Petition for Writ of Certiorari — Plummer v. Lederle Laboratories
Supreme Court brief1987
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87-2800
O. FILED
4UG 18 1987
JOSEPH F. SPANIOL, UR
Supreme Court of the United Stes —“ __
In The
October Term, 1987
HARRY PLUMMER,
Petitioner,
VS.
LEDERLE LABORATORIES, A Division of AMERICAN
CYANAMID COMPANY,
Respondent.
PETITION FOR A WRIT OF CERTIORARI TO THE UNITED
STATES COURT OF APPEALS FOR THE SECOND CIRCUIT
ALFRED S. JULIEN
JULIEN & SCHLESINGER, P.C.
Attorneys for Petitioner
Two Lafayette Street
New York, New York 10007
(212) 962-8920
STUART A. SCHLESINGER
Of Counsel
4873
*NJ 201) 257-6850¢'800) 3 APPEAL *NY 212) 340-4640°MA 617) 542-1114
OC 202) 783-7288*¢PA 215) 925-0500*USA 300) 5 APPEAL
pe bd .
yp rimters.ine.
QUESTION PRESENTED
1. In a product liability case involving the oral polio vaccine,
where two juries answered special interrogatories and specifically
found that the respondent drug manufacturer’s warnings were
inadequate and that this was a proximate cause of the petitioner’s
injuries, was the United States Court of Appeals for the Second
Circuit correct in entering judgment, notwithstanding the verdict,
in favor of the respondent, on the alleged ground that a
‘*reasonable jury could not have found proximate cause’’ and
thus in essence, deprived the petitioner of his constitutional Seventh
Amendment right to a jury trial?
LIST OF PARTIES
The parties in the litigation in the United States Court of
Appeals for the Second Circuit are all identified in the caption.
il
TABLE OF CONTENTS
Page
Question Presented... sc 5 5 sn cea ee i
Riot oF Parties oo 5 ces es ieee eee i
Tabite of Comeeeea . «oc i ein eee ll
Tabs of CMON. £060 ae ee ee il
Opinions Below «2... 6.005 5 ckcddisesspussen ene 2
Sectement of Juriedictios. .... 665.0. k cin 02a sa thee eee 2
Cunmiiiand Provisions Involved .............0ce00s 2
Statement of the Case... .i.cisc0useu meee eaten 3
Reasons for Granting the Wit... . <<. see ce denees 5
I. Article Seven of the Constitution prohibits the court
from reexamining the findings of fact made by the
jury which are supported by the record.......... 6
Comelusion ... 0.6 cccsssesesan eee 10
TABLE OF CITATIONS
Cases Cited:
Flood v. Wyeth Laboratories, 228 Cal. Rptr. 700 (Ct. App.
20 Dist., Aumpuet &; FR. s..acdinnc cece 5
il
Contents
Givens v. Lederle, 556 F. 2d 1341 (Sth Cir. 1977)....... 3
Lavender v. Kurn, 327 U.S. 645. 66 S. Ct. 740 (1946)
A ea IEE N Er ae a a 7, 8
Layne & Bowler Corp. v. Western Well Works, Inc., 261
me ot, So ok. S22, 67 L. Ed. 712 (1922)....... 9
Mattivi v. South African Marine Corporation, ‘‘Huguenot’’,
er ee Ge, COM sive kes eccnsneocss 8
Paul v. Boschenstein, 105 A.D. 2d 248, 482 N.Y.S. 2d 870
EE s,s 5 sk kos WA Ooo eo he O88 3
Tennant v. Peoria & P.U. Ry. Co., 321 U.S. 802, 64S. Ct.
go sg lige oe ea 7
Statute Cited:
ee ee ee 2
Rule Cited:
I i in cnc acu ases bine uvscesese's 8
United States Constitution Cited:
re eee i esudaddewes Be Me eg tu
Other Authorities Cited:
New York Times, Saturday Nov. 15, 1986 pg. 1 ........ 5
Piyescweme Teek Reference ................... ccc eees 3
iv
Contents
APPENDIX
Appendix A—Order of the Second Circuit Denying Plaintiff’s
RE COe TRI oi a oon cc hk a oe eee hades.
Appendix B—Decision of the United States Court of Appeals
for the Second Circuit, Reported at 819 F. 2d 349
ee en, NE, ny ha 8e AVR Rees Te oe bek cowe Rees.
Appendix C—Mandate of the Second Circuit Granting
Lederle’s Appeal Granting Lederle Judgment N.O.V.
and Dismissing the Complaint Denying Plaintiff’s
I iad ce hea Rad ek RUA eens
Appendix D—Judgment Dated August 11, 1986 in Favor
to hc cated aaa eka an eae ee uae <
Appendix E—Order of the District Court, Honorable John
E. Sprizzo, Dated July 24, 1986, Refusing to Set
Asi@e the Jury’s Socomd Verdict ...........020005-
Appendix F—Order Dated September 2, 1986, Denying
the Plaintiff’s Motion to Amend the Judgment for
Interest Running from an Earlier Date.............
Appendix G—Transcript of Court’s Decision Dated February
es WN coca caesar Nakai eda a eee es cs
Appendix H—Order of the Honorable John E. Sprizzo
Dated February 24, 1986, Granting Defendant’s Motion
for a New Trial After the First Jury’s Verdict in Favor
of Plaintiff and Limiting the Issues for the Second Trial
Pursuant to the Court’s Oral Directions in the Opinion
Contained in the Transcript of February 21, 1986
2a
Page
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26a
28a
30a
36a
60a
No.
In The
Supreme Court of the United States
October Term, 1987
HARRY PLUMMER,
Petitioner,
VS.
LEDERLE LABORATORIES, A Division of AMERICAN
CYANAMID COMPANY,
Respondent.
PETITION FOR WRIT OF CERTIORARI TO THE UNITED
STATES COURT OF APPEALS FOR THE SECOND CIRCUIT
To the Honorable William H. Rehnquist, Chief Justice of the
United States, and to the Honorable Associate Justices of the
United States Supreme Court:
Petitioner, Harry Plummer, respectfully prays that a writ of
certiorari be issued to review the decision dated May 19, 1987
and the mandate and judgment dated July 16, 1987, of the United
States Court of Appeals for the Second Circuit, which were entered
in this case granted the respondent judgment n.o.v. and dismissed
the petitioner’s claim.
OPINIONS BELOW
The opinion of the United States District Court for the
Southern District of New York, the Honorable John E. Sprizzo,
dated February 21, 1986 on the respondent’s motion to set aside
the first jury’s verdict is reproduced in the Appendix and has not
been reported officially or unofficially. The opinion and order
of the United States District Court, Southern District of New York,
the Honorable John E. Sprizzo, dated July 24, 1986, denying
the respondent’s application for a new trial or judgment n.o.v.
following the second trial is printed in the Appendix and has not
been reported officially or unofficially. The opinion of the United
States Court of Appeals for the Second Circuit is printed in the
Appendix and is officially reported at 819 F.2d 349 (2d Cir. 1987).
The order of the United States Court of Appeals for the Second
Circuit, denying the petitioner’s motion for rehearing en banc
is reproduced in the Appendix and has not been reported officially
or unofficially.
STATEMENT OF JURISDICTION
The mandate of the United States Court of Appeals for the
Second Circuit which is sought to be reviewed is dated July 16,
1987. The opinion of the United States Court of Appeals for the
Second Circuit is dated May 19, 1987. The order denying the
motion for a rehearing en banc is dated July 2, 1987. The
jurisdiciton of this Court is invoked under 28 U.S.C. § 1254(1).
CONSTITUTIONAL PROVISIONS INVOLVED
The Seventh Amendment provides in pertinent part:
‘‘In Suits at common law, where the value in
controversy shall exceed twenty dollars, the right
of trial by jury shall be preserved, and no fact tried
by a jury, shall be otherwise reexamined in any
Court of the United States, than according to the
rules of common law.’’
STATEMENT OF THE CASE
This petition is being brought by a 51 year old man who
is now confined to a wheelchair because he contacted polio when
he came into contact with his granddaughter who had recently
been immunized with the defendant’s oral polio vaccine (Orimune).
‘For years the respondent claimed that its vaccine could not cause
polio to persons who came into contact with someone who had
been vaccinated with it. See Givens v. Lederle, 556 F.2d 1341,
1344 (Sth Cir. 1977). The respondent now admits that contact
polio is possible, in fact, claims that it was so well known that
there was no need to warn of it.
The polio vaccine had been administered by a doctor in South
Lake Tahoe, California, who in his testimony, claimed that he
was aware of the risks of contact polio.* Petitioner brought the
action claiming that this respondent, the manufacturer and
distributor of the vaccine, had failed to adequately warn of the
real risks of developing contact polio and had failed to warn of
what precautions must be taken to avoid contact polio, which
is totally avoidable if the proper precautions are taken.
Contact polio is polio which afflicts someone who has himself
not been vaccinated and who comes into contact with someone
who has been vaccinated with the live polio vaccine manufactured
by the respondent. In order to avoid contact polio, an adult who
° This doctor is a defendant in an action brought in the State of California
and of necessity had to claim that he was aware of those risks of contact polio
which had been published in the Physician’s Desk Reference (P.D.R.). if not,
he would be admitting his own negligence. See Paul v. Boschenstein, 105 A.D.2d
248, 482 N.Y.S.2d 870 (2d Dept. 1984).
has not been vaccinated should avoid contact with an infant’s
spittle or stool for thirty days after the vaccination.
The case came on to be heard in the United States District
Court for the Southern District of New York. A jury answered
special interrogatories, specifically finding that the respondent’s
warnings were inadequate and that this was a proximate cause
of the petitioners injuries and entered a general verdict in favor
of the plaintiff for $3,200,000.
The District Court set aside the first jury’s verdict on grounds
not raised by the respondent, but raised sua sponte by the District
Court, that in giving a supplemental charge to the jury, the court
erred in failing to specifically recharge the jury that the petitioner
might somehow be a cause of his coming down with polio.
The District Court specifically found that there was sufficient
evidence for the jury to have ruled in favor of the petitioner and
limited the retrial to the issue of causation.
At the second trial a second jury answered 7 special
interrogatories and again found that the respondent’s warnings
were inadequate and that this was a cause of the petitioner’s
injuries. The respondent’s motion to set aside the second verdict
was denied and judgment entered for the petitioner.
The respondent then appealed from that judgment. The
United States Court of Appeals for the Second Circuit made the
astonishing finding that judgment notwithstanding the verdict
should be entered for Lederle ‘‘because a reasonabie jury could
not have found proximate cause,’’ 819 F.2d at 359, and then went
on to direct the dismissal of the petitioner’s complaint.
REASONS FOR GRANTING THE WRIT |
The decision and order of the United States Court of Appeals
for the Second Circuit should be reviewed by this Court because
any reasonable reading of the record indicates that there was
sufficient evidence for two juries to make their specific findings
that the respondent’s warnings were inadequate and that this was
a proximate cause of the petitioner’s harm.
What the Second Circuit did, in violation of the Seventh
Amendment, was in fact legislation by judicial fiat and social
engineering, under the guise of a judicial decision; it reexamined
the jury’s findings of fact, which were fully supported by the
record, when they had no right to do so, under the Seventh
Amendment.
