# Petition — Upjohn Co. v. Mauldin

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Petition
- **Published:** January 1, 1983
- **Citation:** 464 U.S. 848

## Text

al I aa
I SUL 16
POO hia Lene

IN THE

Supreme Court of the United States

October Term, 1983

THE UPJOHN COMPANY ,.*

Petitioner,
VS.
O. L. MAULDIN,

Respondent.

PETITION FOR WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF
APPEALS FOR THE FIFTH CIRCUIT.

McCUTCHEN, BLACK, VERLEGER
& SHEA,
ROBERT K. WREDE,
BETTE ANN BAKER,
600 Wilshire Boulevard,
Los Angeles, Calif. 90017,
(213) 624-2400,
Attorneys for Petitioner,
The Upjohn Company.

(Footnote of Parent Companies, Subsidiaries and
Affiliates appear on inside cover)

Parker & Son. Inc.. Law Printers. Los Angeles. Phone 724-6622

*Parent Companies, Subsidiaries and Affiliates to The
Upjohn Company:
Admiral Company of Japan, Ltd.
Owned by: The Upjohn Company
Mitsubishi
ISOPOR — Companhia Portuguesa Isocianatos, Lda.
Owned by: The Upjohn Company
Quimigal
Kasei Upjohn Company
Owned by: The Upjohn Company
Mitsubishi Chemical Industries, Ltd.
P.T. Upjohn Indonesia
Owned by: The Upjohn Company
Dian Paramita Tamzil
Japan Upjohn Lt.
Owned by: The Upjohn Company
Sumitomo Chemical Company Limited
Korea Upjohn Lt.
Owned by: The Upjohn Company
Yu Yu Industrial Co. Ltd.
Tuk Ham Yu
Seung Sik Yu
Mrs. Hi Joo Koh
Seung Pil Yu
Seung Zi Yu
Miss Seung Sun Yu
Kye Hong Kwon
Xanco Upjohn S.A.
Owned by: The Upjohn Company
Agustin Jousas

i
Question Presented.

Did allowing a lay jury to find that two prescription drugs
manufactured by defendant medically caused plaintiff's dis-
ease in the total absence of expert testimony to that effect,
violate the defendant's constitutional right to a trial by a
jury capable and willing to decide the case solely on the
evidence before it?

*

TABLE OF CONTENTS

Page
SINE occ cocets cod canwuacasueiohdeasweeasassonuss i
NIN ax cccncccunedsclucsdstees cuimieiavecurcrsesersenys |
Opinion Below ............000 putnvtans telaoegidaceaieiand |
PN 540 si sceccndnashisveavbedicscoancataabuceissuiiiaes 2
Constitutional Provision Involved ..............6.0ccceeu es 2
MIE GE CE adie cotndacschiadccecvadedcccsuvanciness 2
Argument for Granting the Wit .............ccccceeeeee ees 8
A. This Petition Presents a Question of Broad
Application and Constitutional Dimensions .... 8
B. The Result Below Runs Contrary to Legal Prin-
ciples Long-Established Nationwide ............. 13

C. The Fifth Circuit’s Offhand Generalization That
Facts May Be Proven by Both Direct and Cir-
cumstantial Evidence Does Not Obviate the In-
dispensability of Expert Testimony in Such Cases

1. Only Experts Are Competent to Draw In-
ferences of Medical Causation in Cases Such
C6 EO vc vivcci cadena atna tee akiniracas 17

2. Laymen Could Not Rationally Infer Medical
Causation From the Record in This Case

a. The Temporal Relationship ............. 19

b. Simply Because the Drugs Occasion-
ally Can Cause Such Disease Is Insuf-
ficient to Establish That They Did in
WOE ME Siu iinsednannccivoeassarteuniaees 22

Ds aE NE a shileksssccseiscnsstunvicbes 22
Without Expert Testimony on Causa-
tion, the Jury’s Conclusion That the

iil

Page
Drugs Caused Mauldin’s Illness Was
PECTS SHCCUIMION ....4cccsasvescoesecerens 23
D. The Fifth Circuit's Mauldin Opinion Radically
Departs From Long-Established Precedent in the
Circuit as Interpreted by the Supreme Court 24
Conclusion

MiSs chduacncbassaisaraus epeentusgsencssweas App. p. |

iV

TABLE OF AUTHORITIES

Cases Page

American Can Co. v. Dart Industries, 205 U.S.P.Q.
ee fe ts Ce anu hin inbe sens 8

American Export Lines Inc., Complaint of, 73 F.R.D.
CE Ln ncciccscnenerecacueneetacssovdcess 8

Anderson v. Nixon, 10 Ut. 262, 129 P.2d 216 (1943)

Bearman v. Prudential Ins. Co. of America, 186 F.2d
COZ (iG Civ. SSE) .....cccces. 13, 14, 15, 24, 25, 29

Bernstein v. Universal Pictures, 79 F.R.D. 59 (S.D.N-Y.
I ee Roa caabeensaoanan 8

Boise Cascade Securities Litigation, In re, 420 F.Supp.
I, I on ccc sn ccdstnsnncdctandbascans 8

Bowles v. Bourdon, 148 Tx. 1, 219 S.W.2d 779 (1949)

Cullum v. Seifer, | Cal.App.3d 20, 81 Cal.Rptr. 381
ae eI Lc cAc dou cuesupactsiagunivevstass 17

Curtis v. General Motors Corp., 649 F.2d 808 (10th
decal Creguteceriiiencedkecsdnsate dines 1S, 29

Davis v. Firestone Tire and Rubber Co., 196 F.Supp.
I ME. ID 6 xis faedircncuavessensvesctvsaxdcesss 8

Denney v. Siegel, 407 F.2d 433 (3rd Cir. 1969) ...... 27
Dimick v. Schiedt, 293 U.S. 474 (1935) .......c.c08 12

Ewing v. Goode, 78 Fed. 442 (Cir. S.D. Ohio, W.D.
1897 [subsequently the 6th Circuit]) ......... 13, 14, 16

Page
Fitzgerald v. A.L. Burbank Co., 451 F.2d 670 (2nd Cir.
NS cee acs padincanivs Wid banduuecseesivssishen? 27
Fitzgerald v. Manning, 679 F.2d 341 (4th Cir. 1982).. 16
Folk v. Kilk, 53 Cal.App.3d 176, 126 Cal.Rptr. 172

Se ie a aki why pea crkbenaspaikdesuienvess ss 17
Foster v. United States, 214 F.Supp. 181 (S.D. Miss.
[bata SPEER CORREA A Enea eee 21

Franklin v. Shelton, 250 F.2d 92 (10th Cir. 1957) .... 15
Frisone v. United States, 270 F.2d 401 (9th Cir. 1959)

Be eT AS a Al a ta ER 6 RE 8, 16
Genesee Merchants Bank & Trust Co. v. Payne, 161
Pe Oe ee es OOM, SIE) chee esdesessaenencess. 21
Gicas v. United States, 508 F.Supp. 217 (E.D. Wis.
el eet U ops jsesenvanasdsseieesaetss 21
Grismore v. Consolidated Products Co., 232 lowa 328,
Oe RROD cc sirsncseinicsccissventwandsesseese 17
Gwathmey v. United States, 215 F.2d 148 (Sth Cir.
eens kateb ces yhvavceinacesisceses 8
Harrison v. Weller, 423 S.W.2d 226 (Mo. App. 1967)
eae ee cee kk ies Sah okc end Unskv a caw en vsasasden 17
Hegger v. Green, 646 F.2d 22 (2nd Cir. 1981) ........ 16
Hirsh v. Safiarir, 12 N.Y.Supp.2d 568, 257 A.D. 212
Tiere ies uses udassinests casei essipnas «eee 17
Hyde Properties v. McCoy, 507 F.2d 301 (6th Cir. 1974)
Saal cls ATE Oly no ee 8
Inter-Caribbean Shipping Corp. v. Sentilles, 256 F.2d
I UE is akeacinesencdanccsnaessecxe> 25, 26
Japanese Electronic Products Antitrust Litigation, In re,
be Bo fe le A) pre 10, 11

Kubs v. United States, 537 F.Supp. 560 (E.D. Wis.
NE Cie Aaah del rabirciradhchdndasiavetanke:ssctecsecese 21

vi

Page

Longfellow v. Vernon, 57 Ind. App. 611, 105 N.E. 178
SO at tireka. - scnrnecrniecalianskatermaceredianae Netntae

ee

POND cuisiincaitennia anes tres veenkidpeas cance laeemadnads

Lysick v. Walcom, 258 Cal.App.2d 136, 65 Cal.Rptr.
Oe Esse cedar se tsns tenses ene auentsi<ceR nes

M & W Gear Company v. A. W. Dynamometer, Inc.,
Fi Pe WOE CREED Since cecexszcsshtivencvesssavane

Mauldin v. Upjohn Co., 697 F.2d 644 (Sth Cir. 1983)
seaaenwenn eam bandee Lbdatebiiisteanadeteatert 5, 18, 23, 24,

Peters v. Kiff, 407 U.S. 493 (1972) .....................

Picou v. American Offshore Fleet, 576 F.2d 585 (Sth
FR.) | ERE ARNE Neen RET 7 RN re ReneS ee nee

Porter v. American Optical Corp., 641 F.2d 1128 (Sth

<A, |) SGU ie Seiropcrengen Parent rer wate 18, 27, 28,
Prudential Ins. Co. of America v. Bialkowski, 85 F.2d
ee a I es ced cn sendwanncans 15,

Prudential Oil Corp. v. Phillips Petroleum, 392 F.Supp.
1018 (S.D.N.Y. 1975, rev’d on other grounds, 546
Fae ee CR As, SPUD cn kcwbhescscavsvisunacterssers

Radial Lip Machine Inc. v. International Carbide Corp.,
76 F.R.D. 224 (ND. 0. 1977) ..cccccccccsvccssccecese

Ross v. Bernhard, 396 U.S. 531 (1970) .................

