7 Rhode Island OB Practices Settle Unapproved IUD Claims

162017_132140396847214_292624_nSeven Rhode Island obstetrical practices have agreed to settle claims against them alleging that they implanted unapproved versions of the Mirena and ParaGard intrauterine devices (“IUDs”) in patients and then sought the higher reimbursement for FDA-approved IUDs.

An IUD is a small T-shaped medical device, often made of flexible plastic, that is inserted into a woman’s uterus to prevent pregnancy. The Mirena IUD also delivers small amounts of hormone to further help prevent pregnancy.

The $5 million preliminary class-action settlement reached during mediation before a special master appointed by a Superior Court judge will result in about 700 women receiving $3,800 each. The named plaintiffs will each receive an additional $30,000 from the settlement. The proposed class lawyers will receive $2 million from the settlement.

The plaintiffs had sought damages for battery, negligent infliction of emotional distress, medical malpractice, unjust enrichment, and civil conspiracy, alleging that some of the defendants had noticed that some of the foreign-obtained IUDs did not deploy in the same manner as the FDA-approved devices yet they implanted the unapproved IUDs in patients anyway. The settlement has received preliminary approval but must obtain final approval by the Superior Court judge before it becomes binding and effective.

The Rhode Island Department of Health had begun an investigation in 2010 after becoming aware that one of the largest OB practices in Providence, Rhode Island had been implanting unapproved IUDs in women that it had obtained from a foreign country through an 800 telephone number for a company supposedly located in Canada, beginning in January 2009. The foreign-made IUDs’ effectiveness had not been proven.

The OB practices allegedly were able to purchase the foreign-made, unapproved IUDs at half the cost of FDA-approved IUDs but billed health insurers at the rate for FDA-approved IUDs.

The Rhode Island Department of Health’s investigation expanded to include all of the physicians, nurse practitioners, nurse-midwives, and nurses working for the OB practices (more than 10% of Rhode Island’s OB practices were investigated). The unapproved IUDs were seized as part of the investigation.

The OB medical practices participating in the settlement reportedly are the Center for Obstetrics & Gynecology, Partners in Obstetrics & Gynecology, Marc A. Jaffe, M.D., OB-GYN Associates, The Independent Woman, Serena A. Sposato, M.D., and Bayside OB-GYN.


Any time medical providers attempt to line their own pockets by billing for medical devices or services that they know is inappropriate or outright fraudulent, the health of patients and the financial health of health insurers, including federal health care programs financed by taxpayers, are placed at risk or harmed.

If a health care provider is willing to break the law in such a manner, is it a stretch for the health care provider to fraudulently create a patient’s medical record to hide medical negligence that harmed the patient? Is such a health care provider likely to admit to a patient that medical malpractice is the cause of an unexpected medical outcome or continuing or worsening pain and suffering?

If you or a family member may have been harmed by possible medical negligence in Rhode Island or in another U.S. state, you should promptly find a Rhode Island medical malpractice lawyer, or a medical malpractice lawyer in your state, who may investigate your medical malpractice claim for you and represent you in a medical malpractice case, if appropriate.

Visit our website to submit a short, secure form, or telephone us on our toll-free line in the United States (800-295-3959), to find medical malpractice attorneys who may assist you.

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This entry was posted on Sunday, March 22nd, 2015 at 5:56 am. Both comments and pings are currently closed.


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