Paula Kuyat v. BioMimetic Therapeutics, Inc. ( 2014 )

RECOMMENDED FOR FULL-TEXT PUBLICATION
Pursuant to Sixth Circuit I.O.P. 32.1(b)
File Name: 14a0059p.06
UNITED STATES COURT OF APPEALS
FOR THE SIXTH CIRCUIT
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PAULA KUYAT, et al.
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Plaintiff,
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No. 13-5602
CHARLES M. SARAFIN, individually and on
,
>
Plaintiff-Appellant, -
behalf of all others similarly situated,
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v.
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BIOMIMETIC THERAPEUTICS, INC., SAMUEL E. -
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Defendants-Appellees. -
LYNCH, and LAWRENCE E. BULLOCK,
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Appeal from the United States District Court
for the Middle District of Tennessee at Nashville.
No. 3:11-cv-00653—Kevin H. Sharp, District Judge.
Argued: December 4, 2013
Decided and Filed: March 28, 2014
Before: BOGGS, ROGERS, Circuit Judges; STEEH, District Judge.*
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COUNSEL
ARGUED: Patrick V. Dahlstrom, POMERANTZ, GROSSMAN HUFFORD
DAHLSTROM & ROSS LLP, Chicago, Illinois, for Appellant. Randall W. Bodner,
ROPES & GRAY LLP, Boston, Massachusetts, for Appellees. ON BRIEF: Patrick V.
Dahlstrom, POMERANTZ, GROSSMAN HUFFORD DAHLSTROM & ROSS LLP,
Chicago, Illinois, Murielle J. Steven Walsh, POMERANTZ GROSSMAN HUFFORD
DAHLSTROM & GROSS LLP, New York, New York, for Appellant. Randall W.
Bodner, Christopher G. Green, Andrew J. O’Connor, ROPES & GRAY LLP, Boston,
Massachusetts, Nicholas M. Berg, ROPES & GRAY LLP, Chicago, Illinois, Douglas H.
Hallward-Driemeier, ROPES & GRAY LLP, Washington, D.C., Glenn B. Rose,
HARWELL HOWARD HYNE GABBERT & MANNER, Nashville, Tennessee, for
Appellees.
*
The Honorable George Caram Steeh, III, United States District Judge for the Eastern District of
Michigan, sitting by designation.
1
No. 13-5602 Kuyat, et al. v. BioMimetic Therapeutics, Inc., et al. Page 2
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OPINION
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ROGERS, Circuit Judge. In this securities fraud action, the plaintiffs contend
that BioMimetic Therapeutics, Inc. misled investors about Augment Bone Graft’s
prospects for Federal Drug Administration (FDA) approval. According to the plaintiffs,
the FDA privately communicated to BioMimetic that the FDA expected the device’s
clinical trials to prove that Augment was effective based on an analysis of all of the
study’s participants. The clinical trials did not achieve those results. But if BioMimetic
removed from its analysis study participants that did not actually receive treatment, then
the data did indicate that the device was effective. Based on these two analyses,
BioMimetic expressed optimism about Augment’s chances for FDA approval to
investors. The plaintiffs claim that those statements were misleading because
BioMimetic did not tell investors everything it knew about the FDA’s
expectations—particularly the FDA’s desire for the trials to show that the device was
effective based on an analysis of the entire study population. However, the plaintiffs’
complaint does not plead a strong enough inference of scienter, and therefore the district
court did not err in granting BioMimetic’s motion to dismiss the plaintiffs’ complaint.
BioMimetic develops and manufactures products that help heal damaged bones
and muscles. Augment is one of the company’s flagship products; it is designed to
encourage bone growth in patients that undergo foot and ankle surgeries. Historically,
doctors treated these damaged bones and muscles by transplanting healthy tissue from
one part of the patient’s body to the damaged area via a process known as an autograft.
Augment is different from an autograft because the device promotes bone growth via
drugs and can be done in a single operation, while autografts require conducting a
second surgery to harvest the material from another part of the patient’s body. If
Augment works as intended, the device will obviate the need for a surgeon to conduct
the second surgery.
