Petition for Writ of Certiorari — Mazur v. Merck & Co.

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Supreme Covet, tS.

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92-459

NO. 92-

OEF Yo 3992

Oe ee wee

OFFICE OF inf Gocan

aR l

IN THE

SUPREME COURT OF THE UNITED STATES

OCTOBER TERM, 1992

ANTHONY MAZUR AND EDNA MAZUR AS

PARENTS AND GUARDIANS OF LISA MARIE MAZUR,

A MINOR, AND ANTHONY MAZUR AND EDNA MAZUR,

IN THEIR OWN RIGHT,

Petitioners,

MERCK & CO., INC.,

Respondent.

PETITION FOR A WRIT OF CERTIORARI TO

THE UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

RICHARD A. SPRAGUE

THOMAS A. SPRAGUE

DAVID R. DEARDEN*

PAUL CROWLEY

SPRAGUE & SPRAGUE

The Wellington Building, Suite 400

135 South Nineteenth Street

Philadelphia, PA 19103

(215) 561-7681

Attomeys for Petitioners

*Counsel of Record

QUESTIONS PRESENTED

Whether the court of appeals improperly encroached upon

the province of the Pennsylvania state appellate courts by

deciding for itself an important and novel aspect of Pennsylvania's

law of products liability when a Pennsylvania appellate court,

Sitting en banc, is -— even as this Court considers the instant

petition —— deciding that same issue of state law?

Whether the court of appeals clearly misinterpreted

Pennsylvania's law of products liability by merging negligence

concepts with strict liability principles and by permitting a

pharmaceutical manufacturer to delegate its duty to warn the

parents of school children of the risks of an unavoidably unsafe

vaccine?

Whether a misinterpretation of Pennsylvania's products

liability law by the court of appeals, functionally precluding

school children and their parents from obtaining effective redress

for catastrophic injuries suffered as a result of participating in a

mass immunization program involving an unavoidably unsafe

vaccine, warrants the exercise of this Court's certiorari

jurisdiction?

TABLE OF CONTENTS

PAGE

QUESTIONS PRESENTER ...i..se0s55 «eee ea es i

TABLE OF CONTENTS ... 145540856 ee eee ae il

TABLE OF AUTHORITIES «... sss 55 ¥en eee se Vv

OPINIONS BELOW . ... 05.62 405 0 eee a 2

STATEMENT OF JURISORCTION®® 4004505 ee 2

STATEMENT OF THE CAS ..... 0a eee eee 3

REASONS FOR GRANTING THE WRIT ............. 6

i. The Court Of Apeals Improperly

Encroached Upon The Province Of

The Pennsylvania State Appellate

Courts By Deciding For Itself An

Important And Novel Aspect Of

Pennsylvania's Law Of Products

Liability When A _ Pennsylvania

Appellate Court, Sitting En Banc, Is

-- Even As This Court Considers

The Instant Petition -— Deciding

That Same Issue Of State Law ........... 6

alien

TABLE OF CONTENTS (continued)

PAGE

IT. The Court Of Appeals Clearly

Misinterpreted Pennsylvania's Law

Of Products Liability By Merging

Negligence Concepts With Strict

Liability Principles And By

Permitting A Pharmaceutical

Manufacturer To Delegate Its Duty

- To Warn The Parents Of School

Children Of The Risks Of An

Unavoidabiy Unsafe Vaccine .......... 10

II. The Misinterpretation Of Pennsyi-

vania's Products Liability Law By

The Court Of Appeals, Functionally

Precluding School Children And

Their Parents From Obtaining

Effective Redress For Catastrophic

Injuries Suffered As A Result Of

Participating In A Mass

Immunization Program Involving

An Unavoidably Unsafe Vaccine,

Warrants The Exercise Of This

Court's Certiorari Jurisdiction ........... 17

es Sins Sp aka dese wanes ek aeuas 19

-ili-

TABLE OF CONTENTS (continued)

PAGE

APPENDIX

COURT OF APPEALS OPINION ............ Al

DISTRICT COURT OPINION (1991) ......... A83

DISTRICT COURT OPINION (1990) ........ A154

-iv- *

TABLE OF AUTHORITIES

Cases: Page

Azzarello v. Black Bros. Co.,

391 A.2d 1020 (Pa. 1978) ............ Oe 13

Baldino v. Castagna

Cre ie Wr OG TOO 6 66 Kara eee 12,15

Berkebile v. Brantly Helicopter Corp.,

oat Pua Gre ek Ieee 6k a eee eee 12,16

Carrecter v. Colson Equip. Co.,

499 A268 320 (@%. Bapet. Cr. 19GS) ks ese 13

Clay v. Sun Ins. Office Lid.,

wae UG Bee COU 6-0 8 x ewan eee 7

Dambacher by Dambacher v. Malis,

465 A.26 406 (Pa. Super. Cr. 1964). 2. ow cece 13

East River S.S. Corp. v. Transamerica

Delaval, Inc..,

SPO VS. Se CIP cs bs ci ios tug eee 18,19

Erie R. Co. v. Tompkins,

mee WS. OO Clee kn bee ha eee 6,7,8

Fidelity Union Trust Co. v. Field,

Stl US. 1G GSD «nada s mee eee 7

TABLE OF AUTHORITIES (continued)

Cases: Page

Guaranty Trust Co. of N.Y. v. New York,

aoe Ud. DOCG kh k-0 ane 5 ene eee eee 7

Hahn v. Richter,

No. 00019 PHL 1991, 1992 Pa. Super. LEXIS

ate (Fa. Super. Ce. Fed. 15, 1F0E) . we vce canes 8,9,10

Harford Mut. Ins. Co. v. Moorhead,

578 A.2d 492 (Pa. Super. CL. 1990) we ees 13

Holloway v. J.B. Systems, Lid.,

Gu F.06 1060 C6 Ga. UR0Se ok is 6 on ee ee eee 13

Huddleston v. Dwyer, :

Shee . Soe CASO) 5 on kk ce ee eee eee 10

Incollingo v. Ewing,

sae Aas Dee (6. IST oe. cs eee 12,15

Kuisis v. Baldwin—-Lima—Hamilton Corp.,

319 A268 Di4 (Pe. IBTA) occ. sc cee eee 12

Lousiana Power & Light Co. v.

City of Thibodaux,

360 U.S. 25 CI a eee eee 7

Mazur v. Merck & Co.,

9664 F.26 1368 (3d Ce. 1902) oe 2,4,16

-Vi-

TABLE OF AUTHORITIES (continued)

Cases:

Mazur v. Merck & Co.,

P42 F.Sepp. Z5P (E.D.Pe. 1998) . ww eens

Mazur v. Merck & Co.,

FOr Fe. Gor Cae. TFFT) ow we ee

Petty v. United States,

740 F.2d 1428 (8th Cir. 1984) .............05.

Railroad Comm'n of Texas v. Pullman Co.,

Wie Ores a ee as

Salvador v. Atlantic Steel Boiler Co.,

21S AME TE Os I oo eee.

Staymates v. ITT Holub Indus.,

527 A.2d 140 (Pa. Super. Ct. 1987) ............

Vandenbark v. Owens II]. Glass Co.,

te ne

Walton v. Avco Corp.,

1992 WL 2795 (Pa. May 22, 1992) ............

-Vvii-

Page

+. a

a ae

TABLE OF AUTHORITIES (continued)

Statutes: Page

ee ee © ROE CO 2 eee Law eee 2

y gis Ee 2) a rrr re 6

Be eB EI 5 oi ioe oe 6 a he eh RS 17

mS WOE, Fee bi ve swe ciara eae 18

42 Pa.Cons.Stat.Ann. § 8334 (a) (1978) .............. 18

State Constitutions:

es Se ee as oe ek eee ee 8

Rules:

I Se oy ig ae wk on a ee ee 2

Pennsylvania Rule of Appellate

ME heart ily in a yh ck ea ee eee 9

Other Authorities:

RESTATEMENT (SECOND) OF TORTS

RESTATEMENT (SECOND) OF TORTS § 388 ............ 14

-Vili-

NO. 92-

IN THE

SUPREME COURT OF THE UNITED STATES

OCTOBER TERM, 1992

ANTHONY MAZUR AND EDNA MAZUR

AS PARENTS AND GUARDIANS OF

LISA MARIE MAZUR, A MINOR,

AND ANTHONY MAZUR AND EDNA MAZUR,

IN THEIR OWN RIGHT,

PETITIONERS,

MERCK & CO., INC.,

RESPONDENT.

PETITION FOR A WRIT OF CERTIORARI TO

THE UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

The petitioners, Anthony Mazur and Edna Mazur as

parents and guardians of Lisa Marie Mazur, a minor, and Anthony

Mazur and Edna Mazur, in their own right, respectfully pray that

a Writ of Certiorari issue to review the Judgment and Opinion of

the United States Court of Appeals for the Third Circuit entered

on May 20, 1992.

OPINIONS BELOW

The opinion of the Court of Appeals for the Third Circuit

is reported at 964 F.2d 1348 (3d Cir. 1992), and is reprinted in

the appendix hereto at Al-82.'

The opinion of the United States District Court for the

Eastern District of Pennsylvania granting summary judgment on

June 27, 1991 is reported at 767 F. Supp. 697 (E.D. Pa. 1991) and

is reprinted in the appendix hereto at A83-153. The opinion of

the United States District Court for the Eastern District of

Pennsylvania denying summary judgment on June 29, 1990 is

reported at 742 F. Supp. 239 (E.D. Pa. 1990), and is reprinted in

the appendix hereto at A154-254.

STATEMENT OF JURISDICTION

The jurisdiction of this Court to review the judgment of

the Court of Appeals for the Third Circuit entered on May 20,

1992 is invoked pursuant to 28 U.S.C. § 1254(1) (1988). A

Petition For Rehearing was denied by the court of appeals on June

18, 1992.

‘Citations to the Appendix, filed in conformity with Supreme Court

Rule 14.1(k), shall be designated herein as ("A__").

STATEMENT OF THE CASE

Procedural History

Petitioners (hereinafter "the Mazurs") filed a civil action

in the Court of Common Pleas of Philadelphia County, Philadel-

phia, Pennsylvania on October 18, 1985 (October Term, 1985,

No. 2515). Based on the parties’ diversity of citizenship, Respon-

dent (hereinafter "Merck") removed the claim upon petition to the

United States District Court for the Eastern District of Pennsylva-

nia on November 1, 1985. On May 8, 1989, Merck filed a

motion for summary judgment and to exclude expert testimony.

On June 29, 1990, the district court issued an order and

opinion denying the motion for summary judgment as to the

federal preemption and statute of limitations issues, and reserving

judgment on the motion to exclude expert testimony and the

motion for partial summary judgment on the Mazurs' failure to

warn claims. Mazur v. Merck & Co., 742 F. Supp. 239, 266

(E.D. Pa. 1990) (A253-54). The order also extended to the

parties sixty (60) additional days to engage in further limited

discovery and the right to supplement their respective filings. /d.

Merck filed a supplemental motion for summary judgment and to

exclude expert testimony on September 17, 1990.

On June 27, 1991, the district court issued an order and

opinion granting Merck's motion for summary judgment limited

to the issue of whether Merck breached its duty to warn the

Mazurs of the risks and benefits of Merck's measles-mumps-

rubella vaccine (hereinafter "M-M-R II"). Mazur v. Merck &

Co., 767 F. Supp. 697, 715 (E.D.Pa. 1991) (A153). The district

court held that under Pennsylvania law a school nurse can be and

in this case was a "learned-intermediary” and that Merck made

an adequate warning available to the school nurse, thereby

discharging Merck's duty to warn the Mazurs of the possibile

adverse reactions to M—M-R II. /d@ at 715 (A153). The Mazurs

timely filed an appeal to the United States Court of Appeals for

the Third Circuit.

On May 20, 1992, the court of appeals, in an opinion

authored by the Honorable Anthony J. Scirica, held that under

Pennsylvania law the school nurse present at the immunization

site was not a learned intermediary in law or in fact and, there-

fore, warnings regarding M-M-R II were required to be given

directly to the Mazurs. Mazur v. Merck & Co., 964 F.2d 1348,

1355-61 (3d Cir. 1992) (A35-47). It was further held, however,

that because M—M-R II was an unavoidably unsafe pharmaceuti-

cal product, Merck's duty to warn of the vaccine's inherent

dangers could be delegated to a third party and Merck's responsi-

bility for the failure of the third party to warn the Mazurs of M-

M-R II's nsks would be analyzed pursuant to the negligence

standard set forth in section 388 of the RESTATEMENT (SECOND)

OF TORTS, rather than pursuant to the strict liability standard of

section 402A of the RESTATEMENT (SECOND) OF TORTS. 964

F.2d at 1364-69 (A69-82).

Applying section 388's negligence standard of reasonable

care to the facts of the instant case, the court of appeals held that

Merck acted reasonably and satisfied its duty to warn in the mass

immunization context as a matter of law by contracting with the

Centers for Disease Control (hereinafter "CDC") to provide proper

warnings to the ultimate recipients (or their parents) of the risks

of M-M-R II. Accordingly, the court of appeals dismissed the

Mazurs' claims and affirmed the district court's order granting

summary judgment for Merck. Based on the velief that the Court

of Appeals for the Third Circuit has misconstrued Pennsylvania's

strict liability law and the fact that one of the cases upon which

the panei relied was scheduled for reargument before the Superior

Court of Pennsylvania en banc, the Mazurs requested reargument

before the court of appeals en banc. On June 18, 1992, the Third

Circuit denied the Mazurs' petition for reargument.

Facts Relevant To The Issues Presented

On February 26, 1982, Plaintiff Lisa Mazur (hereinafter

"Lisa"), a twelve year old sixth grader in the Philadelphia public

school system, was inoculated with M-M-R II (a vaccine to

prevent measies, mumps and rubella) in a mass immunization

_ program conducted by the Philadelphia School District and the

Philadelphia Health Department. The M—-M-R II vaccine used in

the immunization program was manufactured by Merck and was

purchased by the Philadelphia Health Department from the CDC.

Although a school nurse was present at the time that the

M-M-R II vaccine was administered by a member of the

Philadelphia Health Department, there was no physician in

attendance to act as a “learned intermediary” to assess Lisa

medically, to balance the risks and benefits of the vaccine in light

of her medical condition and needs, and to obtain her “informed

consent” to receive the vaccine. Importantly, at the time of Lisa's

inoculation, her immunological condition was compromised due

to a lengthy illness for which she was treated with a corticoste-

roid, a known contra-indicator for administration of the M-M-R

II vaccine.

Although Merck obligated the CDC by contract to provide

proper warnings to the ultimate vaccine recipients (or to the

parents thereof), Lisa and her parents did not receive any

information regarding the health nsks and benefits associated with

M-M-R II. Seventeen months after receiving the inoculation,

Lisa was diagnosed as suffering from subacute sclerosing

panencephalitis (hereinafter SSPE), a slowly progressing, ulti—

mately fatal, neurological illness whose only scientifically

recognized causes are natural measles virus and measles vaccine.

Today, Lisa requires round-the-clock custodial care. The severe

and irreversible nature of Lisa's illness has emotionally and

financially devastated the Mazur family.

REASONS FOR GRANTING OF THE WRIT OF

CERTIORARI

THE COURT OF APPEALS IMPROPERLY

ENCROACHED UPON THE PROVINCE OF THE

PENNSYLVANIA STATE APPELLATE COURTS BY

DECIDING FOR ITSELF AN IMPORTANT AND NOVEL

ASPECT OF PENNSYLVANIA'S LAW OF PRODUCTS

LIABILITY WHEN A PENNSYLVANIA APPELLATE

COURT, SITTING EN BANC, IS -- EVEN AS THIS

COURT CONSIDERS THE INSTANT PETITION --

DECIDING THAT SAME ISSUE OF STATE LAW

Federal courts in diversity cases must forecast and apply

state law in all cases within their jurisdiction in which federal law

does not govern. Erie R. Co. v. Tompkins, 304 U.S. 64 (1938).

See also Rules of Decision Act, 28 U.S.C. § 1651 (1949). The

federal courts must not substitute their judgment for the law of

the state, to the extent that the law of the state can be determined.

Fidelity Union Trust Co. v. Field, 311 U.S. 169, 178 (1940).

Moreover, the federal courts must exercise care to ensure that

they do not encourage or allow for the development of a "double

system of conflicting laws” in the same state that might deprive

a litigant of the law as established by the forum state simply

because the matter was removed to the federal court system by an

Opponent. Guaranty Trust Co. of N.Y. v. New York, 326 U.S. 99,

112 (1945).

As a corollary to the Erie doctrine, federal jurisprudence

also recognizes "a doctrine of abstention... whereby the federal

courts... restrain their authority because of a ‘scrupulous regard for

the rightful independence of the state governments...."". Railroad

Comm'n of Texas v. Pullman Co., 312 U.S. 496, 501 (1941)

(emphasis added). Thus, in Pudlman this Court abstained from

deciding a question of federal constitutional law and remanded the

case to the district court with instructions to the parties to litigate

certain state law questions in state court. /d. at 501-02. Ina

similar vein, this Court has stayed federal proceedings in diversity

cases in order to minimize federal intrusion in the development of

state law. Louisiana Power & Light Co. v. City of Thibodaux,

360 U.S. 25, 31 (1959) (proceedings stayed pending prompt steps

to secure declaratory judgment), Clay v. Sun Ins. Office Lid., 363

U.S. 207, 212 (1960) (unresoived state law question was appro-

priately certified by federal court to state court for determi-

nation). Thus, federal courts have a long standing obligation,

based upon the Erie doctrine and principles of abstention, to use

restraint when attempting to forecast state law.

