Blood-Borne Illness:Hepatitis, HIV, and Uncertainty

Edward P. RichardsDirector, Program in Law, Science, and Public Health

Harvey A. Peltier Professor of LawLouisiana State University Law Center

Baton Rouge, LA 70803-1000richards@lsu.edu

http://biotech.law.lsu.edu

Blood: The Perfect Culture Media

Any tissue can carry infectious agents between persons Bacteria Virus Prions??

Blood is the biggest problem because it is, by far, the most common tissue that is transferred between persons

Examples of Diseases Spread by Tissue

Syphilis Hepatitis (all types) Rabies

Spread by cornea transplants HIV - virus that causes AIDS Malaria Many other diseases at lower levels

Sharing blood

Transfusions Traumatic blood loss Chronic diseases that lead to anemia

Blood products Clotting agents for hemophilia

Heart lung machines Intravenous drug users who share needles Sex

Blood Banks - History

Mostly non-profit Most are run by or affiliated with the Red Cross Blood processing

Obtain blood from donors Analyze the blood for type Store and deliver blood when needed Keep track of donors of rare blood types

Blood Typing

Basic types A, B, O, AB

Subtypes Rh factor other factors as we learn more

Key issue Get the wrong blood and you die Get wrong Rh factor and it can cause problems if you

get pregnant later

Traditional Liability for Blood

Negligence Giving the wrong blood type Potential errors

Incorrect initial typing of the donor Incorrect record keeping - confusing stored

blood Incorrect typing of recipient Giving the blood to the wrong patient

Traditional Blood Donors

Paid donors Marginal employment

College students Drunks Junkies

Disease problems Not healthy life styles

Hepatitis - the Old Days

Hepatitis means liver inflammation Viral illness Not well understood until the 1980s and 1990s Types

A B Non-A, Non-B (we did not know what, but there

was something there)

Risk of Infection with Hepatitis B

1 in 3 persons receiving a transfusion Multiple units from multiple donors Only takes one bad unit

Consequences of infection Death Liver failure Liver cancer - major global risk Chronic carrier

Could Infection be Prevented?

No specific test for hepatitis in the 1960-70s Most infected persons had elevated levels of

certain liver enzymes that could be measured Everyone knew that screening donors could

reduce the risk of transmission

Why Was Nothing Done?

Blood as life-saving resource Persons with massive blood loss will die

without transfusions Worth the risk Screening donors and blood would reduce the

supply Reduced supply means people would die

Blood as Limiting Resource in Surgery

Blood had a second, and more common, role historically Blood was necessary for many types of elective

surgery Biggest use was old heart-lung machines

Without blood, billions of dollars of elective, and often questionable, surgery would have come to an end

Negligence Liability for Bad Blood

If something could have been done to lower the rate of infection, why wasn't there more litigation?

Who sets the standard of care for blood banks? It is a professional service run by physicians The blood banks

If all of the blood banks use the same standards, can those standards be negligent? Why no T.J. Hooper?

Products/Strict Liability

Restatement of Torts 2nd - 1965 Began to be applied to drugs in the late 1960s Why would it be better for contaminated blood?

Restatement of Torts 402a

(1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if

(a) the seller is engaged in the business of selling such a product, and

(b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.

Defenses under 402a

(2) The rule stated in Subsection (1) applies although

(a) the seller has exercised all possible care in the preparation and sale of his product, and

(b) the user or consumer has not bought the product from or entered into any contractual relation with the seller.

Is Blood a Product?

Product Versus Service Is blood manufactured? What would the defendant say?

Are there other examples of natural products that support products liability? Food? Pits in cherry pie? Eggs contaminated with salmonella?

Which is blood like?

Is the Defendant a Seller?

Everyone In The Chain is Liable Is the hospital or the blood bank a seller? Does it matter that they charge a lot for blood?

Are they really service providers, and the blood is ancillary to the service?

Blood Shield Laws

Some courts were willing to find that blood was a product The level of preventable risk with blood made

this a real threat to blood banks Standard of care would not protect them

States enacted blood shield laws that statutorily defined the process of providing blood as a service, subject only to negligence liability

Policy Impact of Blood Shield Laws

Most were passed late 1960s/early 1970s If the only cause of action is negligence, what is

the key standard of care issue? What if one or more of the blood banks started

screening blood or donors? Given that all of the blood banks are part of the

standards organization, and that most are the same group, what should they do?

