WASHINGTON WRAP-UP

TMJ Implants (TMJI; Golden, CO) has lost the latest round of its battle against CDRH. In July, FDA administrative law judge Daniel J. Davidson ruled in favor of CDRH on every count.

In a sweeping 12-page initial decision, Davidson upheld all aspects of CDRH's case for $630,000 in civil money penalties against the manufacturer of jaw implants. TMJI has not filed 17 medical device reports (MDRs) since 2004 and has tried in vain to obtain FDA's medical or scientific rationale for demanding them.

Davidson gave TMJI 30 days to file full financial disclosures prior to imposition of the civil money penalties. The fines could take effect as early as September. The company has said payment could compel it to shut down. It is considering an appeal to federal court and to Congress. There, members might have sympathy for its position, based on a June 25 Wall Street Journal editorial titled “FDA's Mean Devices.” That piece accuses FDA of bullying small device companies that don't have the resources to absorb market losses caused by agency demands.

Administrative law judges are empowered only to make “recommendations”—not judicial decisions—in disputes between their host agencies and aggrieved parties. Recourse from their “recommendations” is legally available through administrative appeals and U.S. district courts.

TMJI attorney Lynn Watwood wrote a scathing critique of Davidson's decision. Watwood said the decision showed “clear animus” toward the company, ignored documented evidence, and “pulled facts and statements out of context.” He also said the decision “ignored the clear language of the MDR regulation that requires... application of the ‘reasonableness' test.”

Watwood said Davidson did not adequately consider a pivotal issue in TMJI's case. When TMJI disagreed with CDRH's decision to mandate the filing of 17 MDRs, it appealed to the FDA commissioner. The company contends that the issue was not substantively reviewed by the commissioner and should have been resolved on its scientific merits by him before the penalties were asserted.

Davidson, however, writes: “After reviewing TMJI's appeal request, FDA denied the request. In July 2005, FDA Commissioner for External Affairs Sheila Walcoff notified TMJI in writing that its appeal request was denied and that the agency planned to file this action.” In a small-print footnote, he adds: “The wording ‘... that the agency planned to file ...' this action is somewhat inaccurate because it appears that this communication was actually sent after the [civil money penalties complaint] was filed.”

He then goes on to characterize TMJI's protests as the company “apparently seeking further reconsideration of [its] position from the commissioner.” But the firm says it never received any consideration in the first place. Walcoff's letter said any consideration of the appeal would be duplicative and not efficient owing to the civil money penalties case.

Davidson's decision then notes that he had twice rejected TMJI requests to stay the civil money penalty proceedings pending further consideration by the commissioner of the company's position. Why? “Because it appeared highly unlikely, considering the history of this matter, that any further consideration by [the commissioner] would result in a decision contrary to those previously rendered.”

On this point, Davidson concludes that TMJI's interpretation of the MDR regulation “has been considered and rejected by FDA on more than one occasion. The fact that the administrative process provides additional avenues for seeking reconsideration of rulings does not justify the delay of a formal evidentiary proceeding. Under the circumstances, the [civil money penalties action] was not filed prematurely and respondents have had (and continue to have) ample opportunities to have their interpretation of the MDR regulation considered.” This conclusion is without foundation, Watwood said.

He argued that TMJI's position has never been considered by FDA. That would mean its appeal was never denied, but instead rejected without review. “CDRH is not ‘the FDA,' just a lower branch of FDA, with admittedly no final authority to resolve appeal requests to the commissioner,” Watson said. FDA simply said that the law does not require the commissioner to accept all petitions for review. Another disagreement stemmed from the definitions of serious injury and permanent injury, both of which necessitate filing an MDR. Watwood said Davidson ignored testimony given in April by medical experts who could not agree on what is considered a permanent nontrivial injury and the definition of the phrase cause or contributed to. In fact, he said FDA's own witnesses, none of whom had experience with TMJI's devices, “agreed that ‘reasonable men' (physicians) may differ in applying this definition to an adverse medical event.”

“That is why in the opinion of respondents, the term reasonable in conjunction with the medical judgment of a company's expert appears in the MDR regulation as a justifiable reason for filing or not filing an MDR. Thus, the standard is the ‘reasonableness' of the company's decision.”

Davidson, he said, rejected this interpretation, applying instead an “absolute” standard favored by FDA “which does not appear in the MDR regulation. This finding moots FDA's MDR regulation requiring a company under threat of sanctions for noncompliance to investigate adverse events to reach a ‘reasonable' determination. If, as FDA argues under the stricter standard, there is a previously implanted device ‘intrinsically' present, a company can never rule out that its device caused or contributed to the injury. Thus an investigation required by the MDR regulation is utterly meaningless.”

