Amalgam Fillings:

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http://www.piercelaw.edu/risk/vol2/spring/royal.htm Amalgam Fillings:Do Dental Patients Have a Right to Informed Consent?* A. Royal** Introduction An individual may seek the services of a dentist for any number of reasons. After examination, the dentist may determine that the patient has a cavity and inform the patient that the cavity must be filled. Dentists usually do not consult patients to determine what materials to use. Most feel that dialogue with the patient on this issue is unnecessary. However, some materials may be hazardous under certain conditions. New research suggests that mercury amalgam (or "silver") fillings (hereinafter amalgam) may fall into that category. However, the American Dental Association (ADA) supports the use of such fillings and assures "the American people that dental amalgam is

safe."1 The ADA claims that since mercury amalgam has been used for over 150 years, its safety should not be disputed.2 While its position remains largely unsupported by scientific evidence, the ADA challenges those opposed to the use of amalgam fillings (anti-amalgamists) to produce scientific evidence that its use is harmful to humans.3 This challenge has been accepted. The anti-amalgamists have countered by challenging the ADA to demonstrate that safe levels of mercury in human tissues exist before endorsing its use.4 The ADA has yet to respond. Both sides do, however, agree that "[1] [mercury] is one of the most poisonous elements known to man, and [2] mercury amalgam may cause ill effects in those people who are mercury sensitive."5 The mercury used in fillings is hazardous before and during their preparation.6 Also, scrap materials pose an environmental hazard when discarded.7 Research over the past decade demonstrates that their use poses a potential health

hazard to a significant number of the estimated 200 million Americans with amalgam fillings.8 Amalgam continues to be the primary filling material in the U.S., largely due to the ADA's endorsement.9 This article will first examine the history and general issues involved in the use of amalgam fillings. Second, it will review available research to demonstrate the potential health hazards. Third, it will briefly investigate environmental issues and suggest that potential risks extend beyond those posed for patients. Ultimately, the article will address whether, whatever uncertainty may be present, patients do not have a right to be informed of potential risks and of available alternatives. History of Amalgam Fillings Opponents of amalgam have challenged its use in dentistry since its introduction over 150 years ago.10 The first reported use in dental restorations was in 1818.11 Since then, concerns over the toxic effects of mercury have persisted.12 The

American Society of Dental Surgeons, formed in 1840,13 so abhorred the use of amalgam that it required its members to sign pledges that they would not use it.14 In 1848, The Society of Dentists of the City and State of New York suspended eleven of members for "malpractice," because they used amalgam.15 Internal strife over the use of mercury in dentistry led to the formation of the ADA, whose leaders did not oppose its use.16 In the late 1920's, anti-amalgamists challenged the use of amalgam again, as evidence surrounding the toxic effect of certain mercury compounds "appeared indisputable."17 Despite this, the use and popularity of amalgam in dentistry continued to grow rapidly.18 Questions about its safety arose again about fifteen years ago and continue unabated.19 Nevertheless, mainstream dentistry believes it is "most unlikely" that the current "anti-amalgam crusade" will succeed in eliminating its use.20 Amalgam fillings typically comprise 50% pure

elemental mercury, 35% silver, 13% tin, 2% copper, and a trace of zinc.21 The metal powders react with liquid mercury to produce an amalgam (or alloy)22 that provides a flexible material that can be easily packed and shaped.23 Amalgam fillings are often called silver fillings because of appearance and composition.24 The ADA prefers the use of amalgam because fillings are inexpensive and durable, while gold and other composite materials are more expensive and more difficult to fit.25 Because of its flexibility, the use of amalgam arguably requires less skill. Thus, dentists can usually fill a cavity in less time.26 Some, however, believe that alternatives that have been available for several years, may be even stronger and more durable.27 One author proclaimed over fifteen years ago that since "satisfactory alternative tooth-filling materials are available, ... the use of amalgam fillings should be discouraged."28 However, the ADA maintains that there are no

