Court Opinion

ID: 2968817
Source: CourtListenerOpinion
Date Created: 2015-09-22 08:00:22.860732+00
Date Added: 2024-06-11T15:29:00.461248
License: Public Domain

UNPUBLISHED

                  UNITED STATES COURT OF APPEALS
                      FOR THE FOURTH CIRCUIT

                              No. 11-1498

UNITED STATES OF AMERICA ex rel. DEBRA PARKS,

                Plaintiff - Appellant,

          and

CALIFORNIA; DELAWARE; FLORIDA; GEORGIA; HAWAII; ILLINOIS;
INDIANA;   LOUISIANA;   MASSACHUSETTS;   MICHIGAN;  MONTANA;
NEVADA; NEW HAMPSHIRE; NEW JERSEY; NEW MEXICO; NEW YORK;
OKLAHOMA;   RHODE   ISLAND;   TENNESSEE;   TEXAS;  VIRGINIA;
WISCONSIN; DISTRICT OF COLUMBIA,

                Plaintiffs,

          v.

ALPHARMA, INCORPORATED; ALPHARMA BRANDED PRODUCTS DIVISION,
INCORPORATED; FAULDING LABORATORIES; PUREPAC PHARMACEUTICAL
COMPANY,

                Defendants – Appellees,

          and

SEALED DEFENDANT #5; SEALED DEFENDANT #6; SEALED DEFENDANT
#7; SEALED DEFENDANT #8; SEALED DEFENDANT #9; SEALED
DEFENDANT #10; SEALED DEFENDANT #11; SEALED DEFENDANT #12;
SEALED DEFENDANT #13; SEALED DEFENDANT #14; SEALED DEFENDANT
#15,

                Defendants.

Appeal from the United States District Court for the District of
Maryland, at Baltimore.    Richard D. Bennett, District Judge.
(1:06-cv-02411-RDB)
Argued:   May 17, 2012                  Decided:    August 14, 2012

Before KING, DUNCAN, and THACKER, Circuit Judges.

Affirmed by unpublished per curiam opinion.

ARGUED: Joseph Saunders Johnston, MORGAN CARLO DOWNS & EVERTON,
PA, Hunt Valley, Maryland, for Appellant.      Lindsay Buchanan
Burke,   COVINGTON   & BURLING,   LLP,  Washington,  D.C.,   for
Appellees. ON BRIEF: Robert C. Morgan, Angus R. Everton, MORGAN
CARLO DOWNS & EVERTON, PA, Hunt Valley, Maryland, for Appellant.
Thomas S. Williamson, Jr., COVINGTON & BURLING, LLP, Washington,
D.C., for Appellees.

Unpublished opinions are not binding precedent in this circuit.

                                2
PER CURIAM:

           Debra     Parks   appeals    the    district    court’s     grant   of

summary judgment to Alpharma, Inc. (“Alpharma”) on her False

Claims Act (“FCA”) retaliation claim.              See 31 U.S.C. § 3730(h).

Parks argues that the district court erred in ruling that she

failed to make a prima facie case.                  The district court was

correct,   however,     in   deciding       that   Parks   did   not   make    the

requisite showing on the second element of the prima facie case:

that Alpharma had notice of her alleged protected activities.

For this reason, we affirm.

                                       I.

                                       A.

           Parks worked as a sales representative for Alpharma, a

pharmaceutical company, from spring 2002 until her termination

in July 2006.      J.A. 23. 1   For a time, Parks was one of Alpharma’s

most successful employees.         She received many awards, including

“Sales Representative of the Year,” and she was ranked as one of

the top sales representatives nationally.                  Id. at 1943.         In

February 2006, Parks earned Alpharma’s “High Five” award for

     1
       Citations to the “J.A.” refer to the Joint Appendix filed
by the parties in this appeal. Parks’s Second Amended Complaint
states that she began working for Alpharma in 2001, see J.A. 23,
but the district court found that she began in spring 2002, see
id. at 178, and Parks does not challenge this finding on appeal.

                                        3
sales representatives exemplifying five “core values”: “bias for

action,” “creativity,” “courage,” “integrity,” and “teamwork.”

Id. at 1944.

             Parks       was    tasked     primarily         with     promoting     the     drug

Kadian to physicians in Maryland and Delaware.                            J.A. 23-24, 352.

