Opinion
Civil No. 03-1342 (PG).
September 29, 2004
REPORT AND RECOMMENDATION FACTUAL BACKGROUND
The following factual summary is derived from the statements of undisputed facts submitted by the parties. (Docket No. 61, 63 and 74).
Plaintiff Matthew Nestor was born in 1942 and is a resident of St. Croix, VI. Plaintiff underwent surgery for prostate cancer in August 2001 at Hospital Pavia ("Pavia") and he was transfused with four (4) units of packed blood cells during the surgery and with three (3) additional units in the days following his surgery. Of the seven (7) units of packed blood cells transfused to plaintiff, two (2) units (numbered 11GR23686 and 11GS57865) were collected, tested, and distributed by the American Red Cross ("Red Cross") and five (5) units (S52573; S52577; S52465; S52572; and S52910) were collected, tested and distributed by Banco de Sangre de Servicios Mutuos, Inc. ("Banco de Sangre").
In September 2003, plaintiff sued Pavia, the Red Cross and Banco de Sangre alleging he became infected with hepatitis C virus ("HCV") during his August 2001 hospitalization as a result of the transfusions he received after surgery. (Docket No. 12).
i. Red Cross.
The Red Cross is a blood bank licensed to provide services in Puerto Rico and it had a contractual agreement to provide blood products to Pavia in August 2001.
Prior to supplying the units of blood numbered 11GR23686 and 11GS57865 to Pavia, the Red Cross tested samples of units for viral agents, including HCV. However, since a person can be infected with HCV for many years without having symptoms, this test result does not indicate when plaintiff was first infected.
Both donations (blood numbered 11GR23686 and 11GS57865) tested negative for hepatitis C antibodies using the HCV 3.0 antibody test and were found to be non-reactive for HCV using state-of-the-art nucleic acid testing ("NAT") testing.
The donor of unit number 11GR23686 returned to the Red Cross to make a subsequent blood donation on August 6, 2002. This subsequent donation, made almost a full year after the initial donation that was transfused to plaintiff, also tested negative for HCV using both HCV 3.0 and NAT testing.
The donor of unit number 11GS57865 returned to the Red Cross to donate blood on two (2) subsequent occasions, approximately one (1) year and two (2) years after donating the blood that was transfused to plaintiff. Both of this donor's subsequent donations tested negative for HCV using both HCV 3.0 and NAT testing.
The HCV 3.0 test used by the Red Cross is the test approved for the screening of blood donations by the Food and Drug Administration ("FDA"), is recommended by the Centers for Disease Control and Prevention ("CDC"), and is extremely reliable for a negative result.
The CDC has advised that if a person's HCV 3.0 test is negative, there is no need for subsequent testing.
The Red Cross's use of this HCV 3.0 test to screen donated blood in August 2001 was consistent with the professional standard of care in the blood banking field.
Although not required to do so under FDA guidelines, the Red Cross took the additional step of testing its donors' blood using the state-of-the-art NAT test for HCV.
ii. Banco de Sangre.
Banco de Sangre is a corporation duly organized under the Commonwealth of Puerto Rico and renders the service of processing, supply and transfusion of blood and its derivatives.
Banco de Sangre complied with all the federal and local regulations in force at the time in which the blood was provided to Pavia. Banco de Sangre gives an orientation to all possible donors. An interview, a physical evaluation, and a medical history are conducted. A register is kept for donors and a record is opened for every donor with questions related to their medical history, places visited, and sexual and personal behavior.
After the blood is collected, Banco de Sangre follows a procedure stated in its manuals, which includes the test to verify the blood donated is safe for human use and medical treatment, and has no risk whatsoever for its use. This is very rigorous process in which each unit is duly identified.
The bill of lading that contains the number of the units and the dates in which they were sent to Pavia are: Number 66355; 66356, and 66417. These units were sent to Pavia on August 13, 2001 and the unit numbers were: S52573; S52577; S52465; S52572; and S52910.
Banco de Sangre opens a blood processing record for each unit collected in which each donor is identified. Cell and Serum testing were performed and all the negative results are part of the record.
The blood or by-products supplied by Banco de Sangre to Pavia and used for plaintiff's transfusions were duly processed and certified to be free of contaminants, such as HCV. The following studies were performed at Banco de Sangre by Certified Medical Technologists: 1) ABO/Rh; 2) PR Serology; and 3) Screen antibodies.
