Dental Amalgam is an Implant that Must be in Class III

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Attorney Jim Love of the International Academy of Oral Medicine and Toxicology.

Attorney Jim Love of the International Academy of Oral Medicine and Toxicology addresses the FDA on reasons why dental amalgam is an implant that must be in class III

A. Congress’s Mandate on Classification of Medical and Dental Implants

The Medical and Dental Device Amendments of 1976, 21 U.S.C. §§360c, et seq., require FDA to classify dental and medical devices as follows:

(C) In the case of a device which has been referred under paragraph (1) to a panel,and which–

(i) is intended to be implanted in the human body or is purported or representedto be for a use in supporting or sustaining human life, and

(ii)(I) has been introduced or delivered for introduction into interstate commercefor commercial distribution before May 28, 1976, or

(II) is within a type of device which was so introduced or delivered before suchdate and is substantially equivalent to another device within that type, such panelshall recommend to the Secretary that the device be classified in class III unlessthe panel determines that classification of the device in such class is not necessaryto provide reasonable assurance of its safety and effectiveness. If a panel doesnot recommend that such a device be classified in class III, it shall in itsrecommendation to the Secretary for the classification of the device set forth thereasons for not recommending classification of the device in such class.

(Emphasis added.) Amalgam is an implant in the human body and, according to the statutory language, should be placed in Class III.

B. FDA Acknowledges that Dental Amalgam is an “Implant”

Until August 4, 2009, dental amalgam was not an FDA approved dental device. There is no FDA notification of approval, no 510K, and no classification of dental amalgam in the Federal Register.

In 1976, Congress directed FDA to evaluate all medical (including dental) devicesintended for human use and to classify them according to their safety and effectiveness. [41 FR34099, August 12, 1976] To this day, “dental amalgam” is not listed as an accepted and classified dental device, even though it has been the most widely utilized of all dental devices.

The FDA Dental Device Division classified “Dental Mercury” as a Class I device,implicitly concluding that this material is safe and effective as a dental device. [52 FR30082-30108, August 12, 1987] However, FDA thereafter ruled that mercury is not GRAS(Generally Recognized to be Safe). [63 FR 19799-19802, April 22, 1998]

Dental amalgam, when utilized as a dental filling material and placed in living tissue in ahuman body, is a medical/dental device that must be classified under existing law. By definition,it must be classified as an implant and automatically placed in Class III, requiring scientific proofof safety. [43 FR 32988, July 28, 1978] The FDA defines “implant” as “a device that is placedinto a surgically or naturally formed cavity of the human body. A device is regarded as an implantfor the purpose of this part only if it is intended to remain implanted continuously for a periodof 30 days or more, unless the commissioner determines otherwise in order to protect humanhealth.” [43 FR 32994, July 28, 1978]

In 1978, the FDA Dental Device Panel requested that dental amalgam be exempted fromthe FDA Rule definition for “implant.” [42 FR 46035, Sept. 13, 1977] The FDA Commissionerdenied that request and ruled that mercury fillings were an implant. [43 FR 32988, July 28,1978]

C. Mercury Amalgam Must be Classified in Class III

FDA Rules state: “Although no device can be regulated adequately in Class I or Class IIunless there are adequate data and information establishing its safety and effectiveness, a devicefor which there are such data and information may nevertheless require regulation in Class IIIbecause of the public health concerns posed by its use.” [42 FR 46030, 13 Sep 1977] Public healthconcerns have been repeatedly voiced but ultimately ignored by FDA. The scientific communityhas long known that elemental mercury is a highly toxic heavy metal, and many prominentscientists have recommended the discontinuation of mercury fillings as a dental restorative material.

On February 20, 2002, FDA announced a proposed rule entitled: “Dental Devices:Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification ofDental Mercury; Issuance of Special Controls for Amalgam Alloy.” The FDA’s announcedintention was to reclassify Dental Mercury into Class II and accept a “capsule” containingdental mercury on one side and amalgam alloy on the other as a “safe and effective” dentaldevice. However, 21 U.S.C. §360c, as well as the agency’s own regulation, 21 C.F.R. § 860.93,requires dental amalgam to be classified into Class III. To be classified in any other class, theDental Device Panel must file a full statement of the reasons for such classification, including“supporting documentation and data satisfying the requirements of sec. 860.7.” 21 C.F.R. §860.93(b). This regulation provides as follows:

(a) The classification panel will recommend classification into class III of anyimplant or life-supporting or life-sustaining device unless the panel determines that such classification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. If the panel recommends classificationor reclassification of such a device into a class other than class III, it shall set forth in its recommendation the reasons for so doing together with references to supporting documentation and data satisfying the requirements of § 860.7, and anidentification of the risks to health, if any, presented by the device.

