FDA seeks injunction against a Utah medical device manufacturer

[Scott Catron]

(Not sure where to post this, figured most in this forum could appreciate it)

Here's the press release from the FDA: (broken link removed)

The company's responses from their press page: UTMD Updates Status of FDA Lawsuit

Interesting comments in the local paper from the CEO:

"This is not an issue of the facts," Cornwell said. "This is all about pushing people around and politics. Unfortunately, we're running into a situation where government's out of control. We've got to get this exposed in the light of day for people to look at the facts as to who is law-abiding and who the terrorists really are here."

(Rest of it: (broken link removed))

Wow. Pretty strong stuff from a $26+ million company.

 

[Aaron Lupo]

Heaven forbide the FDA is allowed to do their job and keep the public safe. I like the comment from the Company about ISO 13485, kind of makes you wonder who they use as a Notified Body and how they were able to maintain certification.

 

[Wes Bucey]

Recently, I posted a comment that FDA was really cracking down.
Contract Manufacturing Pre-Qualification? How much 'due diligence' to satisfy the FDA
Sidney Vianna gave a link to FDA warning letters in his post
FDA Warning Letters
The link to FDA:
(broken link removed)
I didn't find ANY of the 483s to Utah Medical in first look. Somebody show me the way? (I did subsequently find 2001 warning and response from FDA to Utah's explanations for the observations listed in the warning letter. From the language FDA used, they seemed to think Utah was "jawboning" instead of giving objective evidence.)

BOTTOM LINE:
I would not take a position on either side of this cat fight without a copy of both FDA 483 and the 58 page company response (with 600 pages of reference material) for review. I would have been more sympathetic to Utah Medical if they had posted that stuff on their website in addition to the one-sided "spin letter" press releases.

I have commented here in the Cove and other places that FDA and FAA refuse to take anecdotal evidence and really take offense when someone tries to "jawbone" instead of producing real objective evidence.

True fact - FDA action can negatively affect stock value of target company.

It will be interesting, but have little effect on the rest of the world, to follow this pi**ing match between a mouse and an elephant.

 

[Wes Bucey]

Not only the little guys

Just to show that FDA doesn't care about big or little in going after targets - here's a recent warning (March 2004) to my neighbor in the next town (Abbott Laboratories)
(broken link removed)

I'll be interested in seeing Abbott's response, too. They just finished getting whipsawed over problems in their North Chicago plant which took tens of millions to "cure" to satisfy FDA. Lots of 3rd party consultants and attorneys were in on that feeding frenzy.

You can bet the kids' college funds Abbott CEO won't be accusing FDA of bad faith, regardless of how many millions it ends up costing Abbott.

 

[Scott Catron]

I didn't find ANY of the 483s to Utah Medical in first look. Somebody show me the way?

Wes, as far as I know, the 483s are not posted online as are warning letters. The only 483s I've seen are those that companies have posted themselves.

More news today about this today. Statements from 3 of UMD's directors: https://www.utahmed.com/pr/pr081604.htm

They are supporting the fight with FDA.

The September 2001 warning letter is here: (broken link removed)

Just some thoughts I had while reading it that are good reminders to all in this business:

*Be sure to capture, trend and evaluate any CAPA activities.

*If you say you're going to fix something, make sure it's fixed. Check it in your internal audits at least once a year, and record that you checked it.

*Document all acceptance activities. Even if it's a simple visual inspection, record what the criteria are, how many are inspected and the results of that inspection.

*Validate processes that cannot be fully verified by subsequent inspection and test. Or, to avoid validation, only perform processes that can be fully verified by subsequent inspection and test.

*Have an explicit procedure for investigations. Document all decision-making involved with each complaint or CAPA activity.

*Be careful with rework. Again, have explicit procedures and document all decision-making.

*If a response involves retraining of individuals, record the training session and audit that the training is being adhered to.

*This is a hard one: if you don't catch deficiencies later recorded by and FDA inspector, it's an indication that the audit system isn't working. Having an outside auditor come in once a year is a good way to make sure some fresh eyes examine your system.

