CEO Robert Christensen used TMJI’s YouTube channel to voice his displeasure with the ruling, calling FDA’s actions “egregious” while quoting from the Bible.
The edict came in a 26-page decision against embattled Golden, CO, device maker TMJ Implants Inc. (TMJI) and its octogenarian CEO, Robert W. Christensen. The decision concluded a nine-year string of legal and regulatory battles with FDA over, first, the marketability of TMJI’s grandfathered temporomandibular joint prostheses, and second, $340,000 in civil money penalties for not reporting 17 explants and medical interventions under CDRH’s medical device reporting (MDR) rule.
The three appellate judges, all Republican appointees, dismissed TMJI’s complaint that it had been “ambushed” when taking an appeal to the FDA commissioner that lingered for an unexplained eight months until the civil money penalties case against it was launched. At that point, the appeal was rebuffed as nonobligatory and dismissed as “inefficient and duplicative” in view of the civil money penalties case.
To TMJI’s plea that the civil money penalties should be “estopped,” the judges said that the HHS Departmental Appeals Board’s (DAB) “contrary interpretation of the law was not erroneous,” citing 21 CFR 10.35(d), which says that the FDA commissioner is not constrained by such things as petitions and requests for advisory opinions. “Simply put,” the judges wrote, “whether or not the commissioner had made a final decision regarding petitioners’ review request at the time the civil money penalties case was filed was irrelevant to FDA’s authority to file the [case] at that time. Therefore, the DAB’s similar interpretation of FDA’s authority under 21 CFR 10.35(d) was reasonable.” Similarly, the judges dismissed the company’s claims that a “contract” not to enforce the civil money penalties had effectively been entered into in the filing of its appeal to the commissioner.
The judges also rejected TMJI’s claim that the 17 events at issue did not represent “serious injuries” under 21 USC 360i(a)(1)(A). The device firm said that the physical conditions preceding the device explant or medical treatment—such as pain, swelling, bone growth, and infection—are relatively trivial and are to be expected following the surgical implant of any medical device.
The judges countered that TMJI had misread the applicable regulation, “which does not define ‘serious injury’ in terms of physical significance. Instead, a ‘significant injury’ is a condition that necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure,” according to 21 CFR 803.3. They also said that in each of the 17 disputed events, “a physician surgically explanted the device or otherwise medically treated the patient as a result of the aforementioned physical conditions—conditions which, if left untreated, could permanently impair the temporomandibular joint function.”
The appellate panel also upheld FDA’s position that its regulatory interpretations trump clinical assessments by the company when it comes to deciding whether to file an MDR. Evidence in the record, they said, included MedWatch reports describing the device and the patients’ postimplant symptoms, information received from the company’s own investigations, and testimony from two FDA expert witnesses. “The same evidence amply supports the DAB’s rejection of petitioners’ claim that Dr. Christensen reasonably concluded that TMJI’s devices did not cause or contribute to serious injuries.”
The judges also rejected TMJI’s argument that it could not conclusively determine whether its devices were involved because FDA had redacted the patients’ and reporters’ names, the implant dates, and the event dates. Undermining these objections, the judges said, was the fact that the statute does not limit FDA’s authority to require MDRs only for events that are confirmed by the manufacturer. The voluntary MDR reports had identified TMJI as the manufacturer. “Thus, TMJI had information reasonably suggesting its devices caused or contributed to a serious injury.” The firm was permitted by 21 CFR 803.16 to deny that its devices were involved. However, TMJI was not permitted to “ignore the broad reporting requirements of the statute and its implementing regulations because they do not feel they have all the information they need to confirm that their device caused a serious injury.”
Civil money penalties may be imposed only when the violation constitutes a “knowing or significant departure” from requirements, and again the judges agreed with FDA that the company was aware of its violations. As to the amount of the civil money penalties—both the company and the CEO as an individual defendant were ordered to pay $10,000 for each of 17 instances—the judges found these were reasonable, given that a maximum of $16,500 was allowed by statute.
The petitioners’ complaint that their financial condition was ignored in assessing the penalty “is unfounded,” the judges wrote. “TMJI…refused to submit complete tax returns. Dr. Christensen refused to disclose money or property transfers. Neither petitioner explained a significant drop in profitability from 2004 to 2005 ($624,690 in ordinary business income on approximately $2.7 million in net sales in 2004 versus $203,108 in ordinary business income on the same amount of net sales in 2005) combined with a 52% increase in salaries during the same period.”