All the donors who supplied the blood or blood by products supplied by Banco de Sangre to Pavia and used for plaintiff's transfusion were recently tested again and certified to be negative for HCV. The following tests were performed at Florida Blood Services in Tampa, Florida: 1) Anti-HIV-½ (antibodies for human immunodeficiency virus); 2) HIV-ag (antigen HIV-1); 3) Anti-HCV (HEPATITIS c Virus); 4) Anti-HTLV-I/II (human T-cell lympho-tropic virus); 5) Anti-HBc (hepatitis B core antigen); 6) HbsAG (hepatitis B surface antigen); 7) NAT for HCV RNA (Nucleic Acid Test); 8) NAT for HIV-1 RNA (Nucleic Acid Test); and 9) ALT (Alanine aminotransferase).
The blood transfused to plaintiff was received from various donors.
Banco de Sangre provided Pavia with reports and test results regarding the condition of the blood; circular of information for the use of the human blood, blood components and all the testing performed on the blood. The tests were performed according to FDA regulations and licensed tests, as well as in compliance with standards established by all other pertinent agencies.
PROCEDURAL BACKGROUND
On September 26, 2003, plaintiff filed an Amended Complaint against Pavia, Red Cross and Banco de Sangre alleging he contracted HCV during his hospitalization at Pavia for prostate cancer surgery as a result of transfusions he received during and after the surgery. (Docket No. 12). Plaintiff claims defendants were negligent in providing him with contaminated blood and failed to properly test the blood. Hence, plaintiff avers defendants are strictly liable for marketing a defective product. Plaintiff filed this action a personal injuries action under 28 U.S.C. § 1332 (Docket No. 12, ¶ 9).
On June 17, 2004, the Red Cross filed a Motion for Summary Judgment, Memorandum of Law in Support thereof and a Statement of Undisputed Material Facts. (Docket No. 60 and 61). In essence, the Red Cross moves the Court to enter summary judgment in its favor for lack of causation because plaintiff has no evidence to prove he contracted HCV from any blood provided or tested by the Red Cross. The Red Cross claims the two (2) units of Red Cross blood transfused to plaintiff in August 2001 both tested HCV-negative at the time of donation. Moreover, each Red Cross blood donor returned to donate subsequent to August 2001 and each tested HCV-negative. Furthermore, the Red Cross avers plaintiff cannot demonstrate any breach of the standard of care by the Red Cross in the screening of blood donors and testing donated blood. (Docket No. 60). In addition, the Red Cross contends plaintiff's failure to present any expert witness in this case calls for the dismissal of same. Thus, the Red Cross moves the Court to enter summary judgment based on the fact plaintiff is unable to demonstrate either the blood he received caused his alleged infection with HCV or the Red Cross was negligent in its collection and screening of that blood. (Docket No. 60).
On June 17, 2004, Banco de Sangre filed a Motion for Summary Judgment, Memorandum in Support thereof and Statement of Uncontested Facts. (Docket No. 62 and 63). Banco de Sangre claims the blood it provided to Pavia and was transfused to plaintiff was free of contaminants such as HCV. Banco de Sangre alleges plaintiff has no proof to show the blood it provided was contaminated with HCV nor to rebut the fact that all donors were negative to HCV according to the tests performed. Moreover, Banco de Sangre maintains plaintiff has failed to retain an expert witness in this case, thus failing to prove negligence in this case. (Docket No. 62).
On July 1, 2004, Pavia filed a Motion Joining Motions for Summary Judgment arguing it has been established the blood given to plaintiff could not have caused plaintiff's alleged contamination with HCV. (Docket No. 69).
On July 19, 2004, plaintiff filed a Memorandum in Opposition to the Motions for Summary Judgment and a Statement of Undisputed Facts. (Docket No. 74 and 75). In essence, plaintiff claims strict liability, and not professional negligence standard, should apply to this case. Accordingly, plaintiff avers defendants are strictly liable and he has only to prove the resulting damages of defendants' actions and breach of warranty in providing plaintiff with a product not safe for the human body. Furthermore, plaintiff claims there are genuine issues of fact in controversy which preclude the entry of summary judgment in this case. (Docket No. 75).
On July 20, 2004, the Motions for Summary Judgment and related pleadings were referred to this Magistrate Judge for report and recommendation. (Docket No. 76).
On August 5, 2004, the Red Cross filed a Reply Memorandum in Support of Motion for Summary Judgment claiming strict liability does not apply to plaintiff's claims, plaintiff cannot prove causation, and plaintiff's expert witness "report" is deficient. (Docket No. 85).
On August 9, 2004, Banco de Sangre filed its Reply to Plaintiff's Opposition to Motion for Summary Judgment claiming Banco de Sangre provides a "service" and not a product. Banco de Sangre contends the breach of warranty action and strict liability action "for defective blood products have been virtually precluded" and are not applicable to this case. (Docket No. 87).