(b) The Commissioner will classify an implant or life-supporting or life-sustainingdevice into class III unless the Commissioner determines that such classification isnot necessary to provide reasonable assurance of the safety and effectiveness of thedevice. If the Commissioner proposes to classify or reclassify such a device intoa class other than class III, the regulation or order effecting such classification orreclassification will be accompanied by a full statement of the reasons for so doing.A statement of the reasons for not classifying or retaining the device in class IIImay be in the form of concurrence with the reasons for the recommendation of theclassification panel, together with supporting documentation and data satisfyingthe requirements of § 860.7 and an identification of the risks to health, if any,presented by the device.

In September 2006, a meeting of the Dental Products Panel and the Peripheral and Central Nervous System Drugs Advisory Committee convened to consider, inter alia, whether the conclusions in the FDA’s position statement on amalgam (the “White Paper”) should be deemed “reasonable.” The Joint Panels rejected the FDA contention that the use of dental amalgam maybe considered safe. Clearly, no administrative record exists on which the FDA Commissioneror the Dental Device Panel could rationally conclude that there are demonstrable and reasonable assurances that mercury fillings are safe. Amalgam capsules must therefore be classified in Class III.

{slide=Jim Love Testimony to FDA’s Dental Products Panel 2010}

MR. LOVE: Thank you, distinguished panelists. My name is Jim Love. I am an attorney in Tulsa, Oklahoma. I have practiced primarily in the area of toxic torts over the course of my 27-year career, and I’m the author of two of the four petitions that you’ve hopefully read by now. 

You know, I’ve been listening all morning and I’ve changed my presentation just a little bit. I want to address some earlier comments that surrounded Dr. Edlich’s testimony.

I was the attorney of record for Dr. David Barnes, a dentist who claimed he was poisoned by mercury and amalgam particulate as a result of his occupational exposure to mercury. We sued Kerr Corporation. His claim was that he only used Kerr amalgam in the course of his career. Initially, Kerr filed motions to suppress the evidence we were presenting, claiming it wasn’t scientifically accepted. That motion was denied and then Kerr did something I really didn’t expect them to do. They claimed next, via a motion, that their warning was completely legally adequate. And the warning, as reflected in the material safety data sheet distributed with their warnings, said, among other things, that mercury is a neurotoxin.

And actually my response to that was, well, that’s interesting, Judge, but our claim is that the majority of the exposure came from amalgam particulate generated during amalgam removal, and there’s nothing in here about mixed dental amalgam, and so the warning is inadequate. The court disagreed and I lost the case. I appealed in the Sixth Circuit and the Sixth Circuit, in the published opinion, found that mixed dental amalgam was implicitly included in that warning. So the message here is that mercury is a neurotoxin and mixed dental amalgam is a neurotoxin without qualification. 

I’m also familiar with the learned intermediary doctrine, which is adopted in 48 of the 50 states and requires dentists to pass along manufacturer warnings. Dr. Runner pointed out this morning that FDA does not regulate informed consent and dental behavior, and that’s probably true. But FDA does regulate labeling and I’m very familiar with what those labels say and I’m very familiar with the obligation of dentists to pass along those warnings. I doubt that the prevalent practice in the United States for dentists placing amalgam is to tell the patient, I’m about to put a neurotoxin in your mouth. But that’s actually what’s legally required and is not done.

We know from a Zogby poll that 78 percent of the dental patients with amalgam in their mouth don’t know that mercury is a constituent in dental amalgam. So that message is not getting out. To further compound the problem, those labels are completely at odds with the 2009 FDA final rule, which essentially proclaimed that amalgam is a safe material. 

Perhaps the most important thing I’m going to say this morning arises out of the regulatory scheme governing the classification of implants. Dental amalgam has been determined by FDA to be an implant and as a result, it must be placed in Class III unless there are adequate data and information establishing safety and effectiveness.

As Jim Turner pointed out, the general rule for implants is in Class III and the exception to the general rule is Class II and that does create an obligation for FDA to go forward and demonstrate that adequate information exists to justify the exception to the rule.

Also clear to me is a departure from this regulatory scheme by FDA in evaluating dental amalgam. Despite admitting a virtual dearth of scientific evidence relating to mercury’s effect on the fetus, FDA concludes that this paucity of data equates to safety. 

One of Mark Richardson’s assignments — he’s the representative of SNC-Lavalin that prepared the risk assessment in anticipation of today’s hearing — was to quantify the dose of mercury to which a fetus is exposed. He accepted the assignment, but reported that he found insufficient data on which to render an opinion. We know that the developing brain is particularly sensitive and that it is exposed to mercury; however, we cannot quantify this exposure and have only scantly evaluated its effect on the fetal brain. Ladies and gentlemen, in my humble opinion, that is not adequate data sufficient to show safety.

