Elawyers Elawyers
Washington| Change

Maruho v. Miles Inc., 93-1385 (1993)

Court: Court of Appeals for the First Circuit Number: 93-1385 Visitors: 8
Filed: Dec. 29, 1993
Latest Update: Mar. 02, 2020
Summary: UNITED STATES COURT OF APPEALS FOR THE FIRST CIRCUIT ____________________ No. 93-1385 MARUHO COMPANY, LTD., Plaintiff, Appellant, v. MILES, INC., Defendant, Appellee. (2) Miles' belief, after learning of the negative studies, that Xorphanol was still valuable; ___ ____ __ Gurney v. Tenney, 84 N.E.
USCA1 Opinion









UNITED STATES COURT OF APPEALS

FOR THE FIRST CIRCUIT

____________________


No. 93-1385

MARUHO COMPANY, LTD.,

Plaintiff, Appellant,

v.

MILES, INC.,

Defendant, Appellee.


____________________

APPEAL FROM THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF MASSACHUSETTS

[Hon. Rya W. Zobel, U.S. District Judge]
___________________

____________________

Before

Breyer, Chief Judge,
___________
Aldrich, Senior Circuit Judge,
____________________
and McAuliffe,* District Judge.
______________

____________________

Alan R. Hoffman with whom John R. Cavanaugh and Lynch, Brewer,
________________ _________________ _______________
Hoffman & Sands were on brief for appellant.
_______________
Sydelle Pittas with whom Powers & Hall, P.C. was on brief for
______________ ____________________
appellee.


____________________

December 29, 1993
____________________

______________________

*Of the District of New Hampshire, sitting by designation.



















BREYER, Chief Judge. Miles, Inc., invented and
____________

patented a pain-killing drug called Xorphanol. In 1984,

Miles gave Pars Pharmaceutical Co. the

exclusive right throughout the world to
make, have made, use and sell

Xorphanol, in return for which Pars promised to pay a

royalty and

to use reasonable efforts directly or
through its subcontractors to develop
one or more compounds . . . to the point
of [obtaining] . . . government . . .
approval for . . . [Xorphanol's]
therapeutic use . . . .

In 1988, Pars sublicensed the plaintiff in this lawsuit,

Maruho, Inc., to develop Xorphanol "compounds" and to sell

them in Japan.

According to Maruho, Pars misled it during the

sublicense negotiations. Although Maruho asked Pars to

produce all relevant studies, Pars did not tell it about 1)

an important negative study conducted by the Charterhouse

Research Unit of a well-known British pharmaceutical firm,

Glaxo, Inc., and 2) a less important negative study

conducted by the Director of the Stanford Pain Clinic. Both

of these studies indicated that Xorphanol, while effectively

reducing pain, also caused adverse side effects, such as

headaches, drowsiness, dizziness, and euphoria. Maruho says


-2-
2




















that, had it seen these studies, it would not have bought

the sublicense. In its view, Pars is guilty of fraud.

Maruho, however, seems unlikely to get its money

back from Pars, for Pars is in the midst of bankruptcy

proceedings. Maruho instead seeks recovery from Miles,

Xorphanol's original licensor; and, in this (diversity-

based) lawsuit against Miles, it pleads various theories of

state law. The district court, after examining the evidence

proffered by the parties, granted summary judgment for

Miles. Maruho appeals. We affirm the district court's

judgment.

I

Maruho's Procedural Argument
____________________________

At the outset, Maruho raises a procedural point.

It says that the district court improperly converted a

motion by Miles for judgment on the pleadings, Fed. R. Civ.

P. 12(b)(6), into a motion for summary judgment, Fed. R.

Civ. P. 56, without giving Maruho a "reasonable opportunity"

to present "pertinent material." See Fed. R. Civ. P. 12(b)
___

(court shall treat motion for judgment on pleadings as a

motion for summary judgment where "matters outside the

pleading" are presented to and accepted by the court and




-3-
3




















"reasonable opportunity" to present "pertinent material" is

"given").

The record, however, does not support Maruho's

claim. Miles' motion gave Maruho adequate notice of the

risk of summary judgment, for Miles entitled it "Motion to

Dismiss or, in the Alternative, for Summary Judgment"
_____________________________________________

(emphasis added). We concede that Maruho immediately told

the court that it thought Miles' motion requested summary

judgment on only one count. But Maruho also told the court,
___

in writing at the same time, that it would assume "that all
___

of Miles' contentions are asserted under both Fed. R. Civ.