No. 13-5602 Kuyat, et al. v. BioMimetic Therapeutics, Inc., et al. Page 3
Before BioMimetic can sell Augment in the United States, the FDA must
approve the device. Obtaining FDA approval requires a company (known as a sponsor
in this context) to navigate the complex premarket approval process. To receive
premarket approval, a sponsor must conduct clinical trials that demonstrate the device’s
efficacy and safety. Before obtaining permission to conduct the clinical trials, the
sponsor must receive FDA clearance to test the device on humans. And before the FDA
will grant its permission to conduct those tests, the sponsor must submit a proposed
study plan that governs how the study will be performed and its data analyzed. This plan
is known as a protocol. Sometimes the FDA will object to the initial protocol proposed
by the sponsor and will issue a conditional approval letter that allows the trials to begin
but that requires refinement of the protocol. In those cases, the sponsor will need to
supplement its proposed protocol to address the FDA’s concerns.
After the sponsor completes the clinical trials, it can submit an application for
premarket approval to the FDA. If the agency detects potential problems with the
application, it can issue a “deficiency letter” that asks the sponsor to address any
problems the letter identified. The FDA can also choose to refer the premarket approval
application to a panel of outside experts. After a public meeting, these experts vote on
whether they think the device is safe, effective, and whether its benefits outweigh its
risks. If the device makes it through all of these steps, then the FDA itself will decide
whether or not it will approve the device. The FDA is not bound by the expert panel’s
recommendation and can choose to approve the device or declare it “not approvable.”
BioMimetic filed for permission to conduct clinical trials in June 2005. The
protocol submitted with that application proposed that the “primary effectiveness
analysis” (i.e., the analysis that would determine whether Augment was effective relative
to a control group of patients receiving a traditional autograft implant) would be
conducted based on an intent-to-treat (ITT) population. An ITT population includes
every patient that is randomly assigned to a treatment group (in this case, either
Augment or an autograft). By contrast, a modified intent-to-treat (mITT) population is
a subset of the ITT population that excludes individuals that meet certain criteria (e.g.,
No. 13-5602 Kuyat, et al. v. BioMimetic Therapeutics, Inc., et al. Page 4
patients that are initially assigned a treatment group but that do not actually receive
treatment).
The FDA approved Augment for clinical trials, but wanted BioMimetic to revise
its protocol. BioMimetic submitted a supplement that included an amended definition
of “intent to treat” on April 16, 2007. The supplement stated: “The Intent-to-Treat (ITT)
population is defined as all randomized subjects who received treatment post
randomization. Patients who are randomized and unable to be treated will be considered
as surgical screening failures and will not [be] included in the Intent-to-Treat (ITT)
patient population.” This was not a standard definition of ITT. Because the proposed
definition excluded patients that were randomly sorted into treatment groups, the
definition did not actually describe an ITT population. Rather, the population that
BioMimetic proposed to analyze for its primary effectiveness analysis would more
accurately be described as an mITT population. Thus what BioMimetic was proposing
to do, albeit in a somewhat roundabout way, was analyze an mITT population rather than
an ITT population.
BioMimetic’s proposed change was not lost on the FDA. In a May 18, 2007
letter, the FDA wrote that BioMimetic had “corrected the deficiencies cited in our . . .
conditional approval letter,” and approved the April 16 supplement (which contained the
proposed change from ITT to mITT). But the letter also explicitly addressed the new
definition of ITT. The FDA wrote:
You should also give serious consideration to the following items which
are considered essential for the analysis of your data for the purposes of
determining safety and effectiveness for a future PMA application: . . .
2. The Intent-to-Treat population should be defined as all
randomized subjects in the treatment groups to which they were
assigned, regardless of whether they actually received the assigned
treatment or not. All subjects should be analyzed as randomized even if
no treatment or other treatment was actually received. You may analyze
additionally a group of patients excluded from the ITT due to “surgical
screening failure” . . . ; however, this should be considered and referred
to as a “modified ITT” population versus the “ITT” population (i.e., “true
ITT” population) defined above. You should plan to analyze the true
No. 13-5602 Kuyat, et al. v. BioMimetic Therapeutics, Inc., et al. Page 5
ITT population. You may also analyze a modified ITT (i.e., patients with
“surgical screening failures” who are excluded from the ITT) and the
per-protocol population.
