HIV AIDS Resource Guide/HIV-AIDS Resource Guide.iso/STAT/CASES/SPENC-MI.ASC

Text File | 1993-01-14 | 45KB | 818 lines

/* This case is reported in 810 F.Supp. 952 (E.D.Tenn. 1992). In
this contaminated blood case, the Court finds that a state law
which requires blood products to be tested did not apply to
product that was already produced when the statute went into
effect, that is to say that product on the shelf did not have to
be recalled. *

Jennifer SPENCE, individually and as surviving spouse of Wynne
Spence, deceased, Plaintiff,
v.
MILES LABORATORIES, INC.,
individually and d/b/a Cutter Laboratories, Defendants.
United States District Court, E.D. Tennessee, at Chattanooga.
Nov. 20, 1992.

MEMORANDUM

EDGAR, District Judge.
This Court has previously denied a motion by defendant Miles
Laboratories, Inc. ("Miles") for summary judgment.  This case is
now before the Court on Miles' motion to reconsider.  This motion
raises several issues which will be discussed in this memorandum.
For the reasons discussed herein, Miles' motion for summary
judgment will be GRANTED and the case DISMISSED.

I.   Standard of Review
Fed.R.Civ.P. 56(c) provides that summary judgment will be
rendered if there is no genuine issue as to any material fact and
the moving party is entitled to judgment as a matter of law.  The
burden is on the moving party to conclusively show that no
genuine issue of material fact exists, and the Court must view
the facts and all inferences to be drawn therefrom in the light
most favorable to the nonmoving party. White v. Turfway Park
Racing Ass'n, Inc., 909 F.2d 941, 943 (6th Cir.1990); 60 Ivy
Street Corp. v. Alexander, 822 F.2d 1432,1435 (6th Cir.1987).

[1, 2]  Once the moving party presents evidence sufficient to
support a motion under Rule 56, the nonmoving party is not
entitled to a trial merely on the basis of allegations.  The
nonmoving party is required to come forward with some significant
probative evidence which makes it necessary to resolve the
factual dispute at trial.  Celotex Corp. v. Catrett, 477 U.S.
317,106 S.Ct. 2548, 91 L.Ed.2d 265 (1986); White, 909 F.2d at 943-
44; 60 Ivy Street, 822 F.2d at 1435.  The moving party is
entitled to summary judgment if the non-moving party fails to
make a sufficient showing on an essential element of its case
with respect to which it has the burden of  proof.  Celotex, 477
U.S. at 323,106 S.Ct. at 2552.

[3-6]  The judge's function at the point of summary judgment is
limited to determining whether sufficient evidence has been
presented to make the issue of fact a proper jury question, and
not to weigh the evidence, judge the credibility of witnesses,
and determine the truth of the matter. Anderson v. Liberty Lobby,
Inc., 477 U.S. 242, 249, 106 S.Ct. 2505, 2511, 91 L.Ed.2d 202
(1986); 60 Ivy Street, 822 F.2d at 1435-36.  The standard for
summary judgment mirrors the standard for directed verdict. The
Court must determine "whether the evidence presents a sufficient
disagreement to require submission to a jury or whether it is so
one-sided that one party must  prevail  as  a  matter  of  law."
Anderson, 477 U.S. at 251-52,106 S.Ct. at 2512.  There must be
some probative evidence from which the jury could reasonably find
for the nonmoving party. If the Court concludes that a fair-
minded jury could not return a verdict in favor of the nonmoving
party based on the evidence presented, it may enter a summary
judgment. Id.

II.  Facts

The Court has reviewed the record in the light most favorable to
plaintiff and makes the following findings of fact.  Wynne Spence
was born with hemophilia, an inherited disorder in which the
hemophiliac's own blood lacks certain key "clotting factors"
which are essential to normal blood clotting. Persons with
hemophilia are subject to episodes of uncontrolled bleeding which
can be fatal.  Wynne Spence was first diagnosed as having
Hemophilia B involving a Factor IX deficiency in June 1977 after
an automobile accident. At that time, he received fresh frozen
plasma and a Factor IX blood-clotting factor concentrate
manufactured by Hyland known as PROPLEX.  In January 1981, Mr.
Spence received Factor IX blood-clotting factor concentrate while
undergoing oral surgery for the removal of his wisdom teeth.  Mr.
Spence also received Factor IX blood clotting factor concentrate
in September 1982  while being treated for an injury to his knee.

KONYNE-HT was first licensed by the United States Food and Drug
Administration in October 1984.  KONYNE-HT is a product
manufactured and distributed by Cutter Laboratories which is a
division of Miles.  KONYNE-HT is a Factor IX concentrate derived
from human plasma which has undergone heat treatment during its
processing.  Miles contends that its heat treating process
inactivates any HIV in the plasma obtained from blood donors
which can cause AIDS. [footnote 1]

In July and August 1986, Wynne Spence was treated with KONYNE-HT
as prescribed by his family physician, Vincent Haren, M.D. The
particular KONYNEHT which was administered to Mr. Spence
originated from Lot No. 20P010.  The plasma from which KONYNE-HT
Lot No. 20P010 was derived was obtained from various blood donors
during the period of time from October 1984 through early March
1985. The plasma was processed by Miles beginning on March
18,1985, and continuing through April 3,1985.  The resulting
KONYNE-HT was heat-treated in late May and early June, 1985.
KONYNE-HT Lot No. 20P010 was released by Miles for distribution
on July 16, 1985, and was shipped to Erlanger Hospital in
Chattanooga, Tennessee, on October 1 and 9, 1985.

