The meeting, which includes all scientists within the medical device evaluation office, is a rare gathering and likely to establish a plan for how the agency will handle a slurry of controversial issues including a Congress-initiated investigation of the device division by the Institute of Medicine, according to the New York Times.

The investigation is spurred by allegations from nine scientists who have separated themselves from the FDA, who have signed letters to President Obama charging that agency officials approved medical devices for sale despite often unanimous objections from scientific reviewers.

AAJ has been working with a large coalition of consumer and patient safety groups to push the Medical Device Safety Act (MDSA), legislation that would restore the rights of patients who have been harmed by unsafe medical devices to seek justice in state courts.

Last year a Supreme Court ruling gave manufacturers of medical devices immunity from state tort suits if the device has been approved by the FDA’s pre-market approval process. MDSA would restore the right to patients with medical devices, “as Congress has intended in 1976 they passed legislation on medical device safety,” according to AAJ.

Early this month, people with Medtronic cardiac defibrillators implanted in their chests converged on Washington, D.C., to lobby for passage of MDSA. In 1997, Medtronic suspended the sale of its Sprint Fidelis Defibrillator leads after receiving reports of fatalities connected to the devices. The leads were found to have fractured, which caused them to unnecessarily shock patients or fail to work altogether. According to last year’s Supreme Court ruling, patients harmed by the defibrillators cannot sue because the medical devices were previously approved by the FDA.

SOURCE: Sprint Fidelis Lead Recall › FDA meeting could compromise Medical Device Safety Act

Ron Albrecht

“I don’t trust the unit itself,” he told NWI.com. “You’ve got that fear you’re constantly going to get shocked. It’s very traumatic.”

Because of the faulty defibrillator, Albrecht had to quit his job because he was no longer able to lift heavy equipment. The defective device, he said, has changed his life for the worse.

In 1997, Medtronic suspended sales of its Sprint Fidelis Defibrillators after deaths were linked to the devices. The device’s leads were found to have fractured, which caused them to unnecessarily shock patients or fail to work altogether, putting patients’ lives at risk.

Albrecht was one of the many patients who tried to sue Medtronic over his faulty defibrillator leads but previous legislation prevented him and other victims from doing so. Earlier this week, Albrecht and several victims of malfunctioned heart devices converged in Washington, D.C. to lobby for support of the Medical Device Safety Act, which would allow consumers who have been hurt by defective medical devices to sue the device’s maker even if the devices have been approved by the Food and Drug Administration (FDA).

A spokesman with Medtronic says the industry as a whole is resistant to the proposed act, stating that a 1978 federal law was enacted to ensure that the FDA operates as the arbiter of safety.

SOURCE: Sprint Fidelis Lead Recall › Victim of defective defibrillator lobbies for Medical Device Safety Act

The bill was introduced by Democratic Reps. Frank Pallone Jr. of New Jersey and Henry Waxman of California after a Minnesota federal district court dismissed lawsuits filed against Medtronic by 1,496 individuals harmed by their malfunctioning Medtronic defibrillators.

In 1997, Medtronic suspended the sale of many of its Sprint Fidelis Defibrillator leads after receiving reports of fatalities connected to the devices. The devices were found to have fractured, which caused them to unnecessarily shock patients or fail to work altogether.

The patient convergence in Washington, D.C., was accompanied by public service announcements that feature Don Hickey, who was shocked repeatedly by his Medtronic heart device after undergoing surgery. He later found out doctors replaced his defibrillator with the same, defective model. According to the law, he cannot sue the maker of his medical device.

Alternatively, the videoes also feature Diana Levine, who lost her arm from what she calls faulty labeling of a drug by its manufacturer. She successfully sued both her doctor and the drug company. The injustice she sees is that people, like her, who have been harmed by pharmaceutical companies, can seek justice in court, whereas individuals like Hickey who have been harmed by faulty medical devices, cannot.

“If you can’t hold a corporation responsible when a product with FDA approval hurts you, that’s like giving a corporation a license to hit and run,” Levine told The Minnesota Independent. “What’s really crazy is now there are two laws. The Supreme Court has said that people like me who are hurt by bad drugs can sue. But people like Don who are hurt by bad medical devices cannot. It’s time we finish the job. We need to all work together to pass the Medical Device Safety Act.”

SOURCE: Sprint Fidelis Lead Recall › Patients converge on Capital Hill for right to sue Medtronic

And change is apparently what the FDA needs the most. On Thursday, the Government Accountability Office (GAO) said that from 2003 to 2007, the FDA cleared 228 medical devices for the market without a complete evaluation of their safety and effectiveness. Some of the devices were intended for sensitive and risky uses, such as pacemakers and heart valves, and a few have since been recalled because of malfunction or other problems.

“It all adds up to less-than-rigorous rigorous device review, and it’s placing tens of thousands of Americans at risk,” said Peter Lurie, deputy director of Public Citizen’s health research group, in a report by the Associated Press.

The GAO report (link to PDF of report) did not evaluate the number of people, if any, who were harmed by the hastily approved devices. Instead it focused on the approval process for medical devices, calling into question why FDA scientists are routinely pressured to approve of medical machinery against their professional judgment.

A factor that may be contributing to the FDA’s problem is the quickening pace of technology development. Manufacturers of high-tech medical devices have made giant strides in the past decade, and so the number of devices trying to enter the market has grown. The number of upgraded products up for review has also increased. As technology began to outpace the FDA’s approval process, which was established as a three-tier system in 1976, the Federal government pressured the FDA to speed things up.

With drug companies and medical device manufacturers seeking refuge in legal preemption, the current FDA approval system can be a formula for disaster for the American public. Last year, the U.S. Supreme Court ruled that federal (FDA) approval of medical devices could displace many laws on the state level. In other words, someone who has been harmed by an FDA-approved medical device may have little legal recourse in state courts.

SOURCE: Sprint Fidelis Lead Recall › FDA says approval of medical devices was rushed