Alpharma      advertised          Kadian,         a     sustained-release             morphine

product,      as     a     longer-lasting             alternative         to      other     pain

medications such as Percocet, Vicodin, and OxyContin.                                     Id. at

29.       In this regard, Parks’s job had many facets, including

encouraging        physicians         to    prescribe            Kadian     and    “obtaining

formulary status for Kadian[.]”                        Id. at 358. 2           According to

Parks, in an attempt to persuade Medicaid, Medicare, and state-

funded     health    care      programs      to       add    Kadian    to   their       list   of

formularies and to increase sales, Alpharma conducted clinical

studies      to     show        the    effectiveness,               safety,       and      cost-

effectiveness of Kadian.                   Id. at 1944.             Alpharma would then

produce the results in the form of presentations and abstracts.

             Alpharma          conducted     many           of    these     studies       during

Parks’s tenure.          She claims that she became concerned about the

      2
       According to Parks, a drug achieves “formulary status”
when it is approved for reimbursement by a government-sponsored
or commercial health care program.     Formularies, or lists of
such approved drugs, are normally approved by committees within
a certain program or managed care plan. See J.A. 358-59.

                                              4
methods by which the studies were conducted and the manner in

which the results were presented.

                                     1. SWITCH STUDY

               In 2004, Alpharma considered engaging Dr. Michael S.

Kaplan,    who    operated       multiple           pain    clinics       in     Maryland,     to

conduct    a    study    to    assess      the       efficacy       and    pharmacoeconomic

(cost-saving)      impact       of     switching           patients       from    other      pain

medications to Kadian (hereinafter, the “Switch Study”).                                     J.A.

1945.     Parks denies in an affidavit having any role in hiring

Dr. Kaplan to perform the study, id. at 1945-46, and divulges

that she found Dr. Kaplan to be “inappropriate on a personal

level,” id. at 387.

               Nevertheless, Parks worked regularly with Dr. Kaplan,

and he prescribed the most Kadian in Parks’s sales territory.

J.A.    377-78.         Indeed,       in   an       e-mail     to    Dr.       Joe   Stauffer,

Alpharma’s Vice President of Global Medical Affairs, Parks wrote

that    she    would     be    “dead”      if       Dr.     Kaplan    “g[o]t         angry    and

stop[ped] writing [prescriptions]" for Kadian.                            Id. at 956.         And

in a May 12, 2004 email, Parks sent Dr. Kaplan’s curriculum

vitae to Dr. Mike Royal, Medical Director and Vice-President of

Alpharma      Strategic       Brand    Development,          listing       several      reasons

why Dr. Kaplan would be the best person to perform the Switch

Study.     She concluded, “[h]e is very excited about doing the

‘switch’ study and wants to start ASAP.”                        Id. at 946.           She also

                                                5
told Dr. Royal that Dr. Kaplan is "truly a doctor we want to

keep in our camp," id. at 945-46, and admitted that “it would be

impossible for [her], as a sales rep, to replace that sales

volume,” id. at 393.          She agreed that she “wanted to get Kaplan

going on the study so it wouldn’t adversely affect [her] ability

to achieve or exceed [her] quota[.]”               Id. at 798.     Alpharma

ultimately hired Dr. Kaplan to conduct the Switch Study.

                              2.   KAPLAN METHOD

            Central to the Switch Study was Dr. Kaplan’s personal

method of converting patients from other pain medications to

Kadian (hereinafter, the “Kaplan Method”).             J.A. 1950-51.      The

Kaplan Method involved adding Kadian to a patient’s shorter-

acting pain medication, and once Kadian reached a certain level,

weaning the patient off of the other drug.             Id. at 243.     After

hiring   him   to   perform    the   Switch   Study,   Alpharma   asked   Dr.

Kaplan to train its sales representatives so that they could

present the Kaplan Method to other physicians, in an effort to

increase the number of Kadian prescriptions.            Id. at 201, 1950.

He agreed, and the training presentation took place in August

2005.    Id. at 1950.

            Even though Parks told Dr. Royal that “part of why

[Dr. Kaplan] is so successful in convincing doctors to really

give Kadian a fair trial is his discussion of conversion,” J.A.

                                       6
496, she nonetheless complained about the Switch Study and the

2005 training for three reasons.

