Industry should take note that what FDA perceives as objectionable in an inspection is not necessarily a violation.
In response to a Federal Court opinion rejecting a Food and Drug Administration (FDA) plea for a permanent injunction against device manufacturer Utah Medical Products Inc., several food and drug law attorneys opined that the judge's opinion was an aberration and that the case was unlikely to be a bellwether for the industry. On the contrary, the court victory for Utah Medical should be recognized as a bellwether for the entire industry. Approximately one year ago, after a seven-day trial, Bruce S. Jenkins, United States Senior District Judge, U.S. District Court, District of Utah, Central Division concluded:
Judge Jenkins's opinion is clear and unequivocal. The Department of Justice (DOJ) wisely decided against filing an appeal.
A description of the case, beginning with the results of a June 2001 FDA inspection, should provide a useful perspective. Upon completion of the June 2001 inspection, the FDA investigator presented a FDA Form 483 listing observations of objectionable conditions. The observations listed on an FDA-483 represent conditions perceived as objectionable by the FDA investigator, but it is important to note that these are not violations and are not to be characterized as violations, verbally or otherwise.
After presentation and discussion of these observations, Utah Medical promptly transmitted a comprehensive written explanation with exhibits. The FDA Denver District Office responded on September 4, 2001, with a warning letter. The warning letter requested that Utah Medical submit certification by “an outside consultant” relative to the requirements of the QSR/GMP regulation and initiation and completion of “corrections called for in the report.”
Utah Medical expressed its disappointment with the content of the letter. The company requested a copy of the establishment inspection report (EIR) and requested an opportunity to meet.
On December 21, 2001, representatives of Utah Medical and the FDA district office met in Denver. Utah Medical briefed FDA on its position with the expectation of dialogue. FDA would not provide the EIR. There was no useful feedback provided by the FDA representatives. At the end of a two-hour meeting, the FDA representatives simply asked Utah Medical whether it planned to hire a consultant.
The response to the consultant question was “No,” because Utah Medical believed that it had complied with the provisions of the quality system regulation (QSR). Utah Medical was given no answer. Rather, the FDA representatives asked whether Utah Medical was ready for a reinspection, to which the company replied, “Yes.”
During March and April 2002, FDA inspected again, and the FDA investigator presented a multiple-page FDA-483 for which the recorded discussion with management took more than four hours. In addition to providing the district office with a copy of the tape recording and a transcription, Utah Medical again provided a comprehensive 500-page written response with exhibits.
Utah Medical actively and repeatedly sought feedback from the district office without success for the remainder of the year. At least 40 communications were initiated by Utah Medical representatives to various personnel in the district, the Center for Devices and Radiological Health (CDRH), and the Office of Associate Commissioner for Regulatory Affairs (ACRA) through January 7, 2003, seeking FDA feedback and copies of the relevant EIRs. Few of these communications resulted in direct contact with FDA personnel. None of those contacted provided feedback to the explanations provided by Utah Medical.
To the company's surprise, in January 2003, it received copies of the 2001 and 2002 EIRs. It is FDA policy to provide for such EIR release when the investigatory matter is closed. However, the 66-page 2002 EIR required a time-consuming analysis for which Utah Medical intended to seek a meeting with director of the FDA Denver district office.
In February 2003, the 2002 FDA investigator appeared with another FDA investigator who was considered a device expert. Utah Medical's efforts to delay that inspection, to seek recusal of the 2002 investigator, and to meet with district director Belinda Collins were rejected.
In accordance with FDA procedures, Utah Medical sought relief from the regional director, Dennis Baker, about the content of the 2002 EIR. No meeting occurred, and the company filed a comprehensive request on March 21 with the Office of the Ombudsman at FDA.
On May 15, 2003, FDA regional director Baker, FDA district director Collins, and an attorney from the FDA Office of Chief Counsel met with Utah Medical for four hours at the company's offices. However, as expressed in an internal FDA e-mail produced during discovery, these FDA officials were there only to listen, and they declined to discuss prior inspections or the conduct of FDA investigators.
As with prior inspections, Utah Medical promptly provided a written response to the content of the observations in the 2003 FDA-483. It never received a written or verbal response from any FDA representative, even though, as in the past, an explicit request was made for feedback. However, early in September 2003, FDA representatives advised Utah Medical representatives that it had investigated the March complaint to the ombudsman and found no evidence of bias, wrongdoing, etc.