The usual shelf life or date of expiration of KONYNE-HT in 1985
and 1986 was two years from the date of manufacture. The
expiration  date  on  KONYNE-HT  Lot 20P010 was June 5, 1987.
Wynne Spence was diagnosed as suffering from AIDS on March 22,
1990, after being tested for AIDS for the first time.  Wynne
Spence and Jennifer Spence filed suit against Miles in the
Circuit Court of Hamilton County, Tennessee, on March 20, 1991,
and Miles subsequently removed the case to this Court. Mr. Spence
died on March 24, 1992, as a result of health complications
associated with AIDS. This suit is being carried on by his
surviving spouse, Jennifer Spence, pursuant to Tenn.Code Ann.  20-
5-106(a). Dr. Haren has rendered his expert medical opinion that
Mr. Spence became infected with the AIDS virus in July and August
1986 when Mr. Spence was treated with KONYNE-HT which was
manufactured by Miles using plasma from donors who had not been
tested or screened for the AIDS virus.  Miles disputes that
KONYNE-HT caused Mr. Spence to contract AIDS. Miles asserts that
its heat treatment process is completely effective for
inactivating the AIDS virus and Mr. Spence was infected with the
AIDS virus prior to 1986.

Plaintiff claims that Miles was negligent in not withdrawing from
the market KONYNE-HT derived from blood or plasma which had not
been tested or screened for the AIDS virus, and also negligent
for failing to warn that the plasma it used to manufacture the
KONYNE-HT administered to Mr. Spence had not been tested for the
presence of the AIDS virus.  In the alternative, plaintiff claims
Miles is liable pursuant to Tenn.Code Ann.  68-32-102. These
claims are premised upon Tennessee law and the plaintiff has
invoked the Court's diversity jurisdiction pursuant to 28 U.S.C.
1332.

III.  Analysis

A.   Tenn.Code Ann. Section 68-32-102

[7]  The first question to be resolved is whether plaintiff can
maintain a cause of action against Miles pursuant to Tenn.Code
Ann.  68-32-102 which provides in part:

(a)  All facilities collecting fresh human blood or plasma
directly from an individual donor shall have such blood or plasma
tested for the potential presence of the causative agent for
Acquired Immune Deficiency Syndrome (AIDS).

(b)  Any blood shown by appropriate medical testing to be
potentially contaminated by the causative agent for AIDS shall
not be used for transfusions, or for any other purposes which may
pose a threat of transmission of the virus.

(c)  Any person who contracts AIDS from any contaminated blood or
blood product shall have a cause of action for damages, including
all medical expenses, against any facility supplying untested
blood, if such person can establish that such person received any
untested blood, or blood product derived therefrom, from such
supplier.

The statute was enacted by the General Assembly of Tennessee
effective March 24, 1986.  It creates a new cause of action
whereby a person who contracts AIDS from any untested blood or
blood product can recover damages from the supplying facility.

[8]  Does the AIDS statute provide the Spences a cause of action
in this case? The general rule in Tennessee is that "a statute
will be presumed to operate prospectively and not retroactively
unless it clearly appears from the statute that the Legislature
intended it to operate retroactively.  A statute should not be
given retroactive operation unless its words make that impera
tive." Smith v. State Farm Mutual Auto Ins. Co., 278 F.Supp. 405,
410 (E.D.Tenn. 1967); see also Shultz v. Dempster Systems,  Inc.,
561  F.Supp.  1230,  1232 (E.D.Tenn.1983); Woods v. TRW Inc., 557
S.W.2d 274, 275 (Tenn.1977);  Dailey v. State, 225 Tenn. 472, 470
S.W.2d 608 (1971); Collins v. East Tenn., Va. & Ga. Railroad Co.,
56 Tenn. 841(1872).  Especially when a statute creates a new
right, as does  68-32-102, and the statute is not merely remedial
in nature, it must be applied prospectively only. Tenn. Const.
art. I,  20; Menefee Crushed Stone Co., Inc. v. Taylor, 760
S.W.2d 223, 22627 (Tenn. App.1988); Collier v. Memphis Light, Gas
& Water Div., 657 S.W.2d 771, 775 (Tenn. App.1983); Anderson v.
Memphis Housing Authority, 534 S.W.2d 125, 127-28 (Tenn.
App.1975); cf Morris v. Gross, 572 S.W.2d 902, 907 (Tenn.1978).
Miles collected the plasma, processed it, and manufactured and
distributed the KONYNE-HT Lot No. 20P010 to Erlanger Hospital in
1984-1985 before 68-32-102  became  effective. There is no
language in the statute which indicates that the Tennessee
General Assembly intended the statute to have retroactive
application.  Section 68-32-102 cannot be retroactively applied
to hold Miles liable in damages to plaintiff.

Plaintiff argues, however, that she can make out a viable claim
under 68-32-102 without retroactive application of the statute on
the theory that the operative culpable act which gives rise to
liability is neither the collection of the blood nor the failure
to test it; rather it is the supplying of the contaminated blood
product to the patient.  It is the plaintiff's position that
since the KONYNE-HT was not ultimately supplied by Erlanger
Hospital to Wynne Spence until four months after the effective
date of  68-32-102, the statute is applicable without being given
retrospective application.  In May 1985, an enzyme linked
immunosorbant assay ("ELISA") test became available which can
screen blood and detect antibodies to the AIDS virus. [footnote
2]  Plaintiff concludes that Miles had the means and the legal
obligation under  68-32-102 to test samples from KONYNE-HT Lot
20P010 for the presence of the AIDS virus even after it had been
distributed to the hospital and after the statute's effective
date.

