Re: Amalgam Fillings:

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> http://www.piercelaw.edu/risk/vol2/spring/royal.htm

>

> Amalgam Fillings:

> Do Dental Patients Have a Right to Informed Consent?* A.

Royal** Introduction An individual may seek the services of a

dentist for any number of reasons. After examination, the dentist may

determine that the patient has a cavity and inform the patient that

the cavity must be filled. Dentists usually do not consult patients

to determine what materials to use. Most feel that dialogue with the

patient on this issue is unnecessary. However, some materials may be

hazardous under certain conditions. New research suggests that mercury

amalgam (or " silver " ) fillings (hereinafter amalgam) may fall into

that category. However, the American Dental Association (ADA)

supports the use of such fillings and assures " the American people

that dental amalgam is safe. " 1 The ADA claims that since mercury

amalgam has been used for over 150 years, its safety should not be

disputed.2 While its position remains largely unsupported by

scientific evidence, the ADA challenges those

> opposed to the use of amalgam fillings (anti-amalgamists) to

produce scientific evidence that its use is harmful to humans.3 This

challenge has been accepted. The anti-amalgamists have countered by

challenging the ADA to demonstrate that safe levels of mercury in

human tissues exist before endorsing its use.4 The ADA has yet to

respond. Both sides do, however, agree that " [1] [mercury] is one of

the most poisonous elements known to man, and [2] mercury amalgam may

cause ill effects in those people who are mercury sensitive. " 5 The

mercury used in fillings is hazardous before and during their

preparation.6 Also, scrap materials pose an environmental hazard when

discarded.7 Research over the past decade demonstrates that their use

poses a potential health hazard to a significant number of the

estimated 200 million Americans with amalgam fillings.8 Amalgam

continues to be the primary filling material in the U.S., largely due

to the ADA's endorsement.9 This article will

> first examine the history and general issues involved in the use of

amalgam fillings. Second, it will review available research to

demonstrate the potential health hazards. Third, it will briefly

investigate environmental issues and suggest that potential risks

extend beyond those posed for patients. Ultimately, the article will

address whether, whatever uncertainty may be present, patients do not

have a right to be informed of potential risks and of available

alternatives. History of Amalgam Fillings Opponents of amalgam

have challenged its use in dentistry since its introduction over 150

years ago.10 The first reported use in dental restorations was in

1818.11 Since then, concerns over the toxic effects of mercury have

persisted.12 The American Society of Dental Surgeons, formed in

1840,13 so abhorred the use of amalgam that it required its members to

sign pledges that they would not use it.14 In 1848, The Society of

Dentists of the City and State of New York

> suspended eleven of members for " malpractice, " because they used

amalgam.15 Internal strife over the use of mercury in dentistry led to

the formation of the ADA, whose leaders did not oppose its use.16 In

the late 1920's, anti-amalgamists challenged the use of amalgam again,

as evidence surrounding the toxic effect of certain mercury compounds

" appeared indisputable. " 17 Despite this, the use and popularity of

amalgam in dentistry continued to grow rapidly.18 Questions about its

safety arose again about fifteen years ago and continue unabated.19

Nevertheless, mainstream dentistry believes it is " most unlikely " that

the current " anti-amalgam crusade " will succeed in eliminating its

use.20 Amalgam fillings typically comprise 50% pure elemental

mercury, 35% silver, 13% tin, 2% copper, and a trace of zinc.21 The

metal powders react with liquid mercury to produce an amalgam (or

alloy)22 that provides a flexible material that can be easily packed

and shaped.23 Amalgam

> fillings are often called silver fillings because of appearance and

composition.24 The ADA prefers the use of amalgam because fillings

are inexpensive and durable, while gold and other composite materials

are more expensive and more difficult to fit.25 Because of its

flexibility, the use of amalgam arguably requires less skill. Thus,

dentists can usually fill a cavity in less time.26 Some, however,

believe that alternatives that have been available for several years,

may be even stronger and more durable.27 One author proclaimed over

fifteen years ago that since " satisfactory alternative tooth-filling

materials are available, ... the use of amalgam fillings should be

discouraged. " 28 However, the ADA maintains that there are no

acceptable substitutes,29 although it admits, " the use of composite

resins as a posterior restorative material may eventually replace

amalgam restorations. " 30 In fact, the ADA recognizes that once an

" acceptable " replacement for amalgam is found,

> that " even the possible hazard to dental office personnel of high

levels of mercury vapor from mercury spills could be eliminated. " 31

The ADA adamantly defends mercury usage in tooth restorations whenever

others suggest that it poses a potential health threat on the basis

that it has been used " safely " over the past 150 years.32 Other

reasons behind its support of amalgam may include: 1) ease of use; 2)

