Sciele Pharma, Inc. v. Brookstone Pharmaceuticals, L.L.C.
Filing
327
OPINION AND ORDER GRANTING in part and DENYING in part defendant Acellas 183 Motion to Compel; DENYING defendants 196 Motion to Exclude Testimony of Drs. Gregory and Armstrong; DENYING 197 Motion for Summary Judgment; DENYING 198 Motion to Ex clude Evidence Relating to Product Testing; DENYING 199 Motion to Exclude Testimony of Dr. Reisetter; GRANTING in part and DENYING in part 200 Testimony of Alisha Nielsen; DENYING 204 Motion to Seal Document; DENYING 205 Motion for Partial S ummary Judgment; DENYING 206 Motion to Exclude Expert Opinions of Howard Zandman; DENYING 232 Motion to Seal Document; DENYING 258 Motion to Seal Document; DENYING 259 Motion to Seal Document; DENYING 260 Motion to Seal Document; DENYING [2 61] Motion to Seal Document; DENYING 274 Motion to Seal Document; DENYING 289 Motion to Seal Document; DENYING 296 Motion to Seal Document; DENYING 298 Motion to Seal Document; DENYING 300 Motion to Seal Document; DENYING 313 Motion to St rike; DENYING 314 Motion for a Status Conference; DENYING as moot 326 Motion for Leave to File. Plaintiff shall produce the documents, and disclose the result of the inquiry, directed at page 11 of this Order, within 28 days of this date. Any further motions by Acella on this matter must be filed within 28 days after plaintiffs disclosures and production are complete. Signed by Judge Julie E. Carnes on 8/30/11. (ekb)
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF GEORGIA
ATLANTA DIVISION
SCIELE PHARMA, INC.,
Plaintiff,
CIVIL ACTION NO.
v.
1:09-CV-3283-JEC
BROOKSTONE PHARMACEUTICALS, LLC
a/k/a ACELLA PHARMACEUTICALS,
LLC, ARIZONA NUTRITIONAL
SUPPLEMENTS, INC., and ULTIMATE
FORMULATIONS, INC. d/b/a BEST
FORMULATIONS,
Defendants.
ORDER AND OPINION
This case is presently before the Court on defendant Acella’s
Motion to Compel [183], defendants’ Motion to Exclude Testimony of
Drs. Gregory and Armstrong [196], defendants’ Motion for Summary
Judgment [197], defendants’ Motion to Exclude Evidence Relating to
Product Testing [198], defendants’ Motion to Exclude Testimony of
Dr. Reisetter [199], defendants’ Motion to Exclude Testimony of
Alisha
Nielsen
[200],
plaintiff’s
Motion
for
Partial
Summary
Judgment [205], plaintiff’s Motion to Exclude Expert Opinions of
Howard Zandman [206], plaintiff’s Motion to Seal Various Documents
[204], [232], [258], [259], [260], [261], [274], [289], [296],
[298], [300], defendants’ Motion to Strike [313], plaintiff’s Motion
AO 72A
(Rev.8/82)
for a Status Conference [314], and defendants’ Motion for Leave to
File a Supplemental Response to Plaintiff’s Motion for a Status
Conference [326].
The Court has reviewed the record and the arguments of the
parties and, for the reasons set out below, concludes that defendant
Acella’s Motion to Compel [183] should be GRANTED in part and DENIED
in part, defendants’ Motion to Exclude Testimony of Drs. Gregory and
Armstrong [196] should be DENIED, defendants’ Motion for Summary
Judgment [197] should be DENIED, defendants’ Motion to Exclude
Evidence
Relating
to
Product
Testing
[198]
should
be
DENIED,
defendants’ Motion to Exclude Testimony of Dr. Reisetter [199]
should be DENIED, defendants’ Motion to Exclude Testimony of Alisha
Nielsen [200] should be GRANTED in part and DENIED in part,
plaintiff’s Motion for Partial Summary Judgment [205] should be
DENIED, plaintiff’s Motion to Exclude Expert Opinions of Howard
Zandman [206] should be DENIED, plaintiff’s Motion to Seal Various
Documents [204], [232], [258], [259], [260], [261], [274], [289],
[296], [298], [300] should be DENIED, defendants’ Motion to Strike
[313] should be DENIED, plaintiff’s Motion for a Status Conference
[314] should be DENIED, and defendants’ Motion for Leave to File a
Supplemental Response to Plaintiff’s Motion for a Status Conference
[326] should be DENIED as moot.
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BACKGROUND
This is a Lanham Act case.
Plaintiff Sciele Pharma, Inc.
(“Sciele”) is a pharmaceutical company that develops and sells
branded prescription products, including the prenatal vitamins
PRENATE ELITE and PRENATE DHA.
(Pl.’s Statement of Material Facts
(“PSMF”) [205] at ¶ 6.) Defendant Acella Pharmaceuticals (“Acella”)
is a pharmaceutical company that markets and sells generic products.
(Am. Compl. [139] at ¶ 26.)
Sometime in 2009, Acella developed a
line of prescription prenatal vitamins, known as PNV and PNV-DHA,
to compete with PRENATE ELITE and PRENATE DHA in the prescription
prenatal vitamin market.1
(PSMF [205] at ¶¶ 5, 9.)
Folate is an essential component of prenatal vitamins because
it
helps
at ¶ 21.)
to
prevent
certain
congenital
birth
defects.
(Id.
Most prenatal vitamins contain only folic acid, a
synthetic form of folate that must be metabolized by the body. (Am.
Compl. [139] at ¶ 13.)
Some women are unable to metabolize folic
acid because of a common genetic mutation.
(Id.)
A distinctive
feature of PRENATE vitamins is that they contain a combination of
folic acid and L-Methylfolate (“L-MTHF”), a natural form of folate
1
Defendants Arizona Nutritional Supplements, Inc. (“Arizona”)
and Ultimate Formulations, Inc. (“Best”) manufacture PNV and PNV-DHA
for Acella. (Am. Compl. [139] at ¶¶ 5,6.) Plaintiff named the
manufacturers as defendants in its First Amended Complaint. (Id.)
3
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that is directly usable by the body without additional metabolism.
(Id. at ¶ 14.)
The inclusion of L-MTHF in PRENATE vitamins helps
to ensure that all pregnant women are provided with the full
benefits of folate.
(Id.)
Defendant Acella’s labels and package inserts represent that
PNV vitamins contain the same combination and amounts of folic acid
and L-MTHF as PRENATE vitamins.
(PSMF [205] at ¶ 18.)
However, it
is undisputed that the L-MTHF in PNV vitamins is delivered in a
mixture that also contains D-MTHF, the biologically inert isomer of
MTHF. (Id. at ¶ 44.) Plaintiff presents considerable evidence that
the D,L-MTHF mixture used in PNV is a different dietary ingredient
than the substantially pure L-MTHF that is in PRENATE vitamins.
(Id. at ¶¶ 23-34, 51-59.)
In addition, there is some evidence in
the record that the presence of D-MTHF in the mixture is potentially
harmful, as it may compete with the activity of L-MTHF.
(Id. at
¶ 25.) Thus, plaintiff contends that the labels and package inserts
for PNV vitamins are literally false as to the contents of the
product.
(Am. Compl. [139] at ¶ 59.)
Plaintiff further argues that defendant’s labels are likely to
mislead pharmacists and others in the pharmaceutical distribution
chain.
(Id. at ¶¶ 65-69.)
When two prescription products contain
the same doses of identical ingredients, they become “linked” in
various pharmaceutical databases.
4
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(Id. at ¶ 40, 45.)
Linkage
between two products leads pharmacists to believe that the products
are interchangeable.
(Id.)
Pharmacists are permitted, and even
incentivized, to fill prescriptions with a less expensive linked
product.
(Id.)
PNV vitamins are less expensive than PRENATE
vitamins and, as a result of defendant’s allegedly inaccurate labels
and advertising, PNV vitamins have been linked with PRENATE vitamins
in the major pharmaceutical databases.
