Hill Dermaceuticals, Inc. v. Anthem, Inc.
Filing
141
ORDER denying without prejudice 112 Motion to Compel ; granting 117 Motion to Strike ; denying without prejudice 123 Motion for Protective Order. Signed by Magistrate Judge Thomas B. Smith on 12/8/2016. (EC)
UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF FLORIDA
ORLANDO DIVISION
HILL DERMACEUTICALS, INC.,
Plaintiff,
v.
Case No: 6:16-cv-833-Orl-40TBS
ANTHEM, INC.,
Defendant.
ORDER
This case comes before the Court without oral argument on the following matters:
1) Plaintiff Hill Dermaceuticals, Inc.’s Renewed Motion to Compel Documents
Responsive to Plaintiff’s July 27, 2016 and August 5, 2016 Requests For Production,
Motion To Compel Documents Responsive To Plaintiff’s August 19, 2016 Request For
Production, and Request For Attorneys’ Fees (Doc. 112), and Anthem, Inc.’s Response in
opposition (Doc. 128);
2) Defendant Anthem’s Motion for Protective Order (Doc. 123) and Hill’s Response
in opposition (Doc. 133); and
3). Anthem’s Motion to Strike Plaintiff’s Supplemental Filings (Docs. 57, 77, 81, 82,
84, And 108) For Violation Of Local Rules 3.01(A) and 3.01(C) (Doc. 117) and Hill’s
Response in Opposition (Doc. 132).
Background
As set forth in the pleadings and prior filings, actinic keratosis (“AK”) is a
precancerous skin condition that affects an estimated fifty-eight million people in the
United States (Doc. 25, ¶ 14). Hill developed, manufactures and distributes Tolak®
(fluoracil) 4% Cream (“Tolak”) to treat AK (Id., ¶¶ 1, 14). It contends that Tolak is safer, as
effective, and has a lower wholesale acquisition cost than the other existing brand name
and generic AK drugs (Id., ¶¶ 16-19).
Anthem provides coverage to Medicare Part D participants (Id., ¶ 8). Hill asked
Anthem to add Tolak to Anthem’s Medicare Part D formularies (Id., ¶ 22). Anthem denied
the request, citing “insufficient evidence” to show the advantages of Tolak over the other
AK drugs already included in its formularies (Id., ¶ 23). Hill alleges that it gave Anthem
“overwhelming scientific evidence,” and that Anthem improperly rejected Tolak because it
receives significant rebates from other drug manufacturers (Id., ¶ 45). Hill, which does not
provide rebates on Tolak, alleges that Anthem’s decision not to include Tolak in its
Medicare Part D formularies subjects “Medicare patients to drugs that cause more severe
adverse effects, and are unnecessarily expensive to Medicare Part D participants and the
federal government.” (Id., ¶ 27).
Anthem counters that the Medicare Prescription Drug Improvement and
Modernization Act, which established the Part D benefit, contemplates the negotiation of
prices between plan sponsors and pharmaceutical companies on behalf of Medicare
beneficiaries (Doc. 110 at 5). Anthem also claims that “[r]ebates and discounts which are
‘properly disclosed and appropriately reflected in the costs claimed or charges made by
the provider or entity’ are protected under the discount exception and safe harbor
provisions of the federal anti-kickback statute.” (Id.) (quoting 42 U.S.C. § 1320a7b(b)(3)(A)). According to Anthem, before a drug can be included in its formularies, it
must first be reviewed by the Clinical Review Committee (“CRC”) (Doc. 110 at 22).
Anthem claims that the CRC is an independent committee charged with reviewing “drugs
for efficacy, safety, effectiveness, and clinical aspects in comparison to similar drugs
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within a therapeutic class or used to treat a particular condition.” (Id.). Anthem asserts
that the CRC “may NOT include or consider the following: Rebates or potential rebates;
Costs to the health plan, member or risk bearing entity; Economic outcomes; and/or
Benefit types.” (Id. at 22-23). Anthem maintains that the Medicare Part D regulations
require that clinical decisions be based “’on the strength of scientific evidence and
standards of practice, including assessing peer-reviewed outcomes research data, and
other such information as it determines appropriate.’” (Id. at 23) (quoting 42 C.F.R. §
423.120(b)(1)(v)).
Anthem explains that the insufficient evidence designation given to Tolak is used
“when based upon the data available at the time of the review, the drug has an unclear
treatment profile for the majority of individuals taking the product as compared to other
available products within the therapeutic class of drugs or other available treatment
options.” (Doc. 110 at 23, ¶ 9). Anthem maintains that when the CRC reviewed Tolak
“there were no published scientific literature studies available relating to the risks/benefits
of Tolak.” (Id. at 23). Anthem says its decision was “[b]ased upon the lack of published
scientific literature available on Tolak.” (Id. at 24).
