Dental Health and Healthy Living News

FDA Warns of Amalgam Mercury Danger

But Some Fear FDA Classification will go easy on Amalgams

This article appeared in the September 2008 issue of Dental Truth, a publication of DAMS (Dental Amalgam Mercury Solutions), a non-profit group based in St Paul, Minnesota, USA. Their e-mail contact is dams@usfamily.net.

It was a newsworthy break from the past. On June 4th, 2008, major media around the US reported that the Food and Drug Administration (FDA) has sounded its first ever warning about the safety of mercury coming from dental amalgams. The new language had already posted on the FDA web site and it said, "Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and the fetus." The FDA site also warned, somewhat vaguely, "Pregnant women and persons who have a health condition that makes them more sensitive to mercury exposure, including individuals with existing high levels of mercury bioburden, should not avoid seeking dental care, but should discuss options with their health practitioner." Furthermore, the FDA had promised to classify amalgams by the end of July 2009. Some writers asked: is the FDA moving towards strong curbs, or even a ban, on the dental amalgam filling, which is half mercury?

"It's the start of the death knell for amalgam fillings," enthused Charlie Brown, an attorney has long sparred with the FDA on the amalgam issue. Brown was one of the attorneys who, at the end of 2007, had represented 11 plaintiffs in a lawsuit charging FDA in its 31-year long failure to classify amalgam fillings. The case against the FDA, Moms Against Mercury, et al. v. Von Eschenbach, Commissioner, et al., yielded an out of court settlement in which Brown agreed to drop the suit in exchange for an FDA promise to classify the amalgam filling (regarded as a "dental device") by the end of July next year, and to warn about the potential hazard of mercury from amalgams to children and to the unborn fetus. Brown feels that the settlement he reached will bring about the demise of the mercury amalgam filling because, even if FDA classifies amalgam fillings as a Class II device - safe under certain of use, the warnings attached to amalgam use would trigger a whole new level of public scrutiny that the amalgam product could not survive. Most independent research scientists now call for a halt to the use of mercury in dentistry and amalgam manufacturers such as Kerr (the largest) have strongly worded warning labels warning the dentists who use them about the mercury hazard.

But some observers have remained skeptical about the ultimate result that can be achieved by Brown's settlement with the FDA. The lack of plaintiff approval for the settlement and dismissal of the case also raised some eyebrows. On May 29th, after four hours of mediation, Brown reached the settlement agreement with the FDA and on the following day he dismissed the case - all without consulting any of his clients for their approval. Bob Reeves, an attorney who was a co-counsel with Brown for the plaintiffs, was present during the negotiations. During the negotiations, Reeves expressed qualms about the settlement; he argued that science supports, and calls out for, stronger warnings than the FDA was agreeing to. The FDA should be pushed for a press release regarding the new warnings, he also argued. But Brown rejected Reeves'suggestions.

The position of the plaintiffs going into the mediation had looked strong. Brown and Reeves had boldly filed, on April 22nd, for an injunction ordering the FDA to classify amalgams and to take amalgams off of the market until they do so. At the hearing on the injunction, on May 16th, FDA argued that the 11 plaintiffs "lacked standing" to sue the FDA. But Judge Ellen Huvelle disagreed; at least some of the plaintiffs did have standing to sue, she ruled. She then ordered the parties into mediation. It was under this pressure that the FDA decided to settle.

Misgivings: mistrust of the FDA. Misgivings about what the settlement will lead to center around the FDA's long history of evasion of its responsibilities to protect the public; its public statements have generally parroted the unscientific assurances offered by the ADA. It has often promised Congressional panels that it would act soon to classify amalgams and it has never honored its word. Even now, it wants a one-year delay in the time it can take to classify amalgams in order to evaluate public comments that it has received during a public comment period on amalgams that ended July 28th. An honest classification of amalgam would be as a Class Three device - requiring proof of safety. (How can a dental material that is made out of half mercury not require a proof of safety?). But FDA gives every sign of intending to classify it as a Class Two device - allowable to be marketed subject to certain conditions or limitations. In fact, it has tentatively proposed classification of amalgam that way in the past - to a firestorm of protest.

The FDA, along with its sidekick, the ADA, both know that classification of amalgam as a Class Three device would indeed be amalgam's death knell. How can you prove that amalgam, which serve as a device for time-release of the deadly poison, mercury, be proven safe? Hundreds of thousands of clinical cases of mercury poisoning from amalgam have been established, and amalgam mercury appears to play a role in much - perhaps most - of the chronic illness in our society.

Federal pre-emption, another trick. Further adding to the concerns about the settlement is the likelihood that the FDA and/or the federal courts would declare that its class II classification would pre-empt state laws, or lawsuits filed at the state level by on behalf of patients harmed by amalgams. Such pre-emption is exactly what the ADA is now publicly calling for. In addition to urging that FDA not place special controls on amalgams "such as warnings of limitations on the use of dental amalgam," ADA also urges that "any action by FDA should have pre-emptive effect over state law ...If the FDA mandates certain warnings or information be provided to patients, the ADA believes it is imperative for the FDA to indicate clearly that the agency's regulatory approach pre-empts state and local laws, and state-law product liability actions against dentists who use amalgam products in their practices."

Plaintiff Challenges the Brown Settlement and Dismissal
Plaintiff Karen Palmer has filed a court challenge to the settlement agreed to by Charlie Brown and the dismissal of the case. Her argument to Judge Ellen Huvelle, filed on her behalf by attorney Jim Love, challenged Brown on the grounds that he had not consulted the plaintiffs before finalizing the agreement and the dismissal. Palmer, a Pennsylvania dental assistant who has been severely poisoned by dental amalgam exposure in her work, still cannot work because of the parasthesia (numbness, burning, biting and crawling), chronic fatigue, memory loss and depression that she still continues to experience. "I thought that waiting until the end of July next year was too long and that too many more people would needlessly be harmed by the FDA's inaction," she explained. But Judge Huvelle agreed with Charlie Brown, who argued that the contract that the plaintiffs had signed for his legal services did not require him to obtain approval of his clients before finalizing the settlement and dismissing the suit. Palmer's challenge was dismissed. She is appealing that decision to a court of appeals.

Palmer's challenge to Brown is fueled by a distrust of the FDA and a sense that FDA will continue its regulatory negligence. The former dental assistant said "it is the dental assistants who are mixing, opening and loading the silver mercury amalgam daily that are the first to be exposed to the deadly vapor of mercury, a known neurotoxin..Win or lose, plans are set for the 'perfect storm' that is brewing. Our time is coming and there is no stopping us now!"