WASHINGTON WRAP-UP

To the House of Representatives' initiative to reverse the Supreme Court's Riegel v. Medtronic decision, now add a bill from senators Edward Kennedy (D–MA) and Patrick Leahy (D–VT). In August, they circulated the Medical Device Safety Act of 2008 to undo FDA preemption of state lawsuits brought against medical device companies marketing FDA-approved premarket approval devices. Six additional senators initially signed on as cosponsors.

Spokespersons for the sponsors said that the Supreme Court ruling that state tort claims against medical device manufacturers are preempted by language in the Medical Device Amendments of 1976 leaves consumers with no legal recourse. “Because there is no federal remedy, consumers harmed by medical products have always looked to state and local law to provide compensation for injuries sustained, medical expenses incurred, and lost wages,” they said in a statement. “The Court made the erroneous assumption that FDA approval protects patients from risks discovered after approval. Recent history has made abundantly clear that FDA oversight is not sufficient to protect consumers from a wide range of device risks.”

The statement says the bill would address the ruling by explicitly stating that actions for damages under state law are preserved. It would amend the Medical Device Amendments of 1976 to state that that legislation should not be construed to modify or otherwise affect any action for damages or the liability of any person under state law. The change would be retroactive to the 1976 law's enactment date because, the statement says, Congress did not intend it to preempt damage suits.

Is the Law Just What FDA Says It Is?

Is the law exactly what a midlevel FDA official says it is—or must the agency explain its interpretation when asked? That is the central issue that the U.S. 10th Circuit Court of Appeals is being asked to decide in TMJ Implants v. HHS. The case arises from the small Golden, CO–based company's four-year battle with the agency over 17 disputed medical events involving its devices.

This recurring issue seems unique to medical devices, and to small companies that push back in court when pressed by CDRH on regulatory definitions. So far FDA has lost every time, most recently in U.S. v. Endotec. That company's CEO, Michael Pappas, released a statement in which he said the decision could be a bellwether. “For the first time in history, FDA has brought a suit on custom medical devices and lost. This sends a powerful message to the industry not to fear FDA, or to be intimidated by [its] tactics. Power not only breeds corruption, it also breeds arrogance, and arrogance breeds stupidity.”

Whether TMJ Implants Inc. (TMJI) will be dancing a similar jig remains to be seen. Its 62-page opening brief was filed on August 15 as FDA separately acknowledged that it has no idea of litigation costs to the taxpayers because it keeps no accounting records.

The agency has levied $340,000 in civil money penalties against the 13-employee company and its founder, 83-year-old Robert Christensen. Christensen is protesting FDA's refusal to explain the clinical basis for its demand that he file medical device reports (MDRs) for each of the 17 events in question. Disturbingly, there is no evidence that FDA prosecutors and senior management ever second-guess initial interpretations made by midlevel management—even after the agency loses in court.

A teaching surgeon and inventor of the temporomandibular joint prostheses at issue, Christensen says he followed FDA regulatory requirements and his company's FDA-accepted procedures in evaluating the event reports. Nine of them had been so heavily redacted by FDA that he could not tell whether his devices were even involved.

As his company's qualified medical expert, he says he was unable to determine that any of the events was causally associated with his devices, and FDA had no qualified experts of its own to contradict him. Instead, the agency decided to impose civil money penalties. In doing so, it disregarded an administrative appeal to the commissioner that was sidelined, and saw its original position endorsed by both FDA administrative law judge Daniel Davidson and the HHS Departmental Appeals Board.

Both reviews gave short shrift to Christensen's claim that he was entitled to a clinical-level explanation for why he should file the MDRs against his own clinical judgment. The departmental appeals decision said such “individual professional discussions” in every case could cause the MDR system to collapse.

“Further,” the board added, “given respondents' disparagement of the qualifications of the FDA experts in this case, it is not apparent that FDA could have satisfied respondents' requirements for what Dr. Christensen regarded as a ‘medical expert' by anything short of accepting Dr. Christensen's opinions.”

The board upheld CDRH director Daniel Schultz's position that a “regulatory” rather than a “clinician's” standard rules the MDR system. In its 10th Circuit brief, TMJI says it could find no statutory or regulatory basis for this definitional distinction.

According to TMJI's brief, CDRH stresses “vague and ambiguous” CDRH definitions of “serious injury” and “caused or contributed to,” thereby making “any required analysis of adverse events by the manufacturer...meaningless.”

