In Re: Merck & Co ( 2007 )


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  •                                                                                                                            Opinions of the United
    2007 Decisions                                                                                                             States Court of Appeals
    for the Third Circuit
    7-18-2007
    In Re: Merck & Co
    Precedential or Non-Precedential: Precedential
    Docket No. 06-2911
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    Recommended Citation
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    http://digitalcommons.law.villanova.edu/thirdcircuit_2007/655
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    PRECEDENTIAL
    UNITED STATES COURT OF APPEALS
    FOR THE THIRD CIRCUIT
    Case No: 06-2911
    IN RE: MERCK & CO., INC.
    SECURITIES, DERIVATIVE & ERISA LITIGATION
    CONSOLIDATED DERIVATIVE ACTION
    Hawaii Laborers Pension Plan
    and Halpert Enterprises, Inc.,
    Appellants
    On Appeal from the United States District Court
    for the District of New Jersey
    (MDL No. 1658 and D.C. Nos. 05-cv-01151 & 05-cv-02368)
    District Judge: Hon. Stanley R. Chesler
    Argued April 12, 2007
    BEFORE: SMITH and COWEN, Circuit Judges
    and YOHN,* District Judge
    *
    Honorable William H. Yohn Jr., Senior United States
    District Judge for the Eastern District of Pennsylvania, sitting by
    designation.
    (Filed July 18, 2007)
    Travis E. Downs III
    Joseph D. Daley (argued)
    Lerach Coughlin Stoia Geller Rudman & Robbins
    655 West Broadway, Suite 1900
    San Diego, CA 92101
    Peter S. Pearlman
    Cohn Lifland Pearlman Herrmann & Knopf
    Park 80 Plaza West-One
    Saddle Brook, NJ 07663
    Jeffrey P. Fink
    Robbins Umeda & Fink
    610 West Ash Street, Suite 1800
    San Diego, CA 92101
    Counsel for Appellant
    Robert D. Joffe
    Evan R. Chesler
    Robert H. Baron (argued)
    David Greenwald
    Cravath, Swaine & Moore
    Worldwide Plaza
    825 Eighth Avenue
    New York, NY 10019-7475
    2
    William R. Stein
    Roberta Koss
    Hughes Hubbard & Reed
    1775 I Street, N.W., Suite 600
    Washington, DC 20006-2401
    Counsel for Appellee
    _______________________
    OPINION OF THE COURT
    _______________________
    SMITH, Circuit Judge.
    This case is part of the massive VIOXX-related litigation.
    The primary–and narrow–issue on this appeal is whether the
    District Court erred by refusing to allow the plaintiffs leave to
    amend their complaint with additional materials they had
    proffered to the court to show that amendment would not be
    futile.1
    1
    The parties have also briefed the issue of whether the
    District Court properly granted Merck’s motion to strike
    additional materials proffered by the plaintiffs in their
    opposition to the defendant’s motion to dismiss. This legal issue
    is not significantly different than the after-acquired information
    issue we directly confront. On this point, the plaintiffs are
    correct that this issue “boils down to a single question: May
    plaintiffs use after-acquired materials that defendants voluntarily
    handed over to them–pursuant to a negotiated agreement–to
    3
    This is a shareholder suit, so in the typical situation the
    plaintiffs would have been required to first make demand upon
    Merck’s Board of Directors. However, the plaintiffs pled
    demand futility. The District Court dismissed the suit because
    the plaintiffs did not meet the narrow exception where demand
    may be excused. Specifically, the plaintiffs did not plead with
    particularity facts establishing that demand would have been
    futile at the time they commenced the lawsuit. The District
    Court concluded that the plaintiffs’ allegations of demand
    futility were “patently conclusory.” In re Merck & Co., Inc.,
    
    2006 WL 1228595
    , MDL No. 1658 (SRC), at *13 (D.N.J. May
    5, 2006). The District Court did not permit the plaintiffs to
    amend their complaint with after-acquired information obtained
    as a result of a discovery stipulation between the parties. 