acceptable substitutes,29 although it admits, "the use of composite resins as a posterior restorative material may eventually replace amalgam restorations."30 In fact, the ADA recognizes that once an "acceptable" replacement for amalgam is found, that "even the possible hazard to dental office personnel of high levels of mercury vapor from mercury spills could be eliminated."31 The ADA adamantly defends mercury usage in tooth restorations whenever others suggest that it poses a potential health threat on the basis that it has been used "safely" over the past 150 years.32 Other reasons behind its support of amalgam may include: 1) ease of use; 2) low cost; 3) additional training and equipment required to use alternative materials;33 and 4) potential liability associated with acknowledging the dangers of amalgam previously used. Unfortunately, the cost of a vast array of chronic, degenerative, mental and physical diseases related to mercury exposure in patients,

dentists, dental personnel and society appears to be immeasurable. Mercury Toxicity Mercury has been known to be a poison for thousands of years,34 whether "ingested, inhaled, or absorbed through the skin."35 In the 1800's, British workers who used mercury in the hat making process developed symptoms of mental deterioration on an industry-wide basis.36 The expression, "mad as a hatter," originated from that.37 Also, citizens of Minamata, Japan, endured ten years of misery, crippling deformities and agonizing deaths before industries ceased polluting the local harbor with mercury.38 The mercury was transferred to Minamata citizens when they consumed fish from the polluted harbor. This resulted in more than 10,000 cases of "Minamata disease," which had a 10% mortality rate.39 Today, according to those involved in research, human exposure to mercury is primarily through dental amalgam.40 Mercury has been found to accumulate in vital organs and tissues,

such as the liver, brain,41 and heart muscle.42 Major symptoms of mercury toxicity include emotional instability, tremors, gingivitis, and kidney failure.43 Some also believe mercury may be linked to multiple sclerosis44 and epileptic seizures.45 Further, its affect on the body's immune system is potentially devastating,46 possibly contributing to diseases such as leukemia and hematopoietic dycrasias.47 No direct connection to any specific diseases has yet been made, primarily "because no one has really looked."48 However, as research continues, evidence is accumulating. Dental fillings may yet prove to have effects many times greater than those found at Minamata.49 Patient Exposure to Mercury from Amalgam Restorations Dentists maintain that mercury in "amalgam becomes inert once the fillings have been allowed to set for several days, and that long-term danger to the patient from [mercury] vapor is therefore remote."50 The New England Journal of

Medicine recently reported, "Many important medical questions concerning mercury toxicity remain to be answered."51 The ADA, by contrast, continues to assert that it has enough information to guarantee its safety for use.52 Nevertheless, dentists admit that there is exposure to mercury vapor,53 and the ADA acknowledges that an allergic reaction poses "[a] small but possible risk to the patient."54 However, approximately eleven million Americans are mercury sensitive.55 Further, the ADA agrees that the removal of amalgam fillings "can release relatively large amounts of mercury into the mouth[,] and that may be harmful."56 While de-emphasizing possible risks to patients, the ADA has taken affirmative steps to inform dentists and their personnel of the potential hazards of mercury57 and has established strict guidelines for storing and handling amalgam.58 One author suggests that dentists have both a "moral" and a "legal" duty to protect dental personnel.59

Because the primary danger in dental offices is "the atmospheric mercury vapor,"60 the ADA presents an interesting paradox in its position on amalgam. The organization considers the mercury vapors which threaten dental personnel are "insignificant".61 Recent studies have found that substantial amounts of mercury vapor are released from dental amalgam after chewing gum for just ten minutes.62 Studies have also shown that mercury vapor can be released by "brushing the teeth with commercial toothpaste,"63 "chewing food, drinking hot beverages, and smoking cigarettes."64 Therefore, mercury vapor is continually present.65 Mercury Toxicity From Amalgams Although amalgam subjects dental patients to dangerous mercury vapor,66 when asked if mercury is poisonous, the ADA recommends that dentists answer patients in the following manner: "Not when used as amalgam.... [W]hen mercury is combined with other metals... it reacts with them to form a biologically