[9]  Erlanger Hospital, which did supply untested blood after the
effective date of the statute, is not a defendant in this case.
Miles supplied the KONYNE-HT to the hospital before the effective
date of  68-32-102.  There is nothing in the language of the
statute that evidences an intent to require manufacturers and
suppliers of  blood products to recall and test a product already
on the market before the statute took effect.

 Plaintiff's claim against Miles under 68-32-102 must be
dismissed.

B.   Statute of Repose

[10, 11]  Assuming that plaintiff could have brought an action
against Miles pursuant to  68-32-102, this claim, and the
alternative claim of negligently manufacturing and distributing a
defective product, are time-barred.  Section 68-32-102 contains
no reference to a statute of limitations or statute of repose.
In Tennessee, "the gravamen of an action, rather than its
designation as an action for tort or contract, determines the
applicable statute of limitations."  Pera v. Kroger Co., 674
S.W.2d 715, 719 (Tenn.1984);  see also Cumberland & Ohio Co. v.
First American Nat. Bank, 936 F.2d 846, 849 (6th Cir.1991), cert.
denied, -- U.S. --, 112 S.Ct. 878, 116 L.Ed.2d 783 (1992);
Electric Power Bd. of Chattanooga v. Monsanto Co., 879 F.2d 1368,
1375 (6th Cir.1989), cert. denied, 493 U.S. 1022,110 S.Ct. 724,
107 L.Ed.2d 743 (1990);  Kirby Farms Homeowners Ass'n v.
Citicorp, 773 S.W.2d 249,  251  (Tenn.App.1989);   Vance  v.
Schulder,  547  S.W.2d 927 (Tenn.1977); Prescott v. Adams, 627
S.W.2d 134 (Tenn. App.1981).

[12]  Whether formulated as a "strict liability" claim for
damages resulting from untested blood products under  68-32-102,
or as a negligence claim, the plaintiff's claims manifestly
relate to a product. The Tennessee Products Liability Act, Tenn.
Code Ann.  29-28-102(6) defines a "product liability action" as

all actions brought for or on account of personal injury, death
or property damage caused by or resulting from the manufacture,
construction, design, formula, preparation, assembly, testing,
service, warning, instruction, marketing, packaging or labeling
of any product.  It shall include, but not be limited to, all
actions  based upon the following theories:  ... negligence;  .
.. breach of or failure to discharge a duty to warn or instruct,
whether negligent or innocent; misrepresentation, concealment, or
nondisclosure, whether negligent, or innocent; or under any other
substantive legal theory in tort or contract whatsoever.

The plaintiff's claims clearly fall within Tennessee's broad
definition of products liability actions. See Electric Power Bd.
of Chattanooga v. Westinghouse, 716 F.Supp. 1069,1073
(E.D.Tenn.1988), aff'd, 879 F.2d 1368 (6th Cir.1989), cert.
denied, 493 U.S. 1022,110 S.Ct. 724, 107 L.Ed.2d 743 (1990).
Consequently, they are governed by the statute of repose
applicable to products liability cases, Tenn.Code Ann.  29-28-
103(a), which provides:

Any action against a manufacturer or seller of a product for
injury to person or property caused by its defective or un
reasonably dangerous condition must be brought within  the
period  fixed by  28-3-104, 28-3-105, 28-3-202 and 47-2-725, but
notwithstanding any exceptions to these provisions it must be
brought within six (6) years of the date of injury, in any event,
the action must be brought within ten (10) years from the date of
which the product was first purchased for use or consumption, or
within one (1) year after the expiration of the anticipated life
of the product, whichever is shorter, except in the case of
injury to minors whose action must be brought within a period of
one (1) year after attaining the age of majority, whichever
occurs sooner.

(Emphasis supplied).

The term "anticipated life" is defined in Tenn.Code Ann.  29-28-
102(1) as follows: "The anticipated life of a product shall be
determined by the expiration date placed on the product by the
manufacturer when required by law but shall not commence until
the date the product was first purchased for use or consumption."
Miles was required by law to place the expiration date on all
lots of KONYNE-HT that it manufactured.  42 U.S.C.  262(a)(2);
C.F.R. 610.60(a)(4) and 610.61(d).  The expiration date on the
KONYNE-HT Lot No. 20P010 which was administered to Mr. Spence was
June 5,1987. Thus, plaintiff had one year from June 5, 1987,
within which to timely file the products liability action against
Miles.  Since plaintiff did not file the complaint against Miles
in the Hamilton County Circuit Court until March 20,1991, the
action is time-barred under Tenn.Code Ann.  29-28-103(a).