               First,    Parks      did    not       believe        that    the   other       sales

representatives fully understood the Kaplan Method.                                  She claims

she     was     “inundated          with    calls           and      emails”      from        sales

representatives with questions about it.                           J.A. 988.      In an email

to her supervisors, Mike Slesinski and Peter Hill, Parks stated

that she was “happy that the talk was met with such enthusiasm”

but    was    “hesitant        to   give    any       info     on    the     lecture     without

talking to management” and could not “handle the huge volume of

requests that seems to be building up.”                               Id. at 989.             Parks

proposed a conference call with the sales representatives to

discuss       the   Kaplan     Method      because,          as     she    explained     in     her

deposition, she wanted “to clear up the confusion . . . to be

able to ensure that the reps did understand the [Kaplan Method]

because it was a serious matter and could endanger patient’s

[sic]    safety.”         Id.       at    811.         Parks       also     claims    that      she

complained to Hill about these concerns during field rides with

him, but Hill recalls Parks saying only positive things about

the Kaplan Method.           See id. at 1880.

               Second,     Parks         says        that    she      complained         to     her

superiors that the Kaplan Method encouraged an “off-label” use

of the drug.          Br. of Appellant 16.                  An “off-label” use is one

that    has     not     been    approved         by    the        federal    Food     and      Drug

                                                 7
Administration (“FDA”).                See United States ex rel. Franklin v.

Parke-Davis,       147     F.    Supp.         2d     39,     43-44       (D.        Mass.    2001).

Although    physicians          may    prescribe          drugs     for    off-label          usage,

federal regulations prohibit drug manufacturers from marketing

their    drugs    for    off-label        purposes.            See     id.;      21     U.S.C.   §§

331(a), (d); see also Washington Legal Foundation v. Henney, 202

F.3d 331, 332-33 (D.C. Cir. 2000) (providing background on off-

label use and promotion of pharmaceutical drugs).

            Parks        alleges       that         she     complained          to     supervisors

Slesinski,       Hill,    and     Craig        LaFay        that    representatives            were

simplifying the Kaplan Method and thus promoting an off-label

conversion,      but     none    of     them        recalls    Parks       expressing         these

concerns or ever using the terms “illegal,” “fraudulent,” or

“off-label.”       J.A. 1903-04, 1880, 1891.                        Parks admits that she

did not put in writing her concerns that Alpharma’s marketing

practices were off-label or fraudulent, see id. at 819, 821, and

never used the terms “illegal” or “fraudulent” in conversation,

but rather used the term “off-label,” see id. at 789-90.

            Finally, Parks says that she voiced concerns about the

manner     in    which     the        Switch        Study     and     Kaplan         Method    were

presented.       She claims that the study revealed that converting

patients to Kadian who were also on morphine would result in

increased, not reduced, costs.                      J.A. 1948.        An abstract prepared

by a third party failed to mention this fact, id. at 274-78, and

                                                8
Parks says that she expressed her disapproval that Alpharma had

decided to “bury” such results, id. at 1948.                                 Parks also says

that she spoke with Dr. Stephen Sun, a member of the Alpharma

medical affairs division, who told her that the Switch Study was

a “failure” and that he did not want the results to be released.

Id.      Parks claims that she sent an email “to prove” to her

supervisor that the pharmacoeconomic results had been buried.

Id.    at   1949.          That    email,      however,          simply       states,        “This

[Abstract]     Poster        has     been          presented          now.          It     is    my

understanding        that    [a     nurse      from       Dr.    Kaplan’s       office]          may

present it herself . . . at a District teleconference.”                                    Id. at

281.

             Aside from her own testimony, Parks presents no other

evidence     that    she     expressed      her          disapproval         with    Alpharma’s

handling of the Switch Study abstract, and no reasons why she

believed     Alpharma       was    responsible           for    the    alleged       “burying,”

when a third party actually prepared the abstract.

                             3. COVENTRY PRESENTATION

             Parks     also        says     that          she     complained             about     a

teleconference       presentation         by       Dr.    Kaplan      to     Coventry      Health

Care in February of 2006.             Part of the presentation was meant to

promote     Kadian    as    being    less      prone       to    diversion          (i.e.,      less

prone to be diverted to the black market) than other opioid

drugs.      J.A. 262.        Notably, Parks “arranged for Dr. Kaplan to

                                               9
speak,”     and    she    also      provided      certain         slides     for     that

presentation.       Id.     at    1884.    Nevertheless,          Parks    claims    that

because   Kadian    had     not     been   proven      to    be    less     subject    to

diversion,    she    felt        that   marketing      it    that     way    would     be

considered off-label promotion.