low cost; 3) additional training and equipment required to use

alternative materials;33 and 4) potential liability associated with

acknowledging the dangers of amalgam previously used. Unfortunately,

the cost of a vast array of chronic, degenerative, mental and physical

diseases related to mercury exposure in patients, dentists, dental

personnel and society appears to be immeasurable. Mercury Toxicity

Mercury has been known to be a poison for thousands of years,34

whether " ingested, inhaled, or absorbed through the skin. " 35 In the

1800's, British workers who used

> mercury in the hat making process developed symptoms of mental

deterioration on an industry-wide basis.36 The expression, " mad as a

hatter, " originated from that.37 Also, citizens of Minamata, Japan,

endured ten years of misery, crippling deformities and agonizing

deaths before industries ceased polluting the local harbor with

mercury.38 The mercury was transferred to Minamata citizens when they

consumed fish from the polluted harbor. This resulted in more than

10,000 cases of " Minamata disease, " which had a 10% mortality rate.39

Today, according to those involved in research, human exposure to

mercury is primarily through dental amalgam.40 Mercury has been

found to accumulate in vital organs and tissues, such as the liver,

brain,41 and heart muscle.42 Major symptoms of mercury toxicity

include emotional instability, tremors, gingivitis, and kidney

failure.43 Some also believe mercury may be linked to multiple

sclerosis44 and epileptic seizures.45 Further, its affect on

> the body's immune system is potentially devastating,46 possibly

contributing to diseases such as leukemia and hematopoietic

dycrasias.47 No direct connection to any specific diseases has yet

been made, primarily " because no one has really looked. " 48 However, as

research continues, evidence is accumulating. Dental fillings may yet

prove to have effects many times greater than those found at

Minamata.49 Patient Exposure to Mercury from Amalgam Restorations

Dentists maintain that mercury in " amalgam becomes inert once the

fillings have been allowed to set for several days, and that long-term

danger to the patient from [mercury] vapor is therefore remote. " 50 The

New England Journal of Medicine recently reported, " Many important

medical questions concerning mercury toxicity remain to be

answered. " 51 The ADA, by contrast, continues to assert that it has

enough information to guarantee its safety for use.52 Nevertheless,

dentists admit that there is exposure to mercury

> vapor,53 and the ADA acknowledges that an allergic reaction poses

" [a] small but possible risk to the patient. " 54 However, approximately

eleven million Americans are mercury sensitive.55 Further, the ADA

agrees that the removal of amalgam fillings " can release relatively

large amounts of mercury into the mouth[,] and that may be harmful. " 56

While de-emphasizing possible risks to patients, the ADA has taken

affirmative steps to inform dentists and their personnel of the

potential hazards of mercury57 and has established strict guidelines

for storing and handling amalgam.58 One author suggests that dentists

have both a " moral " and a " legal " duty to protect dental personnel.59

Because the primary danger in dental offices is " the atmospheric

mercury vapor, " 60 the ADA presents an interesting paradox in its

position on amalgam. The organization considers the mercury vapors

which threaten dental personnel are " insignificant " .61 Recent

studies have found that substantial

> amounts of mercury vapor are released from dental amalgam after

chewing gum for just ten minutes.62 Studies have also shown that

mercury vapor can be released by " brushing the teeth with commercial

toothpaste, " 63 " chewing food, drinking hot beverages, and smoking

cigarettes. " 64 Therefore, mercury vapor is continually present.65

Mercury Toxicity From Amalgams Although amalgam subjects dental

patients to dangerous mercury vapor,66 when asked if mercury is

poisonous, the ADA recommends that dentists answer patients in the

following manner: " Not when used as amalgam.... [W]hen mercury is

combined with other metals... it reacts with them to form a

biologically inactive substance. " 67 The ADA instructs its dentists not

to inform patients that amalgam continuously releases mercury -- even

if patients inquire.68 No governmental agency has established safe

standards for mercury intake from dental amalgams. Some experts

believe " there is no safe level of mercury exposure. " 69

> The ADA investigated the possible affects of amalgam fillings in

1984 and assured the nation that, " [a]lthough there is no evidence of

a health threat, we will pursue the question of safety until the

matter is resolved to the satisfaction of the American people. " 70 The

1984 Workshop on The Safety and Biocompatibility of Metals in

Dentistry concluded that mercury is released from amalgam fillings.71

Nevertheless, the ADA maintained that no health problems could result

from such a small amount of exposure.72 When subsequent studies

surfaced linking amalgam fillings to several incurable diseases, the

ADA denied all claims that amalgam could possibly be responsible73 --

while reassured those concerned that it would " continue " to do

everything in its power to resolve any questions as to its safety.74

In response to claims concerning amalgam hazards in 1987, the ADA

boldly responded that such claims are unfounded,75 " unsubstantiated,

undocumented, and unproven. " 76 However,

> numerous studies performed since 1981, " demonstrate a positive

correlation between dental amalgams and mercury levels in the human

brain. " 77 Other countries have taken action to limit or prohibit the

use of amalgam fillings. Two years ago, the Swedish government

" recommended that dentists stop using amalgam to fill the teeth of

pregnant women. " 78 Since then, Swedish authorities determined to ban

the use of all mercury, including its use in amalgam fillings, by

1991, have urged that its use in pregnant women cease immediately.79

Viking Falk, division chief of the Swedish Social Welfare and Health

Administration, said, " We now realize that we have made a mistake.

This has caused people to suffer unnecessarily. " 80 The ADA " quickly

regarded [this report] as 'bogus[.]' " 81 However, the Swedish ban was

subjected to public hearings and subsequently upheld.82 In fact, in

November, 1990, the Swedish government passed a law providing its

citizens the opportunity to have their

> amalgam fillings removed under the national dental plan.83 Also,

legislation has been introduced in Germany to ban the use of

amalgam.84 In Japan, dentists have likewise sought to use alternatives

to amalgam.85 Current research demonstrating strong evidence of

chronic mercury toxicity in patients with amalgam fillings has done

little to persuade the ADA to reevaluate its position. Some dentists

have suggested that their patients consider changing their amalgam

fillings and replace them with non-toxic materials, based on current

research. The ADA has labeled the actions of these dentists

" unethical, " stating that dentists engaging in this practice raise " a

question of fraud or quackery in all but an exceedingly limited

spectrum of cases. " 86 However, current research has prompted groups,

such as the Environmental Dental Association (EDA), to call for a ban

on any use of mercury in dental materials.87 The EDA contends that

using amalgam without informing the patient of

> associated risks and alternatives is " unethical. " 88 A summary of

recent scientific findings, which follows, suggests that health

threats from amalgam exist in laboratory animals and probably in

humans. Current Research Researchers from the departments of

medicine, pathology and physiology from the University of Calgary,

Alberta, Canada, performed revealing experiments during 1989 and 1990

regarding the safety of amalgam fillings. Two studies examined the

effects of amalgam fillings on sheep, while a third studied its

effects on monkeys. The 1989 study placed amalgam fillings into the

mouth of a four year old ewe for 29 days.89 At the end, mercury was

absorbed in the lungs90 (due to " continual breathing of the

'intra-oral air' having mercury vapor " ), the stomach91 (through " the

mixing of intra-oral Hg vapor, amalgam microparticles, and dissolved

mercuric ions with saliva and food before swallowing " ), the jaw

92( " some tissues in the jaw... and tooth root and surrounding

> bone " ), " the brain[,] and several endocrine glands. " 93 The kidneys

had high concentrations of mercury,94 which disproves earlier theories

that mercury is excreted.95 The study concluded that, because about 8%

of inhaled elemental mercury vapor is absorbed into the blood in

humans, it immediately " becomes available for tissue retention. " 96

Since the study found problems resulting from mercury exposure so

quickly, amalgam fillings " remain[ing] in human teeth for eight to ten

years... would allow an extended opportunity for body tissues to be

continuously exposed to Hg [mercury]. " 97 The study concluded: " dental

amalgams can be a major source of chronic Hg [mercury] exposure. " 98

Another study, at the University of Calgary in 1990, investigated the

affect of amalgam fillings on a fetus.99 Five pregnant ewes had

amalgam placed in their teeth at 112 days gestation. This study

demonstrated that mercury from amalgam fillings appear in maternal and

fetal blood and the amniotic

> fluid within two days after placement of the dental

restorations.100 The study concluded that amalgam also accumulates in

maternal and fetal tissues.101 These results prompted the researchers

to conclude: " Dental amalgam usage as a tooth restorative material in

pregnant women and children should be reconsidered. " 102 Mercury

exposure is of particular concern in the developing fetus and in

children due to their low body weight.103 A study performed ten

years ago concluded that pregnant women should avoid exposure to

mercury.104 Previous studies have also demonstrated that mercury

exposure from amalgam can deteriorate the immune system.105 Although

the Calgary studies did not show whether kidney functions returned

after removal of the amalgam, Fritz L. Lorscheider, who was involved

in both of the Calgary studies, concluded: " [we] know that mercury is

highly toxic and that it concentrates in certain parts of the human

body. From the sheep, we know it can alter kidney

> function in animals. That should be enough to get it banned. " 106

The University of Calgary studies were the first to demonstrate that

changes in body functions occur following the implantation of

amalgam.107 Shortly after publication, the findings were reported on

the front page of the Chicago Tribune on August 15, 1990.108 The

article quoted a Food and Drug Administration (FDA) representative as

saying, " In light of emerging scientific data, the FDA needs to

re-examine the use of amalgam. It may be necessary to reclassify

amalgam and take various regulatory actions. " 109 The FDA allowed the

use of amalgam to continue in 1976 because the substance was already

widely in use.110 Some believe the FDA's decision to do so was largely

because of the ADA's influence within the FDA.111 However, after the

animal tests at Calgary, the FDA would probably not allow amalgam to

be used if it were a new product.112 Some Chicago dentists took

exception to the Chicago Tribune's decision

> to give the story so much prominence.113 The ADA has been accused

by anti-amalgam dentists of actively seeking to avoid problems of

liability which might arise through any admissions.114 A more recent

study completed by the University of Calgary found that monkey

kidneys, like sheep kidneys, concentrated large amounts of mercury

when given amalgam fillings.115 Another study of two adult monkeys at

the University of Georgia, in cooperation with the University of

Calgary, concluded that bacteria normally present in the digestive

tracts of monkeys were disrupted.116 The normal bacteria were replaced

by a strain of mercury-resistant bacteria that recycle the metal in

the body instead of allowing the monkey to excrete it.117 Preliminary

research in human subjects indicates that people with silver fillings

also develop bacteria that can use mercury.118 One researcher from the

University of Georgia study stated, " This may... explain why not all

mercury entering the body is

> excreted and high levels are found in certain organs. ... It proves

that mercury is 'bio-available' -- something that dentists have been

denying for years. " 119 However, the ADA dismissed the above " animal

studies as irrelevant to humans, " 120 although a monkey's " dentition,

diet, feeding regimen, and chewing pattern closely resemble those of

humans. " 121 The battle over use of amalgam appears to have become

one of " medical science vs. dental opinion. " 122 However, once the

studies are duplicated and receive greater acceptance in the

scientific world, Eggleston of the University of Southern

California School of Dentistry admits, " positions could change. " 123

Amalgam and the Environment Dental amalgam is classified as a

hazardous material in the work place by OSHA, and excess dental

amalgam must be disposed of according to OSHA's Material Safety Data

Sheet.124 However, the health threat of amalgam scraps may potentially

reach far beyond the work place in the dental

> office. Although most of the industrial uses of mercury have been

reduced, dental offices serve as a major source of mercury

contamination in our environment. This occurs when dental personnel

improperly dispose of scrap dental amalgam. For example, it can

pollute ground and drinking water,125 or vapors released through

incineration can pollute the air.126 Pima County, Arizona Dentists

Suspended Recently, the Pima County (Arizona) Wastewater Management

Department, in cooperation with the Environmental Protection Agency

(EPA), determined that local dentists were illegally dumping mercury

into treated sewer water.127 Tucson experts discovered excess mercury

in the Santa Cruz River, downstream from the county's two sewer

treatment plants.128 Officials traced the source to local dental

offices, which were temporarily closed as a result.129 As of October

1989, 71 of the reported 73 mercury violations in Pima County

(Tucson), since 1985, were directly traced to dental

> offices.130 The reason behind the strict Arizona environmental

law lies in the delicate ecological system of the Santa Cruz River.131

However, local dentists maintained that the mercury must have come

from other sources, and that amalgam poses no environmental threat.

