Amalgam Fillings: Do Dental Patients Have a Right to Informed Consent?

informed_consent1

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.

{slide=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.{/slide}

{slide=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{/slide}

{slide=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{/slide}

{slide=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.{/slide}

{slide=Research as of 1991}

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, David Eggleston of the University of Southern California School of Dentistry admits, “positions could change.”123{/slide}

{slide=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{/slide}

{slide=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. Richard 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.{/slide}

{slide=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{/slide}

{slide=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{/slide}

{slide=Class Action Suit Against ADA}

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.{/slide}

{slide=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 “[b]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.{/slide}

{slide=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{/slide}

michael-royalWritten by Michael Royal in 1991

This paper received the John S. Welch award for outstanding legal writing by a third-year law student at the J. Reuben Clark Law School of Brigham Young University.

Mr. Royal has extensive trial and litigation experience before local courts and state administrative tribunals, and has distinguished himself as a premier litigator in the State of Nevada. Mr. Royal has had the distinguished honor of serving as a Law Clerk to the Chief Justice of the Nevada Supreme Court, the Hon. John C. Mowbray

http://www.royaljoneslaw.com/royal.html#

{slide=REFERENCES}

1 H. QUEEN, CHRONIC MERCURY TOXICITY: NEW HOPE AGAINST AN ENDEMIC DISEASE 24 (1988) (quoting Dr. Donald E. Bentley, ADA President, Bureau of Communications, 211 East Chicago Avenue; Chicago, Illinois 60611) (Special News Release II: ADA President Underscores Safety of Dental Fillings, 1983). See also, COUNCIL ON DENTAL MATERIALS, INSTRUMENTS, AND EQUIPMENT, COUNCIL ON DENTAL THERAPEUTICS, Safety of Dental Amalgam, 106 J.A.D.A. 519, 520 (1983) (“the use of mercury in dental amalgam restorations is safe for patients.”) [hereinafter Safety of Dental Amalgam].

2 See infra note 139.

3 See Friedman, Safety of Dental Amalgam, 260 J.A.M.A. 2295, 2296 (1988) (“There is no evidence that the presence of amalgam restorations poses any risk to the patient.”). See also, Special Report: When Your Patients Ask About Amalgam, 120 J.A.D.A. 398 (1990) [hereinafter Special Report].

4 H. QUEEN, supra note 1, at 24. “Suspected chronic exposure to mercury from dental amalgam should no longer be questioned.” Id. at 22 (citing Vimy & Lorscheider, Serial Measurements of Intra-oral Air Mercury: Estimation of Daily Dose from Dental Amalgam, 64 J. DENT. RES. 1072 (1985)). See also, H. HUGGINS & S. HUGGINS, IT’S ALL IN YOUR HEAD 9 (1985) (“In the hundred of articles we have accumulated on mercury in the body[,]… we have not been able to find even one that would support the claim that mercury is harmless to the patient.”); Hahn, Kloiber, Vimy, Takahashi & Lorscheider, Dental ‘Silver’ Tooth Fillings: A Source of Mercury Exposure Revealed By Whole-Body Image Scan and Tissue Analysis, 3 FEDERATION AM. SOCIETIES FOR EXPERIMENTAL BIOLOGY J. 2641 (1989) [hereinafter Dental ‘Silver’ Tooth Fillings] (footnotes omitted) (“[C]lear experimental evidence regarding its safety has not been demonstrated.”); INTERNATIONAL ACADEMY OF ORAL MEDICINE AND TOXICOLOGY, A SCIENTIFIC RESPONSE TO THE AMERICAN DENTAL ASSOCIATION’S SPECIAL REPORT AND STATEMENT OF CONFIDENCE IN DENTAL AMALGAM 1 (1990) (“In the interest of public safety, we reaffirm our 1985 position that the use of… mercury/silver fillings should be discontinued until such time as primary pathological evidence of amalgam safety is produced.”); CBS News,”Is There Poison In Your Mouth?”, 14 60 Minutes 2, 3 (CBS television broadcast, Dec. 16, 1990) (transcript may be obtained from CBS News, 60 Minutes Transcript, 542 West 57th Street, New York, New York 10019; transcript on file at Princeton University General Library, University of Michigan General Library, and University of Iowa General Library) [hereinafter 60 Minutes] (Dr. Murray Vimy, researcher and dentist at the University of Calgary Medical School stated: “This issue is, chronic exposure, low dose, to a heavy metal…. [N]o one has ever really looked at that aspect of mercury exposure.”).

5 H. QUEEN, supra note 1, at 24. See W. SHAFER, M. HINE & B. LEVY, A TEXTBOOK OF ORAL PATHOLOGY 578 (4th ed. 1983) (“A toxic reaction from absorption of mercury in dental amalgam has been reported on a number of occasions…. [T]his exposure may suffice to bring about allergies manifestations in patients sensitive to the mercury….”); D. SMITH & D. WILLIAMS, 3 BIOCOMPATIBILITY OF DENTAL MATERIALS 29 (1982).

6 R. CRAIG, W. O’BRIEN & J. POWERS, DENTAL MATERIALS: PROPERTIES AND MANIPULATION 94 (4th ed. 1987) (“If mercury is improperly handled in the dental office, a health hazard may result from (1) systemic absorption of liquid mercury through the skin, (2) inhalation of mercury vapor, and (3) inhalation of airborne particles.”).

7 See infra note 140.

8 See infra note 55.

9 Lee, Two Studies Suggest Risk From Silver Fillings, Chicago Tribune, Aug. 15, 1990, section 1, at 1, col. 2.

10 H. QUEEN, supra note 1, at 15.

10 D. SMITH & D. WILLIAMS, supra note 5, at 20. See Dental Fillings Cited as Environmental and Health Hazard, PR Newswire, Raleigh, N.C., Apr. 5, 1990 (The use of amalgam fillings won popularity as a substitute for gold and toxic lead fillings); J. TAYLOR, THE COMPLETE GUIDE TO MERCURY TOXICITY FROM DENTAL FILLINGS 189 (1988) (“Although the detrimental effects of mercury were well known in the 1800’s, there was no inexpensive substitute for gold fillings except for the silver mercury fillings.”).

11 D. SMITH & D. WILLIAMS, supra note 5.

12 J. TAYLOR, supra note 11, at 189.

13 Id.

14 Id. at 188 (citing M. RING, DENTISTRY: AN ILLUSTRATED HISTORY (1985)).

15 Id. at 188.

16 I. MJÖR, DENTAL MATERIALS: BIOLOGICAL PROPERTIES AND CLINICAL EVALUATIONS 22 (Oslo, Norway, 1985).

17 Id.

18 Id.

19 Id. See also, R. CRAIG, W. O’BRIEN, J. POWERS, supra note 6, at 94 (“Until more esthetic restoratives that can function in stress-bearing areas are developed, amalgam will continue to be used.”).