The issue of products liability and the right to bring actions
against manufacturers of vaccines is now before the courts on
numerous occasions. See e.g., Flood v. Wyeth Laboratories, 228
Cal. Rptr. 700 (Ct. App. 2d Dist., August 8, 1986), and there
are various bills in the United States Congress dealing with
immunity for makers of vaccine, compensation for victims injured
by vaccines, etc. See New York Times, Saturday Nov. 15, 1986,
pg. 1. It is admittedly a hot topic upon which there are strong
opinions on each side.
The issue before this Court is whether the United States Court
of Appeals may, contrary to the Seventh Amendment and because
of its own views on the propriety of bringing a product liability
claim against a manufacturer of a polio vaccine, overrule the jury’s
findings of fact, which are clearly supported by the record, so
as to dismiss a plaintiff’s claim when the law and the Seventh
Amendment require otherwise.
The issue before this Court is to make it clear that the United
States Courts of Appeal and District Courts do not have a right
to reexamine or overrule the jury’s findings of fact, so long as
the findings are contained in and supported by the trial record
and the jury’s determination was reasonable.
Issues as to whether or not a negligence or product liability
claim should be permitted against vaccine manufacturers should
be determined by state legislatures and the United States Congress
and not by the Court of Appeals, simply because a jury’s findings,
supported by the record, may not agree with the court’s own views.
ARTICLE SEVEN OF THE CONSTITUTION PROHIBITS
THE COURT FROM REEXAMINING THE FINDINGS OF
FACT MADE BY THE JURY WHICH ARE SUPPORTED BY
THE RECORD.
In the case now before the Court, a review of the record
makes it clear that the jury’s findings were fully supported by
the record. The respondent, in warning of the risks of getting
contact polio, deliberately misstated the risk. The respondent, in
reporting the risk, made it appear that the risk of getting contact
polio was more than one per.million. This was misleading in that
the only people at risk were those adults who iiad not been
vaccinated, and for those persons, the risk was far more
substantial.
In the United States between 1969 and 1976, there were 34
cases of contact polio reported. This was far more than people
getting polio from any other source.
This is not to say that the jury of necessity had to find in
favor of the plaintiff, but once two juries found in favor of the
plaintiff by answering special interrogatories finding that the
warnings were inadequate as had been carefully explained by
petitioner’s expert, Dr. Darryl Salk, there was no basis for the
Court of Appeals to state that no reasonable jury could have so
found.
If the record is reviewed in this case by this Court it will
become clear that the only basis for the Court of Appeals decision
was legislation by judicial fiat and that the record does not support
the decision of the Second Circuit.
It has unfortunately become the custom that many courts
have sought to impose the view of the judge or panel of judges
SO as tO create a social structure acceptable to the court. That,
however, is not the law and limits must be put upon the courts
legislating by judicial fiat in violation of the United States
Constitution and petitioner’s Seventh Amendment rights.
The Constitution makes it clear in the Seventh Amendment
that the findings of fact by a iury shall not be ‘‘reexamined in
any court of the United States.’’ This Court has made it clear
time and again, as it stated in Tennant v. Peoria & P.U. Ry. Co..,
321 U.S. 802, 64 S. Ct. 610 (1944):
‘**Courts are not free to reweigh the evidence and
set aside the jury verdict merely because the jury
could have drawn different inferences or
conclusions or because judges feel that other results
are more reasonable.’’ 321 U.S. at 35.
Similarly, in Lavender v. Kurn, 327 U.S. 645, 66 S.Ct. 740
(1946), this Court stated:
**. . . where, as here, there is an evidentiary basis
for the jury’s verdict, the jury is free to discard
or disbelieve whatever facts are inconsistent with
its conclusion. And the appellate court’s function
is exhausted when that evidentiary basis becomes
apparent, it being immaterial that the court might
draw a contrary inference or feel that another
conclusion is more reasonable.’’ 327 U.S. at 653.
There is no question that where there is no
evidence supporting the jury’s verdict, or that the
verdict could not have been reached on any fair
evaluation of the evidence, that the verdict may
be set aside. See F.R.C.P. Rule 50(b).
However, as the Second Circuit stated in
Mattivi v. South African Marine Corporation,
“‘Huguenot’’, 618 F.2d 163, 167 (2d Cir. 1980),
Judgment n.o.v. should be granted only wien:
‘**(1) there is such a complete absence of evidence
supporting the verdict that the jury’s findings could
only have been the result of sheer surmise and
conjecture, or
(2) there is such an overwhelming amount of
evidence in favor of the movant that reasonable
and fair minded men could not arrive at a verdict
against him.’’ 618 F.2d at 168.
In the case now before the Court, the evidence clearly supports
the specific interrogatories answered by two juries that: (a) the
respondent’s warnings were inadequate; and (b) that this was a
proximate cause of the petitioner’s harm.
For the Second Circuit to have set aside the jury’s verdict
by their reexamining the evidence and claiming that no reasonable
jury could have so found, deprived the petitioner of his
constitutional Seventh Amendment right to a jury trial.
To say that a plaintiff is entitled to a jury trial is merely
lip service if the court may later set aside the jury’s findings if
the court does not agree with the result reached by the jury,
although the jury’s result is reasonable, based upon the evidence.
We are not, in this case, asking this Court to review this
serious personal -injury matter on an individual basis. What is
being asked is that this Court make it clear to the District Courts,
the United States Courts of Appeal and the various state courts,
that the Seventh Amendment is not to be avoided by granting
a jury trial to a party and then having the court make that right
meaningless by the court granting judgment n.o.v., if the court,
for any reason, does not agree with the jury’s findings.
This is a matter -which is of importance to the public as
distinguished from being simply an issue important to the parties
to this litigaiton. See Layne & Bowler Corp. v. Western Well
Works, Inc., 261 U.S. 387, 393, 43 S. Ct. 422, 423, 67 L. Ed.
712 (1922). The issue that is of importance to the public is that
this Court must make it clear that the Seventh Amendment
provides for a meaningful right to a jury trial and that if the jury’s
verdict is supported by the record, judgment n.o.v. may not be
granted, no matter what may be the court’s own views, or the
court’s opinion of what a preferable result would have been. The
courts should not legislate by judicial fiat, reexamining the findings
of a jury which is what occurred in this case.
10
CONCLUSION
For the foregoing reasons, this petition for a writ of certiorari
should be granted.
Respectfully submitted,
ALFRED S. JULIEN
JULIEN & SCHLESINGER, P.C.
Attorneys for Peittioner
STUART A. SCHLESINGER
Of Counsel
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APPENDIX A — ORDER OF THE SECOND CIRCUIT
DENYING PLAINTIFF’S MOTION FOR REARGUMENT
UNITED STATES COURT OF APPEALS
SECOND CIRCUIT
Nos. 86-7768, 86-7798
FILED JUL 2 1987
At a stated Term of the United States Court of Appeals,
in and for the Second Circuit, held at the United States
Courthouse, in the City of New York, on the 2nd day of July
one thousand nine hundred and eighty-seven.
HARRY PLUMMER,
Plaintiff-Appellee,
Cross-Appellant,
«V.*
LEDERLE LABORATORIES, Division of AMERICAN
CYANAMID COMPANY,
Defendant-Appellant,
Cross-Appellee.
A petition for rehearing containing a suggestion that the action
be reheard in banc having been filed herein by plaintiff-appellee,
cross-appellant Harry Plummer,
Upon consideration by the panel that heard the appeal, it is
ORDERED that said petition for rehearing is DENIED.
2a
Appendix A
It is further noted that the suggestion for rehearing in banc
has been transmitted to the judges of the court in regular active
service and to any other judge that heard the appeal and that
no such has requested that a vote be taken thereon.
S/Eiaine B. Goldsmith
Elaine B. Goldsmith
Clerk
3a
APPENDIX B—DECISION OF THE UNITED STATES
COURT OF APPEALS FOR THE SECOND CIRCUIT,
REPORTED AT 819 F.2d 349 (2d CIR. 1987)
Harry PLUMMER,
Plaintiff-Appellee, Cross-Appellant,
LEDERLE LABORATORIES, DIVISION OF AMERICAN
CYANAMID COMPANY,
Defendant-Appellant, Cross-Appellee.
Nos. 692, 1366, Dockets
86-7768, 86-7798
United States Court of Appeals,
Second Circuit
Argued Jan. 14, 1987.
Decided May 19, 1987.
Products liability action was brought based on alleged failure
of manufacturer of oral polio vaccine to warn of danger associated
with taking vaccine. The United States District Court for the
Southern District of New York, John E. Sprizzo, J., entered a
judgment for plaintiff and defendant appealed. The Court of
Appeals, Tenney, District Judge, sitting by designation, held that:
(1) warnings given by manufacturer of oral polio vaccine were
adequate as a matter of law, and (2) plaintiff failed to establish
that inadequacy of warning of manufacturer of oral polio vaccine
was proximate cause of his contracting polio.
4a
Appendix B
Vacated and remanded.
David Jaroslawicz, New York City (Alfred S. Julien, Stuart
A. Schlesinger, Edward J. Sanocki, Jr., Julien & Schlesinger, New
York City, on the brief), for plaintiff-appellee, cross-appellant.
J. Peter Coll, Jr., New York City (Charles W. Gerdts, III,
Laurie J. Gentile, Donovan, Leisure, Newton & Irvine, New York
City, on the brief), fur defendant-appellant, cross-appellee.
Before PRATT and MINER, Circuit Judges, and TENNEY,
District Judge.*
TENNEY, District Judge.
This is an appeal and cross appeal from a final judgment
of the United States District Court for the Southern District of
New York, Sprizzo, Judge, entered upon interrogatory answers
following two jury trials. The first trial commenced on Octcber
1, 1984, and at the conclusion thereof the jury answered special
interrogatories and returned a general verdict for plaintiff Harry
Plummer of $3.2 million. The district court reserved decision on
the motion of defendant Lederle Laboratories (‘‘Lederle’’) to set
aside the verdict, and ordered a second trial limited to the issue
of proximate causation. The second trial commenced on June
2, 1986, and at the conclusion thereof, the jury returned
interrogatory answers in favor of Plummer. A final judgment
awarding $3.2 million in damages to Plummer was entered on
August 13, 1986.
* The Honorable Charles H. Tenney, Senior District Court Judge of the
United States District Court for the Southern District of New York, sitting by
designation.
Sa
Appendix B
Lederle appeals from the district court’s final judgment as
well as its rulings and orders denying Lederle’s motions for
summary judgment, judgment notwithstanding the verdict, or a
new trial. Plummer cross-appeals from the district court’s order
directing a second trial on the issue of proximate causation and
refusing to award him interest from the date of the first jury’s
verdict. We vacate the district court’s judgment and remand for
entry of judgment notwithstanding the verdict. The cross-appeal
is rejected in all respects.
BACKGROUND
This products liability action involves Orimune, a polio
vaccine manufactured by Lederle. All agree that the development
of vaccines against poliomyelitis has been a major achievement
of modern preventive medicine. Ironically, the very success of
the polio vaccines underlies the charge of negligence in this action.