Simoneaux, a Tucson dentist and Southern Arizona Dental

Society President remarked, " There is mercury in the amalgam, but it's

OK to put amalgam in your mouth and it's OK to put it in a

landfill.... [W]e don't want to pollute the environment and we don't

think what we are doing is wrong -- we're dumping amalgam, not free

mercury. " 132 The EPA does not agree. EPA Takes Action in Connecticut

In 1988, a group of 58 New England dentists, the owners of a

chemical company, an " amalgam broker, " and two dental supply companies

incurred liability under Sec. 107 of the Comprehensive Environmental

Response Compensation and Liability Act (CERCLA)133 for improperly

disposing of amalgam at two different waste

> sites.134 An EPA settlement resulted in payment of $69,812 -- about

10% of the cleanup cost of $710,000.135 The U.S. filed suit,136

after which the other defendants eventually settled.137 The U.S.

stated earlier in the pleadings that amalgam is an environmental

hazard. In its complaint, the government averred that since " mercury,

silver, co[p]per and zinc are listed as hazardous substances under

CERCLA... [and] these elements make up dental amalgams, [then] amalgam

is itself a hazardous substance. " 138 Before the consent decree, the

ADA filed to appear, introduce evidence and make oral argument as

amicus curiae on November 7, 1988.139 The ADA hoped to have some

influence on " whether dental amalgam is a regulated material under the

provisions of CERCLA, and whether dental amalgam can be classified as

a 'hazardous substance' pursuant to CERCLA. " 140 After the settlement,

the ADA confidently declared that the government's position and the

subsequent outcome had no affect on

> " [w]hether amalgam is safe for use in the mouth. " 141 One of the

dental supply defendants circulated a letter following the settlement,

interpreting the result as an official declaration by the government

that amalgam was a hazardous substance.142 In an effort to squelch

this misunderstanding, the ADA responded that, although the EPA

considers amalgam to be hazardous, " [t]here has not been a decision by

any court that finds dental amalgam to be a hazardous substance. " 143

The ADA's interpretation of the law appears to be in direct conflict

with the government's in the pleadings and consent decree.144 As for

the circulated letter, the ADA fears it " has tripped an alarm that may

be difficult to silence. " 145 The ADA appears to be in a precarious

position. While its stated purpose, as set forth in Bourdeaudhui,146

is " to advance the health of the public and to promote the art and

science of dentistry..., " 147 it incorrectly represents that dental

amalgam has been " proven to be

> safe and effective.... " 148 Scientific research over the past

several years is at odds with the ADA's latter representation. The

ADA's refusal to seriously consider scientific findings regarding the

hazards of amalgam fillings appears to be in conflict with its purpose

as an organization.149 If amalgam fillings are hazardous to the public

when dumped or otherwise disposed of, then they potentially threaten

the community at large.150 In order to remain a credible organization,

the ADA should welcome scientific research involving amalgam and other

dental materials, and be willing to change its position when the

health and welfare of dental patients and the public are compromised

by dental procedures or dentists.151 Do Patients Have the Right to

Know? It would be prudent for the ADA, at this juncture, to

reconsider its position. It should consider that many dental patients,

once properly informed, might prefer some other substance as a filling

material. For example, a

> physician has a duty to disclose to the patient the contents of a

prescription and any potential side effects.152 Affirmative efforts

are now being directed toward requiring dentists using amalgam to

obtain informed consent from their patients. However, the ADA opposes

any legislation designed to accomplish this.153 Traditionally, the

law of informed consent " insists that an individual's wishes be

honored under all but a very few circumstances. " 154 Justice Cardozo

recognized that " Every human being of adult years and sound mind has a

right to determine what shall be done with his own body.... " 155

Doctors were held to have a duty to inform patients in Salgo v. Leland

Stanford, Jr., Univ. Bd. of Trustees,156 where the California Court of

Appeals found that a physician has a duty to disclose " any facts which

are necessary to form the basis of an intelligent consent by the

patient to the proposed treatment. " 157 Providing sufficient

information to allow patients the

> opportunity for making informed decisions is one of the specific

duties placed upon doctors as part of their responsibilities in

providing professional care of their patients.158 This duty arises

primarily from the doctor-patient relationship, because this

" one-to-one relationship " facilitates " personal consultation and

discussion. " 159 Neither the ADA nor any American dentists are

currently under a specific duty to inform patients of potential

hazards of amalgam fillings, or to offer patients an option of

available alternative materials. No affirmative duty will exist

without state or federal legislation or without a resolution from a

judicial proceeding. Generally, a duty usually exists where

" reasonable persons would recognize it and agree that it exists. " 160

Because the ADA " produces most of the dental health education material

in the United States..., " 161 and steadfastly refuses to acknowledge

the dangers of mercury exposure through amalgam fillings, related health

> hazards may continue to go largely unnoticed. The ADA's present

posture in defense of mercury in dentistry has disastrous

implications. While insisting that this " very serviceable, low-cost

restorative material should [be made] available to the public[,] " 162

the ADA fails to acknowledge the importance of providing information

to patients about the dangers of amalgam. The public should be

informed by dentists of the possible dangers associated with amalgam,

and provided the opportunity to select other available materials. If

the cost of dental treatment is of prime importance, then the patient

should have the benefit of weighing the low-cost benefits of amalgam

against potential hazards associated with chronic mercury exposure.

Once a patient knows the risks, perhaps a more expensive substance

would become more desirable. Often, litigation of this kind arises

from a doctor's failure to disclose material information to the

patient.163 Courts presume that people do not

> desire to be harmed or incur the risk of being harmed.164 This

presumption requires the doctor to demonstrate that the patient was

informed of and consented to the risk.165 In order to succeed in a

suit for informed consent based on negligence, the plaintiff must

establish that a duty to disclose exists.166 Once a duty is

established, a clear nexus between causation and the resulting harm

must be shown.167 While research may provide enough evidence for a

victim of mercury toxicity from amalgam fillings to demonstrate

potential hazards, the causation element poses the biggest obstacle

for the plaintiff. Absent a statute, expert testimony is necessary in

order to establish a duty and then to show that the nondisclosure

resulted in the harm under negligence doctrine.168 Most states use

an objective standard of causation in such cases.169 However,

jurisdictions differ as to who may establish the standard. The

majority rule compels a doctor " to disclose facts which a

> reasonable medical practitioner in a similar community and of the

same school of medical thought would have disclosed to his patient

regarding the proposed treatment. " 170 This standard requires the

plaintiff to demonstrate the necessity of disclosure through expert

testimony.171 One minority approach views the nondisclosure from the

patient's point of view. In the decision making process, based on what

the doctor knew or should have known about the patient's position,

courts using this approach weigh whether a reasonable person under

similar circumstances would have been likely to attach significance to

the information provided.172 This latter standard does not require

expert testimony, but leaves " the court to look only at what the

reasonable person deems to be material in making an informed

decision. " 173 A noted trend has been to follow the minority view,

which adheres to the rule that " the duty to disclose should be

measured by the patient's need for information

> rather than by the standards of the medical profession. " 174

Dentists who continue to use amalgam, despite scientific data raising

questions as to its safety, may argue that the patient needs no

informed consent because " the procedure is simple and the danger

remote and commonly appreciated as remote. " 175 However, the plaintiff

may dispute this defense with expert testimony. A suit brought on

grounds of products liability would be difficult since the patient

never sees and never handles the amalgam. Therefore, no labels with

warnings to patients would be effective.176 However, the FDA may soon

reclassify amalgam " so that sometime in the future manufacturers of

these particular products would have to provide safety and

effectiveness data. " 177 Still, the dental patient is wholly reliant on

the dentist to provide information and facts relating to inherent

risks and other alternatives.178 Class Action Suit Against ADA179

How will the courts determine whether a dentist,

> or an organization, has acted reasonably? Is the dentist who

strictly adheres to the doctrine of the ADA reasonable? What about the

dentist who concludes from available research that amalgams present a

significant risk for patients? For him, being reasonable may result in

harassment by the ADA and loss of licensure to practice, as determined

by his peers on the state licensing board. A federal court will likely

decide this issue in the near future. On September 20, 1990, a class

action suit (hereinafter Kennedy) was filed in federal court.180 Forty

anti-amalgam dentists have charged the ADA with fraud for continuing

to claim that amalgam fillings are safe.181 The Kennedy action also

alleges that the ADA has harassed the plaintiff dentists and attacked

their professional reputations as a direct result of the plaintiffs'