20 Dental ‘Silver’ Tooth Fillings, supra note 4, at 2641.

21 R. CRAIG, W. O’BRIEN, J. POWERS, supra note 6, at 94. “The hardening of the amalgam is the result of two phenomenon — solution and crystallization. When mercury initially comes into contact with the alloy, the particles are moistened by the mercury and they begin to absorb it…. The final result… is an amalgam with… superior properties.” Id. at 97.

22 Id. at 94.

23 Id. (“Mercury is a dense liquid metal that is highly toxic. Mercury of high purity possess a shiny surface.”). See also, D. SMITH & D. WILLIAMS, supra note 5, at 21 (“The purity of dental mercury in the ADA specification is defined by the surface appearance, the residue after pouring, and the nonvolatile residues. Mercury that has a clean surface with mirror-like appearance and pours cleanly can be used satisfactorily for dental purposes.”).

24 Special Report, supra note 3. See also, County Says Dentists Are Dumping Excess Mercury”, Arizona Daily Star, Oct. 16, 1989, at B1, col. 1. “If we can’t use the mercury amalgam, we’ll have to use gold — and a $30 filling will cost $200 or more.” Id. (quoting Richard Simoneaux, a Tucson dentist and Southern Arizona Dental Society President).

25 See generally id.

26 See Choulos & Weiner, It is More Probable Than Not That We will Soon Become Mad As Hatters, or The Legal and Health Effects of the Use of Dental Amalgams, 4 San Francisco Barrister 10, 13 (Jun. 1985).

Advantages of Using Enamel and Dentin Bonding composites vs. Amalgams: They contain no mercury…. They are more thermally insulating and protect the pulp better from temperature changes. They attain full strength very quickly and thus reduce failure from lack of strength and permit finishing and polishing to be done during one placement and appointment. Preparations may be more conservative with less tooth structure lost; little mechanical retention necessary by bonding to tooth structure; and tooth strength increases rather than decreases. No corrosion products are created. Composites have very good esthetics. There is extremely limited marginal leakage.

Id. (quoting M. Ziff, D.D.S., J.E. Hardy, M.D., presentation to Florida Academy of General Dentistry (July 23, 1983)) (emphasis added). See also, Peterson, FDA May Take Closer Look at Silver Fillings’ Safety, USA Today, Oct. 24, 1990, at D4, col. 1 (David Eggleston of the University of Southern California School of Dentistry stated that, “Dental amalgams will [soon] be phased out because of better materials that will be available at the same cost.”).

27 L. DICKEY, CLINICAL ECOLOGY 295 (1976).

28 One ADA expert writes: “The profession has been using amalgam for more than 150 years, and some of these newer materials have been around for only a decade or less, so we don’t have the longstanding of safety with them that we have with amalgam.” Special Report, supra note 3, at 396.

29 NATIONAL INSTITUTE OF DENTAL RESEARCH, Workshop: Biocompatibility of Metals in Dentistry, 109 J.A.D.A. 469, 471 (1984) [hereinafter Biocompatibility].

30 Safety of Dental Amalgam, supra note 1, at 520.

31 Supra note 29.

32 “If you took amalgam off the market tomorrow, a good 40 percent of the American dentists who belong to the American Dental Association would have to be retrained, because in their practices, the prime [material] that they use is dental amalgam.” 60 Minutes, supra note 4, at 10 (quoting Dr. Murray Vimy, researcher & dentist from University of Calgary Medical School).

33 D. SMITH & D. WILLIAMS, supra note 5, at 20 (Mercury toxicity was observed in humans as early as 380 B.C.).

34 H. QUEEN, supra note 1, at 15 (emphasis in original).

35 L. DICKEY, supra note 28, at 294.

36 Id. at 294 (The Mad Hatter, in Alice in Wonderland “had the characteristic slurred speech of the worker in the industry.”). See also, H. QUEEN, supra note 1, at 16.

37 Ingalls, Endemic Clustering of Multiple Sclerosis in Time and Place, 1934-1984, 7 AM. J. FORENSIC MED. & PATHOLOGY 3, 6 (1986).

38 Id.

39 See Vimy, Luft & Lorscheider, Estimation of Mercury Body Burden from Dental Amalgam Computer Simulation of a Metabolic Compartment Model, 65 J. DENT. RES. 1415 (1986); Drilling for Danger?, Newsweek, Oct. 15, 1990, at 80 (“fillings can be the largest single source of exposure to inorganic mercury”). See also, Mercury — An Element of Mystery, 323 NEW ENG. J. MED. 1137, 1139 (editorial by Thomas W. Clarkson, Ph.D., M.D.) (“Amalgam tooth fillings are… possibly the chief source of exposure of a large segment of the U.S. population.”).

40 D. SMITH & D. WILLIAMS, supra note 5, at 33. See also, Eggleston & Nylander, Correlation of Dental Amalgam with Mercury in Brain Tissue, 58 J. PROSTHETIC DENT. 704 (1987) (“Organic mercury compounds and elemental mercury vapor can cause central nervous system damage, and long-term exposure to inorganic (metallic) mercury vapor from dental amalgam may increase the brain tissue concentration of the neurotoxic metal.”); Mercury — An Element of Mystery, supra note 40, at 1138 (“Autopsy data indicate that brain mercury levels are approximately twice as high in people who have had fillings for many years as in those with no fillings….”).

41 H. QUEEN, supra note 1, at 20.

42 D. SMITH & D. WILLIAMS, supra note 5, at 20. See also, Vimy, Takahashi & Lorscheider, Maternal-Fetal Distribution of Mercury (203Hg) Released From Dental Amalgams, 27 AM. J. OF PHYSIOLOGY: REGULATORY, INTEGRATIVE & COMPARATIVE PHYSIOLOGY R944 (1990) [hereinafter Maternal-Fetal Distribution] (footnote omitted) (“Both kidney and liver were shown to be major sites of Hg deposition when human subjects inhaled [mercury] vapor from a nonamalgam source, and kidney and brain are considered to be critical target organs for Hg vapor effects.”).

43 See Ingalls, supra note 38, at 3. See also, Lee, supra note 9; 60 Minutes, supra note 4, at 4-5 (clinical evidence demonstrated some sufferers from multiple sclerosis were dramatically cured or relieved soon after removal of their amalgam fillings).

44 H. QUEEN, supra note 1, at 253.

45 Eggleston, Effect of Dental Amalgam and Nickel Alloys on T-lymphocytes: Preliminary Report, 51 J. PROSTHETIC DENT. 617, 619 (1984) (footnotes omitted) (“An abnormal T-lymphocyte percent of lymphocytes or a malfunction of T-lymphocytes can increase the risk of cancer, infectious diseases, and autoimmune diseases.”).