inactive substance."67 The ADA instructs its dentists not to inform patients that amalgam continuously releases mercury -- even if patients inquire.68 No governmental agency has established safe standards for mercury intake from dental amalgams. Some experts believe "there is no safe level of mercury exposure."69 The ADA investigated the possible affects of amalgam fillings in 1984 and assured the nation that, "[a]lthough there is no evidence of a health threat, we will pursue the question of safety until the matter is resolved to the satisfaction of the American people."70 The 1984 Workshop on The Safety and Biocompatibility of Metals in Dentistry concluded that mercury is released from amalgam fillings.71 Nevertheless, the ADA maintained that no health problems could result from such a small amount of exposure.72 When subsequent studies surfaced linking amalgam fillings to several incurable diseases, the ADA denied all claims that amalgam could possibly be

responsible73 -- while reassured those concerned that it would "continue" to do everything in its power to resolve any questions as to its safety.74 In response to claims concerning amalgam hazards in 1987, the ADA boldly responded that such claims are unfounded,75 "unsubstantiated, undocumented, and unproven."76 However, numerous studies performed since 1981, "demonstrate a positive correlation between dental amalgams and mercury levels in the human brain."77 Other countries have taken action to limit or prohibit the use of amalgam fillings. Two years ago, the Swedish government "recommended that dentists stop using amalgam to fill the teeth of pregnant women."78 Since then, Swedish authorities determined to ban the use of all mercury, including its use in amalgam fillings, by 1991, have urged that its use in pregnant women cease immediately.79 Viking Falk, division chief of the Swedish Social Welfare and Health Administration, said, "We now realize that we

have made a mistake. This has caused people to suffer unnecessarily."80 The ADA "quickly regarded [this report] as 'bogus[.]'"81 However, the Swedish ban was subjected to public hearings and subsequently upheld.82 In fact, in November, 1990, the Swedish government passed a law providing its citizens the opportunity to have their amalgam fillings removed under the national dental plan.83 Also, legislation has been introduced in Germany to ban the use of amalgam.84 In Japan, dentists have likewise sought to use alternatives to amalgam.85 Current research demonstrating strong evidence of chronic mercury toxicity in patients with amalgam fillings has done little to persuade the ADA to reevaluate its position. Some dentists have suggested that their patients consider changing their amalgam fillings and replace them with non-toxic materials, based on current research. The ADA has labeled the actions of these dentists "unethical," stating that dentists engaging in this

practice raise "a question of fraud or quackery in all but an exceedingly limited spectrum of cases."86 However, current research has prompted groups, such as the Environmental Dental Association (EDA), to call for a ban on any use of mercury in dental materials.87 The EDA contends that using amalgam without informing the patient of associated risks and alternatives is "unethical."88 A summary of recent scientific findings, which follows, suggests that health threats from amalgam exist in laboratory animals and probably in humans. Current Research Researchers from the departments of medicine, pathology and physiology from the University of Calgary, Alberta, Canada, performed revealing experiments during 1989 and 1990 regarding the safety of amalgam fillings. Two studies examined the effects of amalgam fillings on sheep, while a third studied its effects on monkeys. The 1989 study placed amalgam fillings into the mouth of a four year old ewe for 29 days.89 At

the end, mercury was absorbed in the lungs90 (due to "continual breathing of the 'intra-oral air' having mercury vapor"), the stomach91 (through "the mixing of intra-oral Hg vapor, amalgam microparticles, and dissolved mercuric ions with saliva and food before swallowing"), the jaw 92("some tissues in the jaw... and tooth root and surrounding bone"), "the brain[,] and several endocrine glands."93 The kidneys had high concentrations of mercury,94 which disproves earlier theories that mercury is excreted.95 The study concluded that, because about 8% of inhaled elemental mercury vapor is absorbed into the blood in humans, it immediately "becomes available for tissue retention."96 Since the study found problems resulting from mercury exposure so quickly, amalgam fillings "remain[ing] in human teeth for eight to ten years... would allow an extended opportunity for body tissues to be continuously exposed to Hg [mercury]."97 The study concluded: "dental amalgams can be a major

