HIV AIDS Resource Guide/HIV-AIDS Resource Guide.iso/STAT/CASES/DO-TRAVE.ASC

Text File | 1993-01-14 | 16KB | 316 lines

/* This case is reported in 698 F.Supp. 780 (D.Minn. 1988).  This
case finds that the Minnesota UCC does not permit strict
liability suits for the alleged supply of blood infected with
HIV. */

J.D. DOE, Plaintiff,

v.

TRAVENOL  LABORATORIES,  INC., d/b/a Hyland Therapeutics, a
division of Travenol Laboratories, Inc., Defendant.

United States District Court, D. Minnesota, Fourth Division.

Nov. 4, 1988.



MEMORANDUM AND ORDER

MacLAUGHLIN, District Judge.

This case is a products liability action in which the plaintiff,
who appears under the pseudonym J.D. Doe, alleges that he
contracted AIDS-Related Complex (ARC) from an antihemophilic
factor which he received prior  to  surgery.   Defendant  Baxter
Healthcare Corporation (Baxter) [footnote 1] brings a motion to
dismiss Doe's strict liability and breach of warranty claims on
the ground that Minnesota law insulates the suppliers of blood
products from such claims.  The motion will be granted.



FACTS

On a motion to dismiss, the Court takes the facts as pled in the
complaint. Hishon v. King & Spalding, 467 U.S. 69, 73,104 S.Ct.
2229, 2232, 81 L.Ed.2d 59 (1984).

Doe is a hemophiliac.  His body does not produce human
antihemophilic Factor VIII, a protein necessary for the effective
clotting of blood. As a result, Doe must take Factor VIII
Concentrate whenever he suffers injury causing bleeding or
undergoes surgery. Factor VIII Concentrate is manufactured by
pooling the blood plasma of thousands of donors and extracting
the desired protein.

In August 1984, [footnote 2] Doe underwent an operation to remove
a kidney stone at the University of Minnesota Hospital and
Clinic. Because of his hemophilia, Doe received prophylactic
quantities of Factor VIII Concentrate from a lot manufactured by
Baxter.

On or about October 10, 1984, the University of Minnesota
Comprehensive Hemophilia Center notified Doe that the lot from
which he had received Factor VIII was being recalled; a donor who
had contributed plasma to that lot had subsequently died of
Acquired Immune Deficiency Syndrome (AIDS). [footnote 3]

In June 1986, almost two years after receiving the Factor VIII
Concentrate processed by Baxter, Doe had his blood tested for the
presence of antibodies to the AIDS virus, HIV. The test results
indicated that Doe had been infected with HIV.  Doe has since
developed ARC and stands a great likelihood of contracting AIDS.

Doe sued Baxter in state court on June 24, 1988 for breach of
warranty, strict liability and negligence.  Baxter removed the
case to federal court on July 22, 1988. Pursuant to Fed.R.Civ.P.
12(b)(6), Baxter now moves to dismiss Doe's breach of warranty
and strict liability claims as failing to state a claim upon
which relief can be granted.