In the instant case, the Court of Appeals for the Third

Circuit had no clear precedent to base its decision that Pennsylva—

nia does not recognize a distinction between defective products

and negligent conduct in strict liability failure to warn cases. The

only case in Pennsylvania that has squarely addressed the strict

liability of a pharmaceutical manufacturer in a failure to warn

case involving an unavoidably unsafe product is Hahn v. Richter,

No. 00019 PHL 1991, 1992 Pa. Super. LEXIS 275 (Pa. Super.

Ct., Feb. 13, 1992). In a two-to—one decision, the Superior Court

panel in Hahn found that in a failure to warn prescription drug

case, the jury instructions under strict liability and negligence

concepts were not different because "(t]he standard to be applied

in determining whether an adequate and proper warning was

provided is the negligence standard of reasonable care." Jd. at 4-

5. However, in a strong and persuasive dissenting opinion, Judge

Del Sole exhaustively reviewed the Pennsylvania cases relating to

*Notably, Pennsylvania has not adopted a certification statute.

Although twenty-six states, through state constitutional provisions or by

Statute, permit federal courts to certify questions concerning state law

to state courts, none of the states constituting the Third Circuit permits

certification of state law questions by the court of appeals. (The

Delaware State Constitution does permit the United States District Court

for the District of Delaware to certify state law questions. Del. Const.

art. IV, § 11 (9)). Because there is no procedure for certifying state law

questions in Pennsylvania, the Third Circuit must be particularly

mindful of the need to exercise restraint whea exploring unsettled waters

of Pennsylvania state law.

duty to warn in section 402A cases and concluded that there is a

total lack of support in case law "for merging all failure to warn

claims under one negligence standard...." /d. at 12. (Del Sole, J.,

dissenting).

On April 23, 1992, the Pennsylvania Superior Court

granted reargument en banc in Hahn thereby signaling that the

Court has a material question affecting the validity of the Superior

Court panel's holding. Cf. Pa.R.App.P. 2543 (Considerations

Governing Allowance of Reargument). The Court of Appeals for

the Third Circuit abused its discretion in failing to exercise due

and proper restraint in light of the en banc reargument granted in

Hahn. Under this circumstance, the court of appeals should have

awaited the ruling by the Pennsylvania appellate court which will

determine how Pennsylvania law should be applied to the facts in

this case.’

The instant matter merits review by this Court not only

because it is clear that the Third Circuit court incorrectly deter-

mined the law of Pennsylvania, see, infra, pp. 10-17, but because

there is a great likelihood that the Superior Court of Pennsylvania,

en banc, will hold that negligence principles are inapplicable to

a strict liability failure to warn claim involving prescription drugs.

In the event of such a ruling while the instant petition is pending,

*If the court of appeals was unaware that the Superior Court of

Pennsylvania granted reargument en banc in Hahn on April 23, 1992

when it issued its opinion on May 20, 1992, it was certainly made

aware of Hahn's procedural history by the Mazurs' application for

reargument. Reargument in Hahn was held before the Superior Court

of Pennsylvania on September 9, 1992.

this Court should reverse the decision of the Third Circuit court.

Vandenbark v. Owens Illinois Glass Co., 311 U.S. 358, 543

(1941) ("Intervening and conflicting decisions will... cause the

reversal of judgments which were correct when entered.”).

Alternatively, this Court may decide to vacate the judgment below

and remand the case to the Third Circuit to reconsider its ruling

in light of the decision in Hahn. See Huddleston v. Dwyer, 322

U.S. 232, 238 (1944) (Doubts about the correctness of a federal

court interpretation of 2 state law raised by an intervening state

court decision will allow the Supreme Court to vacate the

judgment below and remand the case to the court of appeals for

reconsideration).

II.

THE COURT OF APPEALS CLEARLY

MISINTERPRETED PENNSYLVANIA'S LAW OF

PRODUCTS LIABILITY BY MERGING NEGLIGENCE

CONCEPTS WITH STRICT LIABILITY PRINCIPLES

AND BY PERMITTING A PHARMACEUTICAL

MANUFACTURER TO DELEGATE ITS DUTY TO

WARN THE PARENTS OF SCHOOL CHILDREN OF

THE RISKS OF AN UNAVOIDABLY UNSAFE VACCINE

The strict liability standard for vendors began at common

law with the imposition of a high degree of responsibility upon

the victualers, vintners, brewers, butchers, cooks, and other

persons who supplied food and drink to the public. Today, that

high degree of responsibility has evolved to cover all products

which, if defective, may be expected to cause physical harm to

the consumer. See RESTATEMENT (SECOND) OF TORTS § 402A

comment b (1985). However, because of the complexities of the

human body and limitations of medical science, certain medical

products cannot be made safe for all consumers regardless of the

care exercised in their design and manufacture. The archetypical

product that is incapable of being made safe is the vaccine. In

effect, vaccines are unsafe products whose production is justified

because of the great overall public health benefit resulting from

their use. Comment k to the RESTATEMENT (SECOND) OF TORTS

§ 402A thus instructs:

The seller of such [vaccine] prod-

ucts, again with the qualification

that they are properly prepared and

marketed, and proper warning is

given, where the situation calls for

it, is not to be held to strict liability

for unfortunate consequences at-

tending their use, merely because he

has undertaken to supply the public

with an apparently useful and de-

sirable product, attended with a

known but apparently reasonable

risk.

(Emphasis added).

This case, for which review by this Court is sought,

involves a young girl's severe and permanent brain injury which

was caused by inoculation with the measles component of a

vaccine manufactured by Merck. In reversing the district court,

the court of appeals ruled that the mass immunization exception

to the learned intermediary doctrine applied, requiring Merck to

war Lisa Mazur's parents directly of the risks and benefits of

inoculation with M—M-R II in order to escape liability for the

» tragic consequences of an adverse drug reaction. Mazur v. Merck

& Co., 964 F.2d 1348, 1364 (3d Cir. 1992) (A61). However, the

court of appeals further determined that under Pennsylvania law,

the court should treat all section 402A strict liability failure to

warn claims, where vaccines or prescription drugs cause injury or

death, as negligence claims. Jd. at 1355, (A23-25). In other

words, the court of appeals decided that as a matter of Pennsylva—

nia state law, the discharge of a pharmaceutical manufacturer's

duty to warn the parents of school children of the serious health

risks posed by a vaccine is to be judged by negligence —— and not

strict liability -— standards.

In support of its prediction of how the Pennsylvania courts

would interpret Pennsylvania law concerning the elements of a

strict liability failure to warn claim, the court of appeals cited two

negligence cases wherein strict liability was not in issue. /d. at

1354 (A20-23) (citing Jncollingo v. Ewing, 282 A.2d 206 (Pa.

1971) and Baldino v. Castagna, 478 A.2d 807 (Pa. 1984)). In so

doing, the court of appeals ignored the clear weight of authority

demonstrating that Pennsylvania adheres to a formal product/

conduct distinction in evaluating failure to warn claims founded

upon strict liability.

Courts in Pennsylvania have long recognized the theoreti—

cal dam between notions of negligence and strict "no fault"

liability. Walton v. Avco Corp., 1992 WL 2795, 8 (Pa. May 22,

1992). ("This Court has continually fortified the theoretical dam

between the notions of negligence and strict 'no fault' liability.");

Berkebile v. Brantly Helicopter Corp., 337 A.2d 893, 899 (Pa.

1975) ("The crucial difference between strict liability and

negligence is that the existence of due care...is irrelevant.");

Kuisis v. Baldwin -Lima- Hamilton Corp., 319 A.2d 914, 918 (Pa.

1974) ("The principle of strict liability...climinate{s] the issue of

negligence from the case."); Salvador v. Atlantic Steel Boiler Co.,

319 A.2d 903, 906-907 (Pa. 1974) ("[402A] imposes liability on

the seller or manufacturer of a defective product regardless of the

lack of proven negligence.”); Harford Mut. Ins. Co. v. Moorhead,

578 A.2d 492, 501 (Pa. Super. Ct. 1990) ("Pennsylvania courts

consistently analyze the negligence/failure to warn and strict

liability/failure to warn causes of action separately, treating

conduct-related counts apart from product-related counts.")

(citations omitted); Carrecter v. Colson Equip. Co., 499 A.2d 326,

330 n.8 (Pa. Super. Ct. 1985) ("[W]e prefer the terminology

‘inadequate warnings’ to ‘failure to warn' [in a strict liability case]

because the latter language suggests a breach of duty in a way

which tends to connote negligence."); Dambacher by Dambacher

v. Mallis, 485 A.2d 408, 428 (Pa. Super. Ct. 1984). ("[Wle

hold...that in a strict liability case, principles of negligence have

no place."). In fact, it has been observed that the "Pennsylvania

Supreme Court, perhaps more than any other state appellate court

in the nation, has been emphatic in divorcing negligence concepts

from products liability doctrine." Harford Mut., 578 A.2d at 500

(quoting Staymates v. ITT Holub Indus., 527 A.2d 140, 144 (Pa.

Super. Ct. 1987)).

The Third Circuit itself has previously recognized Penn-

sylvania's distinction between negligence and strict liability

concepts. See, e.g., Holloway v. J.B. Sys., Ltd., 609 F.2d 1069,

1073 (3d Cir. 1979) ("[W]e emphasize that negligence concepts

such as... ‘reasonable care’ have no place in suits brought under §

402A.... We read Azzarello [v. Black Bros. Co., 391 A.2d 1020

(1978}] as a signal that evidence and jury instructions regarding

negligence concepts should be kept out of cases brought under §

402A.") (footnote omitted).

By holding that the negligence standard of section 388 of

the RESTATEMENT (SECOND) OF TORTS’ is applicable to a

pharmaceutical manufacturer's duty to warn concerning unavoid-

ably unsafe products -— regardless of whether a lawsuit is

premised upon a theory of negligence or upon a theory of strict

“Section 388 of the RESTATEMENT (SECOND) OF TORTS states:

One who supplies directly or through a third person a chattel

for another to use is subject to liability to those whom the

supplier should expect to use the chattel with the consent of the

other or to be endangered by its probable use, for physical harm

caused by the use of the chattel in the manner for which and by

a person for whose use it is supplied, if the supplier

(a) knows or has reason to know that the chattel is or

is likely to be dangerous for the use for which it is supplied,

and

(b) has no reason to believe that those for whose use

the chattel is supplied will realize its dangerous condition, and

its dangerous condition or of the facts which make it likely to

be dangerous.

(Emphasis added).

liability under § 402A° -- the Third Circuit badly misinterpreted

and misapplied the decisions of the Supreme Court of Pennsylva—

nia in /ncollingo v. Ewing and Baldino v. Castagna (both of

which involved negligence claims only),° and departed from the

*Section 402A of the RESTATEMENT (SECOND) OF TORTS provides:

(1) One who sells any product in a defective condition

unreasonably dangerous to the user or consumer or to his

property is subject to liability for physical harm thereby caused

to the ultimate user or consumer, or to his property, if

(a) the seller is engaged in the business of selling such

a product, and

3 (b) it is expected to and does reach the user or

consumer without substantial change in the condition in which

it is sold.

(2) The rule stated in Subsection (1) applies although

(a) the seller has exercised all possible care in the

preparation and sale of his product, and

(b) the user or consumer has not bought the product

from or entered into any contractual relation with the seller.

"Neither /ncollingo nor Baldino are apposite to this case. Both of

those cases involved claims where adequate warnings reached a learned

intermediary, but the warnings were counteracted by the conduct of the

pharmaceutical company in minimizing the risks of the product in

subsequent sales and promotion campaigns. Thus, 402A strict liability

for failure to warn was not in issue in either case; the sole question was

whether the conduct of the pharmaceutical companies’ agents in

minimizing the risks of the product was negligent. Accordingly, neither

(continued...)

long-standing principle of Pennsylvania state products liability

law that negligence has no place in strict liability cases.

No Pennsylvania court has ever found that a manufac-

turer's duty to warn of a product's risks and benefits is delegable

to a third party under a strict liability analysis, regardless of how

reliable that third party appears to be. On the contrary, a plurality

of the Supreme Court of Pennsylvania has expressly determined

that “(t]he duty to provide a non-defective product is non-

delegable." Berkebile v. Brantly Helicopter Corp., 337 A.2d 893,

903 (Pa. 1975). Accord Petty v. United States, 740 F.2d 1428

(8th Cir. 1984) (in mass-immunization context duty to warm

uitimate recipient of risks and benefits of vaccine is absolute and

non—delegable.) The Third Circuit summarily dismissed the

holding in Berkebile by finding it inapplicable in prescription drug

cases. Mazur, 964 F.2d at 1365, A63-64. In other words, the

Third Circuit interpreted Pennsylvania law as foreciosing action

for. strict liability when prescription drugs are the product at issue.

However, no Pennsylvania court has ever immunized prescription

drug products from the application of 402A strict liability

principles.

For all of the foregoing reasons, the Third Circuit's

decision to legislate its own exception to Pennsylvania's state law

*...continued)

case abrogated the fundamental requirement of a drug manufacturer to

distribute its product properly prepared and accompanied by adequate

warnings to the product user, nor did they abrogate the premise of strict

liability pursuant to 402A, Comment k of the RESTATEMENT (SECOND)

OF TORTS.

governing products liability should be promptly corrected. Insofar

as the decision is grossly at odds with Pennsylvania's state law,

it should be reversed.

It.

THE MISINTERPRETATION OF PENNSYLVANIA'S

PRODUCTS LIABILITY LAW BY THE COURT OF

APPEALS, FUNCTIONALLY PRECLUDING SCHOOL

CHILDREN AND THEIR PARENTS FROM OBTAINING

EFFECTIVE REDRESS FOR CATASTROPHIC INJURIES

SUFFERED AS A RESULT OF PARTICIPATING IN A

MASS IMMUNIZATION PROGRAM INVOLVING AN

UNAVOIDABLY UNSAFE VACCINE, WARRANTS THE

EXERCISE OF THIS COURT'S CERTIORARI JURIS-

DICTION

The practical effect of the decision of the court of appeals

is to carve out an unprecedented exception to the fundamental

duty of a manufacturer to warn a consumer of the nsks and

benefits of a prescription drug when the drug is administered in

a Mass immunization setting to school children under the auspices

of a federal agency. In effect, it leaves the innocent but injured

child without an adequate night of recovery when warnings do not

reach the child or the child's parents. Such a holding is diametni-

cally opposed to the broad policy considerations which underlie

the imposition of strict liability.

The risk of loss between the completely innocent consumer

and the manufacturer of an injury—causing product traditionally

has been imposed on the manufacturer, who is best able to pay

for the damages caused. In this case, however, the Third Circuit

has placed the risk of loss not on the manufacturer, but on the

innocent child who is in the least likely position to pay for the

harm suffered by the offending product.’ By contracting with the

CDC to distribute and administer the measles vaccine that it

produces, Merck has effectively insulated itself from the imposi-

tion of strict liability for its distributor's failure to give adequate

warnings to consumers.

This Court has considered the substantive law of products

liability under section 402A only once. East River S.S. Corp. v.

Transamerica Delaval, Inc., 476 U.S. 858 (1986). While in that

case certiorari was granted to resolve a conflict among the courts

of appeals sitting in admiralty, id at 2298, this Court did

recognize that products liability law in general has long been a

part of the common law of torts and "grew out of a public policy

’Absent gross negligence, the innocent and injured consumer (here,

a twelve year old girl) is precluded from seeking compensation from the

doctors or nurses administering the vaccine. 42 Pa. C.S.A. § 8334

(1978). In addition, no compensation is available from federal agencies

(such as the CDC) because the creation and method of distributing

vaccine warnings is a discretionary function. 28 U.S.C. § 1346 (b)

(1976). By summarily disposing of this case in favor of Merck, the

Third Circuit foreclosed Lisa from receiving any compensation whatever

for her injunes, and severely limited the means by which other innocent

and injured children like Lisa may be compensated in the future.

Indeed, recovery for claims presented under the National Childhood

Vaccine Injury Act, 42 U.S.C. § 300 aa, et seq. (1988), are extremely

limited for children in Lisa's position. Thus, even assuming that Lisa

may have been qualified to present a claim under that Act, any recovery

she may have obtained would have been severely limited.

judgment that people need more protection from dangerous

products than is afforded by the law of warranty.” /d. at 2299.

The East River case highlights the social importance of the

substantive development of products liability and the worthiness

of accepting certiorari to consider such state law issues.

For all of the foregoing reasons, Petitioners respectfully

request that this Court exercise its jurisdiction and grant a writ of

certiorari.

September 16, 1992

CONCLUSION

Respectfully submitted by,

RICHARD A. SPRAGUE

THOMAS A. SPRAGUE

DAVID R. DEARDEN*

PAUL CROWLEY

SPRAGUE & SPRAGUE

135 S. 19th Street

The Wellington Building

Suite 400

Philadelphia, PA 19103

(215) 561-7681

Attomeys for Petitioners

*Counsel of Record

APPENDIX

UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

NO. 91-1613

ANTHONY MAZUR and EDNA MAZUR

as Parents and Guardians of LISA MARIE MAZUR,

as Minor, and ANTHONY MAZUR and EDNA MAZUR.

in their own nght,

Appellants

MERCK & CO., INC.