BioMimetic proceeded to conduct clinical trials over the next couple of years.
The trials ended and BioMimetic issued a press release summarizing the study’s results
on October 13, 2009. That date is the beginning of the class period. According to the
release, Augment was effective when an mITT population was analyzed (i.e., the trial
produced statistically significant results), but not when the analysis was conducted on
the ITT population.
The company addressed the conflicting results of the study in a phone call with
investors that same day. In response to an analyst who asked whether the FDA would
consider only the ITT results, Russ Pagano, BioMimetic’s Vice-President for Clinical
and Regulatory Affairs said:
So, does FDA look at the ITT? No. FDA really looks at the
totality of the dataset, and I think if you do that here, regardless of how
you weight anything, you would see a classic—kind of classic pattern of
a noninferiority outcome in that you’re going to have a number of
outcomes. If you’re truly noninferior to a product in that just typically
you’re going to have a couple that probably do not make it statistically
and hopefully you’ll have the bulk that do. So, I think from a statistical
point of view, we kind of hit the classic pattern of what you would
expect.
FDA—that said, FDA does look at everything. They also said
our protocol calls out for we pre-specified [sic], as we talked about the
takeouts, if you will, from the MITT. FDA approved that. However,
what they do, just to be totally transparent, they frequently in approval
letters will put what they call PMA advisories, where they then make
some suggestions of things you should do per your PMA. It’s in one of
these PMA advisories that they state that they would like to see a true
traditional ITT, which basically includes everybody.
Pagano and Samuel Lynch, BioMimetic’s President and CEO, also argued that there
was regulatory precedent for conducting an analysis on an mITT population. They
explained that Medtronic had obtained approval for a device based on an analysis similar
to the one BioMimetic had used. Finally, BioMimetic argued to investors that the mITT
No. 13-5602 Kuyat, et al. v. BioMimetic Therapeutics, Inc., et al. Page 6
results were more relevant from a clinical perspective, and that the company had defined
who would be excluded from the mITT population before the trials began in order to
avoid injecting bias into the study (the principal danger of using an mITT rather than an
ITT population).
The market reacted negatively after the company released the study data: shares
fell 16% in after-hours trading after the results of the study were revealed. The price of
BioMimetic stock subsequently experienced a “roller coaster ride” as investors grappled
with the implications of the results.
The clinical trials had other problems as well. According to the plaintiffs,
BioMimetic enrolled an insufficient number of participants in the study, compromised
the trial’s effectiveness data by failing to provide baseline imaging against which to
compare post-surgical results, allowed an abnormally high number of protocol
deviations, damaged the integrity of the study by losing documentation, failed to perform
pharmacokinetics studies, neglected to monitor patients who experienced increased
antibody production as a result of being exposed to a human growth factor used by
Augment until their antibodies returned to baseline levels, declined to conduct
reproductive studies on the potential effects of exposure to Augment’s human growth
factor on pregnant women, and bolstered the study’s safety data by failing to report all
adverse events in the study.
After reviewing BioMimetic’s application for premarket approval, the FDA sent
the company a deficiency letter on September 3, 2010. This letter asked for clarification
and additional data relating to numerous parts of the application. Notably for the
purposes of this case, the deficiency letter questioned BioMimetic’s use of an mITT
population for the primary effectiveness analysis. But in a response letter, BioMimetic
explained to the FDA that the Agency had approved the analysis of an mITT population
in the May 18, 2007 letter and reiterated the company’s arguments that the mITT results
were more relevant and that exclusion of certain patients had not biased the study.
After BioMimetic responded to the deficiency letter, the FDA sent BioMimetic’s
premarket approval application to an advisory panel of experts. On May 9, 2011, three
No. 13-5602 Kuyat, et al. v. BioMimetic Therapeutics, Inc., et al. Page 7
days before the meeting with the panel, the FDA released a briefing document to the
public. Among other things, the document expressed concern over BioMimetic’s use
of an mITT population in its analysis. The document explained:
FDA believes that the ITT analysis population as defined in the PMA
should be considered the primary analysis. In addition, FDA advised the
sponsor at the IDE stage that both analysis populations should be
supportive of non-inferiority. Note that the ITT analysis population
preserves the benefits of randomization, while the mITT analysis
population does not (due to excluding subjects for mis-randomization or
not receiving treatment according to protocol.)