DISCUSSION

This case is the most recent in a series of cases nationwide in
which individuals infected with HIV have advanced breach of
warranty and strict liability claims against processors of blood
products.  Every case but one has found that either a state blood
shield statute or state common law barred recovery without a
showing of fault. See, e.g., Coffee v. Cutter Biological, 809
F.2d 191 (2d Cir.1987); Poole v. Alpha Therapeutic Corp., --
F.Supp. -- (N.D.Ill. Apr. 13, 1988); Shelby v. St. Luke's Epis
copal Hospital, 1988 W.L. 28996 (S.D.Tex. Mar. 17, 1988); Doe v.
Cutter Laboratories, No. CA-2-87-0013 slip op. -- F.Supp. --
(N.D.Tex. Feb. 5, 1988); Jones v. Miles Laboratories, Inc., No.
C86-83, -- F.Supp. -- , (N.D.Ga.  Dec. 28,  1987); McKee v. Miles
Laboratories, Inc., 675 F.Supp. 1060 (E.D.Ky.1987) (appeal pend
ing); Clark v. Alpha Therapeutic Corp., No. 87-5230 (S.D.Ill.
Oct. 27,1987); Kozup v. Georgetown University, 663 F.Supp. 1048
(D.D.C.1987), aff'd in relevant part, 851 F.2d 437
(D.C.Cir.1988); Roberts v. Suburban Hospital Assoc., 73 Md.App.
1, 532 A.2d 1081 (1987); Hyland Therapeutics v. Superior Court,
175 Cal.App.3d 509, 220 Cal.Rptr. 590 (1985). But see Doe v.
Miles Laboratories,  675  F.Supp.  1466 (D.Md.1987) (decision
withdrawn and question certified to state court of appeals where
statutory language at time cause of action arose protected
processors and distributors of blood products from liability "for
the virus serum hepatitis").

The statutory and common law protection of the suppliers of blood
and blood products from strict liability and breach of warranty
claims developed during the mid 60's through early 70's in
response to the transmission of the hepatitis virus by blood and
blood products.  At that time, no means existed for ensuring that
blood and its components were not infected with the hepatitis
virus.  States feared that the threat of liability without fault
would drive the suppliers out of the very necessary business of
providing blood.  See Comment, Hospital and Blood Banks Liability
to Patients Who Contract AIDS through Blood Transfusion, 23 San
Diego L.Rev. 875, 883 (1986).

In Minnesota, this issue was first addressed in Balkowitsch v.
Minneapolis War Memorial Blood Bank, 270 Minn. 151,132 N.W.2d 805
(1965).  The plaintiff in Balkowitsch brought breach of warranty
claims against a non-profit blood bank to recover damages after
she contracted hepatitis through a transfusion of impure blood
that had been collected, processed and sold by the blood bank.
132 N.W.2d at 806. The court, adopting the reasoning of Perl
mutter v. Beth David Hospital, 308 N.Y. 100,123 N.E.2d 792
(1954), held that furnishing blood did not constitute a sale of
goods, but a service.  Because warranty claims must be based on a
sale of goods, the holding functioned to protect the defendant
from causes of action which impose liability "on the theory of
implied warranty." 132 N.W.2d at 810. The breach of warranty
claims  were  dismissed.   Although the doctrine of strict
liability for defective products was not adopted in Minnesota
until 1967 [footnote 4] and therefore Balkowitsch cannot itself
be read as protecting the suppliers of blood from strict liabili
ty in tort, there is no question that the reasoning in
Balkowitsch has the effect of barring such claims because, like
claims for breach of warranty, strict liability claims must be
based on a sale of goods.  See, Restatement (Second) of Torts
402A; Hudson v. Snyder Body, Inc., 326 N.W.2d 149 (Minn.1982).

Four years after Balkowitsch was decided, the Minnesota
Legislature adopted the Uniform Anatomical Gift Act, now codified
as amended at Minn.Stat.  525.921 et seq. The Legislature added a
"blood shield" provision which was not part of the Uniform Act.
That provision states:

The use of any part of a body for the purpose of transplantation
in the human body shall be construed, for all purposes
whatsoever, as a rendition of a service by each  and  every
person  participating therein and shall not be construed as a
sale of such part for any purpose whatsoever.

Minn.Stat.  525.928.  "Part" is defined as "organs,  tissues,
eyes,  bones, arteries, blood, other fluids and any other
portions of a human body."  Minn.Stat.  525.921, subd. 6. The
statute follows the reasoning of Balkowitsch and protects any
person participating in the transplantation of a body part from
claims for breach of warranty or strict liability by defining the
activity as a rendition of a service, not a sale.