The Wild CardHIV/AIDS

Prelude

Tuskegee Syphilis Experiment Comes to Light

This experiment began in the 1930s to study the natural history of untreated syphilis in black men.

It was continued until the late 1960s, long after penicillin became available (1945), making syphilis treatment safe and effective.

This study did great harm to the participants, and to their wives and partners and children, who were also infected during the duration of the experiment.

It undermined the credibility of the public health establishment in minority communities and created suspicion of all public health programs targeting minorities.

Stonewall Riots - 1969

Focused public attention on police harassment of gay men and women

Showed the political power of gay voters and supporters in big cities

Made the newly emerging bathhouse culture off limits to public health enforcement

Swine Flu - 1976

Driven by the real fear of a global flu pandemic Vaccine was rushed into production A national compensation program was set up Massive push to vaccinate the public No cases of Swine Flu

Swine Flu - The Epilog

Fear of Guillain-Barre syndrome and the lack of a good lab test lead to over diagnosis

Lawyers helped patients find sympathetic docs Huge liability for the government, (Unthank)

despite limited scientific support (Freedman) Federal and local public health loses credibility

and becomes more politically sensitive

Hepatitis B in Bathhouses - 1976

Data published in 1976 and 1977 showed a huge hepatitis B epidemic in the bathhouses Almost everyone who was active became infected Hepatitis B is sometimes fatal, with long term

complications Nothing was done to close the bathhouses Why?

Distracted by Swine Flu? Politically unwilling to take unpopular action?

Bathhouses and HIV: 1976-1980

HIV was rare initially Bathhouses allow a huge number of different contacts Bathhouses allow mixing of social classes and

nationalities HIV is hard to catch

Bathhouses allow high frequency sex Bathhouses allow high risk sex Bathhouses encourage other STIs, which increase HIV

transmission Bathhouse clientele also included IV drug users

What if the Bathhouses had been Closed in the 1970s?

Without bathhouses, HIV would be a small problem in the US Mathematical models show that bathhouses

amplified the HIV epidemic in gay men Models show that bathhouses are still critical

to the spread of HIV in the US (Thompson) Bathhouses were the start of AIDS

exceptionalism, before AIDS was discovered

HIV and the Blood Supply

What are the characterizes of the persons exposed to HIV during this initial, undetected phase of the epidemic?

Will they be blood donors? What will happen to the persons who get transfusions or

blood products? HIV usually has a long latent period before obvious

infection Allowed large number of persons to be infected before

the first cases of AIDS started to develop in the 1980s

1981 - Ground Zero in the US

GRID and the first cases Gay Related Immunodeficiency Disease GRID was originally concentrated in several

metropolitan areas on the coasts: San Francisco, Los Angeles, Houston, Miami, and in the East Coast Metroplex from Baltimore through Washington DC, New Jersey, New York City to Boston.

Changed to AIDS Acquired Immune Deficiency Syndrome Some of the cases were straight junkies

Working out the epidemiology

Traditional investigation for the first cases Who is infected? Who did they have sexual and other contact with? Where did they go? What did they eat?

The result Exactly the same epidemiology as the hepatitis B in the

bathhouses in the 1970s Exactly the same people

Conclusion - exactly the same mode of transmission

Initial Fears

When it was known that AIDS was a disease of gay men and IV users, questions were raised about whether it could be spread to others Pressure to fire gay waiters and hair dressers Claims of housing discrimination against persons with

AIDS These claims were difficult to substantiate

Civil libertarians pushed to keep information about AIDS secret

Impact on the Blood Supply

AIDS cases start to show up in people who do not fit the profile

Since we know that hepatitis is spread through transfusions, the blood is suspect Blood banks deny that blood is a problem They resist pressure to screen the blood and

donors for hepatitis risk Maybe those folks had secret lives?