            When    Parks    discovered         that   the    presentation          would

involve a discussion of diversion, she wrote an email to Hill to

express these concerns.           The email stated,

      Between us, I am not at all comfortable with this
      approach. If it were me[,] I would not do this. The
      success with Medicaid in [Maryland] was due to a
      strong clinical support from my [doctors] and a great
      detail from Dr. Royal . . . . Nonetheless, I am doing
      all that I can to help [Matt Anderson, Alpharma’s
      Managed Care Representative, who was responsible for
      the presentation].”

J.A. 262.     Hill responded, “I would agree, I think we need to

take a more clinical approach than abuse and diversion.”                           Id. at

1884. 3

      3
       Because Dr. Kaplan was not on Alpharma’s list of approved
speakers, he could not be paid his $500 honorarium for the
Coventry presentation through normal channels.   Parks says that
her supervisors encouraged her to buy Dr. Kaplan a gift
certificate with her company American Express card, but she
refused to do so.    Eventually, Dr. Kaplan was paid by a check
issued by Alpharma.   See J.A. 446-58.   It is not clear whether
Parks desires to use this fact as evidence of an FCA protected
activity or retaliatory behavior on the part of Alpharma.
Regardless, we do not find it persuasive or relevant to our
analysis.

                                           10
                                 4. DOSE-DUMPING STUDY

               The next issue about which Parks says she complained

concerned a “dose-dumping” study conducted by Alpharma.                           In July

2005,    the    FDA      asked    a    competitor          pharmaceutical      company    to

withdraw the pain medication Palladone from the market because a

study had shown risks of dose-dumping, which is the premature

and exaggerated release of the pain-killing component in a drug

caused by alcohol use.             J.A. 57, 202-04.              The FDA then requested

that Alpharma also conduct a dose-dumping study of its own with

regard    to    Kadian.          See   id.    at     57,    1616-18.     The    study    was

completed after Parks’s July 2006 termination, and the final

results      indicated      that       Kadian      was     not   susceptible     to   dose-

dumping risks.         See id. at 1618.

               In   February      2006,      however,       Parks   learned     third-hand

from a competitor’s sales representative that a clinical trial

showed    risks     of    dose-dumping          in    Kadian.       Parks   relayed      the

information to Hill, Slesinski, and Alpharma marketing director

Eric Vandal.          They told her that those rumors were false.                        See

J.A. 772-73, 1547-50, 1955.

               Also in February 2006, Parks was told by an Alpharma

sales representative that the clinical trials were showing a

risk    of   dose-dumping.             J.A.     1955-56.         Parks   says    that    she

relayed this information to Dr. Sun.                         She claims that he told

her to “stop asking questions” and “mind your own business.”

                                              11
Id. at 774.           Dr. Sun has no recollection of this conversation.

See id. at 1201-02, 1218-19.                 Parks also says that she expressed

concerns to Ron Warner, Alpharma’s Vice-President, that Alpharma

was marketing the drug as having no risk when co-ingested with

alcohol, when the dose-dumping study was not yet complete.                              See

id. at 1956-57.

                         5. INTERNET SURVEILLANCE STUDY

              Lastly,       Parks    claims       that   she    complained      about    an

internet surveillance study conducted by Alpharma.                              The study

was     conducted        to     monitor       websites         frequently       used     by

prescription drug abusers, who share messages about their drug

of    choice.         The     results    showed      that      other    drugs    such    as

OxyContin       and    Percocet       were    mentioned        more    frequently      than

Kadian on these sites.              J.A. 1019-20.

              In June 2006, Dr. Stauffer gave a presentation about

the internet surveillance study at a national Alpharma meeting.

Parks alleges that she complained about this presentation to

LaFay   and     Dr.    Stauffer      because      she    was   concerned     that   sales

representatives were using the study to market Kadian as less

prone to abuse and diversion, which was not necessarily true.

                                             12
J.A. 1016-17, 1607, 1957-58.              Neither LaFay nor Dr. Stauffer

remembers those conversations.           See id. at 1034, 1603. 4

                                        B.

              In   March    2006,   Alpharma’s     Human    Resources   Director

Regina Donohue began receiving telephone calls from other sales

representatives       who    were   complaining     about    Parks’s    behavior.