source of chronic Hg [mercury] exposure."98 Another study, at the University of Calgary in 1990, investigated the affect of amalgam fillings on a fetus.99 Five pregnant ewes had amalgam placed in their teeth at 112 days gestation. This study demonstrated that mercury from amalgam fillings appear in maternal and fetal blood and the amniotic fluid within two days after placement of the dental restorations.100 The study concluded that amalgam also accumulates in maternal and fetal tissues.101 These results prompted the researchers to conclude: "Dental amalgam usage as a tooth restorative material in pregnant women and children should be reconsidered."102 Mercury exposure is of particular concern in the developing fetus and in children due to their low body weight.103 A study performed ten years ago concluded that pregnant women should avoid exposure to mercury.104 Previous studies have also demonstrated that mercury exposure from amalgam can deteriorate the

immune system.105 Although the Calgary studies did not show whether kidney functions returned after removal of the amalgam, Fritz L. Lorscheider, who was involved in both of the Calgary studies, concluded: "[we] know that mercury is highly toxic and that it concentrates in certain parts of the human body. From the sheep, we know it can alter kidney function in animals. That should be enough to get it banned."106 The University of Calgary studies were the first to demonstrate that changes in body functions occur following the implantation of amalgam.107 Shortly after publication, the findings were reported on the front page of the Chicago Tribune on August 15, 1990.108 The article quoted a Food and Drug Administration (FDA) representative as saying, "In light of emerging scientific data, the FDA needs to re-examine the use of amalgam. It may be necessary to reclassify amalgam and take various regulatory actions."109 The FDA allowed the use of amalgam to continue in

1976 because the substance was already widely in use.110 Some believe the FDA's decision to do so was largely because of the ADA's influence within the FDA.111 However, after the animal tests at Calgary, the FDA would probably not allow amalgam to be used if it were a new product.112 Some Chicago dentists took exception to the Chicago Tribune's decision to give the story so much prominence.113 The ADA has been accused by anti-amalgam dentists of actively seeking to avoid problems of liability which might arise through any admissions.114 A more recent study completed by the University of Calgary found that monkey kidneys, like sheep kidneys, concentrated large amounts of mercury when given amalgam fillings.115 Another study of two adult monkeys at the University of Georgia, in cooperation with the University of Calgary, concluded that bacteria normally present in the digestive tracts of monkeys were disrupted.116 The normal bacteria were replaced by a strain of

mercury-resistant bacteria that recycle the metal in the body instead of allowing the monkey to excrete it.117 Preliminary research in human subjects indicates that people with silver fillings also develop bacteria that can use mercury.118 One researcher from the University of Georgia study stated, "This may... explain why not all mercury entering the body is excreted and high levels are found in certain organs. ... It proves that mercury is 'bio-available' -- something that dentists have been denying for years."119 However, the ADA dismissed the above "animal studies as irrelevant to humans,"120 although a monkey's "dentition, diet, feeding regimen, and chewing pattern closely resemble those of humans."121 The battle over use of amalgam appears to have become one of "medical science vs. dental opinion."122 However, once the studies are duplicated and receive greater acceptance in the scientific world, Eggleston of the University of Southern California School

of Dentistry admits, "positions could change."123 Amalgam and the Environment Dental amalgam is classified as a hazardous material in the work place by OSHA, and excess dental amalgam must be disposed of according to OSHA's Material Safety Data Sheet.124 However, the health threat of amalgam scraps may potentially reach far beyond the work place in the dental office. Although most of the industrial uses of mercury have been reduced, dental offices serve as a major source of mercury contamination in our environment. This occurs when dental personnel improperly dispose of scrap dental amalgam. For example, it can pollute ground and drinking water,125 or vapors released through incineration can pollute the air.126 Pima County, Arizona Dentists Suspended Recently, the Pima County (Arizona) Wastewater Management Department, in cooperation with the Environmental Protection Agency (EPA), determined that local dentists were illegally dumping mercury