(Am. Compl. [139] at ¶ 45.)
Plaintiff thus contends that pharmacists have been improperly
filling
prescriptions for PRENATE vitamins with PNV, although the
two products contain different ingredients.
(Id. at ¶¶ 65-69.)
Plaintiff filed this lawsuit in an effort to prevent what it
regards as the improper substitution of PNV vitamins for PRENATE
vitamins.
(Compl. [1] at ¶ 96.)
In its amended complaint,
plaintiff asserts claims under the Lanham Act for false advertising
and unfair competition.
(Am. Compl. [139] at ¶¶ 58-89.)
Plaintiff
also asserts a state law claim under the Georgia Uniform Deceptive
Practices Act.
plaintiff
seeks
(Id. at ¶¶ 90-96.)
money
damages,
and
In its request for relief,
an
injunction
permanently
prohibiting defendant from representing that PNV vitamins contain
L-MTHF, or that PNV vitamins are equivalent to or interchangeable
with PRENATE vitamins.
(Id. at 27-30.)
In conjunction with its complaint, plaintiff filed a motion for
a preliminary injunction.
(Pl.’s Mot. for Prelim. Inj. [9] at 2.)
5
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The Court held a hearing on the motion, during which defendant
Acella raised the issue of FDCA preclusion as a ground for dismissal
of the complaint. (Minute Entry [23].) After considering extensive
briefing from the parties on the preclusion issue, the Court denied
Acella’s motion to dismiss.
(Order [137] at 13.)
In the same
order, the Court found that there was no evidence of irreparable
harm, and denied plaintiff’s request for a preliminary injunction.
(Id. at 7.)
Following the Court’s order, the parties completed fact and
expert discovery in the case.
Defendant Acella subsequently filed
a motion to compel, and defendants jointly filed several motions to
exclude expert testimony and other evidence disclosed by plaintiff
during discovery.
(Def. Acella’s Mot. to Compel [183] and Defs.’
Mots. to Exclude [196], [198], [199], and [200].)
Plaintiff
responded with its own motion to exclude testimony from one of
defendants’ experts and numerous motions to seal various documents
and exhibits. (Pl.’s Mot. to Exclude [206] and Mots. to Seal [204],
[232], [258], [259], [260], [261], [274], [289], [296], [298],
[300].)
In addition, the parties filed cross motions for summary
judgment, and related motions to strike and for a status conference.
(Defs.’ Mot. for Summ. J. [197] and Mot. to Strike [313] and Pl.’s
Mot. for Summ. J. [205] and Mot. for Status Conference [314].)
of those motions are presently before the Court.
6
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All
DISCUSSION
I.
Defendant Acella’s Motion To Compel
During discovery, Acella requested documents from plaintiff
related to (1) the date that plaintiff began stability testing the
PRENATE products and (2) any testing conducted on the PRENATE and
PNV products, including testing done by plaintiff’s manufacturers.
(Def. Acella’s Mot. to Compel [183] at 9-13.)
In addition, Acella
requested that plaintiff produce: (1) any communications with Merck
concerning Metafolin, Xolafin or Xolafin-B2, (2) any contracts or
agreements using or defining the term Metafolin or L-MTHF, or
providing
for
a
royalty
or
other
fee
related
to
the
use
of
Metafolin, and (3) any documents that define the term “generic” as
it relates to PRENATE or PNV vitamins. (Id. at 13-15.) Acella does
not dispute that plaintiff produced over 25,000 pages of documents
in response to these requests.
Compel
[324]
at
12-13.)
(Pl.’s Resp. to Def.’s Mot. to
Nevertheless,
objections,
Acella
suspects
that
incomplete.
based
plaintiff’s
(Def.’s Reply [236].)
2
plaintiff’s
on
response
was
Metafolin is the folate source used in PRENATE vitamins.
(DSMF [203] at ¶ 2.)
Plaintiff obtains Metafolin from Merck’s
distributor, Pamlab, LLC.
(Id.)
Xolafin or Xolafin-B are the
folate sources used in PNV vitamins. (Id. at ¶ 3.) Acella obtains
Xolafin and Xolafin-B from a Chinese supplier. (PSMF [205]
at ¶ 35.)
7
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In spite of the volume of documents produced, it is unclear
whether plaintiff has fully responded to the above requests. First,
with regard to documents evidencing the date that plaintiff began
stability testing PRENATE vitamins, plaintiff objected to producing
any documents that were created before the current formulation of
PRENATE was launched in 2008. (Pl.’s Resp. [324] at 13.) The Court
agrees with Acella that documents concerning plaintiff’s stability
testing regimen prior to 2008 are relevant because those documents
could demonstrate deficiencies in, or changes to, plaintiff’s
testing program, and because plaintiff has put stability testing at
issue in this case.
Plaintiff acknowledges that PRENATE vitamins have been on the
market since 2004.
(Id. at 10.)
To the extent any relevant
documents are still within its possession and control, plaintiff
should produce stability testing information regarding PRENATE
vitamins from the date the product was launched.
That information
should include any documents that show the date that plaintiff
initiated its stability testing program.
With regard to the more general testing information concerning
PRENATE, PNV, and their respective ingredients, plaintiff has
refused to produce some documents on the ground that they are in the
possession of “third parties” and are thus not within plaintiff’s
control.
(Def. Acella’s Mot. to Compel [183] at 11-13.)
8
AO 72A
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The
referenced
“third
parties”
are
plaintiff’s
manufacturers,
Pharmetics, Inc. (“Pharmetics”) and Catalent Pharma Solutions Ltd.
(“Catalent”).
(Id. at 12 and Pl.’s Resp. [324] at 2.)
The fact that responsive documents are currently within the
possession of a third party does not necessarily exclude them from
routine party discovery.
Federal Rule 34 requires a party to
produce any documents that are within its “possession, custody, or
control.”
FED. R. CIV. P. 34(a)(1).
In the context of Rule 34,
“control” encompasses not only physical possession, but also “the
legal right to obtain the documents requested upon demand.” Searock
v. Stripling, 736 F.2d 650, 653 (11th Cir. 1984). Applying Rule 34,
plaintiff
has
a
duty
to
make
a
good
faith
effort
to
obtain
responsive documents from its manufacturers, and to produce any
documents that are discovered as a result of that effort.3
Id. at
654 (“the primary dispositive issue is whether [the defendant] made
a good faith effort to obtain the documents” over which he had
control).
As to plaintiff’s communications with Merck, plaintiff objected
to this request on the ground that such communications are protected
3
On the other hand, neither the Court nor plaintiff has the
authority to force plaintiff’s foreign manufacturers to submit to
a deposition, as requested by Acella.
See FED. R. CIV. P.
45(c)(3)(A)(ii). The Court thus DENIES Acella’s motion to compel
to the extent that it asks the Court to “facilitate the depositions
of [plaintiff’s] contract manufacturers.” (Id.)
9
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from discovery by the attorney-client privilege, common interest,
or the work product doctrine.
at 13.)
(Def. Acella’s Mot. to Compel [183]
Acella correctly points out that these privileges do not
protect communications unless they were prepared (1) in anticipation
of or in connection with the litigation or (2) at the direction of
plaintiff’s attorneys.
See Miccosukee Tribe of Indians of Florida
v. U.S., 516 F.3d 1235, 1263 (11th Cir. 2008)(“The attorney work
product privilege generally protects documents prepared by an
attorney in anticipation of litigation.”).
Plaintiff does not specifically spell out how the non-disclosed
information fits within the above standard, except to say that it
has not located any additional responsive non-privileged documents.
Moreover, it is not clear that plaintiff produced a privilege log
in accordance with Rule 26(b)(5), describing the documents that were
withheld as privileged. To the extent it has not done so, plaintiff
should produce such a log so that Acella can more effectively assess
the applicability of any privilege claimed.