efforts to expose hazards of amalgam fillings.182 The plaintiffs

further charge the ADA with continuing to deceive the American public

with assurances about

> amalgam fillings, despite vast scientific evidence, " because they

feared the embarrassment and liability of being proven wrong, and

because they feared that admission of their misrepresentations would

result in a public relations disaster for themselves. " 183 The

plaintiffs in Kennedy are seeking compensatory as well as punitive

damages, an injunction enjoining the ADA from discriminating or

otherwise " intimidating " the plaintiffs, together with an order

requiring the ADA " to correct their wrongdoings. " 184 One attorney

writes: " [t]he most expeditious way to bring about change is to resort

to the courts for punitive damages in certain cases that involve

suppression or destruction of evidence, or fraud by manufacturers on

the public or in the medical profession. " 185 However, several groups

are taking the legislative route to change, proposing laws requiring

informed consent. Legislative Efforts to a Solution The EDA has

called for a ban on the use of mercury in dental

> fillings and is actively promoting informed consent legislation in

several states.186 Colorado may emerge as the leader in strengthening

rights of dental patients. This year, new legislation has been

introduced imposing a specific duty on dentists to provide informed

consent to their patients before placing dental amalgams in their

teeth. The proposed legislation would impose strict liability on

dentists who fail to obtain informed consent from dental patients.187

In addition, the proposed legislation has sought to relieve dentists

of any liability to the state dental board for recommending the

removal of amalgam fillings in the interest of the patients'

health.188 Arguably, the existence of a health hazard should be

brought to the attention of patients through informed consent.

Patients need to know about the availability of safer alternative

materials, despite higher costs and alleged inferior quality.189

Inasmuch as patients must accept the consequences of the fillings

> placed in their teeth, the proposed legislation in Colorado would

leave the decision to the patient, not the dentist. Commentary

supporting the proposed amendments suggests that dentists should be

under the same obligations as other Colorado health providers who

perform treatment or procedures which expose the patient to a

significant risk.190 Proponents of the Colorado legislation reason

that " ecause the potential harm is great, and minimal effort is

needed to inform patients of this potential harm, it would be

reasonable for dentists to provide this information to their patients

before using amalgam. " 191 In addition, advocates admonish state

leaders that, at a minimum, this legislation will protect " those

persons who are more susceptible to or affected by toxic poisons. " 192

Specifically, the proposed statute would require dentists to inform

patients that mercury is in amalgam fillings, the mercury can have

toxic effects, alternative materials are available and the

> patient has the right to choose an alternative material.193

Previous Colorado legislation in this area has failed because

representatives of the Colorado Dental Association, like the ADA, have

said they do not believe silver fillings are a health threat.194 The

ADA has labeled such legislation as " A wolf in legislative

clothing. " 195 In Alaska, State Senate majority leader Pat Rodey

reported that enough evidence exists to establish " reasonable doubt "

as to the safe use of dental amalgam.196 He therefore introduced a

senate resolution, similar to the Colorado proposal, which would

require informed consent from dental patients before the use of

amalgam fillings in patients.197 The Alaska Department of Health and

Social Services advised in a " Concept Paper " in January, 1989,

" persons who have had a large number of amalgam fillings, who have

experienced symptoms commensurate with chronic low level mercury

exposure and who have tried traditional treatments may wish to consider

> replacement therapy. " 198 The proposed Alaska legislation did not

pass as introduced initially,199 but is being reintroduced again this

year. Last year, the Illinois House of Representatives adopted a

House Resolution which requested that 200 the Illinois Department of

Public Health review the studies that have examined the health risks

of mercury in dental fillings and report to the General Assembly by

March 1, 1990, its finding about such risks as well as its

recommendations for providing a means by which dental patients may be

informed of the findings and of the alternatives to mercury content in

fillings when seeking dental treatment. The resolution was referred

to the committee on assignment. No study was performed, and the bill

died in committee. However, it will likely reappear in future

sessions. North Carolina is another state which has considered

legislation structured to provide dental patients with information

about amalgam fillings.201 The legislative

> process is often slow and " replete with economic and political

considerations and often falls wide of the mark. " 202 Over the past

decade, the ADA has postured itself to fight and discredit scientific

research, rather than seek a cooperative venture with fellow

scientists to resolve the matter in good faith.203 It is difficult to

understand why the ADA does not favor informed consent legislation,

since " Empirical evidence suggests that even when undesirable medical

outcomes occur, the greater the degree to which the patient

participates and is informed, the less likely she is to file a

malpractice claim. " 204 By endorsing informed consent, however, the ADA

would have to alter its position on amalgam fillings, and would give

credence to advocates opposing the use of amalgam materials.205 The

ADA's position that amalgam is safe based on 150 years of use is weak

at best.206 The ADA has not produced scientific data which

demonstrates the safety of amalgam fillings. In so doing,

> it has arguably failed in its duty to protect the public, as well

as its own membership, from personal harm due to amalgam usage.207

The ADA may fear the flood gates of litigation will burst when the

American people have all the necessary information about the potential

harmful effects of mercury in amalgam. Intense litigation often

follows when the public discovers it has been unnecessarily exposed to

toxic substances.208 Historically numerous common products were

thought to be safe; for example[,] asbestos, lead, and DDT. In each

case the scientific concerns were immediately discounted by the

industry responsible for the production or use of the material and

often the assertions of safety were initially supported by the

responsible government agencies. After a period of time as the

evidence became overwhelming and legal liability impossible to ignore,

they were regulated or withdrawn from the market. Each of these

products demonstrated pathology after a latency

> period of chronic low dose exposure[,] as does mercury.209

Perhaps the Kennedy210 case will provide swifter resolve to the

amalgam issue and result in adequate information concerning the risks

of amalgam fillings being disseminated to dental patients. Freedom of

choice means patients must receive the information necessary to allow

the best possible opportunity to make an informed decision as to what

dental procedures or materials will be used.211 This should no longer

be a decision reserved for the dentist's sole discretion. Conclusion

One author of a dental text advocates the use of amalgam fillings

based on a risk/benefit analysis, because " the benefit from the

treatment far outweighs any side effects from operative procedures and

dental materials. " 212 However, with so many alternative materials

available, this risk/benefit approach makes little sense. Since the

ADA's declarations of the safety of amalgam fillings is based on

tradition and remains unsubstantiated

> by research, dentists should reassess their legal and ethical

positions. With respect to recent scientific findings about amalgam

fillings, dentists can no longer expect credible support from the ADA,

and should perform due diligence in obtaining knowledge and

information on this subject.213 While the FDA anticipates regulatory

changes based on recent research, one reporter writes: " Until then,

add amalgam fillings to the list of risks Americans must decide

whether or not to bear. " 214 However, no rights to make such an

informed decision are currently afforded to individuals in this

country by law. Legal implications for dentists using the amalgam

fillings are mounting. Evidence of amalgam toxicity and the

availability of safer alternative materials, arguably, substantially

increases the liability of the ADA and pro-amalgam dentists. One

attorney has predicted that mass tort litigation from amalgam

poisonings will soon become a " major courtroom event. " 215 The class action

> suit in Kennedy216 may only be the tip of the litigation iceberg.