The briefing document apparently made investors question Augment’s prospects—the
company’s stock price fell 35% the day the document was released. Despite the
criticism of the clinical trials in the briefing document, the advisory panel voted to
recommend that the FDA approve the device, albeit narrowly. Only ten of the eighteen
panel members voted that Augment’s benefits outweighed its risks. The market reacted
negatively to the narrow vote, and BioMimetic’s stock price experienced a 10% decline
from that day to the next. The class period ended three days later on May 15, 2011.
On January 3, 2012, the FDA issued a non-approvable letter. The letter
explained that the Agency would not approve Augment unless BioMimetic provided
additional information about the trials. The FDA’s concerns stemmed at least in part
from the fact that it concluded that it needed “to evaluate the ‘robustness’ of the data,
given the differences in the outcome of the intent-to-treat and the modified-intent-to-
treat patient population analyses.”
The plaintiffs filed suit on July 6, 2011, approximately two months after the
release of the briefing document. Their complaint alleges that BioMimetic was aware
of numerous deficiencies in Augment’s clinical trials, but spoke optimistically to
investors about the device’s prospects for FDA approval. According to the complaint,
these rosy assessments amounted to securities fraud. The district court disagreed and
granted BioMimetic’s motion to dismiss. The court concluded that the plaintiffs had not
pled facts indicating a strong inference of scienter as required by the Private Securities
Litigation Reform Act of 1995 (PSLRA) and Tellabs, Inc. v. Makor Issues & Rights,
No. 13-5602 Kuyat, et al. v. BioMimetic Therapeutics, Inc., et al. Page 8
Ltd., 551 U.S. 308 (2007). The district court reasoned that the May 18, 2007 FDA letter
gave BioMimetic a basis for telling investors that it had permission to analyze an mITT
population because the letter stated that it approved the supplement where the change
occurred. The district court also concluded that the company’s disclosures (of the study
data, during the investor phone call, and in the company’s various SEC filings) were
extensive enough that no material information was withheld from investors. Thereafter,
the plaintiffs moved under Rule 59 to alter the court’s order granting the motion to
dismiss and for permission to amend their pleadings to address the May 18, 2007 letter.
The plaintiffs attached to the motion a proposed amended complaint that included
evidence from Dr. Gaurino, an expert on the FDA approval process, and additional
allegations relating to the May 18, 2007 letter. The district court denied the motion,
concluding that the plaintiffs had unduly delayed by waiting until after the motion to
dismiss was granted before asking for permission to amend their complaint. This appeal
followed.
The plaintiffs’ complaint did not adequately plead facts giving rise to a strong
inference of scienter as required by the PSLRA. 15 U.S.C. § 78u-4(b)(2)(A). The
plaintiffs’ theory is that BioMimetic knew that the Augment clinical trials went poorly,
but nevertheless spoke favorably about the device’s prospects for FDA approval. In
particular, the plaintiffs argue that the FDA had privately communicated that it expected
BioMimetic to obtain statistically significant results based on an analysis of the ITT
population, but that the company characterized those results as less important than the
analysis of the mITT population.1
The plaintiffs’ complaint identifies numerous misleading statements allegedly
made by the company. Many of those statements cast a favorable light on Augment’s
clinical trials and the device’s chances for success. For example, BioMimetic
characterized the study as producing “positive top line results,” said that the company
1
The plaintiffs argued that other deficiencies in the study, for example the fact that Biomimetic
did not conduct pharmacokinetics studies, also support an inference of fraud. These arguments are not
convincing. Unlike the allegations regarding the use of mITT and ITT, there are no allegations supporting
the notion that the defendants knew that these other supposed deficiencies would hurt Augment’s prospects
for FDA approval.
