United States Court of Appeals
For the First Circuit
No. 07-1794
MISSISSIPPI PUBLIC EMPLOYEES' RETIREMENT SYSTEM,
Plaintiff, Appellant,
v.
BOSTON SCIENTIFIC CORPORATION; James R. Tobin; Paul A.
LaViolette; Fredericus A. Colen; Lawrence C. Best; Stephen F.
Moreci; Robert G. MacLean; Peter M. Nicholas; Paul W. Sandman;
James H. Taylor, Jr.,
Defendants, Appellees.
APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MASSACHUSETTS
[Hon. Joseph L. Tauro, U.S. District Judge]
Before
Torruella, Circuit Judge,
Tashima, Senior Circuit Judge,*
and Lynch, Circuit Judge.
Carolyn G. Anderson with whom Timothy J. Becker, Anne T.
Regan, Zimmerman Reed, P.L.L.P., David S. Nalven, Steve Berman,
Hagens Berman Sobol Shapiro, LLP, Richard A. Lockridge, Gregg M.
Fishbein, Lockridge Grindal Nauen, P.L.L.P., Mike Moore, and Moore
Law Firm were on brief for appellant.
Stuart J. Baskin with whom John Gueli, Kirsten M. Nelson,
Shearman & Sterling LLP, William H. Paine, Timothy J. Perla, and
Wilmer Cutler Pickering Hale & Dorr LLP were on brief for
defendants.
*
Of the Ninth Circuit, sitting by designation.
April 16, 2008
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LYNCH, Circuit Judge. This securities case was brought
against Boston Scientific, a publicly traded manufacturer of
medical devices based in Natick, Massachusetts. The appeal
concerns dismissal of claims based on the company's launch of a new
product, the drug-eluting TAXUS coronary stent, and its eventual
recalls. Plaintiff, a Mississippi pension fund and purchaser of
Boston Scientific stock, alleges that company executives both
withheld material information about problems with the stent and
decisions addressing those problems, and made misleading positive
statements, in violation of sections 10(b) and 20(a) of the
Securities Exchange Act of 1934, 15 U.S.C. §§ 78j(b) and 78t(a),
and the attendant rules and regulations, including Rule 10b-5, 17
C.F.R. § 240.10b-5.
Plaintiff appeals the district court's grant of
defendants' motion to dismiss under Federal Rule of Civil Procedure
12(b)(6). The district court held, in a thoughtful decision, that
plaintiff failed to meet the heightened pleading requirements
imposed by the Private Securities Litigation Reform Act of 1995
("PSLRA"), Pub. L. No. 104-67, 109 Stat. 737. In re Boston
Scientific Corp. Sec. Litig., 490 F. Supp. 2d 142, 152, 162 (D.
Mass. 2007).
Applying the standards recently articulated by the
Supreme Court in Tellabs, Inc., v. Makor Issues & Rights, Ltd., ___
U.S. ___, 127 S. Ct. 2499 (2007), and by this court in ACA
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Financial Guaranty Corp. v. Advest, Inc., 512 F.3d 46 (1st Cir.
2008), we hold that plaintiff has pled claims sufficient to
withstand a motion to dismiss and so we remand the case. Our
remand permits the court, should it choose to do so, to allow a
limited discovery period on the issues raised. See, e.g., Greebel
v. FTP Software, Inc., 194 F.3d 185, 188 (1st Cir. 1999); Gross v.
Summa Four, Inc., 93 F.3d 987, 990 (1st Cir. 1996). "Our ruling
does not mean that plaintiffs' claims have any merit. It means
only that the claims are not to be dismissed at this very early
stage. Nothing has been proven yet." In re Cabletron Sys., Inc.,
311 F.3d 11, 20 (1st Cir. 2002).
I.
On September 23, 2005, the Public Employees' Retirement
System of Mississippi ("PERS") brought suit in federal district
court as the lead plaintiff in a class action against Boston
Scientific and company executives Peter M. Nicholas (Chairman of
the Board of Directors); James R. Tobin (President and Director);
Paul A. LaViolette (Chief Operating Officer and member of the
Executive Committee1); Fredericus A. Colen (Senior Vice President
and Chief Technology Officer); Lawrence C. Best (Senior Vice
President and Chief Financial Officer); Stephen F. Moreci (Senior
Vice President and Group President of Endosurgery); Robert G.
1
LaViolette became Chief Operating Officer in 2004, after
the beginning of the class period.
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MacLean (Vice President of Human Resources); Paul W. Sandman
(Senior Vice President, Secretary, and General Counsel); and James
H. Taylor, Jr. (Senior Vice President of Corporate Operations).
Consolidated Am. Compl. ("CAC") ¶¶ 1, 15-23.
Plaintiff sued on behalf of a putative class of
individuals and entities who purchased equity securities in Boston
Scientific from March 31, 2003 to August 23, 2005. Id. ¶ 1.
Plaintiff alleged that during that period, defendants made false
and misleading statements and caused the market price of the
company's securities to be artificially inflated, both harming
investors and allowing the individual insider defendants to enrich
themselves in excess of $332 million. Id.
Plaintiff's original complaint divided into four
categories its allegations regarding defendants' statements about
a civil lawsuit with Medinol Ltd., a Department of Justice
investigation into a 1998 product recall, the company's
introduction of TAXUS stents to the market, and FDA investigations
and warnings regarding Boston Scientific's plants. Only the TAXUS
stent issue is before us on appeal following the dismissal of all
claims.
In particular, plaintiff advances these theories. By
late 2003 defendants became aware of serious problems in patients
in Europe resulting from the insertion of the new TAXUS stent, not
yet introduced in the United States. The TAXUS stent was
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introduced in the United States in March 2004; American doctors
reported similar problems. In the spring of 2004 defendants made
affirmative statements attributing the problems reported about the
new TAXUS stent to the unfamiliarity of doctors with the new stent.
They did not correct the statements even though they had become
aware that the problem was not doctor unfamiliarity, but rather a
manufacturing defect in the stent that caused the balloon to fail
to deflate. Defendants continued to withhold information about a
manufacturing change Boston Scientific had instituted in December
2003 which would address the defect. They withheld the information
to build up inventory, in order to preserve market share, before
announcing recalls of TAXUS stents based on the potential defects.