Senerjian v. Stetson, 284 Mass. 510, 187 N.E. 829
GUIIUTEE csiiisd tb takapccatocaabadpenetsicetsbannteniibgixusncese

Sentilles v. Inter-Caribbean Corp., 361 U.S. 107 (1959)
piddesasavigubasbetscaigabianain tian icnae 6, 26,

Shepherd v. Midland Mut. Life. Ins. Co., 152 Ohio St.
By BF FEE. FR GID ctnsescsctesececvisesceseses 14,

27

17

Vil

Smith v. Phillips, 455 U.S. 209 (1982) .................
Spivey v. Atteberry, 205 Okla. 483, 238 P.2d 814 (1951)

ee

ee

Swine Flu Immunizaticn Products, In re, 533 F.Supp.
OF esc CA CUED si sd denn tacsdecphasadeeasscnnenels

Swine Flu Immunization, Products Liability Litigation,
in te, 533 F.Sepp. 703 (D.C. Ut. 1982) «............

Tremaine v. H.K. Mulford Co., 176 A. 212 (Sup. Ct.
Fels WIRE ati ecewiensacindvcass-apbedehnd rein dactamMhiinwell

U.S. Steel Corporation, Petition of, 436 F.2d 1256 (6th
ily WEN. vvicivnederkcuvisnienathycenacssalanctecchealaes

United States v. Central Supply Ass'n. 6 F.R.D. 526
CER ER SR ROE ss vesicinkancnccesisbentuceaney ec reeens

United States v. Clapp, 63 F.2d 793 (2nd Cir. 1933)
idkapienncisnibek ateomi ed gts an thion taenandeenis cele ial onaeaanial 15,

United States v. J. B. Williams Co., Inc., 498 F.2d 414
CG ae. HP OUOE oo cocci udecddsksuGlatelcsate oe

United States v. Linton, 655 F.2d 930 (9th Cir. 1981)

ee es
ee

United States Financial Securities Litigation, In re, 609
Fe OE CE UPD vacanesenciicnvednccianwaceevars
United States Radiator Corp. v. Henderson .............

Uris v. State Compensation Dept., 247 Or. 420, 427
PB OPA TMAD: cxcsivitinsiccanbixdestpchbesceeneeene

viii

Page
Walstad v. University of Minnesota Hospitals, 442 F.2d
el As Co canvesvediwevevkwindrerees 16
Webster v. Offshore Food Service, Inc., 434 F.2d 1191
a aad lar si shiubeduivtseneeksnicces 25
Wilson v. State Accident Insur. Fund, 28 Or. App. 509,
Ne ae ain rss en dncdidestevesesevccvete es 17
Constitution
United States Constitution, Fifth Amendment .......... 2
Statute
United States Code, Title 28, Sec. 1254(1) ............. 2
Rules of Evidence
a cccil, seteacesdevsetessdveceseseve 18
Textbook
32A Corpus Juris Secundum, Sec. 1039 .............0065 23

Law Review Articles
Harris and Liberman, Can The Jury Survive the Com-
plex Antitrust Case, 24 N.Y. Law School L.R. 611
ei vaidbis ies irasdavessteevivasactssuss 11
Kirkham, Complex Civil Litigation — Have Good In-
tentions Gone Awry? 70 F.R.D. 199 (1976) ..... 8, 12
O’Connell, Jury Trials in Civil Cases, 58 Ill. B.J. 796

ee aaa cepa biaivedavdespsedecoses sins 8, 17
Schaeffer, Is the Adversary System Working in Optimal
iT Mes FRAUD IOD | vsivccesecescoscesreseses 8
Note, Jury Trials in Protracted Commercial Litigation,
SS Rec GUOWs FID AIOIO) crccccvecsvccsesecascreses 8
Note, Preserving the Right to Jury Trial in Complex
Civil Cases, 21 Stan. L. Rev. 99 (1979) wo... 8

Note, The Right to a Jury Trial in Complex Civil Lit-
igation, 92 Harv. L. Rev. 898 (1979) .............008 8

Page

Note, Unfit for Jury Determination: Complex Civil Lit-
igation and the Seventh Amendment Right of Trial
By Jury, 10 B.C.L. Rev. Sil (E979) ...cecccccsveees 8

Medical Authorities

Sleisenger and Fordtran, eds. *‘The Pseudomembranous
Enterocolitides’’ Gastrointestinal Disease, 2d ed.

ee
IN THE

Supreme Court of the United States

October Term, 1983

THE UPJOHN COMPANY,
Petitioner,
vs.
O. L. MAULDIN,
Respondent.

PETITION FOR WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF
APPEALS FOR THE FIFTH CIRCUIT.

Introduction.

The petitioner the Upjohn Company (‘‘Upjohn’’) respect-
fully prays that a writ of certiorari issue to review the judg-
ment and opinion of the United States Court of Appeals for
the Fifth Circuit originally rendered on February 7, 1983,
and denied again on petition for rehearing and suggestion
for rehearing en banc on April 18, 1983.

Opinion Below.

The opinion of the United States Court of Appeals for
the Fifth Circuit is officially reported in 697 F.2d 644 (Feb-
ruary 7, 1983) and is printed in Appendix A, pp. 1-9 hereto,
infra.

=
Jurisdiction.

The judgment of the United States Court of Appeals for
the Fifth Circuit was originally entered on February 7, 1983.
A Petition for Rehearing and Suggestion for Rehearing En
Bank were duly filed by Upjohn on March 23, 1983 and
denied on April 18, 1983. This petition for Certiorari if
being filed within 90 days of that last date. This Court's
jurisdiction is invoked under 28 U.S.C. § 1254(1).

Constitutional Provision Involved.

The Fifth Amendment to the United States Constitution
guarantees that, ‘‘No person shall be . . . deprived of life,
liberty, or property, without due process of law. .. .”’

Statement of the Case.

In March of 1974, Respondent O. L. Mauldin crushed
and virtually amputated part of his thumb. In order to min-
imize the risk of life-threatening infection, Mauldin’s treat-
ing physician prescribed Lincocin and Cleocin, two strong,
broad-spectrum antibiotics manufactured by Petitioner Up-
john which are noted for their effectiveness in combating
such infections.

Shortly after using Upjohn’s drugs, Mauldin began to
suffer acute diarrhea, elevated temperatures, and a series of
other symptoms diagnosed by his treating doctors as either
gastroenteritis or acute ulcerative colitis. As a result of his
disease, whatever it was, Mauldin underwent major surgery.

Mauldin subsequently sued Upjohn, alleging that his brief
use of Lincocin and Cleocin caused the disease which ne-
cessitated his surgery and that Upjohn was liable to him for
failing adequately to warn prescribing doctors of the risk
that the drugs could cause such a disease.

Two principal issues were tried: First, whether Cleocin
and Lincocin medically caused Mauldin’s disease; and, Sec-

sien

ond, whether Upjohn knew, or should have known, that the
drugs might cause such a disease and failed adequately to
warn prescribing physicians of that risk.

A number of medical experts testified at trial that the
symptoms suffered by Mr. Mauldin were consistent with
both acute idiopathic ulcerative colitis (that is, a type of
colitis of unknown origin) and a related but different disease
known as pseudomembranous colitis. '

Experts further testified that virtually all antibiotics may
cause pseudomembranous colitis on occasion (R.T. Vol. V,
p. 44); that the medical profession has known about the
disease since the latter part of the last century [well before
antibiotics were discovered and used] (R.T. Vol. Il, p. 64,
lines 19-21); that at least one other drug used by Mr. Maul-
din shortly before his operation is known to cause pseu-
domembranous colitis (R.T. Vol. II, p. 127, lines 10-11);
and that pseudomembranous colitis occurs in persons who
have not used antibiotics.

Respecting causes other than drug use, Mauldin’s prin-
cipal expert testified that pseudomembranous colitis occurs
‘*[qJuite often in a seriously ill person after an operation,
an accident, or a depleting illness’’ (R.T. Vol. II, p. 73);
that pseudomembranes may occur with other types of colitis

‘Expert testimony also established that the term ** pseudomembranous
colitis’’ refers to a false membrane which appears to cover the intestine
in a number of different gastrointestinal diseases. In its chapter entitled
‘*The Pseudomembranous Enterocolitides’’, a leading medical text,
Gastrointestinal Disease, 2d ed., edited by Sleisenger and Fordtran,
describes the condition as follows:

‘*The formation of the Pseudomembranes on the surface of une
small or large intestine is a nonspecific response to injury and
only one of the limited pathologic patterns seen in intestinal dis-
ease. Thus is is not surprising that when all cases demonstrating
pseudomembranes are considered together, multiple causes are
included.”*

Gastrointestinal Disease, supra, at 1715 (footnotes omitted,

emphasis added.)

=

(id.); and that pseudomembranes may appear in conjunction
with idiopathic ulcerative colitis (colitis of unknown cause),
one of the diseases Mauldin’s treating physicians suspected
him of having. (R.T. Vol. II, p. 75).

Because extensive scientific research has revealed that
antibiotics may cause such illnesses, one leading researcher
testified that Lincocin-and Cleocin-associated pseudomem-
branous colitis should be considered in a ‘‘differential di-
agnosis’’ involving any patient who has signs and symptoms
similar to those suffered by Mr. Mauldin following use of
antibiotics such as Lincocin and Cleocin. (R.T. Vol. V, p.
44, lines 15-25).

In summary, the experts testified that a disease like Mr.
Mauldin’s may result from a number of causes, known and
unknown, including the use of antibiotics such as Lincocin
and Cleocin, as well as from operations, accidents, and
depleting illnesses.

The experts also testified regarding the substantial dif-
ficulty experienced by highly-trained specialists in discov-
ering whether Lincocin and Cleocin can cause the type of
pseudomembranous colitis allegedly suffered by Mr. Maul-
din in some unknown, but small, percentage of users. (R.T.
Vol. V, p. 43).

Surprisingly, despite the number and broad experience
of the experts used at trial, not one of them testified that
the use of Lincocin and Cleocin probably, possibly, may
have, could have, or even conceivably might have caused
Mr. Mauldin’s disease. There was, in short, not one whit
of expert testimony regarding the medical cause of Maul-
din’s disease.