On August 23, 2004, plaintiff filed a Sur-reply to defendants' replies emphasizing his argument strict liability applies to this case. (Docket No. 92).
The parties have submitted to the Court all pleadings related to defendants' summary judgment requests. Therefore, the case is ready for disposition.
SUMMARY JUDGMENT STANDARD
Summary judgment is appropriate if there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law. FRCP 56(c). Pagano v. Frank, 983 F.2d 343, 347 (1st Cir. 1993); Lipsett v. Univ. of P.R., 864 F.2d 881, 894 (1st Cir. 1988); see Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249, 106 S.Ct. 2505 (1986).
Summary judgment is suitable where "the pleadings, depositions, and admissions on file, together with the affidavits, if any, show there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(c). A fact is material if, based on the substantive law at issue, it might affect the outcome of a case. A material issue is "genuine" if there is sufficient evidence to permit a reasonable trier of fact to resolve the issue in the non-moving party's favor. Anderson, 477 U.S. at 248.
The Court must analyze the factual scenario in this case construing the facts, the record, and all reasonable inferences in the light most favorable to the party opposing summary judgment. Reeves v. Sanderson Plumbing Products, Inc., 530 U.S. 133, 150, 120 S.Ct. 2097, 2110 (2000) (". . . the Court must draw all reasonable inferences in favor of the nonmoving party . . ."); see also, Leahy v. Raytheon Company, 315 F.3d 11, 17 (1st Cir. 2002) (". . . the court must take the record `in the light most hospitable to the party opposing summary judgment, indulging all reasonable inferences in that party's favor'.") ( quoting Griggs-Ryan v. Smith, 904 F.2d 112, 115 (1st Cir. 1990); see also, Plumley v. Southern Container Inc., 303 F.3d 364, 368-69 (1st Cir. 2002); Rosenberg v. City of Everett, 328 F.3d 12, 17 (1st Cir. 2003) (the Court "presents [the facts] in the light most favorable to the plaintiff.")).
ANALYSIS
Even though defendants have submitted separate motions for summary judgment, they all claim entitlement to summary judgment under the negligence medical malpractice standard under Puerto Rico law (Article 1802) on the same grounds; to wit, lack of causation because plaintiff has no evidence to prove he contracted HCV from any blood provided or tested by the Red Cross or Banco de Sangre and transfused to plaintiff while hospitalized at Pavia. Both the Red Cross and Banco de Sangre contend that the seven (7) units in total transfused to plaintiff in August 2001 tested HCV-negative at the time of donation. Furthermore, defendants maintain plaintiff cannot demonstrate any breach of the standard of care by the Red Cross or Banco de Sangre in the screening of blood donors and testing donated blood. More so, when plaintiff has failed to provide an expert witness report in support of his contentions.
Nonetheless, plaintiff in his Opposition asserts the standard applicable in this case is the strict liability standard and not the medical malpractice standard. Plaintiff avers defendants are strictly liable and he has only to prove the resulting damages of defendants' actions and breach of warranty in providing plaintiff with a product not safe for the human body.
Thus, we need first to determine the applicable standard of liability in this case where blood transfusions are in issue.
i. Negligence Standard of Care.
In the required analysis, the court examines the Puerto Rico Civil Code, which states, "[a] person who by an act or omission causes damage to another through fault or negligence shall be obliged to repair the damage so done." P.R. Laws Ann. tit. 31 § 5141 (1991). "Under this proviso, three elements comprise a prima facie case of medical malpractice." Cortés-Irizarry v. Corporación Insular De Seguros, 111 F.3d 184, 189 (1st Cir. 1997).
Following that line, to establish a prima facie case of medical malpractice, a plaintiff must prove, and/or "adduce evidence showing at least three separate things"; (i) the duty owed, conveyed as the minimum standard of professional "knowledge and skill required under the relevant circumstances"; (ii) an act or omission, attributed defendant, transgressing that duty, and; (iii) a sufficient causal nexus between the breach and the claimed harm. McGraw v. United States, 254 F.Supp.2d 242, 245 (D.P.R. 2003); Cortés-Irizarry, 111 F.3d at 189;Rolón-Alvarado v. Municipality of San Juan, 1 F.3d 74, 77 (1st Cir. 1993). See also, Lama v. Borrás, 16 F.3d 473, 478 (1st Cir. 1994). "In the medical malpractice context, an action for damages lies when, by preponderance of evidence, it is proved that the doctor's negligent conduct was the factor that most probably caused the plaintiffs damage." Sierra Pérez v. United States, 779 F.Supp. 637, 643 (D.P.R. 1991); see also, Pérez Cruz v. Hosp. La Concepción, 115 P.R. Dec. 721, 732 (1984).