P. 12 and [summary judgment rule] 56" (emphasis in

original). Maruho then presented to the court three volumes

of documents, which it titled "Plaintiff Summary Judgment

Record." In response to questioning by this court at oral

argument, Maruho could not identify any piece of evidence

that it had lacked the opportunity to submit. Given these

circumstances, Maruho converted Miles' motion into a motion
______

for summary judgment on all counts by presenting pertinent

material outside the pleadings; and Maruho not only had, but

also took advantage of, a "reasonable opportunity" to

present all "pertinent" material. See In re G.& A. Books,
___ ____________________

Inc., 770 F.2d 288, 294-95 (2d Cir. 1985), cert. denied, 475
____ ____________


-4-
4




















U.S. 1015 (1986). The district court was therefore legally

entitled to treat Miles' motion as one for summary judgment

on all counts.

II

Miles' Participation in the Fraud
_________________________________

Maruho argues that Miles is liable as an actual

participant in Pars' fraud, either by "aiding and abetting"

Pars' fraud, by acting "in concert" with Pars, or by

engaging in an "unfair or deceptive act or practice." See
___

Mass. Gen. L. ch. 95, 11; Kyte v. Philip Morris, Inc., 556
____ ___________________

N.E.2d 1025 (Mass. 1990); Restatement (Second) of Torts
______________________________

876(a), (b) (1979) [hereinafter "Restatement (2d)"]. It
_________________

says that, in the circumstances, a showing that Miles either

1) actually knew about the fraud, or 2) should have known
______________ __________________

about the fraud, is sufficient to trigger Miles' liability

as an actual participant. We shall consider, in turn, each

of the two branches of Maruho's argument.

1. Actual knowledge. We shall assume, for
__________________

argument's sake, that a finding that Miles actually knew

about Pars' fraud would trigger Miles' liability.

Nonetheless, like the district court, we do not believe the

record would permit a reasonable juror to make that factual

finding.


-5-
5




















Maruho says that a juror might find Miles' "actual

knowledge" by inferring, from Miles' conceded knowledge that

Maruho was willing to pay $3 million for the sublicense,

that Miles must have known that Pars hid the negative

Xorphanol studies from Maruho. Otherwise, why would Maruho

pay so much for so little? To make the inference, however,

requires some kind of propositional link, such as, "a

knowledgeable firm would likely not have paid $3 million had

it known about the studies." The problem for Maruho is that

this link is missing.

We agree with Maruho that a reasonable juror could

believe that Miles knew the following:

a. After obtaining its license in 1984, Pars
sublicensed Glaxo, Inc., a highly reputable
British firm, to prepare Xorphanol for
marketing. In 1986, Glaxo, after paying Pars
more than $1.5 million for the sublicense,
terminated the agreement.

b. Glaxo cancelled the sublicensing agreement
after its Charterhouse Research Unit tested
Xorphanol by giving ten volunteers single
doses (each in an amount growing from 0.25 mg
to 4.0 mg over the course of several days).
The Charterhouse study showed that many of
these volunteers suffered some significant
adverse side effect not suffered when they
took a placebo.

c. Earlier, in 1985, the Director of Stanford
Pain Clinic had conducted a multidose study
of Xorphanol, giving volunteers several doses
of 2 mg and 4 mg over several days. More of
these volunteers suffered some significant

-6-
6




















adverse side effect than those who received
comparable doses of codeine, a commonly used
pain killer.

d. After Glaxo's 1986 termination, Maruho, in
mid-1987, agreed to pay Pars $3 million for
Japanese sublicensing rights.