The record does not reveal why the experts did not iden-
tify either at trial or in Mr. Mauldin’s medical records, what
caused his unfortunate illness. Perhaps they forgot. Perhaps

alias

they were unable or unwilling to determine what caused his
disease. Whatever the reason, the record contains no such
evidence, as the opinion of the Fifth Circuit clearly con-
cedes. Mauldin v. Upjohn Co., 697 F.2d 644, 646 (Sth Cir.
1983).

Upjohn repeatedly raised this evidentiary deficiency at
trial, moving initially for a directed verdict (R.T. Vol. V,
p. 11) and subsequently for judgment notwithstanding the
jury’s verdict and a new trial — all of which were denied.
Mauldin v. Upjohn Co., supra at 646.

The same point was argued with vigor to the Fifth Circuit,
which concluded (among a number of other substantive and
procedural issues) that the absence of expert testimony con-
necting Lincocin and Cleocin with Mauldin’s illness was
not fatal to his case because ‘‘the record contains circum-
Stantial evidence that either Lincocin or Cleocin caused
Mauldin’s disorder sufficient to require submission of that
question to the jury.”’ Mauldin v. Upjohn Co., 697 F.2d
644, 646 (Sth Cir. 1983).

Cryptically, the Circuit’s opinion does not identify the
‘‘circumstantial evidence’’ which it found ‘‘sufficient’’ to
take the matter to the jury or explain why a lay jury would
be competent to infer medical causation from such evidence
when Mauldin’s treating doctors and expert witnesses failed
to do so.

In essence, the Fifth Circuit held that a lay jury, not
learned in medical science or in the complex and arcane
disciplines relied upon by medical science to distinguish
medical causation from rank coincidence and wholly un-
guided by the testimony of anyone expert in those disci-
plines, could competently conclude that the drugs involved

ee

more probably than not caused Mauldin’s disease.

We submit this holding denied Upjohn its constitutional
right to trial by a jury competent to decide the issues; runs
directly contrary to established precedent in the Fifth and
other Circuits; totally misconstrues this Court’s holding in
Sentilles v. Inter-Caribbean Corporation, 361 U.S. 107
(1959); and turns the law — long-established nationwide
— relating to the proper roles of experts and juries in de-
ciding such highly technical issues on its ear. '

Furthermore, wholly aside from the impact of the fifth
circuit's ruling in this case, Petitioner Upjohn earnestly sub-
mits that allowing juries to decide highly complex. technical

*All prescription drugs cause adverse side effects. Determining whether
a drug actually causes a given medical effect (good or bad) is a highly
complex matter since virtually all human ailments or ‘‘effects’*’ have a
‘natural incidence’’ in that they will occur in the total absence of drug
use, or other identifiable cause. When ailments develop at or about the
same time a drug is being used for reasons unrelated to the drug, the
temporal relationship between use of the drug and onset of the ailment
is pure coincidence.

Sinilarly, a drug may be used to reduce the risk of a given ailment,
such as blood-pressure reducing medication used to reduce the risk of
heart attack because no drug is 100% effective, some people taking
such medication will suffer heart attacks at or about the same time they
are taking it. The temporal relationship here reflects incidence of the
disease in spite of, not because of, the use of the medication.

Because it is extremely difficult to determine whether the appearance
of a disease at or about the time a particular drug is being used 1s
coincidental or actually shows a causal relationship, medical science
relies on specialists known as *‘epidemiologists’’ to determine whether
such caused relationships exist. Making such determinations requires
highly specialized training, detailed data, and the application of ana-
lytical techniques all of which fall far outside the scope of common
knowledge and understanding. Consequently, such judgments must be
made by experts.

‘This Petition asserts a federal constitutional right. Furthermore. in
a diversity case in the Fifth Circuit, a federal standard is applied in
determining whether trial evidence is sufficient to create a jury question
and to defeat a motion for directed verdict or judgment n.o.n. Boeing
Co. v. Shipman, 411 F.2d 365 (Sth Cir. 1969). Federal law regarding
the indispensability of expert testimony in such circumstances thus
controls.

oe

issues falling well outside the common knowledge and ex-
perience of laymen — totally unguided by testimony from
persons specially qualified by knowledge, skill, experience,
training, or education in the discipline involved — would
invite an exponential increase in litigation involving facially
attractive but technically specious propositions; would deny
plaintiffs and defendants, alike, their constitutional right to
a trial by jurors who are competent to decide the issues
presented to them; and would thrust juries squarely into the
province of deciding complex questions in a context offering
no realistic hope that they truly understand the facts and
issues involved — a role that Anglo-American jurisprudence
never contemplated for lay juries and for which they are
simply not equipped.

inl

ARGUMENT FOR GRANTING THE WRIT.
A. THIS PETITION PRESENTS A QUESTION OF BROAD
APPLICATION AND CONSTITUTIONAL DIMENSIONS.

The issue raised by this Petition far transcends the dispute
between the parties. It goes to the very core of the consti-
tutional right of all litigants to trial by **. . . a jury capable
and willing to decide the case solely on the evidence before
it... .”’ Smith v. Phillips, 455 U.S. 209, 217 (1982) (em-
phasis added).

How and if juries should be used to deal with highly
complex and demanding technical issues are issues being
raised with increasing frequency in an expanding range of
contexts.* The existence of this active debate reflects the

“Cases:
Gwathmey v. United States, 215 F.2d 148 (Sth Cir. 1954); Citron vy.
Aro Corp., 377 F.2d 750 (3rd Cir. 1967); United States v. Central
Supply Ass'n., 6 F.R.D. 526 (N.D. Ohio 1947); Hyde Properties v.
McCoy, 507 F.2d 301 (6th Cir. 1974): Prudential Oil Corp. v. Phillips
Petroleum, 392 F.Supp. 1018(S.D.N.Y. 1975, rev'd. on other grounds,
546 F.2d 469 (2d Cir. 1976); American Can Co. v. Dart Industries,
205 U.S.P.Q. 1007 (1979); Bernstein v. Universal Pictures, 79 F.R.D.
59 (S.D.N.Y. 1978): In re Boise Cascade Securities Litigation, 420
F.Supp. 99(W.D. Wash. 1976); /n re United States Financial Securities
Litigation, 609 F.2d 411 (9th Cir. 1979); Radial Lip Mach. Inc. v.
Intern. Carbide Corp., 76 F.R.D. 224 (N.D. Ill. 1977), United States
v. J. B. Williams Co. Inc., 498 F.2d 414 (2nd Cir. 1974); Davis v.
Firestone Tire and Rubber Company, 196 F.Supp. 407 (N.D. Cal.
1961): United States v. Staggs, 553 F.2d 1073 (7th Cir. 1977); Com-
plaint of American Export Lines Inc., 73 F.R.D. 454 (S.D.N.Y. 1977).
Frisone v. United States, 270 F.2d 401 (9th Cir. 1959); In Re Swine
Flu Immunization, Products Liability Litigation, 533 F.Supp. 703 (D.C.
Ut. 1982).
Commentaries:
Note. Preserving The Right To Jury Trial In Complex Civil Cases, 21
Stan. L. Rev. 99 (1979), Note. The Right To A Jury Trial In Complex
Civil Litigation, 92 Harv. L. Rev. 898 (1979); Note, Jury Trials In
Protracted Commercial Litigation, \0 Conn. L. Rev. 775 (1978); Note,
Unfit For Jury Determination: Complex Civil Litigation And The Sev-
enth Amendment Right of Trial By Jury, 20 B-C.L.Rev. S511 (1979),
Schaeffer. /s The Adversary System Working In Optimal Fashion? 70
F.R.D. 79 (1976). Kirkham, Complex Civil Litigation — Have Good
Intentions Gone Awry? 70 F.R.D. 79 (1976); O'Connell. Jury Trials
in Civil Cases, 58 Ill. B. J. 796, 800 (1970).

= =

impact of society’s increasing technical specialization on
our judicial processes; the ever-widening gulf between in-
stinct and intellect which the technological revolution has
wrought; and an increasing awareness of ‘‘the practical abil-
ities and limitations of juries.’’ Ross v. Bernhard, 396 U.S.
531, 538 n.10 (1970).

Life presents each of us, daily, with a bewildering array
of decisions. With some of these we are well equipped to
deal using ‘‘common sense,”’ personal experience, and ac-
quired skills. The more complex of these decisions, how-
ever, are beyond our intellectual and experiencial scope,
necessitating our reliance on specially trained individuals to
translate those complexities which transcend our under-
Standing into terms with which we are competent to deal
and to advise us based upon their specialized capabilities.

As microcosms of our society, juries are faced with a
similar dichotomy. Some judgments they are called upon
to make fall squarely within the scope of common knowl-
edge and judgmental competence: Did someone exercise
reasonable care in the driving of his automobile or the fenc-
ing-in of his animals? Was he drunk? How old was he? Is
the witness believable?

Many issues which juries increasingly are called upon to
decide, however, fall totally outside the realm of common
knowledge and experience: Did pilot error cause an air crash?
Was a skyscraper adequately designed to withstand earth-
quakes? Did a physician meet the applicable standard of
medical care in making his diagnosis, or identifying the
cause and administering the treatment respecting a patient’s
illness?

Lay juries are not equipped to deal with such issues on
their own for the simple reason that common sense and
knowledge frequently lead us astray when applied to such

a

complex technical questions. Indeed, the pitfalls inherent
in applying ‘‘common sense’’ to complex technical issues
are many and varied. In the absence of scientific data and
analysis, for example, common sense applied to sensory
perceptions led mankind to believe for centuries that the
earth was both flat and at the center of the universe. In the
absence of scientific proof to the contrary, provided by
physicists, mathematicians, and astronomers, even the most
intelligent person likely would believe both of those prop-
ositions to be true even today.

In order to protect juries against being led astray by su-
perficially appealing but specious propositions, the law has
traditionally required parties burdened with proving facts
falling outside the sphere of common knowledge and un-
derstanding to prove those facts through the use of expert
testimony. Only through the medium of expert testimony
may evidence bearing on such issues be translated into a
form which will allow persons not learned in the discipline
involved to be ‘‘capable’’ of reaching reasoned judgments
respecting such issues.

