Lori Anderson v. K-V Pharmaceutical Company ( 2015 )

United States Court of Appeals
For the Eighth Circuit
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No. 14-2592
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Frank Julianello, on behalf of himself and all others similarly situated
lllllllllllllllllllll Plaintiff
Lori Anderson
lllllllllllllllllllll Plaintiff - Appellant
v.
K-V Pharmaceutical Company; Gregory J. Divis, Jr.; Scott Goedeke; Thomas McHugh
lllllllllllllllllllll Defendants - Appellees
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Appeal from United States District Court
for the Eastern District of Missouri - St. Louis
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Submitted: March 12, 2015
Filed: July 2, 2015
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Before MURPHY and SHEPHERD, Circuit Judges, and HARPOOL,1 District
Judge.
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SHEPHERD, Circuit Judge.
1
The Honorable M. Douglas Harpool, United States District Judge for the
Western District of Missouri, sitting by designation.
This securities fraud class action involves a class of plaintiffs who purchased
or otherwise acquired shares of K-V Pharmaceutical Company stock during the
period in which the company launched and marketed Makena, its new prescription
drug. The plaintiffs allege that K-V and three of its officers (collectively K-V) made
materially false or misleading statements or omissions related to the product launch.
The district court2 granted K-V’s motion to dismiss, holding the challenged
statements were protected by the safe-harbor provision of the Private Securities
Litigation Reform Act of 1995 (PSLRA), 15 U.S.C. § 78u-4(b), and that the plaintiffs
failed to adequately plead scienter under the PSLRA. The district court also denied
the plaintiffs’ motion for reconsideration of the scope of leave to amend the
complaint, denying the plaintiffs the opportunity to amend the complaint as it related
to allegations from confidential witnesses. The plaintiffs appeal, and we affirm.
I.
The plaintiffs in this action are holders of publicly traded shares of K-V stock
who purchased or otherwise acquired shares between February 14, 2011, and April
4, 2011. Plaintiffs allege that K-V made materially false or misleading statements and
omissions during this period regarding K-V’s marketing, distribution, and sale of its
prescription drug Makena, designed to reduce the risk of pre-term labor for at-risk
pregnant women. In 2008, K-V acquired the rights to the drug, then known as
Gestiva, rebranded it as Makena, and sought exclusive sales rights under the Orphan
Drug Act, 21 U.S.C. §§ 360aa-360ee, from the Food and Drug Administration (FDA).
The Orphan Drug Act, which encourages drug manufacturers to develop drugs for the
treatment of rare diseases or disorders, provides that, with FDA approval,
manufacturers of drugs designed to treat diseases or disorders that affect fewer than
2
The Honorable Audrey G. Fleissig, United States District Judge for the
Eastern District of Missouri.
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200,000 people may obtain seven years of exclusive sales rights. On February 3,
2011, the FDA granted K-V’s request for exclusive sales rights.
On February 14, 2011, K-V held a conference call with investors and filed a
Form 8-K with the Securities and Exchange Commission (SEC), which incorporated
the information discussed in the conference call. At the beginning of the call, K-V
made the following statements:
[C]ertain information provided on this conference call may contain
various forward-looking statements within the meaning of the [PSLRA]
and may be based on or include assumptions concerning the Company’s
operations, future results and prospects. Such statements may be
identified by the use of words such as plan, expect, believe, anticipate,
intend, will, should, could, potential and other expressions that indicate
future events and trends.
All statements that address expectations or projections about the
future, including without limitation statements about . . . the Company’s
strategy for growth, product development, product launches, regulatory
approvals, market position, acquisitions, revenues, expenditures and other
financial results are forward-looking statements. These statements
involve various risks and uncertainties that could cause our actual results
to differ materially from those expressed in such forward-looking
statements. These include the risks and uncertainties under the heading
risk factors in our most recent annual report on Form 10-K and other
periodic reports filed with the SEC which are available on our website .
. . and on the SEC’s website.
Investors are cautioned not to place undue reliance on such
forward-looking statements, as there is no assurance that these matters
contained in such statements will occur. The forward-looking statements
we make on today’s call are based on our beliefs and expectations . . . as
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of today, February 14, 2011 only. We do not undertake any obligation to
revise or update such forward-looking statements.
