Condom Policy Rebuttal

JAN 16, 1992

Dear Friend and Colleague:

My enclosed rebuttal of Richard P. Keeling, M.D., American
College Health Association(ACHA) is self-explanatory and is
critically important to anyone involved in the condom controversy
especially relating to schools of all grades. Obviously my
detailed analysis, The Condom-Is It really Safe Sex?, had a
significant effect for them to send the enclosed memorandum
nationwide to their members! However, this provided me with the
excellent opportunity to further refute even their inadequate
defenses. The ACHA appears to have considerable influence not
only with colleges but the schools frequently look to them as an
authority. You may now help your cause directly and the issue
generally by demonstrating public opposition through any or all
of the following suggestions:

1) Simply copy the enclosed correspondence and send it to the
colleges in your state attention to the president (by name) and
perhaps a copy to the student government. Remember, National
Condom Week is February 14-21!

2) Notify your network and ask them to write letters to President
Bush and Congressperson, Senator -- ACHA receives federal funds
from CDC!

3) Write Dr. Keeling's boss, C. Virginia Moore, PhD, Creighton
Univ., 610 N. 30th Street, Suite 4710, Omaha, Nebraska, 68131.
She is the ACHA President.

4) Ask your colleges for their insurance coverage information
regarding wrongful death claims -- particularly class action
potential arising from this policy.

5) Write Centers for Disease Control (CDC), Atlanta, Georgia, and
request funding information on the ACHA, credentials of Richard
P. Keeling, MD, and Kenneth Steinman.

6) Ask your colleges to provide documentation that the condoms
they distribute were stored/transported from moment of
manufacture to distribution from college under temperature
controlled conditions at all times.

Please copy me on all your correspondence. Be creative. I gave
you the arguments. Remember: Your opposition is planning a
massive campaign to saturate all of education with this policy.
Please do not say, " I'll think about it tomorrow." If you do,
you and your children will be Gone With The Wind! I live and work
with the opposition everyday. Listen to me! Help me help you!!

Your Friend,

Richie Smith (609) 883-7986



1328 Parkside Avenue
Trenton, New Jersey 08638

January 11, 1992

American College Health Association
1300 Piccard Drive, Suite
200 Rockville, MD 20850

Attn: Richard P. Keeling, M.D. Kenneth Steinman

RE: Open Letter: Wrongful Death Liability Resulting from Condom
Advocacy/Distribution

Dear Dr. Keeling and Mr. Steinman:

I am enclosing a publication about me, but not to me, which you
caused to be made and subsequently distributed to apparently a
very wide professional audience. Contrary to your proclamation, I
do not represent myself as a public health official but rather as
a public health professional of more than twenty combined years
experience in STD epidemiology and AIDS prevention and control.
In exercise of protected Constitutional rights, I speak as a
citizen, parent, and taxpayer and, therefore, do not hold myself
out as a representative of any official agency. I am very
surprised an disappointed that you apparently accord no respect
of such an important distinction so clearly set forth in the
credit line disclaimer. Such an obvious blunder could certainly
call into question your ability to perceive other critical subtle
distinctions. Furthermore, if such a publication were went to my
place of employment one might be compelled to seek an
accountability in substance and motivation. However, I first wish
to address your uncited and unsubstantiated declarations which
you offered as attempted rebuttal to one of many issues I raised
regarding HIV prevention through condom use.

1)

ACHA Opinion: No responsible clinician or educator ever
guarantees the effectiveness of condoms. A wrongful death claim
would depend on such a guarantee.

Legal Reality: Wrongful death claims do not require or depend on
a guarantee by defendant. It is only necessary that the plaintiff
was led to an unjustifiable reliance based on a substantial
certainty of protection.