Appellees

Argued January 23, 1992

Before: STAPLETON, SCIRICA and ALITO,

Circuit Judges

OPINION OF THE COURT

In this products liability action appellants Lisa

Mazur and her parents seek compensatory and punitive

damages from appellee Merck & Co., Inc. for failure to

warm that the use of its vaccine could result in serious

neurological illness. The District Court entered summary

judgment for Merck on the ground that it provided an

adequate warning to a learned intermediary, and, in the

alternative, exercised reasonable care to inform users of the

risks of its vaccine by contractually obligating the United

States Centers for Disease Control (CDC)' to warn

' The CDC is an arm of the Public Health Service of the

United States Department of Health and Human Services. It is

charged with protecting the public health of the nation by

providing leadership and direction in the prevention and control

of diseases and responding to emergencies. The CDC also

provides assistance to state and local health agencies in the form

vaccinees directly. Mazur v. Merck & Co., Inc., 767 F.

Supp. 697 (E.D. Pa. 1991). Because we conclude that

Merck satisfied its duty to warn by contractually obligating

the CDC the warn vaccinees directly, we will affirm.

In response to a measles epidemic in the late 1970s,

the Philadelphia Department of Public Health proposed a

regulation, later adopted by the School Board of Health,

requiring all school children to be vaccinated against a

variety of pediatric diseases. Under the regulation, school

nurses were instructed to review the health records of about

300,000 students city-wide to determine which vaccines, if

any, they needed, and to obtain written permission from

students’ parents for vaccination in appropriate cases.

(footnote no.1 continued...)

of project grants to assist them in activities aimed at eliminating

certain diseases, including measles. See 42 U.S.C. § 247 (1988).

Where adequate proof of prior vaccinations or diseases was

not forthcoming, students were considered unimmunized.

Based on a recommendation and information from

the CDC, Dr. Robert G. Sharrar, a director of the

Philadelphia health department, selected M—M-R II (MMR

II) as the measles vaccine for the city’s immunization

program. MMR II is a live—virus vaccine for simultaneous

immunization against measles, mumps, and rubella. It is a

prescription drug and has been manufactured by Merck

since 1978 under a license from the United States Food and

Drug Administration.

The MMR II vaccine is distributed in vials

containing an FDA-approved "package circular," descnbing

the risks attendant to the vaccine's use. In Apml 1981 the

package circular contained the following statement about

the risk of contracting subacute sclerosing panencephalitis

(SSPE), a fatal, slowly progressing neurological disease,

from inoculation with the MMR II vaccine:

There have been reports of [SSPE] in children who

did not have a history of natural measles but did

receive measles vaccine. Some of these cases may

have resulted from unrecognized measles in the first

year of life or possibly from the measles

vaccination. Based on estimated nationwide measles

vaccine distribution, the association of SSPE cases

to measles vaccination is about one case per million

vaccine doses distributed. This is far less than the

association with natural measles, 5-10 cases of

SSPE per million cases of measles. The results of

a retrospective case—controlled study concluded by

the [CDC] suggest that the overall effect of measles

vaccine has been to protect against SSPE by

preventing measles with its inherent nsk of SSPE.

The package circular also contained the following paragraph

on revaccination:

Based on available evidence, there is no

reason to routinely revaccinate children

Originally vaccinated when 12 months of age

or older; however; children vaccinated when

younger than 12 months of age should be

revaccinated. The decision to revaccinate

should be based on evaluation of each

individual case.

The Philadelphia Health Department purchased the

MMAR II vaccine for the city's immunization program from

A6é

the CDC, which had purchased it from Merck. Merck was

at first reluctant to sell its MMR II vaccine to the CDC, but

relented after the CDC agreed to the following contractual

provision:

The [CDC] represents and agrees that it will

(1) take all appropriate steps to assure that

all vaccine supplied to various locations

within the 50 states,. . .pursuant to the terms

of this contract, shall be administered to

each patient on the basis of an individualized

medical judgment by a physician, or (2) take

all appropriate steps to provide to such a

patient (or to the patient's parent or

guardian) meaningful warnings relating to

the nsks and benefits of vaccination, in form

and language understandable to such patient,

parent or guardian.’

Opting to proceed under the latter clause, the CDC

drafted an "Important Information Statement," designed to

inform parents of the risks of inoculation with the MMR II

vaccine in lay terms. It then obligated state and local

* The identical provision was contained in all three purchase

agreements entered into between Merck and the CDC for use of

the MMR II vaccine in the public health sector.

health agencies who purchased MMR II vaccine from it,

including the Philadelphia Health Department, to distribute

the Important Information Statement to vaccinees, parents,

or their guardians. The Important Information Statement

was distributed to nurses at a district-wide informational

meeting on the city's immunization program, and was

forwarded to parents by way of their children.

pertaining to the risks associated with use of the MMR II

vaccine. But she admits to having been notified of the

immunization program, and, in particular, receiving a letter

from the school district explaining the program with an

attached immunization record and written permission form.

Mrs. Mazur neither signed nor returned the permission

form.

Instead, she called Lisa's school principal and an

official at the Board of Education, and told them that Lisa

was immunized for measles in 1973 and that she would not

consent to her revaccination. Then, to prevent Lisa from

being revaccinated, Mrs. Mazur kept her out of school for

a week. But she eventually relented under pressure from

school officials, and sent Lisa back to school. Shortly

thereafter, students were immunized at Lisa's school, the

Andrew J. Morrison School.

The immunization program was administered at the

Morrison School by Edith B. Frederick, a registered nurse.

Nurse Frederick was responsible for personally reviewing

student health records to determine which students had been

previously vaccinated and to check for medical conditions

that might heighten the nsks of vaccination. She also

arranged the immunization forms that were sent home with

students, including the Important Information Statement,

distributed them to students, and collected the permission

forms that were retumed.

Students were inoculated at the Morrison School on

February 26, 1982. They were led into the school

gymnasium single file, one classroom at a time. Nurse

Frederick and a technician who administered the

vaccination shots were situated at a table. As students

approached them, Nurse Frederick took each student's

permission form, checked it against her health records, and

informed the technician which vaccine to administer. Nurse

Frederick also examined the “overall appearance" of

students as they passed by her, and, sometimes, asked them

how they felt. On average it took students three to four

minutes to pass through the line and be vaccinated. No

physician was present during the inoculation, or was any

representative from either Merck or the CDC.

Although Nurse Frederick's records do not include

a Signed permission form for Lisa Mazur, they indicate that

she was inoculated with the MMR II vaccine that day. On

September 7, 1983, shortly after her fourteenth birthday,

A10

Lisa was admitted to St. Christopher's Hospital for Children

in Philadelphia because of "personality changes" and

"abnormal movements." On November 2, 1983, she was

diagnosed with SSPE.

On October 18, 1985, the Mazurs filed this action in

the Philadelphia Court of Common Pleas _ seeking

compensatory and punitive damages. Their complaint

alleges negligence and strict liability claims against Merck

under Pennsylvania law for, among other things, failure to

provide an adequate warning. Merck removed the action to

federal District Court, and moved for summary judgment on

the Mazurs’ failure to warn claims.

Merck contended that (1) the Mazurs' state law

claims were preempted by the pervasive scheme of federal

regulations governing the production, labeling, and

distribution of vaccines; (2) the Mazurs' action was barred

by Pennsylvania's two-year statute of limitations for tort

claims; and (3) Merck met its duty to warn by informing

All

Dr. Sharrar olf the risks associated with the MMR II

vaccine, and, alternatively, obligating the CDC to ensure

that the vaccine was administered by a physician or to

provide meanimgful warnings to vaccinees.

The District Court issued an opinion and order

denying Merck's motion for summary judgment on the

federal preempttion and statute of limitations issues. Mazur

v. Merck & Co. (Mazur I), 742 F. Supp. 239 (E.D. Pa.

1990). But it reserved judgment on the issue whether

Merck met its duty to warn, and instead allowed further

discovery and additional filings on this matter. Merck then

filed a supplemental motion for summary judgment, which

the District Court granted. Mazur v. Merck & Co. (Mazur

II), 767 F. Supp. 697.

Drawing, on its earlier opinion, the District Court

held that (1) Merck had a "duty to exercise reasonable care

to inform those for whose use [its MMR II vaccine] was

supplied of the ffacts which make it dangerous"; (2) Nurse

Al2

Frederick acted as a learned intermediary, because she

"made a considered medical judgment" as to which students

should be vaccinated on February 26, 1982; (3) the package

circular constituted an adequate warning; and (4) Merck

reasonably relied on the CDC to see that users were

informed of the risks of its MMR II vaccine directly. Jd.

Accordingly, the district court granted summary judgment

for Merck.’ This appeal followed.

II.

We have jurisdiction under 28 U.S.C. §1291. We

are required to address two novel issues of Pennsylvania

> Because the district court granted Merck's

supplemental motion for summary judgment, it did not

address the issue of proximate causation. Mazur I], 767 F.

Supp. at 698 n.1. At oral argument, Merck asserted that,

even assuming Merck breached its duty to warn, the Mazurs

have failed to establish that this breach was a proximate

cause of Lisa Mazur's condition. Because we conclude that

Merck satisfied its duty to warn as a matter of law, we do

not reach the issue of proximate causation.

Al3

products liability law: first, whether the learned

intermediary rule extends to a registered nurse who

supervises the vaccination of students as part of a city-wide

immunization program; and second; whether a vaccine

manufacturer may satisfy its duty to warn in the mass

immunization context by contractually obligating the CDC

to inform users of the risks of its vaccine directly.

Our review of the district court's thorough and

careful opinions and order granting summary judgment is

plenary. Erie Telecommunications, Inc. v. City of Erie, 853

F.2d 1084, 1093 (3d Cir. 1988). We apply the same

principles governing the district court's determination

whether to grant summary judgment:

[W]e must be convinced that the prevailing

party has successfully demonstrated "that

there is not genuine issue as to any material

fact and that the moving party is entitled to

judgment as a matter of law." Moreover, all

inferences must be drawn against the movant

... and in favor of the nonmovant.

Al4

Id. (citations omitted). Merck bears the "ultimate

burden of showing the absence of a genuine issue as to any

material fact." Gans v. Mundy, 762 F.2d 338, 343 (3d

Cir.), cert. denied, 474 U.S. 1010 (1985). But if this

standard is met, the burden shifts to the Mazurs to establish

a "genuine issue of materia! fact." Jd.

We apply Pennsylvania law and must predict how

the Pennsylvania Supreme Court would decide this case.

"The decisions of the Pennsylvania Superior Court, while

not controlling, are "indicia of how the [Pennsylvania

Supreme Court] might decide" the issue." Bohus v. Beloff,

950 F.2d 919, 924 (3d Cir. 1991) (quoting McNasby v.

Crown Cork & Seal Co., 888 F.2d 270, 281 (3d Cir. 1989)).

Al5

Our first task is to determine whether the district

court properly formulated Merck's duty to warn. As the

district court noted, "ordinarily" Pennsylvania courts impose

strict liability on manufacturers of products sold "in a

defective condition unreasonably dangerous to the user or

consumer" under section 402A of the Restatement (Second)

of Torts.* Mazur I, 742 F.Supp. at 251 (citing Jncollingo

* §402A. Special Liability of Seller of Product for

Physical Harm to User or Consumer.

(1) One who sells any product in a defective

condition unreasonably dangerous to the user or

consumer or to his property is subject to liability for

physical harm thereby caused to the ultimate user or

consumer, or to his property, if

(a) the seller is engaged in the business of

selling such a product, and

(b) it is expected to and does reach the user

Or consumer without substantial change in

the condition in which it sold.

(2) The rule stated in Subsection (1) applies

although

Al16

v. Ewing, 282 A.2d 206, 219 (PA. 1971)). Products sold

without adequate warnings of the risks attendant to their use

are considered defective. /d.; see Restatement (Second) of

Torts §402A cmt. h.

However, as the district court observed, "the strict

liability rules for prescription drugs, such as vaccines, are

somewhat different under Pennsylvania law." /d. These

products fall into the category of “unavoidably unsafe

products" set forth in comment K to section 402A of the

Restatement.’ Id. (citing Incollingo, 282 A.2d at 219).

(a) the seller has exercised all possible care

in the preparation and sale of his product,

and

(b) the user or consumer has not bought the

product from or entered into any contractual

relation with the seller.

Restatement (Second) of Torts §402A (1965). Section 402A

was adopted as the law of Pennsylvania in Webb v. Zern,

220 A.2d 853 (Pa. 1966).

> k. Unavoidably unsafe products. There are some

products which, in the present state of human knowledge,

Al7

"Such a product, properly prepared, and accompanied by

directions and warning, is not defective, nor is it

unreasonably dangerous." Restatement (Second) of Torts

§402A cmt. k.

are quite incapable of being made safe for their intended

and ordinary use. These are especially common in the field

of drugs. An outstanding example is the vaccine for the

Pasteur treatment of rabies, which not uncommonly ieads to

very serious and damaging consequences when it is

injected. . . . Such a product, properly prepared, and

accompanied by proper directions and warning, is not

defective, nor is it unreasonably dangerous. The same is

true of many other drugs, vaccines, and the like, many of

which for this very reason cannot be legally sold except to

physicians, or under the prescription of the physician... .

The seller of such products, again with the qualification that

they are properly prepared and marketed, and proper

(footnote no. 5 continued...)

warning is given, where the situation calls for it, is not held

to strict liability for unfortunate consequences attending

their use, merely because he has undertaken to supply the

public with an apparently useful and desirable product,

attended with a known and apparently reasonable risk.

Restatement (Second) of Torts §402A cmt. k.

Al8

With respect to "unavoidably unsafe products," the

district court said, the "strict liability principles of section

402A do not apply." Mazur I, 742 F. Supp. at 252.

Instead, the district court held that section 388 of the

Restatement (Second) of Torts® applies, regardless whether

° §388. Chattel Known to be Dangerous for Intended

Use.

One who supplies directly or through a third person

a chattel for another to use is subject to liability to

(footnote no. 6 continued...)

those whom the supplier should expect to use the

chattel with the consent of the other or to be

endangered by its probable use, for physical harm

caused by the use of the chattel in the manner for

which and by a person for whose use it is supplied,

if the supplier

(a) knows or has reason to know that the

chattel is or is likely to be dangerous for the

use for which it is supplied, and

(b) has no reason to believe that those for

whose use the chattel is supplied will realize

its dangerous condition, and

Al9

the plaintiff's failure to warn claim is founded in negligence

or strict liability. Under that section, "the supplier has a

duty to exercise reasonable care to inform those for whose

use the article is supplied of the facts which make it likely

to be dangerous." Jd. at 252 (quoting /ncollingo, 282 A.2d

at 220 n.8) (emphasis in original).

Thus, the district court concluded:

Since the Mazurs assert that Merck is both

strictly liable and liable for negligence in

failing to warn them of the dangers of the

MMR II inoculation, a liability analysis

under either theory will depend on whether

Merck complied with the "duty to exercise

reasonable care to inform" the Mazurs of

health risks associated with MMR II use.

Id. We agree.

Although the Mazurs apparently do not dispute that

— one eee . .

inform them of its dangerous condition or of

the facts which make it likely to be

dangerous.

Restatement (Second) of Torts §388 (emphasis added).

A20

they argue that the district court erred by failing to

distinguish between a prescription drug manufacturer's duty

to warn in strict liability as opposed to negligence.

According to the Mazurs, "[w]hen a particular product is

not accompanied by an adequate warning, the product is

defective and the manufacturer is strictly liable under

section 402A, regardless of the care which the manufacturer

took to ensure that proper warnings would accompany that

product."

Although adequacy of warning is relevant to the

determination whether a prescription drug manufacturer has

met its duty to warn, the Pennsylvania Supreme Court has

consistently formulated the prescription drug manufacturer's

duty to warn under the section 388 "reasonableness"

standard. The seminal case is /ncollingo v. Ewing. There

are the parents of a child who died after being administered

Chloromycetin, a broad spectrum antibiotic, brought a

negligent failure to warn claim against the prescription drug

A21

manufacturer. The Pennsylvania Supreme Court began its

analysis of the plaintiffs' failure to warn claim by looking

to section 402A of the Restatement. However, because it

found Chloromycetin to be an “unavoidably unsafe

product," the court held that section 388 of the Restatement

supplied the defendant's duty to warn. 282 A.2d at 22 &

n.8.’

The Mazurs contend that /ncollingo is inapposite

because the plaintiffs' failure to warn claim in that case was

founded in negligence, and the supreme court's conclusion

’ The Jncollingo court explained:

Since the strict liability rule of §402A is not

applicable, the standard of care required is

that sét forth in §388 of the Restatement

dealing with the liability of a supplier of a

chattel known to be dangerous for its

intended use. Under this section, the

supplier has a duty to exercise reasonable

care to inform those for whose use the

article is supplied of the facts which make it

likely to be dangerous.

282 A.2d at 220 n.8.

A22

that section 388 governed was based on the absence of a

strict liability claim. However, the Jncollingo court's

conclusion that section 402A of the Restatement did not

apply was based on its determination that Chloromycetin is

within the category of “unavoidably unsafe products," not

the absence of a strict liability failure to warn claim.

Therefore, because the MMR II vaccine is an "unavoidably

unsafe product," we believe /ncollingo is controlling here.

Baldino v. Castagna, 478 A.2d 807 (Pa. 1984), is

instructive. Although the underlying action in that case was

founded in negligence, the Pennsylvania Supreme Court

made clear that section 388 governs failure to warn claims

founded in strict liability:

In Jncollingo we held that, assuming proper

preparation and warning, a manufacturer of

drugs is not strictly liable for unfortunate

consequences attending the use of otherwise

useful and desirable products which are

attended with a kncwn but apparently

reasonable risk. /d. at 221. Rather, such a

manufacturer is liable only if he fails to

exercise reasonable care to inform those for

A23

whose use the article is supplied of the facts

which make it likely to be dangerous. Id. at

220 n.8 (citing section 388 of the

Restatement (Second) of Torts).