R. Doc 91-2, at 2-3.
The non-exclusive risk factors listed in the Form 10-K mentioned at the
beginning of the call included the following: “new product development and launch,
including the possibility that any product launch may be delayed or unsuccessful,
including with respect to Gestiva™,” “acceptance of and demand for our new
pharmaceutical products, including Gestiva™,” and “the possibility that any period
of exclusivity may not be realized, including with respect to Gestiva™, a designated
Orphan Drug.” R. Doc. 91-1, at 3.
On the February 14, 2011 investor call, K-V announced that the FDA had
approved Makena and granted it orphan-drug status. K-V informed investors that it
planned to charge $1,500 per injection, with the average patient requiring nearly
$30,000 worth of injections. K-V also announced a program called Makena Care
Connection, which would offer administrative, educational, and financial assistance
to patients, and indicated that women with household incomes of up to $100,000
would be eligible for this program. K-V asserted that this would include
approximately 85% of households in the United States. K-V also indicated that it
believed health insurers would provide coverage for Makena because the average cost
relating to a pre-term birth—$51,000—was higher than the average cost of Makena
injections—$30,000. The price point of $1,500 an injection marked a 14,900%
increase from the price at which compounding pharmacies offered a previous version
of the drug. The parties do not dispute that the success of Makena was critical to K-
V’s survival.
During the call, K-V was asked specifically about the possibility of off-label
compounding pharmacies joining the market for Makena. K-V explained that it
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believed the FDA regulations to be very clear and that the FDA generally prohibits
distribution of compounded products that are the same as FDA-approved products.
With respect to the FDA’s enforcement of exclusivity, K-V made the following
statements:
[W]e believe that the regulations and laws are very clear. I think it’s fair
to say that compounding pharmacies are not FDA-approved
manufacturing facilities and that FDA regulations and state pharmacy
laws generally prohibit the distribution of compounded products that are
the same or essentially the same as FDA-approved products.
We also believe that compounded pharmacies are aware of these
laws and regulations, and our expectation is that they will adhere to them.
I think it’s also fair to say that, despite the availability of compounded
product, there have been moms on the sidelines because of significant
logistical and financial barriers to access that are typically associated with
non-FDA approved products.
And I’ll just close by saying that everything we have designed
around Makena is to remove these barriers and to make sure that we fulfill
our corporate commitment, which is to make Makena accessible to all
eligible patients.
R. Doc. 91-2, at 12-13. Asked about the price point of $1,500 per injection, K-V
reiterated its belief that, because of the high cost of pre-term birth, Medicaid and
insurers would cover the cost. K-V also stated that “we’ve done a lot of homework
around this particular decision. And we believe our pricing approach is supported by
a very comprehensive market research plan which included all stakeholders.” R. Doc.
91-2, at 14.
On February 17, 2011, K-V sent a letter to compounding pharmacies informing
them that they should no longer make unapproved formulations of Makena and
warned that if the pharmacies continued production they would be subject to FDA
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enforcement actions. On March 8, 2011, K-V issued a press release indicating
Makena would become available for prescribing on March 14, 2011, and describing
the financial assistance program. K-V also filed a Form 8-K with the SEC that
included financial projections based on the sales launch of Makena. K-V released
Makena to the public and, after K-V revealed the pricing structure, a swift negative
reaction erupted. The March of Dimes withdrew its support and refused to allow K-V
to use its name in association with Makena. Two United States senators issued a
press release expressing their concerns over the price point and the insufficiency of
the financial assistance program. They also released a letter they sent to the Federal
Trade Commission urging an investigation and mentioned their concerns during an
appropriations hearing.
On March 30, 2011, the FDA issued a statement that it did not intend to take
enforcement action against compounding pharmacies that compounded the equivalent
of Makena, informing the pharmacies that the “FDA understands that the
manufacturer of Makena, KV Pharmaceuticals, has sent letters to pharmacists
indicating that FDA will no longer exercise enforcement discretion with regard to
compounded versions of Makena. This is incorrect.” R. Doc. 91-8, at 1. The FDA
further explained, “[i]n order to support access to this important drug, at this time and
under this unique situation, FDA does not intend to take enforcement action against
pharmacies that compound [the chemical equivalent of Makena] . . . .” R. Doc. 91-8,
at 1. On April 1, 2011, in the wake of this backlash, K-V announced that it was
reducing the price of Makena to $690 an injection. Nevertheless, the price of K-V
stock plummeted, dropping from $9.75 a share on March 17, 2011, to $5.00 a share
on April 4, 2011.