[13-15]  Plaintiff argues for the application of Tennessee's one-
year personal injury statute of limitations, Tenn.Code Ann.  28-3-
104.  If this statute were to be applied, this suit would have
been timely filed, because it was filed within one year after Mr.
Spence discovered, or in the exercise of reasonable care should
have discovered, that he had AIDS.  Beaman v. Schwartz, 738
S.W.2d 632 (Tenn.App.1986). However, for the reasons discussed
above, the products liability statute of repose,  29-28-103(a)
applies to plaintiff's claims. As a statute of repose,  29-28-
103(a) imposes an outer limit or ceiling upon the time within
which a claim can be brought. Wayne v. Tennessee Valley
Authority, 730 F.2d 392, 401(5th Cir.1984), cert. denied, 469
U.S. 1159, 105 S.Ct. 908, 83 L.Ed.2d 922 (1985); Johnson County,
Tenn. v. US. Gypsum  Co.,  580  F.Supp.  284,  290
(E.D.Tenn.1983); Hawkins v. D & J Press Co.,  Inc.,  527  F.Supp.
386,  388-89 (E.D.Tenn.1981); Buckner v. GAF Corp., 495 F.Supp.
351, 355 (E.D.Tenn.1979). The one year personal injury statute of
limitations,  28-3-104, is specifically referenced in the
products liability statute of repose, and is to be construed in
pari materia therewith. Pridemark Custom Plating v. Upjohn Co.,
702 S.W.2d 566, 570 (Tenn. App.1985); Milligan v. American Hoist
and Derrick Co.,  622 F.Supp. 56, 58 (W.D.Tenn.1985).  The
judicially created discovery rule cannot extend the ceiling or
absolute time limit established by the statute of repose.
Johnson County,  580 F.Supp. at 290; Buckner, 495 F.Supp. at 355.
See also Mathis v. Eli Lilly & Co., 719 F.2d 134,145 (6th
Cir.1983).

C.   Constitutional Guarantees of Equal Protection of the Laws
and Open Courts

[16]  Plaintiff contends that the statute of repose in  29-28-
103(a) violates the equal protection guarantees of the United
States Constitution [footnote 3] and the Tennessee Constitution,
[footnote 4] as well as Article I, Section 17, the "open courts"
provision of the Tennessee Constitution. [footnote 5]

The Tennessee products liability statute of repose and similar
statutes elsewhere, have been consistently upheld against similar
constitutional challenges as a proper exercise of legislative
authority to reasonably limit the exposure to liability of prod
uct manufacturers and sellers. Kochins v. Linden-Alimak, Inc.,
799 F.2d 1128 (6th Cir.1986); Wayne, 730 F.2d at 404; Mathis, 719
F.2d at 141-146; Stutts v. Ford Motor Co.,  574  F.Supp.  100
(M.D.Tenn.1983); Jones v. Five Star Engineering, Inc., 717 S.W.2d
882 (Tenn.1986). Cf, Alexander v. Beech Aircraft Corporation,
952 F.2d 1215,1224-25 n. 12 (10th Cir.1991) (Indiana statute of
repose); Hartford Fire Ins. v.  Lawrence, Dykes, Goodenberger,
740 F.2d 1362, 1366-73 (6th Cir.1984) (Ohio statute of repose);
Barwick v. Celotex Corp., 736 F.2d 946 (4th Cir.1984) (North
Carolina statute of repose); Burris v. Ikard, 798 S.W.2d 246, 249
(Tenn.App.1990) (Tennessee medical malpractice statute of
repose); Harrison v. Schrader, 569 S.W.2d 822 (Tenn.1978).  After
reviewing the applicable law, the Court concludes that the plain
tiff's attack on the constitutionality of Tenn.Code Ann.  29-28-
103 must fail.

There is one facet of the plaintiff's equal protection claim
which requires further discussion. Section 29-28-103(b) provides
that the time limits in the statute of repose,  29-28-103(a),
"shall not apply to any action resulting from exposure to
asbestos." Plaintiff maintains that persons who contract AIDS are
so similarly situated to persons who incur injuries as a result
of exposure to asbestos (both diseases have long periods of
latency) that they should be afforded the same legislative
protection. Plaintiff argues there is no rational basis for
distinguishing between AIDS and asbestos when it comes to
applying the products liability statute of repose. [footnote 6]
Plaintiff proposes that the solution to the problem is for this
Court to extend application of the exemption in Tenn.Code Ann.
29-28 103(b) concerning asbestos to AIDS cases.

[17, 18]  The Equal Protection Clause of the Fourteenth Amendment
directs that all persons similarly situated should be treated
alike. Cleburne v. Cleburne Living Center, 473 U.S. 432, 439,105
S.Ct. 3249, 3254, 87 L.Ed.2d 313 (1985); Plyler v. Doe, 457 U.S.
202, 216, 102 S.Ct. 2382, 2394, 72 L.Ed.2d 786 (1982). However,
"the Constitution does not require things which are different in
fact or opinion to be treated in law as though they were the
same." Id. at 216,102 S.Ct. at 2394 (quoting Tigner v. Texas, 310
U.S. 141,147, 60 S.Ct. 879, 882, 84 L.Ed. 1124 (1940). A
legislative classification does not violate equal protection when
it distinguishes persons as being dissimilar upon some rational
basis for the purpose of advancing the legitimate interests of
society. Kochins, 799 F.2d at 1138.

[19]  The state legislature has the discretion to determine what
is different and what is the same.  "A legislature must have
substantial latitude to establish classifications that roughly
approximate the nature of the problem perceived, that accommodate
competing concerns both public and private, and that account for
limitations on the practical ability of the State to remedy every
ill."  Plyler, 457 U.S. at 216, 102 S.Ct. at 2394.  In Cleburne,
473 U.S. 432, 105 S.Ct. 3249, the Supreme Court explained:

The general rule is that legislation is presumed to be valid and
will be sustained if the classification drawn by the statute is
rationally related to a legitimate state interest ....  When
social or economic legislation is at issue, the Equal  Protection
Clause  allows  the States wide latitude, ... and the Consti
tution presumes that even improvident decisions will eventually
be rectified by the democratic processes.