Depending on the outcome of this case, " the mass litigation which will

follow may well exceed other mass toxic tort cases.... " 217 The

evidence available suggests, " the mercury amalgam issue is an internal

Love Canal waiting to be exposed. " 218 If this is correct, then the

ADA, its members and other pro-amalgam dentists may soon have an

opportunity to defend their position in the courts. Ultimately, it may

take federal legislation to save traditional dentistry from financial

ruin.219 C * This paper recently received the S. Welch

award for outstanding legal writing by a third-year law student at the

J. Reuben Law School of Brigham Young University

> http://www.piercelaw.edu/risk/vol2/spring/royal.htm

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Welcome and most definitely, you may share with others. That is what this group is about. And if you have any questions, just let us know and we will try to help. :-) Please share or read, it's what you will feel comfortable with.

I am Joy, Michlele is co-owner, and Marty is moderator. This group is a little different. I believe our health is affected by many aspects of life, be it our attitudes, what is done to our foods, what pharmaceuticals we use, our laws, and so on.

Blessings, Joy

[ ] Re: Amalgam Fillings:

Can I copy and share this information with my friends on myspace???>> http://www.piercelaw.edu/risk/vol2/spring/royal.htm> > Amalgam Fillings:> Do Dental Patients Have a Right to Informed Consent?* A.Royal** Introduction An individual may seek the services of adentist for any number of reasons. After examination, the dentist maydetermine that the patient has a cavity and inform the patient thatthe cavity must be filled. Dentists usually do not consult patientsto determine what materials to use. Most feel that dialogue with thepatient on this issue is unnecessary. However, some materials may behazardous under certain conditions. New research suggests that mercuryamalgam (or "silver") fillings (hereinafter amalgam) may fall intothat category. However, the American Dental Association (ADA)supports the use of such fillings and assures "the American peoplethat dental amalgam is safe."1 The ADA claims that since mercuryamalgam has been used for over 150 years, its safety should not bedisputed.2 While its position remains largely unsupported byscientific evidence, the ADA challenges those> opposed to the use of amalgam fillings (anti-amalgamists) toproduce scientific evidence that its use is harmful to humans.3 Thischallenge has been accepted. The anti-amalgamists have countered bychallenging the ADA to demonstrate that safe levels of mercury inhuman tissues exist before endorsing its use.4 The ADA has yet torespond. Both sides do, however, agree that "[1] [mercury] is one ofthe most poisonous elements known to man, and [2] mercury amalgam maycause ill effects in those people who are mercury sensitive."5 Themercury used in fillings is hazardous before and during theirpreparation.6 Also, scrap materials pose an environmental hazard whendiscarded.7 Research over the past decade demonstrates that their useposes a potential health hazard to a significant number of theestimated 200 million Americans with amalgam fillings.8 Amalgamcontinues to be the primary filling material in the U.S., largely dueto the ADA's endorsement.9 This article will> first examine the history and general issues involved in the use ofamalgam fillings. Second, it will review available research todemonstrate the potential health hazards. Third, it will brieflyinvestigate environmental issues and suggest that potential risksextend beyond those posed for patients. Ultimately, the article willaddress whether, whatever uncertainty may be present, patients do nothave a right to be informed of potential risks and of availablealternatives. History of Amalgam Fillings Opponents of amalgamhave challenged its use in dentistry since its introduction over 150years ago.10 The first reported use in dental restorations was in1818.11 Since then, concerns over the toxic effects of mercury havepersisted.12 The American Society of Dental Surgeons, formed in1840,13 so abhorred the use of amalgam that it required its members tosign pledges that they would not use it.14 In 1848, The Society ofDentists of the City and State of New York> suspended eleven of members for "malpractice," because they usedamalgam.15 Internal strife over the use of mercury in dentistry led tothe formation of the ADA, whose leaders did not oppose its use.16 Inthe 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 ofamalgam in dentistry continued to grow rapidly.18 Questions about itssafety arose again about fifteen years ago and continue unabated.19Nevertheless, mainstream dentistry believes it is "most unlikely" thatthe current "anti-amalgam crusade" will succeed in eliminating itsuse.20 Amalgam fillings typically comprise 50% pure elementalmercury, 35% silver, 13% tin, 2% copper, and a trace of zinc.21 Themetal powders react with liquid mercury to produce an amalgam (oralloy)22 that provides a flexible material that can be easily packedand shaped.23 Amalgam> fillings are often called silver fillings because of appearance andcomposition.24 The ADA prefers the use of amalgam because fillingsare inexpensive and durable, while gold and other composite materialsare more expensive and more difficult to fit.25 Because of itsflexibility, 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 overfifteen years ago that since "satisfactory alternative tooth-fillingmaterials are available, ... the use of amalgam fillings should bediscouraged."28 However, the ADA maintains that there are noacceptable substitutes,29 although it admits, "the use of compositeresins as a posterior restorative material may eventually replaceamalgam 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 highlevels of mercury vapor from mercury spills could be eliminated."31 The ADA adamantly defends mercury usage in tooth restorations wheneverothers suggest that it poses a potential health threat on the basisthat it has been used "safely" over the past 150 years.32 Otherreasons behind its support of amalgam may include: 1) ease of use; 2)low cost; 3) additional training and equipment required to usealternative materials;33 and 4) potential liability associated withacknowledging the dangers of amalgam previously used. Unfortunately,the cost of a vast array of chronic, degenerative, mental and physicaldiseases related to mercury exposure in patients, dentists, dentalpersonnel and society appears to be immeasurable. Mercury Toxicity Mercury has been known to be a poison for thousands of years,34whether "ingested, inhaled, or absorbed through the skin."35 In the1800's, British workers who used> mercury in the hat making process developed symptoms of mentaldeterioration on an industry-wide basis.36 The expression, "mad as ahatter," originated from that.37 Also, citizens of Minamata, Japan,endured ten years of misery, crippling deformities and agonizingdeaths before industries ceased polluting the local harbor withmercury.38 The mercury was transferred to Minamata citizens when theyconsumed fish from the polluted harbor. This resulted in more than10,000 cases of "Minamata disease," which had a 10% mortality rate.39Today, according to those involved in research, human exposure tomercury is primarily through dental amalgam.40 Mercury has beenfound to accumulate in vital organs and tissues, such as the liver,brain,41 and heart muscle.42 Major symptoms of mercury toxicityinclude emotional instability, tremors, gingivitis, and kidneyfailure.43 Some also believe mercury may be linked to multiplesclerosis44 and epileptic seizures.45 Further, its affect on> the body's immune system is potentially devastating,46 possiblycontributing to diseases such as leukemia and hematopoieticdycrasias.47 No direct connection to any specific diseases has yetbeen made, primarily "because no one has really looked."48 However, asresearch continues, evidence is accumulating. Dental fillings may yetprove to have effects many times greater than those found atMinamata.49 Patient Exposure to Mercury from Amalgam Restorations Dentists maintain that mercury in "amalgam becomes inert once thefillings have been allowed to set for several days, and that long-termdanger to the patient from [mercury] vapor is therefore remote."50 TheNew England Journal of Medicine recently reported, "Many importantmedical questions concerning mercury toxicity remain to beanswered."51 The ADA, by contrast, continues to assert that it hasenough 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, approximatelyeleven million Americans are mercury sensitive.55 Further, the ADAagrees that the removal of amalgam fillings "can release relativelylarge amounts of mercury into the mouth[,] and that may be harmful."56 While de-emphasizing possible risks to patients, the ADA has takenaffirmative steps to inform dentists and their personnel of thepotential hazards of mercury57 and has established strict guidelinesfor storing and handling amalgam.58 One author suggests that dentistshave both a "moral" and a "legal" duty to protect dental personnel.59Because the primary danger in dental offices is "the atmosphericmercury vapor,"60 the ADA presents an interesting paradox in itsposition on amalgam. The organization considers the mercury vaporswhich threaten dental personnel are "insignificant".61 Recentstudies have found that substantial> amounts of mercury vapor are released from dental amalgam afterchewing gum for just ten minutes.62 Studies have also shown thatmercury vapor can be released by "brushing the teeth with commercialtoothpaste,"63 "chewing food, drinking hot beverages, and smokingcigarettes."64 Therefore, mercury vapor is continually present.65 Mercury Toxicity From Amalgams Although amalgam subjects dentalpatients to dangerous mercury vapor,66 when asked if mercury ispoisonous, the ADA