    Id. at 17-18.
    We conclude that the District Court erred in denying the
    plaintiffs leave to amend their complaint with additional
    materials on the ground that the materials were acquired as a
    result of a consensual discovery agreement made by Merck and
    the derivative plaintiffs. We remand the case to the District
    Court to determine whether, even with these additional
    materials, amendment would have been futile.
    flesh out and amplify the core allegations in an existing
    complaint?” To the extent that the information in the plaintiffs’
    opposition to the defendant’s motion to dismiss was obtained as
    a result of the discovery stipulation agreement, it must be
    considered on remand.
    4
    I.
    The District Court has stated the facts of this complicated
    case concisely and accurately, so we repeat them here:
    Merck is a global pharmaceutical company incorporated
    in New Jersey, which researches, develops, manufactures
    and markets a broad range of medicines and vaccines that
    improve human and animal health. Plaintiffs are
    shareholders bringing this action on behalf of Merck
    against all individuals who were serving on Merck's Board
    of Directors as of March 11, 2004–the date the first
    shareholder derivative action relating to VIOXX was
    filed–as well as thirteen other current or former directors
    and officers of the company.
    VIOXX is a member of a class of pain medications known
    as non-steroidal anti-inflammatory drugs (“NSAIDs”).
    VIOXX is one of a new generation of “selective” NSAIDs
    called COX-2 inhibitors, which are designed to reduce
    inflammation and pain while avoiding the risk of serious
    gastrointestinal side effects associated with traditional
    NSAIDs. After receiving approval from the Food and
    Drug Administration (“FDA”), VIOXX was introduced to
    the market in May 1999. VIOXX was marketed and sold
    for over five years until September 30, 2004, when Merck
    voluntarily withdrew the medication.
    5
    Plaintiffs contend that scientists within Merck were aware
    that VIOXX may cause cardiovascular problems for its
    users as early as 1996. Plaintiffs allege that, from
    approximately 1996 to 2004, Merck made public
    statements which promoted the use of VIOXX for
    treatment of arthritis, and for other pain sufferers. None of
    these statements, however, mentioned any cardiovascular
    risks associated with the use of VIOXX, despite
    Defendants’ alleged knowledge of this problem. Plaintiffs
    contend that Defendants continued to have the Company
    conceal VIOXX’s health risks and repeatedly emphasized
    safety despite scientific data to the contrary.
    In 1999, Merck initiated an 8,000-person VIOXX
    Gastrointestinal Outcomes Research (“VIGOR”) trial
    designed to prove the drug’s gastrointestinal safety
    benefits. The trial compared people taking a high dose of
    VIOXX with those taking naproxen, and excluded those at
    a high risk of heart problems. The results of the VIGOR
    study came in on March 9, 2000. The results showed that
    VIOXX patients suffered fewer stomach problems than the
    naproxen group, but significantly more blood-clot related
    problems. These results were published in the New
    England Journal of Medicine in November of 2000.
    Although the article discussed VIOXX’s benefits for the
    stomach, it did not discuss in any detail information about
    potential cardiovascular complications.
    6
    On February 8, 2001, Merck executives met with the FDA
    Arthritis Advisory Committee to discuss VIOXX and the
    VIGOR trial. During the meeting, approximately seven
    doctors discussed cardiovascular complications associated
    with VIOXX. Plaintiffs maintain that Defendants,
    nonetheless, caused Merck to issue a press release on May
    22, 2001 in which the Company “reconfirmed the
    favorable cardiovascular safety profile of VIOXX.”