Commentary: Present policy statements of safe sex, safer sex,
protected sex, etc. all convey a substantial certainty of condom
reliability against HIV under the actual conditions of use (in
vivo.) As we shall see later, the condom has never been
specifically observed and tested under this condition. Anyone
giving such information and/or providing the device has a duty to
fully disclose the lethal risk otherwise: they incur users to an
unjustifiable reliance. Furthermore, when colleges and/or
organizations such as the ACHA through examples such as the
enclosed publication, trivialize other safe options such as
abstinence and monogamy they are party to the liability by
increasing the ambit of foreseeable risk. Many states have
"learned intermediary" doctrines and the argument could easily be
made that an institution is a "learned intermediary" in which a
student would place reliance MacDonald v. Ortho Pharmaceutical
Core., 475 N.E. 2d 65 (Mass. 1985). Consequently, the faulty
message and particularly provision of the device is the
substantial factor in the harm and defendant college has breached
the duty and liability attaches.

2)

ACHA Opinion: Though condoms have been promoted and distributed
for decades as contraceptives (without guarantees), there have
been no suits against clinicians, educators, retailers or
manufacturers when condoms failed to prevent pregnancy.

Legal Reality: Pursuant to HIV infection, a plaintiff filed a
lawsuit on March 28, 1991 for failure of a lambskin condom to
prevent HIV as advertised. This also resulted in a FDA court
mandated labeling change prohibiting such condoms to be
advertised for STD/HIV prevention Today lambskin -- tomorrow
latex. What college wants the dubious and potentially costly
distinction of being the test case for the first successful
wrongful death claim involving a latex condom? Also, let us not
forget the Dalkon Shield -- 193,000 claimants = 2.4 billion
judgment! No guarantees either. Furthermore, how will such
litigation(s) impact on an institution's bond rating, trustees,
benefactors and essentially public image. !

Commentary: Consider these realities: HIV is 450 times smaller
than sperm. Conception is generally possible only under limited
conditions and times (one week average.) Disease infection can
occur any day at any time. Conception due to condom failure would
only occur during the "fertile window" and the result is life.
HIV infection due to condom failure occurs virtually anytime
resulting in an insidious, prolonged and agonizing death. It
defies belief that any responsible coalition of "clinicians or
educators" or others would equate these distinctive realities.
However, I assure you a jury will see the difference, especially
when they realize that sound public health practices which have
always been reliable in the past have been abandoned!

3)

ACHA Opinion: Most condom failures are actually user failures; to
prevail in a liability action a plaintiff would have to prove the
user failure did not occur.

Legal Reality: Once plaintiff asserts the proper and consistent
use of condoms the burden of proof shifts to the defendant
(college) to prove otherwise. How do you disprove the assertion?

Commentary: Actually the ACHA declaration raises several
interesting proof related issues all of which will lie at the
door of defendant college and now the ACHA.

a) User failure is an unsubstantiated claim and therefore a
faulty assumption.

The latex membrane is most vulnerable to viral particle transfer
at the moment of ejaculation. It is then that each partner has
increased vascularization, the condom membrane is most fatigued
from the act of intercourse and the force of ejaculation tests
the membrane most. The condom has never been tested in vivo at
this critical moment so degree of user failure is an assumption
subject to direct proof attack.

b) Lowest standard of proof necessary.

Wrongful death claims usually involve issues of material fact
necessitating jury trials -- generally a plaintiff emotional
advantage. The standard of proof in such civil actions is only
the preponderance of the evidence. This is the lowest standard
meaning only that which is more likely than not. Restatement
(Second) of Torts, # 433B cmt. a

c) Burden shifting.

Once the plaintiff asserts your argument that a condom was always
and properly used, the burden shifts to defendant college to
prove otherwise. This now creates a very difficult proof problem
because introduction into the record of past sexual history let
alone names of partners can be a horrendous admissibility
problem. Furthermore, suppose the plaintiff claims all partners
were unknown "pick-ups." How do you produce unlocatable unknown
partners to impeach the testimony? Fueled by your own rhetoric of
"sexually active youth" such a claim would not seem implausible.
Would it?

d. Apportionment of Harm by Defendant College and ACHA.

By the enclosed mailing to ACHA Institutional Members you have
taken an unsolicited aggressive point position to not only
advocate a flawed and lethal policy, but the ACHA has now gone on
official record of trivializing other safe options including my
unrefuted warnings for the protection of human life. The case
could be made that the ACHA now stands in the chain of liability
where the defendant college could indemnify itself by impleading
the ACHA as a third party defendant. If the harm is indivisible,
then defendant college and the ACHA could be joint and severally
liable -- each responsible for the total amount of damages. In
either case where apportionment of the harm is capable or not,
the burden of proof regarding the amount of apportionment or its
discharge is upon each actor. Restatement (Second) of Torts #
433B(2)(3).