Id. at 810 (emphasis added). See also White v. Weiner, 562

A.2d 378, 384 (Pa. Super.) (applying section 388 to strict

liability failure to warn claim), aff'd without op., 583 A.2d

789 (Pa. 1991); McDaniel v. Merck, Sharp & Dohme, 533

A.2d 436, 445-46 (Pa. Super. 1987) (same). But cf.

Hartford Mut. Ins. Co. v. Moorhead, 578 A.2d 492 (Pa.

Super 1990).° Accordingly, we agree with the district

* In Hartford Mutual Insurance Co. the Pennsylvania

Superior Court distinguished between failure to warn claims

founded in negligence and strict liability on the ground that

a negligent failure to warn claim charges improper conduct

whereas a strict liability failure to warn claim charges a

defective product. 578 A.2d at 501. Significantly, the

product at issue in that case —- sulphur strips used for

making wine - is not within the category of "unavoidably

unsafe products" set forth by comment k to section 402A of

the Restatement (Second) of Torts. Therefore, the court had

no occasion to invoke the section 388 "reasonableness"

standard applied in J/ncollingo v. Ewing.

A24

The Pennsylvania Superior Court made this clear in

Hahn v. Richter, No. 00019, 1992 Pa. Super. LEXIS 275

(Pa. Super. Feb. 13, 1992). In that case the plaintiff

brought a failure to warn claim against the manufacturer of

Depo-Medrol, a corticosteroid prescribed to the plaintiff by

his physician. The jury returned a verdict for the

(footnote no. 8 continued...)

defendant, finding that it did not negligently fail to warn

users of the nsks of Depo—Medrol. The plaintiff appealed

on the ground that the jury should have been instructed

separately on failure to warn in strict liability, but the

Pennsylvania Superior Court affirmed. Because Depo-

Medrol is "unavoidably unsafe," the court said that "[t]he

standard of care to be applied in determining whether an

adequate and proper warning was provided in the

negligence standard of reasonable care." /d. at *4-7. One

judge dissented on the grounds that Hartford Mutual

Insurance Co., carved out a distinction between negligent

and strict liability failure to warn claims, and, in any event,

Depo-Medrol is not "unavoidably unsafe." Jd. at *7-15

(Del Sole, J., dissenting).

Courts in other jurisdictions have distinguished

between negligent and strict liability failure to warn claims

on a conduct/product basis, see, e.g., Petty v. United States,

740 F.2d 1428, 1440-41 (8th cir. 1984) (applying lowa

law), though commentators have criticized this distinction

as being based more on semantics than sound policy, see

Henderson & Twerski, Doctrinal Collapse in Products

Liability: The Empty Shell of Failure to Warn, 65 N.Y.U.L.

Rev. 265, 275-278 (1990); Keeton, The Meaning of Defect

A25

court that Merck's duty to warn users of the risks of its

MMR II vaccine is governed by section 388 of the

Restatement. The more difficult question is whether the

As the district court noted, it is established under

Pennsylvania law that a prescription drug manufacturer may

meet its duty to warn by providing an adequate warning to

a "learned intermediary," as opposed to the general public

or individual users. Mazur J, 742 F. Supp. at 252 (citing

Incollingo, 282 A.2d at 220). A learned intermediary is one

who exercises "individual medical judgment bottomed on a

in Products Liability Law - A Review of Basic Principles,

45 Mo. L. Rev. 579, 586-87 (1980). In any event, at least

in cases involving "unavoidably unsafe products," the

Pennsylvania Supreme Court has not distinguished between

a prescription drug manufacturer's duty to warn in

negligence versus strict liability.

A26

knowledge of both patient and palliative," but, according to

the district court, need not be a physician. /d. (quoting

Reyes v. Wyeth Lab., 498 F.2d 1264, 1276 (Sth Cir.), cert.

denied, 419 U.S. 1096 (1974)).

Where vaccine is not dispensed by a learned

intermediary, but to "all comers at mass clinics," courts in

other jurisdictions have said that "it is the responsibility of

the manufacturer to see that warnings reach the consumer,

either by giving warning itself, or by obligating the

purchaser to give warning." /d. at 253 (quoting Davis v.

Wyeth Lab., Inc., 399 F.2d 121, 131 (9th Cir. 1968)). This

has become known as the "mass immunization exception"

to the learned intermediary rule. But, as the district court

Observed, is better viewed as one context where the

prescription drug manufacturer is obligated to warn users

directly. Mazur II, 767 F. Supp. at 700.

The district court held that Merck met its section

388 duty to warn by providing an adequate warning (the

————————

A27

mackage circular) to a learned intermediary (Nurse

Frederick), and, in the alternative, by contractually

obligating the CDC to see that its MMR II vaccine was

administered by a physician or to provide meaningful

warnings to vaccinees. We must determine whether either

or both of these rulings are correct as a matter of law.

B. - LEARNED INTERMEDIARY

In Mazur I the district court predicted that "the

Pennsylvania courts . . . would hold that in appropnate

Circumstances a nurse can act as a learned intermediary,"

but left for trial the determination whether Nurse Frederick

acted as a learned intermediary under the facts here. 742

F. Supp. at 255. In Mazur II, however, the district court

found that "[{l]ooking at the totality of her qualifications and

what she did, it is clear that Nurse Frederick was acting as

a learned intermediary at the time of Lisa's inoculation."

A28

767 F. Supp. at 711. The Mazurs challenge this conclusion

both as a matter of law and fact.

The learned intermediary rule was first adopted by

the Pennsylvania Supreme Court in /ncollingo v. Ewing,

282 A.2d at 206. Under this rule,

It is the duty of the prescribing physician to

be fully aware of (1) the characteristics of

the drug he is prescribing, (2) the amount of

the drug which can be safely administered,

and (3) the different medications the patient

is taking. It is also the duty of the pre-

scribing physician to advise the patient of

any dangers or side effects associated with

the use of the drug as well as how and when

to take the drug. The warnings which must

accompany such drugs are directed to the

physician rather than to the _patient-

consumer as "[iJt is for the prescribing

physician to use his independent judgment,

taking into account the data supplied to him

from the manufacturer, other medical

literature, and any other sources available to

him, and weighing that knowledge against

the personal medical history of his patient,

whether to prescribe a given drug."

Cayle v. Richardson-Merrell, Inc., 584 A.2d 1383

(Pa. 1991) (quoting Makripodis v. Merrell-Dow

A29

Pharmaceuticals, Inc., 523 A.2d 374, 378 (Pa. Super. 1987)

(internal quotation omitted)). See also White v. Weiner, 562

A. 2d 378.

As the district court observed, courts in other

jurisdictions have held that nurses may act as learned

intermediaries under certain circumstances. See, e.g.,

Rohrbough v. Wyeth Lab., Inc. 719 F. Supp. 470 (N.D.W.

Va. 1989), aff'd, 916 F.2d 970 (4th Cir. 1990); Walker v.

* In White the Pennsylvania Superior Court explained

that

the rationale for th{e learned intermediary]

tule is obvious: It is the physician who has

the superior knowledge in the circumstances

because he or she is able to balance the risks

associated with the prescription drug against

its utility "in light of his [or her] personal

knowledge of the patient's medical history."

562 A.2d at 386 (quoting Leibowitz v. Ortho

Pharmaceutical Corp., 307 A.2d 449, 457 (Pa. Super.

1973)). See generally Rheingold, Products Liability — The

Ethical Drug Manufacturer's Liability, 18 Rutgers L. Rev.

947, 987 (1964) (discussing the policies underlying the

learned intermediary rule).

A30

Merck & Co., 648 F. Supp. 931 (M.D. Ga. 1986), aff'd

without op., 831 F.2d 1069 (11th Cir. 1987).’° To date,

however, no Pennsylvania court has recognized that anyone

Other than a physician may be a learned intermediary.

In two recent cases Pennsylvania courts have

declined to extend the learned intermediary | tule to

pharmacists. In Makripodis v. Merrell-Dow

Pharmaceuticals, Inc. the parents of a deformed infant

brought a products liability action against the manufacturer

of Bendectin, a prescription drug taken during the early

Stages of pregnancy to prevent nausea, and the pharmacy

from whom the plaintiffs purchased the drug. Among other

things, the plaintiffs alleged that the pharmacy "was strictly

liable in tort as Bendectin was a defective product,

unreasonably dangerous due to the absence of proper

warnings." 523 A.2d at 375. The trial court granted

A31

summary judgment for the pharmacy, and the Pennsylvania

Superior Court affirmed on the ground that retail

pharmacists have no independent duty to warm patient-

consumers of the risks of prescription drugs they dispense.

Id. at 378.

The Superior Court reasoned that "the warnings

which are required to be given by the manufacturer must be

directed to the physician," because it is for the physician to

exercise his "independent medical judgment" to determine

which drugs should be prescribed given the patient's

medical history and _ condition. Id. Imposing an

"independent duty to warn" on pharmacists would ill serve

the purposes behind the learned intermediary rule, because

"the retail pharmacist is in most instances unfamiliar with

the medical history and condition of the patient-consumer

and, in any event, is not a physician, trained in the

diagnosis and treatment of diseases." Jd. Thus, warnings

by pharmacists "would be inadequate to enable the average

A32

consumer to evaluate the benefits and risks attendant to the

use of such drugs." /d. at 379.

The Pennsylvania Supreme Court adopted the

reasoning of Makripodis in Coyle v. Richardson-Merrell,

Inc. The facts of that case are almost identical to

Makripodis: the parents of a deformed infant brought a

products liability action against the manufacturer of

Bendectin and the pharmacy from whom the plaintiffs

purchased the drug. In Coyle, however, the plaintiffs did

not allege that the pharmacy was strictly liable for failure

to warn, but rather that it was strictly liable as the supplier

of a defective product."’ The trial court granted summary

judgment for the pharmacy, and the Pennsylvania Superior

Court and Supreme Court affirmed. 584 A.2d at 1384.

. As the Coyle court noted, "[i]t is not entirely clear

in what sense . . . the drug was defective beyond that it

allegedly carried a risk, of which no warning was given, of

causing the child of the pregnant woman for whom it was

prescribed of developing with malformed limbs." 584 A.2d

at 1386.

A33

The Supreme Court refused to impose strict liability

upon pharmacists for failure to warm. The plaintiffs’

argument, the court said, "g{a]ve scant attention to the rule

of Incollingo and its rationale." Jd. at 1386. For, "[u|nder

that rule, information about the risks of medicines is

provided to the person who most needs and can best

evaluate it-the physician-to be shared with and explained

to the patient in the context of his or her individual medical

circumstances." /d.

As the Court explained, under the distribution

system for prescription drugs, "[p]hysicians exercising

sound medical judgment act as intermediaries . . .,

preempting, as it were, the exercise of discretion by the

supplier—pharmacist, and, within limits, by the patient-

consumer." Jd. "{I]t is not the pharmacist on whom the

public ‘is forced to rely' to obtain the products they need,"

but rather the physician. Jd. at 1387. "Physicians act as

exclusive intermediaries." Jd.

A34

We find the Pennsylvania courts' reasoning in

Makripodis and Coyle instructive on whether the learned

intermediary rule extends to nurses’? under Pennsylvania

law. Like pharmacists, nurses generally are not capable of

providing the degree of individualized medical judgment

rendered by physicians, and are not authorized

independently to prescribe drugs.’ This is because nurses

'2 Pennsylvania law recognizes several types of health

care professionals, many of which might generically be

referred to as nurses. E.g., 49 Pa. Code §18.6 (1992)

(nurse—midwives); id. §18.21 (certified registered nurse

practitioners); id. §18.141 (physician assistants); id.

§21.145 (licensed practical nurses). We use the term

"nurse" here to refer to the "registered nurse," as defined by

63 Pa. Cons. Stat. Ann. § 213 (Purdon Supp. 1991) and 49

Pa. Code §§ 21.1 and 21.11 (1992).

'° The Pennsylvania Nursing Law explicitly excludes

from the "practice of professional nursing" "acts of medical

diagnosis or prescription of medical therapeutic or

corrective measures, except as authorized by rules and

regulations jointly promulgated by the State Board of

Medicine and the [State Board of Nursing]." 63 Pa. Cons.

Stat. Ann. § 212 (1); accord 49 Pa. Code § 21.1.

Specialized nurses, like the "certified registered nurse

practitioner," may “perform acts of medical diagnosis or

prescription of medical therapeutic or corrective measures,"

A35

are not required to undergo the ngorous medical training

4 As such, we

necessary to become a licensed physician.

do not believe "the rule of Jncollingo or its rationale"

extends to nurses. See Coyle, 584 A.2d at 1386.

To be sure, as the district court observed, nurses

often perform tasks "similar to" those performed by

physicians, and are therefore more like physicians than are

pharmacists. See Mazur I, 742 F. Supp. at 255. But these

tasks are typically performed under the supervision of, or in

collaboration with, physicians. For instance, registered

nurses may administer drugs to a patient, but only those

"ordered for that patient by a licerised doctor." 49 Pa. Code

§ 21.14 (1992). Likewise, immunization is a "proper

but only "in collaboration with and under the direction of

a physician licensed to practice in [Pennsylvania]." Jd.

§ 21.251.

'* Compare 49 Pa. Code § 17.1 (requirements for

license without restriction for medical doctors) with id. §§

21.21-.23 (requirements for license for certified registered

nurses). —

A36

function" of the registered nurse, but only if "[a] written

order has been issued by a licensed physician," and "[t]he

policies and procedures under which the registered nurse

may administer immunizing agents . . . have been

established by a committee representing the nurses, the

physicians and the administration of the agency or

institution." Jd. § 21.16.

At bottom it is the physician who is required to

make the individualized medical judgment of what

treatment to administer in a given instance, and it is the

physician who is ultimately held accountable for that

decision.” | Thus, in the distribution system for

'S As the District Court noted, 42 Pa. Cons. Stat. Ann.

§ 8334(a) (1982) extends a limited grant of immunity from

liability to both physicians and nurses who administer

vaccines in the mass immunization context. Although this

provision may be further evidence that physicians and

nurses act alike in certain respects, we do not find it

dispositive of the issue whether nurses may be learned

intermediaries under Pennsylvania law.

A37

prescription drugs warnings are directed to physicians and

not nurses or pharmacists. "{I]nformation about the risks of

medicines is provided to the person who most needs and

can best evaluate it-the physician—to be shared with and

explained to the patient in the context of his or her

individual medical circumstances." Coyle, 584 A.2d at

1386.

Accordingly, we do not believe the Pennsylvania

Supreme Court would extend the learned intermediary rule

As we have noted, courts have formulated different

liability rules in the mass immunization context. See Davis

v. Wyeth Lab., Inc., 399 F.2d at 131. The principal reason

for the so-called mass immunization exception to the

learned intermediary rule is that when vaccines are

administered under "clinic-like" conditions, it is difficult,

if not impossible, to render the type of individualized

medical care required of the learned intermediary. See id.

Therefore, although 42 Pa. Cons. Stat. Ann § 8334(a) may

be evidence that nurses act like physicians in the mass

immunization context, we doubt it reflects a legislative

judgment that nurses act like learned intermediaries in the

mass immunization context. Of course, it remains to be

seen whether the immunization program here is within the

mass immunization exception. We examine this issue infra

Part II(C).

A38

to nurses. But even assuming there are circumstances in

which a nurse may act as a learned intermediary under

Pennsylvania law, we do not think it can be said, as a

matter of law, that Nurse Frederick acted as a learned

intermediary under the facts here.’°

The district court found that, based on the "totality

of her qualifications and what she did, it is clear that Nurse

Frederick was acting as [a] learned intermediary at the time

of Lisa's inoculation." Mazur II, 767 F. Supp. at 711. It

explained:

Nurse Frederick had the required general education,

experience, and authority. She had specialized

knowledge concerning the proposed treatment to be

administered. She had read the Important

Information Statement on at least two occasions

before the vaccines were administered. She had

_ particularized understanding of measles, mumps, and

'© Merck asserts that Dr. Sharrar acted as a learned

intermediary as well. For the reasons articulated by the

district court, see Mazur I, 742 F. Supp. at 253-54, we find

this argument untenable. Therefore, we limit our analysis

to the question whether Nurse Frederick acted as a learned

intermediary. ;

———————————E

A39

rubella; their symptoms and complications; and the

vaccines intended to prevent them. She knew of the

more common side effects of those vaccines.

Specifically, she was aware that encephalitis could

follow the measles virus and the measles vaccine. .

. . She was an experienced medical professional

with specific training as to the vaccine in question.

In sum her knowledge of the "palliative" was

sufficient. She was knowledgeable as to health

issues of school-age children. Parents relied upon

her expertise to aid them when they had questions

concerning the school health programs and their

child's needs. She reviewed the records of the

children at the Morrison school and made

individualized decisions concerning each of them.

On February 26, 1982, Nurse Frederick checked the

students, including Lisa, for visible signs of illness.

Ultimately, Nurse Frederick “made a considered

medical judgement," and permitted Lisa to receive

her MMR II vaccine.

Id. (citations omitted). We disagree.

