1988 Expert Witness

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December 15, 1988 Author: Thomas Drees

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF HAWAII

JOHN DOE,

CIVIL NO. 87-8232

PLAINTIFF,

vs.

CUTTER BIOLOGICAL,

a division of Miles Laboratories, Inc.,

et. al.,

Defendants.

AFFIDAVIT OF THOMAS DREES

STATE OF CALIFORNIA

COUNTY OF LOS ANGELES

Comes now Thomas Drees, being first duly sworn on oath, deposes and says as follows:

He has been retained as an expert witness in the case of John Doe v. Cutter, et. al.

1. He is an expert in the area of the manufacturing, marketing, safety, supply, and processing of blood products. He was the Chief Executive Officer of Alpha Therapeutics, one of the Defendants in this case from 1978 to November, 1983.

2. He has reviewed the documents supplied to him by Plaintiff’s counsel, Mr. Kozak.

3. He has come to the conclusion based upon the documents reviewed, the expertise he has acquired from his experience in the blood products industry and his research in the field that the Defendants in this case failed to act reasonable and prudently in the manufacture of Factor 8 and further, that said failure resulted in the infection of Ken Binkley with HIV virus.

4. Cutter, Alpha, Armour and Baxter failed to develop heat treated Factor 8 in a timely manner given the technology available in the 1970s and 1980-1981. Alpha was able to develop heat treated Factor 8 in six months, once I was aware of the urgency of the pasteurization process in late 1982. However, the other fractionators were much farther along in the development process, particularly Cutter and Baxter. Cutter was owned by a German Co., Bayer and could not fail to be aware of the German pasteurized Factor 8 which was available on the German market in 1976. Yet, they failed to obtain a license for their pasteurized Factor 8 until February, 1984. Likewise, the other fractionators took much too long to develop their pasteurized products in view of the urgency of preventing the spread of Hepatitis B and NonA, NonB which was killing many Hemophiliacs per year. The feasibility of using heat to inactivate viruses was known to the industry in the early 1970s. I personally attended a meeting in August of 1982 where a paper was presented which detailed the process for pasteurizing Factor 8. There is no reason for the Defendants to not have had pasteurized product on the market by 1980 had reasonable and prudent research and development been used by the Defendants.

5. In November of 1982, I attended a meeting of ABRA which was held in Anaheim, California. A concurrent meeting of the AABB was held at the same site on the same dates as is usually the custom in the blood industry. At the meeting I heard a presentation of Dr. Bruce Evatt of the CDC in which he describe the AIDs epidemiology. I was shocked and horrified. I was also very surprised that no one had informed me of this terrible disease and its relationship to the blood industry before the meeting. No other representatives at the meeting seemed surprised or motivated to take any immediate action. Further, the members of the AABB informed us that they did not care to hear what Dr. Evatt had to say regarding anything about the new epidemic. So far as I know, Dr. Evatt went home to Atlanta without even addressing the AABB meeting.

6. In December of 1982 and January of 1983, I attended meetings of the BPAC and CDC in Bethesda, Maryland and Atlanta, Georgia, respectively. At these meetings the following points were made very clear:

7. AIDS was most likely caused by an "unknown transmissible agent" similar to Hepatitis B and NonA, NonB.

8. The "high risk groups" who sere at risk for the transmission of this disease were the same carriers for Hepatitis, specifically, homosexuals, IV drug abusers, and Haitians.

9. There was at least a 88% correlation between positivity for the HB Core Antibody and those infected with AIDS up to that point in time.

10. I immediately directed our plasma collection centers to desist taking any plasma from high risk donors and to screen as vigorously as possible for these high risk groups. These directives went into effect on December 26, 1982.

11. The other fractionators dragged their feet on instituting donor screening and did not completely institute screening for the most serious high risk donor, i.e., homosexuals, until March or April, 1983.

12. To a very large degree, the safety standards in the fractionator industry are influenced by the ABRA of which all fractionators were members from 1980 to 1985. The four fractionator defendants in this case produce virtually all the Factor 8 produced in this country. This is a very large and lucrative business with substantial sales overseas. In my work for the Office of Technology Assessment, we compiled sales figures for the amount of sales by the industry as of 1985 on an annual basis. Sales at that time in the marketing of Albumin and Factor 8 alone totalled 1.2 billion dollars among the four Defendants. Half of these sales were the result of overseas transactions.

13. I was severely criticized by my competitors for taking the immediate actions that I did regarding screening for high risk donors. Further, my superiors at Alpha were highly critical of my action. It is my firm belief that the actions I took in late 1982 in good conscience to protect the public from the AIDS virus were in large part the reason for my being terminated from Alpha as it’s CEO in November 1983.

14. Although I was not aware of the goings on at various meetings that were attended by my subordinates of the BPAC, NIH, CDC, ABRA, NHF and AABB, specifically Penny Carr, our regulatory representative, it is now apparent to me after reviewing the documents in this case that there was a "conspiracy" at work among the various fractionators to avoid using the surrogate test known as the HB Core Antibody Test. I was not aware of this even at the time of my deposition, July 1988. Had I been properly advised by my medical advisors at Alpha regarding the correlations between HB and NonA NonB, I would have implemented the HB Antibody Test at the same time I began using the screening for high risk ggroups at our donor centers (December 26, 1982).

15. Recently, counsel has provided me with further documents which indicate to me that the fractionators in conjunction with Dennis Donohue of the FDA and the AABB and ARC conspired to prevent the use of the HB Core Test from being implemented as the standard of care. They did this to prevent having to incur the expense of the test, and to avoid having to reject donors who were positive for the test. Of course, this needed to be done in any event to comply with FDA regulations which required that only normal, healthy donors be used as donors. Persons who have a history of viral Hepatitis are not considered "Normal healthy donors" as evidenced by the fact that every donor is asked if he has ever had hepatitis before being allowed to donate or sell his blood or plasma. If he answers in the affirmative he is permanently rejected as a blood donor. A positive test result for the HB Core Antibody is tantamount to the finding of a history of viral hepatitis.

16. I have long been a strong advocate of the "paid for" plasma system in the U.S.A. because I do not see any other way to supply the nation’s Hemophiliacs with the clotting factor they need. Further, we can obtain a consistent medical history since the donors are repeated so regularly. However, I was never aware of the effect of failing to use the HB Core test until this litigation. I had always assumed that the industry would use those tests available to insure that the highest standards of care were being realized in the fractionation industry. It is now clear to me that the HB Core Test should have been used from the time it became available through Abbott Laboratories in 1975. If it had been used from 1975, countless deaths from HB and NonA, NonB would have been avoided. Further, Ken Binkley and thousands of other Hemophiliacs would not have AIDS today, as this disease would have never been allowed into the blood supply in any great degree.

17. The fact that there was such resistance to the use of the HB Anti Core Test by the blood industry, and the blood industries resistance to take the most obvious and needed precautions to the AIDS epidemic convinces me that there was a concerted effort by the influential leaders of the blood industry to save dollars at the expense of lives, even when it was clear beyond any doubt that there was widespread contamination of the blood supply in November, 1982.

Further affiant sayeth naught.

[Signed: Thomas C. Drees]

THOMAS C. DREES

Subscribed and sworn to before me

this 15th day of December, 1988.

[Signed: Angela R. Terwilliger]

Notary Public, State of California

My commission expires: July 26, 1991

Not for commercial use. Solely to be used for the educational purposes of research and open discussion.

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