Meanwhile, while withholding this material information, several of
the individual defendants traded on the open market in unusual
patterns and unusual amounts. When the material information was
finally and belatedly disclosed, the market price for Boston
Scientific stock plummeted downward. The stock price dropped 7.6%
after the company announced an expanded recall and revealed that
three deaths and several dozen serious injuries had been connected
to balloon deflation failure, and it dropped another 6.6% when the
company expanded the recall of the TAXUS stent for a second time.
CAC ¶¶ 100, 102.
The defendants' theory is that at the time the company
received some thirty to forty reports of problems in Europe of
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balloon non-deflation following stent insertion, it was unable to
identify anything about the device itself that would cause the
problem and attributed the problem to doctor unfamiliarity.
Defendants' brief argues that independently and
[i]n an effort to improve the device, Boston
Scientific tried completely to eliminate the
possibility of balloon non-deflation. It
eventually identified a means to do so, by
changing the manner of bonding the delivery
catheter to the balloon and by implementing an
additional inspection test at the end of the
manufacturing process. These proposed
modifications were submitted to the FDA for
approval in April 2004 and approved by the FDA
the following month. In June 2004 Boston
Scientific began manufacturing the "new"
device.
After it identified how to completely
eliminate what was already an infrequently
occurring issue, Boston Scientific was able to
re-analyze its "old" Taxus inventory. That
process led to the identification of specific
lots that had the potential for non-deflation.
Out of an abundance of caution, Boston
Scientific voluntarily recalled a limited
number of specific production lots of its
"old" Taxus stents in July and August 2004.
It is the company's position that the changes would have
been implemented "whether it got a complaint or not." The removal
of the possibility that the balloon would fail to deflate by the
manufacturing change did not prove there was a defect, much less
that the company knew at an earlier date of a connection between
the manufacturing change and the problem that necessitated the
recalls, or that it was obliged to disclose it.
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A. Plaintiff's Allegations
Plaintiff brought the suit as a putative class action.
The class period plaintiff claims is relevant to this narrowed
appeal is December 2, 2003 to August 5, 2004.
In 2001, Boston Scientific decided to produce a drug-
eluting stent2 to compete with a similar product manufactured by
Johnson & Johnson. CAC ¶ 86. Boston Scientific's product is known
as TAXUS® Express Paclitaxel-Eluting Monorail® Coronary Stent
System. Id.
TAXUS debuted in Europe in January 2003. Id. ¶¶ 87, 92.
Plaintiff alleges that defendants felt "tremendous pressure" to
introduce TAXUS into the U.S. market because the company was losing
market share to Johnson & Johnson. Id. ¶ 87. While in the process
of obtaining final FDA approval for TAXUS, defendants allegedly
downplayed news that could delay the U.S. launch, such as failing
to disclose in a timely manner an FDA major deficiency letter that
the company received in September 2003. Id. ¶ 89. Meanwhile,
2
Coronary stents are tiny tubes placed in patients'
arteries to ameliorate blockages and facilitate blood flow. Drug-
eluting stents (also called "coated" or "medicated" stents) slowly
release drugs aimed at reducing restenosis, a narrowing of the
arteries that can occur after a stent is implanted. Stents are
implanted in arteries using a delivery catheter.
In 2002, Boston Scientific marketed a coronary stent
system called the Express², which combined its highly successful
Express™ coronary stent and Maverick® balloon dilation catheter,
which uses a tiny balloon to inflate the artery and permit the
stent to be inserted. TAXUS uses the same delivery catheter as the
Express²; the systems differ in that Express² is a bare metal stent
whereas TAXUS is a drug-eluting stent.
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defendants "provided to the investment community a drum roll
leading up to the FDA's approval of TAXUS which was deafening."
Id. ¶ 90. Plaintiff alleges that in anticipation of FDA approval
and in response to positive comments made by defendants, analysts
upgraded their rating of Boston Scientific stock, and by March
2004, the price of Boston Scientific stock on the New York Stock
Exchange hit a new high, trading at over $40 a share. Id. ¶¶ 15-
23, 91, 100.
On March 4, 2004, the FDA approved TAXUS for marketing
and distribution in the United States. Id. ¶ 92. Plaintiff
alleges that Boston Scientific "trumpeted [TAXUS's] immediate
impact in the Company's effort to take over market share for
stents." Id. Meanwhile, defendants did not disclose complaints
they had received from doctors in Europe that the balloon used
during insertion of the TAXUS stent did not deflate. Id. ¶ 93.
Defendants also knew that the Express² metal stent, upon which the
new TAXUS stent was based, "had a history of significant problems."
Id.
Despite this knowledge, defendants "minimized and
misrepresented . . . problems," including in the company's Form 10-
Q for the quarter ending March 31, 2004, which Boston Scientific
filed with the SEC on May 7, 2004. This report stated that the
company was "reviewing a limited number of reports related to
balloon withdrawal difficulty during TAXUS angioplasty procedures."
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Id. In meetings with analysts, defendants "further downplayed the
complaints" by attributing the problems to doctor unfamiliarity
with TAXUS rather than balloon non-deflation. Id.
Meanwhile, plaintiff alleges, defendants knew "the
problems with TAXUS were much more significant, based on the
complaints they had received out of Europe and the complaints which
were rolling in as a result of the product rollout in the United
States." Id. ¶ 95. In December 2003 defendants allegedly had
begun planning a manufacturing change for TAXUS because they had
become aware that the problem with TAXUS was not doctor
unfamiliarity but rather a "manufacturing defect." This
manufacturing change, which according to defendants was approved by
the FDA in May 2004, related to the manner of the laser bonding of
the delivery catheter and balloon. Defendants did not disclose
this manufacturing change to the public prior to July 2, 2004, when
they referred to it in a conference call with analysts. Id. ¶¶
95, 98. Defendants also discussed the manufacturing change in the
press releases announcing subsequent recalls on July 16 and August
5.
Plaintiff alleges that defendants had an obligation to
disclose this manufacturing change to the public at some point
prior to July 2 because it was necessary to correct defendants'
earlier and continuing statements that the adverse reports related
to U.S. doctors' unfamiliarity with TAXUS rather than to a defect
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with the product itself. As plaintiff put it at oral argument:
"The disclosure that we are asking for is that as soon as they
learned that . . . the problems with TAXUS were not related to
doctor [un]familiarity . . . they had a duty to disclose that."