    On August 22, 2001, researchers at the Cleveland Clinic
    published a study in the Journal of the American Medical
    Association (“JAMA”) which discussed the VIGOR study
    and Celecoxib Long-term Arthritis Safety Study
    (“CLASS”) studies. The article stated that “[t]he
    annualized myocardial infarction rates for COX-2
    inhibitors in both VIGOR and CLASS were significantly
    higher than that in the placebo group.... The available data
    raise a cautionary flag about the risk of cardiovascular
    events with COX-2 inhibitors.” Plaintiffs allege that prior
    to the publication of the article, Defendants caused Merck
    to publicly claim that “VIOXX does not result in any
    increase in cardiovascular events compared to placebo,”
    and that it had “additional data beyond what [the
    Cleveland Clinic] cite[s], and the findings are very, very
    reassuring.” On September 17, 2001, the FDA sent
    Defendant Gilmartin a warning letter stating that Merck’s
    promotional campaign “minimizes the potentially serious
    cardiovascular findings that were observed in the
    [VIGOR] study, and thus, misrepresents the safety profile
    7
    for VIOXX.” In May 2004, Harvard researchers published
    the results of a Merck-sponsored study which “found
    VIOXX was associated with an elevated risk of heart
    attacks (39% higher), compared to the use of Celebrex or
    a placebo.” Plaintiff alleges that Defendants “demanded
    that researchers delete or tone down their findings,” and
    that prior to publication of the results, Defendants
    removed the name of a Merck employee who had worked
    on the study from the list of authors.
    On August 25, 2004, Dr. David Graham, an FDA
    researcher, presented the results of an FDA study at a
    medical conference. The results showed that higher doses
    of VIOXX “may have led to more than 27,000 heart
    attacks and sudden cardiac deaths” and triple the risk of
    heart attacks and death. Plaintiffs contend that the
    following day, Defendants caused Merck to state publicly
    that they “strongly disagree[d] with Graham’s conclusion,
    and that ‘Merck stands behind the efficacy, overall safety
    and cardiovascular safety of VIOXX.’”
    Plaintiffs further allege that Defendants threatened and
    intimidated numerous academics who publicly questioned
    or discussed the safety of VIOXX. Plaintiffs maintain that
    certain Merck directors held the power to withdraw
    important funding from academic research and also
    cancelled the presentations of doctors who questioned the
    safety of VIOXX.
    8
    See In re Merck & Co., Inc., 
    2006 WL 1228595
    , at **1-3
    (internal citations omitted).
    Because of the harm allegedly caused by VIOXX, Merck
    now faces thousands of lawsuits. These lawsuits come in a
    variety of forms, including product liability and shareholder
    derivative actions. On February 23, 2005, the Judicial Panel on
    Multidistrict Litigation transferred all VIOXX-related
    derivative, securities and ERISA actions to the District of New
    Jersey for pre-trial consideration and/or coordination.
    Consolidation occurred on May 6, 2005. The plaintiffs in this
    case filed their complaint on June 20, 2005, arguing that demand
    on Merck’s Board of Directors would be futile. On June 27,
    2005, the Magistrate Judge approved a discovery stipulation
    agreement between the parties that stated, in relevant part, that
    “all discovery in the Consolidated Derivative Action, except for
    requests for production of documents focused on the Merck
    Board of Directors’ actions concerning VIOXX prior to Merck’s
    voluntary withdrawal of VIOXX on September 30, 2004, shall
    be stayed pending the Court’s ruling on the motion to dismiss
    the Consolidated Derivative Complaint, unless the Court enters
    an order permitting such discovery to proceed.”
    In late August 2005, Merck filed a motion to dismiss on
    the grounds that the plaintiffs had failed to make a pre-suit
    demand upon the March 2004 Board and had failed to
    adequately plead demand futility. In November 2005, the
    plaintiffs filed a redacted version of their memorandum in
    opposition to the defendants’ motion to dismiss. The plaintiffs
    9
    also filed an unredacted version of their opposition under seal,
    which contained arguments and factual assertions that relied on
    after-acquired information the plaintiffs obtained during the
    course of discovery. On December 22, 2005, Merck filed a
    motion to strike the extraneous documents in the plaintiffs’
    opposition memorandum. At an April 5, 2006 hearing, the
    District Court granted Merck’s motion to strike because it
    concluded that much of the information in the plaintiffs’
    unredacted brief was not contained in the complaint and did not
    constitute the type of material that can be considered on a
    motion to dismiss pursuant to Rule 12(b)(6). The general rule
    in demand futility cases is that discovery may not be used to
    supplement demand futility allegations.
