“FDA, You Failed Me” by Dr. Robert Christensen |

“FDA, You Failed Me” by Dr. Robert Christensen


FDA fail 2“FDA, You Failed Me”
(LinkedIn – Medical Devices Group)

Frequent group contributor 89-year-old Dr. Robert Christensen has a story to tell. And a plea for change.  These are his words. He writes,

“Back in 1960, I invented and commercially sold the first implantable device for temporomandibular joint disorder (uncontrollable teeth grinding). In our best year, we did $5
million in sales.

My device was grandfathered in 1976 from the Medical Device Regulation Act which introduced medical device classifications. In 1993, FDA classified mine as Class III… then, in 1998, demanded a pre-market approval (PMA) on my device which had nearly 40 years’ in-market experience!

I fought and won. But lead FDA investigator (Dr. R) was looking for millions in government grants to study TMJ disorder. She also had ties to my competitor (TMJ Concepts). Eventually, a corrupt system bankrupts me.

Dec-98: FDA requests a PMA of my company, TMJ Implants (TMJI).

May-99: Dr. R asks me to skip my panel meeting. I attend anyway.

May-99: TMJI wins a 9-0 vote for approval in Wash, D.C.

Jul-99: Dr. R calls and states my devices were not approved and demands a 510(k). I am to discontinue operations and marketing. I cut staff from 38 to 19.

Jul-99: Competitor TMJ Concepts wins an 8-0 panel approval with a weaker product and weak clinical data.

Jan-01: FDA Director of Device Evaluation Bernard Statland urges Dr. R and the Division Director to approve the device. They are mad.

Jan/Feb-01: My company completes PMA and is granted FDA clearance.

May-01: Dr. R’s associate files a petition to rescind the clearance. The motion is denied.

Aug-04: Denver’s lead FDA investigator (Mr. N) conducts a routine inspection and asks me for an “under the table” payment. I refuse.

Sep-04: Mr. N notes 17 events in which TMJI did not file MDRs (medical device reports for serious events). The charges are false.

Nov-04: I write Dr. Schultz, the head of FDA’s Center for Devices and Radiological Health (CDRH), with my strong objection.

Nov-04: Schultz suggests I appeal to the FDA Commissioner. I get no response for eight months.

Jul-05: I’m assessed a Civil Money Penalty of $630,000 for 17 violations plus another $170,000 against my home. (I’m unaware of any other such case.) An FDA co-worker testifies Mr. N told him he ‘had it out for TMJI and wanted to do them in.’

Apr-09: Our appeal is heard with an administrative law judge. It is a sham. We lose.

Jun-10: TMJI files bankruptcy.”

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Dr. Bob (as I’ve come to know him) included a personal note to me.

“Joe, I documented the names and facts in my book “FDA, you were WRONG!”
< Buy this Kindle book at Amazon now >

Thanks for shining light on my story. I hope it sparks an active conversation in the Medical Devices Group and inspires a new generation of medical device leaders to fight for what’s right.

Perhaps we’ll collect stories from other members and, together, we can ensure all medical devices ground in real patient benefits can be made available to the marketplace.

I’d like to leave you with one more thought. Former FDA Chief Counsel Peter Barton Hutt famously claimed, ‘If you beat the FDA in court, you have an angry FDA that is willing to slit your throat. When the FDA loses a case, it has a mind like an elephant. It’s just something you’ve got to understand about the FDA. Once the agency makes a collective decision, trying to make it let go is almost impossible. These are FDA crusades – in a real sense they are vendettas.'”

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What do you think of Dr. Bob’s story? Do you believe “the other side” would tell a different story?

Are you familiar with situations where device companies were subjected to overly burdensome regulations – or even corruption – here or abroad?

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Do you have a story to share with the world, as Dr. Bob did with us today? Email me at JHage@MedicalDevicesGroup.net and we may feature you in a group announcement.

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From 10x (wish you were here!),

Joe Hage
Medical Devices Group Leader
Posted By Joe Hage

3 responses to “FDA, You Failed Me” by Dr. Robert Christensen

  1. Sandra witt September 18th, 2016 at 9:11 am

    I made my own adverse event report to the Fda over 7 revision knee surgeries for implant removal. The manufacturer never reported it despite the surgical rep present during all surgeries. Donna sue engleman at the Fda only put a watch on the company the salesman won an award this year for highest sales. Jack Charles Jieafa Stryker. DR Richard Lewis Levitt orthopedic loss my case in n court Witt vs howmedica Stryker.
    Yes they are tainted None of them fully release their conflict of interests I have documentation to prove it.
    I now live on pain pills,severe pain.very limited mobility ankle pain depression fear metallosis.

        Reply

  2. Jonathan J. Edmisten January 24th, 2017 at 2:19 pm

    I have gone through 38 operations and I have had salistic implan rib graph Kent prostrate joints Christmas tmi implants 3 sets of tmi concepts total joint prostitution and I just had a set of tmi concepts bilateral total joint replacement in November 2015 the last 8 months I have been in total agiony and the surgon
    has ignored me compleatly so I called tmi and got the vice president who Spock with me for hour or more amd told me to see another doctor and game me names so I am now going to get some type of help what you think

        Reply

  3. n lettich September 6th, 2017 at 6:33 pm

    In 1998 Dr R came very close to tell me to have TMJ concepts put in. I did complain about her to the FDA but was told that I was mistaken that she would not have done that. Another patient also told me a story about DR R. I did have them put in and have been in agony ever since. I did have a muscle problem that was overlooked perhaps on purpose so they could go to another level of approval. I did complain to the head of the device unit and TMJ concepts did ask me to see another surgeon.He as more informative about Wolford.Afew years later I was back in the same hospital-different doctor who really gave me the low down about Wolford. Over the years I have spoken to several of his patients who are suffering from allergies,(not being tested).
    Muscle problems etc. Everything on that protocol is being ignored. All is research is bogus. I have advised the FDA and TMJ concepts and nothing has been done. I am sure that the protocol is there for a reason. All of his patients should sue Tmj concepts and Wolford. Oh wait you can’t because of the medmal in Tx. No wonder he stays there to experiment on his patients.
    you

        Reply

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