In the months following the U.S. launch of TAXUS, Boston
Scientific's stock price rose and defendants began to sell large
quantities of their own stock. CAC ¶ 96. Plaintiff specifically
points to the following stock sales, all of which occurred within
two months of the FDA's March approval of TAXUS: over $40 million
by James R. Tobin; over $54 million by Lawrence C. Best; over $4
million by Fredericus A. Colen; and over $3 million by Robert G.
MacLean. Id. Additionally, defendant Paul LaViolette sold
approximately $3 million worth of company stock in June of 2004.
Id. ¶ 18. Plaintiff argues that these sales demonstrated "unusual
patterns" and occurred in "unusual amounts."
On July 2, 2004, Boston Scientific announced that it was
voluntarily recalling two lots of TAXUS stents (a total of 200
stents), which had not yet been implanted in patients. Id. ¶ 97.
In a press release announcing the recall, the company stated that
the FDA had received reports of one death and sixteen serious
injuries associated with balloon non-deflation, along with eight
reports of balloon malfunction that had not caused injury. Id.
The press release explained that the recall was due to
"characteristics . . . related to a narrowing in the area where the
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catheter and balloon are laser welded," a problem referred to as
"focal neckdown." "This narrowing resulted in the potential for
impeded deflation and removal of the balloon after stent
placement."
The manufacturing change that defendants had put into
motion in December 2003 addressed the problem of focal neckdown by
changing the manner of the laser welding of the catheter and
balloon. In a conference call with analysts on July 2, defendants
asserted that this manufacturing change had been in progress before
the TAXUS launch and "would have been submitted whether we got a
complaint or not." Id. ¶ 98.
Two weeks later, on July 16, defendants voluntarily
expanded the company's recall to 85,000 TAXUS stents and 11,000
Express² stents -- which use the same delivery catheter as TAXUS --
and admitted knowing of two additional serious injuries associated
with TAXUS as well as two deaths and twenty-five serious injuries
associated with balloon deflation failure in Express² stents. Id.
¶ 100. In a press release announcing this recall, defendants
assured the public: "The Company implemented review of its
manufacturing process, additional inspections, and an FDA-approved
modification to the manufacturing process for these products. The
current and future production are not expected to experience
similar balloon deflation problems."
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After defendants announced this expanded recall on July
16, Boston Scientific's stock price dropped $3.09 per share, or
7.6%, to $37.40. Id. ¶ 100. Plaintiff connects the drop in stock
price to the revelations of the deaths and injuries associated with
the TAXUS and Express² stents. Id.
Plaintiff alleges that during July and early August 2004,
defendants "continued to try to reassure the market about the
safety of the Company's products through the issuance of public
statements which were false and misleading." Id. ¶ 101. In
particular, during a conference call with analysts on July 26,
2004, defendant Paul LaViolette responded to concerns about TAXUS
by saying, "[Y]ou are dealing with simple lag time in the
marketplace conversion of newer products, not necessarily a
continuation of complaints from the new issue product." Id. At a
meeting with a local hospital official on July 29, LaViolette
stated that the company had "identified and fixed the problem."
Id. On August 4, he stated that the problem was a "nuisance." Id.
On August 5, Boston Scientific announced that it was
voluntarily recalling an additional 3,000 TAXUS stents.3 Id. ¶
102. The press release announcing the recall stated that it was
prompted by the company's "ongoing monitoring" and noted that since
the company had "modified its manufacturing process, implemented
3
The complaint states the date of the third recall as
August 4, but the press release announcing the recall is dated
August 5.
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new tracking software and introduced new inspection protocols," it
had not had any confirmed non-deflation problems caused by focal
neckdown in the units made with these changes in place. At this
time, the company's stock price dropped another $2.41, or 6.6%.
Id.
By the end of 2004, Boston Scientific had recalled 99,000
TAXUS and Express² stents because of manufacturing defects that
plaintiff alleges had caused three deaths and dozens of serious
injuries. Id. ¶ 103. The company spent over $57 million on these
recalls. Id. ¶ 101. Between July 2, 2004, when the first recall
was announced, and August 5, 2004, when the recall was expanded for
a second time, the company's stock price dropped 21%. Id. ¶ 103.
Plaintiff's theory is that the investing world was aware
of reports of patient death and injury involving TAXUS. However,
defendants said that the problems with the TAXUS stents were caused
by doctor unfamiliarity with the new product. It was natural for
investors to conclude the problems would disappear over time as
doctors became more familiar with the product, and there would be
no recalls. Having given that explanation, the defendants,
plaintiff argues, were required to disclose as soon as they could
the connection between the patient problems, the manufacturing
defect, and the manufacturing change remedying this problem.
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B. District Court Opinion
In dismissing the TAXUS claims, the district court
reasoned in a series of discrete steps.4 It first noted that there
was no violation in not disclosing the FDA major deficiency letter
regarding TAXUS that Boston Scientific had received in September
2003, before the U.S. release of the product. Rather, the major
deficiency letter was simply "a step in the FDA approval process
which [Boston Scientific] had no duty to disclose." In re Boston
Scientific, 490 F. Supp. 2d at 158; see also id. at 158 n.91
(citing 21 C.F.R. § 814.37(b) ("A major deficiency letter informs
the applicant that its PMA [Premarket Approval Application] lacks
significant information needed for FDA to complete the scientific
review of, and render a final decision on, the PMA.")).
The court next turned to the adverse reports from doctors
that defendants received prior to announcement of the recalls of
the TAXUS and Express² stents in July and August of 2004. The
court examined the company's statements that complaints received
from American doctors in the spring of 2004 were comparable to
complaints it had received the previous year from European doctors.
Plaintiff asserted that these statements were false when made
because the company knew that the problems in both Europe and the
United States resulted from a product flaw rather than from the
4
We discuss the district court's opinion only as it
pertains to the TAXUS claims because only that part of the opinion
is being appealed.
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stated reason of doctor unfamiliarity with TAXUS. However, the
district court concluded, plaintiff provided "little in the way of
facts to support this claim. Lead Plaintiff pleads no facts to
suggest that the complaints [Boston Scientific] received from
American doctors were different than those it received from
European doctors." Id. at 159.