46 Huggins, Proposed Role of Dental Amalgam Toxicity in Leukemia and Hematopoietic Dycrasias, 11 INT. J. BIOSOCIAL & MED. RES. 84 (1989). See also, Royal, When Traditional Oriental or Modern Medicine Fail: Could Dental Amalgams Be Contributing to Our Declining Health ?, 18 AM. J. ACUPUNCTURE 205, 210 (1990) (“Chronic mercury intoxication, like syphilis, can mimic many different diseases as it slowly destroys cells, tissues and organs….”).

47 See Drilling for Danger?, supra note 40.

48 “It is believed that dental amalgams constitute the major source of exposure to inorganic Hg in the general population.” Hahn, Kloiber, Leininger, Vimy & Lorscheider, infra note 115, at 3256 (footnote omitted).

49 Dental ‘Silver’ Tooth Fillings, supra note 4, at 2641 (footnote omitted). See also, R. CRAIG, W. O’BRIEN & J. POWERS, supra note 6, at 97. It should be clearly understood… that once amalgamation occurs, for all practical purposes, no free (unreacted) mercury is associated with the amalgam restoration. The mercury in an amalgam is alloyed with silver or tin and no longer has the toxic properties of unreacted mercury. If, however, amalgam is heated beyond approximately 80 C, liquid mercury can form on the surface of the amalgam, and its vapor can present a health hazard. Id. But see Biocompatibility, supra note 30, at 470 (“Additional studies in this area are required to more accurately assess the possible risk to patients.”); INTERNATIONAL ACADEMY OF ORAL MEDICINE AND TOXICOLOGY, supra note 4, at 3 (citing Stock, Die Gefahrlichkeit des quecksiberdamphes, 39 Z. AGNEW CHEM. 461 (1926)) (“Published experimental evidence as early as 1926 has demonstrated that mercury is not locked in, but is released from fillings.”).

50 Mercury — An Element of Mystery, supra note 40, at 1138.

51 Supra note 1.

52 One author writes:

[T]here are ample experimental data which show that measurable amount of mercury vapor is released from both newly placed and aged amalgams…. [However,] the available evidence suggests that the health hazards of mercury to patients from amalgam restorations are negligible, with the exception of allergic reactions…. The potential danger to patients from mercury vapor inhalation in the dental office is considered remote because of the short duration of the office visit.

D. SMITH & D. WILLIAMS, supra note 5, at 28-29.

53 R. CRAIG, W. O’BRIEN, J. POWERS, supra note 6, at 95. See W. SHAFER, M. HINE & B. LEVY, supra note 5.

A toxic reaction from absorption of mercury in dental amalgam has been reported on a number of occasions…. [A] thorough review of the literature and numerous studies on the absorption and excretion of mercury [indicates] that the amount of estimated exposure to mercury from dental amalgam is not sufficient to cause mercury poisoning in the conventional sense. Nevertheless this exposure may suffice to bring about allergies manifestations in patients sensitive to the mercury….

Id. See also, I. MJÖR, supra note 17, at 24 (“allergy to mercury is a real, reported, and documented side effect. However, its frequency is low and the clinical symptoms are usually of insignificant nature.”).

54 See Dental ‘Silver’ Tooth Fillings, supra note 4, at 2645 (footnote omitted) (“In North America 5.4% of the population display contact hypersensitivity to Hg [mercury].”).

55 Richards, Maverick Dentists Question Safety of Typical Fillings, Wall St. J., Nov. 28, 1988, at B1, col. 5. See also, Biocompatibility, supra note 30, at 470 (“Studies have demonstrated that patients are exposed to mercury vapor when amalgams are placed as a restoration….”); Peterson, supra note 27 (quoting David Eggleston, researcher and dentist with the University of Southern California School of Dentistry) (“when amalgam is removed, ‘there is a temporary elevation of mercury in the blood…. The first trimester of pregnancy would be of particular concern.”); infra note 79 (regarding threats to pregnant women and mercury exposure).

56 See ADA Advertisement, Protect Yourself and Your Staff… Against One of the Hazards of Your Profession With the ADA’s Mercury Testing Service (copy available from American Dental Association, Council on Dental Research, 211 East Chicago Ave., Chicago, Illinois, 60611 1985); Brodsky, Cohen, Whitcher, Brown, Jr. & Wu, Research Reports: Occupational Exposure to Mercury in Dentistry and Pregnancy Outcome, 111 J.A.D.A. 779, 780 (1985) (“For dental personnel, mercury is absorbed directly into the body through handling and by inhalation of mercury vapors.”).

57 ADA RECOMMENDATIONS

Mercury has a high vapor pressure and should be stored in a cool place. Baseboard heaters should be avoided since spills collect at the edges of rooms and the higher temperature at the baseboard will raise the mercury vapor level above the safe limit. Carpeting of operatories is not recommended to avoid absorption of any spilled mercury. A no-touch technic of handling mercury should be used. Water spray and high-volume evacuation should be used when removing old amalgam restorations or finishing new ones since heating releases some mercury vapor. A face mask should be used to avoid breathing amalgam dust.

R. CRAIG, W. O’BRIEN & J. POWERS, supra note 6, at 95. The ADA also recommends “a yearly mercury urinalysis of all dental office personnel.” D. SMITH & D. WILLIAMS, supra note 5, at 23 (footnote omitted). However, “urinary mercury levels appear to have little or no diagnostic significance, and are useful only as a convenient means of assessing whether mercury exposure has occurred.” Id. at 26. See also, Biocompatibility, supra note 30, at 470 (“there appears to be little correlation between levels in urine, blood or hair, and toxic effects.”).

WARNING:”If mercury is improperly handled in the dental office, a health hazard may result from (1) systemic absorption of liquid mercury through the skin, (2) inhalation of mercury vapor, and (3) inhalation of airborne particles.”

R. CRAIG, W. O’BRIEN & J. POWERS, supra note 6, at 94. Recent surveys suggest that one out of ten dental offices in the U.S. may be in technical violation of the mercury exposure limit as recommended by the National Institute for Occupational Safety and Health (NIOSH) at 0.05 mg of mercury per cubic meter of air determined as a time-weighted average for an 8 hr. work day. D. SMITH & D. WILLIAMS, supra note 5, at 23 (footnotes omitted).

58 D. SMITH & D. WILLIAMS, supra note 5, at 22.

Occupational exposure of personnel to potentially hazardous levels of mercury vapor is a very real concern to the practicing dentist in the U.S. because of (1) moral responsibility to protect self and employees from any source that may constitute a serious threat to health and welfare, and (2) legal responsibility as an employer under the Occupational Safety and Health Act [OSHA] of 1970. … Currently, OSHA enforces a standard of 0.1 mg mercury per cubic meter of air in the work place.” Id. (emphasis added).

59 Id. at 21. “Inhalation of mercury vapor in the atmosphere is the major exposure route in dental personnel….” Id. at 33.