    On May 5, 2006, the District Court granted Merck’s
    motion to dismiss the plaintiffs’ complaint with prejudice, and
    also denied the plaintiffs’ leave to amend their complaint to
    supplement their demand futility allegations based on
    information acquired through discovery.2
    2
    We do not have a proposed amended complaint from the
    plaintiffs. This Court has refused to permit leave to amend
    when the party failed to provide the proposed amended
    complaint, because “the court had nothing upon which to
    exercise its discretion.” Lake v. Arnold, 
    232 F.3d 360
    , 374 (3d
    Cir. 2000). However, our situation is different here, because the
    District Court acknowledged that such a complaint would
    “incorporate information obtained in discovery, stricken from
    use in the instant Motion to Dismiss, to supplement and
    10
    II.
    The District Court exercised diversity jurisdiction over
    this case pursuant to 28 U.S.C. § 1332(a)(1). Our jurisdiction is
    pursuant to 28 U.S.C. § 1291, because the District Court’s
    dismissal with prejudice constituted a final order.
    We review both a district court’s refusal to grant the
    plaintiffs’ leave to amend their complaint and a district court’s
    ruling on demand futility under Federal Rule of Civil Procedure
    23.1 for abuse of discretion. Kanter v. Barella,--- F.3d ----, No.
    05-5398, 
    2007 WL 1519894
    (3d Cir. May 25, 2007); Hill v. City
    of Scranton, 
    411 F.3d 118
    , 125 (3d Cir. 2005). To the extent
    that the District Court made conclusions of law, our review is de
    novo. See Blasband v. Rales, 
    971 F.2d 1034
    , 1040 (3d Cir.
    1992).
    In this case, we are confronted with the decision by the
    District Court that held, as a matter of law, that after-acquired
    information obtained through the stipulated discovery agreement
    could not be used to supplement the plaintiffs’ demand futility
    allegations. We review this conclusion of law de novo. Both
    parties agree that we should apply New Jersey law to this case,
    as “federal courts hearing shareholders’ derivative actions
    involving state law claims apply the federal procedural
    particularize” the initial complaint. In re Merck & Co., Inc.,
    
    2006 WL 1228595
    , at *17.
    11
    requirement of particularlized pleading, but apply state
    substantive law to determine whether the facts demonstrate
    demand would have been futile and can be excused.” Kanter,
    
    2007 WL 1519894
    , at *2.
    III.
    A.      Demand
    Shareholder derivative suits typically require plaintiffs to
    make pre-suit demand on the board of directors that the board
    bring suit on behalf of the corporation. 
    Blasband, 971 F.2d at 1048
    . The reason for this requirement is that “[t]he decision to
    bring a lawsuit or to refrain from litigating a claim on behalf of
    the corporation is a decision concerning the management of the
    corporation and consequently is the responsibility of the
    directors.” 
    Id. (citations omitted).
    There are narrow exceptions
    when shareholders will be excused from making demand. The
    New Jersey Supreme Court has adopted Delaware’s demand
    futility standard. In re PSE & G S’holder Litig., 
    801 A.2d 295
    ,
    310 (N.J. 2002); Kanter, 
    2007 WL 1519894
    , at *4 (“Because the
    New Jersey Supreme Court in PSE&G sought guidance from
    Delaware’s decisional law, we will do the same here.”). As the
    New Jersey Supreme Court stated, “for shareholder plaintiffs in
    New Jersey to withstand a motion to dismiss for failure to make
    a demand, they must plead with particularity facts creating a
    reasonable doubt that: (1) the directors are disinterested and
    independent, or (2) the challenged transaction was otherwise the
    product of a valid exercise of business judgment.” In re PSE &
    12
    
    G, 801 A.2d at 310
    . If, as in this case, the board of directors is
    being accused of a failure to act, then the second prong
    technically does not apply and demand futility must be shown
    through the first prong.3 
    Id. at 309-10.