Furthermore, defendant college in turn could invoke the defense
that the ACHA is the "learned intermediary" upon whom the college
relied for guidance that led to the negligent act. In fact,
through this aggressive advocacy is the ACHA now implicitly
offering to indemnify every college for each wrongful death claim
pursuant to HIV infection arising from the flawed policy?

4)

ACHA Opinion: A plaintiff would have to establish that HIV
transmission happened on an exact occasion when a properly used
condom failed, and that there could never have been other risk
exposures.

Legal Reality: If any other risk (intervening) is introduced and
it is substantially related to the defendant's original harm
causing negligence, the intervening risk is not a superseding
cause, and the defendant is still liable for the harm caused.
Restatement (Second) of Torts # 442A, 442B.

Commentary: The issue you attempt to sustain as a defense is that
of a superseding intervening cause. However, the facts of the
instant matter betray its transparency and offer virtually no
shield of defense.

Consider these facts: Latex is heat, cold, light and pressure
sensitive and adversely affected by humidity, ozone, air
pollution as well as the mere passage of time -- deterioration.
Condoms are rarely, if ever, stored/transported in compliance
with federal guidelines subjecting them to intense heat and cold.
As previously noted, they are not specifically tested (in vivo)
for intended use and only 144 out of each lot of 1,000 are
randomly, examined by a superficial static test. "Use
effectiveness" claims are derived from epidemiological studies
and cannot be compared with precision. 21 C.F.R. # 310/502
(1990). Furthermore, you admit that condoms are unrealistic by
acknowledging alarming user failure! Nevertheless, in apparent
defiance as well as absence of full disclosure of the above
realities you advocate, promote and support the distribution of
condoms as Safe/Protected Sex. Risk Reduction by definition adds
another risk, and "adding a new risk increases the total risk,
even if the new risk is smaller than other risks the subject
normally encounters." Hershey, Nathan and Miller, Robert, D.,
Human Experimentation and the Law, Germantown, Maryland, p. 52
(1976).

The critical element in determining whether-an intervening cause
can relieve a defendant of liability is foreseeability. If the
intervening cause is foreseeable the defendant is liable because
"upon looking back from the harm" to the defendant's original
negligent conduct the intervening cause was not extraordinary.
Therefore it remains a substantial factor in bringing about the
harm. Restatement (Second) of Torts, # 435. It is precisely this
reason why advocates and providers of condoms are liable.

While the technical inadequacies of condoms are extremely
contributory in the failure and therefore the negligence, it is
the nature of the failure that is lethal. In congressional
testimony in 1987, Mildred Crenshaw, M.D., past president of the
American Association of Sex Educators, Counselors and Therapists
said, "I am no stranger to condoms. They don't make me
uncomfortable. . . . However, I am also a scientist and I don't
like what I know about condoms when it comes to protecting us
against a deadly and incurable virus." The essence of the concern
is that the failure is irreversibly total when HIV ensues. She
goes on to say, "The failure rate isn't in the practice, it's in
being human." Therefore, when you combine condom technical
inadequacy with human failure the risk is not only foreseeable it
is inevitable. Furthermore, it is the very risk of the original
negligence and to advocate and provide that risk under the guise
of "safe" or "protected" is negligent conduct with a justifiable
and unescapable liability! Your policy encourages and even
promotes the same behavior with another foreseeable/inevitable
risk. Finally, because you have now made the risk more attractive
and desirable you have maximized the risk!

Personal Liability of State Officials

I predicted in my detailed analysis/critique that the U.S.
Supreme Court would appropriately strip away some of the immunity
from state officials. Relying on many of the very cases I cited,
the Supreme Court on November 5, 1991 in an 8-0 decision, said
that state officials may be held personally liable for damages
based upon actions taken in their official capacities. Hafer v.
Melo, 112 S. Ct. 358 (1991) (See Enclosure.) This holding
confirms the court's reluctance to afford blanket immunity to
state officials for their acts even in official capacities. If
sustained in a wrongful death claim, do realize the devastating
effect that could have on a state college president, dean,
instructor, etc? Private colleges are even more vulnerable
because "deep pocket" private benefactors and trustees would be
logical targets of litigation now with the erosion of privity
requirements. Remember that if sued personally, the state may not
be obligated to provide counsel or indemnification to the
official! However, there is nothing to prevent the original
plaintiff, college, state official, benefactor, etc. all from
filing various actions against the ACHA and its officers for all
the reasons previously enumerated and more.