Being ‘‘capable’’ of deciding a case based on the evi-
dence, as required by the due process clause, means that a
jury not only must possess the ability to perceive the evi-
dence, but must also be able to understand and bring to
bear on that evidence informed intellectual processes.

The ability of jurors to comprehend the evidence pre-
sented in a complex trial — that is, their capability to arrive
at reasoned conclusions based upon that evidence — was
expressly found to be an essential element of ‘‘due process’’
by the Third Circuit in /n re Japanese Electronic Products
Antitrust Lit., 631 F.2d 1069 (3rd Cir. i980) (hereafter
“Electronic Products’):

The primary value promoted by due process in fact-
finding procedures is ‘to minimize the risk of erroneous

jo

decisions.’ [Citations.] A jury that cannot understand
the evidence and the legal rules to be applied provides
no reliable safeguard against erroneous decisions.
Moreover, in the context of a completely adversary
proceeding, like a civil trial, due process requires that
‘the decisionmaker’s conclusion . . . rest solely on the
legal rules and evidence adduced at the hearing.’ Gold-
burg v. Kelly, 397 U.S. 254, 271, 90 S.Ct. 1011, 1022,
25 L.Ed. 2d 287 (1970). Unless the jury can understand
the legal rules and evidence, we cannot realistically
expect that the jury will rest its decision on them.

Id. at 1084.

As Chief Judge Seitz concluded:

Our liberties are more secure when judicial decision-
makers proceed rationally, consistently with the law,
and on the basis of evidence produced at trial. If the
jury is unable to function in this manner, it has the
capacity of becoming itself a tool of arbitrary and er-
ratic judicial power.

Electronic Products, supra, at 1085.

The commentators, too, have identified a jury’s ability
to understand what has been perceived as an inherent req-
uisite of ‘‘due process:”’

Due process is synonymous with fairness, and at a
minimum would seem to require that the fact-finder be
capable of rendering a reasoned verdict based upon an
understanding of the evidence and the law.*

In a footnote supporting the foregoing proposition, the
article's authors cite Peters v. Kiff, 407 U.S. 493 (1972):
. . . [WJhere the Supreme Court recently reaffirmed

the well-established concept ‘that the Due Process
Clause protects, a defendant from jurors who are ac-

‘Harris and Liberman, Can the Jury Survive the Complex Antitrust
Case? 24 N.Y. Law Sch. L.Rev. 611, 620 (1979).

ae, ae

tually incapable of rendering an impartial verdict, based
on the evidence and the law.’ /d. at 621, n.46 (em-
phasis added).

Similarly:

Due process of law entails a process under which
litigated matters will be decided by an arbiter within
whose competence they lie. . . . To afford merely the
Opportunity to present evidence and argument in a forum
unable to comprehend them is simply a mockery of
justice.°

We certainly do not suggest, as recently has been ad-
vanced with some frequency,’ that juries should have no
role in deciding complex technical questions. However, we
do assert — most vigorously — that the law is long-estab-
lished that when an issue falls outside the ambit of common
experience and knowledge, a jury of laymen is not com-
petent to decide that issue in the total absence of testimony
from a qualified expert or experts. Furthermore, it has long
been established that questions of medical causation — such
as that involved here — fall squarely within that rule.

This Court has properly observed that, *‘Maintenance of
the jury as a fact-finding body is of such importance and
occupies so firm a place in our history and jurisprudence
that any seeming curtailment of the right to a jury trial should
be scrutinized with the utmost care.’’ Dimick v. Schiedt,
293 U.S. 474, 486 (1935). See also, Beacon Theatres v.
Westover, 359 U.S. 500, 501 (1959).

We submit that the holding we attack ‘‘curtailed’’ Up-
john’s constitutional right to trial by a ‘‘capable’’ jury.
Allowing juries to decide the increasingly complex technical

"J. Kirkham, Complex Civil Ligitation — Have Good Intentions Gone
Awry? 70 F.R.D. 79, 208 (1976).

See Commentaries, at p. 8 fn. 4.

—_ on

issues raised in modern litigation without expert guidance
would encourage suits predicated on facial plausibility rather
than sound scientific principle, and deny plaintiffs and de-
fendants alike their right to trial by ‘‘capable’’ jurors. The
Fifth Circuit's adoption of a rule dispensing with the need
for expert testimony in such circumstances is a constitutional
infirmity which consequently *'. . . should be scrutinized
[by this Court] with the utmost care."’

This Petition respectfully seeks such scrutiny.

B. THE RESULT BELOW RUNS CONTRARY TO LEGAL
PRINCIPLES LONG-ESTABLISHED NATIONWIDE,

The propositions that 1) Juries are not competent to decide
issues falling outside the ambit of common knowledge or
experience without expert assistance; and 2) Complex ques-
tions of medical causation are just such issues, have been
oft-repeated.

In a frequently cited opinion rendered before the turn of
the century, for example, William Howard Taft — then a
Circuit Judge and subsequently both President of the United
States and Chief Justice of this Court — wrote:

. . . (W)hen a case concerns the highly specialized area
of treating an eye for cataract, or for the mysterious
and dread disease of glaucoma, with respect to which
a layman can have no knowledge at all, the court and
jury must be dependent on expert evidence. There can
be no other guide, and, where want of skill or attention
is not thus shown by expert evidence applied to the
facts, there is no evidence of it proper to be submitted
to the jury,

Ewing v. Goode, 78 Fed. 442, 444 (Cir. $.D. Ohio,

W.D. 1897 |subsequently the 6th Circuit}).

The rule articulated in Ewing v. Goode, supra, respecting
the indispensability of expert testing to proving medical
causation has been adopted nationwide. In Bearman v. Pru-

—) oo

dential Ins. Co. of America, 186 F.2d 662 (10th Cir. 1951),
for example, the issue was whether a death was medically
caused by an accident or by disease. As in the case at bar,
a number of expert medical witnesses testified but, as in
the case at bar, none of them testified that an accident
suffered a number of weeks prior to the death in question
was its medical cause. The Circuit found the absence of
medical testimony regarding a causal connection between
the accident and the death fatal to the plaintiff's case.

Addressing the insufficiency of the expert medical tes-
timony, the Chief Judge wrote:

Whether there was causal connection between the
accident and resulting injury and the atherosclerosis,
the rupture of the atheromatous abscess, the throm-
bosis, or the coronary occlusion presented a question
for solution not within the competency of laymen, and
a question with respect to which, only a medical expert
with training, skill and experience could form a con-
sidered judgment and express an intelligent opinion,
Indeed, it perhaps would require a medical expert trained
and experienced in a specialized field.

Bearman v. Prudential Ins. Co. of America, 186

F.2d 662, 665 (10th Cir, 1951).*

More recently, the Tenth Circuit reiterated the Bearman
rule in the following terms:

It is uniformly held that where injuries complained
of are of such character as to require skilled and profes-
sional persons to determine the cause and extent thereof,
they must be proved by the testimony of medical
experts. ...

‘Citing Ewing v, Goode, supra; the dissent in United States Radiator
Corp. v. Henderson, 68 F.2d 87 (10th Cir. 1933) and cases there cited;
and Shepherd v, Midland Mut, Life Ins, Co., 152 Ohio St. 6, 87 N.E.2d
156, 160, 12 A.L.R, 2d 1250 (1949),

oa ee

Franklin v. Shelton, 250 F.2d 92, 97 (10th Cir.
1957).

That Bearman is still alive and well as illustrated by the
Tenth Circuit’s 1981 opinion in Curtis v. General Motors
Corp., 649 F.2d 808 (10th Cir. 1981) where the court cited
it for the proposition that ‘*. . . the cause of death — the
causal connection between the accident and the resulting
injury — presented questions ‘not within the competency
of laymen’ and the testimony of an expert was required.”’
Id. at 813.

Learned Hand recognized the indispensability of expert
testimony where ‘the origin and course’’ of a disease is
concerned in United States v. Clapp, 63 F.2d 793 (2nd Cir.
1933). According to Judge Hand, whether the plaintiff suf-
fered from a doudenal ulcer at the time his war risk insurance
lapsed and whether the ulcer permanently disabled him,

.. Was not for a jury to determine upon its own
uninformed intuitions. It was a strictly medical ques-
tion; without the help of those skilled in science, the
conclusions of laymen upon such an issue were without
adequate basis, and necessarily mere speculation, Only
those familiar with the origin and course of the malady
were competent to testify, and without testimony a
verdict stood unsupported.

Id. at 795,

Not long after Learned Hand's Clapp decision, the Fourth
Circuit heard an appeal in another insurance case alleging
accidental death. As in Bearman, those claiming under the
policy in Prudential Ins. Co. of America v. Bialkowski, 85
F.2d 880 (4th Cir. 1936), argued that an accident had caused
the insured’s death. The carrier argued, to the contrary, that
the insured had died from an unrelated ear disease. Con-
flicting expert testimony had been given regarding the cause
of death. Wrote the Fourth Circuit:

—

{W]e must look to the evidence of medical experts
as to the cause of insured’s death. [Citation omitted. }
Such a question is purely medical.

Id. at 882.

The Ninth Circuit considering a similar issue, wrote:
It is well settled that only expert testimony will be
allowed on technical questions of causation.
Frisone v. United States, 270 F.2d 401, 403 (9th
Cir. 1959).
Likewise the Eighth Circuit:
{|W ]hen the causal relation issue is not one within
the common knowledge of laymen, causation in fact
cannot be determined without expert testimony.

Walstad v. University of Minnesota Hospitals, 442
F.2d 634, 639 (8th Cir. 1971).

And more recently, the Second Circuit:

Under New York law, except where ‘the common
experience and knowledge of a jury of laymen’ can
‘bridge this scientific gap’ [citation omitted], a plaintiff
has the burden of producing expert medical testimony
showing proximate cause in medical malpractice
actions,

Hegger v. Green, 646 F.2d 22, 28 (2nd Cir. 1981).