recommends that dentists answer patients in thefollowing manner: "Not when used as amalgam.... [W]hen mercury iscombined with other metals... it reacts with them to form abiologically inactive substance."67 The ADA instructs its dentists notto inform patients that amalgam continuously releases mercury -- evenif patients inquire.68 No governmental agency has established safestandards for mercury intake from dental amalgams. Some expertsbelieve "there is no safe level of mercury exposure."69 > The ADA investigated the possible affects of amalgam fillings in1984 and assured the nation that, "[a]lthough there is no evidence ofa health threat, we will pursue the question of safety until thematter is resolved to the satisfaction of the American people."70 The1984 Workshop on The Safety and Biocompatibility of Metals inDentistry concluded that mercury is released from amalgam fillings.71Nevertheless, the ADA maintained that no health problems could resultfrom such a small amount of exposure.72 When subsequent studiessurfaced linking amalgam fillings to several incurable diseases, theADA denied all claims that amalgam could possibly be responsible73 --while reassured those concerned that it would "continue" to doeverything in its power to resolve any questions as to its safety.74 In response to claims concerning amalgam hazards in 1987, the ADAboldly responded that such claims are unfounded,75 "unsubstantiated,undocumented, and unproven."76 However,> numerous studies performed since 1981, "demonstrate a positivecorrelation between dental amalgams and mercury levels in the humanbrain."77 Other countries have taken action to limit or prohibit theuse of amalgam fillings. Two years ago, the Swedish government"recommended that dentists stop using amalgam to fill the teeth ofpregnant women."78 Since then, Swedish authorities determined to banthe use of all mercury, including its use in amalgam fillings, by1991, have urged that its use in pregnant women cease immediately.79Viking Falk, division chief of the Swedish Social Welfare and HealthAdministration, said, "We now realize that we have made a mistake.This has caused people to suffer unnecessarily."80 The ADA "quicklyregarded [this report] as 'bogus[.]'"81 However, the Swedish ban wassubjected to public hearings and subsequently upheld.82 In fact, inNovember, 1990, the Swedish government passed a law providing itscitizens 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 ofamalgam.84 In Japan, dentists have likewise sought to use alternativesto amalgam.85 Current research demonstrating strong evidence ofchronic mercury toxicity in patients with amalgam fillings has donelittle to persuade the ADA to reevaluate its position. Some dentistshave suggested that their patients consider changing their amalgamfillings and replace them with non-toxic materials, based on currentresearch. The ADA has labeled the actions of these dentists"unethical," stating that dentists engaging in this practice raise "aquestion of fraud or quackery in all but an exceedingly limitedspectrum of cases."86 However, current research has prompted groups,such as the Environmental Dental Association (EDA), to call for a banon any use of mercury in dental materials.87 The EDA contends thatusing amalgam without informing the patient of> associated risks and alternatives is "unethical."88 A summary ofrecent scientific findings, which follows, suggests that healththreats from amalgam exist in laboratory animals and probably inhumans. Current Research Researchers from the departments ofmedicine, pathology and physiology from the University of Calgary,Alberta, Canada, performed revealing experiments during 1989 and 1990regarding the safety of amalgam fillings. Two studies examined theeffects of amalgam fillings on sheep, while a third studied itseffects on monkeys. The 1989 study placed amalgam fillings into themouth of a four year old ewe for 29 days.89 At the end, mercury wasabsorbed in the lungs90 (due to "continual breathing of the'intra-oral air' having mercury vapor"), the stomach91 (through "themixing of intra-oral Hg vapor, amalgam microparticles, and dissolvedmercuric ions with saliva and food before swallowing"), the jaw92("some tissues in the jaw... and tooth root and surrounding> bone"), "the brain[,] and several endocrine glands."93 The kidneyshad high concentrations of mercury,94 which disproves earlier theoriesthat mercury is excreted.95 The study concluded that, because about 8%of inhaled elemental mercury vapor is absorbed into the blood inhumans, it immediately "becomes available for tissue retention."96Since the study found problems resulting from mercury exposure soquickly, amalgam fillings "remain[ing] in human teeth for eight to tenyears... would allow an extended opportunity for body tissues to becontinuously exposed to Hg [mercury]."97 The study concluded: "dentalamalgams can be a major source of chronic Hg [mercury] exposure."98 Another study, at the University of Calgary in 1990, investigated theaffect of amalgam fillings on a fetus.99 Five pregnant ewes hadamalgam placed in their teeth at 112 days gestation. This studydemonstrated that mercury from amalgam fillings appear in maternal andfetal blood and the amniotic> fluid within two days after placement of the dentalrestorations.100 The study concluded that amalgam also accumulates inmaternal and fetal tissues.101 These results prompted the researchersto conclude: "Dental amalgam usage as a tooth restorative material inpregnant women and children should be reconsidered."102 Mercuryexposure is of particular concern in the developing fetus and inchildren due to their low body weight.103 A study performed tenyears ago concluded that pregnant women should avoid exposure tomercury.104 Previous studies have also demonstrated that mercuryexposure from amalgam can deteriorate the immune system.105 Althoughthe Calgary studies did not show whether kidney functions returnedafter removal of the amalgam, Fritz L. Lorscheider, who was involvedin both of the Calgary studies, concluded: "[we] know that mercury ishighly toxic and that it concentrates in certain parts of the humanbody. 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 thatchanges in body functions occur following the implantation ofamalgam.107 Shortly after publication, the findings were reported onthe front page of the Chicago Tribune on August 15, 1990.108 Thearticle quoted a Food and Drug Administration (FDA) representative assaying, "In light of emerging scientific data, the FDA needs tore-examine the use of amalgam. It may be necessary to reclassifyamalgam and take various regulatory actions."109 The FDA allowed theuse of amalgam to continue in 1976 because the substance was alreadywidely in use.110 Some believe the FDA's decision to do so was largelybecause of the ADA's influence within the FDA.111 However, after theanimal tests at Calgary, the FDA would probably not allow amalgam tobe used if it were a new product.112 Some Chicago dentists tookexception to the Chicago Tribune's decision> to give the story so much prominence.113 The ADA has been accusedby anti-amalgam dentists of actively seeking to avoid problems ofliability which might arise through any admissions.114 A more recentstudy completed by the University of Calgary found that monkeykidneys, like sheep kidneys, concentrated large amounts of mercurywhen given amalgam fillings.115 Another study of two adult monkeys atthe University of Georgia, in cooperation with the University ofCalgary, concluded that bacteria normally present in the digestivetracts of monkeys were disrupted.116 The normal bacteria were replacedby a strain of mercury-resistant bacteria that recycle the metal inthe body instead of allowing the monkey to excrete it.117 Preliminaryresearch in human subjects indicates that people with silver fillingsalso develop bacteria that can use mercury.118 One researcher from theUniversity of Georgia study stated, "This may... explain why not allmercury entering the body is> excreted and high levels are found in certain organs. ... It provesthat mercury is 'bio-available' -- something that dentists have beendenying for years."119 However, the ADA dismissed the above "animalstudies as irrelevant to humans,"120 although a monkey's "dentition,diet, feeding regimen, and chewing pattern closely resemble those ofhumans."121 The battle over use of amalgam appears to have becomeone of "medical science vs. dental opinion."122 However, once thestudies are duplicated and receive greater acceptance in thescientific world, Eggleston of the University of SouthernCalifornia School of Dentistry admits, "positions could change."123 Amalgam and the Environment Dental amalgam is classified as ahazardous material in the work place by OSHA, and excess dentalamalgam must be disposed of according to OSHA's Material Safety DataSheet.124 However, the health threat of amalgam scraps may potentiallyreach far beyond the work place in the dental> office. Although most of the industrial uses of mercury have beenreduced, dental offices serve as a major source of mercurycontamination in our environment. This occurs when dental personnelimproperly dispose of scrap dental amalgam. For example, it canpollute ground and drinking water,125 or vapors released throughincineration can pollute the air.126 Pima County, Arizona DentistsSuspended Recently, the Pima County (Arizona) Wastewater ManagementDepartment, in cooperation with the Environmental Protection Agency(EPA), determined that local dentists were illegally dumping mercuryinto treated sewer water.127 Tucson experts discovered excess mercuryin the Santa Cruz River, downstream from the county's two sewertreatment plants.128 Officials traced the source to local dentaloffices, which were temporarily closed as a result.129 As of October1989, 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 environmentallaw lies in the delicate ecological system of the Santa Cruz