Although Nurse Frederick is unquestionably

qualified as a registered nurse, we cannot agree that she

possesses the minimum qualifications and experience

required of the learned intermediary. Nurse Frederick

stated herself that the "emphasis" of her formal education

was on "education" rather than "nursing." As part of her

training to become a registered nurse, she learned how to

A40

administer vaccines. But although Nurse Frederick had

some classes in medication, she was never trained in

weighing the risks and benefits of vaccination in a given

instance. In 1980 Nurse Frederick attended a one-year,

nurse practitioner program at the University of

Pennsylvania. But this program centered on physical

examinations of children, and did not include detailed

instruction On immunization or pediatric diseases.

Although Nurse Frederick is experienced in

administering and dispensing drugs, she is not authorized to

prescribe drugs. When Nurse Frederick dispensed drugs as

part of a pediatric course she took at Philadelphia General

Hospital, she did so only pursuant to "doctor's orders." As

a school nurse, Nurse Frederick may only dispense Tylenol

to children.

Nurse Frederick is capable of describing the

symptoms of measles, and is aware that various side effects

and complications can result from inoculation with measles,

A41

mumps, and rubella vaccines. However, at the time Lisa

Mazur was vaccinated, Nurse Frederick was unaware that

SSPE is a possible complication of measles vaccine.

Moreover, as the district court noted, Nurse Frederick was

unable to 'state how a virus travels through the body, how

a virus causes illness, or how a vaccine prevents illness."

Mazur IT, 767 F. Supp. at 709. Likewise, although she was

aware that children running fevers should not be vaccinated.

Nurse Frederick was unable to explain why, and said that

in such a case she would refer the child to a physician.

Nurse Prederick’s only knowledge of the MMR II

vaccine was obtained from her participation in the city's

immunization program, and in particular, the Important

Information Statement, which she reviewed at least twice.

Nurse Frederick does not remember reading the package

circular, though she was aware that it came with each vial

of MMR II vaccine. Moreover, although she had "access"

to vials of MMR II vaccine on the day it was administered

A42

to students at the Morrison School, Nurse Frederick said

that the "vaccines were not in her hands" and "were entirely

managed by the Department of Health Technician.""’

Accordingly, we do not believe Nurse Frederick

possessed the cumulative medical knowledge and

experience necessary to make an individualized judgment as

to which students should have been vaccinated on February

26, 1982, let alone to recognize the "characteristics" of the

MMR II vaccine, determine "the amount of the drug which

[could] be safely administered" and assess "the different

medications the patient is taking." See Makripodis, 523

'7 We agree with the district court that, for purposes of

determining whether Merck met its duty to warn by

providing an adequate warning to a learned intermediary, it

is immaterial whether Nurse Frederick actually read the

package circular so long as it was made available to her.

Mazur II, 767 F. Supp. at 712-13. However, the fact that

Nurse Frederick may have never reviewed the package

circular is relevant to the determination whether she acted

as a learned intermediary on the day Lisa Mazur was

inoculated, and we must assume at this stage that Nurse

Frederick was not familiar with the package circular's

contents.

A43

A.2d at 378. Nor do we think she acted like a learned

intermediary that day.

Although Nurse Frederick virtually ran the

immunization program at the Morrison School, our focus

here is on how she acted the day Lisa Mazur was

inoculated. As we have noted, Nurse Frederick took each

student's permission form, checked it against her health

records, and informed the technician which vaccine to

administer. In addition to cross-checking records, Nurse

Frederick said that "one of [her] jobs . . . [was] to be kind

of eyeballing the boys and girls to see whether they looked

ill that day or if there was some reason they should not get

the vaccine." She elaborated that, as students passed by

her, she examined their "overall appearance," looking for

"obvious things” such as signs of lethargy, runny eyes and

noses, coughing and sneezing, and, sometimes, asked them

how they felt or put her arm around them. Nurse Frederick

did not ask students whether they were on medication that

ile

A44

day, and does not remember whether she turned any

students away because of their "overall appearance."

As the Court of Appeals observed in Reyes v. Wyeth

Laboratories, the "choice . . . [of the learned intermediary]

is an informed one, an individualized medical judgment

bottomed on a knowledge of both patient and palliative."

498 F.2d at 1276. Nurse Frederick had sufficient

knowledge of neither patient nor palliative. As a result, she

was incapable of rendering an individualized medical

judgment as to which students should be vaccinated. This

is not to say that Nurse Frederick did not perform her job

on the day Lisa Mazur was inoculated, only that she did not

act as a learned intermediary between Merck and vaccinces.

Accordingly, we cannot agree, as a matter of law,

facts here."® Because we conclude that Nurse Frederick

'8 The cases in which courts in other jurisdictions have

extended the learned intermediary rule to nurses are not to

A45

the contrary. See text accompanying supra note 10. In

Rohrbough v. Wyeth Laboratories, Inc. the district court

applied the learned intermediary rule to a nurse who

administered a vaccination to the plaintiff in a public health

clinic. The court noted that the plaintiff "did not receive

(her vaccination] as a part of a mass vaccination program

but after talking with the Registered Nurse who ultimately

(footnote no. 18 continued...)

made a considered medical judgment and administered the

shot." 719 F. Supp. at 478. Moreover, the plaintiff in that

case neither contended that the nurse was not "sufficiently

experienced to be a ‘learned intermediary" nor argued that

"she was not apprised of the risks associated with the .. .

vaccine. Id.

In Walker v. Merck & Co. the district court held that

the learned intermediary exception applied to nurses under

Georgia law. That case involved the administration of the

MMR II vaccine to a pregnant high school student as part

of a county-wide immunization program similar to

Philadelphia's program here. The plaintiff "received [her]

MMR II injection from a licensed practical nurse who was

aware of the risks associated with MMR II, particularly the

risks for pregnant females, and who stated that she had read

and understood the circular accompanying the MMR II."

648 F. Supp. at 934. In addition, the nurse who

administered the vaccine, who had experience as a licensed

practical nurse but no specialized training in vaccination,

"stated unequivocaHy" that before she administered the

vaccine to the plaintiff she explicitly asked her whether she

was sexually active and whether there was a possibility she

A46

was not a learned intermediary, we do not address at this

point whether the package circular constituted an adequate

warning.” Instead, we must next determine whether

was pregnant. /d. at 933.

In finding the learned intermediary rule applicable,

the Walker court relied squarely on a Georgia Court of

Appeals decision, Singleton v. Airco, Inc., 314 S.E.2d 680

(Ga. App. 1984), which extended the learned intermediary

rule to nurses under Georgia law. The plaintiff in Singleton

(footnote no. 18 continued...)

died after developing malignant hyperthermia, a known

adverse effect of an anesthetizing agent manufactured by

the defendant. The court found the "drug insert warnings

adequate for the use of a professional trained in the

administration of anesthesia, and that the [defendant was]

not in any way responsible for [the plaintiff's] death." /d.

at 682. Significantly, the nurse who administered the

anesthesia to the plaintiff had written a paper on malignant

hyperthermia while she was studying to become an

anesthesiologist, and "was familiar with the drug inserts and

stated that she made a hobby of collecting this information

while she was a student." Jd. See also Holley v. Burroughs

Wellcome Co., 330 S.E.2d 228 (N.C. App. 1985) (extending

learned intermediary rule to nurse/anesthesiologist under

similar facts), aff'd, 348 S.E.2d 772 (N.C. 1986).

'9 As we have noted, to meet its duty to warn under

the learned intermediary rule, a prescription drug

manufacturer must provide an adequate warning to a

pian

A47

Merck was obligated to warn users of the risks of its MMR

II vaccine directly under the mass immunization exception

to the learned intermediary rule.

Although it determined that Nurse Frederick was a

learned intermediary, the district court assumed, for

purposes of argument, that she was not and went on to

consider whether the mass immunization exception is

applicable here. It found that exception inapplicable,

because "there was no evidence Merck foresaw that no

learned intermediary. /ncollingo v. Ewing, 282 A.2d at 220.

Because we conclude, as a matter of law, that Nurse

Frederick did not act as a learned intermediary under the

facts here, it is not necessary to decide whether the package

circular constitutes and adequate warning. We address the

adequacy of the package circular infra Part II(D), however,

(footnote no. 19 continued...)

in determining whether Merck satisfied its duty to warn by

contractually obligating the CDC to warn users directly.

A48

learned intermediary would be present at inoculation, the

Health Department program was not large enough tc be a

mass immunization program, and the vaccine was not

dispensed to "all-comers." Mazur I, 742 F. Supp. at 257.

We disagree.

As we have discussed, where vaccine is not

dispensed on the basis of an individualized medical

judgment but to "all comers at mass clinics," courts in other

jurisdictions have held that "it is the responsibility of the

manufacturer to see that warnings reach the consumer,

either by giving warning itself, or by obligating the

purchaser to give warning." Davis v. Wyeth Lab., Inc., 399

F.2d at 131. The Pennsylvania Supreme Court has yet to

address the applicability of this so-called mass

immunization exception under Pennsylvania law. However,

we assume, for purposes of our analysis here, that it would

A49

adopt the reasoning of the mass immunization cases under

the appropriate circumstances.”

0 The Pennsylvania Supreme Court has yet to be

presented with a situation where the mass immunization

exception would apply. However, it has adhered to the

(footnote no. 20 continued...)

"rule of Jncollingo [and] its rationale," Coyle, 584 A.2d at

1386, the mass immunization exception has been accepted

in other jurisdictions, and there is no contrary authority

under Pennsylvania law.

In Taurino v. Ellen, 579 A.2d 295 (Pa. Super. 1990),

the Pennsylvania Superior Court held that the manufacturer

of Loestrin, an oral contraceptive, was not liable for failing

to warn users directly where that drug was dispensed at a

women's clinic by an employee who was not a physician.

However, this holding was premised on the assumption that

the "manufacturer ha[d] no reason to know that this w[ould]

occur," Jd. at 928, and, as we discuss above, the

applicability of the mass immunization exception tums on

the foreseeability that a vaccine will be dispensed without

a learned intermediary present. Therefore, Taurino is

inapposite.

In any event, because we conclude infra Part II(D)

that Merck satisfied any duty it had to warn users directly

by contractually obligating the CDC to warn vaccinees of

the risks of its MMR II vaccine, we need not decide the

applicability of the mass immunization exception under

Pennsylvania law.

ASO

As we have noted, the mass immunization exception

is better thought of as one context where a prescription

drug manufacturer is obligated to warn users directly of the

facts which make its product dangerous. That is, it restores

the prescription drug manufacturer's duty to warn users

directly, which is satisfied indirectly where the prescription

drug manufacturer provides an adequate warning to a

learned intermediary, because the rationale supporting the

learned intermediary rule buckles where prescription drugs

are dispensed without an individualized medical balancing

of the risks and benefits to the user. The seminal cases on

the mass immunization exception to the learned

intermediary rule, Davis v. Wyeth Laboratories, Inc. and

Reyes v. Wyeth Laboratories, are instructive.

In Davis the plaintiff contracted polio after being

vaccinated for that disease as part of a nationally sponsored

immunization program, and sued the manufacturer of the

vaccine for, among other things, failure to provide an

AS1

adequate warning. The jury returned a verdict for the

defendant, but the court of appeals reversed on the ground

that "the manufacturer [had] a duty to warn the consumer

(or make adequate provision for his being warned) as to the

risks involved." 399 F.2d at 130.

The Davis court explained:

Ordinarily in the case of prescription drugs

warning to the prescribing physician is sufficient.

In such cases the choice involved is essentially a

medical one involving an assessment of medical

risks in the light of the physician's knowledge of his

patient's needs and susceptibilities. Further it is

difficult under such circumstances for the

manufacturer, by label or direct communication, to

reach the consumer without a warming. A warning

to the medical profession is in such cases the only

effective means by which a warning could help the

patient.

Here, however, although the drug was denominated

@ prescription drug it was not dispensed as such. It was

dispensed to all comers at mass clinics without an

individualized balancing by a physician of the risks

involved. In such cases... warning by the manufacturer

—

A52

to its immediate purchase will not suffice. The decision

(that on balance and in the public interest the personal risk

to the individual was worth taking) may well have been that

of the medical society and not that of [the manufacturer].

But just as the responsibility for choice is not one that the

manufacturer can assume for all comers, neither is it one

that he can allow his immediate purchaser to assume. Jn

such cases, then, it is the responsibility of the manufacturer

to see that warnings reach the consumer, either by giving

warning itself or obligating the purchaser to give warning.

Id. at 130-31. (emphasis added).

In Reyes the Court of Appeals adopted the reasoning

of Davis on similar facts. The plaintiff in that case

contracted polio slightly more than two weeks after she was

vaccinated for that disease at a county health clinic. The

vaccine was administered by a registered nurse; no

physician was present. The nurse who administered the

vaccine said that she read the package circular

. |

AS3

accompanying the vaccine, but did not warn the plaintiff of

the risks of vaccination.

The plaintiff sued the manufacturer of the vaccine

for, among other things, failure to warn. The defendant

argued that it met its duty to warn by inserting an adequate

warning — the package circular — in the vials of vaccine,

and that Davis was distinguishable because (1) whereas the

plaintiff in Davis was vaccinated as part of a mass

immunization program, the plaintiff in Reyes was

vaccinated at her parents’ request; (2) whereas the plaintiff

in Davis was vaccinated by a pharmacist, the plaintiff in

Reyes was vaccinated by a "public health nurse"; (3)

compared to the defendant in Davis, it "played a reiatively

passive role" in the national immunization program; and (4)

unlike the defendant in Davis, it "had no knowledge that the

vaccine would not be administered as a prescription drug."

498 F.2d at 1277.

AS4

The Reyes court found the defendant's arguments

unpersuasive. Embracing the rationale of Davis, the court

first observed that "[w]here there is no physician to make

an ‘individualized balancing . . . of the risks,’ . . . the very

justification for the [iearned intermediary rule] evaporates."

Id. at 1276 (quoting Devis, 399 F.2d at 131). The court

then rejected the defendant's attempt to distinguish Davis on

the facts presented.

None of the asserted grounds for distinguishing

Davis justifies a different result here. The first two

arguments are admittedly distinctions between Davis

and the instant controversy, but they have no

bearing on the rationale of the Davis opinion.

Whether vaccine was received during a mass

immunization program or an on-going program

whether it was administered by nurse or pharmacist,

it was, in both cases, dispensed without the sort of

unindividualized medical balancing of the risks to

the vaccinee that is contemplated by the prescription

drug exception.

The third and fourth asserted reasons for

distinguishing Davis from this case are essentially the same:

[the defendant] took no active part in the vaccination

}

AS5

process here, and did not know that its vaccine would be

dispensed without procedures appropriate for distribution of

prescription drugs. Were we to conclude that [the

defendant] neither knew nor had reason to know that its

vaccine would be dispensed without prescription dmg

safeguards, we might be able to hold that the rationale in

Davis is inapplicable here. But [the defendant] had ample

reason to foresee the way in which its vaccine would be

distributed. Jd. at 1277 (emphasis added). The Court

concluded that the defendant "was required to warn

foreseeable users, or see that the Texas Department of

Health” warned them." /d.

As Davis, and particularly Reyes, suggest, it is not

the size of the immunization program which dictates

whether the mass immunization exception is applicable, but

71 Like the CDC here, the Texas Department of Health

had purchased the polio vaccine from the defendant in

Reyes, and shipped it to county health authorities for

distribution. 498 F.2d at 1270.

A56

rather whether the vaccine was dispensed without an

individualized medical balancing of the risks and benefits

of inoculation and the foreseeability that the vaccine would

be dispensed in this manner.” The scope of the

immunization program is, of course, relevant to the

determination whether it is foreseeable that a vaccine will

be dispensed under "clinic-like" conditions, but it is not

controlling. Therefore, we cannot agree that the size of the

city's immunization program alone, which initially involved

a pool of some 300,000 potential vaccinees city-wide,

~ The cased cited by the district court in which courts

have construed the mass immunization exception narrowly

are not to the contrary. See Mazur J, 742 F.2d at 255. As

we have noted, in Walker v. Merck & Co., 648 F. Supp. at

934, the district court found that the nurse who

administered the vaccine was a learned intermediary.

Therefore, it follows that the mass immunization exception

was not applicable. See supra note 18. Likewise, in Petty

v. United States, 740 F.2d at 1440 (emphasis added), the

court of appeals opined: "The duty to warn is imposed on

the manufacturer and in a mass-immunization context,

where there is no learned intermediary, the duty extends to

the ultimate recipient of the vaccine.”

AS7

precludes the application of the mass immunization

exception here.

We have already determined that the MMR II was

not dispensed by a learned intermediary on the day Lisa

Mazur was inoculated. Students were led into the

gymnasium at the Morrison School and vaccinated in

"assembly line" fashion: no individualized medical

judgment was rendered as to which students should be

vaccinated that day.~ Cf. Hurley v. Lederle Lab., 863

* Merck argues that the mass immunization exception

is inapplicable, because about two-thirds of the 300,000

students originally eligible for the «y's immunization

program had ben. weeded out by the time the MMR II

vaccine was actually administered. However, as the Mazurs

point out, these students were excused largely on the basis

of an administrative process of elimination. That is, the

vast majority of these students were eliminated because of

medical records revealing that they had already been

(footnote no. 23 continued...)

vaccinated. With respect to the remaining 100,000 students,

or at least those who attended the Morrison School, there

was no individualized medical judgment made as to who

should be inoculated. Our focus here is on these students.

AS58

F.2d 1173 (Sth Cir. 1988).% Therefore, the pertinent

inquiry here is whether Merck knew or had reason to know

that its vaccine would be dispensed in this manner.

** In Hurley the recipient of a whooping cough vaccine

and his parents sued the manufacturer of the vaccine for,

among other things, failure to provide an adequate warning.