The most recent federal appellate pronouncement of this
principle we have found comes from the Fourth Circuit in
a 1982 opinion which both cites and quotes Ewing v. Goode,
supra, in several places — illustrating that venerable case’s
continuing vitality. As the Fourth Circuit views the rule:

Just as negligence or violation of the standard of care
[in a medical malpractice action] must ordinarily rest
on expert opinion evidence, so proof of causation —
that is that the defendant's negligence was ‘more likely’
or ‘more probably’ the cause of the plaintiff's injury
— requires expert testimony.

Fitzgerald v. Manning, 679 F.2d 341, 350 (4th Cir.

1982) (footnotes omitted).

=, a

State precedents regarding the indispensability of expert
testimony to establish medical causation are equally con-
sistent and even more numerous.”

As noted legal scholar, educator, and appellate advocate
Erwin Griswold once observed — ‘‘The jury trial at best is
the apotheosis of the amateur.’’'® When the issues being
tried transcend the competence of the amateur into the realm
of the professional, the law is clear: Due process requires
that the professionals — not the amateurs — guide the fact-
finding process.

The record below made quite clear that pseudomembranes
like Mr. Mauldin’s may result from numerous causes, known
and unknown. Identifying the cause of Mauldin’s was a job
for an expert, not a panel of laymen.

C. THE FIFTH CIRCUIT’S OFFHAND GENERALIZATION
THAT FACTS MAY BE PROVEN BY BOTH DIRECT AND
CIRCUMSTANTIAL EVIDENCE DOES NOT OBVIATE THE
INDISPENSABILITY OF EXPERT TESTIMONY IN SUCH
CASES.

1. Only Experts Are Competent to Draw Inferences of
Medical Causation in Cases Such as Mauldin’s.

In response to Upjohn’s contention that **Mauldin failed
to offer any direct medical evidence that either Lincocin or
Cleocin probably caused his colitis,’* the Fifth Circuit cited

“See, e.g., Cullum v. Seifer, 1 Cal.App.3d 20, 81 Cal.Rptr. 381
(1969); Lysick v. Walcom, 258 Cal.App.2d 136, 65 Cal.Rptr. 406
(1968); Folk v. Kilk, 53 Cal.App.3d 176, 126 Cal.Rptr. 172 (1975),
Shepherd v. Midland Mutual Life Ins., 152 Ohio 6, 87 N.E.2d 156
(1949); Grismore v. Consolidated Products Co., 232 lowa 328, 5 N.W.2d
646 (1942); Spivey v. Atteberry, 205 Okla. 483, 238 P.2d 814 (1951);
Uris v. State Compensation Dept., 247 Or. 420, 427 P.2d 753 (1967);
Stacey v. Williams, 253 Ky. 353, 69 S.W.2d 697 (1934), Longfellow
v. Vernon, 57 Ind. App. 611, 105 N.E. 178 (1914); Anderson v. Nixon,
104 Ut. 262, 129 pag 216 (1943); Lorenz v. Lerche, 157 Minn. 437,
196 N.W. 564 (1923); Hirsh v. Safiarir, 12 N.Y.Supp.2d 568, 257
A.D. 212 (1939); Bowles v. Bourdon, 148 Tx. 1, 219 S.W.2d 779
(1949); Harrison v. Weller, 423 S.W.2d 226(Mo.App. 1967); Senerjian
v. Stetson, 284 Mass. 510, 187 N.E. 829 (1933); Wilson v. State Ac-
cident Insur. Fund, 28 Or.App. 509, 560 P.2d 289 (1977).

'"K. O'Connell, Jury Trials In Civil Cases?, 58 Ill. B.J. 796, 800
(1970).

=

the general proposition that, ‘‘The plaintiff's burden is to
prove causation by a preponderance of the evidence, which
may be met by direct or circumstantial evidence.’ ’’ Maul-
din v. Upjohn, 697 F.2d 644, 646 (Sth Cir. 1983), quoting
Porter v. American Optical Corp., 641 F.2d 1128, 1142
(Sth Cir. 1981).

The Circuit's opinion cryptically follows this generali-
zation with the observation that, *‘The record contains cir-
cumstantial evidence that either Lincocin or Cleocin caused
Mauldin’s disorder sufficient to require submission of that
question to the jury.”’ /d. at 646. Unfortunately, the Circuit
chose not to identify the evidence from which it felt a lay
jury could so infallibly infer that ‘‘either Lincocin or Cleocin
caused Mauldin’s disorder,’* even though neither Mauldin’s
treating physicians nor his (or anyone’s) medical experts
had so concluded or testified. Nor did it conclude that the
Causation issue in this case was so simple and straightfor-
ward as to fall within the ambit of common knowledge and
experience. Indeed, given the record, it could not have so
concluded.

We do not disagree with the general proposition that either
direct or circumstantial evidence may be sufficient to sup-
port a finding of fact. But the Circuit’s reference to this
general proposition avoids, rather than meets, Upjohn’s ar-
gument that experts alone are competent to find medical
causation — whether they rely on direct or circumstantial!
evidence.

The Circuit's opinion miscarries in its failure to recognize
that only experts were qualified to draw an inference of
medical causation connecting Mauldin’s use of Lincocin or
Cleocin and his disease — whether based upon ‘‘circum-
stantial’’ evidence during trial or otherwise.'' This they sim-
ply did not do.

"See, F.R. Evid. § 801(b).

=

2. Laymen Couid Not Rationally Infer Medical Caus-
ation From the Record in This Case.

The Circuit's failure to identify the circumstantial evi-
dence which it found ‘‘sufficient’’ to justify the jury’s find-
ing of causation leaves us to speculate regarding just what
it found so persuasive. An examination of the record, how-
ever, reveals no evidence which would justify allowing lay-
men to draw the necessary inference of causation.

The only evidence in the record which might bear on the
Causation question is as follows: First, a chronological or
‘‘temporal’’ relationship existed between Mauldin’s use of
the drugs and the subsequent onset of his symptoms. Sec-
ond, one expert testified at trial that Cleocin-associated col-
itis is One type of pseudomembranous colitis associated with
antibiotic therapy and, hence, that pseudomembranous col-
itis should be considered in « doctor's differential diagnosis
of any patient who develops symptoms like Mr. Mauldin’s
while taking Cleocin or after recently having completed a
course of Cleocin. Third, the warnings that accompany Lin-
cocin and Cleocin state that cases of severe and persistent
diarrhea have been reported in association with use of the
drugs and that such diarrhea has at times resulted in acute
colitis.

None of this evidence — taken collectively or separately
— would support a conclusion by laymen that Mauldin’s
use of the drugs and the subsequent manifestation of his
disease was anything other than rank concidence, as we now
discuss.

a. The Temporal Relationship.

Mauldin’s evidence regarding temporal relationships was
essentially as follows:

1. Mr. Mauldin did not have a history of gastroin-
testinal problems prior to his thumb injury (al-

ee

though he had suffered a kidney stone attack six
weeks earlier);

Mr. Mauldin received treatment for his thumb in-
jury with Lincocin and Cleocin; and,

3. Subsequent to Mr. Mauldin’s use of the drugs, he
developed a series of symptoms which one of his
witnesses diagnosed at trial as pseudomembranous
colitis.

Concluding that Mauldin’s disease was caused by his use
of the drugs simply because one followed the other is a
classic illustration of the “‘post hoc ergo propter hoc’’ fal-
lacy, which has been aptly described as ‘‘an obscure but
melodious way of saying that there is no causal
connection.’’'?

to

The argument that a subsequent event is the result of a
prior event based solely on this temporal relationship has
consistently been rejected as fallacious by courts nationwide.

Most recently, the insufficiency of evidence of a temporal
relationship to support a finding of causation has been re-
iterated in cases arising out of the federal government's
Swine Flu Immunization Program. Pursuant to this program,
over 40 million people received flu vaccine shots. Because
many of those people coincidentally suffered medical prob-
lems of varying seriousness or at about the same time they
took the shots, a flood of litigation ensued in which medical
causation was the key issue. In such cases, the courts con-
sistently have held that the existence of a simple temporal
relationship is not sufficient to establish legal causation:

The critical question presented in these cases is the
causal relationship between the immunization and
claimed illness. However, mere temporal relationship

'"M & W Gear Company v. A. W. Dynamometer, Inc., 97 lll. App.3d
904 (1981).

=,

between the onset of a disease and the vaccination is
insufficient to establish legal causation. . . . All that
has been shown here is a temporal relation; and that
is insufficient to carry the burden of proof which rests
upon plaintiff.

In re Swine Flu Immunization Products, etc., 533

F.Supp. 567, 572, 581 (D.C. Colo. 1982), (em-

phasis added).

The relation of [plaintiff's injuries] with the admin-
istration of the swine flu vaccine, however, is a purely
temporal connection. There is nothing in the record
other than the mere time sequence to connect the vac-
cine with plaintiff's difficulties.

Lung v. United States, 535 F.Supp. 100, 103 (E.D.

N.Y. 1982).

The Swine Flu program vaccinated over forty million
people; coincidence of the shot and other unrelated
events is inevitable.

Kubs v. United States, 537 F.Supp. 560, 561 (E.D.

Wis. 1982).

In Gicas v. United States, 508 F.Supp. 217, 219-220
(E.D. Wis. 1981), the court even rejected two medical opin-
ions that the vaccine caused plaintiff's arthritis because each
‘was based on nothing more than a temporal relationship
between the date of the swine flu innoculation and the onset
of the plaintiff's injuries.”’