With respect to the manufacturing change which Boston
Scientific initiated prior to the U.S. launch of TAXUS, the court
rejected plaintiff's allegations that this change was evidence that
defendants knew TAXUS was defective and that the change was
material information that should have been disclosed. Id. Here
the district court invoked the doctrine of fraud by hindsight. The
court reasoned that a manufacturing change does not necessarily
mean that a product is defective or that a company knows that a
product is defective since "[c]ompanies frequently adjust and
change their products, and no rule requires a company to inform the
public every time it modifies its manufacturing process." Id. The
court pointed out that Boston Scientific's manufacturing change was
conducted with the FDA's knowledge, at a time when the company had
received only a limited number of complaints from European doctors,
which had been tapering off. Id. at 160. Plaintiff did not
contest that the manufacturing change was set in motion before
TAXUS's release in the United States and would have been made
regardless of whether the company received complaints from U.S.
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doctors. Id. The district court further noted that "[t]he recalls
were limited, and only applied to a fraction of the TAXUS stents
released on the domestic market." Id. Thus, the court concluded,
while "[i]n hindsight . . . it appears that this manufacturing
change may indeed have been material," id. at 159, plaintiff failed
"to allege facts that provide a strong inference that at the time
of the manufacturing change, Defendants knew that TAXUS was
defective or that the product would later be recalled," id. at 160.
With respect to defendant Paul LaViolette's July 29, 2004
remarks that Boston Scientific had identified and fixed the problem
with TAXUS, the district court also invoked the doctrine of fraud
by hindsight. A week after LaViolette's statements, the company
initiated an additional recall of 3,000 TAXUS stents. However, the
district court reasoned, there is no liability where "a plaintiff's
claim rests on the assumption that the defendants 'must have known
of the severity of their problems earlier because conditions became
so bad later on.'" Id. (quoting In re Boston Tech., Inc. Sec.
Litig., 8 F. Supp. 2d 43, 53 (D. Mass. 1998)). Here, the court
concluded that plaintiff failed to allege facts giving rise to a
strong inference that LaViolette knew at the time of his remarks
that they were false or that an additional recall would be
necessary. Id.
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II.
On appeal, plaintiff argues that the district court erred
in several respects. It argues that the court misapplied the
doctrine of fraud by hindsight, resulting in the imposition of too
stringent a pleading standard. More specifically, it claims that
the court erroneously drew factual inferences against plaintiff
regarding the manufacturing change and failed to account for the
materiality of the change. Plaintiff further argues that the court
misapplied the fraud by hindsight doctrine to LaViolette's remarks
by discounting the temporal proximity between his statements and
the third TAXUS recall, and it challenges the district court's
factual assumption that the recall was limited in scope. Finally,
plaintiff faults the district court for failing to consider the
allegations of insider trading presented in the complaint.
Overall, plaintiff argues the district court atomized the complaint
and did not look at the overall pattern.
A. Pleading Requirements
We evaluate de novo whether a complaint meets the
requirements of the PSLRA. ACA Fin., 512 F.3d at 58. As with any
Rule 12(b)(6) motion to dismiss, we accept well-pled factual
allegations in the complaint as true and make all reasonable
inferences in plaintiff's favor. Id. The standard most recently
articulated by the Supreme Court is that a complaint must allege "a
plausible entitlement to relief" in order to withstand a motion to
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dismiss under Rule 12(b)(6). Bell Atl. Corp. v. Twombly, ___ U.S.
___, 127 S. Ct. 1955, 1967-69 (2007); ACA Fin., 512 F.3d at 58.
A claim for securities fraud under section 10(b) and Rule
10b-5 must contain six elements: (1) a material misrepresentation
or omission; (2) scienter; (3) a connection with the purchase or
sale of a security; (4) reliance; (5) economic loss; and (6) loss
causation. ACA Fin., 512 F.3d at 58 (citing Dura Pharm., Inc. v.
Broudo, 544 U.S. 336, 341-42 (2005)). Only the first two elements
are at issue in this appeal.
Information is material if a reasonable investor would
have viewed it as "having significantly altered the total mix of
information made available." Gross, 93 F.3d at 992 (quoting Basic
Inc. v. Levinson, 485 U.S. 224, 232 (1988)) (internal quotation
marks omitted). The PSLRA provides that a misleading statement or
omission is alleged when plaintiff claims that defendant made "an
untrue statement of a material fact," 15 U.S.C. § 78u-4(b)(1)(A),
or "omitted to state a material fact necessary in order to make the
statements made, in light of the circumstances in which they were
made, not misleading," id. § 78u-4(b)(1)(B). "While a company need
not reveal every piece of information that affects anything said
before, it must disclose facts, 'if any, that are needed so that
what was revealed [before] would not be so incomplete as to
mislead.'" Cabletron, 311 F.3d at 36 (quoting Backman v. Polaroid
Corp., 910 F.2d 10, 16 (1st Cir. 1990) (en banc)).
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Scienter is a "mental state embracing intent to deceive,
manipulate, or defraud." Ernst & Ernst v. Hochfelder, 425 U.S.
185, 193 n.12 (1976); ACA Fin., 512 F.3d at 58. This circuit has
held that a plaintiff can demonstrate scienter by showing that
defendants either "consciously intended to defraud, or that they
acted with a high degree of recklessness." Aldridge v. A.T. Cross
Corp., 284 F.3d 72, 82 (1st Cir. 2002).
Securities fraud allegations also must meet the standards
of Federal Rule of Civil Procedure 9(b)5 and the PSLRA, which
imposes heightened pleading requirements on private securities
litigation. The PSLRA requires that when alleging that a defendant
made a material misrepresentation or omission, a complaint must
"specify each statement alleged to have been misleading [and] the
reason or reasons why the statement is misleading." 15 U.S.C. §
78u-4(b)(1). If the allegation is "made on information and
belief," then the complaint must "state with particularity all
facts on which that belief is formed." Id.
