Alifax Holding Spa v. Alcor Scientific Inc. et al

Filing 337

MEMORANDUM AND ORDER: Defendants' Motion to Strike the Declaration of Robert H. Stier, Jr. (Dkt No. 302-2) and Exhibit Thereto (Dkt. No. 302-3) (ECF No. 310 ) is GRANTED. The Declaration of Robert H. Stier, Jr. (ECF No. 302-2) is hereby deemed struck and will not be relied upon for any purpose by the Court in its post-trial rulings. The supplemental attachments to Alifax's opposition memorandum are similarly deemed struck - So Ordered by Chief Judge William E. Smith on 6/18/2019. (Urizandi, Nisshy)

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF RHODE ISLAND
___________________________________
)
ALIFAX HOLDING SPA,
)
)
Plaintiff,
)
)
v.
)
C.A. No. 14-440 WES
)
ALCOR SCIENTIFIC INC.; and
)
FRANCESCO A. FRAPPA,
)
)
Defendants.
)
___________________________________)
MEMORANDUM AND ORDER
WILLIAM E. SMITH, Chief Judge.
Before the Court is Defendants’ Motion to Strike the Declaration of Robert H. Stier, Jr. (Dkt. No. 302-2) and Exhibit Thereto
(Dkt. No. 302-3), ECF No. 310.

The Defendants argue that the Stier

Declaration is improper and ask the Court to reject (1) counsel’s
Excel spreadsheet calculations and a related graph based on trial
exhibit 484; (2) counsel’s screen capture of information contained
in what he represents is a searchable online database maintained
by the U.S. Food and Drug Administration; (3) unauthenticated copies of purported “Administrative Procedures for CLIA Categorization,” ECF No. 302-3, and “Guidance for Industry and Food and Drug
Administrative Staff,” ECF No. 321-1; and (4) an unauthenticated
copy of an iSED operator’s manual, ECF No. 321-2.
agrees.

The Court

There is no basis to accept this eleventh-hour evidence.

The Defendants’ motion to strike is therefore GRANTED.

I.

Discussion
The First Circuit’s ruling in Lussier v. Runyon, 50 F.3d 1103

(1st Cir. 1995), provides more than adequate guidance here.

In

that action, plaintiff tried his claims of disability discrimination to a district judge.

Id. at 1106.

The court heard damages-

related evidence at trial concerning the plaintiff’s eligibility
for a disability retirement annuity but was “[d]issatisfied with
the trial evidence on this subject.”

Id. at 1113.

The court

therefore ordered the parties to make post-trial submissions concerning these benefits.

Id.

The court ultimately relied on this

new information to reduce plaintiff’s damages.

Id.

The First Circuit vacated the district court’s judgment.

Id.

“It is a fundamental principle of our jurisprudence,” wrote Judge
Selya for the Court, “that a factfinder may not consider extrarecord evidence concerning disputed adjudicative facts.” Id. Certain circumstances permit a district court to exercise his or her
discretion to re-open the evidentiary record.

But the record in

Lussier was not re-opened, thus the district court improperly
weighed additional evidence without providing the parties “the
standard

prophylax[es]”

of

trial:

the

cross-examine, impeach, and contradict.

opportunity

to

object,

Id. at 1113, n.13.

The

principle of judicial notice provided no safe harbor because the
relevant facts were neither generally known nor undisputed.
2

Id.

at 1114.

As the court in the Eastern District of Virginia summed

it up: “Lussier espouses the proposition that a court, no matter
what its motivations, may not undertake the unilateral pursuit of
extra-record evidence nor under any circumstances consider evidence advanced by one party concerning disputed material facts
that the opposing party is not presented an opportunity to challenge.”

Mercexchange, L.L.C. v. eBay, Inc., 467 F. Supp. 2d 608,

617 (E.D. Va. 2006).
Extra-record evidence of disputed material facts is precisely
what Alifax has offered in the contested submissions.

Regarding

the Stier Declaration, counsel’s use of the Microsoft Excel goes
beyond creating an alternative depiction of trial exhibit 484:

it

creates new evidence by purporting to calculate a trendline and to
report an R2 value reflecting the data’s “fit.”

The results of

specific mathematical computations are not facts that “exist in
the unaided memory of the populace.”
F.3d 18, 23 (1st Cir. 1999).

United States v. Bello, 194

Alifax notes that the members of the

jury had access to a laptop running Excel, but that fact does not
demonstrate that a trendline and R2 value were or are capable of
being “accurately and readily determined from sources whose accuracy cannot reasonably be questioned.”