The consistent unwillingness of courts to accept temporal
relationships as sufficient proof of causation is well justified.
While an effect logically can never precede a cause, and
thus a temporal relationship is an indispensable ingredient
of causation, such a relationship, without more, does not
prove causation.'*

"See, United States v. Robison, 644 F.2d 1270, 1273 (9th Cir. 1981);
United States v. Linton, 655 F.2d 930, n.2 (9th Cir. 1981), Foster v.
United States, 214 F.Supp. 181, 183-84 (S.D. Miss. 1963), Genesee
Merchants Bank and Trust Co. v. Payne, 161 N.W.2d 17, 24 (S. Ct.
Mich. 1968); Tremaine v. H. K. Mulford Co., 176 A. 212, 215 (S.Ct.
Pa. 1935).

aon, oe

If temporal relationships are insufficient to support expert
opinions regarding imedical causation, a fortiori. they are
insufficient to justify such inferences by laymen.

b. Simply Because the Drugs Occasionally Can Cause Such Dis-
ease Is Insufficient to Establish That They Did in This Case.

There was also evidence from a leading national expert
on pseudomembranous colitis, Dr. Francis Tedesco, that:

It appears that the entity of Clindamycin-associated
colitis is simply another example of pseudomembran-
ous colitis associated with antibiotic therapy... .
Pseudomembranous colitis should now be considered
ina differential diagnosis of any patient who develops
elevated temperature, ileus, or diarrhea while taking
Clindamycin or after recently having completed a course
of Clindamycin.

(R.T. Vol. V, p. 44, emphasis added. )

Dr. Tedesco’s testimony does no more than support the
proposition — which we do not dispute — that Cleocin,
like all other antibiotics, may cause pseudomembranot
colitis on occasion. Just as the possibility that there might
be a causal connection between the alleged cause and sus-
pected effect was not sufficient to prove causation in Bear-
man, supra, the possibility of causal connection raised by
Dr. Tedesco’s testimony falls well short of establishing the
requisite probability in this case.

Significantly, neither Dr. Tedesco nor anyone else opined
that Cleocin or Lincocin even might have caused Mr. Maul-
din’s colitis. In any event, a possibility is not sufficient to
support a finding of causation.

c. The Warnings.

The last item of ‘‘circumstantial’’ evidence to which the
Circuit may have been alluding was a reference in the warn-
ings accompanying the drugs to the effect that cases of

severe and persistent diarrhea have been reported in asso-
ciation with the use of the drugs and, at times, have resulted
in acute colitis. See, Mauldin, supra at 697 F.2d at 646,
n.2.

Ironically, a major issue at trial was Mauldin’s claim that
those warnings about the possibility of colitis were inade-
quate to inform prescribing doctors that the drug might
cause Mauldin’s disease. Indeed, throughout the trial, Maul-
din presented expert testimony that the warnings did not
adequately inform doctors that the drugs may cause pseu-
domembranous colitis (see, R.T. Vol. II, p. 62).

In order to hold Upjohn liable for its failure adequately
to warn prescribing physicians of the possibility that the
drugs might cause pseudomembranous colitis, the jury itself
must have found the warnings inadequate to notify even
practicing physicians of the risk. If, as the jury necessarily
found, the Lincocin and Cleocin warnings were inadequate
to inform experts (prescribing physicians) of the risk of a
possible causal relationship between the drugs and pseu-
domembranous colitis, we submit it would be impossible
for a lay jury to infer a causal connection in Mauldin’s case
based upon such warnings.

d. Without Expert Testimony on Causation, the Jury’s Conclusion
That the Drugs Caused Mauldin’s Illness Was Mere Speculation.

It is hornbook law that, for evidence to be sufficient to
warrant a finding of fact by a jury, **. . . the circumstances
must lead to the conclusion with reasonable certainty, and
must have sufficient probative force to constitute the basis
for a legal inference and not for mere speculation.”’ 32A
C.J.S. § 1039 (emphasis added). As the foregoing discus-
sion makes clear, however, there was no evidence from
which a jury — as opposed to an expert — could reasonably
infer that the drugs in question caused Mauldin’s disease.

pon, ae

The Circuit’s causal observation that causation may be
proved by either direct or circumstantial evidence totally
misses the point. Both direct evidence (finding a bottle cap
in a child’s stomach and concluding that the sharp-edged
cap is the cause of bleeding lacerations in the child’s throat
and stomach) and indirect evidence (using blood tests, elec-
tro-cardiograms, work and medical histories, blood pressure
tests, and the like, to conclude that work-related stress has
caused a heart attack) are certainly indispensable to medical
experts in diagnosing, identifying the cause or causes of,
and treating diseases. Except in the most unusual circum-
Stances, however, laymen are not qualified to make such
diagnoses, to identify causal relationships, or to decide upon
proper courses of treatment. These things the experts must
do. This is especially so in cases involving rare and esoteric
diseases such as pseudomembranous colitis.

We submit that because the jury was not legally competent
to infer that Mauldin’s use of Lincocin or Cleocin medically
caused his disease, their conclusion that a causal connection
existed must have been based upon impermissible specu-
lation, conjecture, or surmise. As Learned Hand put it,
‘*[w]ithout the help of those skilled in science, the conclu-
sions of laymen upon such an issue were without adequate
basis, and necessarily mere speculation.’* Clapp, supra, 63
F.2d at 795.

D. THE FIFTH CIRCUIT’S MAULDIN OPINION RADICALLY
DEPARTS FROM LONG-ESTABLISHED PRECEDENT IN
THE CIRCUIT AS INTERPRETED BY THE SUPREME
COURT.

Bearman vy. Prudential Ins. Co. of America, supra, 186
F.2d 662 (10th Cir. 1951), already discussed at some length,
involved extensive medical testimony. As in the instant
case, however, none of the experts in Bearman testified that
they believed that an accident suffered by the decedent more

aie

probably than not caused the disease which undisputedly
killed him, even though the onset of his disease followed
closely on the heels of the accident.'* Hence, the plaintiff
lost.

More than a decade ago Bearman was cited with approval
by the Fifth Circuit in Webster v. Offshore Food Service,
Inc., 434 F.2d 1191 (Sth Cir. 1970), which expressly held
that a trier of fact may not substitute its own ‘‘practical
judgment”’ for that of the experts where **. . . the testimony
bears on technical questions of medical causation beyond
the competence of lay determination.’’ /d. at 1193.

Furthermore, the law of the Circuit has long been that
such expert testimony must be to the effect that the causal
connection is probable, as expressly stated in /nter-Car-
ibbean Shipping Corporation vy. Sentilles, 256 F.2d 156 (5th
Cir. 1958), where the Circuit cited Bearman for the follow-
ing proposition:

It appears to be well settled that medical testimony
as to the possibility of a causal relation between a given
accident or injury and the subsequent death or impaired
physical or mental condition of the person injured is
not sufficient, standing alone, to establish such rela-
tion. By testimony as to possibility is meant testimony
in which the witness asserts that the accident or injury
‘might have,’ ‘may have,’ or ‘could have’ caused, or
‘possibly did’ cause the subsequent physical condition
or death or that a given physical condition (or death)
‘might have,’ may have,’ or ‘could have’ resulted or
‘possibly did’ result from a previous accident or injury
— testimony, that is, which is confined to words in-
dicating the possibility or chance of the existence of
the causal relation in question and does not include

“Unlike the instant case, there was expert testimony in Bearman that
the injury might have caused the death. No such testimony was given
in this case.

— oan

words indicating the probability or likelihood of its
existence. * * * 135 A.L.R. 516.
Inter-Caribbean, supra, at 158.

While the Supreme Court reversed the Circuit’s holding
in Sentilles, it did so not because it found the Circuit's
Statement of the law deficient, but because, contrary to the
Circuit, it found sufficient expert medical testimony in the
record to establish probable medical causation. Sentilles v.
Inter-Caribbean Shipping Corp., 361 U.S. 107 (1959).

The dispositive issue in Sentilles was whether a shipboard
accident ‘‘activated or aggravated’’ the plaintiff's preexist-
ing but dormant tubercular condition. Much medical testi-
mony was given on the topic. Despite expert testimony that
“‘the fall probably aggravated’’ the tuberculosis, the Fifth
Circuit found that the most the testimony established was
that *‘the incident was a possible cause of the aggravation.’
Inter-Caribbean, supra, at 158."

The Supreme Court reversed, holding that the expert tes-
timony was indeed sufficient to establish a probable causal
connection between the plaintiff's accident and his disease:
One specialist testified that, based upon his examination of
x-rays taken before the injury, he ‘‘felt’’ that the plaintiff
was tubercular before the accident and that ‘* ‘acute dis-
semination of the tuberculosis’ might be a consequence of
the accident.’’ (361 U.S. 109). A second specialist opined
that the accident and the plaintiff's diabetes were ‘‘the most
likely causes of the aggravation of the tuberculosis’’, al-
though he was not able to state ‘‘which of the two it is more
likely was responsible in this instance.’’ (/d.) A third expert
said he ‘was of the opinion that the accident ‘probably
aggravated [plaintiff's] condition,’ though he would not say

‘In the instant case, no expert even speculated about a possible cause
of Mauldin’s disease.

—,

definitely. . . .°* (/d.)

In finding the above testimony sufficient, the Supreme
Court held, in essence, that, *‘the matter does not turn on
the use of a particular form of words by the physicians in
giving their testimony. . . ."’ (/d.) Clearly, so long as the
substance of the expert testimony is that causation probably
exists, that will be sufficient, even though the *‘magic words"’
of probability have not been used.

This Court's Sentilles opinion thus simply cannot be read
as abrogating the need for expert testimony to prove medical
causation (although it concededly has been miscited in sup-
port of that proposition on occasion'®), At most the opinion
stands for the proposition that an expert testifying about
medical causation need not use the magic words of *‘prob-
ability,’ so long as his testimony — taken as a whole —
is to the effect that the causal relationship is ‘‘probable.**

Nor does the opinion in Porter v. American Optical Corp..,
641 F.2d 1128 (Sth Cir. 1981), cited by the Fifth Circuit
in support of dispensing with the need for expert medical
testimony in Mauldin, stand for the proposition that expert
testimony is not needed where medical causation is the issue.
Porter expressly alludes to extensive expert testimony to
the effect that the injured party had a ‘‘strong case of as-
bestosis’* and that ‘asbestosis was a significant and major
condition leading to [Porter's] death.’* /d. at 1142.

