Blood-Borne Illness: Hepatitis, HIV, and Uncertainty

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. Traditional Blood Donors • Paid donors • Marginal employment • College students • Drunks • Junkies • Disease problems • Not healthy life styles

9. Hepatitis - the Old Days • Hepatitis means liver inflammation • Viral illness • Not well understood until the 1980s and 1990s • Types in 1980 • A • B • Non-A, Non-B (we did not know what, but there was something there)

10. 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

11. 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

12. 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

13. 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

14. 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?

15. Products/Strict Liability • Restatement of Torts 2nd - 1965 • Began to be applied to drugs in the late 1960s • Why would it be better for plaintiffs suing over contaminated blood?

16. 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.

17. 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. • [No standard of care defense]

18. 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?

19. 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?

20. 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

21. 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?

22. The Wild CardHIV/AIDS Prelude

23. 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.

24. 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

25. 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

26. 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 • D.A. Freedman & Philip B. Stark, The Swine Flu Vaccine and Guillain- Barré Syndrome:  A Case Study in Relative Risk and Specific Causation, 23 Evaluation Review 619 (1999) • Federal and local public health loses credibility and becomes more politically sensitive • Welcome to your world

27. 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?

28. 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

29. 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

30. HIV and the Blood Supply in the 1970s • 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

31. 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

32. 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

33. 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

34. 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 • What is their economic incentive?

35. 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

36. 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

37. 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

38. 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

39. 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

40. 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

41. 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

42. 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

43. The Rest of the AIDS Story

44. 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?

45. 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

46. 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)

47. 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 supported anonymous testing

48. 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

49. 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)

50. 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?