Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Beasley Allen Law Firm attorneys P. Leigh O’Dell and Ted G. Meadows filed a lawsuit on April 29, 2009, on behalf of Patrick M. Lancaster of Alabama, alleging that the plaintiff suffered injuries as a result of having been implanted with a Sprint Fidelis Lead manufactured by Medtronic, Inc. The lawsuit names defendants Medtronic Inc., Medtronic Puerto Rico, Inc., and Medtronic Puerto Rico Operations Co.

The complaint incorporates by reference the relevant portions of the Master Consolidated Complaint for Individuals on file with the Clerk of the Court for the United States District Court for the District of Minnesota in the matter In Re MEDTRONIC, INC., SPRINT FIDELIS LEAD PRODUCT LIABILITY LITIGATION.

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U.S. District Judge Richard Kyle dismissed thousands of lawsuits against Medtronic Inc., manufacturer of the faulty Sprint Fidelis defibrillators that have allegedly injured and killed several people. Attorneys serving the patients, however, may seek to have the judge disqualified from the case because he never disclosed that his son works for the law firm representing Medtronic.

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Medtronic Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, announced last week that it had reached a settlement agreement regarding another of its faulty medical devices. The company has agreed to pay out $114 million to settle product liability lawsuits filed as the result of injuries cased by its malfunctioning Marquis line of implanted cardiac defibrillators. Despite the huge settlement agreement, Medtronic said it does not admit liability in the litigation.

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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.

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Medtronic, Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, is the now the subject of two separate investigations. A Senate panel wants information about Medtronic’s October Sprint Fidelis Defibrillator Lead recall, while a second investigation by the US Justice Department is looking into allegations that Medtronic made illegal payments to foreign physicians.
Medtronic suspended sales of the Sprint Fidelis Leads after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. It is through the lead that a defibrillator is able to sense when a patient’s heart rhythm is out of sync. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart.

Following the recall, it was learned that Medtronic had been receiving reports that indicated the Sprint Fidelis Lead had a higher-than-normal fracture rate for months. The incident has raised questions about the Food & Drug Administration’s (FDA) regulation of medical devices, and of the Medtronic’s response to early reports of lead problems.

Medtronic has acknowledged in a Securities and Exchange Commission (SEC) filing that the Senate Finance Committee has requested information about ties between the medical-device industry and practicing physicians and information about Medtronic’s suspended distribution of its Sprint Fidelis family of defibrillation leads. The Senate panel is probing the FDA’s oversight of medical-device components.

Medtronic said in the same SEC filing that it is the subject of a Justice Department probe into illegal physician payments. The U.S. attorney’s office for the Eastern District of Pennsylvania asked for information on payments or gifts to physicians or physician’s groups related to the purchase of the company’s cardiac stents and cardiac-therapy devices.

The U.S. attorney also asked Medtronic to provide documents related to its relationship with a specific customer. The customer wasn’t identified in the SEC filing. In September, the SEC began an informal probe of Medtronic, seeking information about possible violations of the Corrupt Foreign Practices Act, which is meant to stop bribes to foreign officials.

This is not the first time Medtronic’s relationships with physicians has come under scrutiny. Earlier this year, Sen. Charles Grassley, R-Iowa, requested information from Medtronic about the company’s payments to orthopedic surgeons, and questioned whether they improperly influenced physician decisions about which products to use.

Monetary agreements with physician consultants are common in the medical device industry, where doctors are paid for their work developing products and then, in some cases, for helping to train other doctors in how to use the products. Medtronic insists that it only provides physicians with compensation that is fair, relative to current market values, and is compliant with the law.

December 6th, 2007 by Staff with NewsInferno.com