"The elements of the tort are: (1) the basic norms ("normas minimas") of knowledge and medical care applicable to general practitioners or specialists; (2) proof that the medical personnel failed to follow these basic norms in the treatment of a patient; and (3) a causal relation between the act or the omission of the physician and the injury by the patient." Sierra Pérez, 779 F.Supp. at 643; see also, Medina Santiago v. Dr. Alván Vélez, 120 P.R. Dec. 380 (1988); Pagán Rivera v. Municipio De Vega Alta, 127 P.R. Dec. 538 (1990). See also generally Oliveras v. Abreu, 101 D.P.R. 209, 226, 1973 WL 35678 (1973); Wilson v. Government, 699 F.Supp. 20, 23 (D.P.R. 1988).
Further, under Puerto Rican law there exists the rebuttable presumption that the attending physician has observed reasonable degree of care while providing medical treatment. Saez v. Municipio De Ponce, 84 PRR 515, 1962 WL 14885 (1962); Ramos Orengo v. La Capital, 88 PRR 306, 1963 WL 14897 (1963); Del Valle Rivera v. U.S., 630 F.Supp. 750, 756 (D.P.R. 1986).
ii. Strict Liability Standard of Care.
The theory of implied warranty of liability evolved from the common law doctrine of product liability. The Supreme Court of Puerto Rico adopted the doctrine of product liability from the common law in the case of Mendoza v. Cervecería Corona, 97 D.P.R. 493 (1960). Specifically, 31 L.P.R.A. § 5141 makes persons responsible for the damages caused by the damages caused by their negligence. Under this section the Supreme Court of Puerto Rico has developed a strict liability standard for manufacturers of defective products.
To establish strict liability for a design defect under Puerto Rico law, plaintiff must show defendants "place[d] a product on the market, knowing that it is to be used without inspection for defects, and it has a defect that causes injuries."Malavé-Felix v. Volvo Car Corp., 946 F.2d 967, 971 (1st Cir. 1991). Puerto Rico has generally adopted the Restatement (Second) of Torts § 402A, which provides that "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." Restatement (Second) of Torts § 402A(1) (1963 Supp. I 2002). However, under Puerto Rico law, the defect in the product does not have to be "unreasonably dangerous to the user or consumer." See Cruz Vargas v. R.J. Reynolds Tobacco Company, 218 F.Supp.2d 109, 119 (D.P.R. 2002), citing Montero Saldaña v. Am. Motors Corp., 107 D.P.R. 452 (1978). Rather, plaintiff needs only establish that the product is unsafe. See Id;
Prado Alvarez v. R.J. Reynolds Tobacco Co., 313 F.Supp.2d 61, 73-74 (1st Cir. 2004).
iii. Applicable Standard of Care to Cases of Blood Collection and Transfusions.
Plaintiff's main argument in opposition to the request for summary judgment is that the strict liability standard of care applies in this case and that Puerto Rico statutory law is silent on the standard applicable to blood transfusions. As such, plaintiff avers he only has to prove his damages. In turn, defendants argue the general medical malpractice standard of care is the one applicable to this case.
Neither this District nor the Court of Appeals for the First Circuit has ruled upon the issue of which standard of care applies to cases of blood collection and transfusions. Thus, we make a brief analysis of the applicable legislation and jurisprudence in other jurisdictions to determine which standard applies in this case.
In Perlmutter v. Beth David Hospital, 308 N.Y. 100, 123 N.E.2d 792 (1954), the New York Court of Appeals was first to conclude, based on public policy considerations, that the distribution of blood constituted a "service" and not a sale.Id. at 794. As explained in Doe v. Cutter Biological, a Div. of Miles, Inc., 852 F.Supp. 909, 919 (D. Idaho 1994), the Perlmutter holding precluded a plaintiff who contracted hepatitis from a contaminated blood transfusion, from recovering on breach of warranty claims.
Appeal was dismissed by Doe v. Cutter Biological, a Div. of Miles, Inc.,, 89 F.3d 844 (9th Cir. 1996).
Subsequently, at least 48 states codified the Perlmutter holding in what have come to be known as "blood shield statutes." In addition to precluding recovery based on implied warranties, blood shield statutes also preclude actions based on strict liability in tort.
See Kathryn W. Pieplow, Comment, Aids, Blood Banks and the Courts: The Legal Response to Transfusion-Acquired Disease, 38 S.D. L.Rev. 609, 622-625, nn. 80-86 (1993) (article provides nationwide listing of blood shield statutes). See Doe, 852 F. Supp. at 919.