At the outset, it should be noted that there are two different
types of polio vaccine. Oral polio vaccine, technically referred
to as poliovirus vaccine, live, oral, trivalent (“‘OPV’’), developed
by Dr. Albert Sabin, contains three live but weakened strains of
virus that nonetheless provoke the vaccinee’s immune system to
respond and develop antibodies effective against the wild strain
of the virus. Injected polio virus (‘‘IPV’’), developed by Dr. Jonas
Salk, contains killed, or inactivated strains of virus. The Salk
iPV vaccine was developed first and the Sabin OPV vaccine
became avaiiable shortly thereafter. Orimune is the trade name
for the OPV vaccine manufactured by Lederle. Both vaccines aided
in greatly reducing the incidence of polio in the United States.
Notwithstanding certain inherent risks, OPV became the
vaccine of choice in the United States and most of the world for
a number of reasons. First, because OPV is administered orally,
6a
Appendix B
commonly on a sugar cube, it is far easier to distribute than IP V
which must be injected with a hypodermic needle. Second, the
interaction of the live virus in OPV with the immunological system
confers lifetime immunity. IPV, in contrast, requires periodic
readministration in the form of ‘‘booster shots’’ to maintain
immunity. Third, the oral administr::ion of OPV stimulates
production of antibodies in the gastrointestinal tract as well as
in the bloodstream, thus producing bowel immunity which
interrupts the method of transmitting the wild strain of the virus.
Over time, the interruption of the virus’ transmission path is
expected to eradicate the wild strain. Finally, persons vaccinated
with OPV shed vaccine viruses through feces and saliva to
nonvaccinated persons, thereby conferring immunity on them as
well.
To understand the risks inherent in OPV, it is necessary to
comprehend the immunization process. The live but weakened
viruses of OPV grow in the intestinal tract of the vaccinee. The
growing viruses trigger the vaccinee’s immune system to produce
antibodies which render the vaccinee immune to the disease after
30 days. Rarely, but at a statistically predicable rate, the virus
reproduced in the vaccinee’s intestinal tract reverts to the virulent
form. When this occurs, the vaccinee or persons coming in close
contact with the vaccinee during the 30-day period may contract
polio. Unvaccinated adults can take two precautions to avoid the
risk of ‘‘contact polio’’: (i) alternative vaccination with IP V prior
to contact with the vaccinee; and (ii) avoidance of contact with
the vaccinee for one month, during which time live polio viruses
are being shed from the intestional tract of the vaccinee via the
saliva and feces.
In November 1979, Orimune was prescribed and administered
to Plummer’s infant granddaughter, Mavis Lyster, by Dr. Abby
Cohen. Dr. Cohen did not convey any warnings to Mavis’ mother.
7a
Appendix B
Plummer thereafter contracted a condition diagnosed as paralytic
poliomyelitis. It is undisputed for the purposes of this appeal that
Plummer had never been vaccinated and contracted polio through
contact with his granddaughter.
In a deposition, Dr. Cohen stated that his education and
training had informed him that there was a slight risk in
administering OPV inasmuch as the vaccinee or those coming in
contact with the vaccinee could potentially develop paralytic
disease. His reading of professional journals confirmed that polio
could be transmitted via ‘‘secretions from the mouth, but much
more commonly by way of stool.’’ Joint Appendix (‘‘JA’’) 184.
He described the risk of contact polio as ‘‘small,’’ admitting that
he ‘‘probably did not know [the statistics on its occurrence].”’
He also indicated he was aware that both the 1977 package insert
for Orimune and articles in professional journals recommended
that doctors warn patients concerning the risks of OPV. However,
he expressed his view concerning the necessity of conveying
warnings as follows:
My feeling . . . was that there is an extremely
minute percentage of people who will have the
complications from the drug. I felt that, again,
because I had never experienced [other practicing
physicians] giving these warnings, it . . . wasn’t
necessary for me to do it; and. ..I felt... that
giving the warning .. . could scare off parents
from bringing children in for future vaccinations,
which to me were much more important than the
warning itself for the few number of people who
are going to contract disease... .
JA 182-83.
8a
Appendix B
The Warnings at Issue
Under established law, the sellers of dangerous products may
be required to include on containers of these products directions
or warnings as to their use. Restatement (Second) of Torts, § 402A
comment j (1965). It is undisputed that certain types of drugs,
such as polio vaccines, are dangerous. /d., comment k. Therefore,
in assessing the potential liability of prescription drug
manufacturers, it is essential to review the informational inserts
provided with the drugs.
The Orimune package insert describes in detail the risks of
administering OPV. The ‘*‘Adverse Reactions”’ section of the June
1979 package insert, the principal warning at issue here, states
in pertinent part:
Paralytic disease following the ingestion of live
poliovirus vaccines has been, on rare occasion,
reported in individuals receiving the vaccine, as
well as in persons who were in close contact with
vaccinees. Most reports of paralytic disease
following ingestion of the vaccine or contact with
a recent vaccinee are based on epidemiological
analysis and temporal association between
vaccination or contact and the onset of symptoms.
Most authorities believe that a causal relationship
exists.
The Center for Disease Control reports [the ’
number of doses distributed for certain years and
the number of occurences of contact polio and
vaccine-associated polio]... .
a ©
9a
Appendix B
The risk is estimated to be one case in a recipient
for every 20 million doses of vaccine distributed
and one case in a contact for every 6 million doses
distributed.
The risk of vaccine-associated paralysis is extremely
small for vaccinees, susceptible family members
and other close personal contacts. However, the
responsible physician should convey or specifically
direct personnel acting under his authority to
convey the warnings to the vaccinee [or] parent
of the possibility of vaccine-associated
paralysis prior to administration of the vaccine.
When the attenuated vaccine strains are to be
introduced into a household with adults who have
never been vaccinated, some physicians may choose
to wive these adults at least two doses of IPV a
month apart ... before the children receive
ORIMUNE. The benefit of being protected against
polio is believed to greatly outweigh any risk from
polio vaccine.
Thus, the 1979 package insert advises that unvaccinated
individuals may avoid the risk of contracting contact polio from
Orimune vaccinees by receiving an IPV vaccination prior to
contact.
The 1977 Orimune package insert' was also introduced into
1. The ‘‘Adverse Reactions’’ section of the 1977 insert states in pertinent
part:
Expert opinion is in agreement that the administration
(Cont'd)
10a
Appendix B
evidence and it varies from the 1979 insert by stating that ‘‘expert
opinion is in agreement that the administration of [OPV] is
generally an effective and safe method of protecting populations
against the natural disease’, and that ‘‘[t]he estimated risk of
vaccine-induced paralytic disease occurring in vaccinees or those
in close contact with vaccinees is extremely !ow.’’ It did not give
a breakdown of the estimated number of cases of contact polio,
as the 1979 warning did. Also, it did not advise physicians to
consider administering IPV to previously unvaccinated individuals
who might come in contact with the Orimune vaccinee, as a
precaution against contact polio. Rather, it merely stated that
(Cont'd)
of live oral poliovirus vaccines is generally an effective and
safe method of protecting populations against the natural
disease. Paralytic disease following the ingestion of live
poliovirus vaccines has been reported in individuals receiving
the vaccine, and in some instances, in persons who were in
close contact with subjects who had been given live oral
poliovirus vaccine. The rare occurrence of ‘‘vaccine related
cases’’ were considered ‘‘compatible”’ with vaccine induced
disease where certain epidemiological criteria including certain
incubation, clinical and laboratory values could be judged
compatible with vaccine as a cause. It has been estimated
that the risk of vaccine induced paralytic poliomyelitis is about
one chance per million doses.
The estimated risk of vaccine-induced paralytic disease
occurring in vaccines or those in close contact with vaccinees
is extremely low. However, the ‘‘risk’* should be considered
by the physician and such information should be conveyed
to the parent(s) at the time of vaccination. Those parents of
a vaccinee who have noi had previous polio vaccination should
probably be considered among those aduits as subject to
increased risk of exposure and in this special situation, in
the judgment of the physician responsible, protection may
be needed for these intimate contacts.
lla
Appendix B
‘‘parents of a vaccinee who have not had previous polio
vaccination should probably be considered among those adults
as subject to increased risk of exposure and in this special situation,
in the judgement of the physician responsible, protection may
be needed for these intimate contacts.’’
Dr. Darrell Salk, son of the doctor who discovered IPV,
testified as an expert witness for the plaintiff. He stated that in
his opinion Lederle’s warnings inaccurately estimated the number
of occurrences of contact polio per doses distributed as one in
6 million, and misleading failea to compare the risk of contracting
contact polio relative to the risk of contracting wild polio.
However, he admitted that Lederle’s method of stating the risk
is also used by most medical authorities in the United States,
including the United States Public Health Service Advisory
Committee on Immunization Practice (JA 298, 304; 314-19) and
Centers for Disease Control (JA 334-35), the Committee on
infectious Diseases of the American Academy of Pediatrics (JA
308), and an Institute of Medicine Study of Poliovirus vaccines
(JA 334-38).
The Centers for Disease Control provided the data in the
1979 insert stating the risk of contact polio per doses distributed.
JA 334-336; Brief for Appellant, at 39. The insert was approved
by the Bureau of Biologics (presently the Office of Biologics
Research and Review) of the Food and Drug Administration in
June, 1979, as required by 21 C.F.R. §§ 600-601 (1986).
Procedural Rulings
Although Plummer’s compiaint originally alleged several
theories of liability, the case did not proceed to trial on all of
them. After the completion of discovery, Lederle moved for
i2a
Appendix B
summary judgment on the grounds that (i) its warnings were
adequate as a matter of law and (ii) there was no proof that claimed
inadequacies in the warnings proximately caused the injury because
Dr. Cohen knew of the risks of contact polio but made a conscious
decision not to convey any warning to the parents of the vaccinee.
Plummer contended that the warnings were inadequate because
they failed to recommend any precautions that could be taken
to avoid the risk of contact polio, citing as examples (i) alternative
administration of IPV to unvaccinated individuals prior to contact
with the vaccinee, or (ii) avoiding contact with the vaccinee for
one month.
The district court rendered an oral ruling denying Lederle’s
pre-trial motion for summary judgment but substantially
narrowing the issues to be tried. In accordance with this ruling,
the parties prepared a Joint Pre-Trial Order dated May 4, 1984
which reflected the district court’s view that the only issues
remaining to be tried, as a matter of law, were (i) whether Lederie
had a duty adequately to advise the reasonable physician of
precautions to be taken in connection with the prescription and
administration of Orimune; (ii) whether Lederle satisfied such a
duty; (iii) assuming that Lederle did not satisfy its duty, whether
that failure was the proximate cause of plaintiff’s damages.
The case proceeded to trial. The jury returned a verdict that
Lederle was liable to Plummer for damages in the amount of $3.2
million, finding that the 1977 insert was inadequate because it
did not include general precautions on either of the two specified
precautions for avoiding the risk and the 1979 insert was
inadequate because it did not include general precautions or the
second specified precaution, although it was adequate in
recommending the first specified precaution, alternative
administration of IPV. The jury further found that Lederle had
13a
Appendix B
used reasonable efforts in distributing the 1979 insert and that
it had been received by Dr. Cohen. The jury concluded that
Lederle’s inadequate warnings were a proximate cause of plaintiff’s
injury and Dr. Cohen’s failure to warn was not the sole cause
of plaintiff’s injury.’