The record, however, also shows the following

facts, which are not significantly disputed:

a. Xorphanol was potentially a very valuable
product. The market for pain killers amounts
to several billion dollars annually.
Xorphanol seemed to have the pain killing
properties of a narcotic, such as codeine,
without any addictive quality. Financial
newspapers spoke initially of expected
"annual worldwide" Xorphanol "sales of at
least $50-100 million."

b. Miles, after receiving "updated IND
information on Xorphanol," (which Maruho says
included the Stanford, as well as the
Charterhouse, studies), wrote Pars a letter
in which it basically accepted the fact that
the Charterhouse study was negative, but
nonetheless pointed to other, positive,
studies; urged Pars to perform further
studies; noted the large sales of combination
and other pain killers; and concluded, in
reference to Xorphanol, that "there is still
a place for a moderate to strong, orally
active, non-dependence producing" pain
killer.

c. Other studies in the record show Xorphanol as
having highly desirable pain-killing effects,
with the frequency of side effects depending
upon the study and the dose. The studies all
make clear that codeine and other pain
killers also have side effects, and that,
since many of the side effects are
subjective, placebos have them as well.


-7-
7




















d. The experts differed about the significance
________
of the Charterhouse study, with at least one
prominent expert finding that it was not
critically important and did not warrant
abandoning the Xorphanol project. Dr. Louis
Lasagna, the Dean of Tufts University School
of Graduate Biomedical Sciences, examined the
Charterhouse study and concluded that:

1) "[T]here is nothing in the
Charterhouse data that is
disturbing about the 0.25 and
0.5 mg doses, and even at the
1.0 and 2.0 mg doses, there is
no reason for excessive
anxiety about adverse effects,
if one compares the results on
active drug with the results
with placebo."

2) "There is nothing in this
report, in my opinion, that
would call for a halt to
clinical testing of Xorphanol
at doses up to (and including)
2 mg."

3) "In my view it is premature to
make a judgment as to the
clinical utility and safety of
this drug in the absence of
more clinical trial data."

The upshot is a record that, even when viewed in

Maruho's favor, shows (1) a product potentially worth a

great deal of money; (2) Miles' belief, after learning of

the negative studies, that Xorphanol was still valuable; (3)

experts (at Glaxo) who thought that Xorphanol was not worth

developing; but (4) a respected expert who thought that

Xorphanol was still worth developing. Had Maruho presented

-8-
8




















favorable expert testimony on the relevant question --

whether the hidden studies were conclusive to the point that

a reasonable pharmaceutical executive would have thought

Xorphanol had little or no value --- the jury might have had

a basis for reaching a favorable conclusion about what Miles

knew. But Maruho presented no such expert testimony. And,

our lay reading of the record, including the relevant

studies, leads inexorably to the conclusion that experts

differed in their views about Xorphanol's value, with Miles

indisputedly arguing for further development. That fact, in

turn, means that Miles need not have concluded, from the $3

million payment, that Pars must have hidden the studies.

And, a reasonable jury could not conclude that Miles in fact
__ ____

knew about Pars' misconduct.

2. "Should have known." Maruho argues that Miles
_________________

is liable as long as it "should have known" about Pars'

fraud. The record, however, even when interpreted favorably

to Maruho, supports the factual part of this claim only to

the point where a reasonable juror might find that Miles

should have been suspicious -- and no further. And, that

factual finding does not provide sufficient basis for a

legal finding that Miles is liable as an actual participant

in the fraud.


-9-
9




















First, insofar as Maruho's "actual participant"

theories rest upon a tortfeasor's intentional action, a
___________

finding about what Miles "should have known" is insufficient

for a finding of an actual unlawful intent, whether one

defines that "intent" in terms of a "purpose" or, more

broadly, as a "belie[f] that the consequences are

substantially certain to result from [the act]."

Restatement (2d) 8A (1965). The Massachusetts courts have
________________

made clear that a defendant "aids and abets" a tortfeasor

only if, at the least, the defendant actually knows about
_____

"its substantial, supporting role in an unlawful

enterprise." Kyte, 556 N.E.2d at 1028. Similarly, the
____

Massachusetts courts have held that a defendant acts "in

concert" with a tortfeasor only if the defendant "agrees" to

work toward the unlawful result. See, e.g., id. at 1027-28;
___ ____ __

Gurney v. Tenney, 84 N.E. 428 (Mass. 1908). Without actual
______ ______

knowledge that Pars was hiding negative tests, Miles can

neither have known of Pars unlawful (i.e., fraudulent)

objective nor have agreed to help achieve it.

