Court Opinion

ID: 2677339
Source: CourtListenerOpinion
Date Created: 2014-06-05 21:00:07.028015+00
Date Added: 2024-06-11T09:35:46.284038
License: Public Domain

United States Court of Appeals
                        For the First Circuit

No. 13-1085

              IN RE: GENZYME CORP. SECURITIES LITIGATION,

       DEKA INTERNATIONAL S.A. LUXEMBOURG; CITY OF EDINBURGH
     COUNCIL AS ADMINISTERING AUTHORITY OF THE LOTHIAN PENSION
             FUND; GOVERNMENT OF GUAM RETIREMENT FUND,

                        Plaintiffs, Appellants,

        VIVIAN OH, individually and on behalf of all other
     similarly situated; JON RAHN, individually and on behalf
                 of all others similarly situated;
                  GENZYME INSTITUTIONAL INVESTORS,

                              Plaintiffs,

                                  v.

      GENZYME CORPORATION; HENRI A. TERMEER; DAVID P. MEEKER;
        MICHAEL S. WYZGA; ALLISON LAWTON; MARK R. BAMFORTH;
                        GEOFFREY MCDONOUGH,

                        Defendants, Appellees.

           APPEAL FROM THE UNITED STATES DISTRICT COURT
                 FOR THE DISTRICT OF MASSACHUSETTS

           [Hon. George A. O'Toole, U.S. District Judge]

                                Before

                   Torruella, Ripple,* and Thompson,
                            Circuit Judges.

*
    Of the Seventh Circuit, sitting by designation.
     Daniel L. Berger, with whom Jay W. Eisenhofer, Diane T. Zilka,
Shelly L. Friedland, Grant & Eisenhofer P.A., Avi Josefson, John
Rizio-Hamilton, Ann M. Lipton, Bernstein Litowitz Berger &
Grossmann LLP, Bryan A. Wood, John H. Sutter and Berman DeValerio,
were on brief for plaintiffs-appellants.
     John D. Donovan, Jr., with whom Robert G. Jones, Mark D.
Vaughn and Ropes & Gray LLP, were on brief for appellee Genzyme
Corporation.
     Michael T. Marcucci, with whom John D. Hanify and Jones Day,
on brief for appellees Termeer, Meeker, Wyzga, Lawton, Bamforth and
McDonough.
     Richard A. Samp, with whom Cory L. Andrews and Washington
Legal Foundation, on brief as amicus curiae.

                           June 5, 2014

                               -2-
            TORRUELLA, Circuit Judge.         This is an appeal from orders

of   the   District   Court    of    Massachusetts    granting    Defendants-

Appellees' motion to dismiss, and subsequently denying Plaintiffs-

Appellants'    post-judgment        motions   to   amend    the   complaint.

Plaintiffs, a class of investors, brought this securities fraud

action against Genzyme Corporation ("Genzyme"), and several company

executives (the latter hereinafter collectively referred to as the

"individual defendants").       The Consolidated Class Action Complaint

("complaint")    charges      all    defendants    with    acts   constituting

securities fraud in violation of Section 10(b) of the Securities

Exchange Act, and with violations of Section 20(a) on the part of

the individual defendants.

            Upon de novo review, we agree with the district court

that the complaint fails to meet the exacting pleading standard

that securities fraud claims must satisfy.                The allegations set

forth in the complaint fail to convey a cogent and compelling

inference of deceitful intent, or reckless disregard of the truth,

on the part of defendants.            Scienter has not been pled, and,

accordingly, we affirm the district court's order of dismissal.

            We also find, not without taking some exception, that the

district court did not abuse its discretion in denying plaintiffs'

post-judgment motion to amend the complaint.

                                       -3-
                                 I. Background

            As this is a review of a motion to dismiss, we recite the

facts of the case as alleged in the nonmoving party's complaint,

resolving any ambiguities in their favor.               Ocasio-Hernández v.

Fortuño-Burset, 640 F.3d 1, 5 (1st Cir. 2011).

            Genzyme    is   an   international     pharmaceutical    company

engaged in the business of developing and selling biologics.

Biologics, as opposed to chemically-synthesized pharmaceuticals,

stem from natural sources and are developed through a complex

manufacturing process designed to mitigate the ever-present risk of

contamination.        Companies wishing to market biologics to the

general populace must obtain approval from the Food and Drug

Administration ("FDA") through a biologics license application

("BLA").

            At the time of the conduct at issue in this case, three

of Genzyme's main products were biologics related to the treatment

of rare metabolic disorders resulting from the absence of certain

enzymes (lyosomal storage disease, or "LSD" drugs).                Cerezyme,

Fabrazyme and Myozyme were developed to treat the rare Gaucher,

Fabry, and Pompe diseases, respectively.           In 2008, both Cerezyme

and Fabrazyme were greater earners than Myozyme, bringing in

approximately $1.7 billion in revenue combined.            However, Myozyme

was   an   up-and-coming    treatment   that     had   recently   become   the

fastest-growing product in Genzyme's history, jumping from $59

                                      -4-
million in revenue in 2006 to $296 million in 2008.                 A substantial

reason     for    the   products'     success   was     a    complete     lack    of

competition.       All three are considered "orphan" drugs under the

Orphan Drug Act of 1983, 21 U.S.C. §§ 360aa-ee, which grants

limited monopolies to companies that develop drugs to treat rare

disorders that might not otherwise be commercially viable for

development and production. Genzyme's monopoly of Cerezyme expired

in 2001, with Fabrazyme and Myozyme scheduled to expire in 2010 and

2013, respectively.