Hill’s amended complaint seeks a preliminary and permanent injunction compelling
Anthem to withdraw or suspend its refusal to include Tolak in its Medicare Part D
formularies (Doc. 25 at 15). Hill also prays for a declaratory judgment that Anthem’s
decision not to list Tolak in its Medicare Part D formularies violates Federal regulations
and Section 1860D-4(b) of the Social Security Act (Id., ¶ 36). Hill complains that Anthem
has tortuously interfered with its customers (Id., ¶ 39), and that Anthem’s actions violate
the Florida Deceptive and Unfair Trade Practices Act (Id., ¶ 42). Lastly, Hill alleges that
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Anthem’s actions constitute an unlawful restraint on trade in violation of 15 U.S.C. § 1 and
FLA. STAT. § 542.18 (Id., ¶¶ 47-61).
The Discovery Motions
The parties have wrestled with the appropriate scope of discovery in this case. The
instant motions reflect concerns about production or disclosure of allegedly confidential
materials, information concerning other drugs, and information regarding rebates, fees,
discounts or other financial details. After these motions were filed, 1 the Court held a
hearing (Docs. 124, 139) and issued several pertinent Orders (Docs. 125, 126, 127, 131
and 136) which address many of the same or similar matters raised in these motions. 2
And, as Anthem notes, it has already agreed to produce some of the documents and the
Court assumes that has occurred. Thus, it is not clear which discovery requests, if any,
remain legitimately at issue. As it is likely that subsequent events have rendered much of
the discovery disputes moot, Hill’s motion to compel (Doc. 112) and Anthem’s motion for
protective order (Doc. 123) are DENIED, without prejudice to renewal, if necessary, as to
any specific matter that is still in dispute, despite a good faith conference under Local
Rule 3.01(g).
The Motion to Strike
Anthem moves to strike multiple supplemental filings (Docs. 57, 77, 81, 82, 84, and
108) filed by Hill without leave of Court. Hill objects. Although motions to strike “are
1 Hill’s motion was filed November 4, 2016 (Doc. 112) and Anthem’s motion was filed November
15, 2016 (Doc. 123).
The instant motions were not ripe at the time of the hearing, so they were not directly discussed.
Nonetheless, Hill propounded similar discovery requests to Blue Cross Blue Shield of Florida, Inc., also
Defendant in this consolidated case. The appropriate scope of discovery with respect to those requests was
discussed at length at hearing, and an Order was subsequently entered (Doc. 136). To the extent Hill,
through counsel, clarified the scope of its discovery requests as to Florida Blue, the Court assumes a
similar stance with respect to Anthem. See Doc. 136 at 7. As no pertinent defenses unique to Anthem have
been raised, it is safe to assume that conclusions similar to those set forth in that Order apply, as well.
2
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generally disfavored by the Court and are often considered “time wasters,” Luxottica Grp.
S.P.A. v. Cash Am. E., Inc., No. 6:16CV728ORL31DAB, 2016 WL 4157211, at *1 (M.D.
Fla. Aug. 2, 2016), Anthem’s motion is well taken.
Local Rule 3.01(a) provides that in a motion or any other application for an order, a
party shall file a single document containing a statement of the basis for the request and
memorandum of legal authority. M.D. FLA. R. 3.01(a). Local Rule 3.01(b) requires that
any response opposing a motion shall be filed in a single document. M.D. FLA. R. 3.01(b).
Local Rule 3.01(c) provides that “[n]o party shall file any reply or further memorandum
directed to the motion or response allowed in (a) and (b) unless the Court grants leave.”
M.D. FLA. R. 3.01(c). These rules apply “as a basis to strike documents filed by [a party]
that are frivolous, not filed in support of any motion, immaterial to any pleading or motion
currently pending, or that fail to advance any aspect of litigation in [a] case ....” Farrell v.
Florida Republicans, No. 2:13-CV-140-FTM-29, 2013 WL 5498277, at *8 (M.D. Fla. Oct.
