We have written about the numerous safety and health problems involving medical devices in past issues. The companies manufacturing medical devices have known for a long time that regulation by the FDA was not very effective. Many have taken full advantage of that fact. According to a recently released Public Citizen report, the number of moderate and high-risk devices recalled in the past fiscal year was 1,201, nearly double the 566 recalls in fiscal year 2007. The increasing rate of recalls and the tragic cases outlined in Public Citizen’s report, titled “Substantially Unsafe: Medical Devices Pose Great Threat to Patients; Safeguards Must be Strengthened, Not Weakened,” show that current FDA regulations are failing to protect the public from dangerous medical devices.
It appears Congress has turned its focus to medical device policy. As you may recall, a U.S. House of Representatives Energy and Commence subcommittee held a hearing earlier this year to discuss the reauthorization of the medical device user fee program (MDUFA). Unfortunately for the American people, lawmakers are under constant and heavy pressure from the medical device industry to weaken medical device oversight. In response, lawmakers have introduced numerous bills that would lower standards for clinical testing of new medical devices and would water down conflict-of-interest regulations for reviewers of devices. These are only some of the changes being attempted. For example, one proposal goes so far as to change the mission of the FDA to favor industry interests over public health. These bills would leave the public even more vulnerable to dangerous devices. As I have written in prior issues, the public is pretty much in the dark on what happens in Congress. That is also true as to the FDA’s work.
The FDA has two chief processes for reviewing moderate and high-risk devices for sale: 510(k) and premarket approval (PMA). Each process has serious deficiencies. The 510(k) clearance process, used to approve at least 95 percent of moderate and high-risk devices, fails to provide safeguards most Americans would expect for medical products. The process relies primarily on a manufacturer’s demonstration that a proposed device is “substantially equivalent” to a device already on the market, called a “predicate device.”
This process provides very little assurance that the new device is safe or effective because the process permits modified devices to enter the market without adequate clinical testing. A prime example is the metal-on-metal hip replacement device, sold by DePuy Orthopaedic, a subsidiary of Johnson and Johnson. As we have reported, that device was recalled from the market. The FDA cleared DePuy’s metal-on-metal hip implant for market under the 510(k) process, rather than the more rigorous PMA process intended for such devices. This was despite the fact that the device displayed novel technological features, which should have required further studies and evaluation.
Such technological deviations from predicate devices should be cause for clinical testing. Yet the device went on to be implanted in thousands of patients even though it degraded faster than any other competitor hip implant on the market at the time. Many patients experienced extreme pain due to the wear and tear of the metal inside the hip and shedding of metal fragments into the tissues surrounding their hip joints. Many lost their full mobility.
The PMA process used by the FDA is more stringent that the 510(k) process, but it also has its weaknesses. It’s reserved for the relatively few devices that are deemed both as posing a high risk and incorporating novel technology. PMA generally requires clinical testing, but the standard is significantly lower than the standard for approval of new prescription and over-the-counter drugs. For example, the FDA approved Medtronic’s Sprint Fidelis implantable cardiac defibrillator leads (thin wires that connect the defibrillator to the heart to protect patients against cardiac arrest) as a modified version of a previous Medtronic defibrillator that had received premarket approval in 1993.
It was soon discovered that the leads were prone to fracture, delivering unnecessary and painful electric shocks to the heart or failing to work at all. Approximately 1,000 injuries and at least five deaths were reported as associated with use of the device. Medtronic recalled 268,000 units of the defective device in 2005. As of 2011, half remained implanted in patients. Some patients implanted with the recalled device eventually filed lawsuits against Medtronic, seeking to hold the company accountable for the injuries caused by the faulty devices.
However, relying on Riegel v. Medtronic, the 2008 U.S. Supreme Court decision, a federal court in Minnesota held that the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act preempted most state tort law claims because the device was subject to the FDA’s PMA process. Thus, patients with claims for injuries caused by Medtronic’s Sprint Fidelis are barred from seeking redress in court. Another significant loophole in device regulation is the difficulty of tracking defective devices once they are on the market. One might expect that recalled devices would be easily traceable to affected patients, similar to the ease with which recalled automobile parts can be traced back to affected cars, but so far a comparable tracking system has yet to be implemented.
Recalled devices today can be traced only to a distributor or user facility (such as hospital or clinic), not to the specific patients who received the device. In 2007, Congress mandated the FDA implement a unique device identifier system to speed up detection of dangerous devices on the market and facilitate recalls. Rules implementing such a system still have not been finalized. The FDA has only drafted a proposed rule, which is currently awaiting approval at the Office of Management and Budget.
The medical device industry’s campaign to expedite medical devices’ path to the marketplace involves loosening regulatory loopholes and advocating subpar standards. As Congress prepares to take up medical device policy as part of the reauthorization of MDUFA, the industry has stepped up its lobbying efforts. In 2011, the medical device industry spent $33.3 million lobbying Congress. In just the third and fourth quarters, at least 225 industry lobbyists – including 107 who previously worked for the federal government – lobbied members of Congress or executive branch officials on issues relating to the medical device approval process.
Efforts are underway to counteract the aggressive efforts by the medical device industry lobbyists. Safety experts, advocates and researchers from Public Citizen continue to provide critical information about the device safety process to Congress and to the public. Public Citizen is galvanizing thousands of activists to contact their members of Congress and let them know that the medical device approval process must be strengthened, not weakened. That’s most important. It’s time to replace the current device approval process with one that puts patient safety over company profits.
Source: Public Citizen
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