They said that Parks was “making inappropriate and disrespectful

comments      about    her     supervisors,”        “inquiring     into     other

employees’ salaries and merit increases,” and “spreading rumors”

about    an   extramarital     affair    between    Hill    and   another   sales

representative.       J.A. 1765.        In early March 2006, Donohue also

learned from Slesinski that Parks was telling others that she

was “unhappy” with her 2005 merit increase.                Id.

              As a result, Donohue conducted an investigation into

the complaints about Parks.             Donohue interviewed Hill, LaFay,

and Slesinski on March 8, 2006, regarding Parks’s complaints

     4
       Parks presents other allegations in an attempt to show
that Alpharma engaged in retaliatory behavior. For example, she
claims that Hill made derogatory comments about her physical
appearance, mocked her hair color, threatened to fire her unless
she attended a meeting in Amelia Island, and urged her to leave
her father-in-law’s funeral in New Jersey to go on a field ride
with him.     See J.A. 428-29, 460-61, 1958.      Because these
allegations were made in support of Parks’s claim on the third
prong of the prima facie case, we find them to be irrelevant to
our analysis here.

                                        13
about     her       merit    increase. 5         She     also   conducted        telephone

interviews with other sales representatives concerning Parks’s

alleged       behavior.        Donohue     took    extensive        notes      during    her

investigation, which suggested that several employees complained

that Parks had been a negative influence on the sales force

because she spread rumors, criticized Alpharma’s management, and

acted like a “bully.”           J.A. 1766-67, 1808-15.

               Ultimately, on May 5, 2006, Donohue and another human

resources manager, George Rose, met with Parks to discuss the

complaints.          Shortly thereafter, on May 8, 2006, Parks’s lawyer

faxed     a   letter    to    Alpharma,    and     accused      Hill    of     retaliating

against Parks by claiming that she was spreading false rumors

about him.          In the letter, Parks asked that Alpharma investigate

her   claim     of    Hill’s    alleged    retaliation.           See    J.A.     1873-75.

They did so and found no support for her allegations.                                Id. at

1768-70.

               At    the     conclusion    of      the     investigation        into     the

complaints about Parks, Alpharma legal counsel Elissa Halperin

notified       Parks    that    no   disciplinary          action      would    be     taken

against her, but she warned both Parks and her attorney to keep

      5
       Notably, however, the evidence                     shows that Parks did not
know about her merit increase until                      March 16, 2006.   Because
this discrepancy bears on the third                      prong of the prima facie
case, it is immaterial to our analysis                   here.

                                            14
that investigation confidential, and especially not to discuss

the results of the investigation with other employees.                                See

J.A. 560-62, 1846.          Nonetheless, on June 14, 2006, Hill informed

Donohue      that     Parks    was     disclosing        some    details       of    that

investigation to another sales representative.                        Donohue spoke

with   this     sales     representative,       who   confirmed       in   a   written,

signed statement, that Parks had done so.                   See id. at 1843.

              On July 24, 2006, Alpharma terminated Parks.                           J.A.

661,   1773.        According    to    Alpharma,      the    company’s      management

decided    to      terminate    Parks’s    employment       as    a   result    of    the

numerous complaints regarding her insubordinate behavior and as

a   result    of    her   failure     to   keep    the    internal       investigation

regarding her allegations confidential.                     Id. at 1682-83, 1772-

73, 1846-47.

                                           C.

              On     September       13,   2006,      two       months     after      her

termination, Parks filed under seal this qui tam action as a

relator.      In her Second Amended Complaint, filed June 23, 2008,

she alleged that Alpharma paid illegal kickbacks to providers to

induce them to prescribe Kadian, in violation of the federal

Anti-Kickback Act, 42 U.S.C. §§ 1320a-7b(b), and that it made

false representations about Kadian’s effectiveness and risks and

improperly promoted on-label and off-label uses of the drug, in

violation of the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-

                                           15
97.    See J.A. 17-109.        Parks averred that, by these practices,

Alpharma     caused    prescriptions         to    be   written       based   on    false

pretenses and false claims to be submitted to government-funded

health     insurance    programs       for     reimbursement.             Thus,     Parks

asserted that Alpharma violated the provisions of the FCA and

defrauded federal and state governments out of tens of millions

of dollars.       See id. at 69; Br. of Appellant 4.

