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Ignoring an Inconvenient Truth

FDA’s annual report of significant legal decisions seems to be incomplete without a mention of Utah Medical.

James G. Dickinson

April 1, 2008

9 Min Read
Ignoring an Inconvenient Truth


mddi0802p30a.jpgIn case you were wondering whether FDA was going to learn from its loss in court to Utah Medical, the answer is apparently no.

Just as with three previous agency defeats in federal court, the Utah Medical case has been omitted from The Enforcement Story, the agency's official public report of significant legal decisions, which is published annually by the Office of Regulatory Affairs (ORA).

The Utah Medical case is legally significant because it established that, in quality system regulation or GMP compliance, a medical device company is free to depart from the prescriptive direction of FDA officials—that “many roads lead to Rome.” In other words, government enforcement of penalties requires officials to identify which Code of Federal Regulations requirements are being violated by a device firm, not dictate methods that a company must use to comply with those regulations.

In normal circumstances, such guidance from the federal judiciary could lead to a change in agency practices. The current practice is one of prescribing “how to” advice to industry, through workshops, speeches, informal advice, interpretive guidances, and other means, as opposed to “what to” advice.

However, shortly after the Utah Medical decision was handed down, a senior FDA attorney was reputed to have said, informally among other lawyers, that the decision was delivered by an “aberrant” judge. (Utah Medical judge Bruce S. Jenkins, who was appointed by President Carter in 1978, actually has a long list of home-state accolades and honors to his credit.)

Since then, no FDA or Department of Justice attorney associated with the case, or any other federal official, has been willing to discuss the case, either on or off the record. Because most professional legal forums in what is known as the “FDA bar” rely heavily on the fraternal participation of FDA attorneys, that reliance effectively discourages anyone from discussing this case in formal programs. It's as if it has simply vanished.

When I reported on Jenkins's record in January on FDAweb.com, it attracted a sneering anonymous comment from someone who seemed to be familiar with the case from FDA's perspective. “These plaudits all come from the judge's alma mater or the Utah [State] Bar. Utah is well known as a rogue state with uber-libertarian sentiments regarding federal regulation of any kind, and that sentiment is even more prevalent in the realm of drug, device, and dietary supplement regulation.”

Two separate requests for an explanation for the omission from ORA's most responsible officer, associate commissioner for regulatory affairs Margaret O'K. Glavin, garnered no response.

Apparently, in FDA's mind, this “aberrant” and inconvenient truth never was.

In an agency over which commissioners may reign but not rule, as reported last month, why should we be surprised if, below these nominal commissioners, subordinates may overrule the orders of judges?

New Guidance Issued on CLIA Waivers

FDA has issued a guidance for industry and FDA staff, titled Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices. It makes recommendations to manufacturers seeking to submit information through a CLIA waiver application to FDA and modifies recommendations presented in draft guidances released in 2001 and 2005, respectively.

The HHS secretary has authorized FDA to determine whether particular tests are simple and have an insignificant risk of an erroneous result under CLIA regulations. Only diagnostic tests that meet these
criteria are eligible for a waiver.

FDA says the guidance recommends an approach for manufacturers to use in demonstrating that a test meets these criteria. As part of demonstrating an insignificant risk of erroneous result, FDA recommends that studies be conducted to demonstrate a test's accuracy.

FDA says its recommendations are based on interpretation of the law, experience with CLIA complexity determinations, and interactions with stakeholders. Manufacturers may adopt a different approach for their waiver application if it meets the CLIA statutory requirements.

The guidance covers components of a CLIA waiver application, demonstrating “simple,” “insignificant risk of an erroneous result,” “insignificant risk of an erroneous result—accuracy,” labeling for waived tests, and safeguards for waived tests.

The guidance may be accessed at www.fda.gov/OHRMS/DOCKETS/98fr/08-d-0031-gdl0001.pdf.

Changes in Updated Guidance

Changes from previous guidances include the following:

  • Greater emphasis on scientifically based flex studies and validation or verification studies, linked to the risk assess­ment for each device.

  • Recognition that reference methods may not be available for every device type.

  • Additional emphasis on the use of quality control procedures.

  • Greater emphasis on intended users during studies testing a device.

  • Updated study recommendations with emphasis on use of patient specimens, in an intended use environment, over time.

FDA Seeks Tougher Court Sentences


John Fleder is not convinced that the sentencing system is broken, or that FDA's proposed changes to sentencing guidelines are necessary.

FDA is making a pitch to the U.S. Sentencing Commission for more-stringent maximum sentences. The commission is considering new sentencing guidelines.

In February, FDA assistant commissioner for accountability and integrity William McConagha told the Sentencing Commission that it should determine the adequacy of the existing guidelines for the Federal Food, Drug, and Cosmetic Act (FD&C Act), which covers medical devices.

“We at FDA believe that establishing an appropriate penalty framework for violations of…[the FD&C Act] is critical to provide a specific and general deterrent to crimes that threaten…the public health,” McConagha testified. “For that reason, we believe that realistic sentencing guidelines for these offenses are of vital importance to the agency's public health mission.”