It appears from the record that plaintiff adequately responded
to the remainder of Acella’s requests, including its request for (1)
any contracts or agreements that use or define the terms Metafolin
or L-MTHF and (2) any and all documents that provide the market
definition of the term “generic” as it relates to PRENATE or PNV
products.
(Pl.’s Resp. [324] at 11-12.)
10
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In response to Acella’s
motion, plaintiff represents that it has not located any additional
non-privileged documents that are responsive to these requests.
(Id. at 12.)
Given the volume of plaintiff’s response, the Court
has no reason to doubt that representation.
For the foregoing reasons, the Court GRANTS in part and DENIES
in part Acella’s Motion to Compel [183].
In accordance with its
rulings, the Court directs plaintiff to:
(1)
Produce documents sufficient to show the date plaintiff
began stability testing the PRENATE products;
(2)
Make a good faith effort to obtain any previously
undisclosed documents from its manufacturers Pharmetics
and Catalent relating to testing of the PRENATE and PNV
products and their respective ingredients, including
documents sufficient to show the validation of any method
used to test those products; and
(3)
To the extent it has not already done so, produce a
privilege log in accordance with Rule 26(b)(5) that
describes the basis for any claimed privilege with
respect to plaintiff’s communications with Merck.
It is apparent to the Court that plaintiff attempted to respond to
Acella’s requests in good faith, and that plaintiff in fact produced
a wealth of responsive documents.
Accordingly, the Court DENIES
Acella’s request for fees and costs associated with this motion.
The Court also DENIES Acella’s request to reopen discovery except
for the limited purpose of producing those documents specified
above.
11
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II.
Defendants’ Motion To Exclude Evidence Of Product Testing
In a related motion, defendants jointly ask the Court to
exclude any evidence of product testing offered by plaintiff, in
particular evidence concerning the shelf life or active ingredient
content
of
PNV
vitamins.
(Defs.’
Mot.
to
Exclude
[198].)
Defendants argue that this evidence should be excluded as a sanction
for plaintiff’s refusal, in its initial response, to produce all
responsive documents concerning product testing.
(Id. at 4.)
Alternatively, defendants contend that the testing evidence is
irrelevant, because the complaint does not adequately allege a claim
concerning PNV’s shelf life or active ingredient content. (Id.)
Finally, defendants question the competence of plaintiff’s proposed
witness, John Lockwood, to testify about testing that “may have been
performed” on PNV products by certain unidentified third parties.
(Id. at 5.)
As explained below, all of these arguments are
unpersuasive.
The Court thus DENIES defendants’ motion to exclude
[198].
As an initial matter, the complaint clearly is broad enough to
encompass plaintiff’s claim that PNV’s label is misleading as to the
shelf
life
and
active
ingredient
content
of
PNV
vitamins.
Plaintiff’s claim is based on evidence suggesting that Acella does
not test PNV vitamins to ensure that the vitamins maintain their
labeled active ingredient concentration for 24 months, which is the
12
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labeled expiration date.
(See Pl.’s Mot. for Summ. J. [205] at 5.)
The claim is thus part and parcel of plaintiff’s more general claim
that PNV vitamins are not identical to PRENATE vitamins in strength
or concentration, and do not deliver their active ingredients at the
same rate and in the same amount as PRENATE vitamins.
[139] at ¶¶ 42, 51-52, 56.)
(Am. Compl.
Product testing evidence is obviously
relevant to this claim.
Neither would it be appropriate to exclude the evidence as a
sanction for plaintiff’s initial refusal to produce all of the
testing documents requested by defendants.
As discussed above,
plaintiff produced over 25,000 pages of documents in response to
Acella’s discovery requests, and many of those documents concerned
product testing. (Pl.’s Resp. to Def.’s Mot. to Compel [324] at 1213.)
The Court has ordered plaintiff to make a further effort to
obtain testing documents from its manufacturers, and to produce
documents showing the date when plaintiff initiated its own testing
regimen.
However, there is no evidence that plaintiff withheld any
responsive documents in bad faith.4 Consequently, there is no basis
to exclude product testing evidence as a sanction against plaintiff.
4
In fact, defendants’ motion is based, in part, on their
suspicion that tests of PNV “may have been performed” by third
parties associated with Merck. (Defs.’ Mot. to Exclude [198] at 5.)
Plaintiff has assured the Court that it is not aware of any such
tests. (Pl.’s Resp. to Defs.’ Mot. to Exclude [264] at 3.)
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With regard to Mr. Lockwood, plaintiff identified him on
January
8,
2010
as
an
individual
conducted on PRENATE products.
knowledgeable
(Id. at 11.)
employed as plaintiff’s Director of Quality.
about
testing
Mr. Lockwood is
(Id.)
As such, he is
familiar with the quality standards that are applicable to PRENATE
vitamins,
including
the
stability
specifications
that
PRENATE
vitamins must meet and the testing that is routinely done to ensure
their compliance.
(Id. at 14.)
Defendants have not presented any
basis on which to preclude Mr. Lockwood from testifying generally
as to facts and information derived in the usual course of his
employment.
If defendants have objections to specific portions of
Mr. Lockwood’s testimony, they should raise those objections at
trial.
III. Daubert Motions
Both parties have filed motions to exclude proffered expert
testimony under Rule 702 of the Federal Rules of Evidence and
Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 588 (1993). Rule
702 provides:
If scientific, technical, or other specialized knowledge
will assist the trier of fact to understand the evidence
or to determine a fact in issue, a witness qualified as
an expert by knowledge, skill, experience, training, or
education, may testify thereto in the form of an opinion
or otherwise.
14
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FED. R. EVID. 702.
Pursuant to Rule 702, expert testimony is
admissible when (1) the expert is qualified to testify competently,
(2) the expert’s methodology is reliable and (3) the expert’s
testimony will assist the trier of fact to understand the evidence
or to determine a fact at issue in the case. Allison v. McGhan Med.
Corp., 184 F.3d 1300, 1309 (11th Cir. 1999).
The Daubert Court emphasized the district court’s “gatekeeping”
role to ensure that scientific testimony is relevant and reliable
before it is admitted as evidence.
Daubert, 509 U.S. at 589-90.
See also Hudgens v. Bell Helicopters/Textron, 328 F.3d 1329, 1342
(11th Cir. 2003)(noting “the repeated emphasis the Supreme Court has
placed
upon
the
district
court’s
‘gatekeeping’
role
in
the
determination of whether expert evidence should be admitted”). This
gatekeeping obligation applies “not only to testimony based on
‘scientific’ knowledge, but also to testimony based on ‘technical’
and ‘other specialized’ knowledge.”
Carmichael, 526 U.S. 137, 141 (1999).
Kumho Tire Co., Ltd. v.
The overarching goal of
Daubert’s gatekeeping requirement is to ensure that an expert
“employs in the courtroom the same level of intellectual rigor that
characterizes the practice of an expert in the relevant field.” Id.
at 152.
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A.
Drs. Gregory and Armstrong
Plaintiff offers the testimony of Drs. Gregory and Armstrong,
leading
experts
in
folate
chemistry
and
stereochemistry
respectively, in support of its assertions that (1) the active
ingredient in PNV vitamins is not properly described as L-MTHF and
(2) the D,L-MTHF used in PNV vitamins is a distinct substance from
the L-MTHF used in PRENATE vitamins, with different physical,
chemical and biological properties.
Exclude [250] at 2.)
(Pl.’s Resp. to Defs.’ Mot. to
Defendants have filed a motion to exclude the
testimony of Drs. Gregory and Armstrong on that ground that neither
expert is part of the relevant market for the products at issue.
(Defs.’ Mot. to Exclude [196] at 2.)
In addition, defendants argue
that Dr. Gregory’s opinion concerning the potentially harmful
effects of D-MTHF is unreliable.
proposed
testimony
of
Drs.
(Id.)
Gregory
The Court finds that the
and
Armstrong
meets
the
requirements of Daubert and Rule 702, and thus DENIES defendants’
motion to exclude [196].