Id. at 440,105 S.Ct. at 3254 (citations omitted). This relatively
relaxed rational basis standard reflects the "awareness that the
drawing of lines that create distinctions is peculiarly a
legislative task and an unavoidable one.  Perfection in making
the necessary classifications is neither possible nor necessary.
Such action by a legislature is presumed to be valid."
Massachusetts Bd. of Retirement v. Murgia, 427 U.S. 307, 314, 96
S.Ct. 2562, 2567, 49 L.Ed.2d 520 (1976).  The Sixth Circuit has
held that state legislatures are presumed by federal courts to
have acted constitutionally in making state laws. Kochins, 799
F.2d at 1136; Hartford Fire, 740 F.2d at 1366. A statutory
classification or discrimination does not violate equal
protection "if any state of facts reasonably may be conceived to
justify it." Dandridge v. Williams, 397 U.S. 471, 485, 90 S.Ct.
1153, 1161, 25 L.Ed.2d 491 (1970) (quoting McGowan v. Maryland,
366 U.S. 420, 426, 81 S.Ct. 1101, 1105, 6 L.Ed.2d 393 (1961)).
The Supreme Court of Tennessee has adopted a virtually identical
equal protection standard of analysis under Article XI, Section 8
of the Tennessee Constitution. Kochins, 799 F.2d at 1136;
Harrison, 569 S.W.2d at 825-26.

[20-24]  The deferential rational basis standard is not applied
to every legislative classification.  If a classification
involves invidious discrimination by either impermissibly
interfering with a fundamental right or it operates to the
peculiar disadvantage of an inherently suspect class, it is
subject to strict judicial scrutiny to determine whether the
classification has been precisely tailored to serve a compelling
governmental interest. Murgia, 427 U.S. at 312, 96 S.Ct. at 2566;
Plyler, 457 U.S. at 216 17,102 S.Ct. at 2394-95; In re Grand Jury
Proceedings, 810 F.2d 580, 587 (6th Cir. 1987); Kochins, 799 F.2d
at 1136.  The instant case does not involve a "fundamental"
right.  See Charles v. Baesler, 910 F.2d 1349, 1353 (6th
Cir.1990). The proper test  for  determining  whether  Wynne
Spence was a member of a suspect class is stated in Bowen v.
Gilliard, 483 U.S. 587, 107 S.Ct. 3008, 97 L.Ed.2d 485 (1987). Un
der Bowen, a plaintiff must (1) have suffered a history of
discrimination; (2) exhibit obvious, immutable or distinguishing
characteristics that define him as a member of a discrete group
and (3) show that the group is a minority or politically power
less. Id. at 602-03, 107 S.Ct. at 3018. See also Lyng v.
Castillo, 477 U.S. 635, 638, 106 S.Ct. 2727, 2729, 91 L.Ed.2d 527
(1986). Suspect  classifications  which  require heightened
judicial scrutiny are race, alienage, national origin, and sex.
Cleburne, 473 U.S. at 440-41, 105 S.Ct. at 3254-55. Persons
suffering from AIDS are not members of an inherently suspect
class for purposes of equal protection analysis. Harris v.
Thigpen,  727  F.Supp.  1564,  1570 (M.D.Ala.1990); judgment
aff'd in part, vacated in part on other grounds, 941 F.2d  1495
(11th  Cir.1991); Cordero v. Coughlin, 607 F.Supp.  9, 10
(S.D.N.Y. 1984); cf, Wayne, 730 F.2d at 404.  The rational basis
standard must, therefore, be used to examine  29-28-103.

[25, 26]  Since plaintiff challenges the Tennessee products
liability statute of repose as violating the constitutional
guarantee of equal protection, she bears the burden of showing
that the different classifications of asbestos and AIDS-related
claims do not rationally further a legitimate state interest In
re Grand Jury, 810 F.2d at 587.  Plaintiff has not met this
burden. AIDS is significantly different from asbestos-related
injuries in that persons who knowingly uses blood or blood
products can take a readily available medical test within six
months to determine if they have been infected with HIV.  In
1984, the medical community reached a consensus that HIV is the
virus which causes AIDS and that AIDS can be transmitted by
blood.  See McKee v. Cutter Laboratories, Inc., 866 F.2d 219, 224
(6th Cir.1989). By May 1985, the ELISA test was made available
which screens blood for antibodies sensitive to HIV.  There is no
proof that any such comparable test exists to diagnose asbestos-
related diseases in their earliest stages within a short time
after the exposure. There is an unusually long period of latency
of up to more than 2030 years before the onset of some asbestos-
related diseases and before they can be medically diagnosed. Ins.
Ca North America v. Forty-Eight Insulations, Inc., 633 F.2d 1212,
1214 (6th Cir.1980); Borel v. Fibreboard Paper Products, 493 F.2d
1076, 1083-85 (5th Cir.1973), cert. denied, 419 U.S. 869, 95
S.Ct. 127, 42 L.Ed.2d 107 (1974); Pottratz v. Davis, 588 F.Supp.
949, 956 (D.Md. 1984);  Eagle-Picher Industries, Inc. v. Liberty
Mutual Ins. Co., 523 F.Supp. 110, 115 (D.Mass.1981), judgment
modified, 682 F.2d 12 (1st Cir.1982), cert. denied, 460 U.S.
1028,103 S.Ct. 1279, 75 L.Ed.2d 500 (1983).  Given these factors,
the Court is convinced that there is a rational basis for the
Tennessee Legislature to exempt asbestos-related injuries from
the products liability statute of repose and not to exempt other
long-term continuing type injuries such as becoming infected with
HIV from contaminated blood products.  See, e.g., Wayne, 730 F.2d
at 404 (distinguishing asbestos from phosphate slag-related
injuries under equal protection analysis); Pottratz, 588 F.Supp.
at 954-56 (distinguishing asbestos from Dalkon Shield
intrauterine contraceptive device).

