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.

By MATTHEW PERRONE
AP Business Writer

WASHINGTON (AP) — A day after the Supreme Court decided that federal rules do not protect drugmakers from state lawsuits, Democrats in Congress moved to overturn a decision that has shielded medical device companies from similar legal action.

On Wednesday the court turned away Wyeth’s claim that it could not be sued in state courts for its drug Phenegran, because it had already been approved by the federal Food and Drug Administration. The ruling upheld a $6.7 million award to a Vermont woman who lost her arm after she was improperly injected with the company’s nausea medication.

Seizing on the decision, Democrats on Thursday reintroduced a bill that would allow similar lawsuits against companies that make heart devices, catheters, hip replacements and other devices.

“Yesterday the Supreme Court rightfully upheld a patient’s right to legal recourse after sustaining an injury from a pharmaceutical product,” said Rep. Frank Pallone, D-N.J. “Today, we introduce legislation that gives patients that same right when injured by a medical device.”

The idea that corporations are shielded from state liability claims by federal rules is relatively new and was pushed aggressively under the Bush administration.

Last year, the Supreme Court agreed with the pre-emption policy in a case involving medical devices, ruling a patient injured by a catheter from Medtronic could not sue under state laws. That case turned on a provision of federal law prohibiting states from imposing their own requirements on the devices. There’s no similar provision for drugs.

Since then thousands of lawsuits against Medtronic and other device companies have been dismissed by lower courts, citing the Supreme Court’s decision.

But Pallone and other Democrats said Thursday that decision ignored decades of precedent, in which lawsuits brought by patients in state courts helped bolster safety regulation at the federal level. The bill to restore liability claims against device makers is co-sponsored by Rep. Henry Waxman, who chairs the Energy and Commerce Committee. He is expected to hold hearings on the issue in coming weeks.

The device industry’s chief lobbying group quickly slammed the effort, saying it will “produce a chilling effect on medical innovation, create more lawsuits and ultimately result in higher health care costs for all Americans.”

The Advanced Medical Technology Association, or AdvaMed, said the legislation would allow state courts to second-guess medical experts at the FDA and create a “patchwork of inconsistent and confusing guidance.”

Despite opposition from industry, the Medical Device Safety Act enjoys support from a broad range of interest groups, including consumer advocates, trial lawyers and AARP. With companion legislation introduced by U.S. Sen. Ted Kennedy, D-Mass., many analysts have already predicted the measure will become law.

Earlier in the day AdvaMed rolled out its first-ever advertising guidelines for companies like Medtronic Inc., Johnson & Johnson and Boston Scientific Corp. Among other things, the guidelines urge companies to state the risks of their implants clearly and concisely when advertising them to consumers.

The device industry has begun attracting new scrutiny from lawmakers as companies increasingly pitch their implants to consumers via TV and magazine advertisements.

Copyright 2009 The Associated Press.