               In April of 2006, the FDA approved Genzyme's BLA for

Myozyme       manufactured    in    Genzyme's   Framingham,        Massachusetts,

facility.        This version of Myozyme was produced in 160-liter

("160L")      bioreactors.         However,   Genzyme       soon   realized      that

production on a small scale would be insufficient to meet market

demand.       As such, Genzyme developed a manufacturing process for

creating Myozyme in a 2000-liter ("2000L") bioreactor in its

Allston,      Massachusetts     facility.       To    differentiate       the    two

products, Genzyme termed the 2000L Myozyme "Lumizyme." Genzyme was

able     to    obtain   quick      approval   for    Lumizyme      with   European

pharmaceutical regulators, but needed to reapply for a new BLA with

the FDA for the U.S. market.              Genzyme also planned to obtain

regulatory approval to develop a 4000-liter ("4000L") version of

Myozyme at its plant in Geel, Belgium, for the European market. In

the meantime, Myozyme quickly became an unquestionable success for

                                        -5-
Genzyme.    Analysts considered approval of the Lumizyme BLA to be

critical for Genzyme's future earning potential, as it represented

a large untapped market for an in-demand product.

            Genzyme initially revealed its plans for the Lumizyme BLA

on the first day of the Class Period, October 24, 2007.             During a

conference call, David Termeer, who served as Genzyme's CEO, told

investors   that   the   company   had    filed   an    application    for   a

"supplemental"     BLA   for   Lumizyme   based   off    of   the   company's

previously-approved 160L Myozyme BLA.1       Termeer stated he expected

that approval of the supplemental BLA would occur in the first

quarter of 2008.    He also gave a positive outlook for all three of

Genzyme's LSD drugs.

            On April 21, 2008, however, the FDA notified Genzyme that

a supplemental BLA was insufficient, and it would need to submit a

separate BLA for Lumizyme approval.         After Genzyme submitted the

revised BLA in May, the FDA gave Genzyme a "PDUFA date" of

November 29, 2008, as mandated by the Prescription Drug User Fee

Act ("PDUFA") of 1992,     21 U.S.C. §§ 379g-h.2       Termeer continued to

1
    A "supplemental" BLA allows companies to obtain rapid,
streamlined approval for drugs that are substantially similar to
previously-approved products.
2
   The PDUFA allows the FDA to collect fees for applications, but
requires the FDA to set a target date for approval of the
application. This target date, however, is not a guarantee of
approval nor is it binding on the FDA.

                                    -6-
give an optimistic outlook for Lumizyme approval throughout the

summer of 2008.

           In September of 2008, Genzyme's manufacturing facility in

Geel, Belgium, suffered a bioreactor failure. At the time, Genzyme

had been working towards approval from European regulators to

develop   Myozyme   at   the    4000L   scale   at   Geel.   An   internal

investigation ensued as to the cause of the breakdown, which was

unknown at the time.           Genzyme did not publicly disclose the

bioreactor failure at that time.        Notwithstanding these events, in

February of 2009, Genzyme secured approval from the European

Medicines Agency ("EMEA") to produce Myozyme 4000L at Geel.

           In October of 2008, the FDA conducted an inspection of

the Allston, Massachusetts plant.           The FDA routinely conducts

inspections to determine if facilities are complying with Current

Good Manufacturing Practices ("CGMP") standards for biologics

manufacturers.      As a result of the inspection, the FDA noted

several variations from CGMP at Allston.        The FDA summarized these

findings in a Form 483 ("October 2008 Form 483").            The form was

sent to Termeer, as it is common protocol for the FDA to present

Forms 483 to top management officials.               A Form 483 contains

advisory language that make clear it lists only "inspectional

observations and do[es] not represent a final agency determination

regarding your compliance."       Genzyme responded to the October 2008

Form 483 on October 31, 2008, with a proposed plan to remedy the

                                    -7-
problems by March 31, 2009, though it did not receive an immediate

reply from the FDA.     The October 2008 Form 483 made no mention of

the Lumizyme BLA and it did not otherwise note that the drug's

approval process might be jeopardized.

            Briefly   after   receiving   the   October   2008   Form   483,

Genzyme conducted a conference call with market analysts on

October 22, 2008.     No mention was made of the October 2008 Form 483

or of Genzyme's response.       One analyst asked Allison Lawton3 if

anything had been discussed during a recent FDA Advisory Committee

meeting that could affect the Lumizyme BLA.         Though no defendant

mentioned the October 2008 Form 483, Lawton stated that "[i]t was

really just a discussion about the biochemical differences [between

Myozyme and Lumizyme]" and that the clinical data was "the most

important piece."      On that note, Senior Vice President Geoffrey

McDonough shared the news that the FDA Advisory Committee had

confirmed the clinical effectiveness of Lumizyme at the 2000L

scale, stating that "the likelihood of approval seems to be more

certain."    During this conference call, Termeer projected that

analysts could expect a return of $4.70 per share in 2009, a figure

that assumed approval of Lumizyme in November of 2008.             At that

3
   Lawton held numerous positions with Genzyme during the class
period, including Head of Regulatory Organization; Senior Vice
President of Global Access, Quality Systems & Regulatory Affairs;
Senior Vice President of Regulatory Affairs and Corporate Quality
Systems; and her current position as Senior Vice President of
Global   Product   Access.       Generally   speaking,   Lawton's
responsibilities focused on regulatory compliance.

                                   -8-
time, the PDUFA date the FDA had provided Genzyme continued to be

November 28, 2008.

          Also   in   November,    the    Allston    plant   experienced   an

episode of bioreactor failure similar to the one experienced at the

Geel plant months earlier.       These events slowed manufacturing for

the company and forced Genzyme to ramp down production of Cerezyme

and Fabrazyme at Allston.     The company dipped into its supply of

Cerezyme, Fabrazyme, and Myozyme to make up for the manufacturing

shortage, which left Genzyme vulnerable to a lack of supply that

could affect sales if problems continued.           Though an investigation

of the causes of the equipment failures at Allston and Geel was

underway, the bioreactor failures were not disclosed to investors

at that time. However, company officials did inform investors that

"tight" Myozyme inventories could potentially limit sales unless

the company could secure European approval of a 4000L version of

Lumizyme for production in Geel, which it would eventually secure

a few months later in February of 2009.