2. The first jury was asked:
1. Do you find that the ... [1977 insert] ... failed
to advise a reasonably prudent private physician that [an
unimmunized adult should be given an IPV inoculation?}
2. Do you find that the. . . [1977 insert] . . . failed to
advise that unimmunized adults should [avoid contact with
OPV-vaccinated infant for one month]?
3. Do you find that the .. . [1977 insert] . . . failed to
advise 2 reasonably prudent private physician of the necessary
precautions to be taken to avoid contact with any individual
immunized with [OPV]?
4. [Same as question (1), with respect to 1979 insert]
5. [Same as question (2), with respect to 1979 insert]
6. [Same as question (3), with respect to 1979 insert]
7. Do you find ... that the 1979 insert ... was
disseminated in a reasonable manner to the medical profession
prior to November 3, 1979?
8. Do you find . . . that Dr. Cohen received the 1979
insert... prior to November 3, 1979?
9. If the amswer to any one of questions #1 through #6
is **Yes"’ do you find . . . that the inadequacy of defendant’s
warning was a proximate cause of the plaintiff’s injury?
(Cont’d)
l4a
Appendix B
Lederle moved for judgment notwithstanding the verdict or
a new trial, contending that its warnings were adequate as a matter
of law and that the charge on proximate causation was erroneous.
The district court ordered a new trial limited to the issue of
proximate cause, reasoning that the jury might have been misled
by an erroneous supplemental instruction which failed to point
out that the defendant could be exonerated not only by the doctor’s
negligence but also by the patient’s contributory negligence. The
judge ruled over Lederle’s objection that it would allow Plummer
to introduce evidence at the second trial concerning his theory
- that the package inserts ‘‘minimized the risk’’ of contact polio.
The second jury answered seven questions. In response to
questions | and 2, the jury agreed that the defendant’s package
insert minimized the risk of contact polio and that this
minimization influenced Dr. Cohen to not give any warnings. The
remaining five questions asked whether each inadequacy of the
inserts (as found by the first jury) was a legal cause of plaintiff’s
injury. All of these questions were answered affirmatively except
question 7, to which the jury responded that the 1979 insert’s
failure to advise of general precautions was not a legal cause of
plaintiff’s injury.’ The clerk entered a judgment in favor of
plaintiff.
(Cont'd)
10. Do you find . . . that the plaintiff’s injury was caused
solely by the independent decision of Dr. Cohen to administer
[OPV] to the plaintiff’s grandchild without informing the
plaintiff’s daughter of the risks incident thereto and the
precautions to be taken in that regard?
All of the questions except numbers 4 and 10 were answered affirmatively.
JAS4-57.
3. The second jury was asked:
(Cont’d)
15a
Appendix B
Lederle again moved for a new trial, on the ground that the
second jury’s answers to questions 6 and 7 were irreconcilably
inconsistent. Lederle claimed that questions 6 and 7 were
redundant, and therefore the jury could not simultaneously
conclude: (i) that the 1979 insert was inadequate in failing to
recommend as a specified precaution avoidance of contact with
the vaccinee for one month (response to question 6) and (ii) that
(Cont'd)
1. Do you find ... that the manner in which the
defendant described the risk of vaccine associated contact
polio in the package insert minimized that risk?
2. If [yes to the above], did that description influence
Dr. Cohen to not give any warnings?
3. Do you find. . . that the defendant’s failure to advise
[physician in 1977 insert] that a program of IPV inoculation
for unimmunized adults should be considered was a legal cause
of the plaintiff’s injury?
4. Do you find. . . that the defendant’s failure [to advise
physician in 1977 insert] that unimmunized adults should not
come in contact with [OPV-vaccinated infant] for
approximately one month was a legal cause of plaintiff’s
injury?
5. Do you find. . . that the defendant’s failure (to advise
physician in 1977 insert] of the necessary precautions to be
taken to avoid contact with [OPV-vaccinated infant] was a
legal cause of plaintiff’s injury?
6. Same as question (4), with respect to 1979 insert.
7. Same as question (5), with respect to 1979 insert.
All of the questions except number 7 were answered affirmatively. JA
133-34.
l6a
Appendix B
the insert adequately recommended general precautions (response
to question 7). Lederle’s motion was denied in an order dated
July 24, 1986.
DISCUSSION
A federal court sitting in diversity must follow the law directed
by the Supreme Court of the state whose law is found to be
applicable, and if there is no direct decision by the highest court
of that state, the federal court should determine what it believes
that state’s highest court would find if the issues were before it.
See Meredith v. Winter Haven, 320 U.S. 228, 234-37, 64 S.Ct.
7, 10-12, 88 L.Ed.9 (1943). Plaintiff is a California resident, his
granddaughter was inoculated with Orimune in California, and
he developed polio in California, as well. Thus, New York’s choice
of law rules, which apply to this action by virtue of the holding
in Klaxon Co. v. Stentor Elec. Mfg., 313 U.S. 487, 496, 61 S.Ct.
1020, 1021-22, 85 L.Ed. 1477 (1941), dictate that California
substantive law applies because that is the place where plaintiff’s
injury occurred. Fort Howard Paper Co. v. William D. Witter,
Inc., 787 F.2d 784, 795 (2d Cir. 1986); Wright v. Carter Prod.,
Inc., 244 F.2d 53, 56-57 (2d Cir. 1957).
Issue of the Adequacy of the Warnings
_ It is undisputed that polio vaccines are inherently dangerous
drugs. The seller of such a product may be required to give
directions or warning as to use on the product’s container.
Restatement (Second) of Torts, § 402A comment j (1965).* Once
4. Restatement (Second) of Torts, § 402A comment j, states:
In order to prevent the product from being unreasonably
(Cont'd)
17a
Appendix B
the warning is given, there is a presumption that it will be read
and heeded. Jd. Comment k to § 402A of the Restatement
(Second) of Torts acknowledges that vaccines may sometimes cause
damaging consequences when injected, but that the diseases they
are designed to combat also are terrible. The comment provides:
(Cont’d)
dangerous, the seiler may be required to give directions or
warning, on the container, as to its use. The seller may
reasonably assume that those with common allergies, as for
example to eggs or strawberries, will be aware of them, and
he is not required to warn against them. Where, however,
the product contains an ingredient to which a substantial
number of the population are allergic, and the ingredient is
one whose danger is not generally known, or if known is one
which the consumer would reasonably not expect to find in
the product, the seller is required to give warning against it,
if he has knowledge, or by the application of reasonable,
developed human skill and foresight should have knowledge,
of the presence of the ingredient and the danger. Likewise
in the case of poisonous drugs, or those unduly dangerous
for other reasons, warning as to use may be required.
But a seller is not required to warn with respect to
products, or ingredients in them, which are only dangerous,
or potentially so, when consumed in excessive quantity, or
over a long period of time, when the danger, or potentiality
of danger, is generally known and recognized. Again the
dangers of alcoholic beverages are an example, as are also
those of foods containing such substances as saturated fats,
which may over a period of time have a deleterious effect
upon the human heart.
Where warning is given, the seller may reasonably assume
that it will be read and heeded; and a product bearing such
a warning, which is safe for use if it is followed, is not in
defective condition, nor is it unreasonably dangerous.
18a
Appendix B
[B]oth the marketing and the use of the vaccine
are fully justified, notwithstanding the unavoidable
high degree of risk which they involve. 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 legally be sold
except to physicians, or under the prescription of
a physician. It is also true in particular of many
new or experimental drugs as to which, because
of lack of time and opportunity for sufficient
medical experience, there can be no assurance of
safety, or perhaps even of purity of ingredients,
but such experience as there is justifies the
marketing and use of the drug notwithstanding a
medically recognizable risk. The seller of such
products, 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 attending their use, merely because
he has undertaken to supply the public with an
apparently useful and desirable product, attended
with a known but apparently reasonable risk.
Thus, drug manufacturers are obligated by law to provide
doctors and/or consumers with adequate knowledge of the hazards
of the drugs they manufacture. If they do so, they are held not
to a strict liability standard for the consequences attending the
use of the product, but to a negligence standard. Brown v. Superior
Court, 182 Cal.App.3d 1125, 227 Cal.Rptr. 768 (1 Dist.), petition
for review granted, 229 Cal.Rptr. 663, 723 P.2d 1248 (1986). In
19a
Appendix B
a negligence action, the adequacy of warnings is determined based
on their ‘‘reasonableness.’’ Finn v. G.D. Searle & Co., 35 Cal.3d
691, 700, 200 Cal.Rptr. 870, 875, 677 P.2d 1147, 1152 (1984).
If the drug is given under clinic-type conditions the manufacturer
is obliged to warn consumers directly. In the case of prescription
drugs dispensed: by physicians, the obligation is to warn the
physician. This ‘‘prescription drug rule’’ has been followed by
the courts of California. See Fogo v. Cutter Laboratories, Inc.,
68 Cal.App.3d 744, 754, 137 Cal.Rptr. 417, 423 (1 Dist.1977);
Magee v. Wyeth Laboratories, Inc., 214 Cal.App.2d 340, 348,
29 Cal.Rptr. 322, 328 (2 Dist.1963). The rule was explained in
Reyes v. Wyeth Laboratories, 498 F.2d 1264 (Sth Cir.), cert.
denied, 419 U.S. 1096, 95 S.Ct. 687, 42 L.Ed.2d 688 (1974), as
follows:
Prescription drugs are likely to be complex
medicines, esoteric in formula and varied in effect.
As a medical expert, the prescribing physician can
take into account the propensities of the drug, as
well as the susceptibilities of his patient. His is the
task of weighing the benefits of any medication
against its potential dangers. The choice he makes
is an informed one, an individualized medical
judgment bottomed on a knowledge of both
patient and palliative. Pharmaceutical companies
then, who must warn ultimate purchasers of
dangers inherent in patent drugs sold over the
counter, in selling prescription drugs are required
to warn only the prescribing physician, who acts
as a ‘‘learned intermediary’’ between manufacturer
and consumer.
498 F.2d at 1276.
20a
Appendix B
The parties do not seriously dispute that in the present case
we are considering Lederle’s duty to direct warnings to the
prescribing physician and the medical profession in general, rather
than to the patient. The parties’ primary dispute is over the type
of warnings required to be given to meet the manufacturer’s duty
under California law.
The second jury agreed with Plummer’s claims that the
warnings issued by Lederle regarding Orimune improperly (i)
minimized the risk of contact polio and (ii) failed to specify
precautions that could be taken to avoid these risks. On this appeal,
we must determine whether the district court properly construed
California law applicable to this action as allowing Lederle to
be found liable to Plummer if inadequacies of this nature were
present in Lederle’s warnings. Lederle contends that such
inadequacies are, as a matter of law, insufficient to support the
jury’s verdict.
With regard to the issue of alleged minimization of the risk
in product warnings, the California authority most closely
analogous to the instant case is Kearl v. Lederle Laboratories,
172 Cal.App.3d 812, 218 Cal.Rptr. 453 (1 Dist.1985). The facts
underlying Kear/ differ in only two ways from those in the present
case: (i) contact polio was not involved (i.e., the vaccinee herself
contracted the disease from the administration of Orimune); and
(ii) the vaccine was administered in a clinic-type setting so the
court was required to review manufacturer warnings transmitted
directly to the patient, rather than through a ‘“‘learned
intermediary’’ such as a doctor. The claims regarding the adequacy
of the warnings in Kear/ are almost identical to those asserted
by Plummer in the present case. The Kear/ court noted that Lederle
had warned the patient directly of the risk of contracting polio
from the vaccine, and mentioned the alternative vaccine, IPV.