into treated sewer water.127 Tucson experts discovered excess mercury in the Santa Cruz River, downstream from the county's two sewer treatment plants.128 Officials traced the source to local dental offices, which were temporarily closed as a result.129 As of October 1989, 71 of the reported 73 mercury violations in Pima County (Tucson), since 1985, were directly traced to dental offices.130 The reason behind the strict Arizona environmental law lies in the delicate ecological system of the Santa Cruz River.131 However, local dentists maintained that the mercury must have come from other sources, and that amalgam poses no environmental threat. Simoneaux, a Tucson dentist and Southern Arizona Dental Society President remarked, "There is mercury in the amalgam, but it's OK to put amalgam in your mouth and it's OK to put it in a landfill.... [W]e don't want to pollute the environment and we don't think what we are doing is wrong -- we're dumping amalgam, not

free mercury."132 The EPA does not agree. EPA Takes Action in Connecticut In 1988, a group of 58 New England dentists, the owners of a chemical company, an "amalgam broker," and two dental supply companies incurred liability under Sec. 107 of the Comprehensive Environmental Response Compensation and Liability Act (CERCLA)133 for improperly disposing of amalgam at two different waste sites.134 An EPA settlement resulted in payment of $69,812 -- about 10% of the cleanup cost of $710,000.135 The U.S. filed suit,136 after which the other defendants eventually settled.137 The U.S. stated earlier in the pleadings that amalgam is an environmental hazard. In its complaint, the government averred that since "mercury, silver, co[p]per and zinc are listed as hazardous substances under CERCLA... [and] these elements make up dental amalgams, [then] amalgam is itself a hazardous substance."138 Before the consent decree, the ADA filed to appear, introduce

evidence and make oral argument as amicus curiae on November 7, 1988.139 The ADA hoped to have some influence on "whether dental amalgam is a regulated material under the provisions of CERCLA, and whether dental amalgam can be classified as a 'hazardous substance' pursuant to CERCLA."140 After the settlement, the ADA confidently declared that the government's position and the subsequent outcome had no affect on "[w]hether amalgam is safe for use in the mouth."141 One of the dental supply defendants circulated a letter following the settlement, interpreting the result as an official declaration by the government that amalgam was a hazardous substance.142 In an effort to squelch this misunderstanding, the ADA responded that, although the EPA considers amalgam to be hazardous, "[t]here has not been a decision by any court that finds dental amalgam to be a hazardous substance."143 The ADA's interpretation of the law appears to be in direct conflict with the government's in the

pleadings and consent decree.144 As for the circulated letter, the ADA fears it "has tripped an alarm that may be difficult to silence."145 The ADA appears to be in a precarious position. While its stated purpose, as set forth in Bourdeaudhui,146 is "to advance the health of the public and to promote the art and science of dentistry...,"147 it incorrectly represents that dental amalgam has been "proven to be safe and effective...."148 Scientific research over the past several years is at odds with the ADA's latter representation. The ADA's refusal to seriously consider scientific findings regarding the hazards of amalgam fillings appears to be in conflict with its purpose as an organization.149 If amalgam fillings are hazardous to the public when dumped or otherwise disposed of, then they potentially threaten the community at large.150 In order to remain a credible organization, the ADA should welcome scientific research involving amalgam and other dental materials,

and be willing to change its position when the health and welfare of dental patients and the public are compromised by dental procedures or dentists.151 Do Patients Have the Right to Know? It would be prudent for the ADA, at this juncture, to reconsider its position. It should consider that many dental patients, once properly informed, might prefer some other substance as a filling material. For example, a physician has a duty to disclose to the patient the contents of a prescription and any potential side effects.152 Affirmative efforts are now being directed toward requiring dentists using amalgam to obtain informed consent from their patients. However, the ADA opposes any legislation designed to accomplish this.153 Traditionally, the law of informed consent "insists that an individual's wishes be honored under all but a very few circumstances."154 Justice Cardozo recognized that "Every human being of adult years and sound mind has a right to