With respect to scienter, the complaint must, "with
respect to each act or omission . . ., state with particularity
facts giving rise to a strong inference that the defendant acted
5
Rule 9(b) requires that in alleging fraud or mistake, "a
party must state with particularity the circumstances constituting
fraud or mistake." Fed. R. Civ. P. 9(b). In securities fraud
cases, this requirement is comparable to and effectively subsumed
by the requirements of the PSLRA. See ACA Fin., 512 F.3d at 58
n.7.
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with the required state of mind." Id. § 78u-4(b)(2) (emphasis
added). This requirement that plaintiffs plead facts giving rise
to a strong inference of scienter differs from the general rule
applied to other cases that a reasonable inference is sufficient to
survive a Rule 12(b)(6) motion; in the PSLRA "Congress has
effectively mandated a special standard for measuring whether
allegations of scienter survive a motion to dismiss." Greebel, 194
F.3d at 195.
The Supreme Court's recent decision in Tellabs clarified
that scienter should be evaluated with respect to "the complaint in
its entirety, as well as other sources courts ordinarily examine
when ruling on Rule 12(b)(6) motions to dismiss, in particular,
documents incorporated into the complaint by reference, and matters
of which a court may take judicial notice." Tellabs, 127 S. Ct. at
2509; see also ACA Fin., 512 F.3d at 58. "The inquiry . . . is
whether all of the facts alleged, taken collectively, give rise to
a strong inference of scienter, not whether any individual
allegation, scrutinized in isolation, meets that standard."
Tellabs, 127 S. Ct. at 2509. Tellabs also directed that courts
consider "not only inferences urged by the plaintiff . . . but also
competing inferences rationally drawn from the facts alleged," id.
at 2504, and held that a complaint survives when there are equally
compelling inferences for and against scienter, id. at 2510; see
also ACA Fin., 512 F.3d at 59.
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B. Plaintiff's Allegations
We evaluate plaintiff's allegations in this context. In
reviewing a motion to dismiss under Rule 12(b)(6), courts
ordinarily will consider only documents attached to the complaint,
but have made exceptions "for documents the authenticity of which
are not disputed by the parties; for official public records; for
documents central to plaintiffs' claim; [and] for documents
sufficiently referred to in the complaint." Watterson v. Page, 987
F.2d 1, 3 (1st Cir. 1993).6
1. Manufacturing Change
Plaintiff alleges that defendants failed to disclose
information about the manufacturing change prior to July 2, 2004,
and this information was material. The primary motive alleged for
the delay is that defendants wanted to build up inventory before
announcing product recalls. Under the requirements of section
6
We do not consider the transcripts of conference calls
mentioned by both parties in their briefs and attached as an
appendix to plaintiff's brief. In an order dated October 30, 2007,
we rejected plaintiff's motion to expand the record before this
court to include three transcripts that were not before the
district court. We held that plaintiff had not demonstrated the
"extraordinary circumstances" necessary to invoke this court's
power to supplement a record under Federal Rule of Appellate
Procedure 10(e)(2). United States v. Muriel-Cruz, 412 F.3d 9, 12
(1st Cir. 2005). We further held that although the complaint
"contained some brief quotations from the documents, it did not
expressly incorporate the entire documents, including the
additional statements that [plaintiff] relies upon in its appellate
brief." We also noted that regardless of whether the district
court could have considered the transcripts if they were offered
below, they had not been so offered.
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10(b) and Rule 10b-5, plaintiff must demonstrate both that the
defendants omitted material information and that they did so with
the requisite scienter.
Securities actions raise questions of what corporate
managers knew and when they knew it. These issues are pertinent
both to materiality and to scienter. Moreover, something may be
material because of other information or explanations that have
been given by defendants. Thus plaintiff does not need to rely on
a theory that there was an independent duty to disclose the
manufacturing change. Further, we do not reach the district
court's reasoning on the materiality, standing alone, of either
manufacturing changes or the receipt of FDA major deficiency
letters.
The existence of a material omission is usually a
question for the trier of fact. See ACA Fin., 512 F.3d at 65
(citing Shaw v. Digital Equip. Corp., 82 F.3d 1194, 1217 (1st Cir.
1996)). In this case, we cannot say that as a matter of law the
complaint fails to raise a reasonable inference that this was a
material omission.
The company's own statements draw a connection between
the manufacturing change and the resolution of the balloon non-
deflation problems, whether or not the earlier product had a
defect. Indeed, Boston Scientific's Form 10-Q for the quarter
ending June 30, 2004 included the following statements: "As a
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result of its investigation, the Company has implemented reviews of
its manufacturing process, additional inspections, and an FDA-
approved modification to the manufacturing process for [TAXUS and
Express² stents]. The Company believes these measures will be
effective in reducing the occurrence of balloon non-deflation."
Because the manufacturing change, in combination with
other changes, would have the effect of reducing balloon non-
deflation, a jury could find that the company's continuing
assertions that reported problems about TAXUS in the United States
resulted from doctor unfamiliarity with the product rather than any
defect in the product were misleading unless accompanied by
disclosure of the manufacturing change and its connection to the
balloon non-deflation problem. See Cabletron, 311 F.3d at 36.
Among other things, the existence of this manufacturing change was
pertinent to the issue of potential recalls, and it would raise the
question whether, if there were continuing problems or recalls, the
company would have on hand sufficient new products incorporating
the manufacturing change in order to allow the company to replace
the original TAXUS stents and maintain market share.
Assuming that a jury could find a material omission, the
next requirement under section 10(b) and Rule 10b-5 is that
defendants acted with the requisite scienter in not disclosing the
manufacturing change sooner, i.e., prior to the first recall
announced on July 2, 2004. Knowingly omitting material information
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is probative, although not determinative, of scienter. Aldridge,
284 F.3d at 83 ("[T]he fact that the defendants published
statements when they knew facts suggesting the statements were
inaccurate or misleadingly incomplete is classic evidence of
scienter."); see also ACA Fin., 512 F.3d at 65.
Plaintiff alleges that at some point prior to the FDA
approval of TAXUS in March 2004, defendants knew that the problem
with TAXUS was not doctor unfamiliarity but rather a manufacturing
defect, and the company had already determined how to fix that
defect. Specifically, plaintiff alleges that prior to the U.S.
launch of TAXUS, defendants knew of adverse reports from doctors in
Europe about balloon non-deflation, and that they also knew that
the Express² metal stent, which used the same delivery system as
TAXUS, had a "history of significant problems." CAC ¶ 93.