No. 13-5602 Kuyat, et al. v. BioMimetic Therapeutics, Inc., et al. Page 9
was “encouraged by the results seen to date in Augment’s clinical development,” and
stated that it felt “confident in the PMA [the company] submitted for Augment earlier
this year.” The plaintiffs assert that these statements were misleading because
BioMimetic knew that the FDA expected it to obtain statistically significant results
based on an ITT population and so the results were not nearly as positive as
BioMimetic’s statements otherwise suggested. Other statements related directly to
which population the FDA approved for the primary effectiveness analysis for the
device. In a 2009 earnings call, the company stated: “we met our pre-specified primary
endpoint and believe that we have demonstrated a clear picture of non-inferiority,” and
the company referred to the mITT population as “the pre-specified primary study
population” in a 2010 press release. These statements were alleged to be false because
the company knew that mITT was not the approved population.
The plaintiffs’ complaint does not give rise to a strong inference of scienter.
According to Tellabs, a court addressing whether a plaintiff has pled a strong enough
inference of scienter must “take into account plausible opposing inferences” that the
facts in the complaint generate. 551 U.S. at 323. A plaintiff only clears the high hurdle
imposed by the PSLRA if “a reasonable person [would] deem the inference of scienter
at least as strong as any opposing inference.” Id. at 326. Frank v. Dana Corp., 646 F.3d
954, 961 (6th Cir. 2011) reemphasizes that we must conduct a holistic review of the
pleadings. Under such a review, a reasonable person would conclude that the inference
of scienter in this case is not as strong as the opposing inference. BioMimetic could
legitimately believe that the statistically significant results it achieved based on an
analysis of the mITT population would be sufficient to obtain approval by the FDA.
BioMimetic proposed analyzing an mITT population for its primary effectiveness
analysis in its April 16, 2007 supplement. The FDA subsequently approved the
supplement that proposed this change, giving the company reason to believe it had
permission to conduct the primary analysis on the mITT population. The clinical trials
occurred, and an analysis based on an mITT population yielded statistically significant
results, thereby indicating that Augment achieved non-inferiority. The allegations in the
complaint therefore indicate that the trials showed that the device was effective based
No. 13-5602 Kuyat, et al. v. BioMimetic Therapeutics, Inc., et al. Page 10
on an analysis that BioMimetic believed the FDA had approved. All of the supposedly
misleading statements are consistent with that interpretation. While BioMimetic may
have ultimately been mistaken about which population the FDA wanted the company to
use for the primary effectiveness analysis, there are no facts suggesting the company
knew this at the time its representatives spoke.
The May 18, 2007 letter does not support an inference of scienter. The letter
does make clear that the FDA expected BioMimetic to conduct an analysis of both a
“true ITT” and an mITT population. But the letter does not indicate that the FDA
wanted the primary effectiveness analysis to be conducted on the ITT population.
Rather, the letter concerns itself with ensuring that BioMimetic defined ITT and mITT
properly in the premarket approval application by telling the company that the “Intent-
to-Treat population should be defined as all randomized subjects in the treatment groups
to which they were assigned, regardless of whether they actually received the assigned
treatment or not.” The letter says nothing either way about whether ITT must or must
not serve as the primary benchmark for success.
The 2010 Deficiency Letter is similarly ambiguous. In the letter, the FDA stated
that the original protocol called for the primary analysis to be performed using the ITT
population, that BioMimetic had not justified its switch from ITT to mITT, and that
using an mITT population risks introducing bias into the analysis. In its response letter,
BioMimetic explained that it understood the May 18 letter to have meant that the
primary study population “could be considered a modified intent to treat [population]
and [be] presented in the PMA” so long as it was labeled as such (i.e., labeled as mITT
and not ITT). Then BioMimetic proceeded to justify the propriety of analyzing an mITT
population by making essentially the same arguments it had made to investors when the
results of the trials were revealed: the company had excluded patients from the mITT
population in a manner that avoided introducing bias into the study, and an analysis of
an mITT population was a better indicator of whether the device was effective. It is hard
to imagine that BioMimetic would risk the agency’s ire by defending its use of mITT as
the primary population based on the FDA’s prior approval if the FDA had clearly not
No. 13-5602 Kuyat, et al. v. BioMimetic Therapeutics, Inc., et al. Page 11
given such approval. Like the May 18, 2007 letter, nothing in the deficiency letter
indicates that the FDA told BioMimetic to use an ITT population for the primary
effectiveness analysis.
