Blood-Borne Illness:
Hepatitis, HIV, and Uncertainty
Edward P. Richards
Director, Program in Law, Science, and Public Health
Harvey A. Peltier Professor of Law
Louisiana State University Law Center
Baton Rouge, LA 70803-1000
richards@lsu.edu
http://biotech.law.lsu.edu
Blood: The Perfect Culture Media
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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
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Syphilis
Hepatitis (all types)
Rabies
 Spread by cornea transplants
HIV - virus that causes AIDS
Malaria
Many other diseases at lower levels
Sharing blood
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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
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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
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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
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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
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Paid donors
Marginal employment
 College students
 Drunks
 Junkies
Disease problems
 Not healthy life styles
Hepatitis - the Old Days
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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
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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?
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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
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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
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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
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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
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(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
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(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?
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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?
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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
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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
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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 Card
HIV/AIDS
Prelude
Tuskegee Syphilis Experiment Comes to
Light
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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
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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
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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
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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
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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?
Bathhouses and HIV: 1976-1980
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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?
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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?
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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
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http://www.aegis.com/news/sc/1989/SC890404.ht
ml
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
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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
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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
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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)
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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?
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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?
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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?
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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
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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
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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
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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
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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
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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
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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