River.131However, local dentists maintained that the mercury must have comefrom other sources, and that amalgam poses no environmental threat. Simoneaux, a Tucson dentist and Southern Arizona DentalSociety President remarked, "There is mercury in the amalgam, but it'sOK to put amalgam in your mouth and it's OK to put it in alandfill.... [W]e don't want to pollute the environment and we don'tthink what we are doing is wrong -- we're dumping amalgam, not freemercury."132 The EPA does not agree. EPA Takes Action in Connecticut In 1988, a group of 58 New England dentists, the owners of achemical company, an "amalgam broker," and two dental supply companiesincurred liability under Sec. 107 of the Comprehensive EnvironmentalResponse Compensation and Liability Act (CERCLA)133 for improperlydisposing of amalgam at two different waste> sites.134 An EPA settlement resulted in payment of $69,812 -- about10% of the cleanup cost of $710,000.135 The U.S. filed suit,136after which the other defendants eventually settled.137 The U.S.stated earlier in the pleadings that amalgam is an environmentalhazard. In its complaint, the government averred that since "mercury,silver, co[p]per and zinc are listed as hazardous substances underCERCLA... [and] these elements make up dental amalgams, [then] amalgamis itself a hazardous substance."138 Before the consent decree, theADA filed to appear, introduce evidence and make oral argument asamicus curiae on November 7, 1988.139 The ADA hoped to have someinfluence on "whether dental amalgam is a regulated material under theprovisions of CERCLA, and whether dental amalgam can be classified asa 'hazardous substance' pursuant to CERCLA."140 After the settlement,the ADA confidently declared that the government's position and thesubsequent outcome had no affect on> "[w]hether amalgam is safe for use in the mouth."141 One of thedental supply defendants circulated a letter following the settlement,interpreting the result as an official declaration by the governmentthat amalgam was a hazardous substance.142 In an effort to squelchthis misunderstanding, the ADA responded that, although the EPAconsiders amalgam to be hazardous, "[t]here has not been a decision byany court that finds dental amalgam to be a hazardous substance."143The ADA's interpretation of the law appears to be in direct conflictwith the government's in the pleadings and consent decree.144 As forthe circulated letter, the ADA fears it "has tripped an alarm that maybe difficult to silence."145 The ADA appears to be in a precariousposition. While its stated purpose, as set forth in Bourdeaudhui,146is "to advance the health of the public and to promote the art andscience of dentistry...,"147 it incorrectly represents that dentalamalgam has been "proven to be> safe and effective...."148 Scientific research over the pastseveral years is at odds with the ADA's latter representation. TheADA's refusal to seriously consider scientific findings regarding thehazards of amalgam fillings appears to be in conflict with its purposeas an organization.149 If amalgam fillings are hazardous to the publicwhen dumped or otherwise disposed of, then they potentially threatenthe community at large.150 In order to remain a credible organization,the ADA should welcome scientific research involving amalgam and otherdental materials, and be willing to change its position when thehealth and welfare of dental patients and the public are compromisedby dental procedures or dentists.151 Do Patients Have the Right toKnow? It would be prudent for the ADA, at this juncture, toreconsider its position. It should consider that many dental patients,once properly informed, might prefer some other substance as a fillingmaterial. For example, a> physician has a duty to disclose to the patient the contents of aprescription and any potential side effects.152 Affirmative effortsare now being directed toward requiring dentists using amalgam toobtain informed consent from their patients. However, the ADA opposesany legislation designed to accomplish this.153 Traditionally, thelaw of informed consent "insists that an individual's wishes behonored under all but a very few circumstances."154 Justice Cardozorecognized that "Every human being of adult years and sound mind has aright to determine what shall be done with his own body...."155Doctors were held to have a duty to inform patients in Salgo v. LelandStanford, Jr., Univ. Bd. of Trustees,156 where the California Court ofAppeals found that a physician has a duty to disclose "any facts whichare necessary to form the basis of an intelligent consent by thepatient to the proposed treatment."157 Providing sufficientinformation to allow patients the> opportunity for making informed decisions is one of the specificduties placed upon doctors as part of their responsibilities inproviding professional care of their patients.158 This duty arisesprimarily from the doctor-patient relationship, because this"one-to-one relationship" facilitates "personal consultation anddiscussion."159 Neither the ADA nor any American dentists arecurrently under a specific duty to inform patients of potentialhazards of amalgam fillings, or to offer patients an option ofavailable alternative materials. No affirmative duty will existwithout state or federal legislation or without a resolution from ajudicial proceeding. Generally, a duty usually exists where"reasonable persons would recognize it and agree that it exists."160Because the ADA "produces most of the dental health education materialin the United States...,"161 and steadfastly refuses to acknowledgethe dangers of mercury exposure through amalgam fillings, related health> hazards may continue to go largely unnoticed. The ADA's presentposture in defense of mercury in dentistry has disastrousimplications. While insisting that this "very serviceable, low-costrestorative material should [be made] available to the public[,]"162the ADA fails to acknowledge the importance of providing informationto patients about the dangers of amalgam. The public should beinformed by dentists of the possible dangers associated with amalgam,and provided the opportunity to select other available materials. Ifthe cost of dental treatment is of prime importance, then the patientshould have the benefit of weighing the low-cost benefits of amalgamagainst potential hazards associated with chronic mercury exposure.Once a patient knows the risks, perhaps a more expensive substancewould become more desirable. Often, litigation of this kind arisesfrom a doctor's failure to disclose material information to thepatient.163 Courts presume that people do not> desire to be harmed or incur the risk of being harmed.164 Thispresumption requires the doctor to demonstrate that the patient wasinformed of and consented to the risk.165 In order to succeed in asuit for informed consent based on negligence, the plaintiff mustestablish that a duty to disclose exists.166 Once a duty isestablished, a clear nexus between causation and the resulting harmmust be shown.167 While research may provide enough evidence for avictim of mercury toxicity from amalgam fillings to demonstratepotential hazards, the causation element poses the biggest obstaclefor the plaintiff. Absent a statute, expert testimony is necessary inorder to establish a duty and then to show that the nondisclosureresulted in the harm under negligence doctrine.168 Most states usean objective standard of causation in such cases.169 However,jurisdictions differ as to who may establish the standard. Themajority rule compels a doctor "to disclose facts which a> reasonable medical practitioner in a similar community and of thesame school of medical thought would have disclosed to his patientregarding the proposed treatment."170 This standard requires theplaintiff to demonstrate the necessity of disclosure through experttestimony.171 One minority approach views the nondisclosure from thepatient's point of view. In the decision making process, based on whatthe doctor knew or should have known about the patient's position,courts using this approach weigh whether a reasonable person undersimilar circumstances would have been likely to attach significance tothe information provided.172 This latter standard does not requireexpert testimony, but leaves "the court to look only at what thereasonable person deems to be material in making an informeddecision."173 A noted trend has been to follow the minority view,which adheres to the rule that "the duty to disclose should bemeasured 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 raisingquestions as to its safety, may argue that the patient needs noinformed consent because "the procedure is simple and the dangerremote and commonly appreciated as remote."175 However, the plaintiffmay dispute this defense with expert testimony. A suit brought ongrounds of products liability would be difficult since the patientnever sees and never handles the amalgam. Therefore, no labels withwarnings to patients would be effective.176 However, the FDA may soonreclassify amalgam "so that sometime in the future manufacturers ofthese particular products would have to provide safety andeffectiveness data."177 Still, the dental patient is wholly reliant onthe dentist to provide information and facts relating to inherentrisks and other alternatives.178 Class Action Suit Against ADA179 How will the courts determine whether a dentist,> or an organization, has acted reasonably? Is the dentist whostrictly adheres to the doctrine of the ADA reasonable? What about thedentist who concludes from available research that amalgams present asignificant risk for patients? For him, being reasonable may result inharassment by the ADA and loss of licensure to practice, as determinedby his peers on the state licensing board. A federal court will likelydecide this issue in the near future. On September 20, 1990, a classaction suit (hereinafter Kennedy) was filed in federal