The briefing document, by contrast, clearly does state that the primary analysis
should be based on the ITT population. But this document was released at the end of the
class period and well after the allegedly misleading statements were made. The
document does indicate that BioMimetic must have known that the FDA expected ITT
to be the primary analysis by the end of the class period, but the document has little
bearing on what the company did or did not know at the time the allegedly misleading
statements were made, and it does not support a strong inference of scienter. Similarly,
a district court in California concluded that a complaint did not plead facts creating a
strong inference of scienter because the complaint did “not allege any facts showing that,
at the time Defendants made their forward-looking statements, FDA compliance
problems existed, Defendants actually knew of the[] problems, or that the[] problems
would preclude FDA approval . . . .” Yanek v. Staar Surgical Co., 388 F. Supp. 2d 1110,
1126 (C.D. Cal. 2005).
Of course the lack of statistically significant results undoubtedly hurt Augment’s
prospects—but BioMimetic fully disclosed the results of the study and told investors that
the FDA wanted to see an analysis of both the ITT and mITT populations. And the
market apparently understood the significance of the results of the study because
BioMimetic’s stock price dropped 16% after the company released the data. It is
doubtful that the company intended to defraud investors in light of its willingness to
disclose information that harmed its share prices. Other courts have concluded that
disclosing adverse information to the public negates an inference of scienter. See, e.g.,
In re Worlds of Wonder Sec. Litig., 35 F.3d 1407, 1425 (9th Cir. 1994).
Furthermore, nothing in the record indicates that the FDA declared that the
presence or absence of statistically significant results in an analysis of the ITT
population was the FDA’s absolute requirement. According to BioMimetic’s press
release discussing the non-approvable letter, the FDA sought additional information
No. 13-5602 Kuyat, et al. v. BioMimetic Therapeutics, Inc., et al. Page 12
from BioMimetic so that the FDA could “evaluate the ‘robustness’ of the data, given the
differences in the outcome of the intent-to-treat and the modified intent-to-treat patient
population analyses.” That statement does not suggest that the lack of statistically
significant results in the ITT population necessarily doomed Augment in the FDA’s
eyes. While perhaps the lack of statistically significant results in the ITT population
played a part in the FDA’s decision, nothing in the relevant materials suggests that the
company knew those results would be the device’s downfall or that such a lack was so
obvious an impediment to the device’s success that BioMimetic’s failure to perceive the
risk of non-approval was reckless—i.e., that the company engaged in “highly
unreasonable conduct” that was “an extreme departure from the standards of ordinary
care,” PR Diamonds, Inc. v. Chandler, 364 F.3d 671, 681 (6th Cir. 2004)
In fact, several factors indicate that BioMimetic rightfully expressed optimism
about the device’s prospects. The FDA had previously approved other devices based on
mITT analyses. Augment proved itself by obtaining regulatory approval in both Canada
and Australia. BioMimetic had previously succeeded in obtaining approval for GEM
21S, a product that contained the same drug as Augment. And the advisory panel of
experts vindicated BioMimetic’s optimism by voting to recommend that the FDA
approve the device.
In summary, the more compelling inference that can be drawn from the pleadings
is that BioMimetic was justified in expressing optimism about Augment’s prospects for
success despite the lack of statistically significant results produced by an analysis of the
ITT population. BioMimetic may have ultimately been wrong about which population
would be analyzed for the primary effectiveness analysis, but a reasonable person would
more easily than not infer that BioMimetic believed that it had permission to use an
mITT population for the analysis at the time that it spoke to investors. See Tellabs, 551
U.S. at 323. Therefore, the district court properly dismissed the plaintiffs’ complaint.
The district court moreover did not abuse its discretion in refusing to grant the
plaintiffs leave to amend their complaint. The plaintiffs asked the district court for
permission to amend on two occasions: the first time was in the final sentence of their
No. 13-5602 Kuyat, et al. v. BioMimetic Therapeutics, Inc., et al. Page 13
brief in opposition to BioMimetic’s motion to dismiss, and the second came in the form
of a post-judgment motion made after the district court granted the motion to dismiss.