The brief, which includes detailed descriptions of the 17 events, argues:

Since under such an interpretation the manufacturer can never be right, this is just another example of the sort of FDA broad interpretation that was struck down recently in the case of U.S. v. Utah Medical Products Inc. as an example of the “virtue of generality and the vice of imprecision.”

FDA's failure to back up its definition's reasonableness, the brief says, “collapses the opinion of [Davidson] and the [board] as a fury that signifies nothing for this court. There can be no preponderance of the evidence unless there is evidence to prove that FDA (CDRH) did complete and document a review for each and every one of the 17 events, just as TMJI and Dr. Christensen did in complying with their MDR procedures as required by the regulation and statute.”

The brief labels “most damning” an admission by the current commissioner, Andrew von Eschenbach, that this amounted to a “process failure, which alone should be enough for the court to overrule the administrative ruling of” Davidson and the Departmental Appeals Board.

Other TMJI arguments in the brief include the contention that in accepting Schultz's invitation to appeal CDRH's position to the commissioner, a written “contract” had been entered into obligating the commissioner to consider the appeal; his failure to do so means that “FDA should at least be estopped from applying the [civil money penalties] enforcement action” as a matter of equity. TMJI waited eight months for a response from the commissioner, which came after the enforcement action was begun—an action that had allegedly been planned two years previously. The response declined to consider the appeal because the determination about a fine was under way, a maneuver the 10th Circuit brief calls an “ambush.”

Mitigating Factors Cited in Brief

The brief also claims TMJI should be given the benefit of other “mitigating factors” against imposition of the civil money penalties, including:

FDA Doesn't Track Resources in Enforcement Actions

When it comes to enforcement actions against regulated industry, FDA has a “blank check” and keeps no records related to resource expenditures, either monetary or employee time. This is the conclusion to be drawn from three recent and uniform agency responses to Freedom of Information Act (FOIA) requests for documentation on resources expended in two controversial enforcement actions. They are the 2005 federal court QSR/GMP loss to Utah Medical Products (Midvale, UT), and its four-year-old ongoing MDR case against TMJI (see previous story).

The first response, reported here last month, came from Office of Chief Counsel deputy chief counsel for program review Ann Wion. She said her office had “no responsive record” to my request for “legal expense summary documents showing accumulative dollar amounts and full-time equivalent (FTE) employee resources expended in all regulatory enforcement activities and [civil money penalties] litigation against [company] ...”

Subsequent inquiries revealed that, as in all other government agencies, such attorney work product records have been shielded forever from public access since a 1983 Supreme Court ruling. Nevertheless, I still await a Department of Justice response to my request for a cost accounting of its expenses in these cases.

Meanwhile, trying another tack, I broadened and revised my request at FDA to exclude attorney work product. It now encompasses “estimates of inspection time, investigation time, compliance officer time, center review time, and Office of Chief Counsel review time, expressed in both dollar and FTE terms, for FDA work performed in preparing compliance and enforcement action, exclusive of actual litigation expense, against” Utah Medical and TMJI.

In due course, I again received a neg-ative response from Wion, advising “we have no responsive records from the Office of Chief Counsel.” I also received one from CDRH Freedom of Information Branch officer Joy Lazaroff, saying that “we did not find the requested records.” She added that such information “is not maintained” by CDRH and that this was a partial response; other unnamed FDA components would separately respond. Presumably one of those was Wion's office.

Another component might be FDA's Denver district office, where the inspections of both Utah Medical and TMJI were based. Colleague John Scharmann, a former Denver district director himself, advised me that field investigators do make out time sheets regarding their inspections, and report travel and other inspection-related expenses that might be accessible under FOIA. I immediately submitted a request for those documents.

Scharmann doesn't believe similar records are kept for employees in other parts of FDA. This impression is reinforced by a former FDA headquarters official who added that he believes FDA should adopt a cost-accounting approach for employee time, so that answers can be given for such questions as, “What is the cost of each action that FDA takes? For example, what is the cost of a warning letter or seizure or litigation from start to finish? I don't think FDA exercises that kind of accountability at the present time. The question is, why not? How are they accounting for resources—especially when they continually say that the agency does not have enough resources?”