The furnishing of Factor VIII Concentrate is squarely within the
meaning of section 525.928.  First, Factor VIII is a portion of
human blood and "part," as defined in the statute, includes blood
or any other portion of the human body. [footnote 5] Second, the
University of Minnesota Hospital used Factor VIII Concentrate to
transfuse into plaintiff's body during an operation for the
purpose of ensuring that his blood would clot. Third, Baxter, a
"person" within the meaning of the statute, [footnote 6] prepared
the Concentrate which was furnished to the hospital.  In
preparing the Concentrate, Baxter participated in the use of the
blood derivative. By including every person participating in the
use of a body part, and defining person to include corporations,
the Minnesota Legislature ensured that entities like Baxter would
fall within the statute's protection.

Plaintiff argues that section 525.928 is designed only to provide
the donor of an anatomical gift or his estate with "certain
protections and immunities," relying principally on the fact that
the section is located with those provisions of Minnesota law con
cerning probate proceedings.  Plaintiff's argument is untenable.
The implications drawn from the statute's location in the Code
cannot be so great as to contradict the plain meaning of the
statute's language.  In light of the Balkowitsch holding, the
statute is clearly an effort to protect entities like Baxter from
liability without fault.  The statute provides that the use of
any part of a body "shall be construed, for all purposes
whatsoever, as a rendition of a service by each and every person
participating therein and shall not be construed as a sale of
such part for any purpose whatsoever."   Minn.Stat.  525.928
(emphasis added). Moreover, the fact that this section is
codified amongst the probate laws is not inconsistent with the
statute's plain meaning. In fact, statutory provisions shielding
the processors of blood from strict liability and breach of
warranty claims are located within the Anatomical Gift Acts in
other states.  See, e.g., Iowa Code  142A.8 (1988 Supp.);
N.C.Gen.Stat.  130A-410 (1987); Va.Code  32.1-297 (1985);
Wyo.Stat.  35-5-110 (1988).

The public policy considerations relevant to the transmission of
the AIDS virus through distribution of Factor VIII Concentrate
are identical to those raised by the transmission of the
hepatitis virus through whole blood. [footnote 7]  The first
cases of the syndrome that has since been named AIDS were
diagnosed in June and July of 1981. Kozup v.  Georgetown
University,  663 F.Supp. 1048,1051 (D.D.C.1987), affd in relevant
part, 851 F.2d 437 (D.C.Cir.1988). In July 1982, three cases of
pneumocystis carinii pneumonia, one of the infections that
characterizes AIDS, were diagnosed in hemophiliacs.  663 F.Supp.
at 1051.  By January 1983 some health care professionals and
public health organizations had come to believe that the still
unidentified virus was blood-borne.  663 F.Supp. at 1051-52.
However, it was not until early 1984 that the medical community
reached a consensus  that AIDS  was  transmitted through blood
and soon afterwards, in April 1984, scientists identified a
virus, initially called HTLV-III, as the cause of AIDS.  663
F.Supp. at 1052.  The virus was later renamed HIV. By May 1985,
an enzyme-linked immunosorbent assay (ELISA) test that could
detect antibodies to the AIDS virus in the blood became
available. 663 F.Supp. at 1052.  Despite use of the ELISA test,
suppliers of blood and blood products have been unable to insure
that the blood supply is 100 percent free from HIV.  This is
because a person infected with HIV may not develop antibodies
detectable by the ELISA test until several weeks or even months
after the infection began.  Transmission of Human Immu
nodeficiency Virus (HIV) by Blood Transfusions Screened as
Negative for HIV Antibody, 318 New.Eng.J.Med. 473, 476 (Feb. 25,
1988).

