Mikulski asked Dr. Hamburg if she would heed concerns made by whistleblowers, such as those made by a group of employees at the Center for Devices and Radiological Health that in January accused the FDA of carelessly approving medical devices which ultimately put patients’ health and safety at risk.

Dr. Hamburg replied that she would see to it that critical issues and concerns raised by whistleblowers would be addressed by the agency if she is confirmed as commissioner.

The scientists allege that the FDA had approved medical devices for sale even after their review of many medical devices had resulted in serious objections by the scientific team reviewing them. One device approved under such circumstances included Medtronic cardiac defibrillators. It was later found that many of the defibrillators had defective leads that had caused the defibrillators to unnecessarily shock patients or fail to work all together. According to a Supreme Court ruling last year, because the devices had been approved by the FDA, those injured by the faulty devices were unable to sue the manufacturer.

As a result, a large collation of consumer and patient safety groups teamed up 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.

SOURCE: Sprint Fidelis Lead Recall › Hamburg hopes to create a culture in FDA where concerns are heard

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

Medtronic recalled the defibrillators in 2007 after five deaths occurred in patients who had the devices implanted in them. It was discovered that the Sprint Fidelis leads, or cables that connected to the devices, had fractured causing the defibrillators to unnecessarily shock patients or fail to work all together. Since the recall, Medtronic has increased the number of fatalities linked to the devices to 13.

About 150,000 Americans still have the defibrillators. Medtronic advises patients to discuss with their doctors whether the benefits of removal outweigh the risk, adding that it should be done only as a last resort. Removing the cables can be dangerous. Four patients have already died during the device removal process. Some experts fear that that number will climb if patients don’t seek out skilled doctors at medical centers to perform the extractions.

Finding credible medical centers may also present challenges. Data on the number or the success rates of lead extractions is generally not available to the public.

For those who do choose to have extractions, Medtronic is supplying replacement leads. However, the $15,000 to $20,000 cost of the surgery to remove and implant the new leads is falling on the shoulders of private insurers or Medicare.

SOURCE: Sprint Fidelis Lead Recall › Patients, doctors face tough choice about removing faulty heart devices

A new study published Monday in the Heart Rhythm medical journal suggests that the more than 200,000 recipients of  Medtronic heart defibrillator leads may be at a greater risk than previously thought.

The leads, known as Sprint Fidelis lead, connect electrical defibrillators to the hearts of patients with aberrant cardiac rhythms and deliver a jolt to the heart as needed to return the heartbeat to a normal rhythm. The devices were recalled by Medtronic two years ago after fractures were spotted in the devices, which caused them to fail. Medtronic says the faulty leads may have contributed to five deaths.

Removing the leads can put patients at serious risk. Medtronic and some health experts have advised that the leads not be removed unless the device showed signs of fracturing. An estimated 150,000 Sprint Fidelis leads remain in patients.

But the latest study, conducted by Dr. Robert G. Hauser of the Minneapolis Heart Institute and Dr. David L. Hayes of the Mayo Clinic, suggest that patients’ risk increases as the devices age. The report has some experts suggesting that, contrary to previous advice, for some patients, removing the Fidelis lead may be appropriate if the benefits outweigh the risks.

The study is based on data from 3,000 patients who had any brand of defibrillator leads implanted at the Minneapolis Heart Institute or the Mayo Clinic between 2004 and 2008. Twenty-eight percent of the leads were the Sprint Fidelis brand. The data showed that 3.75 percent of the Sprint Fidelis leads failed compared to 0.6 percent for other leads. The data also showed the failure rate was increasing.

Medtronic stands on its own data, issuing a statement: “It is important to note that data collected from center to center would be expected to vary. We believe that our analyses are representative of overall Fidelis performance.”

According to the New York Times, Congressional Democrats plan to reintroduce legislation that would nullify a Supreme Court decision last month to dismiss lawsuits against Medtronic for the defective leads, citing a ruling last year that shielded makers of certain medical devices from product liability lawsuits.

SOURCE: Sprint Fidelis Lead Recall › Study shows heart leads may fail as they age

If Medtronic is successful, the thousands of people injured by the company’s defective devices, as well as those hurt by faulty drugs and devices made by other manufacturers, would not be able to receive compensation for their injuries in state courts.

The Medtronic Supreme Court case stems from a lawsuit filed by the family of a New York man who suffered severe medical complications when a Medtronic-made balloon catheter burst during a procedure to clear his arteries. The man’s family sued Medtronic, claiming his injuries were caused by the catheter’s negligent design, manufacture and labeling, despite the fact the device had won FDA approval. The case was thrown out by a US District Court judge and then by the US Court of Appeals. The family is now appealing to the US Supreme Court.

