Medtronic, Inc. has acknowledged that they are the subject of multiple federal investigations regarding their marketing practices and the recent Sprint Fidelis defibrillator lead recall. The Senate Finance Committee and the Justice Department have both asked the company for information as part of investigations of wrongdoing. They also face thousands of potential lawsuits from individuals who received one of the defective wires, which are used to connect implantable defibrillators to the heart.
It was reported yesterday in the Wall Street Journal that the global medical device manufacturer acknowledged the federal investigations as part of a filing with the SEC (Securities and Exchange Commission).On October 15, 2007, a nationwide Medtronic recall was issued for all models of the Sprint Fidelis defibrillator lead. Defects in the lead could cause the thin electrical wire to fracture or break, resulting in electrical shock or device failure.
A lot of controversy has surrounded the approval of this device by the FDA, since no specific testing was required before it was introduced in 2004. In addition, many have expressed concerns about the timing of the defibrillator lead recall, as the Company delayed removal of the device from the market for many months, allowing thousands of people to receive the lead which was known to be dangerous and defective.
Medtronics indicates that the Senate Finance Committee has requested information regarding the defibrillator lead recall as well as information about alleged payments made to doctors by the company. Shortly after the recall, the company was also the subject of a letter from the U.S. Congressional Committee on Oversight and Government Reform, which was sent to the commissioner of the FDA inquiring about the Sprint Fidelis lead’s approval process and when the FDA first learned about the risk that the leads could fracture.
A separate Medtronic investigation has been initiated by the Justice Department, through the U.S. attorney’s office for the Eastern District of Pennsylvania. The U.S. attorney requested that the company provide information about payments made to doctors outside of the United States. The alleged payments could be in violation off the U.S. Foreign Corrupt Practices Act, which is designed to prevent companies from bribing foreign government officials.
Any defibrillators implanted since 2004 could have the Sprint Fidelis lead. To determine if you, a friend or family member may be impacted by the recall, contact your doctor for medical advice and contact our office for a free legal consultation.