Medical Device & Diagnostic Industry Magazine
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Originally Published September 2000

James G. Dickinson

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If you market your device for a use FDA has not approved and an injury results, can the plaintiff sue you for "fraud on FDA" under the Food, Drug, and Cosmetic (FD&C) Act?

In July, the Supreme Court agreed to consider this question, which has associated First Amendment issues, when it accepted Buckman v. Plaintiffs' Legal Committee. This case involves the private right of thousands of patients to sue device manufacturers in state courts for injuries caused by off-label uses.

The case addresses issues the court ignored in 1996, when it ruled in Lohr v. Medtronic that FDA approval of a device does not activate the 1976 Medical Device Amendments' preemption clause in a way that would stop state-court product liability suits against device makers. In that case, FDA supported these state-level private actions against manufacturers of approved products on the theory that they reinforce the need for companies to comply with FDA regulations.

The new litigation takes its case name from Buckman Co., a consulting firm based in Pleasant Hill, CA. Buckman Co. helped the Cleveland-based AcroMed Corp. (now owned by Johnson & Johnson) get FDA 510(k) approval for bone screws intended for use only in long bones. In this case, however, the screws were used in the spines of the plaintiffs. Bone-screw manufacturer Sofamor Danek, the American Academy of Orthopedic Surgeons, and the Scoliosis Research Society joined Buckman in defending the class action suit.

The Third Circuit Court of Appeals ruled in November 1998 that preemption did not apply in this situation, and thus overturned a U.S. district court denial of the plaintiffs' suit. The appellate panel wrote that the plaintiffs' case "boils down to a contention that the litigation of suits of this kind is fundamentally inconsistent with the regulatory process established by the [FD&C Act]. We see no inconsistency between FDA having the exclusive prerogative of bringing actions to enforce the FD&C Act and preserving the right of people in the plaintiffs' position to bring common law fraudulent misrepresentation claims." Moreover, the Third Circuit majority declared, contrary to arguments by Buckman et al., this was not tantamount to letting state courts second-guess FDA.

The majority agreed that if Buckman had in fact committed fraud on FDA by seeking approval for one use while intending to market for another use, this would expose the manufacturer to both civil and criminal liability and earn it an injunction against marketing.

But the majority said this does not mean that only FDA has a right to take action under the FD&C Act; nor does it mean, as Buckman persuaded the lower court, that FDA has no authority to deny 510(k) clearance if it discovers the subterfuge during its review of the 510(k)—the alleged element of fraud. The plaintiffs contend that, "Were it not for [the misrepresentations that the applicant's intended use was in repairing fractures of the long bones], FDA would not have issued 510(k) clearances . . . for any purpose, the devices would not have been introduced into interstate commerce, and the plaintiff would not have been exposed to the dangerous device which was surgically implanted in the plaintiff's spine."

Calling its holding "a narrow one," the Third Circuit majority ruled that "one, the plaintiffs' 'fraud on FDA' theory of liability is not so at odds with traditional principles of tort law that Buckman is entitled to a dismissal of all claims against it at this stage; and two, if the state law of fraudulent misrepresentation would impose liability on Buckman in the circumstances alleged, that law would not be preempted by the [Medical Device Amendments]."

In a dissenting opinion, Judge Robert E. Cowen directly challenged the majority on the issue of off-label use. "The difficulty not confronted by the majority," Cowen wrote, "is that there is a very real tension created between endorsing off-label uses but preventing marketing for those uses. Close questions will be raised about whether a manufacturer was simply responding to doctors' desirable demand for off-label uses, or whether a manufacturer was impermissibly trying to create an off-label market and circumvent FDA's regulation. As matters stood before this decision, FDA was left to police the boundary between permissible and impermissible responses to off-label demand. The majority's theory, however, now throws into the jury box the question of when unacceptable 'marketing' has taken place."

Cowen cited FDA's loss in the 1998 First Amendment suit brought by the Washington Legal Foundation, where a D.C. federal judge ruled that FDA had unconstitutionally restricted commercial speech in three guidance documents because less-restrictive means of achieving the government's interest were available. That case, Cowen said, showed that "difficult and subtle balancing is called for in evaluating manufacturers' roles in the creation and distribution of information about off-label uses of drugs and medical devices. The problem is not easily dismissed. Once it is accepted that off-label uses are desirable, it is difficult to maintain that doctors should be shielded from truthful information concerning when and how to use a product for an off-label use. Patients will benefit by having their doctors informed about off-label uses."

Cowen said that contrary to the majority's position, "the problem of allowing juries to determine when a manufacturer has improperly advertised an off-label use is not only that it will impose too stringent a rule, chilling dissemination of valuable information about off-label uses; it is also that jury decisions lack the consistency of an agency-enforced rule." Apart from the potential damage of restricting beneficial information about off-label uses and the need for a consistently enforced rule wherever the line is drawn, Cowen added that a jury's assessment of liability is problematic in a third sense: "Massive liability will be imposed where FDA would not find any misconduct, and the cost of medical devices will be needlessly raised," he said. "The majority permits liability for fraud on FDA when a jury concludes that a manufacturer conducted impermissible marketing, demonstrating that the manufacturer 'defrauded' FDA in its statement of intended purpose."

Speaking in July, CDRH deputy director for science and regulatory policy Philip J. Phillips declared that "it is time . . . to eliminate the artificial distinctions we have been maintaining in the premarket review program." Phillips's remarks were part of his announcement of "a systems approach to premarket review."

His goal is a full integration of the premarket review program as a high priority, starting in the Office of Device Evaluation's program operations staff (POS).