60 See Choulos & Weiner, supra note 27, at 11.

With approximately 85 percent of the population in the United States carrying mercury and nickel amalgam fillings in their teeth, the American Dental Association… [is] very emphatic in precautioning dentists and technicians to protect themselves from known hazards of working with mercury compounds. Yet, this august body continues to recommend the use of mercury in the oral cavities of patients, including children.

Id. (emphasis in original). See also, H. HUGGINS & S. HUGGINS, supra note 4, at 11 (“the dental association is telling us that the only safe place to store amalgam is in the mouth.”).

61 Dental ‘Silver’ Tooth Fillings, supra note 4, at 2641 (footnote omitted) (mercury levels were six times higher than before gum chewing). See also, Maternal-Fetal Distribution, supra note 43, at R939 (“In humans, the continuous release of Hg vapor from dental amalgam tooth restorations is markedly increased for prolonged periods after chewing.”); Mercury — An Element of Mystery, supra note 40, at 1138 (“The vaporization of mercury is stimulated during chewing and for several minutes thereafter.’).

62 Dental ‘Silver’ Tooth Fillings, supra note 21, at 2641 (footnote omitted).

63 H. QUEEN, supra note 1, at 22-23. Another researcher concludes: “If the capacity of mercury vapors to inflict central nervous system injury is a proven fact, so, too, the capacity of lead fumes to deliver the metallic poison through inspired air is incontestable.” Ingalls, supra note 38, at 6 (1986) (citing Putman, Quicksilver and Slow Death, Natl. Geographic 507 (Oct. 1973)).

64 See infra note 96.

65 Choulos & Weiner, supra note 27, at 12 (“the growing concern is the possibility of immune suppression and other serious effects of mercury leaching from dental fillings.”).

66 Special Report, supra note 3, at 395 (emphasis added). See also, INTERNATIONAL ACADEMY OF ORAL MEDICINE AND TOXICOLOGY, supra note 4.

It is a fallacy that mercury is neutralized when it is combined with other components of silver dental amalgam…. Mercury is diluted by the other components of amalgam in what may be considered a solid solution. Although the vapor pressure of mercury is reduced, mercury vapor is still released.

Id. at 2 (quoting Dun, Harmful Vapors in the Office: A Report of the Findings of the 1985 ODA/RCDS Survey of Mercury Vapor in Dental Offices in Ontario, Ontario Dentist 37-38 (1988)).

67 Special Report, supra note 3, at 395-96 (dentists are instructed to say, “no evidence exists that associates this minute amount of mercury vapor with any toxic effects.”). See also, Friedman, supra note 3. But see infra at 157 (research demonstrates that low doses of mercury have toxic effects).

68 Lee, supra note 9 (citing mercury toxicity experts Thomas Clarkson of the University of Rochester Medical School and Lars Friberg of the Karolinska Institute in Stockholm, Sweden). See H. QUEEN, supra note 1, at 15 (“While acceptable limits are often quoted by the federal regulatory agencies and health agencies, mercury is a poison at any level….” (emphasis in original)). See also, Lee, supra note 9 (Michael Ziff, an Orlando dentist, stopped using amalgam about nine years ago and believes “[t]he ADA should stop the use of this material until it can prove amalgam is safe.”); INTERNATIONAL ACADEMY OF ORAL MEDICINE AND TOXICOLOGY, supra note 4, at 3 (“Toxicology experts maintain that there is no threshold level of mercury exposure which can be considered totally harmless.”).

69 H. QUEEN, supra note 1, at 253 (quoting Edgar W. Mitchell, Ph.D., secretary to the ADA’s Council on Dental Therapeutics, ADA News Release I: Experts to Review Safety of Metals in Dentistry (Dec. 1983)).

70 H. QUEEN, supra note 1, at 253 (citing National INSTITUTE OF DENTAL RESEARCH, Workshop: Biocompatibility of Metals in Dentistry, 109 J.A.D.A. 469 (1984)).

71 H. QUEEN, supra note 1, at 253 (author’s note) (“To my knowledge, no further research (funded by either the ADA or NIDR) has been stated, or even planned, as a result of this workshop.”).

72 Id. at 254 (quoting John Stanford, Ph.D., biochemist and secretary to the ADA Council on Dental Materials, Instruments and Equipment, ADA News Release I: Experts to Review Safety of Metals in Dentistry (Dec. 1983) (“There is no evidence relating dental amalgam to… diseases and afflictions [such as multiple sclerosis & epileptic seizures]. To our knowledge, no cause-effect relationship has ever been established.”).

73 Id. (quoting Edgar W. Mitchell, Ph.D., secretary to the ADA’s Council Dental Therapeutics, ADA News Release I: Experts to Review Safety of Metals in Dentistry (Dec. 1983) (“We wish the public to be as certain as we are that dental amalgam is safe, and we will pursue this matter until that certainty is assured.”).

74 Id. (quoting ADA president, Dr. Donald E. Bentley, ADA News Release II: ADA President Underscores Safety of Dental Fillings (Dec. 1983)). See also, Peterson, supra note 27 (ADA spokesman Chuck Green said, “There is no reason for the public to be concerned and no reason to seek removal of fillings.”).

75 H. QUEEN, supra note 1, at 256 (quoting Richard Asa, ADA Manager of Media Services for the ADA, telephone interview in the spring of 1987).

76 Eggleston & Nylander, supra note 42, at 704 (footnotes omitted). (“The ADA bases its position on studies performed in 1957 by Frykholm, indicating there is little or no risk to the patient. … However, Frykholm’s study did not address long-term accumulation of mercury on the brain tissue.”).

77 Richards, supra note 56.

78 2 Dental & Health Facts 1 (Nov. 1989) (citing Atterstam, Socialstyrelsen Stops Amalgam Use, Svenska Dagbladet (May 20, 1987). See also, Eggleston & Nylander, supra note 42, at 706 (footnotes omitted).

(“The temporary high levels of mercury in the blood immediately following the removal and placement of dental amalgam has been documented…. The removal and insertion of dental amalgam for gravid patients, or women of child-bearing age with the possibility of pregnancy, should be avoided whenever practical.”).

See also, Peterson, supra note 27.

79 Dental & Health Facts, supra note 79.

80 S. Res. 12, 16th Leg., 1989 Alaska 1st. Sess. (“Concept Paper”).

81 Id.

82 60 Minutes, supra note 4.

83 Id. at 11 (re: Swedish laws) (“A total ban [in Germany] is expected within the year.”).

84 Richards, supra note 56 (citing Nobumasa Imura, a professor at Kitasito University in Tokyo).

85 The ADA has defined “quack” as “an ignorant or dishonest practitioner.” What Can Be Done About Dental Quackery?, 115 J.A.D.A. 679 (1987) (quoting WEBSTER’S MEDICAL DESK DICTIONARY). However, it is unclear whether ADA members or other pro-amalgam dentists who continue to use amalgam fillings and refuse to acknowledge research pertaining to the safety of amalgam are sufficiently “ignorant” under the ADA’s accepted definition. But see INTERNATIONAL ACADEMY OF ORAL MEDICINE AND TOXICOLOGY, supra note 4, at 9 (emphasis added) (“The ADA… is apparently suggesting that dentists deliberately violate their own code of ethics and withhold vital information from their patients and the public. Such action cannot help but intentionally violate the patients right to full informed consent.”); infra at 168.