Second, insofar as Maruho tries to predicate

liability upon Miles' negligence, a jury could find, at the

very worst, nothing more than a negligent failure to act
_______

upon a suspicion, that is, an omission on Miles' part. To


-10-
10




















predicate tort liability upon a negligent omission, one must

find a special relationship, between defendant and

plaintiff, that imposes a duty upon the defendant to take

positive steps to protect the plaintiff. See Restatement
___ ___________

(2nd) 291 comment f (negligent "nonfeasance" requires a
_____

special relationship), 314 & comments a, c (1965) (stating

the general rule that liability for failure to take action

for the aid or protection of another is limited to

situations in which there exists some special relationship

between the parties). We are not aware of any authority

suggesting that the simple relationship

"licensor/sublicensee" automatically, by itself, creates
___

such a duty. The exceptional situations in which authority

supports the existence of such a duty are not present here.

See id. 314A-324A (listing exceptions to the general rule
___ __

of non-liability, none of which encompasses the licensor-

sublicensee relationship). Finally, Maruho has not argued

any other ground that might support the existence of the

necessary duty. We therefore agree with the district court

that no such duty existed.

3. Maruho argues that Miles has violated chapter

93A of the Massachusetts General Laws by engaging in an

"unfair or deceptive act or practice." Mass. Gen. L. ch.


-11-
11




















95, 11. But, to prove a violation, Maruho must show

conduct that involves some kind of "rascality." Tagliente
_________

v. Himmer, 949 F.2d 1, 7 (1st Cir. 1991). Maruho has cited
______

no authority that would justify such a finding where a

licensor has only suspicion, not actual knowledge, of a

licensee's improper conduct, and where the licensor has no

duty to act to protect the potential victim. The

circumstances simply do not indicate "rascal-like" behavior

on Miles' part. We therefore do not believe the

Massachusetts courts would find a violation of the chapter.

III

Vicarious Liability
___________________

Maruho says that, even if Miles is without fault,

it is nonetheless "vicariously" liable for the harm Pars

caused, either because Pars was Miles' agent, or because

Miles and Pars were engaged in a "joint venture" (or "joint

enterprise"). The theories of vicarious liability that

Maruho argues, however, all require Maruho to show that

Miles had the legal right to control Pars' negotiating

activity. See, e.g., Lyon v. The Ranger III, 858 F.2d 22,
___ ____ ____ ______________

27 (1st Cir. 1988) (joint enterprise exists where

participants "'ha[ve] an equal right to direct and control

the conduct of the other[s] concerning acts or omissions


-12-
12




















which cause, or contribute to the causation of, injury.'"

(quoting Adams v. Dunton, 187 N.E. 90, 92 (Mass. 1933));
_____ ______

Payton v. Abbott Labs, 512 F. Supp. 1031, 1036 (D. Mass.
______ ___________

1981) (joint venture requires "joint [but not necessarily

equal] control of the objectives of the undertaking and of

the means of achieving those objectives"); Restatement
___________

(Second) of Agency 1 comments a, b (1958); W. Page Keeton
__________________

et al., Prosser and Keeton on the Law of Torts 72, at 519-
______________________________________

20 (5th ed. 1984) (joint enterprise requires something that

shows a mutual right of control). Yet Maruho can make no
_____

such showing here.

The licensing agreement between Miles and Pars did

not give Miles any right to participate in or control the

negotiation and granting of sublicenses. And the record

provides no evidence of any statement, or action, by Miles

that suggests any right to control Pars' negotiating

activity. We concede that, sometimes, a jury might use

evidence of actual control as a basis for inferring the

existence of a corresponding legal right. But here, there

was no actual control. Miles did not even know that Pars

and Maruho were negotiating a sublicense until the

negotiations were already roughly seven months old; and it

first learned the terms of the proposed contract -- such as


-13-
13




















the fee Maruho was to pay for the sublicense -- only a few

weeks before the contract was scheduled to take effect.

