Beaufort News

OB/GYN office manager pleads guilty to buying devices not approved by FDA

An office manager at Advanced Women's Care of the Lowcountry, a Hilton Head Island-based obstetrics and gynecological practice, has pleaded guilty to state charges of buying intrauterine devices not approved by the Food and Drug Administration.

Doctors at the practice inserted the birth control devices into patients, according to court records.

Jason Pampucha, 38, pleaded guilty Aug. 25 and was sentenced to two years probation by Circuit Court Judge Carmen Mullen. Pampucha could have been sentenced to two years in prison plus a $5,000 fine, according to Mark Plowden, a spokesman for the S.C. Attorney General's Office. He will serve no prison time because the judge suspended a two-year prison sentence.

As part of the sentence, Pampucha also paid the state Attorney General's Office $8,000 in investigative costs, court records show.

And depending on the outcome of a civil suit in federal court, Advanced Women's Care may have to refund $37,287 to the state's Medicaid program -- the amount the program reimbursed the practice for the IUDs.

Six local women who say they received the IUDs at Advanced Women's Care also have filed court papers saying they intend to sue the practice and its founder, Dr. Tracy Blusewicz.

Attempts to reach Blusewicz, Pampucha and his attorney were unsuccessful. A receptionist at Advanced Women's Care said Thursday that Pampucha was assisting a patient.

While the case against Pampucha focused on him ordering devices not approved by the FDA -- a federal agency -- he was indicted by the state because he sold the devices in the state, bringing the case under the state's jurisdiction, according to the indictment.

THE BACKGROUND

From June 2008 to November 2009, Pampucha, who purchased supplies for the practice, ordered Mirena brand IUDs from a Canadian supplier, according to the indictment by the Attorney General's Office.

The IUDs were then placed in patients at Advanced Women's Care, some of whom were Medicaid recipients, the indictment said. It was unclear how many patients received the IUDs.

Advanced Women's Care billed the S.C. Medicaid Program for the IUDs, and the Medicaid program reimbursed the practice $37,287, the indictment states. That amount is now being held in escrow by Pampucha's lawyer but could be refunded to the Medicaid program depending on the outcome of a federal civil suit, Plowden said.

Pampucha has agreed to cooperate with law enforcement agents investigating false Medicaid claims at the practice and to fully disclose evidence related to the case, according to his plea agreement.

He also agreed to submit to a polygraph test about his involvement in any Medicaid fraud, the agreement said.

The investigation was conducted by the S.C. Attorney General's Office Medicaid Fraud Control Unit and the Office of Inspector General in the U.S. Department of Health and Human Services, Plowden said.

THE PATIENTS

Six former patients are claiming the birth-control devices injured them.

They have submitted court papers saying they intend to file malpractice suits against Dr. Blusewicz. They say she knowingly implanted misbranded IUDs in them, according to court documents. State law requires those pursuing medical-negligence claims to first serve notice they intend to sue and take part in mediation before actually filing suit.

Johnny Felder, the attorney representing the women, claims they suffered severe physical injuries as a result of negligence by the practice and Blusewicz. The women seek unspecified punitive damages.

Ann Brock, a paralegal assisting with the women's cases, said the IUDs contained hormones that are not approved by the FDA. She declined to cite specific injuries but said the women have been affected.

"They all have different symptoms, but many are having to have doctors' visits quite regularly," she said.

Brock said the firm expects to file at least five more notices to sue.

Although the devices were not approved by the FDA, they were manufactured by the same company and at the same plant as other IUDs legitimately sold in the U.S., said Plowden, the spokesman for the Attorney General's Office.

Blusewicz has no history of disciplinary action by the state's medical board, according to the S.C. Department of Labor, Licensing and Regulation.

Blusewicz is married to Pampucha, according to Brock. Pampucha is also a real estate salesman, according to the S.C. Department of Labor, Licensing and Regulation.

Follow reporter Cassie Foss at twitter.com/LcBlotter.

Hilton Head OB/GYN office manager pleads guilty to buying non-FDA approved IUDs

ON THE WEB

For more information about non-FDA approved IUDs, visit http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm219837.htm

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