On October 3, 2003, DOJ directed a sign-or-sue letter to Utah Medical counsel advising of its intent to seek permanent injunctive relief relating to the alleged QSR violations. The letter provided an opportunity for settlement through execution of a consent decree. Settlement negotiations were not productive, but a team of three investigators reinspected Utah Medical over a five-week period during February and March 2004.
Again, Utah Medical provided a prompt and extensive response to the seven 483 observations. This response included an extensive supplement to the prior 2003 inspection. FDA, as it did after the 2002 and 2003 inspections, did not reply to Utah Medical. Utah Medical engaged the services of another law firm to pursue mediation to address and resolve pending issues. CDRH rejected the offer of mediation by the law firm.
From 2001 through 2004, Utah Medical applied the communication approaches to FDA that are recommended by FDA and industry advisors. Utah Medical continued to pursue good-faith dialogue with FDA and DOJ counsel. Nonetheless, DOJ filed a lawsuit seeking permanent injunctive relief on August 9, 2004. The next day, without any notification to Utah Medical, FDA issued a damaging and misleading press release regarding the company's 483s.
Utah Medical and two individuals were forced to defend themselves against FDA accusations that they believed were untrue or unsupportable. A lengthy and comprehensive discovery process produced speculation as to FDA's reasons for pursuing this approach, but no definitive reason was found.
The truth is contained in the text of thousands of internal FDA documents, including e-mails and the depositions of 17 individuals. At least 20 individuals within FDA and DOJ were in a position to prevent this litigation. Some of these individuals lied or performed in a manner that was disgraceful to the image and reputation of FDA.
It is not the intent or objective of this commentary to question the performance of all FDA personnel. Those FDA employees who perform as expected should recognize that the evidence produced about the performance of some FDA employees is not to be attributed to them or to the best interests of the reputation of the FDA. Counsel for Utah Medical has communicated to FDA personnel offers to apply remedial measures for the benefit of Utah Medical and FDA. These offers were rejected.
Over time, the public will be able to judge whether present FDA policy makers will have learned anything from this experience.
In the meantime, there are lessons for representatives of industry. Entering into litigation with FDA as a plaintiff or defendant is usually the least desirable method to resolve a dispute. Legal counsel is responsible for identifying the range of available options and the benefits and risks for each option. It is the client, however, who is ultimately responsible for making the decision, but a go-along-to-get-along approach is never optimal for a device manufacturer that is confident— through independent verification if necessary—that its devices and activities are lawful.
Utah Medical and its employees and supporters clearly believe that the company was acting honorably and lawfully. The company remains confident about the excellence of its devices to serve the needs of healthcare practitioners and patients. At no time during the four years was there any recall, identification of a defective device, or safety or effectiveness issue for any Utah Medical device.
FDA was wrong to expend a considerable amount of its limited resources to pursue a small but competent Utah Medical. The facts were unusual only in that the discovery demonstrated weakness and poor performance by some FDA personnel. Likewise, personalities had nothing to do with the facts but a great deal to do with the competence, motivation, and performance of certain FDA personnel.
What truly matters is the opinion of the trier of fact and law, Bruce S. Jenkins. He expressed in part the following opinions:
This is an unusual case. The safety of the products manufactured by Utah Medical has never been an issue.
The court has been impressed as well by the Utah Medical's design of product, its record-keeping of each stop along the way, the acceptance in the market of the products, the Company's uniform processing of complaints, and the manner in which change is made in practice and procedure as a result of complaint handling.
The fact that the road chosen by Utah Medical may be different in degree than that thought to be appropriate by a regulator does not mean that it is wrong, or in violation of regulations.
It makes no sense for the court to order Utah Medical to do something they are already doing.
For the FDA-regulated medical device industry, this litigation and the court's opinion is a reminder that FDA allegations of violation, whether in a warning letter or a sign-or-sue letter, may not be based on sufficient evidence to prove that a violation has occurred. Utah Medical believed in its innocence, and FDA had the burden to prove that there was guilt. FDA and those who pursued this initiative within FDA failed.
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