          That   same   month,    the    FDA   informed   Genzyme   that   it

considered aspects of its application to be a major amendment to

its earlier Lumizyme BLA, and that it would take more time to

review the changes.     Accordingly, the FDA set a new PDUFA date of

February 28, 2009.    Genzyme promptly disclosed this information to

investors, stated that it expected Lumizyme to be approved by the

                                    -9-
new PDUFA date, and that this news would not affect the projected

earnings of $4.70 per share for 2009.

           Over the next several months, the defendants maintained

that Lumizyme would be approved and the company was in a good

position to meet increasing demand for Cerezyme and Fabrazyme.

During one conference call with analysts, an investor asked for

more information about "incomplete process validation runs" at the

4000L plant in Geel.    These runs were affected by the bioreactor

failures, the cause for which was unknown at the time.              McDonough

stated that "the way to think about that is part of the normal

development process that we would undergo for any new facility."

European authorities approved 4000L Myozyme for manufacture in Geel

shortly thereafter in February of 2009.

           Having received no response from the FDA as to its

proposed remedies to the October 2008 Form 483, Genzyme submitted

a supplemental response to the FDA on February 23, 2009. Four days

later, the FDA replied with a Formal Warning Letter ("February

Warning Letter"), as well as a Complete Response Letter, both

addressed to Termeer and later published on the FDA website.             The

Complete   Response   Letter   stated    that   the   FDA   would    withhold

approval of Lumizyme until the issues in the February Warning

Letter were addressed. The February Warning Letter reiterated many

of the issues that were contained in the October 2008 Form 483,

while also critiquing Genzyme's proposed remedies as insufficient.

                                  -10-
            On   March   2,    2009,    Genzyme   issued   a   press    release

disclosing both the February Warning Letter and the Complete

Response Letter.    Genzyme also disclosed the October 2008 Form 483

for the first time.       That same day, Genzyme filed the company's

Form 10-K for 2008, which stated that the February Warning Letter

reiterated many of the problems first identified in the October

2008 Form 483, and that approval of Lumizyme was conditioned on

resolution of these issues.

            Genzyme held a conference call that same afternoon,

during which Termeer notified investors that Lumizyme would not be

approved by the expected PDUFA date of February 28, 2009.                  While

making these disclosures, Genzyme maintained that it would be able

to address all of the issues the FDA had raised and that it would

obtain approval of Lumizyme several months down the road.                     A

contemporaneous press release quoted Termeer as saying that the

issues could be resolved "within three to six months" and that the

company was "confident that the products produced at the Allston

facility    continue     to    meet    the    highest   quality   and     safety

standards." During the conference call, Lawton stated that Genzyme

was confident that they could respond in full to the February

Warning Letter by the end of the week.             Senior Vice President of

Corporate   Operations        and   Pharmaceuticals     Mark   Bamforth    told

investors that the issues raised by the February Warning Letter

would not have an impact on Genzyme's ability to produce drugs

                                       -11-
manufactured at Allston, including Cerezyme and Fabrazyme.           In

light of the news, Genzyme adjusted its projections to account for

a six-month delay in Lumizyme approval, predicting a 12-cent per

share drop and a $60 million decrease in Myozyme revenue.

           Not surprisingly, the market reacted negatively to this

news.   JP Morgan commented that "we remain troubled at the lack of

disclosure of the Form 483 issuance last fall, since we believe

investors would have been more cautious on near-term Myozyme

approval."      Some also criticized Genzyme for issuing a press

release after trading closed on Monday despite receiving the letter

on Friday, and some suspected that a four percent drop in Genzyme

stock on Friday could be attributed to early leakage of the

letters.     After the March 2, 2009 disclosures, Genzyme's shares

fell by $4.04, or approximately seven percent.

           On   March   24,   2009,   Genzyme's   2008   Annual   Report

anticipated Lumizyme approval in mid-2009.         On April 22, 2009,

Genzyme reported its earnings for the first quarter of 2009, with

Myozyme sales falling more than $20 million below estimates.

Genzyme again attributed this to "tight" Myozyme supply, but did

not disclose the bioreactor problems in Geel or Allston. That same

day, Lawton told investors that the Lumizyme BLA was on schedule

and said that "at this point we've actually resolved all of any

outstanding items with [the] FDA."

                                  -12-
            The FDA reinspected the Allston plant in mid-May of 2009,

but did not issue any warnings or advisory materials at that time.

After this inspection, Genzyme adjusted its timeline for the

Lumizyme BLA approval and resubmitted its BLA to the FDA.        The

company acknowledged that a PDUFA was likely six months away, but

was optimistic that the FDA would work with them to expedite

approval.

            On June 16, 2009, Genzyme detected a third bioreactor

failure event, the second such outbreak in Allston.       This time,

Genzyme publicly announced the bioreactor failure, and acknowledged

that it had suffered two such events in Allston and Geel in late

2008.   Genzyme explained that internal investigations had recently

shown the failures were due to the outbreak of a rare virus,

Vesivirus 2117. In order to sanitize the plant, Genzyme halted all

production of Cerezyme and Fabrazyme in Allston.      As Genzyme had

already begun selling off its Cerezyme and Fabrazyme inventory in

order to increase Allston production of Myozyme, this led to

further supply constraints on these drugs.

            Genzyme denied to investors that the Vesivirus 2117

contaminations were linked to the CGMP issues identified by the

FDA, stating that the FDA had signed off on plant conditions during

their May 2009 re-inspection. Termeer stated that no formal letter

signing off on the plant had been received, but Lawton said that

while they had no written communication, they had positive verbal

                                 -13-
communication from the FDA inspectors. While Genzyme stated it had

not yet identified the source of the viral outbreaks, it believed

the virus was related to the raw materials used in the biologics.

The company also predicted it would not need another inspection and

that Lumizyme was on track for November 2009 approval, or possibly

earlier.

            Genzyme released its second quarter earnings statements

on July 22, 2009.       Due to the shutdown of the Allston plant,

Genzyme    adjusted    its   projections      for    the    year   downward

considerably.     A press release accompanying the earnings statement

revealed Genzyme's plans for 4000L Myozyme/Lumizyme in the United

States for the first time. On a conference call, Termeer explained

that in order to "simplify operations in Allston" and dedicate all

of the reactors to Cerezyme and Fabrazyme, the company would not be

pursuing commercial sales of 2000L Lumizyme in the United States.