He said that the current guidelines are inadequate to address the significant public health consequences of various FD&C Act offenses. Most FD&C Act offenses, he said, involved adulterated or misbranded products.

Products, he said, can be adulterated or misbranded for many reasons set forth in the FD&C Act. The existing sentencing guidelines don't directly address whether misbranded or adulterated FDA-regulated products can be viewed as having value when loss is calculated. So McConagha suggested revising the guidelines to provide that, in those cases, loss would include the amount paid for the product with no credit for a product's purported value.

That proposal drew fire from attorneys at the Washington, DC–based law firm of Hyman, Phelps & McNamara, who said it “raises many questions and concerns. First, creative lawyers in the context of civil litigation may try to employ FDA's proposed finding to seek a monetary recovery based on that

“Second, the change would almost certainly dramatically increase sen-tences to be imposed in cases where loss is at issue, including all felony cases.

“Third, if adopted, it may make it very difficult for companies and individuals to work out guilty pleas with the government because the guidelines will warrant a sentence that the defense will find intolerable.”

The firm's FDA law blog says FDA's position is “breathtaking in its scope.” The attorneys note that every day, many manufacturers distribute products that are not in full compliance with all FD&C Act mandates and thus are technically adulterated and misbranded. Such distribution routinely occurs with FDA's knowledge, the blog says. To say that all adulterated and misbranded products are worthless “raises serious legal and policy issues that the commission should fully explore before adopting FDA's suggestion.”

John Fleder, a director in the law practice, said there is “no evidence that the system is broken or that the proposed changes…are necessary or appropriate based on the FD&C Act statutory scheme, the purposes of the guidelines, or the actual record of FD&C Act criminal enforcement.”

Multiple Violations Alleged at Hill-Rom

An inspection last June at Hill-Rom's Batesville, IN, facility where VersaCare beds are manufactured found quality system and medical device reporting violations, according to a January 15 warning letter from FDA's Detroit district office.

Reporting violations included the following:

  • Failure to report to FDA no later than 30 days after the company became aware of information reasonably suggesting that a marketed device has malfunctioned, and that the device would be likely to cause or contribute to a death or serious injury.

  • Failure to submit a written report to FDA of any correction or removal of a device to reduce a risk to health posed by the device.

  • Failure to submit reports of initiating corrections or removals.

The company's responses to these violations also were inadequate, the warning letter said. Hill-Rom was told to respond within 15 days with specific steps taken to correct the violations, documentation of corrective actions taken, and an explanation of plans to prevent these or similar violations from occurring again.

Other Violations at Hill-Rom

Quality system violations found during the inspection last June included the following:

  • Failure to establish and maintain procedures for implementing corrective and preventive action.

  • Failure to establish and maintain adequate procedures for reviewing and evaluating complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications.

The warning letter said the company's response to these observations was inadequate because there was no evidence submitted of revised procedures.

Medtronic Infusion Pumps Recalled

FDA has classified as Class 1 (most severe) a recall involving Medtronic's SynchroMed EL Implantable Infusion Pump Models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. There is a potential pump-motor stall problem that affects motors manufactured before September 1999. “If a pump motor stalls, drug delivery will stop suddenly and without warning,” an FDA recall notice says. “This stoppage will result in loss of therapy, return of the patient's symptoms, and/or symptoms of drug underinfusion or withdrawal.”

Stryker Trident Acetabular Cups Recalled

Stryker has recalled all Trident PSL and Hemispherical Acetabular Cups manufactured at its Cork, Ireland, manufacturing facility after the devices failed to meet the company's internal acceptance criteria. The recall follows a corporate-wide “comprehensive review of internal processes” that resulted after FDA sent the firm a warning letter in November about GMP problems found during an inspection at Stryker's Mahwah, NJ, facility. The warning letter said violations and inspectional observations may be symptomatic of serious problems in Stryker's manufacturing and quality assurance systems.

FDA Cites Siemens Molecular Imaging

An inspection last summer at Siemens Medical Solutions's molecular imaging division facility in Knoxville, TN, found quality system problems in the firm's manufacture of molecular imaging diagnostic equipment.

A January 28 warning letter from FDA's New Orleans district office included the following violations:

  • Failure to establish and maintain adequate procedures to control design validation, including software validation and risk analysis, where appropriate.

  • Failure to establish and maintain adequate procedures for implementing corrective and preventive action to ensure that quality data sources are analyzed to identify existing and potential causes of nonconforming product or other quality problems. Also, failure to employ appropriate statistical methodology where necessary to detect recurring quality problems.

  • Failure to establish and maintain adequate procedures to ensure that the cause of nonconformities relating to product, processes, and the quality system is investigated.

The warning letter says a response from the company last August to the FDA-483 observations was inadequate. The firm was told to correct the violations and to respond within 15 days listing the specific steps taken to ensure that the violations do not occur again.

Copyright ©2008 Medical Device & Diagnostic Industry

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