Defendants concede that Drs. Gregory and Armstrong are both
qualified to render an expert opinion in this case.
(Defs.’ Reply
[293] at 1.) Dr. Gregory has studied the absorption, metabolism and
function of B-vitamins such as folates for 33 years.
[250] at 8.)
(Pl.’s Resp.
He is the author of more than 160 journal articles,
30 review articles and 25 book chapters, many of which address the
16
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bioavailability, absorption and metabolism of folate.
(Id.)
His
work was used by the National Institutes of Health, the Centers for
Disease Control and Prevention, and the United States Department of
Agriculture in revising the Recommended Dietary Allowance for
folate.
(Id. at 8-9.)
Dr. Armstrong is similarly well-qualified as an expert.
Dr.
Armstrong has published and presented extensively in the field of
stereochemistry.
(Id. at 9.)
He is the former Editor-in-Chief of
the peer-reviewed scientific journal Chirality, which publishes
articles concerning chiral chemistry in relation to physiology.
(Id.)
Currently, Dr. Armstrong is the Associate Editor of the
Journal of Analytical Chemistry, where he handles all articles
dealing with chiral separations.
(Pl.’s Resp. [250] at 9.)
Nor can defendants credibly dispute the relevance of the
proposed testimony of these experts.
Both Dr. Gregory and Dr.
Armstrong will offer opinions on a central issue in this case:
whether a mixture of D-MTHF and L-MTHF is a chemically distinct
substance from the substantially pure form of L-MTHF, such that the
labeling of PNV vitamins is literally false or misleading.
9-10.)
(Id. at
Specifically, Dr. Gregory will testify as to the following,
based on his experience, training and education:
(1) the term L-
MTHF refers solely to the substantially pure L diastereoisomer, (2)
diastereomeric mixtures such as D,L-MTHF are chemically distinct
17
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entities from single isomer forms such as L-MTHF because they have
different chemical, physical and biological properties, and (3) LMTHF has advantageous biological benefits that distinguish it from
D,L-MTHF.
(Id.)
Likewise, Dr. Armstrong will testify that a
diastereomeric mixture such as D,L-MTHF and a single diastereomer
such
as
L-MTHF
are
different
chemical
entities
referenced by their distinct chemical names.
that
must
be
(Id. at 10.)
Defendants’ principal objection to the proffered testimony is
that Drs. Gregory and Armstrong are “career academics” who have no
practical experience in pharmacy or medicine, and who are thus not
part of the relevant market for PRENATE or PNV products.
Mot. to Exclude [196] at 1-2, 10-13.)
(Defs.’
As noted above, Drs. Gregory
and Armstrong are well-qualified to testify as to the opinions that
are set forth in their expert reports, including their opinions
concerning the differences between, and nomenclature conventions
governing, L-MTHF and D,L-MTHF.
That they are not also pharmacists
or physicians does not render their opinions any less relevant or
reliable. See Tuscaloosa v. Harcros Chem., Inc., 158 F.3d 548, 56465 (11th Cir. 1998)(noting that an expert’s testimony need not
singlehandedly establish every element of plaintiff’s claim to be
admitted under Rule 702).
Their testimony is an important “piece
of the puzzle that the plaintiff[] endeavor[s] to assemble before
the jury” in this case.
Id. at 565.
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As to the potentially harmful effects of D-MTHF, Dr. Gregory’s
opinion on this issue is sufficiently reliable to present to the
jury.
Based on his familiarity with diastereomers in general, and
his review of several peer-reviewed studies and scientific journal
articles concerning the behavior of D,L-MTHF in particular, Dr.
Gregory concludes that the biologically “inert” D-MTHF isomer may
interfere with the body’s absorption of L-MTHF.
at 20-22.)
(Pl.’s Resp. [250]
To the extent that defendants challenge the factual
basis for Dr. Gregory’s opinion, that is an issue that generally
goes to
credibility and weight, as opposed to admissibility.
Bonner v. ISP Tech., Inc., 259 F.3d 924, 929 (8th Cir. 2001).
See
also Maiz v. Virani, 253 F.3d 641, 667 (11th Cir. 2001)(permitting
an accounting expert to opine on forensic accounting issues based
on
“reasonable
assumptions
applicable contracts”).
regarding
the
requirements
of
the
Any perceived gaps in the evidentiary
support for Dr. Gregory’s opinion should likewise be addressed on
cross-examination.
B.
Dr. Reisetter
Plaintiff offers the testimony of Dr. Brian Reisetter in
support of its claim that PNV’s labeling is misleading to consumers.
(Pl.’s Resp. to Defs.’ Mot. to [251] at 2.)
Dr. Reisetter is a
licensed pharmacist with a doctorate in pharmacy administration.
(Id.)
In addition to working as a practicing pharmacist, Dr.
19
AO 72A
(Rev.8/82)
Reisetter
has
worked
for
several
years
as
a
consultant
for
pharmaceutical companies in the marketing of their products. (Id.)
In this role, Dr. Reisetter has accumulated over twenty years of
experience in formulating and evaluating surveys that involve the
pharmaceutical industry, including litigation surveys.
(Id.)
In connection with his work on this case, Dr. Reisetter
conducted a survey on the labeling information included in the
package inserts for PNV vitamins.
(Reisetter Report, attached to
Defs.’ Mot. to Exclude [199] at Ex. A.)
One hundred and fifty
pharmacists provided data for the survey, including two to three
pharmacists from each state.
pharmacists
vitamins.
reviewed
the
(Id. at ¶ 92.)
(Id. at ¶ 86.)
package
inserts
The participating
for
PNV
and
PRENATE
They were then asked to determine, based
on the inserts, how similar the two products were and whether they
were appropriate for substitution.
survey
results,
Dr.
Reisetter
(Id.)
concluded
After analyzing the
that
PNV’s
labeling
information is confusing because it leads pharmacists to believe
that
PNV
appropriate
vitamins
generic
are
pharmaceutically
substitutes
for,
equivalent
PRENATE
to,
vitamins.
and
(Id.
at ¶¶ 1-4.)
Defendants concede that Dr. Reisetter is qualified to testify
as an expert in this case, and that courts routinely accept his
testimony.
(Defs.’ Br. in Supp. of Mot. to Exclude [199] at Reply
20
AO 72A
(Rev.8/82)
[292].)
Moreover, there is no question that Dr. Reisetter’s
opinions are highly relevant.
Like the testimony of Drs. Gregory
and Armstrong, Dr. Reisetter’s testimony bears on a central issue
in this case:
whether PNV’s labeling is misleading such that it
results in improper substitution decisions.
See Hickson Corp. v.
N. Crossarm Co., Inc., 357 F.3d 1256, 1261 (11th Cir. 2004)
(“Consumer survey research often is a key part of a Lanham Act claim
alleging that an advertisement is misleading or deceptive.”).
Primarily,
defendants
Reisetter’s testimony.
[199]
at
11-21.)
question
the
reliability
of
Dr.
(Defs.’ Br. in Supp. of Mot. to Exclude
Specifically,
defendants
argue
that
Dr.
Reisetter’s study is fundamentally flawed because it relied on
outdated package inserts for PNV, rather than the current inserts
and labels.
(Id. at 11-12.)
According to defendants, PNV’s label
and inserts now contain disclaimers that would have impacted the
survey results.
(Id. at 13.)
In addition, defendants claim that
Dr. Reisetter’s survey is unreliable because it lacked appropriate
controls.
(Id. at 14-16.)
Finally, defendants assert that Dr.
Reisetter’s sample size was too small and that he used leading and
biased questions.
(Id. at 16-21.)
None of the alleged flaws in Dr. Reisetter’s survey supports
exclusion of his testimony.
As an initial matter, the package
inserts used in Dr. Reisetter’s survey are the same inserts that
21
AO 72A
(Rev.8/82)
Acella
provided
launched.
to
the
pharmaceutical
databases
(Reisetter Report [199] at ¶¶ 52-53.)
when
PNV
was
Based on the
information provided in those inserts, the databases made the
decision to link the PNV and PRENATE products.