Feds Scrutinize Cordis Biliary Stents

In a single sentence of its quarterly SEC filing, Johnson & Johnson disclosed that it had responded to a June subpoena from the U.S. attorney in Massachusetts for information relating to sales of its Cordis subsidiary's bile duct stents. Earlier this year, Abbott Laboratories and Boston Scientific said they were cooperating with Department of Justice probes into their biliary stent marketing.

A Cordis spokesperson said that the company was cooperating and responding to the subpoena and declined further comment for the news media.

There have been reports to FDA that the stents are often used off-label to open blood vessels in the legs. There also have been allegations that such off-label uses are injuring patients.

Cook Criticizes Drug-Eluting Stent Tests

Cook Group (Bloomington, IN), which manufactures diagnostic and interventional products for several medical specialties, is questioning some tests that FDA proposes to require for non-clinical and clinical studies of drug-eluting stents. In August 1 comments to FDA's draft guidance, Cook says the “enormous amount of testing detailed in these documents may not all be relevant to patient safety and may not reflect a least-burdensome approach.”

Although some of the proposed studies and test methods may provide interesting information, Cook says, they are not predictive of drug-eluting stent safety and effectiveness in a clinical environment. The company says this is true of some of the design validation testing as well as proposed quality control batch-lot release testing.

The company also questions the scope that FDA intends for the parent guidance document as compared with the companion document. And it asks how the information provided in the documents is to be applied, and whether one guidance has more relevance than the other in certain areas of testing.

FDA Detects Quality Problems at X Spine Systems

An inspection at X Spine Systems' Miamisburg, OH, facility in April found quality system violations in the firm's work on implantable spinal systems. According to a July 15 warning letter from FDA's Cincinnati district office, violations cited on an FDA-483 included the following:

The warning letter said a written response by X Spine to the inspection could not be fully evaluated because the company had said it was still developing procedures for numerous proposed corrective actions. The company was told to report specific steps that have been taken to correct the violations and prevent them from reoccurring. The firm was also told to provide a timetable for any actions still to be completed.

FDA Denies Bovine Thrombin Advisory Opinion

FDA has denied a request for an advisory opinion on whether all bovine thrombin products must contain the required hemostatic abnormality warning language in a box, or if using a box is limited to a particular product class.

The request was filed by Alston & Bird, an Atlanta-based law firm. It also asked whether Vascular Solutions' bovine thrombin products must contain such a boxed warning. The request also asked whether the required placement of the warning information, boxed or unboxed, is limited to instructions for use and package inserts, or whether it must appear in all labeling, promotional, or advertising materials for all bovine thrombin products.

Jeffrey Shuren, FDA's associate commissioner for policy and planning, replied that the agency can deny requests for advisory opinions when, as in this case, the request covers a particular product, ingredient, or label, and does not raise a policy issue of broad applicability.

Shuren said that based on the request, however, FDA will consider the need to provide clarity for the labeling of bovine thrombin–based hemostatic products through guidance or another process that the agency deems
appropriate.

CDRH Issues Flutter Device Guidance

CDRH has published a guidance for industry and FDA staff titled, Clinical Study Designs for Catheter Ablation Devices for Treatment of Atrial Flutter. It addresses using a randomized clinical trial approach in designing clinical studies for catheter ablation devices that treat atrial flutter.

The guidance says the first several premarket approval (PMA) applications approved for treating atrial flutter relied on clinical data from single-arm trials because no devices were approved for treating this condition.

Recently, however, approved investigational device exemption studies and PMA applications have used the option of a randomized trial given availability of PMA-approved ablation catheters indicated for treating atrial flutter.

The guidance covers background, scope, study design, study endpoints, study groups, statistical considerations, sample size, follow-up of study subjects, anticoagulation parameters, investigator selection and training, data collection forms, and study
monitoring.

To view the guidance, visit www.fda.gov/cdrh/ode/guidance/1678.html.

Boston Scientific Recalls NexStent System

Boston Scientific is recalling its NexStent monorail, NexStent carotid stent, and monorail delivery system because the tip may detach during carotid artery stenting. A CDRH recall notice says a detached tip could lead to increased procedure time and cause vessel wall injury, stroke, or emergency surgery to remove the detached tip.

The notice says the recalled units were manufactured from June 12, 2007, through May 2, 2008. The recall does not affect already implanted stents. CDRH says a company voluntary recall letter on June 6 described the issue, identified the affected product, requested that customers stop using or distributing the product, provided direction of returning recalled devices to the company, and included a tracking form to be returned to the company.

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