Plaintiff also alleges that defendants received numerous adverse
reports in the spring of 2004 from U.S. doctors, which they
"minimized and misrepresented," and attributed to doctors'
unfamiliarity with the new product. Id. Yet defendants proceeded
with the U.S. launch of TAXUS and did not disclose this information
until July 2, 2004.
Plaintiff alleges that defendants withheld this
information to allow the company to build up its inventory of new,
non-defective products which had been made with the manufacturing
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change in place, in order to avoid loss of market share.7
Plaintiff also alleges that several of the defendants engaged in
insider trading during this lag period, benefitting from the delay.
Inferences supporting plaintiff's allegations about
defendants' knowledge can be drawn from statements in Boston
Scientific's Form 10-Q for the quarter ending June 30, 2004, filed
on August 9, 2004. The Form 10-Q discusses the company's voluntary
recall of the TAXUS Express² stent "due to characteristics in the
delivery catheters that have the potential to impede balloon
deflation during a coronary angioplasty procedure. Further
analysis and investigation of the TAXUS Express² (paclitaxel-
eluting) and Express² (bare metal) stent systems, both of which
share the same delivery catheter, revealed that certain additional
production lots exhibited these same characteristics." This
statement acknowledges a connection between the balloon non-
deflation problem and the characteristics of the delivery catheter.
The statement also acknowledges that the company had been
conducting ongoing analysis and investigation of the problem and as
a result voluntarily expanded its recall on July 16. The statement
goes on to say that the company would continue to work with the FDA
to monitor the non-deflation problem.
7
Companies, of course, have other reasons not to have made
an announcement from which some might have inferred there may have
been a product defect causing injury and death, which could have
been avoided by using different manufacturing techniques.
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Tellingly, the statement also says that "[a]s a result of
its investigation, the Company has implemented . . . an FDA-
approved modification to the manufacturing process." (Emphasis
added.) To the extent the company may be arguing that there was no
connection between the manufacturing change and any characteristics
of the catheter, defendants' own statements can be read to say that
they implemented the manufacturing change in response to adverse
reports, not independent of them.
Defendants made a similar statement in the press release
announcing the July 16 expanded recall. After noting that the
company had conducted "further analysis and investigation" that
demonstrated the need for an expanded recall, the press release
states: "The Company implemented review of its manufacturing
process, additional inspections, and an FDA-approved modification
to the manufacturing process for these products. The current and
future production are not expected to experience similar balloon
deflation problems."
Defendants make a different argument, addressed below,
that even if the manufacturing change did solve the problem by
preventing balloon non-deflation, that does not mean they knew the
connection or were obliged to disclose it earlier.
Plaintiff gave a reason why defendants withheld
information: so that they could build up an inventory of "new"
TAXUS stents prior to announcing the recalls, thereby minimizing
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supply disruptions and maximizing profit. In support of this
theory is the fact that defendants asserted in their Form 10-Q for
the quarter ending June 30, 2004 that they had been able to use
their "existing supply of coronary stents not subject to the recall
to replenish the U.S. market," although they also noted that they
were unable to replenish the European market with existing stock
and were hoping to do so during the third quarter of 2004.
Similarly, in the press release announcing the July 16 recall,
defendant James Tobin stated that, "We're fortunate that current
TAXUS inventory levels will minimize service disruption in the
United States, but we do expect some disruption internationally."
Plaintiff's proposed inferences are that defendants knew
about the connection between adverse reports and the manufacturing
change well before July 2, and withheld that information in order
to build up inventory prior to announcing recalls. Under the PSLRA
these inferences must be strong and must be weighed against
competing ones. Defendants' inferences are that the manufacturing
change was implemented for "innocuous" reasons not owing to any
defect in the product, and that they did not know of a connection
between the manufacturing change and the adverse reports they were
receiving from U.S. doctors until the time of the first recall.
Defendants' inferences are supported by the fact that balloon non-
deflation complaints that defendants received from doctors in
Europe in 2003 faded over time, indicating that such complaints
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were in fact tied to doctor unfamiliarity. Additionally,
defendants' press releases and Form 10-Q for the quarter ending
June 30, 2004 stated that it was not the manufacturing change alone
but rather this change in combination with others, including an
improved inspection process, that would prevent non-deflation in
the future. At no point did defendants communicate that the
manufacturing change alone would fix the non-deflation problem.
Given these allegations, the district court held that
plaintiff failed to plead facts providing a strong inference that
at the time of the manufacturing change, defendants had the
requisite scienter. In re Boston Scientific, 490 F. Supp. 2d at
160. It reasoned that the manufacturing change was implemented
with the FDA's knowledge and approval, at a time when the company
had received only a "limited number of complaints from Europe which
had tapered off after the product's release." Id. Moreover,
defendants asserted and plaintiff did not dispute that the
manufacturing change would have been put into place regardless of
whether the company received complaints from doctors in the United
States. Id. The district court did not address the key question
of inferences about whether defendants knew that the manufacturing
change was related to non-deflation complaints at some point prior
-29-
to the July 2 recall, not just when they first initiated the
change.8
The district court did not have the benefit of the
Tellabs opinion, which reversed a higher standard for scienter
imposed by the prior law of this circuit. We apply Tellabs and
that leads us to a different result. While there is support for
defendants' inferences, we think, at this stage, that plaintiff's
inferences are at least equally strong. First, there is a very
reasonable inference that defendants initiated the manufacturing
change as a result of non-deflation complaints it had received from
Europe, even if these complaints had tapered off over time.
Other inferences may be drawn favorable to plaintiff by
proper recognition of the limits of the doctrine of fraud by
hindsight. Fraud by hindsight refers to allegations that assert no
more than that because something eventually went wrong, defendants
must have known about the problem earlier. "[A] plaintiff may not
simply contrast a defendant's past optimism with less favorable
actual results, and then 'contend[] that the difference must be
8
Plaintiff and defendants dispute the extent of the
recall, with plaintiff arguing that all pre-manufacturing change
stents were recalled and defendants responding that approximately
445,000 "old" TAXUS stents had already been shipped and implanted
and therefore were not problematic or recalled. We need not
resolve this factual question at this point because the extent of
the recall is largely irrelevant to our analysis. There seems not
to be a dispute that a connection existed between the manufacturing
change and the non-deflation problem that necessitated the recall.