Wynne Spence's death is indeed tragic. In his case, Tenn.Code
Ann.  29-28-103(a) effectively prevents him from litigating his
claim against Miles. However, the statute represents public
policy which affords plaintiffs what the legislature deems to be
a reasonable time to present their claims; and it protects
defendant and the courts from having to deal with stale cases
where the search for the truth and justice may be seriously
impeded by the death or disappearance of witnesses, fading
memories, disappearance of documents or other loss of material
evidence. United States v. Kubrick, 444 U.S. 111, 117, 100 S.Ct.
352, 357, 62 L.Ed.2d 259 (1979).  In the preamble to  29-28-103,
the Tennessee General Assembly stated that the purpose of the
statute of repose is to protect the public interest by making
product liability insurance more readily available at a
reasonable cost to manufacturers and sellers so that the cost of
products may be lessened to consumers. The statute provides a
reasonable time within which an action to recover damages may be
commenced against a manufacturer or seller while limiting
liability to a specific period of time so that product liability
insurance premiums can be reasonably and accurately calculated.
Ch. 703, Tenn.Pub.Acts 468-469; Kochins, 799 F.2d at 1139;
Mathis, 719 F.2d at 139.  The Tennessee statute of repose, then,
was enacted for stated purposes. It is the role of the
legislature, not this Court, to pass on the wisdom of that
purpose. Hargraves v. Brackett Stripping Machine Co., 317 F.Supp.
676, 683 (E.D.Tenn.197O).

D.   No Irreconcilable Conflict

[27]  Plaintiff next contends that Tenn.Code Ann. 29-28-103(a)
should not be applied to AIDS cases because it would create an
irreconcilable conflict with Tenn. Code Ann. 68-32-102. The
Tennessee Legislature is presumed to know the state of the law on
the subject under consideration at the time it enacts
legislation. Jenkins v. Loudon County, 736 S.W.2d 603, 608
(Tenn.1987); Neff v. Cherokee Ins. Co., 704 S.W.2d 1, 5
(Tenn.1986). According to plaintiff, it is inconceivable that the
Tennessee Legislature would create a new cause of action under
68-32-102 for its citizens who contract AIDS through contaminated
blood products but intend that the products liability statute of
repose would apply so that the vast majority of AIDS cases would
have already expired by the time the cause of action accrued.
The action accrues when the person contracts AIDS.  The AIDS
syndrome is the final stage or result of the HIV infection and
the symptoms of AIDS are usually manifested after an indefinite,
protracted incubation period often lasting years.  In other
words, an individual who is infected with the AIDS virus may show
no signs of having the disease and may not actually develop AIDS
for many years.  Thus, plaintiff argues that if the products
liability statute of repose is applied here, the policy
underlying 68-32-102 of creating a cause of action for persons
suffering from AIDS is frustrated or thwarted before it can apply
because the statute of repose would extinguish the right to
maintain an action under  68-32-102 before the plaintiff is
injured by contracting AIDS.

[28-32]  In analyzing this question, the Court is guided by the
rules of statutory construction and the law governing implied
amendment or repeal summarized by the Supreme Court of Tennessee
in Jenkins, 736 S.W.2d at 6074)8.  Where two acts conflict and
cannot be reconciled, the prior act will be repealed or amended
by implication but only to the extent of the inconsistency
between them.  However, the repeal of a statute by implication is
not favored and there must be an irreconcilable conflict or
repugnancy between the statutes that is plain and unavoidable to
work a suspension of the earlier statute. Statutory provisions in
pari materia must be construed together and the construction of
one statute, if doubtful, may be aided by the consideration of
the words and legislative intent indicated by the other statute.
Furthermore, harmonious effect should be given to all statutes on
a subject whenever reasonably possible. Where the repealing
effect of a statute is doubtful, the statute is strictly
construed to effectuate its operation consistent with the
previous legislation.  Where the later statute does not cover or
embrace all of the provisions of the earlier one, and does not
manifest a clear and unmistakable intention to provide and
substitute a new system for the old, the provisions of the
earlier statute not clearly covered by the later statute are
unaffected and still in force.  Id.

[33]  When these principles are applied in this case, the Court
concludes that there is not an irreconcilable conflict between
the products liability statute of repose and Tenn.Code Ann.  68-
32-102.  Section 68-32-102 contains neither a statute of limita
tions nor a statute of repose. The Tennessee Legislature has not
manifested a clear, unmistakable intent in  68-32-102 to repeal
or amend by implication the products liability statute of repose.
There is no irreconcilable conflict between the two statutes and
the Court concludes that Tenn. Code Ann.  29-28-103(a) applies to
causes of action brought pursuant to  68-32-102. Tenn.Code Ann.
68-302-102 can and should be construed to be consistent and
harmonious with  29-28-103(a) in the absence of a clear
irreconcilable conflict.