Rather, the company hoped to obtain BLA approval of 2000L Lumizyme,

and then file a supplemental BLA for 4000L Lumizyme manufactured in

Geel.     During the call, McDonough conceded that even if 2000L

Lumizyme    was   approved   in    November   of    2009,   approval   of   a

supplemental BLA would take at least four additional months,

meaning commercial sales of Lumizyme in the U.S. would not take

place until at least 2010.        Following this news, Genzyme's shares

dropped approximately eight percent.

                                    -14-
            On July 27, 2009, the FDA sent a letter to Genzyme,

stating that it planned to reinspect the plant due to Genzyme's

inadequate response to several of its concerns.          According to the

FDA, Genzyme had yet to validate the cryoshippers -- special

equipment designed to transport biological material in a frozen

state -- despite earlier promises to do so.           Similarly, Genzyme

had failed to implement promised maintenance procedures.           Genzyme

disclosed the letter to the public on July 31, 2009 and received a

negative response from the market.          Shares fell an additional 7.75

percent following the disclosure.

            Meanwhile, the shortage of Cerezyme and Fabrazyme caused

regulators to take action.          The FDA reached out to several of

Genzyme's competitors for help addressing the shortage of these

drugs in July of 2009.          The FDA fast-tracked approval for drugs

manufactured by Genzyme competitor Shire in an effort to treat

Gaucher and Fabry diseases.         In August of 2009, Genzyme admitted

that the continuing shortage of Cerezyme and Fabrazyme meant that

those drugs were in danger of losing their lucrative "orphan"

monopoly.

            On   August   14,    2009,   Termeer,   Lawton,   Bamforth   and

Executive Vice President David Meeker wrote a private, undisclosed

letter to the FDA addressing the organization's recent concerns.

The letter acknowledged "systemic causes" for the problems in

Allston and stated that "[w]e plan to make fundamental systemic and

                                     -15-
cultural changes as appropriate."     The letter further recognized

that "the viral investigation . . . . must be completed in the

context of the broader compliance remediation activities."      The

letter also acknowledged the FDA's most recent observations and

proposed new remedies to address the concerns.    Publicly, Genzyme

continued to project Lumizyme approval in November of 2009.

          On the final day of the Class Period, November 13, 2009,

several events transpired.   First, Genzyme and the FDA issued a

public notice to healthcare providers, explaining that vials of

Cerezyme, Fabrazyme, and Myozyme were discovered to have been

contaminated with foreign particles, such as steel and non-latex

rubber. The notice warned that ingesting such particles could have

serious negative health effects on patients.

          That same day, the FDA sent a second Form 483 ("November

2009 Form 483") to Termeer, as well as a second Complete Response

Letter, once again suspending the Lumizyme BLA.   The November 2009

Form 483 noted numerous CGMP violations, including several problems

that had been first pointed out in the October 2008 Form 483.

Genzyme disclosed the form shortly after these events were made

public; Genzyme's shares dropped sharply once again, declining more

than seven percent.

          In the post-class period, defendants held a conference

call to address the issues stemming from the November 2009 Form 483

and the denial of the Lumizyme BLA.    The conference call revealed

                               -16-
that many of the issues relating to the contaminated drugs were

related to the plant's fill/finish capabilities, the process in

which vials are filled and then sealed.     During the call, Termeer

traced many of the issues in Allston back to 2006, when the company

decided to add Myozyme production lines on top of existing lines

for Cerezyme and Fabrazyme.   The resulting inventory shortage that

occurred for Cerezyme and Fabrazyme "clearly can never happen

again," Termeer stated.    During that same call, Meeker conceded

that the problems related to fill/finish were the result of old

equipment in the Allston facility and that the company had been

aware of the problems, stating that the problem was "not new" and

"these were elements that we obviously knew about."            Shortly

thereafter, Genzyme announced it would shut down the Allston plant,

abandon pursuit of a 2000L Lumizyme BLA, and move forward with

attempting to receive approval for 4000L Lumizyme manufactured in

Geel.

          The end of the road approached as the FDA filed a

complaint in federal court on May 24, 2010 to permanently enjoin

Genzyme from committing violations of the Food, Drug and Cosmetics

Act, 21 U.S.C. §§ 310-399f.       As a result, the FDA and Genzyme

entered into a consent decree requiring Genzyme to pay $175 million

in fines, transfer certain operations out of Allston, and undertake

a   comprehensive   remediation   plan   under   the   supervision   of

independent experts.

                                  -17-
           The plaintiffs, on behalf of all purchasers of Genzyme

stock during the relevant time period, filed their complaint in

this action on March 1, 2010, suing Genzyme Corporation, Termeer,

Meeker, Lawton, McDonough, Bamforth and Chief Financial Officer

Michael Wygza.     The complaint alleges that the defendants violated

the   Securities    Exchange   Act    by    making   false   or   misleading

statements to investors in connection to the Allston plant and the

Lumizyme BLA approval process.

           The defendants filed a motion to dismiss the complaint

for failure to state a claim upon which relief could be granted,

and the district court dismissed the complaint on March 30, 2012.

While the court found that "plaintiffs' theory is plausible, and

perhaps even reasonable," the allegations in the complaint were

"too speculative to give rise to a strong inference of scienter"

under the heightened pleading standards of the Private Securities

Litigation Reform Act ("PSLRA"), 15 U.S.C. § 78u-4(b).               As the

dismissal of the complaint was with prejudice, the plaintiffs moved

for relief from judgment and for leave to amend the complaint. The

district court denied both motions on December 21, 2012, finding

that any new evidence plaintiffs wished to present could have been

presented earlier.     This appeal followed.

