Alifax Holding Spa v. Alcor Scientific Inc. et al

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 	Decla-
ration 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 cop-
ies 	of 	purported 	“Administrative 	Procedures 	for 	CLIA 	Categoriza-
tion,” 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. 	The 	Court
agrees. 	There is no basis to accept this eleventh-hour evidence.
The Defendants’ motion to strike is therefore GRANTED.
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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 discrimina-
tion 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 con-
cerning 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 	extra-
record evidence concerning disputed adjudicative facts.” 	Id. 	Cer-
tain 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 	opportunity 	to 	object,
cross-examine, 	impeach, 	and 	contradict. 	Id. 	at 	1113, 	n.13. 	The
principle 	of 	judicial 	notice 	provided 	no 	safe 	harbor 	because 	the
relevant 	facts 	were 	neither 	generally 	known 	nor 	undisputed. 	Id.
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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 	evi-
dence 	advanced 	by 	one 	party 	concerning 	disputed 	material 	facts
that 	the 	opposing 	party 	is 	not 	presented 	an 	opportunity 	to 	chal-
lenge.” 	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.” 	United States v. Bello, 194
F.3d 18, 23 (1st Cir. 1999). 	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 accu-
racy 	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 	in-
formation. 	Lussier, 50 F.3d at 1114.
The 	Court 	reaches 	the 	same 	conclusion 	concerning 	Alifax’s
screen captures from an FDA website, the CLIA categorization pro-
cedures, 	and 	the 	iSED 	operator’s 	manual. 	See 	Stier 	Decl. 	¶ 	6;
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.” 	Pl.’s 	Opp’n 	to
Defs.’ 	Mot. 	to 	Strike 	2, 	ECF 	No. 	322. 	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 	Categoriza-
tion,” 	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 	But 	this
evidence is also faulty. 	As Alcor argues, no witness has 	authen-
ticated this document2 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.
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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. 	Ali-
fax 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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