Thus, just as was the case with the hepatitis virus, blood
processors are not able through the exercise of due care to
insure that the blood supply is free from HIV Yet, their various
products must remain available.  Hemophiliacs, like Doe, depend
on the availability of Factor VIII Concentrate which has
lengthened and improved the quality of their lives.  Because the
market for these products is small, [footnote 8] their
availability would be threatened if the cost of the inherent risk
of HIV infection were imposed on the manufacturer. Therefore,
despite the devastating consequences resulting from the
transmission of HIV through products like Factor VIII Concen
trate, virtually every court that has considered the question has
interpreted blood shield statutes to apply to the commercial
processors of antihemophilic factors. Coffrey v. Cutter
Biological, 809 F.2d 191 (2d Cir.1987);  Poole v. Alpha
Therapeutic Corp., -- F.Supp. -- (N.D.Ill.1988); Jones v. Miles
Laboratories, Inc., -- F.Supp. --, No. C86-83 (N.D.Ga. Dec. 29,
1987); McKee v. Miles Laboratories, Inc., 675 F.Supp. 1060
(E.D.Ky.1987) (appeal pending);  Clark v. Alpha Therapeutic
Corp., No. 87-5230 (S.D.Ill. Oct. 27,1987); Hyland Therapeutics
v. Superior Court, 175 Cal.App.3d 509, 220 Cal.Rptr. 590 (1985);
Roberts v. Suburban Hospital Assoc., 73 Md.App. 1, 532 A.2d
1081(1987). Contra, Doe v. Miles Laboratories, 675 F.Supp. 1466
(D.Md.1987) ("[t]hose who choose to operate in the economic
marketplace play by the rules applicable to all"; decision
subsequently withdrawn and question certified to state court of
appeals).

This decision does not, of course, foreclose recovery upon a
showing of negligence.

Accordingly, based on the foregoing, and upon review of all the
files, records and proceedings herein,

IT IS ORDERED that Baxter's motion to dismiss Doe's claims for
breach of warranty and strict liability be granted.



FOOTNOTES:

1.   Baxter Healthcare Corporation was formerly known as Travenol
Laboratories, Inc.  Hyland Therapeutics is a division of Baxter.
The caption for this case refers to the defendant "Travenol
Laboratories, Inc., d/b/a Hyland Therapeutics, a division of
Travenol Laboratories. Inc."

2.   Although the complaint alleges that the operation took place
in July 1984, apparently the surgery took place in August of that
year. Plaintiffs Memorandum of Law in Opposition to Defendant's
Motion to Dismiss Pursuant to Rule 12(b)(6) at 2.

3.   AIDS is caused by a virus, the Human Immunodeficiency Virus
(HIV), which destroys the natural immunity system serving to
protect the body against disease.

4.   McCormack v. Hankscraft Co., 278 Minn. 322, 154 N.W.2d 488
(1967).

5.   The Texas Blood Shield Statute, Tex.Civ.Prac. & Rem.Code
Ann.  77.003, like the Minnesota statute, employs the term "body
part."  That term is defined as "any tissue, organ, blood or
components thereof from  a  human."   Id.  77.001.  In Doe v.
Cutter Laboratories, -- F.Supp. -- No. CA-2-87-0013, slip op.
(N.D. Tex. Feb. 5, 1988), the court held that a supplier of blood
derivative products, including lyophilized plasma products (like
Factor VIII), was immune under the blood shield statute from
strict liability and breach of warranty claims.

6.   The Uniform Anatomical Gift Act defines per. son to include
an individual, a corporation, a partnership or any other legal
entity.  Minn. Stat.  525.921, subd. 7.

7.   Plaintiff argues that the Court should not decide this
motion without taking evidence on the relevant public policy
considerations. The necessary facts are, however, well-documented
and plaintiff fails to suggest any new considerations which might
be revealed through discovery.

8.   Baxter states that the entire patient population for Factor
VIII Concentrate is between 10,000 and 20,000 people. Fewer than
10,000 of these are severe A hemophiliacs.  Baxter also states
that more than seventy-five percent of severe A hemophiliacs were
infected with HIV by the end of 1982. Defendant's Reply to
Plaintiff's Memorandum in Opposition to Its Motion to Dismiss
Pursuant to Rule 12(b)(6) at 10.