As one commentator recognized in the article referenced to in footnote 3: The "fundamental purpose underlying strict tort liability is to force hazardous products from the market." Conversely, blood and blood products are highly desirable medical products which cannot, with present scientific technology, be made completely safe. In recognition of the fact that blood [and blood products are] too essential . . . to be forced from the market, legislatures have provided the blood industry some immunity from liability. Id. at 622. See Doe, 852 F. Supp. at 919.
The Second Circuit in Coffee v. Cutter Biological, 809 F.2d 191, 193-94 (2nd Cir. 1987) recognized that blood shield statutes in other states "uniformly have been interpreted as barring strict liability claims, whether or not the statute contains an express bar to such claims." See also, Samuels v. Health and Hospitals Corp., 591 F.2d 195, 197 (2nd Cir. 1979) (a plaintiff must prove negligence under law of New York in order to recover from a hospital or blood bank inasmuch as law of New York denies benefits to recipients of blood of its general warranty and strict liability rules).
Other Circuits have similarly ruled. See McKee v. Cutter Laboratories, Inc., 866 F.2d 219, 222 (6th Cir. 1989) (making reference to Coffee, the Sixth Circuit ruled the Kentucky blood shield statute, defining a blood product transaction as rendition of a service, barred strict liability claims arising out of death of hemophiliac from contaminated antihemophilic blood product); Kirkendall v. Harbor Insurance Co., 887 F.2d 857, 859 (8th Cir. 1989) (the implied warranties of the Uniform Commercial Code therefore do not apply to blood, and blood is not a "product" for purposes of imposing strict liability in tort. See Ark.Stat.Ann. § 20-9-802 (1987));Fruge's Heirs v. Blood Services, 506 F.2d 841 (5th Cir. 1975) (Louisiana statute by designating blood sales as "medical services" effectively bars claim based on strict liability in supply of whole blood and its components); Doe v. Miles Laboratories, Inc., Cutter Laboratories Div., 927 F.2d 187, 195 (4th Cir. 1991) (a blood clotting agent was not an unreasonably dangerous product and therefore does not subject its manufacturer to strict liability in tort); Kozup v. Georgetown Univ. Hosp., 663 F.Supp. 1048, 1058 (D.D.C. 1987), aff'd in pertinent part, 851 F.2d 437 (D.C. Cir. 1988), aff'd on remand, 906 F.2d 783 (1990) (strict liability theories should not be applied to a hospital's provision of blood to its patients).
Plaintiff in this case has not provided any convincing evidence for this Court not to take into account the reasoning of at least 48 states which have acknowledged, either through jurisprudence or legislation, that blood collection and storage is a service and not a product and as such, strict liability should not be applied to transfusion cases.
Plaintiff's argument as to the alleged application of the strict liability standard to the instant case is unpersuasive. Plaintiff makes his argument in a vacuum and fails to cite any case law or legislation in which the strict liability standard has been applied to blood transfusion cases. Plaintiff cites two (2) cases from the Supreme Court of Puerto Rico in support of his claim that strict liability applies in this case. None of these cases is applicable to this case inasmuch both deal with products and not services and none of them deals with blood storage or transfusions. For example, inRivera Santana v. Superior Packaging, 132 D.P.R. 115 (1992) plaintiffs filed, under the strict liability standard, a claim against several companies which provided products that contributed to the burns suffered by a deceased employee in a pharmaceutical factory when he was cleaning an area and a spark caused an explosion and sudden fire. In Mendoza, 97 D.P.R. at 499 plaintiff sued defendant, under the strict liability standard, because he bought some bottles of "Malta Corona" and after drinking a "Malta" he became intoxicated suffering from nausea, diarrhea and general malaise and had to be hospitalized.
In view of the foregoing, we follow the legislation and jurisprudence of at least 48 states which have determined the strict liability standard should not apply to blood collection and storage, including transfusions, since blood is a service and not a product. Accordingly, it is recommended that the standard applicable to blood suppliers such as the Red Cross and Banco de Sangre be the negligence standard of care and not the strict liability standard.
iv. Application of the Negligence Standard of Care to this Case.
The Red Cross moves the Court to enter summary judgment because plaintiff is unable to demonstrate either the blood he received caused his alleged infection with HCV or the Red Cross was negligent in its collection, screening and testing of the blood and the donors. In addition, the Red Cross contends plaintiff's failure to present any expert witness in this case calls for the dismissal of same. (Docket No. 60).