Although FRCP 15 instructs courts to “freely give leave” to amend, that liberal policy
does not apply to the plaintiffs’ one-sentence request. A “request for leave to amend
almost as an aside, to the district court in a memorandum in opposition to the
defendant’s motion to dismiss is . . . not a motion to amend.” La. Sch. Emps.’ Ret. Sys.
v. Ernst & Young, LLP, 622 F.3d 471, 486 (6th Cir. 2010) (internal quotation marks
omitted). Plaintiffs’ motion contained precisely that kind of throwaway language. The
final sentence of their memorandum in opposition reads: “Alternatively, Plaintiffs
request leave to amend the Complaint in the event that the Court finds that it falls short
of the applicable pleading standards in any respect.” Furthermore, the plaintiffs did not
submit a copy of the revised complaint at the time they filed their memorandum in
opposition. Normally, a party seeking an amendment should attach a copy of the
amended complaint. See Shillman v. United States, 221 F.3d 1336, 2000 WL 923761,
at *6 (6th Cir. 2000) (unpublished table decision). Both because the plaintiffs did not
present an adequate motion and because they did not attach a copy of their amended
complaint, the district court did not abuse its discretion in refusing to allow the plaintiffs
to amend their complaint based on the final sentence of the plaintiffs’ memorandum in
opposition.
The district court also did not abuse its discretion in denying the plaintiffs’ post-
judgment motion. In this case, the timing of plaintiffs’ motion is relevant. Morse v.
McWhorter, 290 F.3d 795, 800 (6th Cir. 2002). Plaintiffs made their motion after the
district court granted BioMimetic’s motion to dismiss. “[I]n the post-judgment context,
we must also take into consideration the competing interest of protecting the finality of
judgments and the expeditious termination of litigation.” Id. (internal quotation marks
omitted). Balancing these interests requires a court to “be particularly mindful of not
only potential prejudice to the non-movant, but also the movant’s explanation for failing
to seek leave to amend prior to the entry of judgment.” Id.
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The plaintiffs put forward no good excuse for delaying until after the
district court’s judgment. The plaintiffs sought to amend their complaint to address
BioMimetic’s arguments relating to the May 18, 2007 FDA letter by including evidence
from Dr. Gaurino, an expert on the FDA approval process. But the plaintiffs had access
to the FDA letter ten months before they filed their post-judgment motion. Furthermore,
plaintiffs had apparently retained Dr. Gaurino long before the FDA letter was revealed.
They thus presumably had access to his views on the letter when it was attached to
BioMimetic’s motion to dismiss. This court has previously explained that a district court
“acts within its discretion in denying a Rule 15 and a Rule 59 motion on account of
undue delay—including delay resulting from a failure to incorporate previously available
evidence.” Leisure Caviar, LLC v. U.S. Fish & Wildlife Serv., 616 F.3d 612, 616 (6th
Cir. 2010) (internal quotation marks and alterations omitted).
The plaintiffs’ excuse—that they had no way of knowing that the May 18, 2007
letter would factor heavily in the district court’s decision—does not pass muster. Rule
15’s permissive amendment policy should not permit plaintiffs to “use the court as a
sounding board to discover holes in their arguments, then reopen the case by amending
their complaint to take account of the court’s decision.” Id. (internal quotation marks
omitted). We recently rejected a similar argument in Ricker v. Zoo Entm’t, Inc., 534 F.
App’x 495 (6th Cir. 2013). There, the plaintiff argued that “he ‘was unaware of what
defects, if any, the Court would perceive in the Complaint,’ and first deserved ‘the
opportunity to analyze the supposed deficiencies in the Complaint to determine whether
he [could] cure them.’” Id. at 501. The plaintiffs’ explanation in the instant case is
identical. The district court did not abuse its discretion in Ricker, and neither did the
court in this case. The propriety of refusing to grant leave to amend is buttressed by the
fact that the usual liberal standards under Rule 15 do not apply to cases governed by the
PSLRA. “[T]he purpose of the PSLRA would be frustrated if district courts were
required to allow repeated amendments to complaints filed under the PSLRA.” Miller
v. Champion Enters. Inc., 346 F.3d 660, 692 (6th Cir. 2003).
For the foregoing reasons, we AFFIRM the judgment of the district court.