Maybe in the end, no one wins. That's the assessment of a device industry attorney who anonymously posted the following on my Web site:

TMJI has chosen to fight to the death over its duty to report to FDA on 17 cases that the FDA already knew about from MedWatch forms initially filed to the agency and forwarded to TMJI. TMJI has had an option, since day one, of filing MDRs with disclaimers such as ‘unable to confirm it is our product,' ‘unable to verify information with a health professional,' and ‘appears to be related to a preexisting condition unrelated to the device.' TMJI chose not to follow that course. (Of course, each disclaimer carries with it the implied representation that TMJI is not lying to the government. Could that be a factor?) As a result, the taxpayers and TMJI have spent large sums of money disputing the regulation. Has TMJI benefited from its refusal to file MDRs with appropriate and truthful disclaimers? Has FDA benefited from a battle that could have been circumvented by clarifying its regulation through notice-and-comment procedures? Has anyone benefited from this dispute?

Bausch & Lomb Lens Solution Plant OK'd

An FDA inspection of a troubled Bausch & Lomb contact lens solution manufacturing plant and distribution center in Greenville, SC, found that both facilities are in compliance, the company said in July. The inspection came months after the firm received a warning letter detailing quality system problems at the plant.

Bausch & Lomb said that at the end of the most recent inspection, FDA indicated that all corrective actions required from the earlier inspection and subsequent warning letter had been completed. No negative observations were made.

A seven-week FDA inspection at the facility that began in March 2006 found “serious systemic” quality system regulation (QSR) problems, according to the warning letter issued in October from FDA's Atlanta district office. It acknowledged the company's efforts to address outstanding deficiencies but said the QSR violations were systemic and relevant to all products manufactured at the facility.

The warning letter also said the firm's contact lens solutions were misbranded because the company failed or refused to furnish information required by the medical device reporting regulation. Atlanta district director Mary Woleske said the company's responses to violations noted on the FDA-483 were inadequate, and that it often failed to provide necessary documentation of corrective actions taken.

The March 2006 inspection concentrated on the company's MoistureLoc contact lens solution, which was subject to a worldwide recall to eliminate health risks associated with Fusarium keratitis. The warning letter said FDA's investigator did not find problems that would warrant product recall or field correction with other products produced at the facility.

Shelhigh Throws in the Towel

In a June 22 federal court consent decree, Shelhigh Inc. (Union, NJ) agreed to stop distributing its implantable medical devices until it complies with CGMPs, the quality system regulation, and medical device reporting requirements. The company's decision came after nine weeks of defiance.

At the height of its defiance, Shelhigh publicly accused FDA of refusing to disclose MDRs implicating the company's devices in public health concerns. Instead, the company charged, FDA invited it to submit a Freedom of Information Act request while the agency alerted healthcare providers and patients to file such reports.

The consent decree requires Shelhigh to retain independent expert consultants to inspect its facility and certify to FDA that corrections have been made. FDA also will continue to monitor the firm's progress through a series of periodic inspections.

“Shelhigh may resume manufacturing, but not distributing, devices in phases after FDA has approved its plan for bringing its seized products and manufacturing processes into compliance with FDA law,” an FDA news release stated.

“After Shelhigh has completed corrective actions and been allowed to resume manufacturing, the company must hire an independent auditor to inspect its facility at least once a year. Results of these audit inspections will be reported directly to FDA,” the release continued. If the company fails to comply with the decree, FDA can order additional sanctions, including recalls and monetary penalties.

“It is critical that companies comply with FDA's manufacturing rules so that medical devices, especially the kind of implantable devices made by Shelhigh, are safe and effective,” CDRH Director Daniel Schultz said in the release.

On April 17, U.S. marshals acting on a request from FDA seized all finished devices and components at Shelhigh's manufacturing facility because of concerns about the devices' sterility. The firm makes a variety of devices, including pediatric heart valves and conduits, surgical patches, dural patches, annuloplasty rings, and arterial grafts.

After the seizure, FDA requested that Shelhigh recall all of its medical devices remaining in the marketplace. The company refused. In what may be seen as a small victory for the firm, however, FDA did not invoke its authority to require Shelhigh to recall its devices. However, in May, Integra LifeSciences Corp. (Plainsboro, NJ) said it was recalling all of Shelhigh's EnDura No-React Dural Substitute products, which Integra distributes.

Judge Skewers FDA Preemption in Device Case

Former FDA chief counsel Daniel Troy was known for his controversial efforts while in office to promote across-the-board FDA preemption of state tort cases. That is, he sought to prevent lawsuits from being filed in state courts over safety issues already decided by FDA. A federal judge in a recent device case disagreed, and the decision could deal a blow to Troy's view.

In Leopoldo Duron v. Guidant et al., Minnesota federal judge Donovan W. Frank effectively revived the idea that state torts complement and strengthen resource-depleted FDA's regulatory oversight of industry. While in office and since, Troy has argued the opposite, saying that it deterred companies from sharing all they knew with the agency for fear of attracting tort litigation, and acted as a brake on innovation. Several judges have recently ruled against his position while others have agreed with it, setting the stage for a potential Supreme Court resolution.