The Smoking Guns

AIDS cases in children who had transfusions undermined the theory that blood was not the cause

At least one transfusion-related AIDS case was traced back to a donor with AIDS

Breaking Ranks

At least one blood bank started screening donors Sexual preference Drug use Bathhouse exposure

Persons with a positive history were turned away Got heat for discrimination

What does this do to standard of care? All the blood banks started donor deferral

The Bathhouses Redux Bathhouses in NY were left open until 1985, when

death weakened the opposition to closing (St. Marks Baths)

Public health experts who pushed to close bathhouses lost their jobs (Joseph 1993)

Gay activists, bathhouse owners, and even health department employees claimed that bathhouses were good places to do sex education

Some never closed and many others have reopened

The HIV Test

In 1985 a blood test for HIV became available As soon as the HIV test was available, blood

banks started to use it to screen blood There were negligence claims based on delays

of a few weeks by some blood banks in getting the test online

Donor deferral was still used because there can be a 6 month delay between infection and the test turning positive

Second Round of AIDS Litigation

Blood shield laws were held to apply to HIV Plaintiffs had to make a negligence

argument The key was T.J. Hooper

There was a lot of information about the hepatitis risk, which was preventable

There was federal guidance that recommended donor deferral

Who were the Plaintiffs?

The best plaintiffs were persons receiving blood products to prevent clotting disorders They have to get multiple treatments They almost all got infected

Negligence Using pooled blood Not treating the products to kill infectious

agents

The Litigation

http://www.aegis.com/news/sc/1989/SC890404.html

Eventually there were global settlements Plaintiffs are dying, makes it hard to hold out Blood banks are non-profit community

resource Juries do not want to put them out of business

Blood Fears

Post AIDS, the public was scared of blood and blood banks changed their ways No more paid donors (unless they really, really

need your blood) Extensive donor questioning and deferral Testing for everything they can think of

Important Note

The LA SC says the three year limitations period in the MMA is prescriptive, not peremptive: The three-year limitation is prescriptive, not

peremptive. Hebert v. Doctors Memorial Hospital, 486 So.2d 717, 724 (La. 1986), reaff'd in State Board of Ethics v. Ourso, 2002-1978, p. 4 (La. 4/9/03), 842 So.2d 346, 349.

They just have not found a case where they are willing to allow an exception

Hepatitis C

Remember non-A/non-B hepatitis? Another variant was characterized in the 1990s Hepatitis C

Liver disease General debility

Spread by transfusions Long latency - can show up 30 years later

Other Modes of Transmission for Hepatitis C (and B)

sharing and equipment used to inject drugs unsterile tattooing, body piercing and skin penetration

procedures household practices (such as sharing razor blades and

toothbrushes) occupational procedures (eg, needlestick and sharps

injuries) certain sexual activities mother to baby.

What are the Scientific Issues in a Hepatitis C Claim?

How can it be negligent to fail to prevent an unknown disease?

When did the standard for screening blood change?

Is hepatitis C affecting the same people as hepatitis B?

What are the Legal Issues in a Hepatitis C Claim?

Before the blood shield law? SOL or prescription? Discovery rule? What is the state had not adopted products

liability then? Post-blood shield? Post-MMA?

The Future for Hepatitis

Good vaccine for hepatitis A & B Now required for kids, not just "persons at risk" In the long term, both will decline dramatically in the

community No vaccine for C yet, no good data on prevalence or other

risk factors There is a D, but seems to be limited to co-infection with

B E, F, G...???

The Rest of the AIDS Story

Public Health Reporting

The debate shifted to the identification of HIV carriers who had not yet developed AIDS

Some states required reporting positive HIV tests by name, as with all other communicable diseases Colorado passed the first HIV reporting law

None of the states with high numbers of AIDS cases required named HIV reporting It was argued that the only reason to report was to get

people treated Since there was no treatment, why report?

The Politics of Reporting

Constitutional Basis Whale v. Roe, 429 US 589 (1977)

Hepatitis was reportable Most of the initial cases of AIDS were known to the health

department Privacy issues

Would the health department tell your boss? Would we set up AIDS concentration camps? Would you lose your health insurance?