                                     -18-
                                  II. Discussion

A. The order of dismissal

             As with any motion to dismiss, our analysis centers on

the complaint, and we accept all well-pleaded factual allegations

as true and draw all a reasonable inferences in favor of the

plaintiff.     Hill v. Gozani, 638 F.3d 40, 55 (1st Cir. 2011).                In

order to survive a motion to dismiss, the complaint must plead

sufficient facts to render the plaintiff's entitlement to relief

plausible, and not merely possible.             Bell Atl. Corp. v. Twombly,

550 U.S. 544,    557    (2007).       As   to   allegations   of   fraud   in

particular, Federal Rule of Civil Procedure Rule 9(b) requires

plaintiffs to plead the circumstances of fraud with heightened

specificity.       Hill, 638 F.3d at 55.

             To state a claim for securities fraud under Section

10(b), a plaintiff must allege: (1) a material misrepresentation or

omission; (2) scienter, or a wrongful state of mind; (3) in

connection with the purchase or sale of a security; (4) reliance;

(5) economic loss; and (6) loss causation.             In re Stone & Webster,

Inc., Sec. Litig., 414 F.3d 187, 195 (1st Cir. 2005).              A complaint

alleging violations of Section 10(b) must plead facts giving rise

to a "strong inference" of scienter. 15 U.S.C. § 78u-4(b)(2).

Scienter     may    be     pled   by    "showing    that   defendants    either

'consciously intended to defraud, or that they acted with a high

degree of recklessness.'"              Miss. Pub. Emps. Ret. Sys. v. Bos.

                                        -19-
Scientific Corp., 523 F.3d 75, 85 (1st Cir. 2008)(internal citation

omitted).     An inference of scienter is "strong" only if it is

"cogent and at least as compelling as any opposing inference one

could draw from the facts alleged."            Tellabs, Inc. v. Makor Issues

& Rights, Ltd., 551 U.S. 308, 324 (2007).                "[W]here there are

equally strong inferences for and against scienter, Tellabs now

awards the draw to the plaintiff." ACA Fin. Guar. Corp. v. Advest,

Inc., 512 F.3d 46, 59 (1st Cir. 2008).

            The 140 page complaint, though seemingly an attempt at

artful pleading, is an ill organized and convoluted collection of

364 paragraphs.     The events are not alleged chronologically, and

the happenings that plaintiffs allege were concealed, as well as

the statements alleged to be misleading, are often not clearly

paired to related events, dates, characters or a time-line.                  Not

without considerable difficulty, we have endeavored to organize the

allegations of fraud into three main categories.               We first discuss

the   circumstances      surrounding     the   alleged   concealment    of    the

October    2008   Form   483.      We   then   discuss   the    purported    non-

disclosure of the viral outbreaks at the Allston and Geel plants.

Finally,    we    address    the    defendants's      allegedly     misleading

assertions of Lumizyme's timely approval and disingenuous revenue

and performance projections.

                                        -20-
             1. October 2008 Form 483

             As to the October 2008 Form 483, plaintiffs essentially

contend that defendants concealed the form with fraudulent intent.

This theory fails for several reasons, not the least persuasive of

which is the fact that defendants ultimately disclosed the form not

long after its relevance became apparent to Genzyme.

             After the FDA carried out its inspection of the Allston

plant sometime between late September and early October 2008, it

issued the October 2008 Form 483 to CEO Termeer. The form detailed

several observations regarding potential compliance problems with

CGMPs.   The FDA did not postpone the PDUFA date for Lumizyme of

November 29, 2009 by way of the October 2008 Form 483, nor did the

form otherwise state that the Lumizyme BLA had been compromised.

             Shortly thereafter, on October 22, 2008, Genzyme issued

a press release, and held a conference call with analysts regarding

the general state of affairs at the company. During the conference

call, executives generally touted positive projections for Genzyme.

As to approval of the Lumizyme BLA in particular, CEO Termeer

referenced    the   recent   decision   by   an   FDA   advisory   committee

approving the therapy, and stated that they were "working very hard

with the FDA to get everything done at that time, [the as of yet

PDUFA date of November 29, 2008] that still needs to be done."

Asked by an analyst if anything had been discussed during the

"closed manufacturing session" that might affect BLA approval for

                                   -21-
Lumizyme, Lawton replied that the discussion mainly centered on the

differences   in   the   scale   of    production   between   Myozyme   and

Lumizyme, and on the clinical data on Lumizyme; an FDA advisory

panel had recently vouched for the clinical effectiveness of

Lumizyme.   Neither Lawton nor any other defendant made any mention

of the October 2008 Form 483 at that time.

            Towards the end of November, the FDA informed Genzyme

that the Lumizyme BLA was substantially distinct from the Myozyme

BLA, and that it would require more time to review the application.

The PDUFA date was extended to February 28, 2009. Genzyme promptly

disclosed the new PDUFA date to investors, but not the earlier

receipt of the October 2008 Form 483.

            Defendants would not make any mention of the October 2008

Form 483 until March 2, 2009, shortly after receipt of the February

Warning Letter and the first Complete Response Letter, both of

which addressed some of the observations in the October 2008 Form

483.   All three documents were disclosed simultaneously, that same

day.

            We first note that Section 10(b) does not create an

affirmative duty to disclose.          In re Bos. Scientific Corp. Sec.

Lit., 686 F.3d 21, 27 (1st Cir. 2012).               A duty to disclose

information earlier omitted arises only when affirmative statements

were made and the speaker "fail[ed] to reveal those facts that are

                                      -22-
needed so that what was revealed would not be so incomplete as to

mislead."      Id.

            The      facts      alleged    here   quite     nicely     track    this

proposition. Though the October 2008 Form 483 was not disclosed by

Genzyme at the time it was issued by the FDA, it was disclosed

roughly four months later upon Genzyme's receipt of the February

Warning Letter and the first Complete Response Letter, which

formalized some of the October 2008 Form 483's observations.                      It

was these latter two communications that crystalized the relevance

of the October 2008 Form 483 to defendants earlier positive

statements regarding Lumizyme's approval.              This rings particularly

true given the advisory language that accompanies all Forms 483, to

the   effect    that      the   circumstances     noted     therein    are     merely

observational in nature, and do not represent the FDA's final

word.4      That     it   was   not   disclosed   at   an    earlier    time     that

plaintiffs' would have preferred, does not amount to a breach of

the duty to disclose, if there ever was one.              ACA Fin. Guar. Corp.,
512 F.3d at 61.