1, 2013).
a) Notice of Filing Declarations In Support of its Motion for Sanctions (Doc.57)
Hill filed its Declarations as a separate document, in violation of Local Rule
3.01(a). Although Hill contends that it made the decision to file the declarations
separately “so [they] could be easily referenced in future filings” (Doc. 132 at 2), attaching
the Declarations to the motion as an exhibit accomplishes the same thing and does not
violate the rule. Now, docket entry 57 is STRICKEN.
b) Plaintiff’s Renewed Motion for Evidentiary Hearing (Doc. 77)
As noted by Anthem, the Renewed Motion for Evidentiary Hearing is effectively
supplemental briefing on a motion already filed and constitutes multiple filings seeking the
same relief. The Court is not persuaded by Hill’s response that the renewed motion
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pertains to an amended motion for preliminary injunction and, as such, was not
duplicative. The Court had already addressed the issue of an evidentiary hearing on the
amended motion. See Doc. 50 at 1 (“As discussed at the status conference, the Court will
notify the parties by separate order should the Court require the benefit of oral argument
on Plaintiff’s Amended Motion for Preliminary Injunction.”). Accordingly, docket entry 77 is
STRICKEN.
c) Plaintiff’s Notice of Filing Articles (Doc.81)
The Notice of Filing Articles was filed as an unauthorized supplement to an
already-filed response brief in violation of L.R.3.01 (b) and filed without leave of Court in
violation of L. R. 3.01(c). Hill argues that “[t]his is a moot issue in light of the Court’s entry
of a Protective Order on November 18, 2016. (Doc. 127).” While this filing may not be
pertinent to any existing matter, in the interest of preserving the integrity of the docket,
docket entry 81 is STRICKEN.
d) Plaintiff’s Motion to Strike Declarations and Enter a Preliminary Injunction, or, in
the Alternative, Renewed Request for an Evidentiary Hearing (Doc. 82).
Anthem argues, correctly, that this filing seeks some of the same relief and
includes the same arguments made in prior motions. Thus, Anthem seeks to strike the
portions of the motion seeking a preliminary injunction and evidentiary hearing. Hill
responds:
The purpose of Doc. 82, as the title suggests, was to request
the Court strike Anthem’s declarations filed in support of
Anthem’s opposition to Hill’s Amended Motion for a
Preliminary Injunction (Doc. 53) and 8 of the 12 pages in the
Motion are dedicated to that purpose. Further, the “Renewed
Request for Evidentiary Hearing” was an alternative request
should this Court deny Hill’s request to strike Anthem’s
declarations, not a stand-alone motion. Because the primary
purpose of this Motion was directed at striking Anthem’s
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declarations (Doc. 53), striking the entire filing is not
warranted.
(Doc. 132 at 5). Hill’s argument does not address the merits of Anthem’s position that the
portions of the motion seeking a preliminary injunction and evidentiary hearing are
duplicative of earlier motions. The portions of the filing related to seeking a preliminary
injunction and evidentiary hearing are STRICKEN.
e) Plaintiff’s Notice of Filing of Amended Declarations In Support of Motion for
Sanctions (Doc. 84)
Anthem argues that this is an unauthorized supplement to Hill’s already-filed
Notice of Filing of Declarations In Support of Motion for Sanctions (Doc. 57). Hill counters
that it filed this Amended Declaration to include new information from its declarant,
Gerardo Mendez. By definition, every amended paper includes something “new.” The
difficulty with Hill’s position is that Hill did not seek leave to introduce the new information.
Absent such leave, the supplemented filing is unauthorized. Now, docket entry 84 is
STRICKEN.
f) Plaintiff’s Supplement to Amended Motion for Preliminary Injunction and
Incorporated Memorandum of Law (Doc. 108)
Hill asserts that it filed this “supplemental authority to support the argument
detailed extensively in its Amended Motion for Preliminary Injunction (Doc. 26).” It argues
that a notice of filing supplemental authority does not fall within the purview of Local Rule
3.01(c), citing Williams v. Heritage Operating, L.P., 8:07CV977 T24MSS, 2007 WL
2302131, at *1 (M.D. Fla. Aug. 8, 2007). The Court is not persuaded. Williams involved a
notice of a recent case in support of arguments already raised. Id. The supplement at
issue here is a seven page brief with attached evidence. It is not a “mere” notice of recent
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case authority. Williams. As it was filed without permission, docket entry 108 is
STRICKEN.
The Court recognizes that some of the objections here are technical and Hill is
correct in its position that defects in form are not equal to defects in substance. But, there
comes a point where failure to adhere to the rules renders the docket unmanageable. The
Court acts now, to prevent that from occurring. To the extent Hill wishes the Court to
consider any of the matters in the stricken documents, it must comply with the local rules
(including Local Rule 3.01(g)) and file an appropriate motion setting forth sufficient
grounds supporting each proposed filing.
DONE and ORDERED in Orlando, Florida on December 8, 2016.
Copies furnished to Counsel of Record
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