Now I wish to address your more personal innuendoes and attacks.
The fact that I refuse to consign young adults to a hopeless
world of barnyard morality incapable of controlling their
passions does not mean I am "unrealistic," "insensitive" or
"judgmental." I lamented earlier your apparent difficulty in
perceiving subtle distinctions. One such distinction is the
difference between making sound professional judgments and being
judgmental. Furthermore, I am not unrealistic to suggest that
everyone morally deserves and is legally entitled to the full
disclosure of lethal risk, for only then can they make informed,
rational and life-saving choices.

I am, however, very dismayed as a taxpayer of the grant monies
you receive that virtually all of your arguments attempted,
albeit unsuccessfully, to discharge the liability but not the
fault! Where is the responsibility in that priority? Furthermore,
I submit a 102 page detailed analysis complete with a legal brief
which has not been refuted to this day by state or federal
agencies. In fact, the United State Supreme Court validated my
claim of state official liability. Did it not? After all of this,
you respond indirectly with four uncited and unsubstantiated
declarations and pronounce my efforts as "simplistic." Something
is wrong with this picture!

You also claim that my bibliography is "unimpressive." Yet, that
bibliography includes the New England Journal of Medicine,
Journal of the American Medical Association, American Journal of
Nursing, University of California Medical Center, Family Planning
Perspectives, FDA Handbook, direct correspondence from the FDA,
Time Magazine, Washington Post, etc. The brief contains cites
from the Code of Federal Regulations (CFR), Federal District and
Circuit Appeals Courts and the United States Supreme Court. Now
there are times when I disagree with the rationale or dispute the
findings of some of these references. Nevertheless, the only
cited authorities I recall in your publication were Richard P.
Keeling, M.D. and Kenneth Steinman. Did I miss the others?
I submit that the condom be deprioritized to the following policy
and disclaimer position.

Because of the deadly realities and legal consequences the use of
the condom as a method of HIV/AIDS prevention should be left to a
matter of personal choice and private commercial purchase
pursuant to an accurate, adequate and full disclosure of lethal
risk.

All prevention messages should reflect this deprioritization
placing the sincere development of risk elimination practices
above risk reduction in the hierarchy of prevention strategies.
Remember, condom dispensers pose additional liabilities not
addressed here!

One last comment regarding your judgmental reference to my lack
of "familiarity with behavioral developments or cultural contexts
of college campuses." Please be advised that I taught on two
college campuses, lectured for the last twenty years to all grade
levels, was a volunteer sponsor for recovering young female,
substance abusers, a club musician in a large band for the last
thirty years which was comprised of more than half college
students and presently attend an inner city university at least
three times per week. It appears that by argument of substitution
and innuendo you have attempted to impugn my character as well.

Nevertheless, from these experiences I am very aware, of the
sexual proclivities of young human nature today. However, I do
not believe they are animals incapable of reason, restraint and
meaningful love only able to respond to better living through
chemistry! Perhaps I have a greater faith in their abilities and
character.

Yes, young adults are in very troubled waters today where the
currents are swift and deep because the choices are deceptive and
dangerous leading to whirlpools of human misery and even death.
Now is not the time to throw them a "rubber raft" of so called
safe sex with lethally random effectiveness. Rather I urge you
and all of our colleagues to be a beacon of empowerment and
provide these exciting and wonderful young adults with a bridge
over troubled waters by replacing Safe Sex with Safe Values.

While I am extremely troubled by your deliberate dissemination of
the enclosed publication about my work and person, I am sure the
events of the future will afford a proper and definitive remedy
to the matter! Nevertheless, I still accord you professional
respect and address you directly.

Sincerely,

Richard W. Smith