86 Dental Ethics and Mercury, Spotlight, Oct. 22, 1990, at 15, col. 1.

87 Id. (EDA President Joyal Taylor, DDS: “Since no one knows just how little mercury it takes to cause permanent damage, as little exposure as possible [to] this powerful poison is the logical and moral course to take.”).

88 Dental ‘Silver’ Tooth Fillings, supra note 4, at 2642.

89 Id. at 2644.

90 Id.

91 Id.

92 Id.

93 Id. “The kidney and endocrine glands are known sites of autoimmune disorders, which brings into question the long-term implications of Hg [mercury] concentration in these tissues from dental amalgams….” Id. at 2645 (quoting Murray Vimy of University of Calgary). See Peterson, supra note 27 (“The average loss of kidney function [in the sheep] was 50%.”).

94 Dental ‘Silver’ Tooth Fillings, supra note 21, at 2644. See also, infra notes 117 and 119.

95 Id. (footnote omitted). See also, INTERNATIONAL ACADEMY OF ORAL MEDICINE AND TOXICOLOGY, supra note 4, at 3. “[The] continual release of mercury will inevitably result in measurable exposure from the 17,000 breaths that a person inhales daily. Once this mercury is inhaled 74% to 100% of the mercury is absorbed from the lung into the blood stream and distributed throughout the body.” Id. (citing Goldwater, Ladd & Jacobs, Absorption and Excretion of Mercury in Man; VII Significance of Mercury in Blood, 9 ARCH. ENV’T HEALTH 735 (1964)).

96 Dental ‘Silver’ Tooth Fillings, supra note 4, at 2645.

97 Id. (footnote omitted) (“Our laboratory findings in this investigation are at variance with the anecdotal opinion of the dental profession, which claims that amalgam tooth fillings are safe. Experimental evidence in support of amalgam safety is at best tenuous.” (emphasis added)). See also, Hahn, Kloiber, Leininger, Vimy & Lorscheider, infra note 115, at 3256.

98 Maternal-Fetal Distribution, supra note 43, at R939.

99 Id.

Highest concentrations of Hg from amalgam in the adult occurred in [the] kidney and liver, whereas in the fetus the highest amalgam Hg concentrations appeared in the liver and pituitary gland. The placenta progressively concentrated Hg as gestation advanced to term, and milk concentration of amalgam Hg postpartum provides a potential source of Hg exposure to the newborn. Id.

100 Id. A study being prepared for publication, sponsored in part by Sweden’s Karolinska Institute, demonstrates that mercury penetrates the placentas of mothers. The mercury accumulates in infant brain tissue. Peterson, supra note 27. “There is a transportation of fairly high concentrations of mercury from the mother to the brain of the fetus…. And that is a warning.” Id. (quoting Dr. Magnus Nylander of Stockholm).

101 Maternal-Fetal Distribution, supra note 43, at R939.

102 INTERNATIONAL ACADEMY OF ORAL MEDICINE AND TOXICOLOGY, supra note 4, at 3. See also, Dental Ethics and Mercury, supra note 87. But see Peterson, supra note 27 (Former president of the American Academy of Pediatric Dentistry disagrees with findings suggesting amalgam can be harmful, especially to children, and continues to use amalgam with the following endorsement: “I want nothing but the best for the children I see.”).

103 World Health Organization: Recommended Health-Based Limits on Occupational Exposure to Heavy Metals. Report of a WHO Study Group, 467 WHO Tech. Rep. Ser. 1 (1980) (“Exposure of women of child-bearing age to mercury vapor should be as low as possible because elemental mercury readily passes the placental barrier.”). See also, Macdonald, Occupational Hazards in Dentistry, 12 J. CALIF. DENT. A. 17 (1984).

104 Eggleston & Nylander, supra note 42.

105 Lee, supra note 9. See also, Drilling for Danger?, supra note 40 (Researcher Murray Vimy of the University of Calgary said that “Mercury ‘seriously compromises’ organ systems in test animals… and ‘should be banned immediately'”); Peterson, supra note 27 (Murray Vimy of the University of Calgary research team challenged the pro-amalgam dentistry world “to investigate thoroughly the possible ramifications of [amalgam’s] use in humans.”).

106 Peterson, supra note 27.

107 Id.

108 Id. (quoting Gregory Singleton, senior dental regulatory reviewer for the federal Food and Drug Administration). See also, Peterson, supra note 27 (the FDA may soon require manufacturers of amalgam to “provide safety and effectiveness data.”).

The FDA’s Dental Products Panel recommended on March 15, 1991 that, while it was confident that amalgam fillings pose no threat to most people, more research must be done to “allay the fears of the public.” Panel Takes the Teeth out of Fears over Dental Fillings, Deseret News, March 16, 1991, at A3, col. 6. Dr. Manville G. Duncanson, Jr., chair of the panel, stated that although “animal studies show sifnificant mercury absorption from dental fillings…, no studies have been done in humans and there is no evidence that amalgam fillings cause disease.” Id.

109 Peterson, supra note 27. See also, Dental Ethics and Mercury, supra note 87; 60 Minutes, supra note 4 (“The FDA remains confident in the value of amalgams in dental care. It says it could ban them, but it won’t do that until it is satisfied there is a health risk.”).

110 60 Minutes, supra note 4.

[T]he FDA’s dental division has been platooned full of American Dental Association people. The entire committee is made up of people from dental institutions, practicing dentists and people from the dental industry who make the dental materials. There is virtually no medical input or basic science input for medicine on that committee. [Thus], anything the ADA wants they pretty much get through the FDA. Id. at 9. (quoting Dr. Murray Vimy).

111 Peterson, supra note 27 (citing Murray Vimy of the University of Calgary).

112 See Voice of the People: Baa, baa, baa, Chicago Tribune, Aug. 29, 1990, section 1, at 15, col. 3 (“As a result of this alert journalism, I am confident that no dentist will ever again do a silver filling on a sheep.”). See also, Voice of the People: Silver Fillings, Chicago Tribune, Sept. 9, 1990, section 4, at 2, col. 3 (“Why then do you give so much exposure and implied credence in what happened to the kidneys of six sheep in Canada? … Would you call a test on six sheep in Canada significant?”).