4
  The parties debate the state of the law as to the materiality of
Forms 483. Because we find the complaint does not sufficiently
plead scienter, we need not reach this particular question. We
note however, the Eight Circuit's view that Forms 483 in general,
as is the case with any other purported evidence, may or may not be
material depending on the circumstances of each case. See Pub.
Pension Fund Gr. v. KV Pharm. Co., 679 F.3d 972, 983 (8th Cir.
2012).

                                          -23-
            More    importantly,      and   fatal   to    this     theory    of    the

complaint, the allegations regarding the October 2008 Form 483 fall

well short of pleading a strong inference of scienter.                      Dearborn

Heights Act 345 Pol. & Fir. Ret. Sys. v. Waters Corp., 632 F.3d
751, 757 (1st Cir. 2011)("A plaintiff must allege facts that make

an inference of scienter 'more than merely plausible or reasonable

-- it must be cogent and at least as compelling as any opposing

inference of nonfraudulent intent'")(internal citation omitted).

At the time of the issuance of the October 2008 Form 483, the PDUFA

date of November 29, 2008 had been left unchanged.                   Furthermore,

also around that same time an FDA advisory committee vouched for

the clinical effectiveness of Lumizyme therapy, indeed a crucial

step   in   the    approval    process.       Though     it   is   possible       that

defendants acted with scienter under these circumstances, the

inference of the requisite intent to defraud is certainly not

cogent or compelling.         Id.   It is more likely that defendants made

no mention of the October 2008 Form 483, because, given the

observational nature of such forms, the fact that it made no

mention of the Lumizyme approval process, and more importantly,

given other significant factors that pointed to Lumizyme approval

-- recent endorsement from the FDA advisory committee, and a steady

PDUFA date -- they likely believed Genzyme continued to be on the

path towards Lumizyme approval.               Tellabs, 551 U.S. at 324 ("A

complaint will survive, we hold, only if a reasonable person would

                                       -24-
deem the inference of scienter cogent and at least as compelling as

any opposing inference one could draw from the facts alleged.").

            Finally, the fact the Genzyme promptly disclosed the

extended PDUFA date -- which was extended in late November for

reasons unrelated to the October 2008 Form 483 -- and that the

October 2008 Form 483 was disclosed only a few months later, in

early March of 2009, along with a full and prompt disclosure of the

February Warning Letter and the first Complete Response Letter,

further undercut any inference of fraudulent intent on the part of

defendants. See In re The First Marblehead Corp. Sec. Lit., 639 F.

Supp. 2d 145, 163 (D. Mass. 2009)(finding that corporation's

related informative disclosures negate inference of scienter).

            2. Bioreactor failures and viral contamination events

            Plaintiffs'   claim    that    defendants'   failure    to

contemporaneously disclose the bioreactor failure events at its

Geel and Allston facility, while simultaneously insisting on the

expected approval of the Lumizyme BLA, is also indicative of

scienter.    As with the alleged non-disclosure of the October 2008

Form 483, these allegations also fail to amount to a strong

inference of fraudulent intent.

            Genzyme initially came across a bioreactor run failure at

its Geel plant in September of 2008.      The cause of the bioreactor

run failure was unknown at the time. Accordingly, Genzyme launched

an investigation into the matter.         Later, in October of 2008,

                                  -25-
another bioreactor failure event occurred, this time at the Allston

plant.   A second bioreactor failure event occurred at the Allston

plant sometime in late May of 2009, the third such event for

Genzyme.      Shortly   thereafter,       Genzyme    publicly    disclosed        the

bioreactor failures, the cause of which it had only recently

discovered upon conclusion of a months-long investigation, and

informed investors that the culprit was the rare Vesivirus 2117.

           Plaintiffs claim that defendants concealed the viral

contamination     events    with    deceitful       intent,     as    they    knew,

purportedly,    that    these    issues    would    hamper    approval       of   the

Lumizyme BLA.    For a number of reasons, this theory fails as well.

           As an initial matter, the bioreactor run failures at the

Geel plant bore no relation to FDA approval of the Lumizyme BLA for

production at the Allston plant.          Information regarding that event

is, therefore, immaterial to Lumizyme's BLA approval at Allston.

Hill, 638 F.3d at 57 ("[I]nformation is material only if its

disclosure would alter the total mix of facts available to the

investor and if there is a substantial likelihood that a reasonable

shareholder     would   consider     it     important    to     the    investment

decision.")     (internal       quotations    and    citations        omitted).

Furthermore, the EMEA issued a press release in January of 2009

noting that the manufacturing difficulties at Geel were being

investigated by the company.         Thus, the problems at Geel were not

quite a mystery.

                                     -26-
             As to the specific circumstances regarding any of the

three bioreactor run failures at either plant, and as with the

October 2008 Form 483, defendants had no affirmative duty to

disclose them.     In re Bos. Scientific, 686 F.3d at 27.            This is

particularly so considering that -- even reading the complaint in

the light most favorable to the plaintiffs -- the cause of these

events was unknown to defendants, and would remain a mystery for

several months while an investigation was underway.              Furthermore,

at no point before Genzyme disclosed the results of its internal

investigation did the FDA give any indication that the bioreactor

run failures would hinder approval of the Lumizyme BLA.

             Also, throughout the period while the investigation was

underway, Genzyme kept the market informed by way of several press

releases that supply of Myozyme would remain constrained until EMEA

gave approval of Lumizyme production at the Geel facility.                When

the   EMEA   approved   Geel   for    production    of   Lumizyme,    Genzyme

nonetheless continued to inform the market of their diminishing

supply of all of their LSD therapeutics, as production slowed

because of the bioreactor failures.          Genzyme's constant reports to

that effect continued until it informed investors of the second

bioreactor run failure at Allston, shortly after conclusion of

their   investigation,    when       the    cause   of   these   events    was

ascertained.