Medtronic is arguing that because Congress granted the FDA the authority to determine whether products are safe and effective, state judges and juries should not be allowed to second-guess the FDA once a product is approved for use. Now, the Supreme Court must decide if Congress intended to bar state law claims when it gave the FDA authority to regulate medical devices in 1976.

That law clearly says that states can’t maintain requirements that are different from federal standards. But Congress didn’t specify that those federal standards preempted state common law claims, and device manufacturers didn’t argue that they did until recently. Medtronic and other companies are claiming that allowing state personal injury lawsuits against the makers of defective medical devices and drugs would amount to a state “requirement” different from FDA requirements because such complaints are based on state laws.

Consumer and patient advocates are vigorously opposed to Medtronic’s arguments. They fear that by removing the threat of lawsuits, manufacturers like Medtronic would have no incentive to keep devices and drugs that they know are defective off the market. And the FDA cannot be trusted to keep consumers safe, because the agency has approved some drugs – like Vioxx- and devices based on sloppy or falsified test data. Patient advocates insist that often, lawsuits are the only way evidence of such fraud or faulty tests ever come to light.

Finally, consumer advocates fear that the FDA is simply not up to the job of keeping unsafe drugs and medical devices away from the public. A report issued Friday by three members of the FDA’s own Science Board said that the agency was so poorly organized and short of funds that it could not adequately protect the public.

December 4th, 2007 by Staff with NewsInferno.com

SOURCE: Sprint Fidelis Lead Recall › Medtronic asks Supreme Court to ban personal injury lawsuits

The risk of a defective wire is low. Medtronic said that about 2.3 percent of the estimated 235,000 patients with the defective wire, or 4,000 to 5,000 people, would experience a lead fracture within 30 months of implantation. But learning through tests that one’s defibrillator has a faulty lead can create agonizing decisions for patients and doctors.

One decision is whether to remove the wire, a procedure that carries some risks, or leave it in place alongside a replacement.

Removal carries significant risk of damage to the heart and veins through which the wire wends from the defibrillator, a generator implanted under the skin near the collarbone.

When working properly, defibrillators deliver a potentially life-saving shock if the heart beats rapidly and purposelessly in a rhythm known as ventricular fibrillation. A surge from the device can restore a life-supporting heart rhythm.

If the Medtronic lead, called the Sprint Fidelis, were faulty, it could simply signal the patient to check with a doctor about a possible malfunction. Or it could deliver a painful, body-rocking shock when such a jolt is not needed. Or the device could fail to deliver a life-saving shock when it is needed.

The malfunction does not involve conventional pacemakers without defibrillators, Medtronic said.

Dr. David R. Broudy, a cardiologist and electrophysiologist who implants defibrillators in Seattle, said Monday that he was in the habit of telling all patients about potential complications when he implants defibrillators. He said there was a 2 to 3 percent chance of complications, including serious infections and malfunctions in leads and other parts.

He says he has 92 defibrillator patients who have a Sprint Fidelis lead, although on Monday he received calls from only three of them. Like other doctors, he said he would send letters alerting patients who do not call.

Medtronic also said that it would send letters to all Sprint Fidelis patients.

Defibrillator patients generally carry cards that contain the lead’s identifying numbers, which in the Medtronic recall are 6930, 6931, 6948 and 6949. Each patient is being asked to come in for computerized testing that could detect abnormalities in resistance and other electrical functions that could signal an impending fracture in the lead.

In Seattle, Dr. Broudy said that in trying to assess what to do for each of his patients with the potentially defective lead, he would check factors like the number of times the device had appropriately delivered shocks and the degree of a patient’s anxiety.

“There are different needs for different patients,” he said. Those who have had frequent abnormal heart rhythms, he said, may be more dependent on the device than others. Even patients in whom no evidence of possible cracks in the leads is found will need to have their Medtronic defibrillators reprogrammed.

The quandary will be for those found to have a fractured lead.

Doctors can insert a new lead into the vein if there is room for it, attach it to the heart, and then put a cap on the old one.

The risks of surgically removing the lead depend in part on how long it has been in place. Scar tissue forms around the lead after it is implanted. Removal can produce bleeding from torn veins and damage heart muscle. The risk of such complications ranges from 1.4 percent to 7.3 percent.

Dr. John Kassotis, director of cardiac electrophysiology at the State University of New York Downstate Medical Center in Brooklyn, said, “You can definitely take the leads out if they have been in less than six months and usually if it is less than two years.”

Patients who do need surgical removal of the lead should go to doctors and medical centers that have extensive experience in performing such procedures, experts interviewed Monday said.

October 23rd, 2007

SOURCE: Sprint Fidelis Lead Recall › Heart device recall poses a quandary for patients