Originally Published February 2001
A fraud-based case has elicited a new FDA position on preemption.
- Bleak Budget Outlook
- Industry Protests Postmarket Rule
In 1996, when FDA weighed into the Medtronic v. Lohr Supreme Court case, the agency helped establish the right of product liability litigants to sue medical device companies for injuries caused by FDA-approved products. FDA's theory was that such private suits in state courts were complementary to its own budget-beleaguered efforts to keep device companies in compliance with GMP regulations, adding a potent element of psychological intimidation to FDA's armory. Medtronic (Minneapolis) unsuccessfully argued that FDA approval inoculated it from state-level actions, under the federal preemption law.
In December of last year, FDA was back in front of the Supreme Court arguing against the main thrust of its 1996 position. In this new preemption case, which was brought by the medical device consulting firm Buckman Company, Inc. (Pleasant Hill, CA) against the Plaintiffs' Legal Committee, the agency faced a different set of facts.
This time, FDA said that an "implied" preemption should protect Buckman—acting for the maker of AcroMed (Cleveland) pedicle screws—from the respondents' claims that the company had fraud- ulently obtained FDA 510(k) clearance by not disclosing the intended use of the device. The actual use of the device allegedly resulted in injury to the plaintiffs.
It was all well and good, FDA argued, for preemption to have been disallowed in the Medtronic case where a product defect and violation of FDA GMP regulations were alleged, but preemption should be allowed in the alleged fraud on FDA by Buckman.
FDA's reason for apparently contradicting itself in the two cases is that the agency thinks private litigation in fraud cases would impede its work because of litigant "discovery" demands. Such a case would likely cause FDA to lose its discretion in dealing with fraud. Private litigation in GMP cases would not bring such harassments.
At the core of the Buckman case is the respondents' claim—which FDA doesn't dispute—that Buckman obtained 510(k) clearance for the pedicle screws by telling FDA that the device was intended for use in long bones. However, the device was meant to be marketed exclusively for use in the spine.
Indeed, FDA's amicus brief to the Supreme Court said that Buckman tried two different times to get 510(k) clearance for the spinal use of the device. Buckman was rebuffed both times on the grounds that the reported use of the device wasn't substantially equivalent to any pre-1976 predicate device. In a third try, Buckman tried to get 510(k) clearance for the use of the screws in long bones and other flat bones and succeeded.
More than 2300 lawsuits claiming injuries from spinal implantation led to the present combined case against Buckman. The claims were first rejected, then agreed to by the lower courts, which resulted in Buckman's appeal to the Supreme Court.
FDA welcomed the added legal weight of private litigation against Medtronic because it brought the company into better compliance with GMP regulations. Regarding the new case's charges that Buckman had committed fraud in its successful 510(k) submission, however, it resisted the application of the same type of dual legal pressure.
FDA agreed that the same exemption from express preemption applied in the Buckman case as had applied in the Medtronic case. That is, it maintained that because the state-level requirements for litigation did not conflict with FDA's federal breach-of-GMPs requirements, the cases should be preempted. Its current position is that an "implied," not an express, preemption did block the new cases, however.
Whereas the complaints against Med-tronic involved device design and manufacture and failure to warn—areas of state concern—the complaints against Buckman involved fraud on FDA—an area of preeminent federal concern, said FDA. In the current case, "respondents simply contend that, but for [Buckman's] alleged misrepresentations to FDA, the agency would not have cleared the device for marketing, the device would not have been marketed, and they would not have been injured," FDA's brief told the Supreme Court.
FDA said that its relationships with regulated companies, including the truthfulness of submissions made by those companies, is traditionally its own business and not the business of state courts. Citing other Supreme Court decisions, FDA said, "when state law implicates an area of preeminent federal concern, the presumption against preemption disappears, and the likelihood of a fatal conflict between state and federal law significantly increases."
FDA argued that it would lose its discretion to decide whether it had been defrauded in a 510(k) submission and what sanctions, if any, to apply. In such situations, juries in 50 states could advise on the appropriate sanctions.
Moreover, FDA went on to say that the respondents' claims against Buckman conflict with its decision to grant market clearance for AcroMed's pedicle screws—a decision to be made by FDA alone and one that is due judicial deference.
If such claims were allowed to proceed in state courts, this "would invite highly intrusive inquiries into FDA's internal deliberations," the agency argued. Such inquiries would include what FDA knew about Buckman's intended uses for the AcroMed devices and when the agency learned of them. This would open FDA decision makers up to private-litigant discovery rights, whereas federal employees have been generally immune from third-party subpoenas issued in private litigation since 1951.
In dealing with the intended use of a device, 21 CFR 801.4 allows FDA to consider, in addition to submitted labeling: (1) advertising matter, (2) manufacturer's statements, (3) knowledge that a product is "offered and used for a purpose for which it is neither labeled nor advertised," and (4) the manufacturer's "knowledge" of facts that would give it "notice" that a product "is to be used" for purposes other than those for which the manufacturer offered it.