    The first prong
    nonetheless requires us to look to the business judgment rule, as
    “the entire question of demand futility is inextricably bound to
    issues of business judgment.” Aronson v. Lewis, 
    473 A.2d 805
    ,
    812 (Del. 1984); 
    id. at 813
    (stating that “a conscious decision to
    refrain from acting may nonetheless be a valid exercise of
    business judgment and enjoy the protections of the rule”). In
    this regard, “when the complaint asserts inaction by the board,
    as here, courts will not excuse demand ‘in the absence of
    allegations demonstrating why the board is incapable of
    considering a demand’.” Kanter, 
    2007 WL 1519894
    , at *3
    (quoting In re Prudential Ins. Co. Derivative Litig., 
    659 A.2d 961
    , 975 (N.J. Super. 1995); Rales v. Blasband, 
    634 A.2d 927
    ,
    934 (Del. 1993)). “[W]here inaction is the heart of the
    allegation, the plaintiff bears the burden of demonstrating a
    reasonable doubt as to the validity of the business judgment
    presumption.” Kanter, 
    2007 WL 1519894
    , at *6.
    As we have stated, derivative plaintiffs are required to
    3
    The counsel for the plaintiffs agreed in the motion to strike
    hearing that the focus is on the first prong:
    Court: “In short, I am not dealing with [the] second prong
    of the demand futility test. Correct?
    Derivative Plaintiffs’ Counsel: “In this case all the action
    is going to be in the first prong.” JA215-16.
    13
    establish that demand would have been futile at the time they
    commenced litigation. FED. R. CIV. P. 23.1; N.J. CT. R. 4:32-3.
    A corollary of this rule is that discovery generally may not be
    used to supplement allegations of demand futility. Beam v.
    Stewart, 
    845 A.2d 1040
    , 1056 (Del. 2004) (“In general,
    derivative plaintiffs are not entitled to discovery in order to
    demonstrate demand futility.”); In re PSE & 
    G, 801 A.2d at 312
    (stating that “when a court decides a defendant’s motion to
    dismiss a shareholder’s suit for failure to make a demand as
    required under Rule 4:32-5, the court’s review is generally
    limited to the pleadings”); 
    Rales, 634 A.2d at 934
    n.10
    (“[D]erivative plaintiffs . . . are not entitled to discovery to assist
    their compliance with Rule 23.1.”). This rule serves the
    underlying purpose of the demand requirement. As the District
    Court stated, “[t]he demand requirement would be rendered
    meaningless if a plaintiff who cannot establish demand futility
    when he files suit is nonetheless permitted to amend his
    pleading using materials later obtained during discovery to
    justify his failure to make a pre-suit demand.” In re Merck &
    Co., Inc., 
    2006 WL 1228595
    , at *18. If derivative plaintiffs are
    allowed to obtain discovery after making conclusory allegations
    in their complaints to strengthen those very complaints, then
    shareholder plaintiffs will have incentive to make baseless
    allegations and then engage in discovery fishing expeditions.
    Further, except in narrow circumstances, directors and officers
    should not be burdened with engaging in discovery from
    shareholders who might have no legitimate basis to sue. The
    demand requirement would be effectively circumvented if we
    were to adopt a contrary rule.