(Id. at ¶¶ 58-59.)
The inserts were thus an appropriate subject for Dr. Reisetter’s
survey.
Moreover, defendant did not issue its revised package
insert until after Dr. Reisetter collected his survey data.
(Pl.’s
Resp. [251] at 25.) Dr. Reisetter’s failure to incorporate material
that was not available at the time that he conducted his survey
obviously does not render the survey unreliable.
The other issues identified by defendants go to the weight of
Dr. Reisetter’s testimony, not its admissibility.
See Jellibeans,
Inc. v. Skating Clubs of Georgia, Inc., 716 F.2d 833, 844 (11th Cir.
1983)(holding that technical deficiencies in sampling and question
design affect a survey’s weight, not its admissibility) and Pediamed
Pharm., Inc. v. Breckenridge Pharm., Inc., 419 F. Supp. 2d 715, 729
(D. Md. 2006)(rejecting a similar challenge to survey evidence
proffered by Dr. Reisetter).
There is sufficient indicia of
reliability to admit Dr. Reisetter’s testimony.
With respect to
defendants’ concerns in particular, Dr. Reisetter persuasively
explains the measures taken to control for bias in his survey, and
the Court finds that his questions were not leading or unduly
biased. (Reisetter Dep. [307] at 189-192 and Reisetter Report [199]
22
AO 72A
(Rev.8/82)
at ¶ 86.)
Furthermore, the sample size was sufficiently large to
provide meaningful results.
729.
Accord PediaMed, 419 F. Supp. 2d at
Accordingly, defendants’ motion to exclude Dr. Reisetter’s
testimony [199] is DENIED.
C.
Alisha Nielsen
Finally, plaintiff offers the testimony of Alisha Nielsen as
an expert on the policies and procedures used by pharmaceutical
databases to link a new product to a similar existing drug, and more
specifically the decision to link the PNV and PRENATE products.
(Pl.’s Resp. to Defs.’ Mot. to Exclude [249] at 2-3.)
Ms. Nielsen
is a former employee of First DataBank, one of the two leading
pharmaceutical databases. (Id. at 1.) Ms. Nielsen worked for First
DataBank for thirteen years, first as a Research Associate and then
as Manager of the Editorial Services Department.
(Id.)
In both
capacities, Ms. Nielsen was responsible for reviewing new product
labels and information sheets to determine whether they were so
similar that they should be linked to a similar existing product.
(Id. at 1-2.)
Ms. Nielsen currently owns a business that consults
with pharmaceutical companies in the process of launching new
products to be listed in the pharmaceutical databases.
(Id. at 2.)
Defendants concede that Ms. Nielsen is qualified to testify
generally about database policy and procedure with respect to drug
linkage. (Defs.’ Reply [291] at 8.) However, defendants argue that
23
AO 72A
(Rev.8/82)
Ms.
Nielsen’s
testimony
concerning
certain
codes
used
by
the
databases in making linkage decisions is unreliable because it
conflicts with her prior testimony in a related action pending in
the Eastern District of Louisiana.
(Defs.’ Mot. to Exclude [200]
at 6-9.) Defendants argue further that Ms. Nielsen’s opinions that
rely
upon
the
application
of
stereochemistry,
including
her
testimony concerning the identity of active ingredients and the
veracity of defendant’s labels, are beyond her area of expertise.
(Id. at 9-19.)
Contrary to defendants’ argument, Ms. Nielsen’s prior testimony
concerning the codes used by the databases to classify drugs is
consistent with her testimony in this case.
In both cases, Ms.
Nielsen defined the database terms “GCN” and “GPI” as meaning,
respectively, “group code number” and “group product identifier.”
(Id. at 7-8.)
In her expert report, Ms. Nielsen states the GCN and
GPI codes are used as a guide to help pharmacists identify products
that may be dispensed as generic substitutes for a prescribed
product.
(Id. at 7.)
That statement does not contradict her
testimony in the Louisiana action, the gist of which was that the
databases are careful to avoid any representation that the coding
is definitive evidence of a drug’s generic status.
(Id. at 8.)
Because there is no real inconsistency in her testimony, defendants’
24
AO 72A
(Rev.8/82)
motion [200] to exclude Ms. Nielsen’s opinions concerning database
coding is DENIED.
Moreover, the Court finds that Ms. Nielsen’s general testimony
as to the inner workings of the databases, and her specific
testimony as to the linkage between the PNV and PRENATE products,
is relevant and reliable.
To that end, plaintiff represents that
Ms. Nielsen will testify that: (1) the databases rely on product
labels and information sheets, particularly their identification of
a product’s active ingredient, strength, dosage form and route of
administration, to determine whether a new product should be linked
to a similar
existing product, (2) any conclusion that PNV
contained L-MTHF would have been derived from the label and product
information sheet provided by defendants, and (3) if the label or
product information sheet had indicated that the active ingredient
of PNV was D,L-MTHF rather than L-MTHF, the product would not have
been linked to PRENATE.
(Pl.’s Resp. to Mot. to Exclude [249] at
2-3.)
These opinions bear on a central issue in the case:
linkage
with
PRENATE
in
the
pharmaceutical
databases
PNV’s
and
the
resulting substitution of PNV products when PRENATE was prescribed
to patients.
See Allison, 184 F.3d at 1310 (in the context of Rule
702, evidence is relevant if it will “assist the trier of fact to
understand the evidence or to determine a fact in issue”).
25
AO 72A
(Rev.8/82)
The
opinions are also reliable, as they are based on Ms. Nielsen’s
extensive experience working as a researcher and an editorial
manager for First DataBank.
Accordingly, defendants’ motion [200]
is DENIED to the extent it seeks to exclude Ms. Nielsen’s testimony
as to these particular opinions.
However, the Court agrees with defendants that Ms. Nielsen is
not
qualified
to
offer
any
opinion
that
requires
specialized
knowledge of stereochemistry in general, or of the chemical or
physical properties of D,L-MTHF and L-MTHF in particular. Thus, Ms.
Nielsen’s proposed testimony that “[s]cientists have concluded that
[d]efendants’ product did not contain the stereoisomerically pure
form of L-methylfolate” is improper.
Exclude [249] at 2.)
(Pl.’s Resp. to Mot. to
Ms. Nielsen is no more qualified to render
that opinion than the average juror, upon his consideration of
testimony
from
the
scientists
that
Ms.
Nielsen
is
presumably
referring to: Drs. Gregory and Armstrong.
Plaintiff concedes that Ms. Nielsen is not a scientist.
at 5.)
(Id.
Even a highly qualified expert must limit her opinions to
her particular area of expertise.
See United States v. Brown, 415
F.3d 1257, 1269 (11th Cir. 2005)(refusing to qualify an expert who
had only limited experience with the particular chemical substance
at issue in the case).
Defendants’ motion [200] is therefore
GRANTED as to Ms. Nielsen’s opinions concerning: (1) any distinction
26
AO 72A
(Rev.8/82)
between the chemical or physical properties of D,L-MTHF and L-MTHF,
including whether D,L-MTHF and L-MTHF constitute different active
ingredients, and (2) the actual content of the PNV and/or PRENATE
products, including whether either product contains D,L-MTHF or LMTHF.
D.
Howard Zandman
Defendants offer Mr. Zandman as an expert on damages in this
case, primarily to rebut the testimony of plaintiff’s damages expert
Patrick Braley. (Defs.’ Resp. to Pl.’s Mot. to Exclude [272] at 2.)
Mr. Zandman is a Certified Public Accountant and Forensic Financial
Analyst.
(Id.)
In his expert report, Mr. Zandman opines that
defendant Acella’s net profit from sales of PNV was approximately
seven million dollars, more than twelve million dollars less than
the gross profit figure provided by Mr. Braley.
(Id. at 3.)
Mr.