             As pertinent here, Parks further alleged that during

her    four-year      tenure    with      Alpharma,        she        “questioned       the

marketing instructions her Alpharma supervisors had given her,”

“suggested that Alpharma correct them,” and “began to gather

facts to disclose [Alpharma’s] fraud,” and was terminated in

retaliation for these actions, in violation of the FCA.                             J.A.

67-68, 103-104; see also Br. of Appellant 3.

             The Second Amended Complaint remained under seal while

the    government     investigated      the       allegations,        pursuant     to    31

U.S.C.   §   3730(b)(2).       On   March         10,   2010,    the    Department       of

Justice and Parks executed a $42.5 million settlement agreement

with Alpharma.        Parks received over $5 million dollars for her

role as a whistleblower, pursuant to 31 U.S.C. § 3730(d).                            J.A.

727.

             As   a   result   of   the      settlement,        all    claims     against

Alpharma were dismissed except Parks’s FCA retaliation claim.

Alpharma moved for summary judgment on this claim on February

                                          16
28, 2011, arguing that Parks failed to make a prima facie case.

The court granted the motion, see United States ex rel. Parks v.

Alpharma, Inc., No. 1:06-cv-02411, 2011 WL 1366491 (D. Md. Apr.

11, 2011), 6 and Parks timely appealed.     We possess jurisdiction

pursuant to 28 U.S.C. § 1291.

                                 II.

          We   review   the   district   court’s   grant   of   summary

judgment de novo, viewing “all facts and reasonable inferences

in the light most favorable to . . . the non-moving party” — in

this case, Parks.   United States ex rel. Owens v. First Kuwaiti

Gen. Trading & Contracting Co., 612 F.3d 724, 728 (4th Cir.

2010).   Summary judgment is appropriate if “there is no genuine

issue as to any material fact” and the movant, Alpharma, is

     6
       Parks took other legal actions based on the alleged
circumstances of her termination, including filing a criminal
complaint accusing Hill of assault and battery because he
allegedly "smacked [her] on [her] butt" at a conference, see
J.A. 687-88; a defamation action against Hill and another sales
representative, see id. at 532; and a wrongful termination suit
against Alpharma, see id. at 492, all in state court.       The
criminal investigation was dropped after several of Parks’s co-
workers indicated that Parks had asked them to lie and say they
had witnessed the alleged actions of Hill.     See id. at 1775.
The defamation action was voluntarily dismissed by Parks.   See
id. at 532; Parks v. Armstrong, No. 03C07004974 (Cir. Ct.
Baltimore Co.), filed May 2, 2007, dismissed Mar. 13, 2008. The
wrongful termination suit was dismissed for failure to state a
claim.   See Parks v. Alpharma, Inc., 10 A.3d 199 (Md. 2010);
aff’d, 25 A.3d 200 (Md. 2011).

                                  17
“entitled to judgment as a matter of law.”                             Fed. R. Civ. P.

56(c).

               After       reviewing    the    evidence     of   an    alleged         genuine

issue of material fact, we must ask “whether a fair-minded jury

could    return        a    verdict     for    the    plaintiff       on    the    evidence

presented.        The mere existence of a scintilla of evidence in

support of the plaintiff’s position will be insufficient; there

must be evidence on which the jury could reasonably find for the

plaintiff.”       Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 252

(1986).        Indeed, at the summary judgment stage, the district

court has “the affirmative obligation [] to prevent factually

unsupported       claims       and     defenses      from   proceeding        to       trial.”

Drewitt v. Pratt, 999 F.2d 774, 778-79 (4th Cir. 1993) (internal

quotation marks omitted).

                                              III.

               In adopting the FCA, Congress intended “to protect the

funds    and    property       of    the     government.”        Rainwater        v.    United

States, 356 U.S. 590, 592 (1958).                    An FCA suit “may be brought

against anyone who ‘knowingly presents’ to the government ‘a

false     or    fraudulent           claim     for   payment      or       approval’”      or

“‘knowingly makes . . . a false record or statement material to

a false or fraudulent claim.’”                  Owens, 612 F.3d at 728 (quoting

31 U.S.C. § 3729(a)(1)).

                                               18
            The FCA contains an enforcement mechanism known as the

“qui tam” provision.        See 31 U.S.C. § 3730 (b)-(d).        A qui tam

action is brought by a private party “in the name of the United

States.”    Mann v. Heckler & Koch Defense, Inc., 630 F.3d 338,

343 (4th Cir. 2010).          The FCA also contains a whistleblower

provision, 31 U.S.C. § 3730(h), which “prevents the harassment,

retaliation, or threatening of employees who assist in or bring

qui tam actions.”          Zahodnick v. Int’l Bus. Machs. Corp., 135

F.3d 911, 914 (4th Cir. 1997).