    14
    The District Court began its leave-to-amend discussion
    by laying out the parameters of Federal Rule of Civil Procedure
    15(a), which states in relevant part that “a party may amend its
    pleadings only by leave of court or written consent of the
    adverse party; and leave shall be freely given when justice so
    requires.” The District Court then cited Foman v. Davis, 
    371 U.S. 178
    , 182 (1962), for the proposition that “[i]n the absence
    of undue delay, bad faith or dilatory motive on the part of the
    movant, leave to amend should be freely given.” In re Merck &
    Co., Inc., 
    2006 WL 1228595
    , at *17; see also Lorenz v. CSX
    Corp., 
    1 F.3d 1406
    , 1413-14 (3d Cir. 1993).
    Futility is also a sufficient ground to deny leave to
    amend. Kanter, 
    2007 WL 1519894
    , at *7. “‘Futility’ means
    that the complaint, as amended, would fail to state a claim upon
    which relief could be granted.” In re Burlington Coat Factory
    Sec. Litig., 
    114 F.3d 1410
    , 1434 (3d Cir. 1997). The District
    Court concluded that amendment would have been futile
    because it held that the plaintiffs could not rely on after-acquired
    information to bolster their conclusory allegations of demand
    futility.
    The plaintiffs argue that the District Court improperly
    adopted a bright-line rule whereby after-acquired information
    can never be used in demand futility complaints. The plaintiffs
    rely primarily on our Court’s decision in Blasband as well as the
    Sixth Circuit’s in McCall v. Scott, 
    239 F.3d 808
    (6th Cir. 2001).
    Merck contends that the plaintiffs’ position contradicts the well-
    settled rule that discovery may not be used to supplement
    demand futility allegations.
    15
    In Blasband, a plaintiff filed a derivative action alleging
    that demand was 
    excused. 971 F.2d at 1039
    . The two issues
    were whether Blasband had standing to bring the action and
    whether he established demand futility. The District Court
    dismissed the complaint, concluding that Blasband did not have
    standing and did not adequately plead that demand would have
    been futile. This Court vacated the District Court’s decision and
    remanded, concluding that “[w]e agree with the district court
    that Blasband has not adequately established that he is excused
    from making a proper demand. However, we also believe . . .
    that Blasband does have standing to maintain this derivative
    action, and we therefore hold that Blasband should be given the
    opportunity to move to amend the complaint to allege additional
    facts establishing that a proper demand would have been futile.”
    
    Id. Although the
    opinion did not address whether Blasband
    could use discovery, the Court did not place any limitations on
    the type of information that Blasband could include in his
    amended complaint. Merck argues that Blasband is inapposite
    because it does not specifically address the use of discovery to
    amend demand futility allegations.
    In McCall, the Sixth Circuit reversed a district court
    decision to not consider an affidavit that the plaintiffs included
    in their amended shareholder derivative complaint. The McCall
    Court stated that “facts in existence before the derivative claims
    were filed but not discovered until later, may be considered in
    determining demand 
    futility.” 239 F.3d at 823
    . Merck attempts
    to distinguish McCall by noting that the discovered information
    was dated after the first derivative complaint was filed but
    16
    before the filing of the operative complaint that contained the
    demand futility allegations scrutinized by the court, and that the
    material arose out of discovery from separate (but related)
    litigation.
    We need not wade into the Blasband/McCall debate to
    resolve this issue. We agree with the District Court and Merck
    that, as a general rule, a plaintiff in a shareholder derivative suit
    may not use discovery to amend demand futility allegations.
    Whether the discovered material existed before or after the filing
    of the operative complaint does not alter our analysis. However,
    this case presents a rare exception to this rule because both
    parties voluntarily entered into a stipulated discovery agreement
    that did not preclude the plaintiffs from using this after-acquired
    information in an amended complaint. Thus, the standard
    argument–that allowing discovery in demand futility scenarios
    undermines the authority of the corporation to decide whether
    to bring suit against itself and gives incentive to shareholders to
    engage in fishing expeditions–has no applicability when the
    plaintiffs and the corporation voluntarily agree to permit limited
    discovery.
    B.      The Stipulated Discovery Agreement
    As the plaintiffs note, Merck voluntarily negotiated and
    agreed to the scope of a document production with plaintiffs.
