each of the aforementioned screening requirements. The records confirm that Donor #7 stated that he never had hepatitis, had not been in contact with a hepatitis carrier, and had not received a blood transfusion within the prior six months. Additionally, Donor #7 indicated that he never used injectable drugs, and never had sexual contact with an intravenous drug user. See Def. Mot. for Summ. J., Exh. 6. It is therefore obvious that the Red Cross performed the professionally required screening procedures on Donor #7. According to those procedures, it appeared that Donor #7 was not infected with Hepatitis C. Therefore, as a matter of law, the Red Cross did not screen Donor #7 in a negligent fashion.
Furthermore, the Red Cross did not negligently test Donor #7's blood. At the time of the relevant donation, three tests could reduce the risk of HCV transmission via blood transfusions. The most accurate test was the First Generation Immunoassay HCV Test ("HCV 1.0 test"). The other available tests were the Antibody Hepatitis B Core Antigen test ("anti-HBc"), and the ALT liver enzyme test ("ALT").
The AABB Standards required blood banks to perform the "the most specific" test, which was the HCV 1.0 test. AABB Standards for Blood Banks and Transfusion Services, 13th Edition, B5.520. The FDA regulations did not require performance of any of these tests. See 21 C.F.R. § 640.5.
It is undisputed that the Red Cross performed the HCV 1.0, ALT, and anti-HBc tests Donor #7's blood. It is also clear that each of these tests indicated that Donor #7 was not infected. See Def. Mot. for Summ. J., Exh. 6; and Def. Supp. Mem. of Law, Exh. B; see also Affidavit of Dr. Paul Holland, dated December 21, 1994.
In other words, the Red Cross performed all of the professionally required state-of-the-art tests on Donor #7's blood, and each of these tests indicated that the blood was not infected. Based on those tests, and their results, the Red Cross was not negligent in providing Donor #7's blood for transfusion into the plaintiff.
3. This court will not hold the Red Cross to a "super-standard" of care.
Plaintiff also contends that the blood banking profession's safety standards were themselves deficient, and therefore defendant's compliance with these standards may not have been objectively reasonable. It is true that where a profession has "lagged behind" in adopting reasonable safety procedures, adherence to professional custom is not conclusive on the issue of negligence. Seitzinger v. American Red Cross, 1992 U.S. Dist. LEXIS 18445, 1992 WL 361700 (E.D.Pa. 1992); Smythe, 797 F. Supp. at 152-53. However, if the plaintiff can not offer proof that professional custom was objectively unreasonable, the court will not hold the defendant to a unique and vaguely defined "super-standard" of care. Kozup, 663 F. Supp. at 1057.
In this case, plaintiff has not shown that the blood bank industry's safety standards were deficient in 1991. Nor has he established that the industry "lagged behind" in adopting procedures to detect HCV-infected blood. To the contrary, there is ample evidence that blood collection organizations such as the Red Cross have been at the forefront in implementing procedures to defend against transfusion-transmitted blood diseases.
See e.g. Smythe, 797 F. Supp. at 152-53. Accordingly, plaintiff's attempt to hold the Red Cross to a unique "super-standard" of care is denied, and judgment is granted in favor of the Red Cross on this claim.
4. Defendant is entitled to summary judgment on Plaintiff's "failure to educate" claim.
Plaintiff finally maintains the Red Cross failed to properly educate Temple University doctors regarding the availability and benefits of directed blood donations. See Pl.'s Supp. Resp., at 2-3. A directed blood donation is one which a friend or family member provides for direct transfusion into the patient. According to the plaintiff, members of his family asked the defendant doctors if they could donate blood for his transfusions. The doctors informed these family members that there was not enough time for directed donations. The family members first inquired about directed donations on March 31, 1993. Plaintiff did not receive the infected transfusion until April 7, 1993. With directed donations, the blood is available for transfusion within one to four days after the donation. Thus, it seems the doctors erroneously stated that there was insufficient time to perform directed donations.
Plaintiff argues that if the Red Cross had properly educated Temple doctors of the benefits and time limitations of this process, the doctors might have recommended directed donations. Consequently, plaintiff argues, he may not have been exposed to the infected blood.
To survive summary judgment on this claim, plaintiff must first establish that the professional safety standards placed a "duty to educate" on the Red Cross. The plaintiff can not do this.
None of the FDA Regulations or AABB Standards require blood collection agencies to educate doctors about directed donation programs. Furthermore, according to the Red Cross's blood expert, Dr. Paul Holland, no such professional duty exists. Dr. Holland has been the Medical Director/Chief Executive Officer of the Sacramento Medical Foundation Blood Center ("SMFBC") for over ten years. At SMFBC, he is responsible for insuring that the Center's blood testing and screening procedures met all applicable professional standards. He clearly stated in his affidavit:
The standard practice, procedure and custom of the blood bank profession in 1991, as now, did not impose a duty upon the Red Cross to instruct area physicians regarding policies of its directed donor program.
Affidavit of Dr. Paul Holland P6.
Finally, the plaintiff does not present any convincing evidence that this duty exists. His only support for this theory is a law review article by an economist, Dr. Ross Eckert. In the article, Eckert opines that blood banks should educate hospitals regarding safety developments in the blood transfusion industry. Eckert, The Aids Blood Transfusion Cases: A Legal and Economic Analysis of Liability, 29(1) San Diego L. Rev. 203 (1992). However, Dr. Eckert is not a medical doctor. Also, the article clearly disclaims: "the views that I have expressed in this article are in my private capacity as a nonmedical specialist on the bloodbanking industry, and no official support or endorsement by the FDA is intended or should be inferred". See Eckert, at 203, n.*. In other words, Eckert merely states that in his opinion, blood banks should educate hospitals. He does not profess, and in fact clearly disclaims, that his suggestions represent the blood banking industry's professional standard of care.
Plaintiff has therefore not offered any proof that the blood industry's professional safety standards placed a "duty to educate" on the Red Cross. Furthermore, the AABB Standards, FDA Regulations, and expert testimony demonstrate that no such duty exists. Plaintiff has therefore failed to establish the existence of a professional duty, which is a necessary element of his claim. As a result, the Red Cross is entitled to summary judgment on plaintiff's "failure to educate" claim. See Celotex Corp. v. Catrett, 477 U.S. 317, 322-23, 91 L. Ed. 2d 265, 106 S. Ct. 2548 (1986) (defendant is entitled to summary judgment where the plaintiff fails to establish the existence of an essential element of his claim.)
The Red Cross was not negligent in screening and testing Donor #7's blood. Moreover, the Red Cross did not have a duty to educate Temple University doctors about its directed donor program, and thus can not be held liable under such a theory. Accordingly, summary judgment is granted in favor of the Red Cross.
An appropriate Order follows.
AND NOW, on this 3rd day of January, 1995, upon consideration of the Defendant Red Cross's ("Defendant") Motion for Summary Judgment, the Plaintiff William Giorno's ("Plaintiff") Response, and all replies and supplemental responses thereto, this court ORDERS that the Defendant's Motion is GRANTED and Judgment is entered in favor of the Defendant and against the Plaintiff.
BY THE COURT:
JAMES McGIRR KELLY, J.