Legal Accountability for Wrongful Life

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