determine what shall be done with his own body...."155 Doctors were held to have a duty to inform patients in Salgo v. Leland Stanford, Jr., Univ. Bd. of Trustees,156 where the California Court of Appeals found that a physician has a duty to disclose "any facts which are necessary to form the basis of an intelligent consent by the patient to the proposed treatment."157 Providing sufficient information to allow patients the opportunity for making informed decisions is one of the specific duties placed upon doctors as part of their responsibilities in providing professional care of their patients.158 This duty arises primarily from the doctor-patient relationship, because this "one-to-one relationship" facilitates "personal consultation and discussion."159 Neither the ADA nor any American dentists are currently under a specific duty to inform patients of potential hazards of amalgam fillings, or to offer patients an option of available alternative materials. No

affirmative duty will exist without state or federal legislation or without a resolution from a judicial proceeding. Generally, a duty usually exists where "reasonable persons would recognize it and agree that it exists."160 Because the ADA "produces most of the dental health education material in the United States...,"161 and steadfastly refuses to acknowledge the dangers of mercury exposure through amalgam fillings, related health hazards may continue to go largely unnoticed. The ADA's present posture in defense of mercury in dentistry has disastrous implications. While insisting that this "very serviceable, low-cost restorative material should [be made] available to the public[,]"162 the ADA fails to acknowledge the importance of providing information to patients about the dangers of amalgam. The public should be informed by dentists of the possible dangers associated with amalgam, and provided the opportunity to select other available materials. If the cost of dental

treatment is of prime importance, then the patient should have the benefit of weighing the low-cost benefits of amalgam against potential hazards associated with chronic mercury exposure. Once a patient knows the risks, perhaps a more expensive substance would become more desirable. Often, litigation of this kind arises from a doctor's failure to disclose material information to the patient.163 Courts presume that people do not desire to be harmed or incur the risk of being harmed.164 This presumption requires the doctor to demonstrate that the patient was informed of and consented to the risk.165 In order to succeed in a suit for informed consent based on negligence, the plaintiff must establish that a duty to disclose exists.166 Once a duty is established, a clear nexus between causation and the resulting harm must be shown.167 While research may provide enough evidence for a victim of mercury toxicity from amalgam fillings to demonstrate potential hazards, the

causation element poses the biggest obstacle for the plaintiff. Absent a statute, expert testimony is necessary in order to establish a duty and then to show that the nondisclosure resulted in the harm under negligence doctrine.168 Most states use an objective standard of causation in such cases.169 However, jurisdictions differ as to who may establish the standard. The majority rule compels a doctor "to disclose facts which a reasonable medical practitioner in a similar community and of the same school of medical thought would have disclosed to his patient regarding the proposed treatment."170 This standard requires the plaintiff to demonstrate the necessity of disclosure through expert testimony.171 One minority approach views the nondisclosure from the patient's point of view. In the decision making process, based on what the doctor knew or should have known about the patient's position, courts using this approach weigh whether a reasonable person under

similar circumstances would have been likely to attach significance to the information provided.172 This latter standard does not require expert testimony, but leaves "the court to look only at what the reasonable person deems to be material in making an informed decision."173 A noted trend has been to follow the minority view, which adheres to the rule that "the duty to disclose should be measured by the patient's need for information rather than by the standards of the medical profession."174 Dentists who continue to use amalgam, despite scientific data raising questions as to its safety, may argue that the patient needs no informed consent because "the procedure is simple and the danger remote and commonly appreciated as remote."175 However, the plaintiff may dispute this defense with expert testimony. A suit brought on grounds of products liability would be difficult since the patient never sees and never handles the amalgam. Therefore, no labels with

warnings to patients would be effective.176 However, the FDA may soon reclassify amalgam "so that sometime in the future manufacturers of these particular products would have to provide safety and effectiveness data."177 Still, the dental patient is wholly reliant on the dentist to provide information and facts relating to inherent risks and other alternatives.178 Class Action Suit Against ADA179 How will the courts determine whether a dentist, or an organization, has acted reasonably? Is the dentist who strictly adheres to the doctrine of the ADA reasonable? What about the dentist who concludes from available research that amalgams present a significant risk for patients? For him, being reasonable may result in harassment by the ADA and loss of licensure to practice, as determined by his peers on the state licensing board. A federal court will likely decide this issue in the near future. On September 20, 1990, a class action suit (hereinafter Kennedy) was