The plaintiffs contended that the vaccine was administered

in “a 'clinic-like' atmosphere," and that the mass

immunization exception was thus applicable. 863 F.2d at

1178. The Court of Appeals disagreed:

We are convinced ... the . . . mass immunization

exception . . . is not applicable. Unlike Reyes, here the

child's personal physician prescribed the shot, and the

vaccine was administered under the supervision of the

physician in his office by his nurse. In short, there is no

question whatsoever but that a _ patient-physician

relationship existed before and at the time the immunization

was given. Indeed, Dr. Lanier testified that he had actually

examined the child. Moreover, the Hurleys admitted in

their complaint that the vaccine was administered under the

direction and control of Dr. Lanier.

Id. (emphasis added). By contrast, no patient—

physician relaonship ever exisied as to Lisa Mazur ai tic aioeiad seal all he d

she was inoculated.

AS9

Prescription drug manufacturers are charged with

knowledge of the distribution system in which their

products are sold. As the Reyes court noted:

A drug manufacturer is held to the skill of an expert

in his field, and is presumed to possess an expert's

knowledge of the arts, materials, and processes of

the pharmaceutical business. Included in such

expertise must be a familiarity with practices and

knowledge common in the drug industry as to

distribution and administration of pharmaceutical

products.

498 F.2d at 1277 (footnote omitted). See also Hoffman v.

Sterling Drug, Inc., 485 F.2d 132, 146 (3d Cir. 1973)

(noting that under Pennsylvania law drug manufacturers °

"must be charged with knowledge of the workings of the

distribution system by which they chose to state the

dangerous effects of [drugs they manufacture] and the

short—comings therein").

Merck sold its MMR II vaccine to the CDC for use

by state and local health agencies. Although Merck

contractually obligated the CDC to warn users directly, it

——

A60

did not require it to ensure that a learned intermediary

would be present. Rather, it gave the CDC the option of

seeing that its MMR II vaccine was administered by a

physician or providing meaningful warnings to vaccinees.

From the beginning, it was apparent that the CDC intended

to comply with the duty to warn provision of its purchase

contract with merck by developing the Important

Information Statement. The CDC made no attempt to

ensure that the MMR II vaccine was administered by a

learned intermediary. Indeed, as we have noted, although

health care professionals like Nurse Frederick had access to

the package circular, no provision was made by either the

CDC or Merck to see that they read them. Therefore, we

cannot agree, as a matter of law, that there was no reason

for Merck to foresee that its MMR II vaccine would be

dispensed without an individualized medical balancing of

the risks and benefits of inoculation.

A6él

Because we believe the MMR II vaccine was

dispensed under "clinic-like" conditions on the day Lisa

Mazur was inoculated and it was foreseeable that the

vaccine would be dispensed in this manner, we conclude

that the mass immunization exception is applicable here,

thus obligating Merck to warn users of the risks of its

vaccine directly. The only question remaining is whether

a .

According to the district court, "Merck is not

responsible for Lisa's injuries if it acted reasonably when it

contracted with the CDC and relied upon its guarantee that

the MMR II vaccine would be administered by a physician

or after a meaningful warning had been provided to Lisa or

A62

her parents." Mazur II, 767 F. Supp. at 701. Because it

found that Merck reasonably relied on the CDC to draft the

Important Information Statement and disseminate it to

vaccinees, the district court held that "Merck exercised

reasonable care to be sure the Mazurs were informed

directly of the risks of MMR II vaccinations. Jd. at 708.

We agree.

As we have discussed, in Davis v. Wyeth

Laboratories, Inc. the Court of Appeals held that, in the

mass immunization context, "it is the responsibility of the

manufacturer to see that warnings reach the consumer,

either by giving warning itself or by obligating the

purchaser to give warning.” 399 F.2d at 131. Accord

Reyes v. Wyeth Lab., 498 F.2d at 1276 (holding that, where

no learned intermediary is present, "the manufacturer is

required to warn the ultimate consumer, or to see that he is

warned"). Although it is clear Merck itself made no effort

to warn vaccinees directly, it did contractually obligate the

CDC to do so. Therefore, we must determine whether a

A63

vaccine manufacturer may meet its duty to warn under

Pennsylvania law by obligating the CDC to warn users

directly where the learned intermediary rule in inapplicable.

As the district court observed, in Berkebile v.

Brantly Helicopter Corp., 337 A.2d 893, 903 (Pa. 1975), a

plurality of the Pennsylvania Supreme Court stated that

"(t]he duty to provide a non-defective product is non-

delegable," and, as we have noted, an inadequate warning

renders a product defective. Relying on Berkebile, the

Mazurs argue that Merck cannot "delegate"™ its duty to

warn under Pennsylvania law to the CDC by contractually

obligating it to warn users directly. We disagree.

2% The District Court drew_a distinction between

"delegating" one's duty to warn and "assigning" it. See

Mazur I, 742 F. Supp. at 260 n.28. Because we believe

Berkebile is inapposite for the reasons we express above,

| Gnd j lore the diff '

i . i . f i . i P .

law.

A6é4

Berkebile is first, and foremost, a section 402A case, and is

inapposite here.

The plaintiff in Berkebile, the wife/executrix of a

man killed in a helicopter crash, brought suit against the

manufacturer of the helicopter under section 402A of the

Reseatement (Second) of Torts alleging, among other things,

failure to warn. In discussing the defendant's duty to warn,

the Supreme Court distinguished between the manufacturer's

duty to warn in negligence, which is governed by the

“reasonable man standard," 337 A.2d at 902 (citing Thomas

v. Arvon Prods. Co., 227 A.2d 897 (Pa. 1967)), and the

manufacturer's duty to warn in strict liability which is "to

provide [adequate] warnings in a form that will reach the

ultimate consumer and inform of the risks and inherent

limits of the product," id. at 903.

As we have explained, although the Mazurs' failure

to warn claims were founded in both negligence and strict

liability, Merck's duty to warn is governed by section 388

A65

of the Restatement because the MMR II vaccine is an

“unavoidably unsafe product." Under that section, Merck

has a duty "to exercise reasonable care to inform those for

whose use the article is supplied of the facts which make it

likely to be dangerous." Incollingo v. Ewing, 282 A2Qd at

220 n.8. The commentary to section 388 recognizes that,

in Certain instances, a manufacturer may meet its duty to

warn by entrusting the communication of warnings to third

persons.

Comment / to section 388 provides:

The supplier's duty is to exercise reasonable

care to inform those for whose use the

article is supplied of dangers which are

peculiarly within his knowledge. Jf he has

done so, he is not subject to liability, even

though the information never reaches those

for whose use the chattel is supplied. The

factors which determine whether the supplier

exercises reasonable care by giving this

information to third persons through whom

the chattel is supplied for the use of others,

are stated in Comment n.

Restatement (Second) of Torts §388 cmt. l(emphasis added).

Comment n to section 388 provides in part:

A66

Giving to the third person through whom the

chattel is supplied all the information

necessary to its safe use is not in all cases

sufficient to relieve the supplier from

liability. It is merely a means by which this

information is to be conveyed to those who

are to use the chattel. . . . [I]t is obviously

impossible to state in advance any set of

tules which will automatically determine in

all cases whether one supplying a chattel for

the use of others through a third person has

satisfied his duty to those who are to use the

chattel by informing the third person of the

dangerous character of the chattel, or of the

precautions which must be exercised in

using it in order to make its use safe. There

are, however, certain factors which are

important in determining this question.

There is necessarily some chance that

information given to the third person will

not be communicated by him to those who

are to use the chattel. This chance varies

with the circumstances existing at the time

the chattel is turned over to the third person,

or permission is given to him to allow others

to use it. These circumstances include the

known and knowable character of the third

person and may also include the purpose for

which the chattel is given. . . [T]he care

which must be taken always increases with

the danger involved. . . .

Id. §388 cmt. n (emphasis added).

A67

Accordingly, we believe a vaccine manufacturer may

by obligating the CDC to warn users directly if it informs

| ie oa

and reasonably relies on it to communicate such

information to users in lay terms. But cf Petty v. United

States, 740 F.2d 1428 (8th Cir. 1984).* The

* In Petty the plaintiff filed suit against the federal

government in negligence and strict liability for, among

other things, failure to warn of the risks of a swine flu

vaccination he received. The District Court found the

government liable under Iowa law, and the Court of

Appellees affirmed. Among other things, the Petty court

rejected the government's argument that it statutorily

assumed the vaccine manufacturer's (Merrill—National) duty

to warn users directly:

We recognize that the government has attempted to

statutorily assume the duty to warn the vaccinees,

however, we do not find that this delegation thereby

relieves the manufacturer from liability for any

resulting inadequacy of the warming. The duty to

wam is imposed on the manufacturer and in a

mass-immunization context, where there is no

learned intermediary, the duty extends to the

ultimate recipient of the vaccine. Delegation of the

duty does not, in itself, relieve the manufacturer of

aaa

A68

manufacturer's responsibility is continuous, and it must

therefore apprise the CDC of any risks it later discovers or,

in the exercise of reasonable care, should have discovered.

its obligation, nor should it insulate the |

manufacturer from liability for deficiencies in the |

manner in which the chosen intermediary effectuates

the manufacturer's duty. Although on the side lines,

Mermill-National is assumed to have had the

knowledge of the warning issued and to have had

the ability to affeet the warning.

740 F.2d at 1440. Because the Court found the

government's warming, disseminated in the form of an

Important Information Statement, inadequate, it held that

(footnote no. 26 continued...)

Merrill-National was strictly liable for failure to warn

under Iowa products liability law. Jd. at 1441.

Significantly, Iowa law adheres to a formal

product/conduct distinction in evaluating failure to warn

claims founded in negligence and strict liability. Jd. at

1440; see supra note 8. Accordingly, the Petty court

formulated Merrill—National's duty to warn under Section

402A of the Restatement (Second) of Torts. As we have

discussed, in the prescription drug context, the Pennsylvania

Supreme Court law applies the Section 388 duty to warn

regardless whether the plaintiff's failure to warn claim is

founded in negligence or strict liability. Therefore, Petty is

inapposite.

ial i allel alien

Telied on the CDC to warn users directly tums on the

foreseeability that vaccinees will not be adequately wamed.

Because the uninformed use of vaccines can be life-

threatening, vaccine manufacturers must be held to a high

Standard of care where they choose to obligate the CDC to

warn users directly.’

All that remains to be decided is whether Merck

Satisfied its duty to warn, as a matter of law, under the facts

here. To answer this question, we must first determine

whether Merck properly informed the CDC of the facts

which make its MMR II vaccine dangerous. We focus here

on the adequacy of the package circular contained in each

vial of MMR II vaccine shipped to the CDC for distribution

*” Our analysis here is limited to the Situation where a

vaccine manufacturer obligates the CDC to wam users

directly. We need not address whether it would be

reasonable for a vaccine manufacturer to rely On another

supplier.

A70

in the public health sector.% Our inquiry is guided by the

traditional tort analysis of adequacy of warning.

Under Pennsylvania law the determination whether

a warming is adequate is a question of law. Mackowick v.

Westinghouse Elec. Corp., 575 A.2d 100, 102 (Pa. 1990).

Adequacy of warnings "should be considered with a view

to all the evidence." Berkebile, 337 A.2d at 902. |

Adequacy of wamings is determined on the basis of the

information that was known or knowable at the time the

cause of action accrued. Leibowitz v. Ortho Pharmaceutical

Corp., 307 A.2d 449, 458 (Pa. Super. 1973). Warnings that

meet federal drug labeling requirements are afforded some

deference. White v. Weiner, 562 A.2d at 383.

In Mazur I, the district court determined that the

package circular was adequate in all respects except for the

* By focusing on the package circular, we do not

Suggest that there are not other ways in which a vaccine

manufacturer might inform the CDC of the facts which

make its vaccine dangerous.

——— °°

A71

revaccination statement. Because that "statement provide[d]

no information about the potential risks associated with

revaccination," the Court found that there was a genuine

issue of material fact as to the adequacy of the package

circular's warning. 742 F. Supp. at 258. In Mazur JI

however, the Court concluded that the package circular,

and, in particular, its revaccination paragraph, was adequate

as a matter of law based on the state of medical knowledge

in 1982, the year Lisa Mazur was inoculated. 767 F. Supp.

at 713. We agree with the district court for the reasons it

expressed.

We limit our discussion here to the Mazur's novel

Challenges to the adequacy of the package circular on

appeal. They contend that the package circular improperly

recommends the use of the MMR II vaccine for those over

the age of eight years, despite the lack of clinical studies

establishing that the vaccine could be safely administered

to "adults." However, as Merck notes, the Mazurs have not

“ A72

pointed to any scientific evidence (available in 1982 or

since then) in the record indicating that the MMR II

vaccine poses a greater risk to adults than children.

The Mazurs further assert that the package circular

is inadequate because it Only contraindicates the

administration of the MMR II vaccine for those "receiving"

corticosteroids as opposed to those who "recently received"

them.” But we think it sufficient that the package circular

provided that "patients receiving therapy with

corticosteroids" should not be vaccinated. The package

circular's intended audience is not the ultimate user, but

rather the learned intermediary. See Mackowick, 575 A.2d

* In the six-month period leading up to her

inoculation, Lisa Mazur suffered from pharyngitis, for

which she was treated with the corticosteroid Depo-Medrol

and eventually had her tonsils removed. On February 26,

1982, Lisa was no longer being treated with corticosteroids.

But the Mazurs maintain she was still in an "immuno-

suppressed condition," because of the "long half-life" of

Depo-Medrol, and therefore should have been warned of

the heightened risk of vaccination caused by her recent

corticosteroid use.

A73

at 102 ("[W]arnings must be directed to the understanding

of the intended user."). Here the package circular was

directed to the CDC, who was contractually obligated to

develop a meaningful warning for vaccinees or their

parents.

Finally, the Mazurs argue that the package circular

is inadequate because it give a "self-serving and overly-

tecnnical explanation" of the risk of contracting SSPE from

the MMR II vaccine. As Merck points out, however, that

portion of the package circular pertaining to the risk of

contracting SSPE was taken, almost verbatim, from a 1977

government report on the association between naturally

OcculTing measles, measles vaccine, and SSPE. Moreover,

as we have noted, the package circular's intended audience

here is the CDC, who Merck caeoks obligated to

develop a warning in lay terms.

Accordingly, we believe Merck adequately informed

the CDC of the facts which make its MMR _ II vaccine

A74

dangerous. The second question is whether Merck

reasonably relied on the CDC to communicate this

information to vaccinees directly. The focus here is on the

foreseeability that the CDC would not honor its purchase

contract with Merck, which required it to see that the MMR

II vaccine was administered by a physician or to provide

meaningful warnings to vaccinees. For purposes of this

inquiry, we oe aS we must at this stage, that Mrs.

Mazur never received the Important Information Statement.

As we have noted, from the beginning it was

apparent that the CDC intended to meet its contractual

obligation to warn MMR II vaccinees directly by providing

a meaningful warning to vaccinees rather than ensuring that

the vaccine was administered by a physician. The CDC

developed this warning-the Important Information

Statement-based on Merck's package circular, previous

Studies it had conducted, and its expertise in the field of

alia a a aati tai,

A75

vaccine safety and administration. The district court

concluded that Merck reasonably relied on the CDC to

develop the Important Information Statement and

disseminate it to vaccinees. Mazur II, 767 F. Supp. at 704.

We agree.

As the district court noted, "Merck initially selected

the CDC as the vehicle through which it would provide

is immaterial to our analysis here. In the first place, as we

have noted, we must assume Mrs. Mazur never received the

Important Information Statement. Therefore, even if it is

inadequate, the Important Information Statement could not

have been a proximate cause of Lisa's vaccination. See

Mazur I, 742 F. Supp. at 259-60. More important, our

inquiry here is whether Merck reasonably relied on the

CDC to honor its contractual obligation by developing a

meaningful warning and disseminating it to vaccinees, not 7

and successfully disseminated it to vaccinees. The latter

inquiry would only be appropriate under strict liability

principles, which, for the reasons we have expressed, are

not controlling here. This is not to say, however, that the

Important Information Statement is altogether irrelevant for

purposes of determining whether Merck reasonably relied

on the CDC. As the District Court observed, its contents

may inform our reasonableness analysis in certain respects.

See Mazur II, 767 F. Supps. at 705 n.13.

A76

adequate warnings to consumers because the CDC sold the

vaccine to the state and local health organizations,

Supervised the distribution of vaccines, and had vastly more

experience than Merck did in the public health field." /d.

at 708. Given the resources and funding available to the

CDC, as well as its expertise in immunology and public

vaccination, we believe Merck's decision to rely on the

CDC to warn users directly was reasonable.

As the district court observed:

The CDC is an agency of the Public Health Service

of the United States Department of Health and

Human Services. It is empowered to conduct

Studies, evaluations, tests, and emergency programs

in order to prevent the spread of disease and to

improve public welfare. With respect to vaccines,

it plays a vital role in research, development,

testing, and distribution. It publishes the Morbidity

and Mortality Weekly Report, among other reports,

Studies, and journals to educate public health and

medical professionals about the risks and benefits of

immunization.

Id. at 706 (citations omitted).

The CDC is also affiliated with the Immunization

Practices Advisory Committee, which is responsible for

A77

recommending the use of vaccines in the public health

sector and comprises representatives from the American

Medical Association, the American Academy of Pediatrics,

the American College of Physicians, the American

Academy of Family Practices, the Department of Defense,

the Bureau of Biologics, the National Institutes of Health,

and the Canadian National Advisory Committee on

Immunization.