The Circuit accepted as proven that breathing asbestos
Causes a concentration of asbestos particles in the lung; that
a sufficiently high concentration and buildup of asbestos in
the lung will cause death; and that this disease process —

Picou v. American Offshore Fleet, 576 F.2d 585, 588 (Sth Cir.
1978); Fitzgerald v. A.L. Burbank Co., 451 F.2d 670, 681 (2nd Cir.
1971); Petition of U.S. Steel Corporation, 436 F.2d 1256, 1265 (6th
Cir. 1970); Denney v. Siegel, 407 F.2d 433, 441-442 (3rd Cir. 1969).

= Ss

called asbestosis — can also be a precipitating cause of
other illnesses such as emphysema, bronchitis, and pneu-
monia. /d, at 1133. Whether inhalation of asbestos medi-
cally caused the plaintiff's disease was thus not in issue.

To the contrary, the question in Porter was whether a
respirator used by the decedent, Porter, and manufactured
by defendant American Optical was defective in that it un-
reasonably exposed Porter to the acknowledged medical
cause of his deadly disease — breathing asbestos — because
large quantities of asbestos particles could pass through its
filter.

Defendant American Optical challenged the sufficiency
of the testimony of an expert toxicologist, Dr. William
George, who testified regarding the results of an experiment
he had conducted to determine the percentage of asbestos
fibers which passed through the type of respirator which
plaintiff asserted was defective. Dr. George was not qual-
ified by the Court as an expert in respirator or filter design.
Id, at 1134. He was, however, a qualified toxicologist —
a specialist in the effects, detection, and treatment of poi-
sons. In Dr. George’s opinion, based upon tests he had
personally conducted, an estimated 18% to 20% of the as-
bestos particles in the ambient air surrounding a user of the
respirator passed through its filter. It would not require an
expert to conclude that most, if not all, of the asbestos
particles which passed through the filter would have been
breathed by a user of the device. Given the fact that the
ambient air where Porter worked was loaded with asbestos
particles, and the conceded fact that breathing asbestos is
the medical cause of asbestosis, the link between the defect
(the failure of the respirator to filter out the asbestos) and
Porter's disease (asbestosis) was complete based upon ex-
pert testimony.

es

Porter thus supports, rather than detracts from, the prop-
osition that expert testimony is necessary to support tech-
nical conclusions and that where such issues are involved,
an expert, and not the jury, must draw the necessary tech-
nical inferences from either direct or circumstantial evidence.

Where experts have testified but equivocated, courts have
still been reluctant to say causation was established. In Cur-
tis v. General Motors, 649 F.2d 808 (10th Cir. 1981), for
example, a medical expert said he could not ascertain *‘with
any degree of certainty’’ that a disc injury sustained by the
plaintiif was caused by the manufacturer-defendant’s al-
leged inadequate rollover protection. In Curtis, the Tenth
Circuit (citing Bearman) reversed the lower court's judg-
ment in favor of the plaintiff saying:

The jury could not express a lay opinion as to the cause
of the injury when the medical witness was unable to
express an expert opinion.

Id, at 813.

The court then went on to say:

Expert testimony is required in order for the jury to
avoid pure speculation, or a conclusion arising from
the plaintiff's position after the accident but with no
causal connection to the injury established by anyone's
testimony.

Id, at 813.

We submit that inability unwillingness, or a simple unex-
plained failure of an expert to express such an opinion con-
Stitutes just such a fatal absence of evidence.

Conclusion.

In summary, the indispensability of expert testimony in
proving medical causation in cases like this one has long
been recognized in the Fifth Circuit, as elsewhere. The
practical effect of the Circuit's offhand allusion to the

=

sufficiency of circumstantial evidence is to totally abrogate
that rule, and would foster litigation of highly technical
issues based on the popular appeal of an argument rather
than its scientific soundness.

This Court should not permit jury trials in the Fifth Circuit
to degenerate into no more than ‘the opportunity to present
evidence and argument in a forum unable to comprehend
them,”* or to predicate substantial liability on a jury's ‘‘un-
informed institutions.’ Indeed, such a result would be re-
pugnant to established constitutional concepts of due process.

We respectfully urge that this Petition for Certiorari be
granted as a step toward avoiding that unfortunate result.

Respectfully submitted,
McCuTCHEN, BLACK, VERLEGER
& SHEA,
ROBERT K. WREDE,
BETTE ANN BAKER,
Attorneys for Petitioner,
The Upjohn Company.

APPENDIX A.
Opinion.

O.L. Mauldin, Plaintiff-Appellee v. The Upjohn Com-
pany, Defendant-Appellant. No. 81-3209.

United States Court of Appeals, Fifth Circuit.

Feb. 7, 1983.

Plaintiff, a consumer of antibiotic drugs who suffered
serious adverse reactions to them, brought products liability
action against drug manufacturer. The United States District
Court for the Eastern District of Louisiana, Veronica D.
Wicker, J., entered judgment in favor of plaintiff, and man-
ufacturer appealed. The Court of Appeals, Politz, Circuit
Judge, held that: (1) evidence that either of the two antibiotic
drugs probably caused plaintiff's condition was sufficient
for jury; (2) evidence of inadequacy of manufacturer's warn-
ings of possible adverse effects from use of drugs was suf-
ficient for jury; (3) trial court did not err in admitting into
evidence certain *‘adverse reactions’* reports; (4) trial court
did not err in admitting into evidence photographs made by
pathologist displaying slides of colon tissue assertedly taken
from plaintiff; (5) jury instructions were proper; and (6)
plaintiff's statements of religious belief while testifying to
hardships imposed upon him in efforts to attend church
because of present condition were not unduly prejudicial.

Affirmed.

Henry B. Alsobrook, Jr., Robert D. Bjork, Jr., New
Orleans, La., for defendant-appellant.

Francipane, Regan & St. Pee, Philippi P. St. Pee, Me-
tairie, La., for plaintiff-appellee.

Appeal from the United States District Court for the East-
ern District of Louisiana.

Before GARZA, POLITZ and WILLIAMS, Circuit
Judges.

oalis aie

POLITZ, Circuit Judge:

In this product liability diversity case, the Upjohn Com-
pany, manufacturer of the antibiotics Lincocin and Cleocin'
appeals an adverse verdict in favor of plaintiff O.L. Maul-
din, contending that: (1) Mauldin failed to establish a causal
link between the drugs and his condition, (2) Mauldin failed
to establish the inadequacy of the manufacturer’s warnings,
(3) the trial judge ruled erroneously on evidentiary matters,
and (4) the judge erred in her jury charge. Finding no re-
versible error, we affirm.

Facts

Mauldin severely injured his hand in March 1974 while
working on a lake barge. He was treated by Dr. Herman
E. Walker, Jr., who prescribed Lincocin as a guard against
infection. When Dr. Walker released Mauldin from the hos-
pital, he prescribed Cleocin as a continuing prophylaxis
against infection. Mauldin was scheduled for a follow-up
examination in three weeks.

Shortly after leaving the hospital, Mauldin began to suffer
from a tenacious bout of diarrhea. He was treated by several
physicians, one of whom prescribed the drug Lomotil, but
his condition worsened and he was readmitted to the hos-
pital. Mauldin’s physical condition continued to deteriorate,
and he was ultimately subjected to multiple and extensive
surgical procedures made necessary by ulcerative colitis.
The period of hospitalization exceeded two months.

This tort action began in state court, was removed to
federal court and initially ended in a mistrial. On retrial the
jury returned a verdict for $570,000, grounding liability on
a finding that Upjohn had failed to warn adequately of the

‘Lincocin and Cleocin are Upjohn’s trade names for lincomycin and
clindamycin HC1. respectively

poet, ‘Nav

risk of pseudomembranous colitis posed by the two drugs.
The instant appeal follows the denial of the motion for
judgment n.o.v. or new trial.

Causation

Upjohn challenges causation on two grounds. It first con-
tends that Mauldin failed to offer any direct medical evi-
dence that either Lincocin or Cleocin probably caused his
colitis. In response we note that failure to produce direct
medical evidence is not fatal, for as we observed in Porter
v. American Optical Corp., 641 F.2d 1128, 1142 (5th
Cir. 1981), a products liability case involving Louisiana law,
‘The plaintiff's burden is to prove causation by a prepon-
derance of the evidence, which may be met by direct or
circumstantial evidence.’’ In a case of circumstantial evi-
dence, Upjohn maintains that Mauldin must exclude all
other reasonable hypotheses of causation if he is to prevail
based on such evidence. We disagree. Mauldin does not
bear that onerous burden; his ‘‘evidence need not negate all
other possible causes.’’ /d. (citing Weber v. Fidelity &
Casualty Ins. Co. of New York, 259 La. 599, 250 So.2d
754 (1971), and Jordan v. Travelers Ins. Co., 257 La. 995,
245 So.2d 151 (1971)). The record contains circumstantial
evidence that either Lincocin or Cleocin caused Mauldin’s
disorder sufficient to require submission of that question to
the jury.

Upjohn’s second challenge to causation relates to the
warnings. Essentially, Mauldin complained that the
warnings’ on the package inserts did not adequately inform

“The following information was recited under the heading ** Adverse
Reactions’ ”:
Gastrointestinal: Abdominal pain, nausea, vomiting and diarrhea
or loose stools may occur. Cases of severe diarrhea associated
with blood and mucus in the stools have been reported
Additionally. the following warning was stated in the package insert

(footnote continued on following page)

= a

his physician of possible adverse reactions to the two an-
tibiotics. Because of this failure, Mauldin contended that
Upjohn is liable for the damages caused by his adverse
reaction to the drugs.

In its defense to these contentions, Upjohn refers to the
testimony of Dr. Walker, the prescribing physician, which
indicates that he would have prescribed the medications,
despite stronger warnings, because of the danger of infection
and the reputation of the drugs. Upjohn argues that Dr.
Walker's testimony establishes that any failure on its part
to warn adequately of potential side effects of the medi-
cations was not causally related to the later tragic events.’
Upjohn maintains that Dr. Walker’s testimony severs the
causal chain.