            The version of 31 U.S.C. § 3730(h) in effect at the

time of the filing of Parks’s Second Amended Complaint provided

the following:

     Any employee who is discharged, demoted, suspended,
     threatened,   harassed,   or   in  any  other   manner
     discriminated against in the terms and conditions of
     employment by his or her employer because of lawful
     acts done by the employee on behalf of the employee or
     others in furtherance of an action under this section,
     including investigation for, initiation of, testimony
     for, or assistance in an action filed or to be filed
     under this section, shall be entitled to all relief
     necessary to make the employee whole.

31 U.S.C. § 3730(h) (2006), amended 2009. 7            In order to defeat

summary    judgment   on    her   FCA    retaliation   claim,   Parks   must

“establish a genuine issue of fact showing [that] (1) [she] took

     7
       The statute was amended in 2009 to add “contractor” and
“agent” to “employee” in the list of potential FCA retaliation
plaintiffs. That amendment does not impact this appeal.

                                        19
acts in furtherance of an FCA suit; (2) [Alpharma] knew of those

acts;    and    (3)    [Alpharma]   treated     [her]     adversely   because    of

these acts.”          Owens, 612 F.3d at 735.           All three factors must

exist in order for Parks to prevail.

               Alpharma argues that Parks did not make any of these

three    required      showings.     See    Br.   of    Appellee    18-57.      The

district court held that Parks satisfied the first prong, but

not the other two.         Because we agree that Parks did not satisfy

the second prong – that Alpharma knew that Parks took acts in

furtherance of an FCA suit - we affirm on that ground alone.

               The second prong of the FCA retaliation test, also

known as the “notice” prong, is appropriately viewed from “the

employer’s perspective” and turns on whether “the employer is

aware of the employee’s conduct.”               Mann, 630 F.3d at 344.           In

that regard, this court has held that the employer must be “on

notice that litigation is a reasonable possibility.”                   Eberhardt

v. Integrated Design & Constr., Inc., 167 F.3d 861, 868 (4th

Cir. 1999).

               In Eberhardt, the employee-relator’s job description

involved internal investigation of fraud against the government.

167 F.3d at 868.          This court held that, because of the special

nature    of    his    position,    Eberhardt     could    only    bring   an   FCA

retaliation action by showing that he “expressly stat[ed] an

intention to bring a qui tam suit” or “by any action which a

                                       20
factfinder reasonably could conclude would put the employer on

notice that litigation is a reasonable possibility.”                           Id.

            Parks argues that the Eberhardt “notice” standard “is

a slightly higher standard than the standard applicable in this

case” and “does not apply in this case because [her] job duties

at     Alpharma      never    entailed        investigating          fraud.”         Br.       of

Appellant 35.         She also argues that because the district court

recognized that “internal reporting of allegedly fraudulent or

false     claims       qualifies         as        activity        protected         by     the

whistleblower provisions of the FCA, . . . [it] implicitly found

that    Mrs.    Parks’s       internal    complaints          to     her    superiors          at

Alpharma were identifiable as disclosures of fraud or falsity,”

thus    satisfying      the    notice     prong.         Id.       at    35-36     (internal

quotation marks omitted).            Both arguments lack merit.

               First, in Eberhardt, this court explained that the

employee-relator        must    show    that       his   or   her       actions    “let     the

employer know, regardless of whether the employee’s job duties

include    investigating        potential          fraud,     that      litigation        is    a

reasonable possibility.”             167 F.3d at 868 (emphasis supplied).

Eberhardt      may    have    been   held      to    a   higher         standard     in    that

particular case, inasmuch as his job duties required that he

make certain disclosures of internal fraud and falsity.                              But the

distinction Parks attempts to make is factual, not legal.                                      In

applying the Eberhardt standard, we have a duty to make a “fact

                                              21
specific      inquiry”        as     to     Alpharma’s            knowledge     of     Parks’s

activities and view them in the appropriate context.                                  Hutchins

v. Wilentz, Goldman & Spitzer, 253 F.3d 176, 189 (3d Cir. 2001).

This    inquiry      does     not,    however,            alter    the    legal      framework

described above.