The judges scorned the petitioners’ offer to file the 17 disputed MDRs if FDA promised to drop the civil money penalties. This offer was made only “after the [FDA administrative law judge] had held them liable and after the DAB had affirmed that decision. Offering to abide by the law only after being punished for not doing so does not mitigate the culpability of the initial unlawful conduct, and the DAB’s similar conclusion was not error.”
Christensen’s en banc challenge to the panel cites an internal Tenth Circuit conflict with the earlier (lower court) Utah Medical verdict that found FDA’s view of its own law isn’t the only view permitted. He said that if the decision stands, “there’s no way I can pay it.” He may have to “close the doors and say ‘You win.’”
CDRH Faulted on Use of Medical Device Reports
In an ironic twist of fate, on the same day that TMJI lost its MDR battle with FDA (previous story), the HHS Inspector General (IG) issued a report questioning CDRH’s use of MDRs. It said that the center doesn’t use them systematically to detect and address safety concerns about medical devices.
The IG’s analysis was intended to determine the extent of adverse-event reporting from 2003 to 2007 by manufacturers and facilities that use medical devices, the extent to which manufacturers and facilities that use medical devices comply with adverse-event reporting requirements, and how FDA uses medical device adverse-event data to identify and address safety concerns.
The study found that overall, FDA received twice as many adverse-event reports for medical devices in 2007 than in 2003, although some types of reports decreased. It says that 30-day reports of death, serious injury, and malfunctions accounted for almost all manufacturer reports and drove the overall increase in reports.
Five-day reports made up less than 1% of manufacturer reports and dropped from 432 to 54 reports per year over the five-year period. Most adverse-event reports were submitted on time, but many five-day manufacturer and user facility reports were late.
The IG says that CDRH analysts documented little in their reviews, making it difficult to trace the response to an individual event. Although outcomes of adverse events can result in a variety of postmarket surveillance activities, CDRH cannot link the activities to particular adverse events.
The center was also found to lack an established system to document when adverse-event reports result in on-site inspections. And the IG found that CDRH’s Office of Compliance fails to document which reports resulted in inspections when analysts refer the reports and fails to document on-site inspections in the MAUDE adverse-event database.
“CDRH does not consistently read adverse-event reports for the first time in a timely manner,” the report says. “Analysts read fewer than one-third of adverse-event reports for the first time within 30 days and less than half within 60 days in every year from 2003 to 2007. CDRH’s procedures require that high-priority adverse-event reports be in MAUDE and ready for analysts to review within 96 hours of receipt; however, we were unable to verify CDRH’s compliance with these procedures through its documents.”
In addition, the IG found that CDRH rarely acts when manufacturers and facilities submit reports late. Analysts reported that they generally forward concerns about timeliness only when they notice pervasive problems. In addition, they usually handle concerns informally by calling the
The inability to obtain complete and usable information in adverse-event reports was cited by the IG as a hindrance to analysts’ review of reports. The analysts also said that MAUDE is an impediment because the system doesn’t connect with other CDRH databases, making it difficult to conduct trend analysis.
The study found that CDRH makes only limited use of annual reports. Of the 526 facilities that the IG said should have submitted annual reports for 2006, CDRH could provide only 220 of the reports. The IG could not determine whether facilities had not submitted reports or whether CDRH was simply unable to supply copies.
Recommending that FDA develop a protocol for reviewing adverse-event reports that specifically addresses several needs (see the sidebar), the IG also said the agency should seek legislative authority to eliminate the requirement for user facilities to submit annual reports. This action would decrease the regulatory burden on facilities and on CDRH. Other than a count of total adverse-event reports, all of the information in the annual reports is redundant to the originally submitted reports.
FDA agreed with both recommendations. It indicated that it will develop a clear review protocol addressing the needs identified in the report. The agency said that its new adverse-event database will allow for more extensive documentation of follow-up on adverse events and permit FDA to more readily identify late and incomplete reports. The agency also reported that CDRH has developed a tracking system that facilitates referrals to the Office of Compliance and follows up on them. Finally, FDA said it will take steps to stimulate user facility reporting.
The IG’s Recommendations
The IG told FDA to develop a protocol for reviewing adverse-event reports that would:
- Document follow-up on adverse events.
- Ensure and document that CDRH is meeting its guidelines for reviewing all five-day and Code Blue (pediatric death, multiple deaths, exsanguinations, explosions, fires, burns, electrocutions, and anaphylaxis) adverse-event reports.
- Follow-up with manufacturers that routinely submit late or incomplete reports.
- Enhance outreach strategies to reduce underreporting by user facilities.