-30-
attributable to fraud.'" Shaw, 82 F.3d at 1223 (quoting DiLeo v.
Ernst & Young, 901 F.2d 624, 627 (7th Cir. 1990)).
The doctrine has been applied in a number of different
situations. We recognize that the effect of use of the doctrine at
the Rule 12(b)(6) dismissal stage is to cut off the case as a
matter of law, without further factual development. As some
commentators have stated, "[A]t this stage, a court must be
cautious. The case has not yet developed. In cutting off the case
on the pleadings by citing hindsight, the court is essentially
making a prediction that the discovery process will yield only
evidence that requires the benefit of the hindsight bias to seem
adequate [to support the allegations]." M. Gulati, J. Rachlinski
& D. Langevoort, Fraud by Hindsight, 98 Nw. L. Rev. 773, 787
(2004). Meanwhile, at the pleadings stage, "a bad outcome truly is
relevant to the likelihood of fraud." Id. at 815. Indeed, this
court has held that "in determining the adequacy of a complaint
. . . we cannot hold plaintiffs to a standard that would
effectively require them, pre-discovery, to plead evidence." Shaw,
82 F.3d at 1225. The law "proscribes the pleading of 'fraud by
hindsight,' but neither can plaintiffs be expected to plead fraud
with complete insight." Id. (quoting Denny v. Barber, 576 F.2d
465, 470 (2d Cir. 1978) (Friendly, J.)).
In Shaw, we held that the doctrine did not apply when
plaintiffs provided "a series of factual allegations relating to a
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combination of developments known to the company . . . that could
have provided a basis for advance knowledge of the information"
which was eventually disclosed. Id. at 1224. We held that these
allegations of developments known to the company, along with
(admittedly weak) evidence of insider trading and the temporal
proximity between the date of the alleged omission and the eventual
disclosure (less than a month), were sufficient to survive a motion
to dismiss.9 Id. at 1225.
Defendants in this case urged, and the district court
accepted, that plaintiff's allegations amounted to nothing more
than an allegation of fraud by hindsight: that simply because the
manufacturing change eventually was linked as a remedy for the
balloon non-deflation problem, defendants must have known about the
connection earlier. This approach fails to consider the other
allegations that plaintiff made from supporting documents. For
instance, there is no dispute that the manufacturing change related
to the laser welding of the delivery catheter and balloon, and it
may be inferred this addressed the same problem which resulted in
the recalls. It is also clear that defendants had received non-
deflation reports from doctors in Europe before instituting the
manufacturing change, as well as numerous non-deflation complaints
from U.S. doctors while the company was in the process of
9
Shaw was decided before the PSLRA was enacted, but Rule
9(b)'s particularity requirement is similar to the requirements of
the PSLRA. See supra n.5.
-32-
implementing the change. Moreover, defendants' own SEC filings and
press releases reveal that they reassured the public that they had
implemented the manufacturing change in response to complaints of
non-deflation, so that the "new" TAXUS would not suffer from the
same problems. The company said it had been monitoring, analyzing,
and investigating the problem and appropriate responses. It is
fair to infer the company has highly effective information systems.
Cf. id. at 1224 n.38. Defendants are in a highly regulated
industry and the company, it can be inferred, constantly monitors
reports of patient injury and death and looks for prompt solutions
to such problems.
This is not the classic fraud by hindsight case where a
plaintiff alleges that the fact that something turned out badly
must mean defendant knew earlier that it would turn out badly.
Denny, 576 F.2d at 470. Nor is this a case where there is no
contemporaneous evidence at all that defendants knew earlier what
they chose not to disclose until later. DiLeo, 901 F.2d at 626-7.
2. LaViolette's Statements
Plaintiff also disputes the district court's rejection of
the LaViolette allegations under the doctrine of fraud by
hindsight. The allegations are that defendant Paul LaViolette made
public statements that were "false and misleading" and constituted
a "misrepresentation" (1) when he stated on July 29 -- a week
before the third recall was announced on August 5 -- that the
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problem with TAXUS had been "fixed," and (2) when he stated on July
26 that there was simply a "lag time" in the marketplace's
conversion to the improved version of TAXUS. CAC ¶ 101.
Plaintiff's complaint may be read as alleging a material
omission and as supporting scienter. LaViolette's remarks were
misleading not because the problem had not been "fixed," but
because LaViolette excluded any mention of the upcoming recall. In
other words, it was misleading for LaViolette to say that the
problem had been "fixed" while failing to mention that a third
recall, of another 3,000 stents, would be announced a week later.
As with plaintiff's allegations regarding the
manufacturing change, we cannot say that LaViolette's omission was
immaterial as a matter of law. The investors with whom LaViolette
was speaking in the conference call would very well have wanted to
know about the existence of an upcoming recall in addition to
hearing LaViolette's assurances that the TAXUS problems were in the
past.
With respect to scienter, the district court held that
plaintiff was merely alleging fraud by hindsight because plaintiff
was claiming no more than that LaViolette should have known about
the recall earlier. According to the district court, "Lead
Plaintiff fails to allege facts that provide a strong inference
that Defendant LaViolette knew that an additional recall was
-34-
necessary or that his remarks were false when he made them." In re
Boston Scientific, 490 F. Supp. 2d at 160. We disagree.
This fails to account for the very short amount of time
between LaViolette's remarks, some of which were made on Thursday,
July 29, and the third recall, which was announced the following
Thursday, August 5. Temporal proximity alone is insufficient to
establish a claim for fraud, see Shaw, 82 F.3d at 1225, but this
court has insisted on a "fact-specific inquiry" regarding scienter.
Greebel, 194 F.3d at 196. The extremely short time period here is
strong evidence.
Moreover, LaViolette was the company's Chief Operating
Officer and a point person on TAXUS, and so he would presumably
have been aware of the status of the company's "ongoing monitoring"
of "old" TAXUS stents. CAC ¶¶ 18, 93. The third recall, like the
two before it, was voluntary and initiated by Boston Scientific
rather than the FDA.
3. Insider Trading
Because the district court dismissed on scienter grounds,
it did not consider the insider trading allegations. We do
consider these allegations in the overall mix.