113 Richards, supra note 56. See also, infra note 179.

114 Vimy, Boyd, Hopper & Lorscheider, Glomerular Filtration Impairment By Mercury Released From Dental “Silver” Fillings In Sheep, 33 The Physiologist A-94 (Abstracts) (Aug. 1990); Hahn, Kloiber, Leininger, Vimy & Lorscheider, Whole-Body Imaging Of The Distribution Of Mercury Released From Dental Fillings Into Monkey Tissues, 4 FEDERATION AM. SOCIETIES FOR EXPERIMENTAL BIOLOGY J. 3256 (1990) (“This study clearly demonstrates that the phenomenon of high Hg accumulation in body tissues after dental amalgam placement which we previously reported in sheep (footnotes omitted) is not unique to that species, and is readily demonstrable in primates as well.” Id. at 3258-59).

115 See Summers, Wireman, Vimy & Lorscheider, Increased Mercury Resistance In Monkey Gingival and Intestinal Bacterial Flora After Placement of Dental “Silver” Fillings, 33 The Physiologist A-116 (Abstracts) (Aug. 1990) (mercury was found to attack the primate immune system) [hereinafter Increased Mercury Resistance]; see also, 60 Minutes, supra note 4.

116 Increased Mercury Resistance, supra note 116 at A-116.

117 Lee, supra note 9.

118 Id. (quoting bacteriologist Anne Summers of the University of Georgia).

119 Drilling for Danger?, supra note 40.

120 Hahn, Kloiber, Leininger, Vimy & Lorscheider, supra note 115, at 3256 (“The dental profession’s advocacy of silver amalgam as a stable tooth restorative material is not supported by these findings.”).

121 Peterson, supra note 27 (quoting Murray Vimy of the University of Calgary).

122 Peterson, supra note 27.

123 OSHA to Begin Enforcing “Hazard” Rule, 19 Am. Dental A. News 1 (Aug. 1, 1988).

124 Infra notes 127 and 134.

125 See infra note 150.

126 County Says Dentists Are Dumping Excess Mercury, supra note 25.

127 Id.

128 Id.

129 Id.

130 Id. “Mercury, which can kill as it attacks the central nervous system of animals, ‘accumulates in vertebrates.'” Id. (quoting Bruce Palmer of the Arizona Game & Fish Department).

131 Id.

132 42 U.S.C. Sec. 9607 (as amended by the Superfund Amendments and Reauthorization Act of 1986, Pub. L. No. 99-499, 100 Stat. 1613 (1988)).

133 EPA, Dentists Settle in Mercury Cleanup Case, 19 Am. Dental A. News 1 (Aug. 15, 1988) (Both sites required the removal of twelve hundred ten (1,210) tons of mercury contaminated soil).

134 Id. The dentists settled with the EPA pursuant to 122(h) of CERCLA, 42 U.S.C. Sec. 9622(h) (1988).

135 U.S. v. Eugene L. Bourdeaudhui, Elsie Bourdeaudhui, Edward Battle, Benco Dental Supply Co., Inc., Ott Dental Supply Co., and Smith-Holden, Inc., A. Levanthal & Sons, Inc., Civ. No. H-88-354 (AHN) (D. Conn. June 3,1988), Dept. of Justice file No. 90-11-2-362, EPA Region I Site Numbers 74 & 76 [hereinafter Bourdeaudhui].

136 Id. (Consent Decree, signed July 28, 1989); 1989 EPA Consent LEXIS 14, Civ. No. H-88-354 (AHN) (D. Conn. 1988) (Consent Decree), Dept. of Justice file No. 90-11-2-362, EPA Region I Site Numbers 74 & 76 (LEXIS, Envirn library, Cases file).

137 Bourdeaudhui, supra note 136 (complaint at 4) (citing 42 U.S.C. Secs. 9602 & 42 U.S.C. 9601(14)) (1988) (emphasis added). For purposes of Sec. 107 of CERCLA, amalgam is a mercury compound, a zinc compound, a silver compound and a copper compound. Id. See 40 C.F.R. Sec. 302.4 at 930, 944, 955, 962 (1987). The U.S. also noted that mercury is a hazardous air pollutant under Sec. 112 of the Clean Air Act, 42 U.S.C. Sec. 7412 (1988), 40 C.F.R. Sec. 61.01 (1990), and a toxic pollutant under Sec. 307(a) of the Clean Water Act of 1977, 33 U.S.C. Sec.1317(a) (1988) and 40 C.F.R. Sec.401.15 (1990). Bourdeaudhui, supra note 136 (complaint at 4) (citing 33 U.S.C. Sec. 1317(a) (1988), 40 C.F.R. Sec. 401.15 (1990) (also listing mercury and compounds, silver and compounds, copper and compounds, zinc and compounds)). The EPA has reasoned that “‘any substance that contains a listed hazardous substance is itself a hazardous substance.'” Court OKs ADA Appearance in Amalgam Case, 20 Am. Dental A. News 1 (Jan. 16, 1989).

138 Bourdeaudhui supra note 136 (Motion to Appear, Introduce Evidence, File Brief and Make Oral Argument as Amicus Curiae). The ADA wrote:

The issues involved in this action are of paramount importance to the members of the ADA as well to the general public since their resolution will have a vital impact on the general public and on the manner in which the members may practice their profession in the United States, in that the handling and recycling of dental amalgam is being challenged in the United States. Dental amalgam is the primary restorative material utilized by dentists for the restoration of the teeth of patients.

Id. at 4. As part of its effort to establish the safety of amalgam fillings, the ADA reiterated its resolve that “Dental amalgam has been safely used in the United States for over 150 years and dates back several centuries in other countries.” Id.

139 Id. See also, Court OKs ADA Appearance in Amalgam Case, supra note 138 (“In appearing as a friend of the court, the ADA is doing what it can to ensure that its position on the safety of scrap amalgam is made clear.”).

140 EPA, Dentists Settle in Mercury Cleanup Case, supra note 134 (quoting Mary K. Logan, ADA associate general counsel). The ADA feared the case could set off a legal declaration that dental amalgam could be declared a hazardous substance by a federal court, as it clearly was by the EPA. “In a worst case scenario, scrap amalgam could be declared an environmental hazard, but that is the extent of it.” Id.

141 Court OKs ADA Appearance in Amalgam Case, supra note 138.

142 Id. (quoting Kenneth D. Walma, ADA legal affairs director,”That’s not a federal court talking,” said Mr. Walma. “That’s the EPA; the court has said nothing of the sort.”).

143 See, supra note 137.

144 Court OKs ADA Appearance in Amalgam Case, supra note 138.

145 See supra note 137.

146 Id. (Motion to Appear, Introduce Evidence, File Brief and Make Oral Argument as Amicus Curiae at 2).

147 Id.

148 Supra note 147.

149 A new environmental hazard was recently identified in Britain as a result of the effects of burial funerals to cremation. Dr. Allan Mills, of Leicester University, says that poisonous mercury vapor is being released into the air from the dental fillings of the cremated. Mills, Mercury and Crematorium Chimneys, Nature (London) 615 (Aug. 16, 1990).