The plaintiffs initiated this action alleging that K-V knew, or should have
known, that charging $1,500 per injection without an effective financial assistance
program would hinder Makena’s commercial success. The plaintiffs presented four
specific allegations. First, the plaintiffs alleged that K-V made both false statements
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and omissions about the risk of the FDA not enforcing exclusive sales rights.
Second, the plaintiffs alleged that K-V’s statement that they expected health insurers
to cover the cost of Makena was materially false or misleading when K-V knew the
price per dosage would face stiff opposition. Third, the plaintiffs alleged that K-V’s
statements about working to give all patients access to Makena, creating a financial
assistance program, and creating a marketing strategy were similarly misleading.
Finally, the plaintiffs alleged that K-V’s Form 8-K contained revenue assumptions
that lacked a factual basis because they did not account for the negative reaction to
Makena’s price point. The plaintiffs based their allegations upon information from
unnamed confidential witnesses, who plaintiffs identified as four former employees
or sales representatives.
K-V filed a motion to dismiss, which the district court granted based both on
the applicability of the PSLRA’s safe-harbor provision and on the plaintiffs’ failure
to adequately plead scienter. In the same order, the district court granted the plaintiffs
leave to amend the complaint with respect to their allegations regarding the financial
assistance program but denied their motion as it related to the FDA’s likelihood of
enforcing exclusivity. The plaintiffs declined to amend the complaint regarding the
financial assistance program and filed a motion for reconsideration. The district court
denied the motion for reconsideration, finding that it had already considered the
plaintiffs’ legal arguments in its previous order and that plaintiffs did not present any
arguments sufficient to grant the motion. The district court also dismissed the
remaining claims regarding the financial assistance program. The plaintiffs appeal,
arguing that the district court erred: (1) in holding K-V’s statements regarding the
FDA’s likelihood of enforcing exclusivity were protected by the PSLRA’s safe-
harbor provision, (2) in holding that the complaint failed to allege a strong inference
of scienter regarding the likelihood of FDA exclusivity, and (3) in denying the motion
for reconsideration of the scope of leave to amend the complaint.
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II.
We first consider whether the district court erred in dismissing the plaintiffs’
complaint on the grounds that the safe-harbor provision of the PSLRA covered K-V’s
statements about FDA exclusivity and that the plaintiffs failed to adequately plead
scienter. The plaintiffs assert that the district court erred with respect to the safe-
harbor provision because the challenged statements were not forward-looking or
accompanied by meaningful cautionary language and erred in holding the plaintiffs
failed to adequately plead scienter when they provided detailed allegations from four
confidential witnesses showing K-V knew or should have known the FDA would not
enforce exclusivity. We review a dismissal under Federal Rule of Civil Procedure
12(b)(6) and the PSLRA de novo, “review[ing] the claims to determine their
compliance with the heightened pleading standards of the PSLRA” and “accept[ing]
Plaintiffs’ factual allegations as true and [] draw[ing] all reasonable inferences in their
favor.” McCrary v. Stifel, Nicolaus & Co., Inc., 687 F.3d 1052, 1056 (8th Cir. 2012).
“For claims with a scienter component, which includes claims under Rule 10b–5, the
allegations should give rise to more than just a plausible or reasonable inference of
scienter.” Id. “For material misrepresentation and omission claims, the court must
also determine whether the claims ‘specify each statement alleged to have been
misleading [and] the reason or reasons why the statement is misleading.’” Id.
(alteration in original) (quoting 15 U.S.C. § 78u-4(b)(1)).
Section 10(b) of the Securities Exchange Act of 1934, 15 U.S.C. § 78j(b), and
SEC Rule 10b–5, 17 C.F.R. § 240.10b–5, “prohibit fraudulent conduct in the sale and
purchase of securities.” Ferris, Baker Watts, Inc. v. Ernst & Young, LLP, 395 F.3d
851, 853 (8th Cir. 2005). To successfully state a claim for a securities fraud action
under Section 10(b) and Rule10b–5, a plaintiff must establish six elements: (1) a
material misrepresentation or omission, (2) scienter, (3) a connection to the purchase
or sale of a security, (4) reliance, (5) economic loss, and (6) loss causation. Horizon
Asset Mgmt. Inc. v. H & R Block, Inc., 580 F.3d 755, 760 (8th Cir. 2009). The
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PSLRA contains a safe-harbor provision, which protects defendants from liability
when: (1) they have made forward-looking statements accompanied by meaningful
cautionary language, (2) the forward-looking statement is immaterial, or (3) the
statement is made without actual knowledge that it was false or misleading. 15
U.S.C. § 78u-5(c)(1).