court.180 Fortyanti-amalgam dentists have charged the ADA with fraud for continuingto claim that amalgam fillings are safe.181 The Kennedy action alsoalleges that the ADA has harassed the plaintiff dentists and attackedtheir professional reputations as a direct result of the plaintiffs'efforts to expose hazards of amalgam fillings.182 The plaintiffsfurther charge the ADA with continuing to deceive the American publicwith assurances about> amalgam fillings, despite vast scientific evidence, "because theyfeared the embarrassment and liability of being proven wrong, andbecause they feared that admission of their misrepresentations wouldresult in a public relations disaster for themselves."183 Theplaintiffs in Kennedy are seeking compensatory as well as punitivedamages, an injunction enjoining the ADA from discriminating orotherwise "intimidating" the plaintiffs, together with an orderrequiring the ADA "to correct their wrongdoings."184 One attorneywrites: "[t]he most expeditious way to bring about change is to resortto the courts for punitive damages in certain cases that involvesuppression or destruction of evidence, or fraud by manufacturers onthe public or in the medical profession."185 However, several groupsare taking the legislative route to change, proposing laws requiringinformed consent. Legislative Efforts to a Solution The EDA hascalled for a ban on the use of mercury in dental> fillings and is actively promoting informed consent legislation inseveral states.186 Colorado may emerge as the leader in strengtheningrights of dental patients. This year, new legislation has beenintroduced imposing a specific duty on dentists to provide informedconsent to their patients before placing dental amalgams in theirteeth. The proposed legislation would impose strict liability ondentists who fail to obtain informed consent from dental patients.187In addition, the proposed legislation has sought to relieve dentistsof any liability to the state dental board for recommending theremoval of amalgam fillings in the interest of the patients'health.188 Arguably, the existence of a health hazard should bebrought to the attention of patients through informed consent.Patients need to know about the availability of safer alternativematerials, despite higher costs and alleged inferior quality.189Inasmuch as patients must accept the consequences of the fillings> placed in their teeth, the proposed legislation in Colorado wouldleave the decision to the patient, not the dentist. Commentarysupporting the proposed amendments suggests that dentists should beunder the same obligations as other Colorado health providers whoperform treatment or procedures which expose the patient to asignificant risk.190 Proponents of the Colorado legislation reasonthat "ecause the potential harm is great, and minimal effort isneeded to inform patients of this potential harm, it would bereasonable for dentists to provide this information to their patientsbefore using amalgam."191 In addition, advocates admonish stateleaders that, at a minimum, this legislation will protect "thosepersons who are more susceptible to or affected by toxic poisons."192Specifically, the proposed statute would require dentists to informpatients that mercury is in amalgam fillings, the mercury can havetoxic effects, alternative materials are available and the> patient has the right to choose an alternative material.193Previous Colorado legislation in this area has failed becauserepresentatives of the Colorado Dental Association, like the ADA, havesaid they do not believe silver fillings are a health threat.194 TheADA has labeled such legislation as "A wolf in legislativeclothing."195 In Alaska, State Senate majority leader Pat Rodeyreported that enough evidence exists to establish "reasonable doubt"as to the safe use of dental amalgam.196 He therefore introduced asenate resolution, similar to the Colorado proposal, which wouldrequire informed consent from dental patients before the use ofamalgam fillings in patients.197 The Alaska Department of Health andSocial Services advised in a "Concept Paper" in January, 1989,"persons who have had a large number of amalgam fillings, who haveexperienced symptoms commensurate with chronic low level mercuryexposure and who have tried traditional treatments may wish to consider> replacement therapy."198 The proposed Alaska legislation did notpass as introduced initially,199 but is being reintroduced again thisyear. Last year, the Illinois House of Representatives adopted aHouse Resolution which requested that 200 the Illinois Department ofPublic Health review the studies that have examined the health risksof mercury in dental fillings and report to the General Assembly byMarch 1, 1990, its finding about such risks as well as itsrecommendations for providing a means by which dental patients may beinformed of the findings and of the alternatives to mercury content infillings when seeking dental treatment. The resolution was referredto the committee on assignment. No study was performed, and the billdied in committee. However, it will likely reappear in futuresessions. North Carolina is another state which has consideredlegislation structured to provide dental patients with informationabout amalgam fillings.201 The legislative> process is often slow and "replete with economic and politicalconsiderations and often falls wide of the mark."202 Over the pastdecade, the ADA has postured itself to fight and discredit scientificresearch, rather than seek a cooperative venture with fellowscientists to resolve the matter in good faith.203 It is difficult tounderstand why the ADA does not favor informed consent legislation,since "Empirical evidence suggests that even when undesirable medicaloutcomes occur, the greater the degree to which the patientparticipates and is informed, the less likely she is to file amalpractice claim."204 By endorsing informed consent, however, the ADAwould have to alter its position on amalgam fillings, and would givecredence to advocates opposing the use of amalgam materials.205 TheADA's position that amalgam is safe based on 150 years of use is weakat best.206 The ADA has not produced scientific data whichdemonstrates the safety of amalgam fillings. In so doing,> it has arguably failed in its duty to protect the public, as wellas its own membership, from personal harm due to amalgam usage.207 The ADA may fear the flood gates of litigation will burst when theAmerican people have all the necessary information about the potentialharmful effects of mercury in amalgam. Intense litigation oftenfollows when the public discovers it has been unnecessarily exposed totoxic substances.208 Historically numerous common products werethought to be safe; for example[,] asbestos, lead, and DDT. In eachcase the scientific concerns were immediately discounted by theindustry responsible for the production or use of the material andoften the assertions of safety were initially supported by theresponsible government agencies. After a period of time as theevidence became overwhelming and legal liability impossible to ignore,they were regulated or withdrawn from the market. Each of theseproducts demonstrated pathology after a latency> period of chronic low dose exposure[,] as does mercury.209 Perhaps the Kennedy210 case will provide swifter resolve to theamalgam issue and result in adequate information concerning the risksof amalgam fillings being disseminated to dental patients. Freedom ofchoice means patients must receive the information necessary to allowthe best possible opportunity to make an informed decision as to whatdental procedures or materials will be used.211 This should no longerbe a decision reserved for the dentist's sole discretion. Conclusion One author of a dental text advocates the use of amalgam fillingsbased on a risk/benefit analysis, because "the benefit from thetreatment far outweighs any side effects from operative procedures anddental materials."212 However, with so many alternative materialsavailable, this risk/benefit approach makes little sense. Since theADA's declarations of the safety of amalgam fillings is based ontradition and remains unsubstantiated> by research, dentists should reassess their legal and ethicalpositions. With respect to recent scientific findings about amalgamfillings, dentists can no longer expect credible support from the ADA,and should perform due diligence in obtaining knowledge andinformation on this subject.213 While the FDA anticipates regulatorychanges based on recent research, one reporter writes: "Until then,add amalgam fillings to the list of risks Americans must decidewhether or not to bear."214 However, no rights to make such aninformed decision are currently afforded to individuals in thiscountry by law. Legal implications for dentists using the amalgamfillings are mounting. Evidence of amalgam toxicity and theavailability of safer alternative materials, arguably, substantiallyincreases the liability of the ADA and pro-amalgam dentists. Oneattorney has predicted that mass tort litigation from amalgampoisonings 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 willfollow may well exceed other mass toxic tort cases...."217 Theevidence available suggests, "the mercury amalgam issue is an internalLove Canal waiting to be exposed."218 If this is correct, then theADA, its members and other pro-amalgam dentists may soon have anopportunity to defend their position in the courts. Ultimately, it maytake federal legislation to save traditional dentistry from financialruin.219 C * This paper recently received the S. Welchaward for outstanding legal writing by a third-year law student at theJ. Reuben Law School of Brigham Young University> http://www.piercelaw.edu/risk/vol2/spring/royal.htm> > the numbers can be found after this article on the above link..> > > > ---------------------------------> Looking for last minute shopping deals? Find them fast with Search.>