Medtronic raises death estimate tied to heart device wires

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Posted on 13th March 2009 by Gordon Johnson in Uncategorized

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Date: 3/13/2009

By MATTHEW PERRONE
AP Business Writer

WASHINGTON (AP) — Medtronic, the world’s largest medical device maker, said Friday that 13 patients may have died as a result of problems with its heart device wires that were first disclosed in 2007.

The Minneapolis-based company pulled its Sprint Fidelis defibrillator leads off the market in October 2007 after identifying five patient deaths that may have been caused by the cracked wires.

In a letter sent to physicians Friday, Medtronic raised the number of estimated deaths to 13. The company notes that four of those deaths occurred when physicians tried to extract the wires. Medtronic has recommended patients leave the devices in because the risk of surgery may outweigh the risk of a device malfunction.

“This is likely to be the best choice for the majority of patients,” the company advised physicians.

Defibrillator leads connect patients’ hearts to implanted defibrillators that send an electrical shock if it senses a life-threatening abnormal heart rhythm. A fractured lead can prevent the device from sending a lifesaving shock or cause painful, unnecessary shocks.

Roughly 268,000 of the Fidelis leads have been implanted in patients worldwide, according to the company.

The Food and Drug Administration has received 107 reports of patient deaths where the devices may have played a role. Most of those reports were not filed by physicians, Medtronic notes, but “by family members or attorneys with minimal supporting data.”

After reviewing 89 of those reports, an outside group of physicians assembled by Medtronic judged that 13 deaths may have been caused by problems with the wires.

In recent months, federal judges have thrown out thousands of patient lawsuits against Medtronic, ruling that federal regulations shield the company from lawsuits filed at the state level. Those decisions were based on a Supreme Court decision last year that the federal FDA is the final arbiter of medical device safety.

Democrats in Congress are currently working to pass legislation to overturn that decision.

Shares of Medtronic fell $1.03, or 3.6 percent, to $27.55 in after-hours trading.

Copyright 2009 The Associated Press.

Lawmakers probe Medtronic payments to physicians

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Posted on 2nd October 2008 by Gordon Johnson in Uncategorized

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Date: 10/2/2008 3:33 PM

By MATTHEW PERRONE
AP Business Writer

WASHINGTON (AP) _ Senate lawmakers are pressuring Medtronic to disclose more about its consulting arrangements with physicians, citing prior allegations the company paid kickbacks to surgeons to boost sales of spinal implants.

In separate letters issued Tuesday, Sens. Charles Grassley, R-Iowa, and Herb Kohl, D-Wis., asked the company to provide details about physicians who receive company payments for consulting services.

The two lawmakers have repeatedly criticized the influence pharmaceutical and medical device companies hold over physicians. A bill written by the senators would require companies to disclose all payments to physicians over $500, and last week Eli Lilly became the first drugmaker to volunteer to publish such information.

“I hope that Medtronic will consider making public its payments to physicians in the future and thereby show similar leadership in the device industry,” Grassley wrote in a letter to Medtronic Chief Executive Bill Hawkins. Minneapolis-based Medtronic is the world’s largest device maker.

The company said it is “very supportive of industrywide transparency” in a statement, and pointed out it has supported Grassley and Kohl’s bill.

In 2006 Medtronic reached a $40 million settlement with the U.S. Department of Justice to settle charges that it paid physicians millions in kickbacks to use its spinal repair products. Medtronic denied any wrongdoing. As part of the arrangement, the government agreed to seek dismissal of the two cases brought by former employees in U.S. District Court in Memphis, where the company’s spinal division has offices.

But recent stories by the Wall Street Journal have attracted new scrutiny to the cases against the company, one of which remains sealed. Citing a copy of the sealed lawsuit, the Journal reported Medtronic allegedly entertained surgeons at a strip club, sent them on fully paid trips to Alaska and awarded some royalties on inventions they had no part in developing.

Medtronic said it would not comment on specifics of the case because it is still sealed.

“The Wall Street Journal rehashed allegations of prior conduct that were part of a case that was settled in federal court in July 2006,” the company stated.

In his letter, Grassley also raised questions about more recent allegations. Another lawsuit filed by former employees last year accuses the company of illegally paying doctors exorbitant consulting fees to recommend using its bone graft system for unapproved uses. Doctors are free to use drugs and devices at their discretion, but companies are not allowed to market them for unapproved uses.

Medtronic said it does not pay surgeons to promote Infuse for unapproved uses, but noted “surgeons do have the freedom to practice medicine and use products in an off-label manner.”

The company’s Infuse graft uses a man-made version of a human protein to encourages bone growth. The Food and Drug Administration approved the system to fuse parts of the spine together during lower-back surgery as well as for oral and dental procedures.

However, serious complications have been reported when the graft is used for alternate uses. In July the FDA warned doctors that use of Infuse for neck surgeries has led to problems swallowing, breathing and speaking, which in some cases required additional surgeries.

Copyright 2008 The Associated Press.