I would respectfully submit that the FDA’s demonstrated willingness to equate the absence of evidence with safety is a violation of FDA’s own regulations. Gaps in knowledge mandate Class III classification. 

Meanwhile, we’ve heard from Mark and David Geier that the incidence of autism increases when a mother has five or more fillings. We know from Dr. DeRouen et al., that women who have amalgam dental fillings placed during the first trimester of pregnancy are much more likely to give birth to infants with isolated cleft palate. That was an announcement at a symposium that was widely reported.

Indeed, every time we look for pathology associated with the use of this material, we find it.

Mutter et al. warned just last month that the weight of the evidence supports a causal relationship between mercury exposure and Alzheimer’s disease. 

Two decades ago, Ngim et al. correlated systemic mercury levels with increased risk of Parkinson’s fillings [sic].

Rothwell et al., discussed this morning, found a significant positive linear correlation between amalgam fillings and hearing loss.

The Geiers warned that, contrary to the conclusions of the authors, the Casa Pia data supported those dependent correlations between increasing mercury exposure from dental amalgams and specific urinary porphyrins associated with mercury body burden. Earlier this year, the Geiers also warned us that mercury may significantly impact the pathogenesis of autism spectrum disorder.

This isn’t a record of demonstrated safety. It’s a record that portends ominous health consequences relating to the use of this material.

Let’s look at the recent record that FDA has developed on this issue. In 2006, joint Advisory Panels rejected the proposition that FDA’s White Paper demonstrated safety. Undeterred, FDA developed its final rule, effectively proclaiming that amalgam was safe.

My petition identified 27 points of error, admittedly some more important than others. But in writing the petition, my overriding belief was that properly applied principles of risk assessment could not be used to demonstrate amalgam safety. And my opinion hasn’t been changed by developments in the last year. 

SNC-Lavalin was asked by the International Academy of Oral Medicine and Toxicology, my client, to prepare an updated risk assessment to address some of the errors that I identified in my petition. Dr. Richardson concluded in his report, which you’ve hopefully had a chance to see, that 63 million people with amalgams absorb enough mercury to exceed the current EPA RfC. Sixty-three million people. That’s if we don’t move it.

If the outdated RfC is updated to apply an appropriate uncertainty factor and utilize an appropriate reference paper, pertinently, not including the Fawer paper, the basis for the previous EPA RfC, it is clear that everyone with amalgam fillings is absorbing too much mercury. 

So what have we received? What information have we received with respect to the homework assignments? Well, very briefly, 

Dr. Ginsberg argues for a 100 to 300 UF not applied by EPA. He dismisses the clinical epidemiology on which FDA relies. The EPA RfC, he finds, is not necessarily protected. He believes the level of exposure from amalgam should be assumed to be safe. In short, his comments don’t vary significantly with those appearing in the SNC-Lavalin report.

Dr. Farland believes that the UF of 30 is probably too low and advocates looking at a higher UF. He doesn’t believe that the presence of chlorine gas is fatal to the use of the Fawer study, but admits that it is impossible to quantify the uncertainty introduced by this issue. He believes that the dose absorbed by amalgam bearers ranges from 1 to 7 micrograms per day and concedes that the higher end of this range exceeds the EPA exposure dose.

We can assume that if his request is granted and the UF is upped to 100 or perhaps 300, as he suggests, the percentage of persons whose mercury exposure exceeds the RfC will increase dramatically.

Finally, Dr. Yokel believes that the EPA RfC is protective, but believes the exposure range is properly set at 1 to 15 micrograms a day. Dr. Yokel does not compare this dose to the EPA RfC. But if a daily absorbed dose of 6 to 7 micrograms is too high, certainly 6 to 15 micrograms is too high.

The bottom line is, if we allow these experts to set the RfC where they deem it appropriate and compare that RfC to their estimates of exposure, it’s clear that very substantial portions of the population are faced with mercury exposure that exceeds their RfC.

Clearly FDA has not presented adequate data demonstrating safety such that the classification in Class II can be justified.

In 1993, renowned toxicologist Lars Friberg stood before a different FDA Advisory Committee and advised that dental amalgam should be placed in Class III. Here we are 17 years later and 2-1/2 years after FDA signed a settlement agreement, agreeing to classify dental amalgam. Indeed, we are 34 years removed from the congressional mandate to classify all devices.

A cry of time’s up is not unreasonable or premature. Further consideration of amalgam’s purported safety should take place in the course of the premarket approval scheme that is part of the Class III classification.

Thank you.{/slide}

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