filed in federal court.180 Forty anti-amalgam dentists have charged the ADA with fraud for continuing to claim that amalgam fillings are safe.181 The Kennedy action also alleges that the ADA has harassed the plaintiff dentists and attacked their professional reputations as a direct result of the plaintiffs' efforts to expose hazards of amalgam fillings.182 The plaintiffs further charge the ADA with continuing to deceive the American public with assurances about amalgam fillings, despite vast scientific evidence, "because they feared the embarrassment and liability of being proven wrong, and because they feared that admission of their misrepresentations would result in a public relations disaster for themselves."183 The plaintiffs in Kennedy are seeking compensatory as well as punitive damages, an injunction enjoining the ADA from discriminating or otherwise "intimidating" the plaintiffs, together with an order requiring the ADA "to correct their wrongdoings."184 One

attorney writes: "[t]he most expeditious way to bring about change is to resort to the courts for punitive damages in certain cases that involve suppression or destruction of evidence, or fraud by manufacturers on the public or in the medical profession."185 However, several groups are taking the legislative route to change, proposing laws requiring informed consent. Legislative Efforts to a Solution The EDA has called for a ban on the use of mercury in dental fillings and is actively promoting informed consent legislation in several states.186 Colorado may emerge as the leader in strengthening rights of dental patients. This year, new legislation has been introduced imposing a specific duty on dentists to provide informed consent to their patients before placing dental amalgams in their teeth. The proposed legislation would impose strict liability on dentists who fail to obtain informed consent from dental patients.187 In addition, the proposed legislation

has sought to relieve dentists of any liability to the state dental board for recommending the removal of amalgam fillings in the interest of the patients' health.188 Arguably, the existence of a health hazard should be brought to the attention of patients through informed consent. Patients need to know about the availability of safer alternative materials, despite higher costs and alleged inferior quality.189 Inasmuch as patients must accept the consequences of the fillings placed in their teeth, the proposed legislation in Colorado would leave the decision to the patient, not the dentist. Commentary supporting the proposed amendments suggests that dentists should be under the same obligations as other Colorado health providers who perform treatment or procedures which expose the patient to a significant risk.190 Proponents of the Colorado legislation reason that "ecause the potential harm is great, and minimal effort is needed to inform patients of this

potential harm, it would be reasonable for dentists to provide this information to their patients before using amalgam."191 In addition, advocates admonish state leaders that, at a minimum, this legislation will protect "those persons who are more susceptible to or affected by toxic poisons."192 Specifically, the proposed statute would require dentists to inform patients that mercury is in amalgam fillings, the mercury can have toxic effects, alternative materials are available and the patient has the right to choose an alternative material.193 Previous Colorado legislation in this area has failed because representatives of the Colorado Dental Association, like the ADA, have said they do not believe silver fillings are a health threat.194 The ADA has labeled such legislation as "A wolf in legislative clothing."195 In Alaska, State Senate majority leader Pat Rodey reported that enough evidence exists to establish "reasonable doubt" as to the safe use of dental

amalgam.196 He therefore introduced a senate resolution, similar to the Colorado proposal, which would require informed consent from dental patients before the use of amalgam fillings in patients.197 The Alaska Department of Health and Social Services advised in a "Concept Paper" in January, 1989, "persons who have had a large number of amalgam fillings, who have experienced symptoms commensurate with chronic low level mercury exposure and who have tried traditional treatments may wish to consider replacement therapy."198 The proposed Alaska legislation did not pass as introduced initially,199 but is being reintroduced again this year. Last year, the Illinois House of Representatives adopted a House Resolution which requested that 200 the Illinois Department of Public Health review the studies that have examined the health risks of mercury in dental fillings and report to the General Assembly by March 1, 1990, its finding about such risks as well as its