Zandman further concludes that Mr. Braley overstated plaintiff’s
lost profits resulting from PNV by at least five million dollars
because he did not account for other factors that contributed to
declining sales of PRENATE vitamins.
(Id. at 2-3.)
In its motion to exclude, plaintiff argues that Mr. Zandman’s
opinions
are
unreliable
because
(1)
he
relied
on
financial
statements provided by Acella without independently verifying the
underlying supporting data and (2) he did not quantify the impact
of the “other factors” that allegedly caused some portion of
27
AO 72A
(Rev.8/82)
plaintiff’s lost sales.
argument is persuasive.
(Pl.’s Mot. to Exclude [206].)
Neither
With respect to the net profits analysis,
Mr. Zandman properly relied on financial statements and other
information provided by Acella.
See U.S. v. Steed, 548 F.3d 961,
975 (11th Cir. 2008)(noting that experts are entitled to rely upon
facts or data supplied by third parties).
Mr. Zandman was not
required to audit Acella’s financial statements to render a reliable
analysis.
As explained in connection with certain of Dr. Gregory’s
opinions, to the extent plaintiff is challenging the factual basis
for Mr. Zandman’s analysis, that is an issue that should be
addressed on cross-examination.
Maiz, 253 F.3d at 667.
Mr. Zandman’s “other factors” analysis is likewise admissible.
This analysis is offered to explain factors other than PNV’s
introduction into the market that may have accounted for plaintiff’s
lost sales.
(Zandman Report at 7-12, attached to Pl.’s Mot. to
Exclude [206] at Ex. 1.)
These factors include, among others,
plaintiff’s pricing structure and the introduction of plaintiff’s
new product PRENATE ESSENTIAL into the market.
(Id.)
Based on the
Court’s review of Mr. Zandman’s report, his “other factors” analysis
appears to be derived from the application of basic economic
principles to known or reasonably deduced facts about the prevailing
market conditions when Acella launched PNV.
(Id.)
Mr. Zandman’s
failure to quantify the exact amount of lost sales attributable to
28
AO 72A
(Rev.8/82)
each factor is another topic for cross-examination, but does not
render the entire “other factors” analysis speculative, as plaintiff
suggests.
For all of these reasons, plaintiff’s motion to exclude
[206] is DENIED.
IV.
Motions For Summary Judgment
A.
Summary Judgment Standard
Summary
judgment
is
appropriate
when
the
pleadings,
the
discovery and disclosure materials on file, and any affidavits show
that there is no genuine issue as to any material fact and that the
movant is entitled to a judgment as a matter of law.
P. 56(c).
FED. R. CIV.
A fact’s materiality is determined by the controlling
substantive law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248
(1986).
An issue is genuine when the evidence is such that a
reasonable jury could return a verdict for the nonmovant.
Id. at
249-50.
Summary judgment is not properly viewed as a device that the
trial court may, in its discretion, implement in lieu of a trial on
the merits.
Instead, Rule 56 of the Federal Rules of Civil
Procedure mandates the entry of summary judgment against a party who
fails to make a showing sufficient to establish the existence of
every element essential to that party’s case on which that party
will bear the burden of proof at trial.
477 U.S. 317, 322 (1986).
In such a situation, there can be no
29
AO 72A
(Rev.8/82)
Celotex Corp. v. Catrett,
genuine issue as to any material fact, as a complete failure of
proof concerning an essential element of the non-moving party’s case
necessarily renders all other facts immaterial.
Id. at 322-23
(quoting FED. R. CIV. P. 56(c)).
The movant bears the initial responsibility of asserting the
basis for his motion.
Id. at 323.
However, the movant is not
required to negate his opponent’s claim.
The movant may discharge
his burden by merely “‘showing’-- that is, pointing out to the
district court--that there is an absence of evidence to support the
non[-]moving party’s case.”
Id. at 325.
After the movant has
carried his burden, the non-moving party is then required to “go
beyond the pleadings” and present competent evidence designating
“specific facts showing that there is a genuine issue for trial.”
Id. at 324.
While the court is to view all evidence and factual
inferences in a light most favorable to the non-moving party,
Samples v. City of Atlanta, 846 F.2d 1328, 1330 (11th Cir. 1988),
“the mere existence of some alleged factual dispute between the
parties will not defeat an otherwise properly supported motion for
summary judgment; the requirement is that there be no genuine issue
of material fact.”
B.
Anderson, 477 U.S. at 247-48 (1986).
Defendants’ Motion
To prevail on its Lanham Act claims, plaintiff must show: (1)
that defendants’ advertisements were false or misleading, (2) that
30
AO 72A
(Rev.8/82)
they deceived or had the capacity to deceive consumers, (3) that the
deception had a material effect on purchasing decisions, and (4)
that plaintiff was injured by the false advertising.5
Johnson &
Johnson Vision Care, Inc. v. 1-800 Contacts, Inc., 299 F.3d 1242,
1247 (11th Cir. 2002).
The first element is satisfied by evidence
that the advertisements at issue were either literally false, or
literally true but misleading. Hickson, 357 F.3d at 1261. In their
motion
for
summary
judgment,
defendants
argue
that
there
is
insufficient evidence to support plaintiff’s claim that PNV’s
labeling was either literally false or misleading.
Supp. of Summ. J. [203] at 8-35.)
(Defs.’ Br. in
In addition, defendants reassert
the FDCA preclusion argument made in their motion to dismiss.
(Id.
at 35-43.)
1.
FDCA preclusion does not apply.
Defendants have not persuaded the Court that there is any
reason to revisit its previous ruling as to FDCA preclusion.
FDCA
preclusion is applicable where a plaintiff tries to use the Lanham
Act as a vehicle to enforce the FDCA, or asserts a Lanham Act claim
that “stray[s] ‘too close to the exclusive enforcement domain of the
FDA.’”
Graceway Pharm., LLC v. River’s Edge Pharm., LLC, 2009 WL
5
Plaintiff must also meet the interstate commerce
requirement. Johnson & Johnson, 299 F.3d at 1247. However, that
element is not at issue in this case.
31
AO 72A
(Rev.8/82)
3753586 at *6-7 (N.D. Ga. 2009)(Story, J.)(quoting Summit Tech.,
Inc. v. High-Line Med. Instruments Co., Inc., 922 F. Supp. 299, 306
(D. Cal. 1996)).
See also Sandoz Pharm. Corp. v. Richardson-Vicks,
Inc., 902 F.2d 222, 230 (3rd Cir. 1990)(precluding a Lanham Act
claim based on the labeling of an ingredient as “inactive” when FDA
standards suggested that the ingredient was “active”).
Plaintiff
in this case has done neither.
The determinative factor in the preclusion analysis is the
extent to which the plaintiff relies on the FDCA as a basis for its
claim or, alternatively, the extent to which the Court would be
required to interpret or apply the FDCA or FDA regulations to decide
the claim.
See Graceway, 2009 WL 3753586 at *6 (“courts have been
wary of allowing Lanham Act claims where determining the falsity of
the representation at issue would require the court to interpret and
then apply the regulatory or statutory provisions of the FDCA”) and
Alpharma, Inc. v. Pennfield Oil Co., 411 F.3d 934, 939 (8th Cir.
2005)(“this is not the rare case requiring ‘expert consideration and
uniformity of resolution’”)(quoting United States v. McDonnell
Douglas Corp., 751 F.2d 220, 224 (8th Cir. 1984)).
Plaintiff primarily relies on industry and market evidence,
rather than the FDCA or any FDA regulation, to show that D,L-MTHF
is not the same ingredient as L-MTHF.
21.)
See Axcan Scandipharm Inc. v. Ethex Corp., 585 F. Supp. 2d
32
AO 72A
(Rev.8/82)
(Pl.’s Resp. Br. [262] at 9-
1067, 1074-76 (D. Minn. 2007)(allowing a Lanham Act claim to proceed
where
the
plaintiff
offered
market
evidence
of
the
generally
understood meaning of the terms “substitute” and “generic”) and
Sirius Lab., Inc. v. Rising Pharm., Inc., 2004 WL 2902227 at * 3
(N.D. Ill. 2004)(finding no preclusion where the plaintiff’s claim
could be resolved by relying on a USP standard for the product).