E.   Fraudulent Concealment

[34, 35]  Plaintiff next argues that the products liability
statute of repose should be tolled under the equitable doctrine
of fraudulent concealment. This is a diversity case and
Tennessee's law of fraudulent concealment applies to the
plaintiff's state law claims.  Jarrett v. Kassel, 972 F.2d 1415,
1424 n. 6 (6th Cir.1992); Campbell v. Upjohn Co., 676 F.2d
1122,1126 (6th Cir. 1982).  Where a statute of repose defense has
been asserted and established by the defendant, the burden of
proof shifts to the plaintiff to establish the exception to the
statute of fraudulent concealment.  Benton v. Snyder, 825 S.W.2d
409, 414 (Tenn. 1992).

[36-38]  In order to meet her burden, the plaintiff must prove
that her cause of action was known to and fraudulently concealed
by Miles. Id. ; Ray v. Scheibert, 224 Tenn. 99, 450 S.W.2d 578,
580 (1969). The essential element of concealment may consist of
withholding information where there is a duty to disclose by
virtue of a confidential relationship or making use of some
device to mislead thus involving act and intention. Benton, 825
S.W.2d at 414.  A plaintiff seeking to establish fraudulent
concealment must prove that the defendant took affirmative action
or committed some overt act to conceal the plaintiff's cause of
action and that the plaintiff could not have discovered the
existence of the cause of action despite exercising reasonable
diligence.  Duncan v. Leeds, 742 F.2d 989, 992 (6th Cir.1984);
Id.; Vance, 547 S.W.2d at 930.  "Generally, the affirmative
action on the part of a defendant must be something more than
mere silence or a mere failure to disclose known facts.  There
must be some trick or contrivance intended to exclude suspicion
and prevent inquiry, or else there must be a duty resting on the
party knowing such facts to disclose them." Benton, 825 S.W.2d at
414 (emphasis in original). See also Electric Power Bd., 879 F.2d
at 1377; Soldano v. Owens-Corning Fiberglass Corp., 696 S.W.2d
887, 889 (Tenn.1985).

Plaintiff contends that Miles engaged in fraudulent concealment
by not issuing written warnings with its KONYNE-HT that the blood
donors who provided the plasma used in manufacturing KONYNE-HT
had not been tested for presence of the AIDS virus.  However, the
Court concludes that the doctrine of fraudulent concealment is
not applicable under these facts and does not toll the products
liability statute of repose.  The running of the statute is not
tolled by the mere ignorance and failure of Wynne and Jennifer
Spence to discover the existence of their cause of action.
Soldano, 696 S.W.2d at 889.  Mere silence by Miles or the failure
by Miles to disclose known facts does not constitute sufficient
affirmative action of concealment required to prove fraudulent
concealment.  Moreover, there was no confidential or fiduciary
relationship between Miles and Wynne Spence such as physician and
patient which imposed a higher duty on Miles to disclose the
information about untested blood donors to Mr. Spence.

Miles contends that, assuming arguendo, it did take affirmative
action and committed an overt act of fraudulent concealment,
there is no basis for the Court to read into Tenn.Code Ann.  29-
28-103 an exception for fraudulent concealment which would toll
the statute of repose. Miles points out that in two similar
statutes of repose the Tennessee Legislature has expressly pro
vided an exception for fraudulent concealment, Tenn.Code Ann.  29-
26-116(a)(3) [footnote 7] (medical malpractice), and Tenn.Code
Ann.  28-3-205(b) [footnote 8] (defective improvement of real
estate). Miles argues that the absence of a fraudulent
concealment exception in Tenn.Code Ann.  29-28-103 necessarily
leads to the conclusion that no such exception was intended or
exists, and since  29-28-103 sets an absolute outer time limit
after which no cause of action can be brought, the Court should
not read the doctrine of fraudulent concealment into the statute
because it would undermine the legislature's intent and purpose
in enacting the products liability statute of repose.

The Tennessee courts have not addressed this particular question.
Since the doctrine of fraudulent concealment is not applicable to
the facts of this case, this issue need not be addressed.

F.   Pretrial Order

[39]  Finally,  plaintiff  contends  that Miles has waived the
statute of repose defense because it was not specifically raised
in the final pretrial order.

On June 17, 1991, Miles filed its answer to the complaint wherein
it generally raised the affirmative defense that the complaint is
barred by the applicable statute of limitations and the statute
of repose. (Court File No. 7). The answer does not cite or refer
to a specific statute. In its first motion for summary judgment
(Court File No. 61) and in the final pretrial order entered on
September 14,1992 (Court File No. 69), Miles contended that this
case is a medical malpractice action and the plaintiff's claims
are time-barred by the statute of repose applicable to medical
malpractice actions, Tenn. Code Ann.  29-26116(a)(3). Miles did
not mention Tenn.Code Ann.  29-28-103(a), the statute of repose
for products liability actions.

The Court denied Miles' motion for summary judgment on September
25,1992, ruling inter alia that this is not a medical malpractice
action and  29-26116(a)(3) is not applicable.  (Court File Nos.
76, 77). Eleven days later on October 6,1992, Miles filed its
motion to reconsider wherein it raised for the first time the
specific argument that the complaint is time-barred by the
products liability statute of repose. Plaintiff contends that
Miles should not be permitted to raise the products liability
statute of repose two weeks prior to the trial which was
scheduled to begin on October 20,1992.