2la
Appendix B
The court concluded that this warning adequately informed
plaintiff of the foreseeable risks. It iejected plaintiff’s contention
that the warning was inadequate for failing to state precisely the
exact known risks of contracting polio from OPV relative to
contracting it from wild polio viruses (i.e., without being
vaccinated). The court concluded: ‘‘whatever duty a manufacturer
may have to inform of risks associated with nonuse of a product,
such a duty most certainly cannot be imposed when the relationship
between use and nonuse is statistically close (and quite possibly
immeasurable) and the probability of injury from either course
is extremely remote.*’ 172 Cal.App.3d at 835, 218 Cal.Rptr. at
468. The court held the warning to be adequate as a matter of law.
In the present case, we similarly hold that the warning was
adequate as a matter of law. The first jury found that Lederle
took reasonable efforts to disseminate the 1979 package insert
to the medical profession. The 1979 insert contained statistics
compiled by public health authorities estimating the number of
cases of contact polio per doses of vaccine distributed. This method
of stating the risk of contact polio is used not only by Lederle,
but also by established medical authorities. Even assuming, as
the second jury found, that the warnings did minimize the risk
of contracting contact polio, the fact remains that the probability
of contracting either contact polio or wild polio is extremely
remote. The Kear/ decision thus establishes that the verdict here
cannot be supported by Plummer’s theory that Lederle negligently
minimized the risks of contracting contact polio in its package
inserts.
Plummer further claims that the California Supreme Court
has endorsed an approach that requires manufacturers of
prescription drugs to give warnings of specific precautions that
can be taken to avoid the hazards of its drug, citing Finn, supra,.
22a
Appendix B
This contention is not supportable. Finn merely recognized in
dictum that two types of warnings exist: those which instruct the
consumer regarding use of a product and those which inform him
regarding risks that may follow from use of a product. 35 Cal.3d
at 699, 200 Cal.Rptr. at 875, 677 P.2d at 1152. Nowhere did the
court state that a prescription drug manufacturer would be deemed
negligent for failing to specify precautions in its package inserts.
The California courts have not yet addressed the question of
whether precautions must be specified as a matter of law in
prescription drug cases.
However, Lederle correctly points out that in Dunn v.: Lederle
Laboratories, 121 Mich.App. 73, 328 N.W.2d 576 (1982), a
Michigan appellate court was presented with this same proposed
theory of liability in a contact polio case and was asked to reverse
judgment in favor of Lederle. The court refused to find a duty
to warn of precautions to be taken in connection with prescribing
Orimune. That court stated: ‘‘[cJonsidering the slight risk of
contact polio, the variability of risks of harm (depending on many
personal factors, including cleanliness and frequency and type
of contact with a recently-vaccinated child), the introduction of
individualized medical judgment, and . . . other policy reasons
.., we do not accept plaintiffs’ invitation to add new
requirements to a manufacturer’s duty to warn.’” 121 Mich.App.
at 83, 328 N.W.2d at 581 (footnotes omitted).
In the present case, the judgment of the district court rests
on the jury’s finding that Lederle’s warnings were legally
inadequate because they failed to specify precautions for avoiding
contact polio. We must determine what the California Supreme
Court would decide if it were faced with this question. In the
absence of any applicable California precedent in the prescription
drug context based on a duty to specify precautions, we believe
23a
Appendix B
the California Supreme Court would not expand a manufacturer’s
duty and require that specified precautions be stated, especially
where the warnings are being directed to a ‘‘learned intermediary”’
such as a doctor. In short, judgment notwithstanding the verdict
should have been directed since there is no duty under California
law to specify precautions in the prescription drug context.
The Proximate Causation Issue
The second major issue on appeal relates to the proof of
proximate cause. Lederle claims that Plummer failed to make a
showing sufficient to establish all the elements essential to his
case, thus the motion for judgment notwithstanding the verdict
should have been granted. See Celotex Corp. v. Catrett,
—__.U.S.___, 106 S.Ct.2548, 2554, 91 L.Ed.2d 265 (1986). In
particular, Lederle claims Plummer did not prove that inadequacy
of the warnings was the proximate cause of his injury, since the
testimony established that Dr. Cohen was aware of the risks of
contact polio but as a matter of practice, did not convey these
warnings to the parents of the patient. Lederle claims that the
verdict must be set aside because of. this failure of proof of
proximate causation.
Plummer responds by arguing that the jury was entitled to
discredit Dr. Cohen’s testimony and reach its own conclusion on
proximate cause. Presumably, Plummer contends that the jury’s
conclusion in response to the question on minimization of the
risk, i.e., that Dr. Cohen was prompted not to warn the patients
based on the inadequacies in the warnings to state the true risk,
is the substitute for a finding on proximate cause. In support,
plaintiff cites Stevens v. Parke, Davis & Co., 9 Cal.3d 51, 107
Cal.Rptr. 45, 507 P.2d 653 (1973), a case which imposed liability
on a drug manufacturer because its overpromotion of a dangerous
24a
Appendix B
drug to the medical profession was coupled with a gross
minimization of the risk of prescribing the drug in the product
warnings.
Stevens is distinguishable because in the present case there
is no evidence that Lederle overpromoted Orimune, nor is there
proof that Lederle grossly minimized the risk. At best, Lederele
understated a small risk to make it appear even smaller.
Furthermore, as Lederle notes, the plaintiff failed to prove that
a proper warning would have altered the doctor’s conduct.’ Dr.
Cohen testified that he knew of the information plaintiff claimed
should have been in the insert—that an unimmunized person
should avoid contact with the vaccinee for 30 days— but still did
not warn Plummer’s daughter. As the California intermediate
appellate court has stated, ‘‘no harm could have been caused by
failure to warn of a risk already known.’’ Rosburg v. Minnesota
Mining & Mfg. Co., 181 Cal.App.3d 726, 730, 226 Cal.Rptr. 299,
305 (1 Dist.1986).
According to Plummer, Dr. Cohen’s testimony that he had
a practice of failing to warn his patients of the risk of contact
polio should not be credited because he was an interested witness.
It may be true that Dr. Cohen was an interested witness, but his
was the only testimony on the issue of proximate cause. Even
if the jury failed to credit him, Plummer has not proven an essential
element of his case. Furthermore, even if the warnings had been
stronger, a reasonable jury could not have concluded that Dr.
Cohen would have warned the vaccinee’s mother. Thus, judgment
notwithstanding the verdict should be entered for Lederle because
a reasonable jury could not have found proximate cause.
5. There is no claim or evidence that defendant had knowledge of Dr.
Cohen’s practice not to warn, or of such practice by other physicians.
25a
Appendix B
See Dunn,121 Mich.App. at 85, 328 N.W.2d at 582; Stanback
v. Parke, Davis & Co., 657 F.2d 642, 646 (4th Cir.1981) (doctor
testified he knew of risk but had practice of not informing patients
about it); Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87,
92 (2d Cir. 1980) (‘‘no one eds notice of that which he aiready
knows’’).
CONCLUSION
On Lederle’s appeal, we vacate the judgment of the district
court and remand for entry of judgment notwithstanding the
verdict. Thus, it is not necessary to address Lederle’s claims that
various evidentiary rulings and instructions to the jury were
erroneous, and that the second jury’s answers to certain questions
were inconsistent.
In view of our decision that judgment notwithstanding the
verdict should be granted, Plummer’s cross-appeal is denied in
all respects.
26a
APPENDIX C—MANDATE OF THE SECOND CIRCUIT
GRANTING LEDERLE’S APPEAL GRANTING LEDERLE
JUDGMENT N.O.V. AND DISMISSING THE COMPLAINT,
DENYING PLAINTIFF’S CROSS APPEAL
UNITED STATES COURT OF APPEALS
FOR THE SECOND CIRCUIT
86-7768
86-7798
FILED MAY 19 1987
At a stated Term of the United States Court of Appeals for
the Second Circuit, held at the United States Courthouse in the
City of New York, on the 19th day of May one thousand nine
hundred and eighty-seven.
Present:
HON. GEORGE C. PRATT,
HON. ROGER J. MINER, Circuit Judges.
HON. CHARLES H. TENNEY, District Judge.*
HARRY PLUMMER,
Plaintiff-Appellee, Cross-Appellant,
-V .*
LEDERLE LABORATORIES, Division of AMERICAN
CYANAMID COMPANY,
Defendant-Appellant, Cross-Appellee
* The Honorable Charles H. Tenney, senior District Court Judge of the
United States District Court for the Southern District of New York, sitting by
designation.
27a
Appendix C
Appeal from the United States District Court for the District
of New York
This cause came on to be heard on the transcript of record
from the United States District Court for the District of New York,
and was argued by counsel.
ON CONSIDERATION WHEREOF, it is now hereby
ordered, adjudged and decreed that the judgment in the Lederle
appeal from said District Court be and it hereby is vacated and
remanded to the said District Court for entry of judgment not
withstanding the verdict in accordance with the opinion of this
court.
Further ordered that the Plummer cross-appeal is denied in
all respects pursuant to the opinion of this court.
s/ Elaine B. Goldsmith
Clerk
s/ Edward J. Guardaro
By: Edward J. Guardaro
Deputy Clerk
THIS DOCKET WAS ENTERED ON THE DOCKET ON
7-17-87
28a
APPENDIX D—JUDGMENT DATED AUGUST 11, 1986 IN
FAVOR OF THE PLAINTIFF
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
81 CIVIL 2037 JES
FILED AUG 11 1986
HARRY PLUMMER
Plaintiff
-against-
LEDERLE LABORATORIES, Division of AMERICAN
CYANAMID COMPANY,
Defendant.
A jury trial before the Honorable John E. Sprizzc, U.S.D.J.,
having begun on October |, 1984, and at the conclusion of the
trial the jury having answered the attached interrogatories, and
the jury in so doing having returned a verdict in favor of the
plaintiff in the sum of $3,200,000.00, and the Court having
reserved decision on defendant’s motion to set aside the verdict
and the Court having set aside the verdict and ordered a new
trial as to the issues of proximate cause, a second jury trial having
begun on June 2, 1986, as to the issue of proximate cause only
and at the conclusion of the trial the jury having answered the
attached questions, and the jury in so doing having returned a
verdict in favor of the plaintiff; and the Court having reserved
decision, pending briefing on defendant’s motion to set aside the
verdict; and the Court thereafter on July 28, 1986, having handed
29a
Appendix D
down its order denying defendant’s motion for a new trial, it is,
ORDERED, ADJUDGED AND DECREED: That the
plaintiff have judgment as against the defendant in the sum of
$3,200,000.00.
s/ Raymond F. Burghardt
Clerk
DATED: NEW YORK, N.Y.
August 11, 1986
APPROVED:
s/ John E. Sprizzo
U.S.D.J.
THIS DOCUMENT WAS ENTERED ON THE DOCKET ON
8-13-86.
