Medtronic Agrees to a $4.41 Million Settlement to Resolve False Claims Allegations, Parker Waichman LLP Comments

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The United States Justice Department announced that Medtronic PLC and its affiliate Medtronic companies, Medtronic Inc., Medtronic USA Inc., and Medtronic Sofamor Danek USA Inc. have agreed to a multi-million-dollar settlement with the United States to resolve whistleblower allegations.

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Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices and unapproved medical procedures, is commenting on a recent settlement in a case involving Medtronic Inc. and the United States government. The underlying case is United States of America ex rel. Samuel Adam Cox, III, Meayna Phanthavong, and Sonia Adams v. Medtronic, Inc., Medtronic USA, Inc., and Medtronic Sofamor Danek USA, Inc., Civil No. 12-cv-2562 (PAM/JSM).

The Justice Department announced on April 2, 2015 that Medtronic and its subsidiaries agreed to pay $4.41 million to the government to resolve allegations that the device makers violated the False Claims Act by making bogus statements to the U.S. Department of Veterans Affairs (VA) and the U.S. Department of Defense (DoD) over the country of origin for specific Medtronic products sold to the U.S.

Under The Trade Agreements Act of 1979 (TAA), companies are typically mandated to sell products to the U.S. that are made in the U.S. or another designated country. In this case, according to the settlement agreement, the U.S. alleged that between 2007 and 2014, Medtronic sold products to the United States that were manufactured in China and Malaysia; the two countries are prohibited under the TAA. The products involved are anchoring sleeves sold with cardiac leads used to secure the leads to patients, certain instruments and devices used in spine surgeries, and a handheld patient assistant used with a wireless cardiac device. The agreement covers January 1, 2007, to December 31, 2013, and January 1, 2014 to September 30, 2014 for the handheld patient assistant.

The civil settlement resolves a lawsuit filed under the whistleblower provision of the False Claims Act, which enables private parties to bring lawsuits on behalf of the government for false claims, potentially obtaining a portion of the government’s recovery. This lawsuit was filed by three whistleblowers under the qui tam provisions of the False Claims Act. The whistleblowers will receive $749,700 of the recovered funds, according to the Justice Department.

“Patients should feel confident that the manufacturers of their medical devices followed all of the regulations set forth by the government. When evidence to the contrary is brought to light, one cannot help but wonder whether the manufacturers were dishonest in other ways,” said Gary Falkowitz, Managing Attorney for Parker Waichman LLP.

Under certain circumstances, whistleblowers may maintain their anonymity during most of the whistleblower process, according to Parker Waichman. The firm supports efforts to protect whistleblowers and offers free case evaluations to those individuals who believe their companies may be involved in illegal practices.

Parker Waichman LLP supports efforts to protect whistleblowers and offers free case evaluations to those individuals who believe their companies may be involved in wrongdoings. If you believe that a government entity, consumer product manufacturer, medical device maker, or pharmaceutical company is committing fraudulent activities and would like to maintain your anonymity, contact Parker Waichman LLP at the firm’s Whistleblower page at or call 1-800-LAW-INFO (1-800-529-4636).

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