150 One of the ADA’s “signs” as to “how to spot a quack” is whether a dentist “supports claims with articles published in obscure, pseudoscientific journals or the public media.” How to Spot a Quack, 115 J.A.D.A. 681 (1987). However, no definition of “pseudoscientific” was provided.

151 See infra note 157.

152 The ADA’s position is simple: Since there is no risk involved, informed consent is unnecessary. See 60 Minutes, supra note 4, at 9-10 (Dr. Heber Simmons, ADA spokesman).

153 Kotler, Utility, Autonomy and Motive: A Descriptive Model of the Development of Tort Doctrine, 58 U. CINN. L. REV. 1231, 1260 (1990) (citing Schloendorff v. Society of New York Hosp., 211 N.Y. 125, 105 N.E 92 (1914) (Cardozo, J.)). See also, Note, The Doctrine of Informed Consent Applied to Psychotherapy, 72 GEO. L.J. 1637, 1640 (1984) [hereinafter Doctorine] (footnotes omitted) (“The doctrine of informed consent is the means by which individuals are informed of, and may assert their preferences for, alternative forms of available medical treatment.”).

154 Kotler, supra 154, at 1260 (quoting Schloendorff v. Society of New York Hosp., 211 N.Y. 125, 129-30, 105 N.E. 92, 93 (1914) (Cardozo, J.)).

155 154 Cal. App. 2d 560, 573-75, 317 P.2d 170, 181 (Dist. Ct. App. 1957).

156 Id.

157 Shultz, From Informed Consent to Patient Choice: A New Protected Interest, 95 YALE L.J. 219, 226-27 (1985) (footnote omitted).

158 Kotler, supra note 154, at 1252 (quoting Shultz, From Informed Consent to Patient Choice: A New Protected Interest, 95 YALE L.J. 219, 280 (1985)).

Doctors are universally conceded to be fiduciaries; as such they have special duties to serve their clients’ interests. Patients have been redefining their interests in the direction of more active participation in decision making. In the wake of such redefinition, the nature of fiduciary obligation must also change to stress more advising and less deciding.

Id. at 279 (footnotes omitted).

159 W. KEETON, R. KEETON, D. DOBBS & D. OWEN, PROSSER AND KEETON ON THE LAW OF TORTS (5th ed. 1984) 359 (footnotes omitted) (for example, dentists could be held liable for studies of which they are aware or those which, by reasonable diligence, should be aware). “The evidence is here, and [the public] should say that if it’s not reasonably safe… [it should not be put into a] child’s mouth.” 60 Minutes, supra note 4, at 10 (quoting Dr. Alfred Zamm, allergist & dermatologist).

160 Bourdeaudhui, supra note 136 (Motion to Appear, Introduce Evidence, File Brief and Make Oral Argument as Amicus Curiae at 2).

161 Peterson, supra note 27 (quoting ADA President R. Malcom Overbey).

162 Shultz, supra note 158, at 226-27 (footnote omitted).

163 Kotler, supra note 154, at 1252.

164 Id.

165 See supra note 159.

166 Doctrine, supra note 154 at 1642. See Twerski & Cohen, Informed Decision Making and the Law of Torts: The Myth of Justiciable Causation, 1988 U. ILL. L.R. 607 (1988). See also, Choulos & Weiner, supra note 27. “The proof of proximate may be difficult, but in cases with clearly manifested injuries it is not impossible if expert testimony is up to standard on causation.” Id. at 15.

167 Shultz, supra note 158, at 226-27 (footnote omitted).

168 Comment, Informed Consent: Patient’s Right to Comprehend, 27 How. L.J. 975, 978 (1984) [hereinafter Informed Consent] (quoting Karp v. Cooley, 493 F.2d 408 (5th Cir. 1974), cert. den., 419 U.S. 845 (1974) (majority view)). See also, Shultz, supra note 158, at 248 (footnote omitted).

169 Informed Consent, supra note 169, at 978.

170 Id. at 982 (footnote omitted).

171 Id. at 981 (footnotes omitted). See also, Shultz, supra note 158, at 226-27 (footnote omitted) (This standards requires the patient to establish that the nondisclosed information would not only have induced him, but any reasonable patient to withhold consent).

172 Informed Consent, supra note 169, at 982 (footnote omitted).

173 Id. at 982-83 (footnotes omitted).

174 Id. at (citing Salis v. U.S., 522 F. Supp. 989 (M.D. Pa. 1981)). See supra note 50.

175 See Comment, The Drug Manufacturer’s Duty to Warn — To Whom Does It Extend?, 13 FLA. ST. U. L. REV. 135, 156 (1985) [hereinafter Drug Manufacturer’s Duty (footnote omitted) (“In order for a product warning to be effective, the following criteria must be met: (1) the warning must be received; (2) the warning must be understood; and (3) the individual must act in accordance with the warning.”). See also, Dental Ethics and Mercury, supra note 87 (after recently banning the use of mercury recently in all interior latex paint products, the EPA now requires all latex exterior paint be clearly labeled as to its mercury content).

176 Peterson, supra note 27.

177 Drug Manufacturer’s Duty, supra note 176, at 156 (footnote omitted) (suggesting that since patients rarely receive proper warnings from doctors that a direct manufacturer-to-patient to warn in lay language might be a better way to inform patients). See also, Dental Ethics and Mercury, supra note 87 (the EDA contends dentists who fail to inform patients of mercury-laden fillings are acting unethically).

178 David Kennedy, D.D.S., et al. v. American Dental Association, Civil Action No. 1-90 Civ. 1692 (N.D. Ohio 1990).

179 Id. at 2 (complaint).

180 Id.

181 Id. at 4-7.

182 Id. at 12.

183 Id. at 12-13.

184 Choulos & Weiner, supra note 27, at 13. “The prospect of punitive damages makes a potential offender take notice, particularly when the measure is a portion of corporate profits and has made corporate executives vulnerable to criticism from stockholders who face reduced dividends.” Id. at 13-14.

185 Dental Ethics and Mercury, supra note 87.

186 H.R.J. Res. 1001, 57th Leg., 1990 Colo. 1st Sess. (Proposed 1990 amendment to 12-35-103 COLO. REV. STAT Sec. 5 (1985 Repl. Vol.)) [hereinafter H.R.J. Res. 1001].

(1.7) “Informed consent” means written consent given by a patient prior to any dental procedure or treatment which involves the placement or implant of mercury amalgam or any other dental prosthetic containing mercury, and which is obtained after the patient is sufficiently informed as to the procedures or treatment to be used and all associated risks which a reasonable patient would consider significant in making a decision of whether to undergo the procedure or treatment, including any special risks involved of which the dentist knows or should reasonably know.

(2)… the use of amalgam or any other dental prosthetic containing mercury in the preparation and implant of dental fillings is expressly prohibited where prior written informed consent from the patient is not obtained…. A dentist shall be strictly liable for any injury which results from the placement of mercury amalgam into a patient where written informed consent is not obtained prior thereto.

