“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 [email protected] 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