30a
APPENDIX E—ORDER OF THE DiSTRICT COURT,
HONORABLE JOHN E. SPRIZZO, DATED JULY 24, 1986,
REFUSING TO SET ASIDE THE JURY’S SECOND VERDICT
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
81 Civ. 2037 (JES)
Harry Plummer,
Plaintiff,
-against
Lederle Laboratories, etc.,
Defendant.
The above-captioned action having come before the Court,
and counsel for defendant having filed a memorandum of law
in support of defendant’s oral application for a new trial, and
the Court having considered all issues raised in defendant’s
memorandum and in plaintiff’s responding memorandum, and
all issues raised with respect to defendant’s motion for a new trial,
and the Court having determined that the second jury’s answers
to Questions 6 and 7 are not irreconcilably inconsistent answers
to redundant questions, compare Bernardini v. Rederi A/B
Saturnus, 512 F.2d 660, 662-63 (2d Cir. 1975) with Brunner y.
Maritime Overseas Corp., 779 F.2d 296, 299 (Sth Cir. 1986); Julien
J. Studley, Inc. v. Guif Oil Corp., 407 F.2d 521, 526-27 (2d Cir.
1969), but, rather, distinct answers to separate questions based
upon separate and distinct theories of liability and causation as
advanced by plaintiff at the trials of this action, and the Court
having concluded that the answers to Questions 6 and 7 can and
3la
Appendix E
should be reconciled, see, e.g., Gallick v. Baltimore & Ohio R.
Co., 372 U.S. 108, 119 (1963), and, indeed that all of the jury’s
answers to all of the questions can be so reconciled and that the
jury’s findings support the judgment against the defendant, it is
ORDERED that defendant’s motion for a new trial be, and
hereby is denied.
Dated: New York, New York
July 24, 1986
s/John E. Sprizzo
United States District Judge
32a
Appendix E
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
81 Civ 2037 (JES)
Case Number
JUDGE JOHN E. SPRIZZO
HARRY PLUMMER
as
LEDERLE LABORATORIES, Division of AMERICAN
CYANAMID COMPANY
(FULL TITLE OF CASE - IF NECESSARY USE OTHER SIDE)
APPEARANCES: (include firm name and telephone #)
FOR PLAINTIFF:
Edward Sanocki, Jr. & Ira Newman
Julien & Schlesinger, P.C., 2 Lafayette St.,
NY, NY 212-962-8020
FOR DEFENDANT:
J. Peter Coll & Charles Gerdts III
Donovan Liesure Newton & Irvine,
30 Rockefeller Plaza, NY, NY 212-307-41
TRIAL (JURY) BEGUN: (retrial of proximate cause issue) 6/2/86
continued: 6/3/86, 6/4/86, and concluded 6/5/86.
33a
Appendix E
Jury verdict for Plaintiff on Special Interrogatory questions 1-6.
Jury verdict for Defendant on Special Interrogatory question 7.
Decision reserved pending briefing on Defendant motion to set
aside verdict.
(AN EXTRACT OF THE MINUTES)
CLERK HOWARD VIGORITA
COURT REPORTER William Cohen
34a
Appendix E
QUESTIONS FOR THE JURY
1. Do you find that plaintiff has established by a fair
preponderance of the evidence that the manner in which the
defendant described the risk of vaccine associated contact polio
in the package insert minimized that risk?
Yes x No
2. If you answered the above question yes, did that description
influence Dr. Cohen to not give any warnings?
Yes x No
3. Do you find that plaintiff has established by a fair
preponderance of the evidence that the defendant’s failure to advise
a reasonably prudent private physician in its 1977 insert that a
program of IPV inoculation for unimmunized adults should be
considered was a legal cause of the plaintiff’s injury?
Yes x No
4. Do you find that plaintiff has established by a fair
preponderance of the evidence that the defendant’s failure in its
1977 insert to advise a reasonably prudent private physician that
unimmunized adults should not come in contact with an infant
recently vaccinated with oral polio vaccine for approximately one
month was a legal cause of plaintiff’s injury?
Yes x No.
5. Do you find that plaintiff has established by a fair
preponderance of the evidence that the defendant’s failure in its
35a
Appendix E
1977 insert to advise a reasonably prudent private physician of
the necessary precautions to be taken to avoid contact with an
individual immunized with oral polio vaccine was a legal cause
of plaintiff’s injury?
Yes x No.
6. Do you find that the plaintiff has established by a fair
preponderance of the evidence that the defendant’s failure in its
1979 insert to advise a reasonably prudent private physician that
unimmunized adults should not come in contact with an infant
recently vaccinated with oral polio vaccine for approximately one
month was a legal cause of plaintiff’s injury?
Yes x No
7. Do you find that plaintiff has established by a fair
preponderance of the evidence that the defendant’s failure in its
1979 insert to advise a reasonably prudent private physician of
the necessary precautions to be taken to avoid contact with any
individual immunized with oral polio vaccine was a legal cause
of plaintiff’s injury?
Yes No. x
36a
APPENDIX F—ORDER DATED SEPTEMBER 2, 1986
DENYING THE PLAINTIFF’S MOTION TO AMEND THE
JUDGMENT FOR INTEREST RUNNING FROM AN
EARLIER DATE !
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
81 Civ. 2037 (JES)
FILED SEP 5 1986
Harry Plummer,
Plaintiff,
-against-
Lederle Laboratories, etc.,
Defendant.
ORDER
The above-captioned action having come before the Court
and plaintiff having requested, by letter dated August 21, 1986,
‘*that the Court direct the clerk to enter judgment providing for
interest from October 12, 1984,’ and the Court having considered
all issues with respect to that request,
ORDERED that plaintiff’s request that the Court amend the
Judgment previously entered in the above-captioned case on
August 11, 1986 to provide for interest from October 12, 1984
be, and hereby is denied.
37a
Appendix F
s/ John E. Sprizzo
United States District Judge
Dated: New York, New York
September 2, 1986
38a
APPENDIX G—TRANSCRIPT OF COURT’S DECISION
DATED FEBRUARY 21, 1986
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
81 Civ. 2037
HARRY PLUMMER,
Plaintiff,
-against-
LEDERLE LABORATORIES, Division of AMERICAN
CYANAMID COMPANY,
Defendants.
New York, N.Y.
February 21, 1986
4:30 p.m.
Before:
HON. JOHN E. SPRIZZO,
District Judge
APPEARANCES:
JULIEN & SCHLESINGER
Attorneys for Plaintiff
BY: DAVID JAROSLAWICZ
EDWARD J. SANOCKI
39a
Appendix G
DONOVAN, LEISURE, NEWTON & IRVINE
Attorneys for Defendants
BY: J. PETER COLL, JR.
CHARLES W. GERDTS
THE COURT: Good afternoon. I read your papers. | called
you in because I am going to rule on your motions and I figured
I might as well do it now rather than have you wait until I write
an opinion, since this case has already been delayed a while because
there was some mixup with the filing of plaintiff’s papers and
we didn’t get them.
I have considered all the applications, and the Court rules
as follows:
First of all, the motion for a new trial based upon insufficiency
is denied. I have reviewed the cases, checked the case authorities,
and I am convinced the evidence is sufficient. So I adhere to what
I indicated to you earlier.
With respect to the charge, the argument that the Court
should have charged as to substantial factor in causation I don’t
think is supported by the California Pattern Jury Instructions
nor by anything I see in the law of California, except some
language in appellate opinions which has never been translated
into the jury instructions. So I am not persuaded that the law
of California requires that charge. What’s more, I think the
plaintiff is quite correct in stating that that particular charge was
never requested. I looked at your requests to charge and it isn’t
there. So I would not be inclined to grant a new trial for that
reason.
However, upon reviewing the charge, I think there was an
40a
Appendix G
error in the charge which requires a new trial on the causation
issue. When I gave my supplemental instructions to the jury—
and this is not an argument that was precisely made, but when
I read the charge again, upon reflection I think there is an error
there—I told the jury that the only basis upon which the defendant
could be exonerated is if the doctor was the sole cause of the
injury. That may have had the effect of taking away from the
earlier portion of my charge which correctly pointed out to the
jury the theory as to the plaintiff’s not following the doctor’s
advice. There were two theories upon which the defendant could
have been exonerated, as I put the case to the jury in my main
charge. One was that the doctor was the sole cause, in the sense
that he, by an independent act of his own, decided not to give
the advice; the other one was that, even assuning that the doctor
had given that advice, the plaintiif would not have followed it.
Those were two possible theories upon which the defendant could
have been exonerated. The Court’s charge in its supplemental
instructions took away the second possibility, which had been
pointed out earlier in the charge.
That argument was not made precisely in that form in the
motions. But upon reviewing the charge, I| think it was error to
tell the jury that the sole predicate upon which the defendant could
be exonerated is that the doctor was the sole cause of the injury.
I am still convinced, as I was before, that there is a factual issue
in the case as to whether the doctor’s conduct was impacted by
misinformation which the defendant may have circulated in the
community. I think that raises a jury question.
Therefore, I think the case has to be retried before a jury.
I am not inclined to grant judgment for the defendant, but I think,
since my charge left open the possibility that the jury would think
that the only basis upon which they could exonerate the defendant
4la
Appendix G
was that the doctor was the sole cause of the injury, it eliminated
the possibility that the plaintiff might be a cause. The plaintiff’s
conduct being the sole cause was an issue which was testified about
and was argued and is in the record, and I think my earlier charge
correctly put that to the jury. But that supplemental instruction,
coming as it did when the jury specifically requested a charge
on causation—ordinarily, you could take the position that the
charge as a whole put that issue fairly to the jury—in fairness,
requires a new trial of that issue only.
I am satisfied that the evidence is sufficient, and I am satisfied
that the damage award is adequate. I don’t know that that was
even raised on the motion.
MR. COLL: It was not.
THE COURT: But I think we have to have a new trial on
the causation question, which is one question for the jury. I think
on all other aspects the trial was correct. It will give you time
before the next trial on the causation question, Mr. Coll, to give
me some cases arguing the proposition that the California law
requires a substantial factor instruction.
MR. COLL: I understand.
THE COURT: It is not present in the California jury
instructions, as they correctly point out.
MR. JAROSLAWICZ: Your Honor, if I can be heard—I
don’t think I can change your Honor’s mind—
THE COURT: You can be heard if you want to, but I
considered it very carefully, | read the charge, and | think it is
erroneous.
42a
Appendix G
MR. JAROSLAWICZ: I don’t think there was any objection
made in time so that your Honor could have cured it without
putting the plaintiff—
THE COURT: But there was an objection made, there was
an objection specifically taken to my supplemental instruction.
It was there.
MR. JAROSLAWICZ: Number two, your Honor—
THE COURT: I read the record on it.
MR. JAROSLAWICZ: The jury could have made a finding
of contributory negligence or comparative negligence on the part
of the plaintiff. Their finding that there was no comparative
negligence takes that issue your Honor has raised right out of
the case. They might have found that the doctor was negligent,
the plaintiff was 25 percent comparative negligent, in which case
your Honor would have reduced the verdict.
THE COURT: Did we ask the question as to whether the
plaintiff was contributorily negligent?
MR. JAROSLAWICZ: That was in your Honor’s charge.
THE COURT: Was it in a specific question to the jury? If
I had an answer to a specific question that the plaintiff was not
at all negligent, that would perhaps indicate to me that, even
though my charge was erroneous, it had no impact upon the jury.