Considering this, FDA contended that it has more than adequate power to deal with fraud on itself and doesn't need any help from state courts.
Bleak Budget Outlook
Despite the many improvements at FDA that have led to the approval of innovative new products, the agency admits it has failed to meet its mandates for "rigorous and punctual" review of new product submissions and timely postmarket inspections, according to the FY 2001 FDA Performance Plan. In addition, "a major gap exists between FDA's current clinical research monitoring capability and the level of monitoring that is necessary to ensure that volunteers in these studies are being protected," FDA said, giving unprecedented emphasis to its mounting resources crisis.
The plan reports that except for FDA's user fee–supported program for drugs and biologics, it "has been unable to support its review activities with resources commensurate to the rapid development of increasingly complex healthcare products." While CDRH has shortened PMA review times by redirecting resources from other regulatory activities, reinventing its processes and procedures, and assigning a high priority to important applications, it now faces inevitable product- review slowdowns.
"Inadequate funding hampers the development of knowledge bases that will improve the scientific basis of regulatory guidance and advance science and product development," the plan says. "Formal scientific collaborations and stakeholder interactions that are used as a means to educate and increase the availability of scientific knowledge to consumers, healthcare providers, and academia suffer as well."
FDA's performance plan warns that its lack of resources prevents it from inspecting high-risk medical device firms every two years as required by law. Delays in inspecting firms will increase the potential for unsafe medical devices.
For example, last year hospitals alerted FDA to contaminated iodine surgical swabs. The firm that made the swabs had not been inspected for seven years, meaning that as many as 200,000 people could have been infected. "Earlier detection could have prevented and corrected the problem," FDA said.
The agency added that CDRH in FY 2001 will make the most effective use of limited inspection resources by implementing four key strategies. Among the strategies are leveraging through contracts with the states, other third parties, and outreach to small firms; focusing resources on the highest-risk firms and medical devices; ensuring that inspectors have the scientific and technological support necessary to make quick and valid judgments about medical device compliance; and reengineering the process by implementing quality system inspections that will significantly reduce project time and increase effectiveness.
FDA said it will look to help protect clinical trial volunteers by increasing the number of inspections in FY 2001, with an "emphasis on high-risk trials, such as sponsor-investigators who have a proprietary interest in the product under study and studies enrolling vulnerable populations (mentally impaired, pediatric, etc.)."
FDA's performance plan also said it will review and follow up clinical trial complaints within 30 days. "An infusion of new funds is needed for FDA to improve its programs and particularly to enhance its inspections of clinical investigators," FDA said. With over 30,000 clinical sites to inspect, in FY 1999 FDA only inspected 575.
Industry Protests Postmarket Rule
An FDA proposed rule to implement postmarket surveillance (PMS) would impose substantial, unnecessary burdens on all device manufacturers subject to PMS, AdvaMed stated in comments submitted to FDA. In addition, it could force some small manufacturers out of business and create entry barriers for others. "In many instances the proposed rule appears aimed at stimulating the collection of 'interesting data' rather than data useful in protecting patients," AdvaMed continued. "The burdens imposed by the proposed rule are amplified by its lack of clarity in some of the provisions and the inappropriateness of other provisions."
In its proposal, FDA said the regulation "is intended to ensure that useful data or other information will be collected to address public-health issues or questions related to the safety or effectiveness of devices for which the agency has issued PMS orders." These public health concerns may include the identification of unanticipated adverse events, and the rate of known adverse events as the indications or conditions for use of the device change, said FDA.
FDA's criteria for imposing PMS on any Class II or Class III device are as follows: If the failure of the device would be reasonably likely to have adverse health consequences; if the device is intended to be implanted for more than one year; or if the device is intended to be life-sustaining or life-supporting and is used outside a device user facility.
AdvaMed proposed a list of modifications to the FDA rule. Among its suggestions are that PMS orders contain FDA's justification for selecting PMS over other alternatives; that a mechanism for alerting manufacturers regarding devices that may be affected by PMS be established; and that FDA be required to meet with manufacturers prior to issuing a PMS order to provide guidance for the submission process.
AdvaMed also suggested that a two-tier approach be applied to PMS where manufacturers would educate appropriate staff members at selected centers to be alert for significant complications associated with the use of a particular device. If this resulted in questions about unexpected serious illness or injury related to the device, a second-tier PMS information collection effort directed at addressing the specific question could be conducted.
Lastly, AdvaMed said that FDA should clarify precisely what it means to include device "claims" in a submission, and should define its criteria for PMS plan evaluation. In turn, manufacturers should be required to obtain FDA approval only for significant changes in PMS plans.
James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.
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