Furthermore, Merck carefully researched the CDC

before it agreed to sell its MMR II vaccine to the CDC for

use in the public health sector. As the district court stated,

"Merck based its decision [to rely on the CDC to warm

users directly] on its own past experience with the CDC:

recommendations from physicians; the Bureau of Biologics,

consumer groups; and on conversations with the CDC."

767 F. Supp. at 708. And once Merck made its decision to

rely on the CDC,

A78

lt monitored the CDC's performance through

conversations with these same individuals and

others. . . .[E]ach one of these sources told [it]. . .

that consent forms and Important Information

Statements were being sent by the CDC and, in tum,

to parents by local health organizations participating

in CDC immunization programs. . . . Through its

regular contact with these sources Merck continually

checked the CDC's dissemination efforts. At no

time did it appear the CDC was not doing its job.

Id.

Perhaps, as the district court noted, "Merck might

have been more thorough in its examination [of the CDC]."

It could have, for example, "hired an independent contractor

to review the CDC's conduct." /d. But we are satisfied

that Merck reasonably relied on the CDC to warn vaccinees

directly on the facts before us, and therefore agree with the

district court that "Merck . . .could not have foreseen that

A79

Statement." Jd. Cf. Walker v. Merck & Co., 648 F. Supp.

at 935.”

Accordingly, we cannot accept the Mazurs'

contention that it was foreseeable that the CDC would

“down play" the risks of inoculation with the MMR II

vaccine. There is nothing in the record Suggesting that the

CDC understand the risks of vaccination.22 Likewise, we

*' In Walker the District Court held that Merck satisfied

its duty to warn, as a matter of law, by entering into the

identical contractual provision with the CDC as that here.

The Walker court's holding, however, is Only dictum

because it had already found the learned intermediary rule

Satisfied. See supra note 18. Moreover, as the District

Court observed, the Walker court's analysis of the Merck-

CDC purchase contract was too narrow, because it ignored

altogether the issue whether Merck reasonably relied on the

CDC te warn vaccinees directly. Mazur J, 742 F. Supp. at

261 n.29.

* As Merck points out, the Important Information

Statement provides in part:

Although experts are not sure, it seems that

very rarely children who get the [measles, mumps, and

rubella] vaccines may have a more serious reaction, such as

inflammation of the brain (encepalitis), convulsions with

fever, or nerve deafness.... With any vaccine or drug, there

A80

cannot agree that Merck's reliance on the CDC to warn

vaccinees directly was unreasonable because, given the

"practical difficulties of obtaining informed consent from

children in a school vaccination clinic setting," it was

foreseeable that "some" parents would not receive or heed

the Important Information Statement. As we have

explained, Merck had a duty to exercise reasonable care to

see that vaccinees were informed of the risks of its MMR

II vaccine. For the reasons we have expressed, we are

satisfied that Merck met this duty.

It.

We conclude that the district court properly granted

summary judgment for Merck on the Mazurs' duty to warn

claims. Merck's duty to warn is governed by section 388

of the Restatement (Second) of Torts. Under that section,

is a possibility that allergic or other more common serious

reactions or even death could occur. (emphasis added).

A81

Merck had a duty to exercise reasonable care to inform

vaccinees of the facts which make its MMR II \cccine

dangerous.

Merck could have satisfied this duty b; providing an

adequate warning to a learned intermediary. However,

Nurse Frederick did not, as a matter of law, act as a learned

intermediary between Merck and Lisa Mazur on the facts

here. And because it was foreseeable that the MMR II

vaccine would be dispensed without an individualized

medical judgment of the risks and benefits of inoculation,

Merck was obligated to warn users of the risks of its MMR

II vaccine directly under the mass immunization exception

to the learned intermediary rule.

Nevertheless, Merck met this duty by contractually

obligating the CDC to see that its MMR II vaccine was

administered by a physician or to provide meaningful

warnings to vaccinees. Merck adequately informed the

CDC of the facts which make its MMR II vaccine

A82

dangerous, and reasonably relied on the CDC to

communicate these risks to vaccinees in lay terms.

Accordingly, we hold that Merck satisfied its duty to warn

aS a matter of law, and we will affirm the district court's

order granting summary judgment for Merck.

A8&3

Lisa Marie Mazur, a Minor, in her own

right, and Anthony Mazur and Edna

Mazur, as Parents and Guardians, and

in their own right

MERCK & CO., INC.

Civ. A. No. 85-6494

United States District Court,

E.D. Pennsylvania

June 27, 1991.

DITTER, District Judge.

In this case, a manufacturer is charged with failing

to warn that the use of its vaccine might lead to serious

consequences. Before me is the supplemental motion of

defendant Merck & Co., Inc. for summary judgment and to

A84

exclude expert testimony.’ Plaintiffs Lisa Marie Mazur

and her parents, Anthony and Edna Mazur, claim that Lisa

contracted subacute sclerosing panencephalitis ("SSPE"), a

sever, Often terminal, illness of the central nervous system,

as a result of an inoculation with a measles, mumps, and

rubella vaccine ("MMR II") manufactured by Merck.

Merck's first motion for partial summary judgment

was denied in part and granted in part. Mazur v. Merck,

742 F.Supp. 239, 266 (E.D.Pa. 1990). I denied Merck's

‘At oral argument, Merck withdrew that portion of its

motion concerning expert testimony and causation. Merck

had argued plaintiffs’ experts’ testimony on the causal

relationship between its vaccine and Lisa Mazur's illness

was not supported by the medical literature and did not

create a genuine issue of material fact as to causation.

Merck reserved the right to re—argue that point. Plaintiffs

have withdrawn their claims that Merck's vaccine was

defectively designed and manufactured. Merck had

previously moved for summary judgement on those claims.

The motion is moot as to them. Merck also asserted that

the Mazurs have not shown and could not prove the

proximate cause element of a duty to warn claim. That

issue has been fully briefed by the parties. However, I will

not express an opinion on that point as it is unnecessary to

do so because the motion will be granted on other grounds.

A85

motion as to the federal preemption and statute of

limitations issues. Jd. After a lengthy discussion of the

many other matters raised by the parties, I found that

additional discovery and briefing was necessary and gave

the parties time to conduct both. /d. Specifically, I invited

the parties to address whether or not:

a. Merck acted in accordance with due care

when it contracted with the Center for Disease Control

("CDC") to ensure the presence of a physician at

inoculation or an adequate warning of the risks associated

with vaccination was conveyed to recipients or to their

parents or guardians, id. at 261;

b. the school nurse who supervised the MMR

II inoculation was a learned intermediary, id. at 255;

é. the package circular contained an adequate

warning of the revaccination risks, id. at 258;

d. the proximate cause element of a duty to

warn claim had been satisfied,’ id. at 262-63; and

*As I pointed out above, at 698 n. 1, the proximate

Cause question will not be reached in this opinion.

A86

é. the cause-in-fact element of a duty to warn

claim had been satisfied,’ id. at 266 and n. 33. —

Merck's supplemental motion for summary

judgement will be granted. Merck satisfied its duty to

exercise reasonable care to inform the Mazurs of the

vaccine's risks. Even though no doctor was present, Edith

Frederick, the nurse who supervised the administration of

the vaccine to Lisa Mazur, was a qualified learned

intermediary. She was provided with a sufficient warning

of the risks associated with MMR II inoculation. The

package circular contained an adequate warning of

vaccination risks and accurately reflected the medical

evidence available in 1982. Therefore, Merck cannot be

held liable for Lisa's illness.

"Merck opted to reserve its challenge to the sufficiency

of the Mazurs’ proof of causation until a later date. See

supra at 698 n. 1.

A87

I. FACTS

The facts of this case are described in great detail in

my prior opinion. See Mazur, 742 F.Supp. at 243-45. |

will briefly summarize them here.

In response to a measles epidemic among school

children in Philadelphia in the late 1970's, the City of

Philadelphia, Department of Public Health ("health

department") proposed a regulation, which was later

adopted by the School Board of Health ("school board"),

requiring all children attending a school in Philadelphia to

be vaccinated against a variety of pediatric diseases. The

school board's medical director, Dr. Robert G. Sharrar,

selected Merck's MMR II vaccine for the sieneittnneees

immunization against measles, mumps, a rubella.

Affidavit of Robert G. Sharrar, M.D. ("Sharrar aff."), 9 8,

attached as Merck's exhibit J.

MMR II was packaged in containers which included

an insert descnbing the risks and benefits associated with

A88

its use.* The school board purchased the MMR II vaccines

from the CDC which had, in tum, purchased then from

Merck. The Merck-CDC purchase contract stated the CDC

would assure that a physician be present at each inoculation

or that the CDC would provide MMR II recipients or their

“The April, 1981, package insert or circular contained

the following pertinent information about the risk of

contracting SSPE from the MMR II vaccine:

There have reports of subacute sclerosing

panencephalitis (SSPE) in children who did

not have a history of measles but did receive

measles vaccine. Some of these cases may

have resulted from unrecognized measles in

the first year of life or possibly from the

measles vaccination. Based on estimated

nationwide measles vaccination distribution,

the association of SSPE cases to measles

vaccination is about one case per million

vaccine doses distributed. This is far less

than the association with natural measles, 5-

10 cases of SSPE per million cases of

measles. The results of a retrospective case-

controlled study conducted by the Centers

for Disease Control suggest that the overall

effect of measles vaccine has been to protect

against SSPE by preventing measles with its

inherent risk of SSPE.

A8&9

parents with what Merck and it believed to be an adequate

warning of the risks associated with MMR II immunization.

Opting to proceed under the latter clause, the CDC drafted

an “Important Information Statement" to be sent to all

parents of school-age children. Affidavit of William B.

Freilich, ("Freilich aff."), 1 22 and exhibit 6, attached as

Merck's exhibit E. The Important Information Statement

was sent to parents via their children.

Lisa Mazur received the MMR II vaccine on

February 26, 1982. The vaccine was administered at Lisa's

school under the supervision of Edith B. Frederick, a

registered nurse. Mrs. Mazur claims she never gave her

consent for her daughter's vaccination. She denies receiving

an Important Information Statement or any other warning

about MMR II's risks. She did, however, become aware of

the scheduled immunization, protested Lisa's vaccination to

the school board, and so she would not be vaccinated kept

A90

Lisa out of school for a week prior to the date of the

vaccination.

On November 2, 1983, Lisa was diagnosed as

having SSPE.°

II. DUTY TO WARN

A. The Manufacturer's Duty to Warn.

In my prior opinion in this case, I described and

explained the nature and scope of a vaccine manufacturer's

duty to warn. See Mazur, 742 F.Supp. at 251-53. I need

°SSPE is a slowly progressing, inflammatory disease of

the central nervous system. SSPE most often attacks

children under twenty years of age. Its onset is marked by

mental deterioration and psychological disturbances.

Neurological and motor dysfunctions, such as convulsions,

seizures, visual difficulties, and myoclonic jerks, are often

present. Death usually occurs within onc to three years.

See, e.g., The Merck Manual, 2041 (Merck Sharp & Dohme

Research Laboratories, 15th ed. 1987); Harrison's

Principals of Internal Medicine, 2096 (R. Petersdorf, 10th

ed. 1983). Lisa is still alive, but is presently incapacitated.

A91

not go into such a thorough review here, but a few

comments are necessary.

[1] The standard of care which applies in this

case is set forth in Restatement (Second) of Torts § 388.°

"Under this section, the supplier has a duty to exercise

reasonable care to inform those for whose use the article is

supplied of the facts which make it likely to be dangerous."

*Section 388 provides in pertinent part:

One who supplies directly or through a thiid

person a chattel for another to use is subject

to liability to those whom the supplier

should expect to use the chattel with consent

of the other or to be endangered by its

probable use, for physical harm caused by

the use of the chattel in the manner for

which and by a person for whose use it is

supplied, if the supplier

(a) Knows or has reason to know that the chattel

is or is likely to be dangerous for the use for which

it is supplied, and

(b) has no reason to believe that those for whose

use the chattel is supplied will realize its dangerous

condition, and

them of its dangerous condition or of the facts

which make it likely to be dangerous.

A92

Incollingo v. Ewing, 444 Pa. 253, 282 A.2d 206, 219 n. 9

(1971) (emphasis added). Because MMR II is a

prescription drug product, Merck can Satisfy its duty to

warn the vaccine recipient by exercising reasonable care to

provide an adequate warning to a medical professional who

acts as a "leamed intermediary." Reyes y. Wyeth

Laboratories, 498 F.2d 1264, 1276 (Sth Cir.), cert. denied,

419 U.S. 1096, 95 S.Ct. 687, 42 L.Ed.2d 688 (1974). The

"leamed intermediary rule" recognizes that a medical

professional is qualified by knowledge, experience, and

preparation to exercise his "individual medical judgment

bottomed on a knowledge of both patient and palliative."

Id.

[2] If the vaccine is "dispensed to all comers at

mass immunization clinics without an_ indivualized

balancing by a physician of the risks involved..., [i]t is the

responsibility of the manufacturer to see that warnings

reach the consumer, either by giving warning itself or by

A93

obligating the purchaser to give warming." Davis v. Wyeth

Laboratories, 399 F.2d 121, 131 (9th Cir.1968). Although

this principle has been called the "mass immunization

exception" the learned intermediary rule,’ see, e.g., Hurley

v. Lederle Laboratories, 863 F.2d 1173, 1178-79 (Sth

Cir.1989), it is really one of several circumstances when the

duty to warn the user directly is imposed on the

manufacturer.

If the manufacturer chooses to obligate the purchaser

of the vaccine to give warning, permissible under Davis and

comment n of section 388, the general rule controls and the

manufacturer's warning activities must be examined to see

if they comport with its "duty to exercise reasonable care to

I found previously that mass immunization principles

did not apply in this case because the health department

program was not a "mass immunization," the vaccine was

not dispensed to "all comers," individualized medical

judgments were made that excluded two-thirds of the

potential recipient pool, and Merck could not have foreseen

that no learned intermediary would be present at

inoculations. Mazur, 742 F.Supp. at 255-57.

A94

inform those for whose use the article is supplied of the

facts which make it likely to be dangerous." Incollingo,

252 A.2d at 219 n. 9. The issue of whether or not the

reasonableness standard has been met will most likely tum

on the issue of foreseeability, (i.e., "was it foreseeable that

the purchaser would not provide an adequate warning to the

consumer?" or "was it foreseeable that a learned

intermediary would not be present at inoculation?"). If the

manufacturer acts in accordance with due care it cannot be

liable for the injuries that happen to befall the plaintiff.

B. The Parties’ Contentions.

The Mazurs charge Merck with failing to warn them

of MMR II's risks before Lisa was inoculated. They allege

that they never received any warning from Merck, the CDC,

the health department, or the school board. The Mazurs

posit claims for strict liability and negligence for failure to

warm. These claims depend on proof of four facts: (1)

A95

Merck had a duty to warn adequately Lisa or her parents or

a learned intermediary of the health hazards associated with

MMR II use; (2) Merck breached that duty; (3) Merck's

breach in fact caused Lisa's illness;* and (4) Merck's breach

proximately caused her illness.°

Merck argues it had no duty to warn the Mazurs

directly and it fulfilled its duty to warn by entering into and

relying on its purchase contract with the CDC. It contends

its transactions with the CDC were in accordance with its

"duty to exercise reasonable care to inform those for whose

use the article is supplied of the facts which make it likely

to be dangerous." Incollingo, 282 A.2d at 219 n. 9. Merck

also asserts it did not have a duty to warn Lisa or her

parents directly, because Nurse Frederick was qualified and

in fact acted as a "leamed intermediary," Reyes, 498 F.2d

"See supra at 698 n. 1.

*See supra at 698 n. 1.

A96

at 1276, at the time Lisa received the MMR II inoculation.

Thus, Merck argues it need only have made an adequate

package circular available to Nurse Frederick. It posits that

it has done so. Additionally, it also maintains that the

Mazurs' contention that the revaccination warming was

inadequate is without merit.

With that background in mind, I will first discuss

whether Merck acted in accordance with due care when it

contracted with and relied upon the CDC to provide a

physician or the Important Information Statement to parents.

It did. I will then consider whether or not Nurse Frederick

was a learned intermediary. She was. Because she was, |

will next address whether a warning was made available to

her. It was. Finally, I will analyze whether the package

circular contained an adequate warning of the revaccination

risks. It did. Thus, Merck is entitled to summary judgment

in its favor.

A97

11. DISCUSSION

A. Merck Discharged Its Duty To Warn

Through The CDC Contract.

[3] Merck is not responsible for Lisa's injuries if

it acted reasonably when it contracted with the CDC and

relied upon its guarantee that the MMR II vaccine would be

administered by a physician or after a meaningful warning

had been provided to Lisa or her parents. Mazur, 742

F.Supp. at 260-61.

In the mid-1970's, following Davis v. Wyeth

Laboratories, Inc., 399 F.2d 121 (9th Cir.1968) and Reyes

v. Wyeth Laboratories, 498 F.2d 1264 (Sth Cir.), cert.

denied, 419 US. 1096, 95 S.Ct. 687, 42 L.Ed.2d 688

(1974), Merck reconsidered its vaccine distribution policies.

Freilich. dep. at 109. With these mass immunization

decisions, the courts had created the possibility for

expanded liability, but they had given Merck an out by

permitting it to assign warning tasks to an intermediate

A98

purchaser. Davis, 399 F.2d at 130; Reyes, 498 F.2d at

1276-77. William Freilich, Merck's in-house counsel at

the time, focused on the latter. He saw a way for "Merck

to limit its liability exposure based on the Reyes case."