[40]  The procedures governing pretrial conferences are set forth
in Fed.R.Civ.P. 16. Rule 16(e) provides:
Pretrial Orders.  After any conference held pursuant to this
rule, an order shall be entered reciting the action taken. This
order shall control the subsequent course of the action unless
modified by a subsequent order. The order following a final
pretrial conference shall be modified only to prevent manifest
injustice.

Paragraph 7 of the final pretrial order states that it supplants
the pleadings. (Court File No. 69, p. 8).  It is well settled
that issues incorporated in a final pretrial order may supersede
the pleadings. Moore v. Fenex, Inc., 809 F.2d 297, 300 (6th
Cir.), cert. denied, 483 U.S. 1006,107 S.Ct. 3231, 97 L.Ed.2d 737
(1987); Howard v. Kerr-Glass Mfg. Co., 699 F.2d 330, 333 (6th
Cir.1983). However, the Court has the discretion to modify the
pretrial order to permit a party to raise a new matter in order
to prevent manifest injustice. Daniels v. Board of Educ. of
Ravenna City School, 805 F.2d 203, 210 (6th Cir.1986); Campbell
Industries v. M/V Gemini, 619 F.2d 24, 27-28 (9th Cir.1980). As
the Fourth Circuit stated in Barwick, 736 F.2d 946: "The re
quirements of the pretrial order are not set in stone, but may be
relaxed for good cause, extraordinary circumstances, or in the
interest of justice. However, the terms of the order must be
firmly and fairly enforced by the district judge if it is to
serve the purpose of pretrial management designed 'to secure the
just, speedy, and inexpensive determination of every action.'"
Id. at 954-55, quoting Fed.R.Civ.P. 1.

In the instant case, the Court concludes that Miles should be
permitted to raise the affirmative defense of the products
liability statute of repose even though it was not specifically
mentioned in the final pretrial order.  Miles did generally
assert the defense that the complaint is time-barred by the
applicable statute of repose in its answer. Once the Court ruled
that this case is not a medical malpractice action, Miles did
file its motion asserting the products liability statute of
repose prior to commencement  of  trial.   Although  Miles should
have raised the products liability statute of repose both in its
first motion for summary judgment and the final pretrial order,
it would be manifestly unjust under these facts and circumstances
to rule that Miles has waived the defense and is strictly bound
by the final pretrial order.

Accordingly, an order will enter GRANTING summary judgment in
favor of the defendants and dismissing the plaintiff's claims.

FOOTNOTES

1.   AIDS is an acronym for the term "acquired immune deficiency
syndrome." This syndrome is the final result of infection with
human immunodeficiency virus ("HIV").  Infection with HIV
initiates a process of gradual and accelerating destruction of
the body's natural immune system.  HIV can be present in human
blood, plasma and serum-derived body fluids. It renders
individuals more susceptible to a range of other infections and
diseases which generally would not be life threatening to persons
with normally functioning immune systems.  HIV infection is
conceptualized by scientists as a continuum of disease ranging
from asymptomatic infection to end-stage AIDS.  Virtually ev
eryone infected with HIV will ultimately progress at some point
to active disease. There is no standard rate or pace of
progression.  Some persons remain asymptomatic for long periods
of time-perhaps indefinitely-while others can quickly develop end-
stage AIDS and die.  Although infected and capable of
transmitting HIV to others, a victim can take years to develop
AIDS because of the unusual. unpredictable incubation period.
Periods of survival vary considerably, no one has successfully
recovered from AIDS, and there is as yet no known effective cure
or vaccine. The prognosis for persons with advanced stage HIV
infection is extremely poor. Harris v. Thigpen, 941 F.2d 1495,
15024)3 n. 10 and 11 (11th Cir.1991).

2.   Deposition of Margaret Hilgartner. September

3.   Section 1 of the Fourteenth Amendment of the United States
Constitution provides in part: "No State shall deny to any person
within its jurisdiction the equal protection of the laws."

4.   Article XI, Section 8 of the Constitution of Tennessee
provides in part:

The Legislature shall have no power to suspend any general law
for the benefit of any particular individual, nor to pass any law
for the benefit of individuals inconsistent with the general laws
of the land; nor to pass any law granting to any individual or
individuals, rights, privileges, immunities, or exemptions other
than such as may be, by the same law extended to any member of
the community, who may be able to bring himself within the
provisions of such law.

5.   Article 1, Section 17 of the Tennessee Constitution
provides:
That all courts shall be open; and every man, for an injury done
him in his lands, goods, person or reputation, shall have remedy
by due course of law, and right and justice administered without
sale, denial, or delay. Suits may be brought against the State in
such manner and in such courts as the Legislature may by law
direct.

6.   The Tennessee statute does not mention AIDS claims, and
there is no reason to believe that the legislature has
specifically considered how the statute of repose should apply to
AIDS or to injury resulting from any other disease with a latency
period.

7.   Tenn.Code Ann.  29-261 16(a)(3) provides: "In no event shall
any such action be brought more than three (3) years after the
date on which the negligent act or omission occurred except where
there is fraudulent concealment on the part of the defendant in
which case the action shall be commenced within one (1) year
after discovery that the cause of action exists."

8.   Tenn.Code Ann.  28-3-205(b) provides: "The limitation hereby
provided shall not be available as a defense to any person who
shall have been guilty of fraud in performing or furnishing the
design, planning, supervision, observation of construction,
construction of, or land surveying, in connection with such an
improvement, or to any person who shall wrongfully conceal any
such cause of action."