Fed. R. Evid. 201(b)(2).

Moreover, the trial evidence about Alcor’s correlation test data
(including when it was developed, what the data shows, and what –
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if anything – the FDA may have used it for) are at the heart of
this dispute.

See Mot. by Pl. for Permanent Inj. and Mem. of Law

In Supp. 1 (“Mot. for Perm. Inj.”), ECF No. 302 (“[Alcor] submitted
comparative test data obtained as a direct consequence of its trade
secret theft to the FDA as the only test data supporting its
application for a CLIA designation of iSED [sic] as ‘moderately
complex.’”).

Consequently, the Court will not “defenestrate es-

tablished evidentiary processes” to consider this additional information.

Lussier, 50 F.3d at 1114.

The Court reaches the same conclusion concerning Alifax’s
screen captures from an FDA website, the CLIA categorization proSee Stier Decl. ¶ 6;

cedures, and the iSED operator’s manual.

Mot. for Perm. Inj. Ex. C; Pl.’s Reply Mem. in Supp. of Mot. for
Permanent Inj. Ex. B, ECF No. 321-2.

The Court does not perceive

evidence that the FDA in fact designated the iSED as “moderately
complex” in mid-2014 as “hardly controversial.”
Defs.’ Mot. to Strike 2, ECF No. 322.

Pl.’s Opp’n to

Again, what information

Alcor submitted to the FDA and what – if anything – the FDA did
with that data are disputed material facts.

Alifax did not move

to have this website or the information contained therein admitted
at trial where the Defendants could have meaningfully assayed it.
Lussier, 50 F.3d at 1114 (“[A]ccepting disputed evidence not tested
in the crucible of trial is a sharp departure from standard
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practice.”).

Alifax has not even offered official FDA records

showing the iSED’s CLIA categorization or a copy of an archived
website; it has proposed a screenshot from counsel’s computer.
See Stier Decl. ¶ 6.

The Court is unpersuaded that, under these

circumstances, taking judicial notice of the information reflected
in paragraph 6 of the Stier Declaration would be proper.
As for the “Administrative Procedures for CLIA Categorization,” this document is dated October 2, 2017.

Mot. for Perm.

Inj. Ex. C, at 1. The FDA submissions at issue here occurred in
the winter and spring of 2014. See Tr. Ex. 114, 116. The proffered
document thus has no probative value and is irrelevant.

See Fed.

R. Evid. 401.
In reply, Alifax attempts to remedy this defect by submitting
yet another new document - “Guidance for Industry and Food and
Drug Administrative Staff” – dated March 12, 2014. 1
evidence is also faulty.

As Alcor argues, no witness has

But this
authen-

ticated this document 2 and no foundation has been laid to show that
it qualifies for an exception to the hearsay bar under Fed. R.
Evid. 803.

These deficiencies also scuttle Alifax’s attempt to

1

The document itself appears to have been printed from a
website on June 5, 2019. See ECF No. 321-1.
2

On its face, the document appears to be from the website of
a regulatory consultant and is therefore not self-authenticating
as an “official publication” under Fed. R. Evid. 902.
5

introduce another iSED operator’s manual, ECF No. 321-2, as does
Fed. R. Evid. 201.

On its face, such a document does not qualify

as information “generally known.”

Fed. R. Evid. 201(b)(1). And as

the manual does not appear to identify its effective date range,
it is “subject to reasonable dispute” and inadmissible under Fed.
R. Evid. 201(b)(2). See also Reply in Supp. of Defs.’ Mot. to
Strike the Decl. of Robert H. Stier, Jr. (Dkt. No. 302-2) and
Exhibit Thereto (Dkt. No. 302-3) at 7-8, ECF No. 326.

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III. Conclusion
The Court presided over a three-week trial of this dispute
that followed years of discovery.

Alifax had every opportunity to

produce and present the information that is the subject of the
Defendant’s motion long before the evidentiary record closed. Alifax offers no excuses for its failure do so and no basis whatsoever
to justify re-opening the record.
For the foregoing reasons, Defendants’ Motion to Strike the
Declaration of Robert H. Stier, Jr. (Dkt. No. 302-2) and Exhibit
Thereto (Dkt. No. 302-3) (ECF No. 310) is GRANTED. The Declaration
of Robert H. Stier, Jr. (ECF No. 302-2) is hereby deemed struck
and will not be relied upon for any purpose by the Court in its
post-trial rulings.

The supplemental attachments to Alifax’s op-

position memorandum are similarly deemed struck.
IT IS SO ORDERED.

William E. Smith
Chief Judge
Date: June 18, 2019

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