Freilich dep. at 109. He proposed Merck, other vaccine

manufacturers, CDC representatives, the Immunization

Practices Advisory Committee ("ACIP"), the Bureau of

Biologics, the Food and Drug Administration, the

Committee on Infectious Diseases of the American

Academy of Pediatrics ("Redbook Committee"), state public

health departments, and representatives of parent and

consumer groups meet to discuss alternatives programs. /d.

at 23. At the meeting, three alternatives were suggested.

Id. at 109-10.

The first proposal was to require manufacturers to

be responsible for vaccine administration throughout the

country. /d. at 23 and 107. According to Freilich, this

"ridiculous" idea was dismissed rather readily because none

A99

of the manufacturers had any experience in public health

administration issues and there were a wide variety and

large number of public health agencies and experts in a

better position to deal with large-scale immunization. /d.

at 24 and 107-08.

The second suggestion, one that was adopted by all

of the participants at the meeting, was to lobby for the

establishment of a no-fault compensation fund for children

injured as a result of immunizations. The National

Childhood Vaccines Injury Act of 1986, 42 U.S.C. §§

300aa-33, was the product of this legislative initiative. See

Mazur, 742 F.Supp. at 246-47.

The third alternative, one that was adopted by Merck

and the CDC, was to require the CDC, as the primary

purchaser of Merck's MMR II vaccines, to disseminate

warnings to individuals who would receive the vaccine as

part of a public health program. Freilich dep. at 143

Freilich talked to each of the participants at the meetings

A100

before he made his determination that the Merck-CDC

purchase contract was the best means to ensure that a

warming was provided to vaccine recipients in order to limit

Merck's liability exposure. Jd. at 143-49.

To that end, in the late 1970's and early 1980's,

Merck and the CDC entered into three contracts for the sale

and purchase of MMR II. The Merck-CDC purchase

contract provided in pertinent part that the CDC:

represents and agrees that it will (1) take all

appropmiate steps to assure that all vaccine

supplied to various locations within the 50

States,... pursuant to the terms of. this

contract, shall be administered to each

patient on the basis of an individualized

medical judgment by a physician, or (2) take

all appropriate steps to provide to such a

patient (or to the patient's parent or

guardian) meaningful warnings relating the

risks and benefits of vaccination, in form

and language understandable to such patient,

parent or guardian.

Freilich aff. at 1 17 and exhibits 3, 4, and § attached

thereto. Freilich drafted most of the "duty to warn clause,"

Freilich dep. at 177, but both Merck and the CDC

Cee: a

Al01

negotiated the contract, id. at 178-79, and the CDC made

proposals which were eventually included in the final

document, id. at 183-84.

Soon after entering into the contracts, the CDC set

out to draft a comprehensible, yet substantively adequate

warning for vaccine recipients or their parents. The

Important Information Statement was intended to serve that

purpose. The CDC drafted an Important Information

Statement for all the vaccines it provided to local public

“The CDC never proceeded on a plan to ensure the

presence of a physician at each inoculation. It selected the

alternative route and required local health agencies to use

the Important Information Statement. If, like here, the local

health agency required a learned intermediary to be present

at inoculation, the vaccine manufacturer cannot be held

liable even if the local health agency or the CDC failed to

disseminate the Important Information Statement. In other

words, even though the Merck-CDC contract called for the

CDC to ensure that a physician would be present at each

inoculation—and even though that was not done so far as

Lisa Mazur was concemed-the presence of a learned

intermediary, Nurse Edith Frederick, see infra at 708-711,

precludes imposing responsibility for Lisa's ensuing illness

on Merck.

A102

health agencies. For its sources for ihe manie mumps,

and rubella Important Information Statement, the CDC used

Merck's MMR II package circular, previous CDC Studies,

and its own genera! -xpertise in the fields of vaccine safety

" and administration. Freilich aff. ™ 24-25. Merck did not

materially participate in the preparation of the Important

Information Statement, except for providing the CDC with

the package circulars. Freilich aff. at 1 25.

The CDC obligated, as a condition of purchase, the

state and local health agencies, such as the health

department, to provide vaccine recipients or their parents

with the appropriate Important Information Statements.

Freilich aff. 2 at 1 22; Childhood Immunization Project

Grants: Guidelines for Applications, February, 1980, at

10." The health department distributed the Important

"The Guidelines provide:

VI. USE OF INFORMATION STATEMENTS

ON RISKS AND BENEFITS OF

VACCINATION

A103

Information Statements during the 1981-82 immunization

program.” Deposition of Herbert Hazan, at 25-26,

attached as Merck's exhibit F.

The Mazur’s charge it was not reasonable for Merck

to rely on the CDC because: (1) Merck was improperly

A. In order to assure appropriate provision of

information relating to risks and benefits of

vaccination in programs for which funds are

made available pursuant to this grant,

grantees shall take the following steps:

1. Establish procedures for providing copies of

the appropriate "Important Information"

forms .. to all vaccinees (parents or

guardians) receiving vaccinations in public

Clinic settings... Any other addition to the

forms, or variation from the language or

format of them, must have prior written

approval of the [CDC].

"In the first round of motions, the Mazurs argued the

fact that Mrs. Mazur never received an Important

Information Statement from the health department showed

that Merck acted unreasonably in relying on the CDC to

provide a warning to her. Mazur, 742 F.Supp. at 261. I

rejected this argument because the relevant issue is not

Whether she actually got an Important Information

Statement, but whether Merck could foresee she would not

get one. /d.

A104

motivated to do so; (2) Merck knew the difficulty in

drafting an adequate warning directed to the recipient or her

parents; (3) Merck knew the CDC would draft an Important

Information Statement which downplayed the real risks cf

MMR II inoculation in order to increase the number of

recipients; (4) Merck knew earlier versions of the Important

Information Statement were sometimes not read or not

understood by the recipient or her parents; and (5) Merck

failed to investigate initially and to monitor continually the

CDC's performance under the contract. Merck contends it

contracted with the CDC, after careful negotiation and

planning, because the CDC was in the best position to

provide vaccine recipients with a meaningful warning and

it had no reason to doubt that the CDC would not do so.

I conclude Merck acted in accordance with its duty of care

and the Mazur's arguments to the contrary must be rejected.

A105

3 Merck's Motivation Is Irrelevant.

The Mazurs charge Merck with unreasonable

conduct because of its attempt ‘to limit its liability

exposure." Freilich dep. at 109. The Mazurs assert "that

the impetus for these meetings was not to devise the best

method for warning the public of vaccine nsks, but to

devise a way for Merck and other vaccine manufacturers to

continue to market vaccines, while at the same time

insulating themselves from the specter of liability raised by

the Reyes case." Mazur's resp. at 18. I will assume this is

SO, despite the absence of proof that it is. There is no

requirement, however, that Merck be an altruist before it

can avoid liability. If that were the case, Merck should be

blamed for charging the CDC for the vaccines—it should

have provided them free. Merck is permitted, under the

very decision the Mazurs assert prompted this allegedly

unscrupulous behavior, to obligate a third party to carry out

its warning tasks. Reyes, 498 F.2d at 1276. That Merck

. A106

may have done so to limit its liability exposure rather than

for altruistic or humanitarian reasons is of no consequence.

If the Mazurs' argument is taken to the extreme, few

Suppliers could ever escape liability for the injunes which

their products cause, because most suppliers act with a

profit motive rather than with an altruistic one. Limiting

liability exposure is one way of maintaining whatever profit

Sales create. I am certainly not prepared to foist liability

Onto every manufacturer, distributor, or retailer because it

acts in its own self-interest; any warning, whether provided

by Merck or the CDC, was intended to limit Merck's

liability. Merck could supply its vaccine products without

a warning, and face devastating consequences in the form

of law suits and criminal sanctions. A warning limits the

Chance such things might happen. Merck's motivation in

relying on the CDC is not relevant to the issue of whether

Merck acted in accordance with due care.

A107

Merck Reasonably Relied On The

CDC To Draft The Important

Information Statement.

The Mazurs' second argument focuses on Merck's

unsuccessful attempt to draft a package circular which

could be understood by patients. They argue since Merck

knew it was very difficult to create such a warning, it

Should have known the CDC would not be up to the task.

Essentially, they charge if Merck knew creating an

understandable warning was hard, it acted unreasonably

when it required the CDC to come up with one.

This argument relies on a mischaracterization of

Freilich's deposition testimony. Freilich freely admitted

Merck had tried and failed to develop a "package circular"

that would be comprehensible to vaccine recipients or their

parents. Freilich dep. at 120, 123-25, 127-33, 135-36, and

140-41. Freilich also stated, however, a "consent form" or

an “important information form" can be written for lay

understanding. /d. at 135. The Mazurs glide over the

A108

highlighted terms and attempt to equate them. Freilich

explained that a "patient package circular,” id. at 140, was

different than an important information form in that a

patient package circular must contain "all recommendations

and knowledge that a manufacturer feels is relevant and

important to accompany its product, and ... required ... by

the Federal Government... And that package circular is

required to accompany the product when it's sold in

interstate commerce." /d. at 136. Clearly, what Freilich

was talking about was a document that complied with all -

the requirements of federal drug regulations and was still

comprehensible to a lay person. Merck found the terms

required under federal law to be too technical to be

explained in ordinary language. /d. at 140-41. Merck was

also concerned about the possibility the patient package

circular would not reach the patient because it would be

placed in the vaccine container which is often not- made

available to the patient. /d. at 142. In light of these facts

A109

and given Merck's belief that a comprehensible warning, not

necessarily a patient package circular, could be drafted, it

was reasonable to assign the task of Creating and

disseminating a separate document, the Important

Information Statement, to the CDC.

x The CDC Did Not

Downplay The Risk.

The Mazurs' next contention is the most specious.

Basically, they charge Merck should not have trusted the

CDC, because Merck knew or should have known the CDC

willfully downplays the risks inherent in MMR II

vaccination in order to entice children into receiving the

vaccine. This contention must be rejected for a number of

reasons.

First, the Important Information Statement does not

downplay the risks associated with MMR I] inoculation.

The October 1, 1980, Important Information Statement, the

A110

one used in the 1981-82 immunization drive, carefully and

clearly describes the grave dangers which could result from

measles, mumps, and rubella. Then, it explains who should

receive the correlating vaccines. The side effects of the

vaccines are stated:

About 1 out of every 5 children will get a

rash or slight fever 1 or 2 weeks after

getting measles vaccine lasting for a few

days. Occasionally there is mild swelling of

the salivary glands after mumps vaccination.

Although experts are not sure, it seems that

very rarely children who get these vaccines

may have a more serious reaction, such as

inflammation of the brain (encephalitis),

convulsions with fever, or nerve deafness.

About 1 out of every 7 children who get

tubella vaccine will get a rash or some

swelling of the glands of the neck 1 or 2

weeks after the shot. About 1 out of every

20 children who get rubella vaccine will

have some aching or swelling of the joints.

This may happen anywhere from 2 to 10

weeks after the shot. It usually lasts 2 or 3

days. Adults are more likely to have these

problems with their joints—as many as 1 in 4

may have them. Other side effects, such as

pain, numbness, or tingling in the hands and

feet have also occurred but are very

uncommon.

Alll

With any vaccine or dmg, there is a

possibility that allergic or more serious

reactions or even death could occur.

A warning which plainly states that encephalitis,

convulsions with fever, nerve deafness, serious reactions, or

death may follow immunization is not what a reasonable

juror would call "downplaying" a vaccine's risks. Those

wamings were qccurate given the state of medical

knowledge in 1982, see infra at 40-45, and were in a form

and in terms the intended reader would understand. Had a

vaccine recipient and his parents read the Important

information Statement, they would have understood the real

risks associated with MMR II inoculation.

The Mazurs, through their expert Dr. Kevin C.

Geraghty, contend that there were five inadequacies, i.eé.,

areas in which the CDC downplayed the true risks, in the

A112

1980 Important Information Statement which made Merck's

reliance on the CDC unreasonable”’.

1. the terms encephalitis is not properly

described;

a a proper revaccination warning is not

included;

a certain possible side effects of the measles

vaccine, such as permanent brain damage, blindness, and/or

death, are not listed;

4. recipients should have been warned to defer

vaccination until after consultation with a physician if they

had been hospitalized within the previous 90 days; and

‘The Mazurs cogently argue that the language of the

Important Information Statement is relevant to whether

Merck exercised reasonable care to inform them of the risks

of MMR II inoculation, because, for example, if Merck had

authorized the CDC to disseminate the Important

Information Statement in Latin, as opposed to English, with

the knowledge that very few people understand Latin, that

would not be in accordance with due care. Similarly, it

would not be reasonable for a manufacturer to ask a

delivery company if its trucks were safe when it knew that

the drivers of the trucks were blind, and then nonetheless

award a delivery contract to the delivery company.

Therefore, I will examine the Important Information

Statement to determine if Merck acted reasonably when it

relied upon the CDC to issue it.

All3

. a recipients should have been warned to defer

vaccination until after consultation with a physician if they

had recently received prescription medication.

Affidavit of Kevin C. Geraghty, ("Geraghty aff.") at 1 35,

attached as Mazurs' exhibit 57. These alleged deficiencies

in the Important Information Statement are without merit.

Except for the revaccination complaint, which I will discuss

and reject in the package circular portion of this opinion,

infra at 40-45, I will consider these allegations in tum.

First, the encephalitis charge: it is important to note

that the term encephalitis is used to further specify the lay

description "inflammation of the brain.” Thus, Dr.

Geraghty's accusation is calculated to mislead since the

term encephalitis is in and of itself a description of a

condition. More significant is the fact that encephalitis is

defined in Dorland's Illustrated Medical Dictionary, 483

(24th ed. 1965) as "inflammation of the brain." Dr.

Geraghty's complaint is disingenuous. It is difficult to

understand how the term encephalitis could be better

All4

described to a layman than by its definition. Certainly,

there are types of encephalitis, SSPE, for example, which

could have been listed but that would not have aided the

lay reader because she would not understand what the terms

meant. "Inflammation of the brain" adequately describes

and defines encephalitis for the intended reader of the

Important Information Statement.

I agree that the Important Information Statement

does not use the words "brain damage” or "blindness," but

the clear impression it leaves is that these medical problems

could result from the inoculation. "Inflammation of the

brain" describes damage to the brain, death is listed as a

possible consequence of immunization, and although

blindness is not among the warnings, it is encompassed in

the unspecified "serious reaction” category. Even if

blindness could not be so included, Dr. Geraghty does not

identify any medical research that would support the

A115

inclusion of the term in the Important Information

Statement.“

The ninety—day and prescription drug limitations are

similarly unsupported by the medical evidence available in

February, 1982. Dr. Geraghty does not refer me to a single

article predating 1982 that concludes the physical health of

the vaccine recipient is a causative factor in the onset of

illness following measles, mumps, and rubella vaccination.

Dr. Geraghty also does not explain what the problem is

with the Statement's warning that:

“Dr. Geraghty relies, in part, I assume, on Kazarian,

Optic Neuritis Complicating Measles, Mumps, and Rubella

Vaccination, 86 American Journal of Ophthalmology 544

(1978), to Support his opinion. That article, however,

merely concludes there is a possible relationship between

the trivalent measles, mumps, and rubella vaccine and optic

neuritis. The patient which the article describes was

temporarily without sight in his left eye and that eye was to

some degree impaired for over a year. Optic neuritis is an

inflammation of the optic nerve. A possible correlation

between the vaccine and Optic neuritis would not create the

necessity of a special warning for possible blindness in light

of the other serious side effects described within the

Important Information Statement.

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SOME PERSONS SHOULD NOT TAKE

THESE VACCINES WITHOUT

CHECKING WITH A DOCTOR:

* Those who are sick right now with something

more serious than a cold

* Those with an allergy to an antibiotic called

neomycin.

* Those with cancer or leukemia or lymphoma.

* Those with diseases that lower the body's

resistance to diseases.

* Those with diseases that lower the- body's

resistance to infection such as cortisone or prednisone.

* Those who have received gamma globulin within

the preceding 3 months.

(emphasis in original). These warnings adequately apprise

the vaccine recipient or his parents that the physical health

of the recipient at the time of aa immediately before the

inoculation is an important factor in the immunization

determination, one that should be analyzed by a medical

professional. In sum, there is nothing about the wording of

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the Important Information Statement which made its use by

the CDC and Merck unreasonable.

Second, were I to accept the argument that Merck

knew or should have known the CDC would mislead

children and their parents about the risks inherent in MMR

II inoculation to increase the number of vaccinations, [

would have to find the very agency created to promote and

to protect the public welfare cannot be trusted. The Mazurs

provided me with no reason to do so. The CDC is an

agency of the Public Health Service of the United States

Department of Health and Human Services. It is

empowered to conduct studies, evaluations, tests, and

emergency programs in order to prevent the spread of

disease and to improve public welfare. With respect to

vaccines, it plays a vital role in research, development,

testing, and distribution. 42 U.S.C. § 300aa-2; Freilich aff.

at 19. It publishes the Morbidity and Mortality Weekly

Report, among other reports, Studies, and joumals, to

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educate public health and medical professionals about the

risks and benefits of immunization. Freilich aff. at 9 11.

One of its more important functions is to provide financial

and medical assistance to state and local health agencies,

such as the health department, so they can operate

immunization programs. It performs that function to

increase the number of vaccine recipients, because that

makes for a healthier populace. There is nothing improper

with this goal and there is no evidence from which I can

conclude the CDC sought to achieve this goal by lulling

potential recipients into a false sense of security about the

risks of immunization. The Mazurs have not offered

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