Petition — Upjohn Co. v. Mauldin

Supreme Court brief1983

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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

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. |

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

Page

Longfellow v. Vernon, 57 Ind. App. 611, 105 N.E. 178

SO at tireka. - scnrnecrniecalianskatermaceredianae Netntae

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,

Vil

Smith v. Phillips, 455 U.S. 209 (1982) .................

Spivey v. Atteberry, 205 Okla. 483, 238 P.2d 814 (1951)

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

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.

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

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.

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

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

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-

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.’’'?

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.

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

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.

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.