MR. COLL: I don’t believe we argued, your Honor, the
plaintiff’s contributory negligence here, because this wasn’t a case
where the plaintiff had made some sort of conscious decision or
43a
Appendix G
that we could argue that there was any evidence from which the
plaintiff-—
THE COURT: Do you have the questions there?
~ MR. COLL: I do. I am pulling them out. But I don’t believe
that there was.
MR. JAROSLAWICZ: Your Honor, there was no argument
that the plaintiff was contributorily negligent, and the issue your
Honor has raised does not require a new trial.
THE COURT: No, but if you go back earlier in my charge,
I did tell the jury that you would have to find that the plaintiff
was to follow the instructions of the doctor. I think I did tell
them that, and I think the plaintiff testified to that.
MR. JAROSLAWICZ: That’s correct.
MR. COLL: There is no such question, your Honor. | have
the questions right here.
MR. JAROSLAWICZ: Your Honor is now setting aside the
verdict on an issue that was never raised to this jury because it
just wasn’t an issue.
THE COURT: The plaintiff testified about it and I put it
to the jurv the first time around. Do you have my instructions
the first time around?
MR. JAROSLAWICZ: That was part of the standard
instructions. But the defendant never requested a charge or
question on comparative negligence, because it just wasn’t in this
case.
44a
Appendix G
THE COURT: No, but the charge was plainly incorrect in
telling the jury that the only basis upon which they could exonerate
the defendant is that the doctor’s negligence was the sole cause
of the accident. I am still inclined to think that is the theory upon
which they have to recover before we even get to the plaintiff’s
negligence. But the jury could have found that the doctor’s
negligence in not warning was a cause, or they could have found
the plaintiff would not have followed the doctor’s instructions.
MR. JAROSLAWICZ: Your Honor, if they found the
doctor’s negligence in not warning was ‘‘a’’ cause—it does not
have to be ‘‘the’’ cause—if it is ‘‘a’’ cause, at most you can reduce
it by the amount that the plaintiff might have been negligent.
THE COURT: I understand that, but the charge told the
jury that the only basis upon which the defendant could be
exonerated is if the doctor’s negligence was the sole cause of the
accident. I think that is error.
MR. JAROSLAWICZ: It is error to the plaintiff. The
defendant got a more favorable charge than they were entitled
to. They were told that the doctor had to be the sole cause instead
of simply being a cause. That charge was more favorable to the
defendant than they were entitled to.
THE COURT: Just let me look at the earlier portion of the
charge.
I said here, starting at page 695, and I will read it to you:
‘“*In that regard the defendant’s contention, as I have told
you’’—and I think this portion of the charge is correct—‘‘is that
even if you find the defendant’s conduct to be negligent or that
45a
Appendix G
they are liable to the plaintiff on the theory of strict liability because
the product is defective—and I have drawn that distinction for
you, that is, if you find that the defendant’s conduct was improper
either on the theory of strict liability or on the theory of negligence
in that they didn’t give an adequate warning to the medical
profession at large, in which case you must reach the question
of causation—then the defendant’s argument here is that they
are not responsible for the plaintiff’s injury because there was
a separate and independent intervening cause which broke the
chain of causation.
‘*That is what Mr. Coll referred to in his summation. He
said that Dr. Cohen knew everything there was to know, everything
_the defendant could have told him in any kind of warning, he
made his own judgment not to tell the patient, and but for his
conduct in not disclosing the risk and his conduct in not taking
the precautions, Plummer would not have suffered his injury.
‘In short, the defendant claims that Dr. Cohen’s con@uct
was the sole cause of the plaintiff’s injury and that therefore,
even if you find the conduct of the defendant to be improper
and negligent in any regard, the defendant should not be held
liable, because Dr. Cohen is a separate and independent intervening
cause. That is for you to decide.
‘**The plaintiff argues, on the other hand, this is not so, that
the warning was inadequate. The plaintiff claims that the defendant
contributed to whatever misinformation Dr. Cohen may or may
not have had about the danger of this vaccine, not only because
of the inadequacy of the defendant’s insert but because they had
other advertisements out in the public at large that tended to
contribute to a misunderstanding or which tended to underestimate
the risk, and therefore the defendant contributed to Dr. Cohen’s
46a
Appendix G
misunderstanding of the risks involved and the defendant bears
some responsibility for what happened, even if we assume that
Dr. Cohen was also a cause.
‘*In short, as Mr. Sanocki argued to you on the summation,
the plaintiff’s argument is that even if the doctor is in part
responsible, the defendant is also in part responsible.
But for purposes of the defendant’s defense based upon
causation, if you find that the conduct of the doctor, Dr. Cohen,
was the sole cause of the plaintiff’s injury and that but for his
conduct the injury wouid not have occurred, notwithstanding the
adequacy or inadequacy of the warnings, then you should find
for the defendant on that issue.
“*The defendant has not argued this specifically, but of course
you must find as credible the testimony you have heard from the
piaintiff’s witnesses that if the parents of the child had been told,
they would have refrained from contact or abided by whatever
instructions the doctor gave them:in that regard with respect to
other persons. That is also part of it. That testimony has not
been contradicted. But that is also something you must find.
Obviously, if the doctor had instructed them and if they wouldn’t
have listened to him anyway, then the chain of causation would
also have been broken. I don’t think there has been any testimony
as to that.’’
What I am saying to you is that I put to the jury correctly the
first time that the chain of causation could have been broken either
by the doctor’s conduct or by the plaintiff’s conduct. In giving
my supplemental instruction, I told the jury that the only basis
upon which they could exonerate the defendant was if the doctor’s
conduct was the sole cause.
47a
Appendix G
I think that is error, and I think if you go to the Court of
Appeals on it, it will surely be reversed and you will have wasted
the time and effort of an appeal, so we might just as well correct
it now.
MR. JAROSLAWICZ: Your Honor, I don’t think it is error,
because the jury—
THE COURT: It is nice for you to tell me so, but I think
it is error and it is my charge. I think if one makes a mistake,
the whole purpose of a new trial is to correct it before going to
the Court of Appeals. It is a lot more wasteful in terms of time
and expense to have the case go up there when all that has to
be tried, in perhaps two days or so, is an issue of causation.
Everything else has been resolved.
MR. JAROSLAWICZ: What issue of causation are we going
to retry, Judge?
THE COURT: Whether the defendant’s conduct caused the
plaintiff’s injury. The adequacy of the warning has already been
ruled upon and that stands. The damages stand. All we have to
try is the issue of causation. That is a two-day trial.
MR. JAROSLAWICZ: But, your Honor, with respect to the
comparative causation of the plaintiff or the comparative
negligence of the plaintiff, the jury might find the plaintiff 100
percent comparative, in which case he is out. That is really what
we are talking about.
THE COURT: But the charge was wrong. The charge told
the jury that the only basis upon which they could exonerate the
defendant was if the doctor was the sole cause of the injury. There
48a
Appendix G
was another basis: If the plaintiff’s conduct was the sole cause
of the injury. That is error. You can’t get around that, Mr.
Jaroslawicz.
MR. JAROSLAWICZ: Number one, I think it is something
that is dredged up. Number two, your Honor—
THE COURT: It wasn’t dredged up by them; it was dredged
up by me. I read my charge and it is wrong.
MR. JAROSLAWICZ: It was never raised at the time that
jury was sitting there so your Honor could say, ‘‘Excuse me, there
is a second ground. If you find the plaintiff wouldn’t have done
it anyhow, then you can find for the defendant.’’ But to wait
until after the trial, not to ask your Honor to charge that, and
now to come back and seek a new trial after the jury is gone
is unfair.
THE COURT: If it were a matter of only the issues they
raised specifically, I would have denied their motion, because I
am not convinced that the California law requires a charge on
substantial causation and they did not request one. I agree with
you. But I think my charge was plain error.
MR. JAROSLAWICZ: But where did they object to it in
time to cure it?
THE COURT: First of all, they did object to the supplemental
instructions, although not on that ground. Second of all, even
if they had not objected to the supplemental instructions, I think
it is plain error.
MR. JAROSLAWICZ: I don’t think this jury was misled
49a
Appendix G
for one second. If this jury would have agreed that the plaintiff
had not followed the doctor’s instructions, they would have come
back with a defendant’s verdict. And they didn’t even argue it,
because that wasn’t an issue in the case. They presented no evidence
of that issue. If this jury had come back, your Honor, and
found—and I say this to you very seriously—that the plaintiff
would not have followed the doctor’s instructions, I think your
Honor would have had to set it aside, because there was no
evidence in this record to support that type of claim.
THE COURT: The jury could have disbelieved your client’s
testimony. Your client is an interested witness. The jury doesn’t
have to believe that merely because it was uncontradicted.
MR. JAROSLAWICZ: We agree on that.
-THE COURT: I put that question to the jury. Nobody
objected to my putting that question to the jury. I read it to you.
I had forgotten how clearly I put that question to the jury, but
when I read my supplemental instruction, it was wrong. It is
unfortunate, but I did make a mistake, and that is what motions
for a new trial are for.
MR. JAROSLAWICZ: What issue are we going to retry,
Judge?
THE COURT: Just the issue of causation. The issue I just
described has to be put to the jury as to whether the doctor’s
: conduct was the sole cause or whether the plaintiff would have
foliowed the doctor’s instructions. Normally, Mr. Jaroslawicz,
I would take the position that, having correctly put the issue to
the jury the first time around, if I made a mistake the second
time around, the charge has to be taken as a whole and | might
50a
Appendix G
let the Court of Appeals rule upon that. But coming as it did,
when the jury specifically asked for the charge on causation, and
I charged on causation something which was plainly wrong, it
seems to me I can’t take the position that it is harmless error.
And neither will the Court of Appeals. So you would be just
wasting your time taking an appeal anyhow.
MR. JAROSLAWICZ: The issue we are going to retry, just
so I am clear, Judge, is that if the doctor had warned the piaintiff,
would the plaintiff have followed his instructions?
THE COURT: No. The issue I am going to try again is
whether the defendant’s conduct was the cause of the injury.
MR. JAROSLAWICZ: Was a cause.
THE COURT: A cause, the cause, substantial cause—
whatever you can persuade me the charge should be the next time
around.
MR. JAROSLAWICZ: Then we will be retrying the entire
case, Judge.
THE COURT: No, we won’t. The last time we tried the
adequacy of the warning.
MR. JAROSLAWICZ: The warning has already been found
to be inadequate.
THE COURT: That is what I am saying. That stands.
MR. JAROSLAWICZ: The only question remaining, then,
is: Does the jury find that with an adequate warning the doctor
would have done otherwise?
Sla
Appendix G
THE COURT: Well, that is part of the causation question.
MR. JAROSLAWICZ: And (b) would the plaintiff have
followed the doctor’s instructions had he been given proper
instructions?
THE COURT: That is basically it.
MR. COLL: We have a specific finding, your Honor, as to
the inadequacy in this case.
THE COURT: That stands.
MR. COLL: I understand that. That is, there was no warning
in the insert that advised the doctor to tell the parent or somebody
who would come into contact to stay away from the child for
approximately a month. That is the specific finding of inadequacy
in this case. And the case we are going to try or what remains
to be tried to the jury would be: With that inadequacy, would
the doctor have done something different here?
