Taiwanese Hemophiliacs Infected by US Made HIV-Contaminated Medications: Exhibits

Szmuness 1975 “On the Role of Sexual Behavior in the Spread of Hepatitis B Infection”

Exhibit 1: Cutter Memo to Taiwan supplier re sales of AHF since 1977, 2 April 1985

Exhibit 2: Cutter Memo re meeting with Taiwan Dept of Health, 4-5 Feb 1997

Exhibit 3: Cutter Memo re heat treatment killing AIDS virus, 17 May 1984

Exhibit 4: Cutter Note re AHF study and chimpanzees developing AIDS-like symptoms, 14 Dec 1982

Exhibit 5: July 1982 MMWR reporting hemophiliacs showing symptoms of
disease observed in gay men

Exhibit 6: Oct 1984 MMWR reporting increasing cases of AIDS in hemophiliacs

Exhibit 7: Cutter Memo re plasma screening test recommended by the FDA, 19 Dec 1983

Exhibit 8: Cutter Memo re FDA asking Cutter to voluntarily exclude gays
from plasma collection, 30 Aug 1982

Exhibit 9: Cutter Memo re FDA asking Cutter to exclude high risk donors,
including prisoners, 21 Dec 1982

Exhibit 10: Advertisements in various gay magazines for plasma donors exposed to hepatitis

Exhibit 11: Cutter letter to Warden of Arizona State Prison in Florence re FDA
concern re prisoner plasma, 19 Jan 1983

Exhibit 12: Letter from Cutter’s Oakland Plasma Center to Cutter, that center was found to be in non-compliance re plasma collection from IV drug users, 19 May 1981

Exhibit 13: Cutter Memo re FDA asking for exclusion of plasma from high risk donors, 13 Dec 1982

Exhibit 14: Transcript of Steven Ojala (Cutter) presentation to FDA Committee
opposing mandatory recalls, 19 July 1983

Exhibit 15: Internal Cutter Memo from Mozen that heat treated AHF would
probably be safer,
4 Jan 1983

Exhibit 16: Letter from FDA to Hyland / Travenol approving their heat
treatment license, 21 March 1983

Exhibit 17: Letter from FDA to Miles (Cutter) approving their heat treatment license, 29 Feb 1984

Exhibit 18: Letter from Cutter to FDA, date 9 Aug 1985, that they ceased making and distributing non-heat treated product on 21 June 1985

Exhibit 19: Letter from FDA to Miles/Cutter acknowledging Cutter’s letter of 9 Aug 1985

Exhibit 20: Confidential Cutter Memo of 15 Nov 1984 regarding excess inventory of non-heated AHF

Exhibit 21: Cutter Telex of 29 Nov 1984 regarding continued sale of non-heated AHF to the Far East

Exhibit 22: Cutter’s 1984 Far East Marketing Memo stating that a recall would cost
Cutter $2 Million during 1984

Exhibit 23: Cutter’s 1985 Far East Marketing Memo stating Cutter has no immediate plans to stop selling non-heated AHF, because AIDS was not yet an issue in the Far East, and that “hysteria over AIDS” could cost them to lose sales and profit

Exhibit 24: Telex from Cutter to Hong Kong supplier, dated 6 May 1985, stating that non-heated product is still being sold in Taiwan and other countries, describing non-heated AHF as
“the same fine product”

Exhibit 25: Cutter Memo dated 30 May 1985, regarding FDA request to Cutter to stop making
non-heated AHF

Exhibit 26: Cutter telex dated 31 Oct 1983, recalling AHF lots containing plasma from Austin donor who died of AIDS

Exhibit 27: Cutter Memo of 4 Nov 1983 regarding recall due to Austin donor “diagnosed
as having AIDS”

Exhibit 28: Cutter Telex to Taiwan supplier regarding recall, saying donor was “suspected of AIDS”

Exhibit 29: Cutter Letter introducing sales manual for heat treated AHF, dated 12 April 1984

Exhibit 31: Cutter Marketing Bulletin dated 26 June 1985 saying “Effective immediately, no further exports of non-heat treated AHF” would be made

Exhibit 32: Cutter telex to Taiwan supplier, dated 20 Sept 1985, offering exchange of heat-treated AHF for the non-heat treated AHF

Exhibit 33: Cutter Memo regarding international AIDS symposium in April 1985, and the amount
of information now known about AIDS, in which it was recommended that non-heated AHF
no longer be used

Exhibit 34: Jury verdict of $2 Million in JKB case in Indiana, 20 March 1997

Exhibit 35: Jury verdict of $35.3 Million in Dixon case in Louisiana, 15 March 1999

Exhibit 36: News release dated 19 Feb 1998, regarding Bayer providing “humanitarian aid” to Taiwanese hemophiliacs who contracted HIV

Exhibit 37: News release dated 14 Feb 1998, wherein Bayer claims it had won all litigation cases throughout the world

Exhibit 39: Bayer responses to Discovery requests, 13 Feb 2008, listing participants in the Taiwan aid negotiations

Exhibit 40: Bayer responses to Discovery requests, 26 Oct 2007, regarding Taiwan aid negotiations

Exhibit 42: US Court of Appeals decision on Gruca, which notes that their decision was based upon the fact that the AHF used which infected the person who died of AIDS, was made by another manufacturer other than Cutter

Exhibit 42a: Gruca case settlement with Alpha Therapeutic Corporation, 21 Jan 2003

Exhibit 44: Paragraph 9 of Taiwan Humanitarian Aid agreement, regarding additional compensation to Taiwan claimants, if Bayer pays higher compensation to others

Exhibit 45: Paragraph 18 of attorney’s declaration, that Taiwan humanitarian agreements were signed between 1998 and 2002

Exhibit 46: Letter of 11 May 2004 to Bayer, requesting enforcement of the scale-up clause of the Taiwan agreement, and increased compensation to Taiwan victims

Exhibit 47: New York Times story of 22 May 2003, regarding Bayer’s dumping of infective product in overseas countries

Exhibit 54: Bayer letter of 16 Feb 1998 to Taiwan Department of Health regarding negotiations on humanitarian aid

Exhibit 63: Cutter memo dated 27 Jan 1982, that “hepatitis free” AHF product was being tested, and that Dr. Louis Aledort stated “that once this product is licensed, it would be unethical to place a patient on other therapy”

Exhibit 64: Cutter Memo dated 1 June 1983 regarding hemophiliacs diagnosed with AIDS had used AHF, and that heat-treated AHF in Europe appeared free of hepatitis and thus was safer

Exhibit 65: Cutter Memo dated 6 June 1983 regarding heat treated AHF appearing safer

Exhibit 66: Cutter Marketing Bulletin of 6 July 1983 downplaying heat treatment,
saying not proven, etc

Exhibit 67: Cutter’s ECHO publication to hemophiliacs, dated May 1983, stating there is “no evidence”, and downplaying heat treatment of AHF

Exhibit 68: Cutter Memo of 22 Nov 1983 stating Cutter had made a “corporate commitment” to produce heat treated AHF, that they had a “quality heat treated process” that would be available in early 1984

A sample of hemophiliac lawsuits against AHF manufacturers:

Waage v. Cutter, 926 P. 2d 1145, (Alaska 1996)
JKB v. Armour, et al, verdict 3-20-97
K.D.D. Smith v. Alpha, et al, Orleans Parish, LA, jury award 3-15-99, overturned on SOL, but settled

Federal Regulations requiring companies to use plasma from “normal, healthy donors”:

§§640.51 - Suitability of donors
640.63 - Suitability of donor
§606.140a - Laboratory controls