recommendations for providing a means by which dental patients may be informed of the findings and of the alternatives to mercury content in fillings when seeking dental treatment. The resolution was referred to the committee on assignment. No study was performed, and the bill died in committee. However, it will likely reappear in future sessions. North Carolina is another state which has considered legislation structured to provide dental patients with information about amalgam fillings.201 The legislative process is often slow and "replete with economic and political considerations and often falls wide of the mark."202 Over the past decade, the ADA has postured itself to fight and discredit scientific research, rather than seek a cooperative venture with fellow scientists to resolve the matter in good faith.203 It is difficult to understand why the ADA does not favor informed consent legislation, since "Empirical evidence suggests that even when undesirable

medical outcomes occur, the greater the degree to which the patient participates and is informed, the less likely she is to file a malpractice claim."204 By endorsing informed consent, however, the ADA would have to alter its position on amalgam fillings, and would give credence to advocates opposing the use of amalgam materials.205 The ADA's position that amalgam is safe based on 150 years of use is weak at best.206 The ADA has not produced scientific data which demonstrates the safety of amalgam fillings. In so doing, it has arguably failed in its duty to protect the public, as well as its own membership, from personal harm due to amalgam usage.207 The ADA may fear the flood gates of litigation will burst when the American people have all the necessary information about the potential harmful effects of mercury in amalgam. Intense litigation often follows when the public discovers it has been unnecessarily exposed to toxic substances.208 Historically

numerous common products were thought to be safe; for example[,] asbestos, lead, and DDT. In each case the scientific concerns were immediately discounted by the industry responsible for the production or use of the material and often the assertions of safety were initially supported by the responsible government agencies. After a period of time as the evidence became overwhelming and legal liability impossible to ignore, they were regulated or withdrawn from the market. Each of these products demonstrated pathology after a latency period of chronic low dose exposure[,] as does mercury.209 Perhaps the Kennedy210 case will provide swifter resolve to the amalgam issue and result in adequate information concerning the risks of amalgam fillings being disseminated to dental patients. Freedom of choice means patients must receive the information necessary to allow the best possible opportunity to make an informed decision as to what dental procedures or materials will be

used.211 This should no longer be a decision reserved for the dentist's sole discretion. Conclusion One author of a dental text advocates the use of amalgam fillings based on a risk/benefit analysis, because "the benefit from the treatment far outweighs any side effects from operative procedures and dental materials."212 However, with so many alternative materials available, this risk/benefit approach makes little sense. Since the ADA's declarations of the safety of amalgam fillings is based on tradition and remains unsubstantiated by research, dentists should reassess their legal and ethical positions. With respect to recent scientific findings about amalgam fillings, dentists can no longer expect credible support from the ADA, and should perform due diligence in obtaining knowledge and information on this subject.213 While the FDA anticipates regulatory changes based on recent research, one reporter writes: "Until then, add amalgam fillings to the list of

risks Americans must decide whether or not to bear."214 However, no rights to make such an informed decision are currently afforded to individuals in this country by law. Legal implications for dentists using the amalgam fillings are mounting. Evidence of amalgam toxicity and the availability of safer alternative materials, arguably, substantially increases the liability of the ADA and pro-amalgam dentists. One attorney has predicted that mass tort litigation from amalgam poisonings will soon become a "major courtroom event."215 The class action suit in Kennedy216 may only be the tip of the litigation iceberg. Depending on the outcome of this case, "the mass litigation which will follow may well exceed other mass toxic tort cases...."217 The evidence available suggests, "the mercury amalgam issue is an internal Love Canal waiting to be exposed."218 If this is correct, then the ADA, its members and other pro-amalgam dentists may soon have an opportunity to defend

their position in the courts. Ultimately, it may take federal legislation to save traditional dentistry from financial ruin.219 C * This paper recently received the S. Welch award for outstanding legal writing by a third-year law student at the J. Reuben Law School of Brigham Young University http://www.piercelaw.edu/risk/vol2/spring/royal.htm the numbers can be found after this article on the above link..

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