Similarly, Banco de Sangre seeks summary judgment claiming the blood it provided to Pavia and was transfused to plaintiff was free of contaminants such as HCV. Banco de Sangre alleges plaintiff has no proof to show the blood it provided was contaminated with HCV nor to rebut the fact all donors were negative to HCV according to the tests performed. Moreover, Banco de Sangre maintains plaintiff has failed to retain an expert witness in this case, thus failing to prove negligence in this case. (Docket No. 62).
Pavia joined the motions for summary judgment filed by the Red Cross and Banco de Sangre arguing it has been established the blood given to plaintiff could not have caused plaintiff's alleged contamination with HCV. (Docket No. 69).
In response, plaintiff filed an opposition to the summary judgment request in which he mainly argued the strict liability standard applied and, as such, he only had to prove his damages. We have already disposed of this issue above. In addition, plaintiff makes a res ipsa loquitur argument attempting to bypass his burden of proving causation. In essence, plaintiff maintains he received blood transfusions and now has HCV. Accordingly, there is a "reasonable probability that [he] became infected with the HCV as a result of his exposure to tainted blood from defendants." (Docket No. 75, p. 15). In support of plaintiff's opposition, plaintiff submitted several documents including a letter from Dr. Herbert I. Goldman, specialized in hematology and oncology as his alleged expert witness and a sworn statement from plaintiff. (Docket No. 82, Exh. 1 and 5).
Defendants maintain Dr. Goldman's letter or "report" is untimely and does not meet the requirements of the FRCP 26. In fact, plaintiff concedes Dr. Goldman's letter or "report" is untimely. (Docket No. 92, pp. 13-14).
As properly stated by defendants, the Supreme Court of Puerto Rico has rejected the theory of res ipsa loquitur as the basis for recovery in actions for negligence under Puerto Rico's law.Bacó v. Almacen Ramon Rosa Delgado, Inc., 2000 JTS 122 (Jun 30, 2000). This was recognized by this District Court in Bou Maldonado v. K-mart Corp., 2001 WL 1636768 (D.P.R. 2001). Accordingly, plaintiff's reliance on the res ipsa loquitur doctrine is without merit.
Furthermore, defendants contend Dr. Goldman's one page letter or "report" does not identify any negligence of behalf of defendants. As proposed by defendants, plaintiff's claims in this case must fail because he has not established a casual link between his injuries and the alleged negligent acts of defendants nor a breach of the standard of care in the screening and testing of the blood and the donors.
Generally, a plaintiff in a medical malpractice action may carry his or her burden of proof on the issues of negligence and causation only with he assistance of expert testimony. Mitchell v. United States., 141 F.3d 8, 13 (1st Cir. 1998). Therefore, in cases of medical malpractice what is or is not the proper practice is a question to be determined by the court based entirely on expert testimony. McGraw, 254 F.Supp.2d at 247.
Dr. Goldman's letter is limited to the four (4) following observations: 1) plaintiff was apparently not informed of the risks of transfusion; 2) no abnormal liver function was found when plaintiff was hospitalized in August 2001; 3) a consultation stated plaintiff was told of having abnormal liver tests and this is compatible with acquisition of HCV from blood transfused during his hospitalization for prostate cancer in August 2001 and the diagnosis of HCV was established in June 2002; and 4) Dr. Goldman cannot comment on the validity of the testing of the blood issued to plaintiff nor the retesting of the donors afterwards nor even of the blood transfused to plaintiff indeed came from the supposed donors ("as clerical error is the most frequent cause of transfusion reaction"). (Docket No. 82, Exh. 5).
A perusal of Dr. Goldman's letter shows it clearly fails to establish the required casual link between plaintiff's contamination with HCV and the alleged negligent acts of the Red Cross, Banco de Sangre and Pavia related to the blood transfused to plaintiff. In addition. Dr. Goldman's letter does not prove a breach of the standard of care in the screening and testing of the blood and the donors. The best evidence of this is the fact Dr. Goldman fails to address in his letter the opinion of Dr. Holland by making no reference whatsoever to the same. Moreover, Dr. Goldman states he cannot make any comment on the validity of the testing of the blood issued to plaintiff, nor the retesting of the donors nor even if the blood transfused to plaintiff indeed came from the supposed donors. This clearly shows Dr. Goldman fails to establish the causation between plaintiff's infection with HCV and any negligence of the Red Cross, Banco de Sangre or Pavia. We also note Dr. Goldman's reference to a "clerical error" is of no consequence inasmuch he does not submit any evidence such error occurred in plaintiff's case. Dr. Goldman cites two articles from 1980 and 1990 without explaining how those two articles favor his assertion of a "clerical error." Accordingly, we view this contention of a "clerical error" as a mere speculation.