    The agreement did not result from a District Court ruling. This
    agreement did not restrict the manner in which plaintiffs could
    utilize the documents.
    17
    Paragraph 5 of the June 27, 2005 discovery stipulation is
    particularly relevant to our discussion:
    Without limiting the scope of ¶1 above, all
    discovery in the Consolidated Derivative Action,
    except for requests for production of
    documents focused on the Merck Board of
    Directors’ actions concerning VIOXX prior to
    Merck’s voluntary withdrawal of VIOXX on
    September 30, 2004, shall be stayed pending the
    Court’s ruling on the motion to dismiss the
    Consolidated Derivative Complaint, unless the
    Court enters an order permitting such discovery to
    proceed.
    The general rule that discovery may not be used to supplement
    demand futility allegations has no applicability in a case where
    the parties voluntarily agree to permit discovery to go forward
    on the one area that has particular import for the motion to
    dismiss. We recognize that the discovery stipulation was
    entered into shortly after the initial complaint was filed. This
    stipulation, though, contains no limitation on how this after-
    acquired information may be used. When this fact is coupled
    with the general policy of liberal amendment of pleading
    standards, we must conclude that the District Court should have
    considered this after-acquired information in its discussion of
    whether the plaintiffs may amend their complaint. The District
    18
    Court erred as a matter of law in refusing to consider the
    discovery that resulted from the consensual stipulation. We will
    therefore remand this case so that the District Court may
    examine whether the after-acquired information discovered as
    a result of the stipulation affects its conclusion that amendment
    would have been futile.4
    C.   Whether Demand Would be Futile
    We decline to examine whether demand would have been
    futile in light of the information acquired through the June 27,
    2005 discovery stipulation agreement. We recognize the
    superior position of the District Court in addressing this issue.5
    4
    We reject the argument that allowing consideration of
    information obtained pursuant to a discovery stipulation will
    discourage negotiated settlements of discovery disputes. The
    parties can simply provide in the discovery stipulation a
    provision that information obtained pursuant to the stipulation
    may not be used to supplement demand futility allegations in the
    complaint.
    5
    We also do not address the applicability of Merck’s
    exculpatory charter provision to this case, but we do note that
    courts routinely examine exculpatory agreements in demand
    futility motions to dismiss. See, e.g., Guttman v. Huang, 
    823 A.2d 492
    , 501 (Del. Ch. 2003).
    19
    In the interests of judicial economy, however, we write to
    emphasize that the applicability of the business judgment rule in
    board inaction cases focuses on whether the Board could not be
    considered disinterested (the Aronson first prong) because of the
    potential liability its members face. As the District Court
    properly noted, this standard is quite high, so that in order for
    demand to be excused as futile the board members must face “a
    substantial likelihood” of liability. See 
    Rales, 634 A.2d at 936
    (quoting 
    Aronson, 473 A.2d at 815
    ). The leading case on
    “substantial likelihood” from the Supreme Court of Delaware
    has stated that a board’s actions must be “egregious” to meet
    this standard. See 
    Aronson, 473 A.2d at 815
    . Further, the
    business judgment rule provides directors with a “powerful
    presumption[],” 
    Rales, 634 A.2d at 933
    , “that in making a
    business decision the directors of a corporation acted on an
    informed basis, in good faith and in the honest belief that the
    action taken was in the best interests of the company.” 
    Aronson, 473 A.2d at 812
    . This standard has been oft repeated, and in
    some cases strengthened, in Delaware and New Jersey. See,
    e.g., Parnes v. Bally Entm’t Corp., 
    722 A.2d 1243
    , 1246 (Del.
    1999) (“The presumptive validity of a business judgment is
    rebutted in those rare cases where the decision under attack is so
    far beyond the bounds of reasonable judgment that it seems
    essentially inexplicable on any ground other than bad faith.”
    (quotation omitted)).