Insider trading cannot establish scienter on its own, but
it can be used to do so in combination with other evidence.
Greebel, 194 F.3d at 197-98; Shaw, 82 F.3d at 1224. Insider
trading in suspicious amounts or at suspicious times may be
-35-
probative of scienter. Greebel, 194 F.3d at 197; Greenstone v.
Cambex Corp., 975 F.2d 22, 26 (1st Cir. 1992). Plaintiff alleges
that all defendants engaged in insider trading during the narrowed
class period of December 3, 2003 to August 5, 2004, see CAC ¶¶ 15-
23, and they argue that stock sales of $40.82 million by James R.
Tobin, $54.2 million by Lawrence C. Best, $4.2 million by
Fredericus A. Colen, and $3.3 million by Robert G. MacLean within
the two months following the FDA's approval of TAXUS are
particularly suspicious, see id. ¶ 96.
However, we acknowledge that plaintiff's complaint has
allegations going the other way. Plaintiff alleges that all but
one (Tobin) of these defendants engaged in insider trading at
periods outside of the narrowed class period, including some after
the recalls were announced and the manufacturing change was
disclosed. This undermines the inference that the timing of the
trading was suspicious. Id. ¶¶ 15-23. Plaintiff also does not
allege that the particular timing of the trading was suspicious
other than that it occurred during the eight-month period to which
the appeal is limited: the trading has not been linked, for
instance, to defendants' non-disclosed knowledge of the
manufacturing change or problems with TAXUS.
Defendants respond that many of these stock sales,
including all of Best's and many of Tobin's, were effectuated
pursuant to Rule 10b5-1 trading plans that removed control of the
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sales from the individual defendants. It was defendants' choice to
move to dismiss the case on the pleadings without presenting
evidence. As a result, there is no evidence of when the trading
plans went into effect, that such trading plans removed entirely
from defendants' discretion the question of when sales would occur,
or that they were unable to amend these trading plans.
The insider trading claims as alleged are on the weaker
end of the spectrum. But, as in Shaw, "we think that the
plaintiffs' allegations of insider trading, inasmuch as they are at
least consistent with their theory of fraud, provide some support
against the defendants' motion to dismiss." 82 F.3d at 1224; see
also Greebel, 194 F.3d at 197-98 ("The vitality of the inference to
be drawn depends on the facts, and can range from marginal to
strong." (citations omitted)).
Plaintiff has alleged a significant amount of insider
trading in the months before the announcement of recalls in July,
which caused the stock price to drop. CAC ¶¶ 100, 102. The
company's stock price was at an all-time high in the months before
the recalls were announced, often closing above $40. Id. ¶¶ 15-23,
96, 100. It fits with plaintiff's theory that defendants would
have sold stock at this time, knowing that the price would drop
when the manufacturing change, acknowledging a defect, was
announced. If defendants were unaware of the connection between
the non-deflation reports they were receiving and the manufacturing
-37-
change, a fact finder could reasonably ask why they would have sold
so much stock at a time when the company appeared to be soaring on
the strength of TAXUS.
Given plaintiff's specific factual allegations, the
temporal proximity between LaViolette's statements and the third
recall, and the alleged insider trading, we think that plaintiff
has pled enough to give rise to inferences that are at least as
strong as any competing inferences regarding scienter.
C. Group Pleading
Defendants argue that plaintiff has engaged in
impermissible group pleading and that several of the defendants
should be dismissed from the case now that the subject area has
been narrowed on appeal because they are not specifically alleged
to have been involved with TAXUS.10 The district court did not
address the issue. We decline to address the issue in the first
instance.
We take into account, as in Cabletron, the fact that the
overall complaint survives, the pre-discovery posture of the case,
and the fact that all of the individual defendants held positions
10
Under the group pleading presumption, a court may
attribute all statements to the defendants as collective actions
without considering the liability of each individual defendant.
This court has recognized "a very limited version of the group
pleading doctrine for securities fraud." Cabletron, 311 F.3d at
40. There has been "great debate about the doctrine's continued
existence after enactment of the PSLRA," a question on which this
circuit has not taken a position. Id. We need not here resolve
whether group pleading survives the PSLRA.
-38-
of significant responsibility within the company and therefore
potentially face control person liability under section 20(a).
Cabletron, 311 F.3d at 41. We think the questions should be
resolved in the first instance by the district court.
D. Section 20(a) Liability
Plaintiff has also made allegations against defendants
under section 20(a), which establishes liability for any person who
"directly or indirectly[] controls any person liable" for a
violation of securities laws. 15 U.S.C. § 78t(a). The district
court summarily dismissed the section 20(a) claims on account of
its dismissal of the section 10(b) claims. Reinstatement of
section 20(a) claims is generally appropriate when section 10(b)
claims have been reinstated and the section 20(a) claims had been
dismissed by the district court because of its dismissal of the
section 10(b) claims. Cabletron, 311 F.3d at 41; see also
Nathenson v. Zonagen Inc., 267 F.3d 400, 426 n.29 (5th Cir. 2001);
Hollin v. Scholastic Corp. (In re Scholastic Corp. Sec. Litig.),
252 F.3d 63, 77-78 (2d Cir. 2001).
On appeal, defendants claim that plaintiff has failed to
allege facts demonstrating that any of the individual defendants
are subject to control person liability and therefore the section
20(a) claims should be dismissed even if the section 10(b) claims
are allowed to stand. We disagree. "Control is a question of fact
that 'will not ordinarily be resolved summarily at the pleading
-39-
stage.' The issue raises a number of complexities that should not
be resolved on such an underdeveloped record." Cabletron, 311 F.3d
at 41 (citation omitted) (quoting 2 T.L. Hazen, Treatise on the Law
of Securities Regulation § 12.24(1) (4th ed. 2002)). The practical
effect of reinstating the section 20(a) claims is small since the
same defendants are involved as with the section 10(b) claims, and
individual defendants are not foreclosed from challenging their
liability under section 20(a) in the future. Id. at 41-42.
III.
We do not address the other requirements of section 10(b)
and Rule 10b-5, which were not raised in this appeal by either
party.
We reverse the dismissal and remand the case to the
district court for further proceedings consistent with this
opinion.
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