It’s important that I preface the below letter with a piece of brief information. As included in prior pages and posts on this blog I have shared that I am a victim of a medical implant disaster. That history of my experience as well as the history of The Vitek Proplast Teflon Jaw Implants are included here in this blog. The Vitek Proplast Teflon Jaw Implants that were finally recalled in 1990 is also contained in this blog.
The letter below is from the man who invented these implants. The first cruel irony in this letter is that Mr Homsey calls himself a victim.
Hmmm.. let me see, he makes millions from the sale of implants that have destroyed hundreds of thousands of people’s lives, he files personal and business bankruptcy and flees the USA, only to try to sell the same implants in other countries. The World Health Organization quickly put a stop to these sales after urging from Implants victims here in the USA.
But Mr Homsey is a the victim.
He blames the FDA. Well at least we agree on one who we are also blaming. But for far different reasons. In my participation in a class action torte our legal counsel and our investigators uncovered many inappropriate actions on many levels throughout the medical device approval process. To say fraud was committed is an understatement.
To say that negligence was attached would also be a gross understatement.
From Dr Charles Homsey. No apology here.
The FDA’s Victims
by Charles Homsey
Personal responses by Barefoot Baroness. My opinions are from my experience only
This article appeared on cato.org on September 8, 2001
The Food and Drug Administration, the federal agency that is supposed to certify the safety and efficacy of pharmaceutical products and medical devices, often drives excellent products off the market. I should know. I was a manufacturer of medical devices and a victim — – along with patients deprived of those devices — – of a FDA vendetta.
I wish like millions of others that we had been deprived these implants.
In the 1960s I invented the material Proplast that the FDA itself approved for use in implants for patients with distorted, damaged or destroyed facial structures, jaw joints, thumbs, hips and other body parts. My company, the Houston-based Vitek, manufactured 30 different Proplast implants that were used successfully in some 100,000 patients, successes documented in more than 125 peer-reviewed publications.
One particular jaw implant was provisionally approved by the FDA in 1983. In 1986 I heard reports about some of these implants wearing out. I convened a conference of surgeons who, in a report to the FDA and the oral surgeons’ national association, found fault not with the implants themselves but, rather, with the way some surgeons used them or with the refusal of some patients to follow their treatment plans. But to be on the safe side I stopped promoting the product.
This is categorically untrue that he first heard about the failure of the implants in 1986. My legal documents hold correspondence between Dr Homsey and other participating doctors and medical and educational agencies that date back before 1986. The same year ironically my implants were surgically placed. .
Here Homsey again has no sensitivity for the patients he harmed. He speaks of patients not following their treatment plans. This means we ate, we talked, we swallowed, and we tried to brush our teeth. And this was for me even 5 years post-op that I could not do these things. I could not open my mouth any wider than to put a straw in mouth, chewing was impossible.I was on a liquid soft diet for more years than I remember. My smile was crooked, I had a severe Mal-occlusion. I spent a year going to a pain clinic 3 times a week, and saw every type of doctor and every physical therapy available. In 1990 when the FDA recalled the implants my oral medicine doctor and my surgeon would see that my implants had completely fragmented, the exact reason the FDA recalled these implants. I had bone on bone and severe bone deterioration from the implants.
There was the toxic materials that my body cannot absorb and eliminate. Creating what is called a Giant Cell Reaction. Dr Homsey fails to mention here that in 1990 the FDA recalled his implants, obviously the FDA did find fault with the implants. And please note the date of this letter above.
Dr. Charles A. Homsy, a medical device inventor for nearly four decades, was founder and CEO of both Vitek Inc. and Novamed Inc. He is the author of the recently published Cato Policy Analysis, “How FDA Regulation and Injury Litigation Cripple the Medical Device Industry.”
The FDA was clearing up an approval process mess for medical devices and the litigation he speaks of is my litigation, the class action lawsuit I was part of.
Predatory trial lawyers then got into the act, filing suits over the device against Vitek as well as any company or institute that had anything to do with the device. Most of the lawsuits were summarily dismissed or won by the defendants. But the cost of defense to the Du Pont Company, which supplied Teflon ingredients, was $50 million, and to the hospital where I had invented Proplast, $30 million. In order to continue to obtain liability insurance, I founded a second company, Novamed, to continue to produce safe Proplast implants that had no record of problems.
And there were so many VICTIMS that had legal standing the actual damages awarded to each was far less than even $50,000. Yet many of us have become permanently disabled, in the prime of our careers have no earning power to this day. Lost homes, marriages, and so much more that no amount of monetary damages would ever compensate for.
But the FDA took its lead from the trial lawyers — indeed, it was a source to them of misinformation about the jaw implant — and turned its legal guns on Novamed and on its FDA-approved products. In various complaints that agency aimed the erroneous charges that had been made against the jaw implant at products about which there were no complaints or investigations whatsoever.
This is why we received monetary damages from his company’s Vitek’s bankruptcy proceedings. (But only after his other creditors were paid. first)
These mistakes were pointed out but the FDA persisted in its persecution. Investigation if you do not mind! Eventually it seized the entire stock of FDA-approved Proplast products, and a series of court reversals and re-reversals of that seizure finally forced me in 1992 to shut down Novamed and to team up with a Swiss company to make Proplast products in Europe.
Remember the FDA recalled the implants in 1990. After he moved his business to Switzerland the World Health Organization stopped him from marketing these implants to other country’s as well.And stopped him from marketing them in 3rd world countries.
But the FDA continued its persecution overseas. It posted the erroneous warnings it had made against the jaw implants against all Proplast products through the World Health Organization. It blocked export from the United States of hip implants needed for technical evaluation and testing. Still, Canada, Australia, and the EU granted approval for shipments of all Proplast products from Switzerland. Further, when the Swiss company sought approval to export those products to the United States, where they were still legal, and the FDA’s own Office of Science and Technology found no problems with the implants, the FDA dragged its heels. The years of costly delays and battles took their toll; the Swiss company declared bankruptcy in 1999.
There are too many untruths here as well to even point out.
Who has been harmed by the actions of out-of-control bureaucrats and trial lawyers? Surgeons continue to request Proplast implants and try to secure them for their patients.Name one in the US! There is good reason. In many cases adequate alternatives are not available. Many surgeons have returned to the old, more painful, and invasive procedure for jaw joint replacement involving transfer of a rib bone.And what about cartilage from the back of the patients own ear? Further, to avoid lawsuits or FDA vendettas, many producers of materials required by implant makers discontinued all sales to the implant industry after 1993. The bottom line: The patients are the ultimate victims. The FDA is not protecting their safety but, rather, increasing their torment. And living with Giant Cell Response and a failing auto-immune system is not torment?
There are adequate replacements, a graph from your own body such as I had done in 1992 my own issue. Or from a graph from cadavers.
The Europeans have a better way to approve medical devices. Their governments set out specific, objective, quality and safety standards, but then certify private firms to determine compliance to these standards. Manufacturers are allowed to select the company to certify them. The existence of competing companies makes it almost impossible for FDA-type abuses to occur.
This too me sounds crazier than what our own FDA now does after completely overhauling the approval process for medical devises. Granted I do not know this system but will say that I am certain Homsey likes the idea that he could choose the company which would certify his products.
The FDA has driven many manufacturers and safe products that relieve pain and suffering from the market. Policy makers wishing to deal with a true health care crisis should stop the damage done by this federal agency.
Driven products out that should never have been approved of in the first place. I carry with myself daily the damage the FDA allowed Dr Homsey to cause.