Maruho nevertheless argues that Miles' legal

ability to grant, or deny, Pars a needed extension of the

basic license permitted Miles to influence the terms of, or

to benefit from, the sublicense. But, we have no reason to

believe that the simple, unexercised, practical power to

influence a negotiation could, by itself, create an agency,

or joint venture (or enterprise), for otherwise, every

negotiator would discover himself the agent of, or venturer

with, any of the many persons who might influence the

negotiations. We are not surprised that we could find no

legal authority supporting such a proposition. We add that

the simple fact that Miles might have benefitted from the

sublicense (through the royalty-sharing provision in the

Miles/Pars license agreement) does not make Miles

vicariously liable for Pars' conduct. See, e.g., Payton,
___ ____ ______

512 F. Supp. at 1036 (recognizing that profit sharing and
___

joint control are central to a joint venture); Stock v.
_____

Fife, 430 N.E.2d 845, 847-48 (Mass. App. Ct. 1982) (absent
____

joint control, a common (pecuniary) interest is not enough

to establish a joint enterprise).

IV


-14-
14




















Unjust Enrichment
_________________

Maruho argues that Miles was "unjustly enriched"

by having received a share of the $3 million sublicense fee,

and that it must therefore "return" the share to Maruho.

See Restatement of Restitution 1 (1937) ("A person who has
___ __________________________

been unjustly enriched at the expense of another is required

to make restitution to the other."). The controversial part

of this argument, however, lies in its premise. Did Miles

ever receive a portion of the $3 million?

The relevant facts are not in dispute. Miles and

Pars disagreed about whether Miles was entitled to some of

Maruho's $3 million sublicense fee. Miles argued that the

fee was a "royalty," in which case it was entitled to one-

half. Pars argued that the entire sum represented a return

of Xorphanol development expenses, in which case Miles was

entitled to nothing. Miles and Pars then agreed that Pars

would deposit $1,350,000 of the fee into an escrow account

and retain the remainder. The escrow agreement provided

that the money "shall remain in escrow" until

a. The Parties . . . either reach a
satisfactory agreement as to . . .
distribution; or

b. A final decision is reached by
arbitration . . .; or,



-15-
15




















c. In the event the Parties cannot agree
to arbitration, a final decision on the
distribution . . . is rendered by an
appropriate court . . . .

Eventually, Miles decided not to bring a legal proceeding

and permitted Pars to take the money from escrow.

For Maruho to obtain "restitution" from Miles, it

must show, at a minimum, that Miles had "possession of or

some other interest in" this money. Restatement of
_______________

Restitution 1 comment b. But Miles never did have
___________

possession of the money. The interest that it had (in the

absence of an agreement from Pars as to distribution)

consisted of little more than a right to bring a lawsuit to

obtain money to which its legal right (the record indicates)

was highly uncertain. And, since Pars would not agree, the

escrow served only to isolate and protect the money from

other potential Pars creditors while Miles made up its mind

whether or not to bring suit.

This kind of interest -- at best analogous to an

attachment -- seems to us too slight to count as the kind of

benefit that might support a suit for restitution. This

undefined interest is not analogous to that of a joint owner

in a joint bank account. We can find no convincing analogy

to any other kind of joint ownership. Nor does the record,

read favorably to Miles, show anything of value that Miles

-16-
16




















received for releasing the escrow. (It shows no "promise"

by Pars to engage in development work that it would not

otherwise have undertaken.) The record shows only that

Miles, for a time, thought it had a right to the money and

convinced Pars (in part through its power to extend, or not

to extend, the basic license) to place the money in escrow

while Miles decided whether or not to sue. (If there was

some more tangible interest here, Maruho at least had the

burden of showing just what it consisted of, but Maruho did

not even try to do so.) We are not surprised that we could

find no authority supporting the proposition that such an

"interest" falls within the scope of the Restatement's

description of "enrichment," while we found contrary

authority directly on point. Gilpin v. AFSCME, AFL-CIO, 875
______ _______________

F.2d 1310, 1314-15 (7th Cir.), cert. denied, 493 U.S. 917
_____________

(1989). The authority that Maruho cites, Gill Equipment Co.
__________________

v. Freedman, 158 N.E.2d 863 (Mass. 1959), says that a person
________

may be "unjustly enriched" by money that he does "possess"
____

under a constructive trust created by his promise to assume

"personal responsibility," which trust he violates by later
________ ______________

giving the money to another. That case is not on point.

For these reasons the judgment of the district

court is


-17-
17




















Affirmed.
________














































-18-
18










Source:  CourtListener

Can't find what you're looking for?

Post a free question on our public forum.
Ask a Question
Search for lawyers by practice areas.
Find a Lawyer