This can avoid the following line in a warning letter: "deficiencies similar to those found in the current inspection were found during the inspection conducted in (whenever)". This never looks good.

 

[Scott Catron]

More stuff

Found this while Googling on this subject:

(broken link removed)

More detailed comments from the ex-FDA official about the EIR from the inspection earlier this year.

(broken link removed)

(about 2/3 down the page)

Interesing comments from UMD's lawyer.

Scott

 

[Wes Bucey]

Thanks for the updates, Scott. Keep up the good work. Illuminating flaws in the regulatory system is as important as shedding light on problems with manufacturers.

There is a phrase which helps me get through all the saber rattling:
"Truth will out!" meaning that eventually we'll learn who is right (or if each side has flaws.)

Perhaps a nice, messy court battle will clear the air. I hope the plaintiff has sufficient funds to carry the battle to conclusion without caving in. (Sometimes, even the wealthiest cave in, because the fallout is too damaging to their remaining business. UMD seems to be in between a rock and a hard place - it has to fight or drop out of the competition.)

Lawyers and consultants will be in a feeding frenzy over this one.

 

[Scott Catron]

You have to admire their pluck. Here's how the latest press release starts:

“The reports of my death are greatly exaggerated.” …Mark Twain

UTMD Responds to On-going Customer Questions Prompted by Competitors

This is a strange case. If the public is in so much danger from UMD, why doesn't the FDA move faster? Sounds like a vendetta the more I read about it.

I agree with Wes, I hope they hang in there just so we can watch the show.

 

[Wes Bucey]

I've been involved in a few legal battles over the years. A few of them were with federal authorities. My impression of a normal federal case is that the government alleges multiple counts in "high profile" cases which are subsequently reduced in preliminary hearings. Rarely, a federal prosecutor (not a regulatory agency employee) sees a high profile case as a ticket to his own aspirations for political office or to further the political agenda of the political party in power. In such a case, the prosecutor is particularly intractable to overtures to reduce the severity of the indictment and ratchets up the publicity campaign to a high level.

When the federal prosecutor doesn't see publicity value or an easy win on the horizon, he lets the case ferment at the agency level and doesn't involve the justice department in preliminary hearings or take the case to a grand jury for indictments of criminal allegations.

In instances where the prosecutors drag their feet, the "defendant" and his lawyers usually push for temporary restraining orders against the agency and for declaratory judgments of "not guilty" from a court of competent jurisdiction, especially when the ongoing "cloud" impairs the business of the "defendant."

(I use the term "defendant" even though it may not yet be a defendant [until an indictment is served] because the technical term "respondant" [or "respondent" in some courts] is less descriptive of the true situation when an indictment can be "handed up" almost at the whim of the prosecutor.)

When the organization under scrutiny acts like UMD, I'm absolutely fascinated.

 

[Scott Catron]

Latest News

And now, back to our favorite soap opera, As The FDA Turns:

UTMD Updates Status of FDA Lawsuit

Zingers from this one:

"The FDA fundamentally misconstrues and misunderstands the nature and principles of plastics parts manufacturing"

" 'When you stand for your liberty, we will stand with you.’
…. President George W. Bush, Inauguration Address, January 2005
UTMD asks its elected representatives to support the President’s statement, starting here at home."

"because of our small size, we are not able to simply “appease them to go away” as some are wont to do"

The last quote is interesting, because earlier in the release, the company president states: "There have been a few documentation errors identified in thousands of pages of UTMD documents, spanning a decade or more, that FDA inspectors reviewed during hundreds of hours of multiple inspections since 2001, and some isolated examples where a UTMD employee failed to follow a written procedure. "

Well, if that's the case, wouldn't it have been easier and a lot less expensive to fix these ity bitty tiny little issues, appease the FDA, and let them go away? Or is this a fight about principle? Then why cry about "the value of UTMD’s investors’ holdings" if you're fighting the good fight?

This is better then any reality TV show.

Scott