB/GYN Associates.

Black Market Mirena and Paraguard

According to an article in Pediatric News, most of the claims submitted in the class action involved unapproved Mirena implantation. One health provider was using both Mirena and Paraguard illegally, however it was not immediately clear if any other devices were used. The womens’ lawsuit argues that defendants implied that the IUDs were approved by the FDA to be used in the United States when that was not the case.

Instead, the IUDs were purchased for discounted prices through Canadian websites. Since the substitutes were not approved by the FDA, their integrity, purity, source, handling and identity could not be verified. For a product that is inserted into a patient’s internal organs, this type of substitution is egregiously unacceptable.

Plaintiffs argue that they received a device to which they did not consent, alleging offensive contact and battery among their grievances, and requesting a jury trial. The women claim they were intentionally placed in harm’s way by the defendants, suffering immense embarrassment, emotional distress, and inconvenience, among other injuries.

In a Press Release, the Rhode Island Department of Health estimated that between 400 and 500 women received the counterfeit IUDs, which were implanted beginning in January 2009. All patients who may have been implanted with a non-FDA approved IUD should have been notified in the summer of 2010.

Putting Patients at Risk – Know Your Rights

With the exception of rare circumstances, any use of a medical device or drug not approved by the FDA is against the law. Likewise, using a drug or medical device for uses not explicitly listed on its labels may also be grounds for a lawsuit. Healthcare providers are well aware that both federal and state law requires them to use only drugs and devices purchased through FDA-approved sources, and ambiguous suppliers out of Canada is clearly not one. Legitimate online pharmacies display a seal from the National Association of Boards of Pharmacy (known as a VIPPS seal). A comprehensive list of approved, legal internet pharmacies may be found here. 

This issue was not exclusive to Rhode Island, unfortunately; patients in Massachusetts and Kentucky were also put at risk. As the cost of healthcare in this country increases, more and more people are turning to online pharmacies in a bid to save money. Unfortunately, rogue websites are selling patients and providers drugs and devices that were manufactured in unsanitary or contaminated conditions, leading to serious illness and in some cases, death.

If you or a loved one suffered a serious injury from a Mirena device, whether counterfeit or not, contact our team ofMirena attorneys as soon as possible. There are thousands of Mirena lawsuits pending throughout the country, and many more are expected to be filed. The Mirena IUD is excessively dangerous and no woman seriously injured by it should be burdened with mounting medical bills. We offer free legal consultations Mirena victims from all 50 states.