Phillips says the approach is designed to ensure that the proper level of regulation is applied to products as a result of reengineering options and provisions under the FDA Modernization Act of 1997. "There is nothing more frustrating than getting in a [premarket approval application], processing it, and finding towards the end that it really isn't a PMA," Phillips says. In short, he wants to get products review on track early by instructing his POS in what he calls an "effort in attention." This will save time for both the agency and manufacturers, he claims, and get products to market in the timeliest manner.

The need for a new reform has been created by years of earlier reforms that overlapped one another. Those overlapping reforms blurred the lines between the various premarket review programs—investigational device exemptions, humanitarian device exemptions, premarket approvals, product development protocols, and 510(k)s— creating "artificial distinctions" that hamper the process.

"To regulate the product effectively, we must go through a process and look at all options available," Phillips says. He feels cross-training is one dimension that will make his people think beyond their expertise in applying the proper level of regulation.

FDA's CDRH opened a Web site in July devoted to the reuse of single-use medical devices (SUDs). The site's home page outlines CDRH's current policy stance—"considering" whether it should apply the same regulatory standards oversight to SUD reconditioners as it applies to OEMs, based on the degree of risk inherent in the device and its reuse. Other pages provide relevant FDA documents about the SUD reuse issue, answers to frequently asked questions, standards, a listing of FDA events of relevance, and a page where interested persons can register to receive e-mail notifications about the issue or ask questions.

FDA is establishing a Medical Device Dispute Resolution Panel that will have eight members, the new CDRH ombudsman, Les Weinstein, told a Medical Alley breakfast in Minneapolis in July. Five of the members will be permanent and three temporary. Weinstein was introduced at the meeting by CDRH director David Feigal, who hails from Minneapolis and toured several medical device facilities in the vicinity.

Weinstein told the group that his office, recently established by Feigal, is designed to give focus to a variety of accessible dispute-resolution mechanisms, easing the way for industry to be heard. He said he will also provide an outreach to industry by speaking to trade associations. Weinstein is a member of the Medical Device Industry Initiatives Grassroots Task Force, a joint industry/FDA group working together for mutual benefit.

Weinstein invited industry members to use his services whenever they have problems with CDRH that they have been unable to resolve. He can be reached at 301/443-6220, ext. 119; fax: 301/443-2962; e-mail: a href="mailto:[email protected]">[email protected]. Correspondence should be addressed to the CDRH Ombudsman (HFZ-5), Office of the Center Director, Center for Devices and Radiological Health, 9200 Corporate Blvd., Rockville, MD 20850.

FDA is increasing its efforts to encourage medical device companies to submit their products to non-FDA (third-party or accredited-person) review for marketing clearance. In the July 18 Draft Guidance for Staff, Industry, and Third Parties: Implementation of Third-Party Programs under the FDA Modernization Act of 1997, the agency said all Class II devices are now eligible to participate in a third-party review pilot unless they are excluded by statute.

The agency added, however, that "any 510(k) for a Class II device for which clinical data are needed to make a determination of substantial equivalence will continue to be subject to initial and supervisory review by FDA and will not be processed by FDA under the special procedures for the Accredited Persons Program."

According to the draft guidance, "An accredited person may review a Class II device that does not have device-specific guidance if: (1), the accredited person has previously completed three successful 510(k) reviews under the third-party program; (2), the accredited person contacts the appropriate CDRH Office of Device Evaluation (ODE) branch chief (or designee) before initiating a 510(k) review for a Class II device without device-specific guidance to confirm that the accredited person meets the criteria in paragraph one above and to identify pertinent issues and review criteria related to this type of device; and (3), the accredited person prepares a summary documenting the discussions and submits it to ODE."

FDA intends to review the pilot program in one year to see if the number of third-party 510(k)s has increased significantly and to verify that the timeliness of the reviews is maintained. The agency will also consider whether particular divisions within CDRH's ODE are devoting disproportionate staff time to presubmission discussions with accredited persons. More details are available on the Web.

CDRH's recently appointed Office of Device Evaluation director, Bernard Statland, MD, made his first public appearance at the AdvaMed (formerly HIMA) annual device submissions workshop in Washington, DC, in July. Statland comes to FDA from the North Shore– Long Island Jewish Health System, where he served as medical director and CEO. He also has held positions with the Public Health Service in New Orleans and the National Institutes of Health Clinical Center. Statland, who earned his medical degree in 1968 from the University of Minnesota, also holds a PhD in biochemistry from the same school (1970). He served his residency at the University of Copenhagen and was later the senior resident for clinical pathology at the University of Minnesota Hospitals.

Meanwhile, his predecessor, Susan Alpert, MD, is headed for industry. She accepted a position at C. R. Bard (Murray Hill, NJ) as vice president of regulatory services, effective October 1. Alpert left CDRH late last year to provide leadership for President Clinton's Food Safety Initiative at FDA's Center for Food Safety and Applied Nutrition. In her new capacity at Bard, Alpert will manage the quality, regulatory, medical, clinical, and environmental affairs functions for the company. Alpert is replacing Richard Manthei, who is retiring from C. R. Bard effective this December.

Device manufacturers now have Internet access to search consensus standards by way of CDRH's Web site. The site offers manufacturers the ability to search the agency's database through several means— by standards organization, type of standard, category, product code, reference number, or title. CDRH wants manufacturers to use recognized standards to help expedite the evaluation of premarket submissions. The center says conforming to recognized consensus standards means, in most cases, eliminating the need to review the actual test data for those aspects of the device addressed by the standards.

James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.

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