Moreover, the Court is not required to interpret or apply any
provision of the FDCA to decide plaintiff’s claims.
See Pediamed,
419 F. Supp. 2d at 725 (distinguishing between claims that involve
application and interpretation of the FDCA and claims that do not).
As the Court explained in its previous Order, the simple fact
that a Lanham Act claim touches upon an area that is within the
purview of the FDCA is not a bar to proceeding.
(Order [137] at
13.) Yet, that is the only factor in favor of preclusion here. The
Lanham Act prohibits exactly the type of misconduct that plaintiff
alleges
in
its
complaint:
the
misrepresentation
description of the nature of a product.
and
false
N. Am. Med. Corp. v. Axiom
Worldwide, Inc., 522 F.3d 1211, 1224 (11th Cir. 2008).
Given the
evidence adduced during discovery, it is even more apparent now than
at the motion to dismiss stage that FDCA preclusion does not apply
to this case. Accordingly, defendants’ motion for summary judgment
[197] on preclusion grounds is DENIED.
33
AO 72A
(Rev.8/82)
2.
As
There is sufficient evidence of literal falsity.
noted,
defendant
Acella’s
labels
and
package
inserts
represent that PNV vitamins contain the same combination and amounts
of folic acid and L-MTHF as PRENATE vitamins. (PSMF [205] at ¶ 18.)
However, it is undisputed that the L-MTHF in PNV vitamins is
delivered in a mixture of D-MTHF and L-MTHF.
(Id. at ¶ 44.)
Plaintiff presents considerable evidence that the D,L-MTHF mixture
used in PNV is a different dietary ingredient than the substantially
pure L-MTHF that is in PRENATE vitamins.
Specifically:
L-MTHF
and
(Id. at ¶¶ 23-34, 51-59.)
(1) Drs. Gregory and Armstrong have testified that
D,L-MTHF
are
distinct
substances,
with
different
physical, chemical and biological properties, (2) the American
Chemical Society and the Joint FAO/WHO Expert Committee on Food
Additives (“JECFA”) have recognized that L-MTHF and D,L-MTHF are
distinct dietary ingredients, and (3) the FDA has accepted a New
Dietary
Ingredient
Notification
(“NDI”)
distinguishing
the
substantially pure form of L-MTHF that is found in PRENATE vitamins
from the D,L-MTHF contained in PNV vitamins.
(Pl.’s Resp. [262] at
9-21.)
Whether a statement is literally false in the context of the
Lanham Act is a question of fact.
Osmose, Inc. v. Viance, LLC, 612
F.3d 1298, 1309 (11th Cir. 2010)(“Literal falsity is a finding of
fact reviewed for clear error.”).
34
AO 72A
(Rev.8/82)
Based on the evidence in the
record, particularly the expert testimony of Drs. Gregory and
Armstrong, a jury would be authorized to find that PNV’s labeling
is literally false because PNV vitamins do not in fact contain LMTHF, as represented on their label.
Accordingly, defendants’
motion for summary judgment [197] on the ground that there is
insufficient evidence of literal falsity is DENIED.
3.
There is evidence that PNV’s label is misleading.
In addition, there is sufficient evidence in the record to
support
plaintiff’s
alternative
claim
that
the
PNV
label
is
misleading. Based on his market survey results, plaintiff’s expert
Brian Reisetter concluded that PNV’s label and package inserts are
misleading because they cause pharmacists to incorrectly believe
that PNV vitamins contain the same ingredients as PRENATE vitamins,
and that they are an appropriate generic substitute.
Report [199] at ¶¶ 1-4.)
(Reisetter
Crediting Dr. Reisetter’s testimony, a
jury could reasonably find that PNV’s labeling, although literally
true, is misleading.
Defendants argue that they are nevertheless entitled to summary
judgment on this issue as a result of a disclaimer on PNV’s label
expressly disavowing any claims of equivalence or generic status.
(Defs.’ Br. [203] at 31.)
This argument is disingenuous, at best.
There is an abundance of evidence in the record to suggest that
defendants intended to profit from the substitution that occurs as
35
AO 72A
(Rev.8/82)
a
result
databases.
203.)
of
PNV’s
linkage
to
PRENATE
in
the
pharmaceutical
(PSMF [205] at ¶¶ 13-18 and Prelim. Inj. Tr. [24] at
Based on that evidence, the jury might reasonably conclude
that Acella’s disclaimer was not intended to, and in fact did not,
discourage
substitution.
Accordingly,
defendants’
motion
for
summary judgment [197] on the disclaimer issue is DENIED.
Plaintiff’s Motion6
C.
Citing the evidence discussed above, plaintiff argues that it
is entitled to partial summary judgment on the issue of literal
falsity.
(Pl.’s Br. in Supp. of Summ. J. [205].)
According to
plaintiff, the record overwhelmingly supports its claim that PNV
does not contain the active ingredient that is listed on its label,
L-MTHF.
(Id. at 9-29.)
In addition, plaintiff contends that PNV’s
label is presumptively false as to the shelf life and content of PNV
vitamins.
(Id. at 29-43.)
This contention is based on the alleged
lack of testing by Acella to ensure that PNV vitamins maintain their
active ingredient concentration over the course of their labeled
two-year shelf life.
(Id. at 29-43.)
6
Defendants have filed a motion to strike parts of
plaintiff’s reply.
(Defs.’ Mot. to Strike [313].)
Defendants
complain that plaintiff improperly cited and attached evidence to
the reply. (Id.) The exhibits attached to plaintiff’s reply were
submitted in direct response to arguments made by defendants, and
for the most part the attached evidence was already part of the
evidentiary record in this case. The Court thus DENIES defendants’
motion [313].
36
AO 72A
(Rev.8/82)
1.
The evidence on literal falsity is not conclusive.
As persuasive as it may ultimately prove to be, plaintiff’s
evidence concerning the distinction between L-MTHF and D,L-MTHF does
not conclusively establish literal falsity.
Defendants point to
potential flaws in both the expert testimony and the documentary
evidence offered by plaintiff, which may lead the jury to reject
plaintiff’s claim that the PNV label is literally false.
(See
Defs.’ Mot. to Exclude [196] and Defs.’ Resp. to Pl.’s Mot. for
Summ. J. [270] at 24-36.)
In addition, defendants present conflicting evidence that tends
to support their argument that L-MTHF is (1) reasonably susceptible
to more than one meaning, and (2) understood by the relevant
industry to refer to the L isomer of MTHF, whether it is in its
substantially pure form or combined in a mixture with D-MTHF.
(Defs.’ Resp. to Pl.’s Mot. for Summ. J. [270] at 13-24.)
This
evidence includes the expert testimony of Dr. Jacob Spanier, an
OB/GYN who regularly prescribes folate supplements, and of Jane
Wilson, a practicing pharmacist.
Again,
whether
question of fact.
an
(Id. at 15-16.)
advertisement
is
literally
false
Osmose, Inc., 612 F.3d at 1309.
is
a
Given the
conflicting evidence in this case, summary judgment on literal
falsity is impermissible.
Accordingly, plaintiff’s motion for
partial summary judgment [205] on this issue is DENIED.
37
AO 72A
(Rev.8/82)
2.
Plaintiff is not entitled to judgment as a matter of
law on its shelf life and content claims.
In its motion for summary judgment on the shelf life and
content issue, plaintiff relies on an “establishment claim” theory.
(Pl.’s Br. in Supp. of Summ. J. [205] at 30-32.)
In the Eleventh
Circuit, this theory is available where the defendant has made an
affirmative promotional claim about testing.
Id.
For example, the
defendant in Osmose issued a press release citing “findings” that
its competitor’s treated wood products were susceptible to premature
decay.
Id.