This argument is appealing but not compelling for Dr.
Walker also testified that the regimen he would have fol-
lowed would have differed if he had been made aware of
the severity of the side effects and of the suggested treatment

and was published in the Physician's Desk Reference (PDR):
WARNINGS
The following reactions have been reported with the use of clin-
damycin [Cleocin].
CASES OF SEVERE AND PERSISTENT DIARRHEA HAVE
BEEN REPORTED AND HAVE AT TIMES NECESSI-
TATED DISCONTINUANCE OF THE DRUG. THIS DIAR-
RHEA HAS BEEN OCCASIONALLY ASSOCIATED WITH
BLOOD AND MUCUS IN THE STOOLS AND HAS AT
TIMES RESULTED IN ACUTE COLITIS.
‘We note the following colloquy between counsel for Upjohn and
Dr. Walker.
Q. And with regard to—Doctor, | am going to ask you this:
You said that you didn't know about pseudomembranous colitis
at the time, but even if you had known about it, knowing that the
Cleocin was the best drug on the market to give Mr. Mauldin,
you would have given it to him, anyway, wouldn't you”
A. | probably would have at the time because there was really
no adequate substitute to use.

Ae: aS

of the induced diarrhea.*

The manufacturer of a prescription drug is not obliged to
warn each consumer of the dangers inherent in the use of
its product if the prescribing physician receives adequate
warnings of the potential adverse effects. See Givens v.
Lederle, 556 F.2d 1341 (Sth Cir.1977); Reves v. Wyeth
Laboratories, 498 F.2d 1264 (Sth Cir.), cert. denied, 419
U.S. 1096, 95 S.Ct. 687, 42 L.Ed.2d 688 (1974). Upjohn

‘Dr. Walker testified on cross-examination:
Q. Dr. Walker, you said you might have given the drug Cleocin
anyway. But | am asking you if you would have given the drug
Cleocin anyway, you would have given the drug under the belief
that you knew what its side effects were, is that correct?
A. Yes sir.
Q. And if you knew that a side effect of a particular drug which
you may give to your patient could cause the onset of a certain
sign of symptoms of that disease, would you not yourself be more
alert for the onset of those signs, and at the same time advise
your patient to be more alert for the onset of those signs and
symptoms of this particular adverse reaction?
A. Yes, sir, usually so. If you could expect something to hap-
pen, but on the other hand, | may not have told him all of the
side effects.
You know, sometimes | do, sometimes | don’t.
Q. But if you are concerned about a particular side effect or if
you know about a particular side effect and your patient walks
back into your office a couple days later or a couple weeks later
and says, Doctor, | am in this conditoin, and he describes his
condition to you, and then you know that the condition he has
been describing is the onset of a particular side effect. You would
then know how to treat your patient to avoid a more debilitating,
progressively debilitating type of condition, is that correct?
A. Yes, Sir.
Q. Now—
A. Usually you do, if there is a treatment for it.
Q. That's part of the thing you want to do for your patient, it's
not only to fix his thumb, but it is also to make certain in fixing
his thumb he returns to good and full health rather than being
started on a chain of downward health?
A. Of course. You want to treat the whole patient, not just the
thumb
Q. You mentioned one of the things that you considered in the
package insert was the antidote, ts that correct, the treatment or-
A. Well, | was saying that sometimes they will list an antidote
for a drug. There ts no antidote listed tor Cleocin

a es

contends that its warning, see note 2, was sufficient to alert
Dr. Walker of the potentially dangerous side effects of Cleo-
cin and Lincocin. Although the contention has force, we
are not convinced that it must be accepted as a matter of
law. Rather, in the factual panorama presented by this case,
the contention poses a jury question.

In Timm v. Upjohn Co., 624 F.2d 536, 539 (Sth Cir. 1980),
cert. denied, 449 U.S. 1112, 101 S.Ct. 921, 66 L.Ed.2d
840 (1981), a case also involving Cleocin, we concluded
that in deciding whether the identical warning was suffi-
cient, ‘The jury was entitled to weigh the conflicting state-
ments made by [the prescribing doctor] and the other phy-
sicians along with ail the other evidence presented in the
case.’’ The instant case poses the same question. The jury
heard and was called upon to evaluate Dr. Walker's testi-
mony as to what he understood the warnings to be and how
he might have acted differently if he had been warned or
advised differently. In addition to the testimony that he
probably would have prescribed the drugs regardless of the
more detailed warning, there is further testimony about po-
tential monitoring and cautionary advice to Mauldin and the
impact of the failure to list any remedies or antidotes for
adverse reactions. The evidence presented dictates neither
an affirmative nor a negative answer to the inquiry whether
Dr. Walker would have acted differently if the warnings
had been different. Instead, the evidence presents the classic
question for the trier of fact—in this instance the jury.

Inadequate Warnings

To establish his challenge to the inadequacy of the warn-
ings for Lincocin and Cleocin in the package inserts and in
Physician's Desk Reference, Mauldin offered the testimony
of Dr. Walker as well as that of Dr. Gordon McHardy, an
internist specializing in gastroenterology. Dr. McHardy was

a,

of the opinion that the Upjohn warning did not notify the
practicing physician of the danger of pseudomembranous
colitis as a possible adverse reaction to the use of Cleocin
or Lincocin nor advise of any method of treatment for com-
plications arising from the use of the drugs. Although Up-
john considered Lomotil to be contraindicated in the treat-
ment of Cleocin diarrhea, its warning did not so advise. Dr.
McHardy spoke of the imperative that doctors be ‘‘ade-
quately advised as to the side effects of drugs’? which they
prescribe. Dr. Walker concurred.

Upjohn counters with the testimony of Dr. Francis
Tedesco, an expert in the drafting of warnings such as those
here involved. At trial, Dr. Tedesco attested to the adequacy
of the warnings. Upjohn insists that only an expert in the
preparation or construction of medical product warning
statements can testify properly as to the issue of adequacy.
We cannot accept this argument, for it belies the essential
purpose of the warning. Package inserts and PDR references
are not written for medical experts schooled and skilled in
the writing of warnings. They are written to inform fully
and adequately the medical practitioner who is called upon—
occasionally importuned—to prescribe the medication. The
understanding and perception of the Dr. Walkers and Dr
McHardys is entirely relevant, for the sufficiency of the
warning is dependent upon their reasonably anticipated com-
prehension. The record contains sufficient evidence to sup-
port the jury’s finding that the warnings were inadequate.

Evidentiary Rulings
Upjohn questions the admission into evidence of certain

‘adverse reactions’’ reports,° offered to establish Upjohn’s
awareness of the problems associated with use of the subject

‘The ‘adverse reaction’’ reports are completed by a physician or
hospital personnel and forwarded to the drug manufacturer, informing
the manufacturer that a patient has suffered from a reaction of side
effects which is not detailed on the package insert.

— ow

drugs. Since many of the reports detailed complications
other than pseudomembranous colitis, thereby going beyond
the issue in this case, Upjohn argues that the probative value
of the reports was outweighed by their prejudicial nature,
adversely affecting the jury.°

Our review of the record leads us to conclude that while
Mauldin’s counsel should not have been permitted to dwell
on the reports, the trial judge's limiting instruction’ pre-
vented the type of possible jury confusion criticized by the
Supreme Court in Bruton v. United States, 391 U.S. 123,
88 S.Ct. 1620, 20 L.Ed.2d 476 (1968).

Upjohn also attacks, on grounds of authentication, the
admission of photographs made by pathologist Francis M.
Patton displaying slides of colon tissue. Dr. Patton prepared
the slides from paraffin blocks furnished by another pa-
thologist. On cross-examination, Dr. Patton candidly con-
ceded that he could not attest ‘‘with absolute certainty’’ that
the paraffin blocks contained tissue taken from Mauldin.
Dr. Patton did testify, however, that the numbers on the
pathology reports identified as Mauldin’s were identical to
the numbers on the paraffin blocks identified as Mauldin’s,
and that he observed nothing to indicate a mix-up. Dr. Patton
expressed no doubt as to the match itself. The Federal Rules
of Evidence do not require absolute certainty in authenti-
cation, but rather ‘‘evidence sufficient to support a finding
that the matter in question is what its proponent claims.”’
Fed.R.Evid. 901(a). This measure is met; the photographs
were properly admitted.

"Upjohn also objected to the admission of the reports on hearsay
grounds. Hearsay is not implicated, however, since the reports were
not offered to prove the truth of their contents. See Fed.R.Evid. 801(c).

"The trial judge instructed the jury that these reports could be con-
sidered solely on the issue of notice; they were not to be considered for
the truth of their contents.

a on

Jury Instructions

Upjohn questions the trial judge's statement that ‘‘the
Upjohn Company failed to timely advise physicians as to
the proper method of treating adverse reactions to these
drugs’* and her reference to ‘‘ulcerative-like pseudomem-
branous colitis."’ We accept, arguendo, the substantive va-
lidity of the challenges to this statement and reference. Hav-
ing done so, we examine the entire jury charge. ‘‘In reviewing
the trial judge’s instructions to the jury, we consider the
charge as a whole to determine whether the jury was misled
and whether it understood the issues presented.”’ Timm vy,
Upjohn Co., 624 F.2d at 539 (citing Coughlin v. Capitol
Cement Co., 571 F.2d 290 (Sth Cir. 1978), and Borel v.
Fibreboard Paper Products Corp., 493 F.2d 1076 (Sth
Cir.1973)). Assessed in the light of this rubric, the judge’s
instructions pass muster, since the charge as a whole makes
clear that it was the jury’s province to determine the facts,
including the adequacy of Upjohn’s notice procedures.

Upjohn’s final assignment of error requires little discus-
sion. Upjohn contends that Mauldin’s testimony, by touch-
ing on his practice of attending church and his belief in
‘almighty God,”’ violated Fed.R.Evid. 610 and was unduly
prejudicial. This argument is without merit. The record re-
veals that Mauldin was not attempting to bolster his cred-
ibility through his statements of religious belief but simply
was testifying to the hardships imposed upon him, in his
efforts to attend church, because of his present condition,

AFFIRMED.

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385011_0072%3A1. Public record. Not legal advice.