The opinion of Dr. Holland is dated June 14, 2004 (Docket No. 61, Tab-2) and the letter of Dr. Goldman is dated July 19, 2004. (Docket No. 82, Exh. 5). Accordingly, we must assume Dr. Goldman had the benefit of having Dr. Holland's opinion when he rendered his letter.
Contrary to Dr. Goldman's letter which we find of little value, the Court finds Dr. Paul V. Holland's expert opinion on behalf of the Red Cross to be very persuasive.
The record demonstrates Dr. Holland has extensive training and experience in medicine and blood banking and is knowledgeable about transfusion transmitted infections, including viral hepatitis. Dr. Holland has expertise on state of medical and scientific knowledge of the hepatitis C virus (HCV), its transmissibility through blood and the testing of blood for HCV. Dr. Holland makes a thorough analysis of his findings, after reviewing the transfusion records and test results, to conclude in his opinion the two blood units which were collected, screened and tested by the Red Cross and transfused to plaintiff did not cause his alleged infection with HCV. Dr. Holland explains the two units of blood from the Red Cross were properly tested before the donation and yielded negative to HCV. Dr. Holland indicates the HCV 3.0 test used by the Red Cross is the test approved for the screening of blood donations by the Food and Drug Administration, is recommended by the CDC, and is extremely reliable for negative result. In addition, the Red Cross took the additional step of using the NAT test which is able to detect the virus itself and is able to rule out HCV infection almost immediately after a donor's exposure. Dr. Holland explains that the fact that both of the donors tested HCV negative using both the 3.0 test for antibodies and the NAT test, not only when donating the blood transfused to plaintiff but also on their subsequent donations, establishes to a reasonable degree of medical certainty those donors did not cause plaintiff's alleged infection. Thus, in summary, Dr. Holland affirms the donor and testing records of the two blood units collected and tested by the Red Cross and transfused to plaintiff indicate both donors tested negative for HCV at the time of donation and both have subsequently tested negative for HCV. Given this information, Dr. Holland opines that, to a reasonable degree of medical certainty, plaintiff's exposure to these two Red Cross blood units during his 2001 surgery did not cause his alleged HCV. (Docket No. 61, Tab 2).
Dr. Holland issued a supplemental opinion which was appended to the Red Cross' reply statement to plaintiff's statement of undisputed facts responding to several issues raised by plaintiff in his opposition to the Red Cross' motion for summary judgment. (Docket No. 86, Tab-1). Dr. Holland indicates he has reviewed the January 8, 2003 testing records of Theresa Gaston, plaintiff's wife, which were submitted as part of plaintiff's opposition to the summary judgment request. Dr. Holland explains the test results show Ms. Gaston was non-reactive for hepatitis B e-antigen in January 2003. Dr. Holland explains the test for hepatitis B e-antigen is relevant only to whether hepatitis B virus infection is present and is not indicative of the presence of hepatitis C, which is the one pertinent to this case. Thus, Dr. Holland opines the test results of Ms. Gaston does not indicate she did not have hepatitis c (HCV) as of January 2003. Moreover, Dr. Holland mentions HCV is a single-stranded RNA virus which has the potential to cause inflammation of the liver but does not always do so. Many patients with chronic HCV do not have liver inflammation. However, once a patient develops liver inflammation, he/she has "hepatitis" by definition. Furthermore, Dr. Holland states that a person can be infected with HCV for many years without having any symptoms. Finally, Dr. Holland re-affirms his original opinion of June 14, 2004 that the two Red Cross blood donors at issue in this case were not infected with the HCV virus when they donated blood that was transfused to plaintiff. A person who is not infected with the HCV virus cannot transmit that virus to another person. (Docket No. 86, Tab-1).
Dr. Holland is an evidently qualified physician with expertise on state of medical and scientific knowledge of the HCV, its transmissibility through blood and the testing of blood for HCV with a vast unquestioned experience and impressive credentials. On the contrary, the record is devoid of any reference to the qualifications of Dr. Goldman. Dr. Holland, contrary to Dr. Goldman, makes a full assessment in this case of plaintiff's blood transfusions from the Red Cross as evidenced by his opinion that the Red Cross did not incur in any negligence and that the blood transfused to plaintiff from the Red Cross was not contaminated with HCV. (Docket No. 61, Tab 2). Dr. Goldman's letter just contains some observations, lacks any evidentiary support and it does not rebut or contradict Dr. Holland's opinion of no negligence of the Red Cross. Accordingly, it is speculative. Therefore, we understand Dr. Holland's opinion is reasonable and persuasive when compared to the mere "observations" of Dr. Goldman. Furthermore, Dr. Holland's original opinion and its supplement are undisputed in this case because plaintiff has not presented any evidence to rebut same. Accordingly, there are no genuine issues of material fact in controversy as to this matter.