    In light of the business judgment presumption as well as
    the standard for demand futility in board inaction cases, the
    District Court on remand must inquire into whether the after-
    20
    acquired information, as well as the information contained in the
    initial complaint, supports the position that the Board recklessly
    ignored a well-established link between VIOXX and increased
    cardiovascular risk to establish that the Board acted egregiously
    or in bad faith. Because the plaintiffs do not challenge the
    District Court’s conclusion that the original complaint’s
    allegations were “patently conclusory,” the question before the
    District Court will be whether the additions permitted by virtue
    of this opinion will transform the complaint from patently
    conclusory to a complaint that establishes to a sufficient degree
    of particularity that the March 2004 Directors approved,
    participated in, or caused Merck to make strategic decisions
    regarding the marketing of VIOXX.6
    We also write to state that the District Court properly
    distinguished In re Tower Air, Inc., 
    416 F.3d 229
    (3d Cir. 2005)
    from facts alleged in the plaintiffs’ unamended complaint in this
    case. In Tower Air, we reversed the dismissal of a breach of
    fiduciary duty claim where the company’s officers
    did nothing when they were told by the corporate
    Director of Safety of quality assurance problems
    with aircraft maintenance and of failures to record
    maintenance and repair work. Whether the
    6
    The original complaint’s allegations, however, might be
    viewed in a different light because the after-acquired
    information will presumably amplify those allegations.
    21
    officers’ behavior is construed as an egregious
    decision or as unconsidered inaction, that
    allegation is troubling. Under no circumstances
    should aircraft maintenance problems be ignored.
    Lives are on the line . . . . We can imagine few
    things more egregious. The officers’ alleged
    passivity in the face of negative maintenance
    reports seems so far beyond the bounds of
    reasonable business judgment that its only
    explanation is bad faith.
    
    Id. at 239.
    The plaintiffs analogize the facts of Tower Air to the
    present matter, asserting that the Board, by knowing the
    cardiovascular risks of VIOXX, put “lives on the line” in an
    egregious manner. This analogy is legally and factually
    inapposite.
    With respect to the legal distinctions, Tower Air did not
    deal with demand futility and applied a notice pleading standard
    under Federal Rule of Civil Procedure 8 instead of the
    heightened factual pleading standard under Federal Rule of Civil
    Procedure 23.1.
    This Court in Tower Air suggested that a director or
    officer acts egregiously and in bad faith when the director or
    officer’s passivity/inaction/nonfeasance in the face of a known
    and obvious risk results in a potentially life threatening
    22
    situation. Here, the situation is factually different. As explained
    by the District Court
    First, the safety concerns in Tower Air were
    brought to the attention of the officers controlling
    the company’s management and operations.
    Ignoring safety risks can be more easily
    characterized as “egregious” where the
    information lies in the hand of those officers
    involved in actually running the corporation on a
    day to day basis, as opposed to a group of
    predominantly outside directors with little
    involvement in the operations of the corporation.
    Second, there is a significant difference between
    the safety warnings given to the officers in Tower
    Air, and those allegedly before Merck’s Board.
    The safety information provided to the officers in
    Tower Air revealed documented problems with
    aircraft maintenance and repair work. These
    reports were unquestionably negative and
    illustrated serious risks to public safety.
    In re Merck & Co., Inc., 
    2006 WL 1228595
    , at *13 n.5
    (emphasis added). Of course, we express no opinion about
    whether the newly acquired facts that are included in the
    amended complaint will alter this analysis. The District Court
    will, on remand, examine whether the plaintiffs’ allegations
    show that the Board knew that VIOXX caused cardiovascular
    harm and then chose to do nothing about it. The allegations
    23
    must not simply demonstrate an aloof or negligent Board, but
    nonfeasance that rose to the level of egregiousness or bad faith.
    IV.
    We will therefore reverse and remand the judgment of the
    District Court for consideration of whether the information
    acquired as a result of the stipulated discovery agreement still
    renders the amended complaint futile.
    24