Id. (emphasis added).

187 Id.

(2)… No dentist shall be sanctioned, reprimanded, punished or otherwise prohibited from practicing dentistry by any entity or organization where the dentist has determined, within his or her professional judgment, that the removal and replacement of a mercury amalgam filling is reasonably necessary to restore or protect the patient’s health and safety, and where the dentist proceeds to remove and replace such filling after making this determination….

Id. See also, Consent and Authorization, H.R.J. Res. 1001, 57th Leg., 1990 Colo. 1st Sess.

188 See supra note 29.

189 Supra note 187 (Commentary to proposed 1990 amendment to 12-35-103 COLO. REV. STAT Sec. 5 (1985 Repl. Vol.) at 1).

Within the dental profession, studies have provided substantial scientific evidence that dental amalgam containing mercury can endanger the health and safety of patients who receive amalgam fillings…. At present, dental patients are not typically informed of the potential risks which exist when mercury amalgam is used for dental fillings. The proposed Act seeks to assure the health and safety of all dental patients by requiring dentists to give their patients basic information regarding the risks involved when mercury amalgam is used…. [Disclosures as to the potential risks of mercury amalgam] would undoubtedly be greatly appreciated by the patients, and further strengthen the trust and confidence that the patient has in their dentist.

Id.

190 Id.

191 Id.

192 H.R.J. Res. 1001, supra note 187.

WHEREAS it is a common dental practice in the state to use an amalgam of materials for dental fillings; and

WHEREAS this dental amalgam is thought by most persons to be made only of silver, but its composition is actually 50 percent mercury; and

WHEREAS some studies have shown that toxic mercury vapors can leak from the fillings into the patient’s blood system and lead to mercury poisoning, particularly in chemically sensitive or allergic persons; and

WHEREAS dental patients should have the right to choose which materials are used for their dental fillings, but they often lack basic information from the dentist that would help them make an informed choice;

RESOLVED… dentists will inform their patients that:

a. mercury is contained in most dental filling material;

b. mercury in fillings can have toxic effects on some persons;

c. there are alternative materials that could be used for dental fillings that could have other effects on the person; and

d. they have a right to insist that an alternative material be used.

Id.

193 Dentist Says Silver Fillings Bad, UPI, Jun. 8, 1983 (AM cycle).

194 A Wolf in Legislative Clothing, 120 J.A.D.A. 397 (1990) (specifically referring to proposed legislation in Alaska).

195 S. Res. 12, 16th Leg., 1989 Alaska 1st Sess.; see also, 60 Minutes, supra note 4. “When I measured mercury coming off of fillings, that was ‘reasonable doubt’ in my mind.” Id. at 3 (quoting Dr. Murray Vimy). “There’s a lot of things we don’t know, but I do know that it’s not safe to put something in somebody’s mouth that has a question.” Id. at 7 (quoting Dr. Alfred Zann).

196 S. Res. 12, 16th Leg., 1989 Alaska 1st Sess.

197 Id.

198 A Wolf in Legislative Clothing, supra note 195 (specifically referring to proposed legislation in Alaska).

199 H.R. Res. 1084, 86th Leg., 1989 Ill. 1st Sess. (Offered by Rep. Cowlishaw; Adopted on November, 1, 1989. Signed Michael J. Madigan, Speaker of the House and John F. O’Brien, Clerk of the House); reprinted in 6 Bio-Probe Newsletter 3 (Jan. 1990).

WHEREAS, It is a common dental practice in Illinois to use an amalgam of materials for dental fillings; and

WHEREAS, This dental amalgam, thought by the public to be made only of silver, is actually 50% mercury; and

WHEREAS, Studies have shown that toxic mercury vapors can leak from fillings into the blood system and cause serious health problems, particularly in persons with allergies or chemical sensitivities; and

WHEREAS, Dental patients often lack information that would enable them to avoid having mercury used for their fillings; therefore be it

RESOLVED, BY THE HOUSE OF REPRESENTATIVES OF THE EIGHTY-SIXTH GENERAL ASSEMBLY OF THE STATE OF ILLINOIS, that this body hereby requests that 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; and be it further

RESOLVED, That a copy of this preamble and resolution be presented to the Director of the Illinois Department of Public Health.

Id.

200 A Wolf in Legislative Clothing, supra note 195 (referring to Alaska and North Carolina).

201 Choulos & Weiner, supra note 27, at 13.

202 See Drilling for Danger?, supra note 40 (“Over the last 10 years, researchers have shown that mercury escapes from fillings and winds up in body tissues”).

203 Shultz, supra note 158, at 296 (footnote omitted).

204 While the ADA claims that dental amalgam is safe and effective, it also “believes that dentists should choose the best possible restorative material for each patient on an individual basis. The professional judgment of the dentist and the desires of the patient should be the foundation on which that choice is based.” Special Report, supra note 3, at 398. But see INTERNATIONAL ACADEMY OF ORAL MEDICINE AND TOXICOLOGY, supra note 4, at 9 (suggesting that the ADA Principals of Ethics and Code of Professional Conduct are in conflict because they specifically disapprove of informing patients of the dangers of amalgam fillings, while placing a duty on dentists to report investigations leading to public health threats); 60 Minutes, supra note 4, at 6 (Dr. Murray Vimy says the effect of the ADA’s position that informing patients of the dangers of amalgam is unethical infringes upon “the Constitutional rights of dentists and the rights of patients. [Patients] no longer have freedom of choice and [dentists] no longer have freedom of expression.”); supra note 86.

205 Supra note 29.

206 See supra note 147.

207 H. QUEEN, supra note 1, at 24.

In the U.S., because of the legal aspect, dental authorities who today must set guidelines of acceptable dental protocol may be reluctant to speak out against the use of mercury when such action is warranted. They may fear that dentists who have followed their previous guidelines will become liable…. An extension of this concern may also affect research. Whatever progress is made in getting closer to the truth would most likely be met with a great deal of resistance.

Id. (emphasis added).

208 INTERNATIONAL ACADEMY OF ORAL MEDICINE AND TOXICOLOGY, supra note 4 at 6.

209 Supra note 179.

210 Kotler, supra note 155, at 1260 (citing Schloendorff v. Society of New York Hosp., 211 N.Y. 125, 105 N.E. 92 (1914) (Cardozo, J.)).

211 I. MJÖR, supra note 17, at 24 (because “individual case reports often prevail as evidence… the problem should be dealt with on an individual basis rather than by prohibiting the use of a serviceable dental material.”).

212 See F. Royal, supra note 47 at 210.

213 Drilling for Danger ?, supra note 40 (emphasis added); see supra note 27.

214 Choulos & Weiner, supra note 27 at 14.

215 Supra note 179.

216 Choulos & Weiner, supra note 27 at 14.

217 Id. at 15.{/slide}

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