The plaintiffs specifically challenge the statements K-V made in relation to the
investor call and the statements K-V made in the letter to compounding pharmacies
warning them not to produce compounded Makena. Under the PLSRA, protected
forward-looking statements include, among others: (1) projections of revenues or
other financial items, (2) statements of plans and objectives for future operations, and
(3) statements of the assumptions underlying the previous two categories. 15 U.S.C.
§ 78u-5(i)(1). “In determining whether a statement is truly forward-looking, the
determinative factor is not the tense of the statement; instead, the key is whether its
‘truth or falsity is discernible only after it is made.’” W. Wash. Laborers-Emp’rs
Pension Trust v. Panera Bread Co., 697 F. Supp. 2d 1081, 1093 (E.D. Mo. 2010)
(quoting Harris v. Ivax Corp., 182 F.3d 799, 805 (11th Cir. 1999)).
K-V’s statements were forward-looking. First, they fall within the category of
statements regarding plans and objectives for further operations because they detailed
K-V’s future launch of Makena and the anticipated results. Second, the veracity of
the statements could only be determined after they were made. The statements during
the call expressed that K-V felt the laws and regulations were clear and that they
anticipated that the FDA would enforce exclusivity once Makena was launched.
Critically, this statement is tied to a future event: the launch of Makena. Until this
future event occurred, it could not be determined whether the FDA would vary from
its usual practice of enforcing exclusivity. And there was no evidence at the time K-
V made the statement that the FDA would not enforce exclusivity. Further, the use
of the present tense in the challenged statements does not undermine our
determination that they were forward-looking. The critical inquiry in determining
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whether a statement is forward-looking is whether its veracity can be determined at
the time the statement is made, not the tense of the statement. For the same reasons
discussed above, K-V’s statements utilizing the present tense satisfy this inquiry.
Moreover, these statements may also fairly be categorized as the underlying
assumptions that are recognized as part of the protected forward-looking statements.
Finally, any statements that K-V made in a letter to compounding pharmacies
informing them that K-V would have exclusive sales rights related to the production
of Makena are not actionable because K-V never offered these statements to investors
and these statements were never used in connection with the purchase or sale of
securities. See Ferris, Baker Watts, 395 F.3d at 853 (requiring a connection to the
purchase or sale of a security to state a claim for securities fraud action).
With respect to the requirement that forward-looking statements be
accompanied by meaningful cautionary language, “[c]autionary language must be
extensive, specific, and directly related to the alleged misrepresentation. Cautionary
statements disclosed in SEC filings may be incorporated by reference; they do not
have to be in the same document as the forward-looking statements.” In re Aetna,
Inc. Sec. Litig., 617 F.3d 272, 282 (3d Cir. 2010) (internal quotation marks and
citations omitted). “The requirement for ‘meaningful’ cautions calls for ‘substantive’
company-specific warnings based on a realistic description of the risks applicable to
the particular circumstances, not merely a boilerplate litany of generally applicable
risk factors.” Southland Sec. Corp. v. INSpire Ins. Solutions, Inc., 365 F.3d 353, 372
(5th Cir. 2004).
K-V’s forward-looking statements were accompanied by meaningful cautionary
language. While boilerplate language reciting a list of generally applicable risk
factors is insufficient to satisfy this requirement, we reject plaintiffs’ assertion that
K-V’s language was boilerplate. K-V’s cautionary language was specific and related
directly to the circumstances of Makena’s planned launch. The language K-V used
in its Form 10-K, which was incorporated by reference in the February 14, 2011
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investor call, cautioned investors about the launch of Makena and warned them of
precisely the risks about which they now complain. K-V’s Form 10-K explicitly
identified the risks associated with the FDA’s presumed enforcement of exclusivity.
As this was specific to Makena and its orphan-drug status, we cannot conclude the
cautionary language about this risk was “boilerplate” and only recited generally
applicable risk factors in a generic manner.
K-V’s statements fall within the PSLRA’s safe-harbor provision as forward-
looking statements accompanied by meaningful cautionary language and are not
actionable as a basis for a securities fraud action. Because we conclude that the
challenged statements fall within the PSLRA’s safe-harbor provision, we need not
consider whether the plaintiffs adequately pled scienter. We therefore affirm the
district court’s dismissal of the complaint.
III.