                                     -27-
              Throughout this period, Genzyme also timely and promptly

disclosed the revised PDUFA date handed down by the FDA in November

of 2008, the February Warning Letter and the first Complete

Response Letter. Plaintiffs provide no support for the proposition

that   defendants    knew    all   along    the    cause   of   the   bioreactor

failures.       They ultimately rest support for an inference of

scienter on failure to disclose circumstances at Genzyme facilities

that were, at best, only partially known to defendants.                 However,

Genzyme's efforts to keep the market informed of tightening product

supplies, and of relevant and important exchanges it held with the

FDA, coupled with the fact that the results of the investigation

were relatively promptly disclosed, run counter to any inference of

scienter.     In re First Marblehead, 639 F. Supp. 2d at 163 (D. Mass.

2009).

              Moreover, and again, as a general matter, a corporation

cannot   be    expected     to   inform    the    market   of   any   and   all

developments that might possibly affect stock value.              In re Boston

Scientific, 686 F.3d at 27 ("[C]ompanies do not have to disclose

immediately all information that might conceivably affect stock

prices . . . .").     This general principle is particularly relevant

here, where the defendants did not immediately know the cause of

the first two bioreactor run failures at Geel and Allston.

Bioreactor failures can indeed come about for different reasons.

Accordingly, on these facts, it was proper for Genzyme to open an

                                     -28-
inquiry into the matter, and to wait for a complete picture to

become apparent before making any formal announcements.   See N.J.

Carpenters Pen. & Ann. Funds v. Biogen IDEC Inc., 537 F.3d 35, 45

(1st Cir. 2008); see also Higginbotham v. Baxter Int'l. Inc., 495
F.3d 753, 761 (7th Cir. 2007) ("Managers cannot tell lies but are

entitled to investigate for a reasonable time, until they have a

full story to reveal.").   Under these circumstances, where Genzyme

kept the market apprised of supply shortages, we are not compelled

to infer that defendants acted with fraudulent intent by taking the

time to investigate, and discover, what was essentially unknown to

them.

          3. Assurances of Lumizyme approval and projections

          Plaintiffs' also assert, though more generally, that

defendants deceived the market by repeatedly assuring investors and

analysts alike that the BLA for Lumizyme would be approved in a

timely fashion.   To the extent that defendants' statements were

positive yet generally qualified, were accompanied by disclosures

of relevant exchanges with the FDA, and generally tracked the PDUFA

dates set by the FDA, we find these general statements were not

misleading.

          The FDA initially set a PDUFA date for the Lumizyme BLA

of November 29, 2008. During the October 22, 2008 conference call,

defendants touted Lumizyme's recent advances with the FDA at the

clinical trial stage.      McDonough in particular mentioned they

                                -29-
expected the FDA to take action by the PDUFA date, and that the

likelihood of approval "seemed" to be "taking a more solid shape."

Termeer remarked that they were "working very hard with the FDA to

get   everything   done"   by   the    PDUFA    date.   These   are   hardly

categorical statements, and were well within the expectations set

by the PDUFA date.     Furthermore, lest we forget, the October 2008

Form 483 made no mention of any risk to Lumizyme approval, and,

again, the therapy's clinical effectiveness had been recently

backed by an FDA advisory committee.

           Late in November of 2008, the FDA informed Genzyme that

the Lumizyme BLA would require more time for review, as certain

aspects of the current application were significantly different

from the earlier supplemental one. The FDA issued a new PDUFA date

of February 28, 2009, and until that time, Genzyme's public

communications conveyed the general message that Lumizyme was on

track for approval at that date.             Considering the February 2009

PDUFA date was early in the year, Genzyme maintained that it did

not expect this delay to affect revenue projections for 2009.

           Upon receipt of the February Warning Letter and the first

Complete Response Letter, Genzyme relayed to investors that, by way

of these communications, the FDA had cautioned that Lumizyme

approval would not occur until the problems identified by the FDA

were resolved.     Though defendants employed rather rosy language to

express optimism that Genzyme would eventually be able to appease

                                      -30-
the FDA, their statements as to when the Lumizyme approval would

come about were far from categorical, and they were clear that

approval would be months away.

            From that point forward, throughout most of 2009, all of

Genzyme's   communications    regarding     the   approval     process    were

generally   optimistic,     yet   forward   looking   and     certainly   not

categorical.     Genzyme projected the company's belief that the

problems related to the Lumizyme BLA were being addressed, and the

expectation that Lumizyme approval would come about at some point

later in 2009.       Genzyme's communications were accompanied, and

supplemented,   by   full   and   prompt    disclosure   of    all   relevant

communications from the FDA, and periodic submissions to the SEC,

as well as revised earnings projections.

            On June 16, 2009, Genzyme announced the second bioreactor

run failure at Allston, and as a result of its investigation,

explained the cause for that failure and the earlier October 2008

event. Investors were made aware that the Allston plant would halt

production while the plant was sanitized in order to purge the

viral contamination.        Genzyme also announced that performance

projections, as well as product supplies, would obviously be

negatively affected.

            On July 27, 2009, the FDA informed Genzyme it would

reinspect the Allston plant.          Genzyme disclosed the upcoming

investigation in a July 31, 2009 press release.

                                   -31-
           On November 13, 2009, the last day of the class period,

the FDA issued Genzyme another Form 483 ("November 2009 Form 483"),

and a second Complete Response Letter, this time withholding

approval of Lumizyme.       Genzyme announced receipt of both documents

only several days later, and hosted a conference call announcing

that, due to another viral outbreak, it would have to shut down

Allston once again.        Genzyme again made clear that these events

would negatively impact earnings.