FDA Monitors Ineffective Defibrillation
FDA says it has received reports of 14 events since 2006 in which a 200-J biphasic defibrillator was ineffective in providing defibrillation and cardioversion therapy to a patient. A subsequent shock from a different 360-J biphasic defibrillator resulted in immediate defibrillation and cardioversion, the agency says in a notice on its Web site.
FDA says that the majority of events occurred during attempts at cardioversion of atrial fibrillation, but there was at least one instance with defibrillation of a ventricular arrhythmia. The agency is seeking additional information to interpret the events’ significance and to determine whether FDA actions are advised.
According to FDA, the preliminary analysis of the 14 events does not suggest the need for any change in current clinical practice. The agency urges that any events similar to the 14 be reported for further analysis.
Boston Scientific to Pay $296 Million Settlement
Boston Scientific says that it will pay
$296 million to the federal government as part of an agreement to resolve a Department of Justice investigation into product advisories issued by its Guidant subsidiary in 2005. The problems occurred before Guidant was acquired by Boston Scientific. The settlement is in addition to a $16.75 million agreement in 2007 involving the same companies and state attorneys general.
Under the terms of the latest settlement, Guidant will plead guilty to two misdemeanor charges that are related to failure to include information in reports to FDA. Products involved in the investigation were the Ventak Prizm 2, Contak Renewal, and Contak Renewal 2 devices that were the subjects of the 2005 advisories in question.
“We are pleased [that] this investigation has been resolved,” Boston Scientific CEO Ray Elliott said in a statement. “Guidant and its employees acted in good faith and believed they complied with applicable laws and regulations. We elected to resolve this matter so we could put it behind us and devote our full energies and resources to developing our innovative technologies.”
CDRH Warns Industry about Cybersecurity Duties
Cybersecurity for medical devices and their associated communication networks is a shared responsibility between medical device manufacturers and user facilities. This was the message in a reminder notice posted by CDRH for medical device manufacturers, hospitals, medical device user facilities, healthcare information technology and procurement staff, medical device users, and biomedical engineers.
The center says it is aware that regulations for the cybersecurity of medical devices that are connected to computer networks have been misinterpreted, and emphasizes that:
- Medical device manufacturers and user facilities should work together to ensure that cybersecurity threats are addressed in a timely manner.
- The agency typically does not need to review or approve software changes made for cybersecurity reasons.
- All software changes that address cybersecurity threats should be validated before installation to ensure that they do not affect the device’s safety and effectiveness.
The notice says that “proper maintenance of cybersecurity for medical devices and hospital networks is vitally important to public health because it ensures the integrity of the computer networks that support medical devices.” View the notice at www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm189111.htm.
Abbott Molecular Cited for Quality System Problems
An FDA inspection last summer at Abbott Molecular (Des Plaines, IL) found quality system regulation violations in the firm’s manufacturing of in vitro diagnostic products for human use, according to an August 12 warning letter from FDA’s Chicago district office released in mid-November. Observations recorded on the FDA-483
- Failure to maintain and implement complete procedures for acceptance or rejection of finished device production runs, lots, or batches.
- Failure to adequately control products not conforming to specifications.
- Failure to establish and follow procedures for identifying, documenting, and validating or verifying design changes before they are implemented.
The letter says that the company’s responses to the observations are insufficient and that the company should take prompt action to correct the violations. Abbott was told to submit a list of specific steps taken to correct the violations and prevent them from occurring again. The firm was also instructed to document the corrections along with a timetable for completion.
FDA Issues Negative-Pressure Wound Systems Alert
CDRH is alerting healthcare practitioners to deaths and serious complications, especially bleeding and infection, associated with use of negative-pressure wound therapy systems. A November 13 notice says the agency has received reports of six deaths and 77 injuries associated with the systems over the past two years.
It recommends that facilities select patients for negative-pressure wound therapy carefully, after reviewing the most recent device labeling and instructions. FDA says it’s important to realize that the systems are contraindicated for certain wound types and that patient risk factors must be thoroughly considered before use. Patients should be monitored frequently in an appropriate care setting by a trained practitioner who will be vigilant for potentially life-threatening complications such as bleeding and will be prepared to act if they occur.
The notice says that most of the deaths that have been reported to FDA associated with negative-pressure wound therapy occurred at home or in a long-term care facility. Bleeding was the most serious complication and was reported in six deaths and 17 injury reports. Another 27 reports indicated infection from open wounds or from retention of dressing pieces in the wound. Retention of foam dressing pieces and foam adhering to tissues or embedded in the wound were noted in 32 injury reports.