We next consider whether the district court erred in denying plaintiffs’ motion
for reconsideration of the scope of leave to amend the complaint. The plaintiffs assert
that the district court erred in denying the motion because a court should freely give
leave to amend and the plaintiffs identified new facts concerning the confidential
witnesses that would demonstrate the statements and omissions regarding the FDA’s
likelihood of enforcing exclusivity were materially false and misleading. We review
a district court’s denial of a motion for reconsideration for abuse of discretion. K.C.
1986 Ltd. P’ship v. Reade Mfg., 472 F.3d 1009, 1017 (8th Cir. 2007). We also
review a district court’s denial of leave to amend a complaint for abuse of discretion.
Popoalii v. Correctional Med. Servs., 512 F.3d 488, 497 (8th Cir. 2008). “A court
abuses its discretion when it denies a motion to amend a complaint unless there exists
undue delay, bad faith, repeated failure to cure deficiencies by amendments
previously allowed, undue prejudice to the non-moving party, or futility of the
amendment.” Id.
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Under Federal Rule of Civil Procedure 15(a), “[t]he court should freely give
leave [to amend] when justice so requires.” But “[a]lthough amendment of a
complaint should be allowed liberally to ensure that a case is decided on its merits,
there is no absolute right to amend.” Ferguson v. Cape Girardeau Cnty., 88 F.3d 647,
650-51 (8th Cir. 1996) (citations omitted). “[P]arties should not be allowed to amend
their complaint without showing how the complaint could be amended to save the
meritless claim.” Wisdom v. First Midwest Bank, of Poplar Bluff, 167 F.3d 402, 409
(8th Cir. 1999). But, when considering a motion for reconsideration, the inquiry is
more narrow. “Motions for reconsideration cannot be used to introduce new evidence
that could have been produced while the [] motion was pending.” Chism v. W.R.
Grace & Co., 158 F.3d 988, 992 n.4 (8th Cir. 1998).
The district court did not abuse its discretion in denying the motion for
reconsideration of the scope of leave to amend the complaint. The court granted the
plaintiffs leave to amend the complaint regarding the financial assistance program,
but denied the plaintiffs leave to amend their allegations relating to the confidential
witnesses’ knowledge of what K-V knew about the likelihood of the FDA enforcing
exclusivity. In denying the motion for reconsideration, the court applied Federal Rule
of Civil Procedure 54(b) and determined that none of the plaintiffs’ arguments was
sufficient to warrant expanding the scope of leave to amend.3 The scope of the
3
K-V argues that the district court could have considered the motion under
Federal Rule of Civil Procedure 60(b) rather than under Federal Rule of Civil
Procedure 54(b). We disagree. Rule 54(b) allows a district court to revise a decision
that adjudicates, but does not enter final judgment on, fewer than all claims in an
action with multiple claims. Fed. R. Civ. P. 54(b) (“[A]ny order or other decision,
however designated, that adjudicates fewer than all the claims or the rights and
liabilities of fewer than all the parties does not end the action as to any of the claims
or parties and may be revised at any time before the entry of a judgment adjudicating
all the claims and all the parties’ rights and liabilities.”). The district court concluded
that because it had not yet entered final judgment on any of plaintiffs’ claims when
the plaintiffs filed the motion for reconsideration, Rule 54(b) is the appropriate rule
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motion for reconsideration is critical in our determination that the district court did
not err in denying the motion. A motion for reconsideration is not a vehicle to
identify facts or legal arguments that could have been, but were not, raised at the time
the relevant motion was pending. That is precisely the situation before us. Nothing
in the record indicates that the allegedly new information from the confidential
witnesses was not available to the plaintiffs at the time they opposed the motion to
dismiss. The witnesses were the plaintiffs’ own witnesses and the plaintiffs had every
opportunity to utilize this evidence in opposition to the motion to dismiss. Plaintiffs
are seeking to use a motion for reconsideration for the impermissible purpose of
raising evidence they could have previously raised. The district court thus did not
abuse its discretion in denying the plaintiffs’ motion.
IV.
For the foregoing reasons, we affirm the judgment of the district court.
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under which to consider the motion. We agree. See Auto Servs. Co., Inc. v. KPMG,
LLP, 537 F.3d 853, 856 (8th Cir. 2008) (noting that district court must direct entry
of judgment for purposes of a final judgment when issuing an order dismissing fewer
than all of the claims). The district court did not enter final judgment until after
denying the motion for reconsideration.
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