THE COURT: We are going the try the question of causation
again under the proper instructions. I will give you a chance to
persuade me the next time around that I should charge on
substantial cause. I don’t think the law requires that, and if I
had to set aside the verdict on that basis, I would let it go to
the Court of Appeals, because I am convinced in my own mind
that at least that would be an arguable issue up there. But I think
when I told the jury the only basis upon which the defendant
could be exonerated, it just detracted from the effect of my earlier
instructions. I admit there was no real issue of that and you didn’t
argue that, but I put it to the jury anyway, and I think I should
have put it to the jury anyway. I was surprised when I went back
52a
Appendix G
and read the charge that I had, because I hadn’t remembered
doing that. It is just an off-the-cuff supplemental instruction which
I should not have given that creates the problem. On the basis
of the first charge, the issue of causation would have been fairly
presented to the jury and resolved against the defendant; but I
think, coming as it did in the supplemental instructions, I can’t
take the view that it is harmless error. I think it may very well
be plain error. So we are just wasting our time, I think, if we
don’t correct it now. No one likes to retry cases less than | do,
as you know.
MR. JAROSLAWICZ: I know one person who does.
THE COURT: Less than I am? Who is that, Judge Milton
Pollack?
MR. JAROSLAWICZ: No, that is us.
THE COURT: I know, but you have to be practical about
it and realize that you are probably better off trying the issue
now than having to take an appeal, spending all that money, and
being back here a year from now.
MR. JAROSLAWICZ: Judge, quite frankly I think the Court
of Appeals has an expedited appeal on a case like this, it will
take three months, and then if they send us back on that issue,
we will try it then. I personally don’t think they will send us back.
It was never argued; it wasn’t an issue in the case. Your Honor
did present it to the jury sua sponte. They never argued it. They
never objected to your Honor’s charge. When the jury was here,
nobody objected.
THE COURT: They objected to my supplemental
instructions.
53a
Appendix G
MR. JAROSLAWICZ: Nobody objected on that ground.
To object on a different ground is not a basis for later finding
a different ground, Judge.
THE COURT: No, I think their objection was specific
enough.
MR. JAROSLAWICZ: Their objection was not on the
ground that your Honor should have charged that maybe the
plaintiff was at fault.
THE COURT: Should I read it to you again?
MR. JAROSLAWICZ: The objection had nothing to do with
the plaintiff being at fault.
THE COURT: First of all, he made his first objection in
the middle of page 756 when I cut him off. It is hard to charge
him with not making it. Then he says at the bottom of page 756:
‘*T had the objection before as to the use of the word ‘sole,’
and I renew the objection.’’
That is pretty close to what he should have said. Then I said:
“If that is your objection, I overrule it,’’ etc.
Then he says, at page 757:
‘*That is where I don’t agree with your Honor and that is
why I think that, coming out with that additional supplemental
instruction at this point, in essence focuses their attention on that
rather than on the whole charge.”’
54a
Appendix G
I think that is pretty close. Admittedly it could have been
closer. But I don’t think it makes much difference. I think the
charge I gave was wrong. When a jury asks for a supplementak
instruction and gets a bad instruction, I think it leverages the case
terribly and it should be retried.
I don’t know why you are so upset about it. You just have
to retry one question. You have to bring Dr. Salk back, basically.
MR. JAROSLAWICZ: Well, that is not easy, quite frankly.
Number two, I have the plaintiff who is wheelchair bound.
THE COURT: You don’t even have to bring Dr. Salk back.
His testimony can be read into the record.
MR. JAROSLAWICZ: The effect on a jury of having
testimony read from a record is vividly different from having a
live witness.
THE COURT: We are talking about a very short trial.
MR. JAROSLAWICZ: Can ! ask your Honor when you can
fit us in?
THE COURT: It all depends upon my criminal calendar.
I have a case that is scheduled to be tried next week, and if there
is a plea, I can try you next week. Then I have a criminal trial
starting on March 3 for two to three weeks, another one on March
24, another one on April 7, another one on May 9. Maybe in
June, if I don’t try you next week.
MR. COLL: Might we do this, your Honor: With respect
to the retrial, Mr. Jaroslawicz, Mr. Sanocki and I can sit down,
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Appendix G
having just heard the dates you have given to your criminal cases,
and maybe we could come up with some day or two.
THE COURT: It is only a couple of days.
MR. COLL: That is what I would assume. The last liability
case only took us four or five days’ worth of testimony and, as
you suggested, it addressed essentially the accuracy of the warning
and noi the proximate cause issue. Maybe we can come up with
a day or two that is convenient for us, or a series of them given
to you, and be prepared to go on some sort of short notice with
you.
THE COURT: The only point at which the testimony will
overlap is that I guess we will have to have Dr. Salk testify again
to the fact that the warning you gave minimized the risk. You
remember the testimony about sitting in the first seat in the
orchestra, second seat in the orchestra. It didn’t go only to the
adequecy or inadequacy of the warning but also to the causation.
The reason I say it is a jury question is that you may have
contributed to the general fund of knowledge which impacted
the doctor’s decision, and that goes to the question of causation.
MR. COLL: I understand the Court’s view to be that the
stated reasons by the doctor as to why he did not pass on any
type of warning may have been made not on a sound basis because
of this purported minimization of the risk because of the numbers,
supposedly, as to which Dr. Salk testified.
THE COURT: What Dr. Salk was saying was that there were
only a certain number of people who were really exposed to the
risk, and giving the risk in the dosages given, when 99 percent
of the people who were given dosages were not in that immediate
56a
Appendix G
vicinity of risk, tended to make people out in the community think
it was more safe than it was and therefore could have impacted
the doctor’s decision to administer the drug without telling his
patients about the risk. Even though the doctor said, ‘‘I knew
everything there was to be known about the drug,’’ if among the
things he knew was a minimization of the risk, then I think that
is a jury question, which is why I denied your motion on sufficiency
grounds. | think that the issue ought to be put to the jury in a
clearer way. I really don’t like to have the Court of Appeals do
more work than they do, and if I am convinced I made a mistake,
why should I send it up there in the hope they will disagree with
me?
MR. COLL: I just wanted to have some idea of what we
would be retrying so maybe Mr. Sanocki and I can agree to some
expedited fashion.
THE COURT: I don’t think we need the plaintiff back,
because you didn’t contradict his testimony the first time. Unless
you are going to do it this time, there is no need to bring the
plaintiff back. That coukd be a stipulated fact.
MR. JAROSLAWICZ: If the ground on which you reverse
the verdict, Judge, is that the jury may have disbelieved the
plaintiff, that he wouldn’t have followed the doctor’s instructions
anyway, then if the plaintiff doesn’t have to come back, what
is the basis for overturning the verdict?
THE COURT: You can bring him back if you want the jury
to eee his demeanor. They didn’t attack it the first time, but I
still think his testimony has to be believed.
MR. COLL: There is more in the chain than just the plaintiff,
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Appendix G
the doctor, and Lederle; also in the chain was the plaintiff’s
daughter.
THE COURT: Right.
MR. COLL: So that what we are talking about is a passage
of information through a number of links, not just one or two.
MR. SANOCKI: I don’t know what he is talking about,
Judge. That was all testified to in the first trial.
THE COURT: I understand it was, but if I had kept quiet
and not added to my original instruction on causation, I would
deny their motion and send this case to the Court of Appeals.
MR. SANOCKI: Quite frankly, I think you did a fine job.
Mr. Coll keeps dreaming up arguments until finally apparently
he got one that—
THE COURT: The basis of a new trial is not something that
he dreamed up; it is one that I saw when I read the transcript
in considering the objections made. I accept your argument that
substantial factor may not be the law, they didn’t ask for it, and
therefore I would not set it aside on that ground. But what I told
the jury was that the defendant could only be exonerated if the
doctor’s conduct was the sole cause of the injury. That is just
plain error. It is not so. And coming as it did in the supplementel
instructions, I think there has to be a new trial on that issue.
I apologize to you for that, because it really wasn’t anybody’s
fault but mine. It may very well come out the same the next time
around, but it should be tried under adequate instructions. That
supplemental instruction was just plain wrong.
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Appendix G
Sorry to break bad news to you, Mr. Jeroslawicz, on a Friday
afternoon. What is is and can’t be corrected.
Do you think you will be able to try this case next week if
some time opened up?
MR. JAROSLAWICZ: If we can get Dr. Salk.
MR. COLL: That wouid be fairly difficult for me, because
I am tied up in some discovery next week where I have a deadline.
But the other dates you were suggesting in March and April I
could do.
THE COURT: Let’s see what happens. Some of these
criminal cases may end earlier. Maybe I will get lucky and have
some pleas. I have been involved in criminal cases since September
9, which has backed up my civil calendar.
MR. COLL: That is what we understand. Next week would
be very busy for me.
THE COURT: How about if I gave you a tentative date for
June 2?
MR. COLL: That’s fine.
THE COURT: All right?
MR. JAROSLAWICZ: With the possibility of expediting it,
your Honor.
THE COURT: I will expedite it if my schedule opens up.
I will give you a priority since this case has been hanging around
a while.
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Appendix G
MR. COLL: As I stated, I will talk to Mr. Sanocki to see
if there are some dates that he and I can set aside right now and
let your Honor know it.
THE COURT: Why don’t you carve out June 2 fer now
anyway, and if it takes two or three days, we will try it that week.
Do you want to settle an order on this? Or do you want me
to get something out? I will get something out. Actually it is in
the transcript. I will just have a generic order.
60a
APPENDIX H—ORDER OF THE HONORABLE JOHN E.
SPRIZZO DATED FEBRUARY 24, 1986, GRANTING
DEFENDANT’S MOTION FOR A NEW TRIAL AFTER THE
FIRST JURY’S VERDICT IN FAVOR OF PLAINTIFF AND
LIMITING THE ISSUES FOR THE SECOND TRIAL
PURSUANT TO THE COURT’S ORAL DIRECTIONS IN THE
OPINION CONTAINED IN THE TRANSCRIPT OF
FEBRUARY 21, 1986
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
81 Civ. 2037 (JES)
FILED MAR 3 1986
Harry Plummer,
Plaintiff,
-against-
Lederle Laboratories, etc.,
Defendant.
ORDER
The above-captioned action having come before this Court,
and defendant having filed a motion for judgment notwithstanding
the verdict or, in the alternative, for a new trial, and the Court
having considered all papers, supplemental papers, and arguments
submitted by the parties, and the Court having considered all issues
raised by the motion, and the Court having rendered an oral
decision of the motion in open court on February 21, 1986, it is
=
ad Ot ERT RR TITY TH PC NTN
6la
Appendix H
ORDERED that defendant’s motion for a new trial is granted,
for the reasons outlined by the Court in its oral opinion of
February 21, 1986; and it is further
ORDERED that said new trial shall be limited as outlined
by the Court in its oral opinion; and it is further
ORDERED that all parties and counsel shall be ready for
trial on or after June 2, 1986, and that thereafter counsel shall
be prepared to proceed to trial upon twenty-four hours’ notice
by the Court; and it is further
ORDERED that a Pre-Trial Conference shall be held on June
6, 1986.
s/John E. Sprizzo
United States District Judge
Dated: New York, New York
February 24, 1986
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.