Identifying cases would increase pressure for services Big deal in prisons Many states had mixed motives in reporting

Anonymous Testing

For all other medical conditions, you have to give your name for testing and reporting Health departments had always had a few people give fake

names in sexually transmitted disease (STD) clinics, but the clinic policies did not encourage this

Did not make a difference if it was only a few persons States created exceptions to allow anonymous HIV testing

Claimed this would encourage testing There is no evidence that anonymous testing has a

significant effect on HIV testing (Judson 1988)

Federal Pressure

Congress was lobbied to require anonymous testing sites as a condition of federal funding States with named reporting were forced to

allow anonymous testing Anonymous testing is still offered in most

states The federal government still supports anonymous

testing

Reporting

All communicable disease reporting is local, with data sent from the state to the federal government. There are no national standards or laws for communicable

disease reporting HIV data is very weak because of anonymous testing, lack of

named reporting, and no contact investigation HIV rates and spread are based on models, not real data

Models tend to lag epidemics Models are biased to show that prevention is working

The federal government is now requiring reporting by name to qualify for federal funding The last hold out is California

Contact Tracing

Contact tracing is the best way to find hidden cases Many states do not do contact tracing because they see it

as an invasion of privacy It also requires named reporting and no anonymous

testing to get good input data. It does not require perfect reporting - overlapping

contacts help fill in missing data (Hethcote)

Partner Notification

Warning people who have been exposed to a communicable disease

This has been opposed on privacy grounds. It would interfere with the right to avoid

knowing that one was exposed to HIV. If the contact is monogamous, it is impossible

to hide the identity of the person who exposed them

What about the person being exposed?

Benefits of Contact Tracing and Partner Notification

HIV is hard to catch Many persons who are exposed can be warned before

they are infected Persons who need help in avoiding exposure, such as

poor women, can be given social service support Poor minority women have been hit hard by HIV They do not know they are exposed They need help to deal with infected partners

Remember that headline from the CDC last week?

Does Disease Control Cost too Much?

Contact tracing and partner notification is expensive because HIV is now so common The benefit of preventing cases of HIV is very

high The human and financial costs of the continued

spread of HIV is higher Minority communities are the hardest hit

HIV in Medical Care

AIDS exceptionalism extends to HIV in routine medical care

HIV is not treated the same as other diseases This delays diagnosis and reporting This interferes with effective treatment

HIPAA Whatever the original concerns about privacy of HIV

information, HIPAA has now imposed a rigorous national medical information privacy standard.

HIPAA standards are adequate to protect HIV information.

Consent to HIV testing

HIV testing should be a routine part of medical care Many states have special laws for consent to HIV testing

These require onerous extra paperwork and counseling to order HIV tests

They often require the patient to be told non-medical information intended to discourage testing

These requirements are unique to HIV and interfere with screening pregnant women and others

There are also special medical record keeping requirements for HIV data in some states

AIDS and Other Public Health Laws

Since AIDS was the hottest public health law issue in the 1980s and 1990s, all public health law was seen as AIDS law AIDS activists and civil libertarians lobbied state

legislatures to weaken other public health laws to limit the state's ability to use traditional public health measures in all areas

Quarantine and isolation laws were the main target, but other disease control laws also suffered

Ironically, the Supreme Court is more likely to uphold public health laws now than it was 40 years ago

Where Do We Go From Here?

End AIDS Exceptionalism

The Federal Government's Role

Since the federal government shapes state disease control through its funding, it must change its priorities to encourage proper disease control for HIV

Most goals can be reached with funding incentives and do not require national public health laws

It will require changing state laws and rules

Proposed Requirements for Federal AIDS Funding

End anonymous testing. Named reporting of all positive HIV tests Screen pregnant women End all special requirements for HIV testing

HIV testing should be no different than any other medical test

Post test counseling should not be allowed to stand in the way of testing

Federal Government Funding

Contact tracing Partner notification and assistance Uniform disease reporting A national clearinghouse for HIV reports A national system for assuring that infected persons

receive up to date information on HIV treatment and available social services.

Public health law projects designed to protect existing powers and expand traditional disease control laws

Why HIV Control Matters to National Security The US must have a working national reporting and

communicable disease investigation system This cannot be a shadow plan, used only for

emergencies It must be part of working disease investigation system It must be used every day to maintain staffing and

readiness. HIV costs more than other communicable diseases, yet

little of this money supports disease control. HIV funding could support the public health

infrastructure necessary to respond to public health emergencies