           The    bulk     of   the   statements   plaintiffs   claim   were

misleading, were mere forward-looking projections that are not

actionable Section 10(b) transgressions.               See   In re Stone &

Webster, 414 F.3d at 195; Greeble v. FTP Software, Inc., 194 F.3d
185, 201 (1st Cir. 1999) ("The safe harbor . . . . shelters

forward-looking statements that are accompanied by meaningful

cautionary statements . . . . [and] precludes liability for a

forward-looking statement unless the maker of the statement had

actual knowledge it was false or misleading.").                 Defendants'

statements, though optimistic, expressed belief and not certainty,

and were accompanied by either cautionary language or further

qualifying information.         In re Stone & Webster, 414 F.3d at 195

(holding that forward-looking statements are not fraudulent even if

later   found    to   be   inaccurate,   when   they   are   accompanied   by

meaningful cautionary statements identifying information that may

cause results to differ materially from statements).

                                      -32-
            In sum, as the district court noted, plaintiffs' account

is plausible.   However, their allegations do not muster sufficient

strength to meet the formidable pleading standard set by Congress

for securities fraud claims under Section 10(b).       The element of

materiality is wanting as to some allegations, as is the element of

falsity as to others.     But more importantly, the complaint as a

whole, as well as the allegations individually, fail to compel a

strong inference of scienter on the part of defendants.5

B. The order denying post-judgment leave to amend

            Plaintiffs' challenge to the district court's denial       of

their motion to amend the complaint is, in a way, two-fold.

Plaintiffs first contend that the court erred in dismissing the

complaint    with   prejudice,   particularly   considering    that   the

district court recognized their claims were plausible.        Plaintiffs

also challenge the district court's order denying their post

judgment efforts to amend the complaint.

            A Rule 15(a) motion to amend pleadings is ordinarily

granted freely.      See Fed. R. Civ. P. 15(a)(2).      However, once

judgment has been entered, the district court is without power to

entertain any amendments unless the judgment is set aside.       Fisher

v. Kadant, 589 F.3d 505, 508-09 (1st Cir. 2009).     A motion to alter

or amend a judgment may be granted under Rule 59 only if the movant

5
   As plaintiffs' claims under Section 20(a) are contingent on
those under Section 10(b), we need go no further.

                                  -33-
demonstrates that an intervening change in controlling law, a clear

legal error, or newly discovered evidence warrants modification of

the judgment.    Soto-Padró v. Pub. Bldgs. Auth., 675 F.3d 1, 9 (1st

Cir. 2012).     We review a district court's denial of a motion to

alter judgment for abuse of discretion.      Markel Am. Ins. Co. v.

Díaz-Santiago, 674 F.3d 21, 32 (1st Cir. 2012); ACA Fin. Guar.

Corp., 512 F.3d at 55 ("Review of the denial of [a] Rule 59(e)

motion is for 'manifest abuse of discretion.'") (quoting Council of

Ins. Agents & Brokers v. Juarbe-Jiménez, 443 F.3d 103, 111 (1st

Cir. 2006)).

          We construe plaintiffs' two-pronged attack as a single

challenge -- that the district court should have either altered the

judgment so as to enter a dismissal without prejudice, or should

have granted relief from judgment and allowed the submission of an

amended complaint.     Though we are somewhat concerned with the

district court's order on this front, we ultimately find that it

did not abuse its discretion in denying plaintiffs Rule 59 relief.

          Plaintiffs    sought   post-judgment   leave   to   amend   the

complaint before the district court, arguing that after filing the

complaint they had continued conducting interviews with Genzyme

employees who provided information that further strengthened their

case.   They contend that these witnesses yielded valuable new

information to support new allegations that would bolster the

inference that defendants acted with fraudulent intent throughout

                                 -34-
the class period, and that they should be allowed to amend the

complaint to include these new allegations.

          However, plaintiffs admit that most of this purportedly

new evidence was available to them well before the order of

dismissal. Indeed, many of the interviews were conducted after the

filing of the complaint, and continued after briefings on the

motion to dismiss had subsided.   But most had concluded before the

district court dismissed the complaint on March 30, 2012, two years

after the complaint had been filed. Accordingly, we agree with the

district court that this was not newly discovered, or previously

unavailable evidence, which is the only kind that would warrant

relief from judgment under Rule 59.    United States ex rel. Ge v.

Takeda Pharm. Co., 737 F.3d 116, 127 (1st Cir. 2013);     Marie v.

Allied Home Mortg. Corp., 402 F.3d 1, 7 n.2 (1st Cir. 2005).    We

thus find the district court did not abuse its discretion in

denying plaintiffs' Rule 59 motion.

          We pause to note our discomfort with the district court's

choice to dismiss the complaint with prejudice. The district court

granted relief in the form petitioned for by defendants, and it is

certainly within the bounds of the district court's discretion to

dismiss with prejudice.   However, as we have done in the past, we

again make clear that the PSLRA has not modified the liberal

amendment policy of Rule 15(a).   ACA Fin. Guar. Corp., 512 F.3d at

56.   More to the point, we emphatically reiterate that the PSLRA

                               -35-
does not require that orders of dismissal be with prejudice.            Id.

(quoting Belizan v. Hershon, 434 F.3d 579, 583-84 (D.C. Cir. 2006)

("[H]ad the Congress wished to make dismissal with prejudice the

norm, and to that extent supercede the ordinary application of Rule

15(a), we would expect the text of the PSLRA so to provide.")).

This is particularly so in light of the fact that the PSLRA is a

tool designed to curb vexatious litigation, not a mechanism for

denying bona fide claimants their day in court.          Tellabs, 551 U.S.

at 320.   The latter right is one that Congress specifically sought

to preserve.     Hill, 638 F.3d at 54.    Courts must be mindful of the

will of Congress, and not merely in part.                And our duty to

guarantee access to the courts, is equally paramount.

                              III. Conclusion

            We   find   the   complaint   fails   to   marshal   sufficient

allegations to meet the required pleading standard for securities

fraud claims. We find it is particularly wanting on the element of

scienter.

            We also find the district court did not abuse it's

discretion in denying plaintiffs relief from judgment. Accordingly,

we affirm the judgment of the district court.

            AFFIRMED.

                                   -36-