In an opinion that allowed California resident Leopoldo Duron to continue his product liability case over an allegedly defective Ventak Prizm 2 defibrillator manufactured by Guidant Corp. (St. Paul, MN), Frank declared that “the FDA regulatory system and a state tort system can and should work together.” Guidant's new owner, Boston Scientific, had sought summary judgment on grounds of FDA preemption. In mid-July, Boston Scientific settled the largest class-action lawsuit related to Guidant defects for $195 million. Other class-action suits are pending.

Citing 2004 case law involving a St. Jude Medical product liability case, Frank agreed with Duron and ruled that FDA labeling cannot preempt state law over a risk of which the agency was not aware. There are “triable issues of fact,” Frank wrote. He said that among the issues was whether Guidant disclosed the potential for polyamide degradation before being granted premarket approval and whether it appropriately disclosed information to the public after it received reports of failures.

Frank also rejected a Guidant argument that Duron's negligence- and fraud-based claims are preempted because they were allegedly incorrectly premised on the idea that the company had withheld certain information from FDA. Guidant cited precedent from a 2001 case, Buckman Co. v. Plaintiffs' Legal Comm. That case involved a claim that FDA had been defrauded by a consultant, Frank wrote, without any claim that the products involved were defective. In the present case, there is no fraud-on-FDA claim by Duron; instead, litigation focuses on duties owed to the plaintiff, not FDA.

“In reaching this conclusion,” Frank wrote, “the court is mindful of Guidant's arguments that allowing these claims to go forward will open the floodgates and unfairly stifle medical invention. The court does not see such a harsh result. The FDA regulatory system and a state tort system can and should work together. Each serves different, yet related functions. A regulatory system ensures products on the market have a favorable risk-reward profile, and a tort system provides incentives to manufacturers to develop and maintain safe devices. In this way, private tort remedies strengthen federal standards.”

On June 18, Duron filed a statement of his case in which there are 12 charges against Guidant, including failure to warn, manufacturing defect, negligence, and fraud. A Boston Scientific spokesman said the company is “fully prepared to take the bellwether cases to trial and remain(s) confident that when juries look into the individual facts, they will side with us. Guidant defibrillators continue to be among the most reliable in the industry.”

Some FDA-savvy lawyers say Frank's ruling is “aberrant.” Troy's advocacy, they say, focused on FDA preemption with respect to drug labeling, where there is no statutory preemption, rather than on devices. For devices, there is statutory preemption against a state having any requirement “different from, or in addition to,” an FDA requirement with respect to safety or efficacy. In Riegel et al. v. Medtronic, the U.S. Supreme Court may reconsider its position that labeling approved in a premarket approval application could not be changed in a tort case, as that would result in labeling “different from, or in addition to” the FDA-approved labeling.

FDA Extends Deadline for Plant Registration

FDA has postponed the deadline for the annual registration of medical device establishments. A notice in July said the agency expects to resume annual registrations in October or November. Establishments registered for 2007 will have a valid registration until December 31, the notice said.

FDA said it was delaying annual registrations because upcoming changes may significantly affect the way establishments are registered and the way devices are listed. This includes electronic registration and listing, simpler registration and listing requirements, implementation of the Bioterrorism Act, and congressional consideration of legislation that would impose a registration fee.

Biolog Accused of Unapproved Marketing

A CDRH warning letter in June to Biolog Inc. (Hayward, CA) says the company is marketing its Biolog Microbial ID/Characterization Fully Automated System without FDA marketing clearance or approval.

The warning letter says the system is considered a device under the Federal Food, Drug, and Cosmetic Act. The definition of a device is something that is intended for use in diagnosing disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the body's structure or function. The Biolog system can identify 1900 species of microorganisms.

Biolog has maintained in the past that its device is exempt from premarket review because it should be considered a Class I device. The warning letter says the device is not exempt because there are several important differences between it and Class I devices. The letter did not specify those differences.

The company was given 15 working days to advise CDRH of the steps it was taking to correct the violations.

FDA Cites Stryker Ireland on QSR

An FDA inspection last fall at Stryker Ireland Orthopaedics's facility in Carrigtwohill, Ireland, found QSR violations in the manufacture of Class II and III sterile orthopedic implants, primarily knee-replacement components, hip-replacement systems, and reconstruction and trauma cable systems.

This resulted in a warning letter filed March 15 and released recently. It noted that the firm failed to establish and maintain adequate procedures for:

The letter said some of the company's responses were appropriate and adequate, but others were not. Stryker was told to take prompt action to correct all violations, to submit a listing of specific steps being taken, and to explain how the company will prevent violations from occurring again.

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