A review of the record shows it is devoid of any curriculum vitae of Dr. Goldman.
Even though Banco de Sangre has not submitted an expert witness' opinion in support of its summary judgment request, we find plaintiff has failed to come forth with any evidence to satisfy his burden of proof in this case and establish the necessary causation between the alleged negligent acts of Banco de Sangre and the HCV contracted by plaintiff. In fact, plaintiff has not disputed the evidence on the record referred to herein below which establishes Banco de Sangre complied with all the federal and local regulation in force at the time in which the blood were provided to Pavia. In addition, it is undisputed the blood or by-products supplied by Banco de Sangre to Pavia and used for plaintiff's transfusions were duly processed and certified to be free of contaminants, such as HCV. The following studies were performed at Banco de Sangre by Certified Medical Technologists: 1) ABO/Rh; 2) PR Serology; and 3) Screen antibodies. Furthermore, plaintiff has not contested that all the donors who supplied the blood or blood by products supplied by Banco de Sangre to Pavia and used for plaintiff's transfusion were recently tested again and certified to be negative for HCV. The following tests were performed at Florida Blood Services in Tampa, Florida: 1) Anti-HIV-½ (antibodies for human immunodeficiency virus); 2) HIV-ag (antigen HIV-1); 3) Anti-HCV (HEPATITIS c Virus); 4) Anti-HTLV-I/II (human T-cell lympho-tropic virus); 5) Anti-HBc (hepatitis B core antigen); 6) HbsAG (hepatitis B surface antigen); 7) NAT for HCV RNA (Nucleic Acid Test); 8) NAT for HIV-1 RNA (Nucleic Acid Test); and 9) ALT (Alanine aminotransferase). Finally, plaintiff has not rebutted Banco de Sangre provided Pavia with reports and test results regarding the condition of the blood; circular of information for the use of the human blood, blood components and all the testing performed on the blood. The tests were performed according to FDA regulations and licensed tests, as well as in compliance with standards established by all other pertinent agencies. Accordingly, these facts are undisputed and there are no genuine issues of material fact in controversy as to this matter.
We now address the one (1) page sworn statement submitted by plaintiff in support of his opposition in which plaintiff indicates prior to 2001 he never tested positive for HCV; plaintiff's wife tested negative to HCV; plaintiff has never used illicit or recreational drugs; plaintiff has never injected himself with a needle, had a tattoo or body piercing; plaintiff never received a blood transfusion before 2001; and plaintiff has never had an organ transplant. (Docket 82, Exh. 1). Plaintiff's sworn statement addresses some of the possible causes of HCV but the list is not exhaustive and does not rule out other causes for his HCV infection. Even if we take as true all facts averred by plaintiff in his sworn statement, we cannot avoid the reality there could be other causes for his HCV which are not included in his sworn statement and are not related to the blood transfusions received at Pavia. Therefore, other possible causes of the HCV infection cannot be eliminated. Consequently, plaintiff's sworn statement is insignificant to his contention of defendants' alleged negligence.
In view of the foregoing, plaintiff has failed to prove the blood from the Red Cross or Banco de Sangre that he was transfused during and after his surgery at Pavia caused his alleged HCV infection nor a breach of the standard of care in the screening and testing of the blood and the donors. Hence, it is recommended that the Red Cross and Banco de Sangre not be held liable in this case.
Finally, we likewise recommend that Pavia not be held liable in this case on the same grounds discussed above for which the Red Cross and Banco de Sangre are not liable.
CONCLUSION
Accordingly, it is recommended that the Motions for Summary Judgment submitted by the Red Cross, Banco de Sangre and Pavia BE GRANTED and the present cause of action BE DISMISSED in its entirety as to all defendants.
IT IS SO RECOMMENDED.
The parties have ten (10) days to file any objections to this report and recommendation. Failure to file same within the specified time waives the right to appeal this order. Henley Drilling Co. v. McGee, 36 F.3d 143, 150-151 (1st Cir. 1994);United States v. Valencia, 792 F.2d 4 (1st Cir. 1986). See Paterson-Leitch Co. v. Mass. Mun. Wholesale Elec. Co., 840 F.2d 985, 991 (1st Cir. 1988) ("Systemic efficiencies would be frustrated and the magistrate's role reduced to that a mere dress rehearser if a party were allowed to feint and weave at the initial hearing, and save its knockout punch for the second round").
IT IS SO ORDERED.