Given the defendant’s affirmative representations
concerning testing, the Court held that the plaintiff could prevail
on its false advertising claim merely by showing that the tests did
not establish the proposition for which they were cited.
Id.
The “establishment claim” theory is inapplicable to this case
because
Acella
has
concerning testing.
not
made
any
affirmative
representations
See Johnson & Johnson, 299 F.3d at 1248 (“If
an advertisement cites [consumer] testing, the advertisement is
labeled as an ‘establishment’ claim.”).
Thus, plaintiff cannot
prevail on its false advertising claim merely by showing that Acella
failed to test PNV vitamins to ensure that they maintain their
active ingredient concentration over the course of their labeled
shelf life.
Rather, to prove its shelf life and content claims,
plaintiff must present evidence that PNV vitamins (1) do not in fact
38
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have a two-year shelf life and/or (2) that they do not, at any time
within two years of their release, contain active ingredients in the
amount or concentration that is advertised on the label.
1247.
Id. at
Applying this standard, summary judgment clearly is not
warranted.
In
any
Plaintiff’s motion [205] is thus DENIED.
case,
there
is
some
evidence
in
the
record
to
substantiate PNV’s labeled shelf life and active ingredient content.
(See Defs.’ Resp. to Pl.’s Mot. for Summ. J. [270] at 47-49.)
In
response to plaintiff’s motion, defendants cite testimony showing
that PNV’s expiration date is based on the expiration date of the
raw materials contained in PNV vitamins and the manufacturers’
knowledge of similar raw materials, both of which are confirmed by
manufacturers’
certificates
of
analysis.
(Id.)
Additional
testimony suggests that defendant Acella includes a raw material
“overage” in PNV vitamins that is designed to account for natural
degradation of the product over time.
(Id. at 48.)
Although these
procedures undoubtedly do not meet the internal testing standards
that are applicable to PRENATE vitamins, there is evidence from
which the jury could infer that Acella’s testing procedures are
acceptable within the industry.
(Id.)
For this additional reason,
plaintiff’s motion for partial summary judgment [205] on its shelf
life and content claim is DENIED.
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V.
Plaintiff’s Motions To Seal
Plaintiff has filed several motions to seal various filings and
exhibits submitted to the Court in support of, or in opposition to,
the above substantive motions.
(Pl.’s Mots. to Seal [204], [232],
[258], [259], [260], [261], [274], [289], [296], [298], and [300].)
Plaintiff’s motions to seal all take the same format:
(1) they
refer to a January 25, 2010 Consent Order allowing the parties to
designate documents or information as confidential, and (2) they
represent that “certain information” contained in a particular
filing has been designated by one or more of the parties as
confidential.
(Id.)
The motions do not describe the allegedly
confidential information.
(Id.)
Nor do they provide any further
justification for concealing the information from the public. (Id.)
Although the Court has the authority to seal documents under
Federal Rule 26(c), there is a presumption in favor of public
access.
Cir.
Romero v. Drummond Co., Inc., 480 F.3d 1234, 1245 (11th
2007)(“‘[t]he
common-law
right
of
access
to
judicial
proceedings, an essential component of our system of justice, is
instrumental in securing the integrity of the process’”)(quoting
Chicago Tribune Co. v. Bridgestone/Firestone, Inc., 263 F.3d 1304,
1311 (11th Cir. 2001)).
In order to overcome that presumption, the
movant must show “good cause.”
Id. at 1246.
40
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The Court must then
balance the public right of access against the movant’s interest in
keeping the information confidential.
Id.
In this case, there is no rational basis for balancing the
relevant interests because plaintiff has not even attempted to make
the required good cause showing. Rather, plaintiff has simply cited
a consent order that describes a process by which the parties can
designate information as confidential. Such consent orders help to
facilitate discovery by encouraging full disclosure. However, they
do not supply the good cause needed to seal court records under Rule
26(c).
See In re Estate of Martin Luther King, Jr., Inc. v. CBS,
Inc., 184 F. Supp. 2d 1353, 1362 (N.D. Ga. 2002)(O’Kelley, J.)
(“calling a document confidential does not make it so in the eyes
of the court; these consensual protective orders merely delay the
inevitable moment when the court will be called upon to determine
whether Rule 26(c) protection is deserved”).
As plaintiff has not met the requirements for sealing court
records under Rule 26(c), its motions to seal [204], [232], [258],
[259], [260], [261], [274], [289], [296], [298], and [300] are
DENIED.
In addition to plaintiff’s most recent filings, plaintiff
has previously filed other materials under seal in accordance with
the Court’s order granting as unopposed several motions to seal.
(Order [137].)
The only justification provided for sealing those
documents was a cursory reference to the parties’ consent order.
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AO 72A
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(See Pl.’s Mot. to Seal [89].)
Moreover, it is apparent from
reviewing the docket that defendants have made several filings under
seal without approval from the Court and without even a cursory
justification.
As neither party has met the requirements of Rule
26(c) with respect to any of these documents, the Court will unseal
all of the filings in this case, within 28 days of this Order,
absent a contrary holding by the Court based on a specific and
compelling showing by the particular party.
VI.
Plaintiff’s Motion For A Status Conference
Finally, plaintiff has filed a motion for a status conference
to discuss: (1) the status of the motions that are pending before
the Court, including a “disposition schedule” for the motions, (2)
whether oral argument is warranted on plaintiff’s motion for partial
summary judgment, and (3) setting proposed deadlines for pre-trial
submissions and a date certain for trial.
Conference [314].)
(Pl.’s Mot. for a Status
In other words, plaintiff would like to impose
a deadline on the Court for deciding the pending motions and setting
a date for trial.
Plaintiff’s request is moot as a result of the Court’s rulings
in this Order.
The status of the pending motions is that they have
all been decided.
As the summary judgment motions were extensively
briefed and presumably supported with all of the available evidence,
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AO 72A
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oral argument was not necessary. Pursuant to the Revised Scheduling
Order, pretrial submissions are due 30 days after the Court rules
on summary judgment motions.
(Jt. Revised Sch. Order [152] at 2.)
The Court will not set a date for the trial and pretrial conference
until after that time and until it is clear that the voluminous
motions practice in this case has concluded.
At this time, there
is no need for a status conference to discuss any of these issues.
Accordingly, plaintiff’s motion for a conference [314] is DENIED and
defendants’ related motion to file a supplemental response [326] is
DENIED as moot.
CONCLUSION
For the foregoing reasons, the Court GRANTS in part and DENIES
in
part
defendant
defendants’
Motion
Acella’s
to
Motion
Exclude
to
Testimony
Compel
of
[183],
Drs.
DENIES
Gregory
and
Armstrong [196], DENIES defendants’ Motion for Summary Judgment
[197], DENIES defendants’ Motion to Exclude Evidence Relating to
Product
Testing
[198],
DENIES
defendants’
Motion
to
Exclude
Testimony of Dr. Reisetter [199], GRANTS in part and DENIES in part
defendants’ Motion to Exclude Testimony of Alisha Nielsen [200],
DENIES plaintiff’s Motion for Partial Summary Judgment [205], DENIES
plaintiff’s Motion to Exclude Expert Opinions of Howard Zandman
[206], DENIES
plaintiff’s Motions to Seal Various Documents [204],
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AO 72A
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[232], [258], [259], [260], [261], [274], [289], [296], [298],
[300], DENIES defendants’ Motion to Strike [313], DENIES plaintiff’s
Motion for a Status Conference [314], and DENIES as moot defendants’
Motion for Leave to File a Supplemental Response to Plaintiff’s
Motion for a Status Conference [326].
Plaintiff shall produce the documents, and disclose the result
of the inquiry, directed at page 11 of this Order, within 28 days
of this date.
Any further motions by Acella on this matter must be
filed within 28 days after plaintiff’s disclosures and production
are complete.
SO ORDERED, this 30th day of August, 2011.
/s/ Julie E. Carnes
JULIE E. CARNES
CHIEF U. S. DISTRICT JUDGE
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