Before closing its session last month, the U.S. Supreme Court said that it will review an appeal by the Buckman Co. (Pleasant Hill, California), a consulting firm that helps medical device firms negotiate regulatory issues with the FDA. The company and dozens of other defendants are facing product liability suits related to the bone screws used in spinal surgeries. The high court said it will decide in its next session, beginning in October, whether or not federal law can be preempted by state court decision, the suits in question alleging fraud by companies that had gained FDA regulatory approvals for the devices.
The Medical Device Manufacturers Association (MDMA; Washington) filed an amicus brief urging the court to accept the case, and both the MDMA and the U.S. Department of Justice have filed briefs with the court arguing that state law claims against medical device manufacturers are precluded by the federal law that gives the FDA the authority to conduct premarket review and clearance of devices and drugs. Additionally, MDMA argued that state courts and juries are in no position to judge whether a firm has fraudulently obtained marketing clearance by misrepresenting facts to the FDA.
The appeal challenges a lower court ruling in a suit, representing more than 5,000 individuals, that Buckman misrepresented information used to gain approval for a pedicle screw product made by AcroMed (Cleveland, Ohio). Plaintiffs in the case said that they suffered injuries when implanted with the Variable Screw Placement Spinal Plate Fixation System. That approval came in 1986, but the FDA clearance for using the screws in spinal procedures did not come until 1995. The suit charges that the manufacturers had intended to market the bone screws for spinal applications before winning approval of that application. After consolidation of the cases into one suit, it was thrown out by a judge in Philadelphia who said that federal regulation of medical devices bars such claims under state laws. The suit was then reinstated by a U.S. appeals court.
GAO: Reprocessing safe, oversight poor
At a late-June hearing of the Senate Health, Education, Labor and Pensions Committee, the General Accounting Office (GAO; Washington) said it has concluded that reprocessing certain single-use medical devices (SUDs) has generally proven safe. The report was commissioned by both congressional Democrats and Republicans in response to growing public health concerns – and growing criticism from the medical device industry – that the FDA has failed to provide consistent oversight of the practice. Despite concluding that selected SUDs can be reprocessed safely, Janet Heinrich, associate director of the Health, Education and Human Services Division of the GAO, said that "current medical device surveillance systems almost certainly do not detect all infections and injuries resulting from the use of reprocessed SUDs or medical devices in general."
With the number and extent of injuries resulting from reprocessing an unknowable quantity, the GAO report largely describes the problems associated with getting accurate information rather than recommendations on what remedies may be needed. "I think [the GAO report] raises questions about the regulatory process and the lack of information on the process," Sen. James Jeffords (D-Vermont), chair of the committee, said.
The increase in the number of devices labeled as single-use has some physicians and hospitals questioning the motivation for using the label, the report pointed out. The report states: "[Many health care professionals] told us they distrust the single-use label for some devices because 1) FDA cannot require manufacturers to support the designation of a device as single- use, 2) they perceive that manufacturers have an economic incentive to market devices as single-use that could just as well be sold as reusable and 3) FDA's approval requirements for SUDs are less extensive than those for reusable devices."
The FDA's plan to address issues surrounding reprocessing doesn't include demanding that manufacturers justify a single-use label. The new plan makes major changes to the oversight of SUD reprocessing by extending FDA oversight to hospitals and all third party reprocessors. They are being required to meet all applicable premarket requirements, such as conducting studies and submission of premarket applications for high-risk devices. Lower-risk devices would require a 510(k) submission demonstrating substantial equivalence.
At the hearing, David Feigal, director of the FDA's Center for Devices and Radiological Health, reviewed the agency's data reporting 464 failures of reused SUDs from Aug. 19, 1996, through Dec. 7, 1999, but said those figures showed "no pattern of failures with reused SUDs that differs from patterns observed with the initial use of SUDs." He concluded, however, that "the results of our own research and the information provided by various stakeholders have convinced us that this growing practice needs closer scrutiny and oversight. We believe we are on track to implement a reasonable strategy that will treat all reprocessors of SUDs in the same manner."