              Second,    Parks       appears         to   contend     that,     because    the

district court concluded that she satisfied the first prong of

the FCA retaliation claim, it necessarily should have concluded

that she satisfied the notice prong as well.                             In Mann, although

this court stated that “[c]ombining the protected activity and

notice elements is a perfectly reasonable approach when both

elements are in dispute,” it also cautioned against interpreting

§ 3730(h) “in a manner that would render some of its language

meaningless.”           630    F.3d       at     344      (internal       quotation     marks

omitted).      We must, therefore, avoid collapsing the two prongs

into    the   same    analysis,           and   rather,       separately        address    the

question of whether Alpharma was on notice that FCA litigation

was “a reasonable possibility.”                        Eberhardt, 167 F.3d at 868;

see also Hutchins, 253 F.3d at 188 (holding that the notice

prong “requires the employee to put his employer on notice of

the    ‘distinct     possibility’          of    False      Claims       Act   litigation”);

United States ex rel. McKenzie v. BellSouth Telecomms., Inc.,

123 F.3d 935, 944 (6th Cir. 1997) (“An employee must supply

sufficient facts from which a reasonable jury could conclude

                                                22
that the employee was discharged because of activities which

gave   the   employer     reason   to   believe   that   the   employee    was

contemplating a qui tam action against it.” (internal quotation

marks omitted)).

             Parks fails to satisfy her burden because she does not

present sufficient evidence to show that Alpharma was on notice

that FCA litigation was a reasonable possibility.                   She argues

that she made “internal complaints that [we]re identifiable as

disclosures of fraud or falsity to the employer,” which were

sufficient    to   “put   [Alpharma]     on   notice   of   [her]    protected

activity.”     Br. of Appellant 30.            According to Parks, these

alleged “protected activit[ies]” include,

               •   “investigat[ing] and question[ing] some of
                   Alpharma’s     illegal    and     promotional
                   activities concerning Kadian,” id. at 3;

               •   “complaining to her superiors at Alpharma
                   that the [Kaplan Method] was ‘off-label,’”
                   id. at 16;

               •   “objecting   to   the   proposed   off-label
                   [Coventry] presentation [on diversion],” id.
                   at 20;

               •   “complain[ing] directly to Mr. LaFay about
                   Alpharma’s     decision    to   bury    the
                   pharmacoeconomic   results   of the  Switch
                   Study,” id. at 29;

               •   “complain[ing] directly to Mr. LaFay about .
                   . . the internet surveillance study,” id.;
                   and

                                        23
               •    “rais[ing]   her   concerns  regarding   the
                    alcohol clinical trials [of the dose-dumping
                    study] with Mr. Warner,” id.

            Nothing in Parks’s proffered evidence, however, shows

that anyone at Alpharma would have reasonably believed that she

was contemplating or acting in furtherance of an FCA action.

Indeed,    Parks’s    complaints     were    clearly   couched     in   terms    of

concerns     and    suggestions,     not     threats   or    warnings    of     FCA

litigation.        See Zahodnick, 135 F.3d at 914 (affirming summary

judgment for the employers where employee “merely informed a

supervisor of [a] problem,” “never informed anyone that he was

pursuing a qui tam action,” and provided “no evidence that [the

employers]     were     aware   of      [employee’s]        alleged     protected

activity”); see also Luckey v. Baxter Healthcare Corp., 183 F.3d

730, 733 (7th Cir. 1999) (“An employer is entitled to treat a

suggestion for improvement as what it purports to be rather than

as a precursor to litigation.”); United States ex rel. Yesudian

v. Howard Univ., 153 F.3d 731, 743 (D.C. Cir. 1998) (“Merely

grumbling to the employer about . . . regulatory violations does

not satisfy the requirement – just as it does not constitute

protected activity in the first place.”).

            Furthermore, copious documentary evidence shows that

Parks was an employee who was supportive and enthusiastic about

promoting Kadian and appeasing Dr. Kaplan.              It is clear that it

was   in   Parks’s    best   interest       professionally    to   support      and

                                        24
promote    the    clinical        studies      about      which    she    now    complains.

Even if we view Parks’s complaints and objections in a vacuum,

however – including her explicit use of the term “off-label” to

her   supervisors       –    there     is   no    indication       that    such    internal

criticism would have put Alpharma on notice of a False Claims

Act lawsuit, as required under Eberhardt and 31 U.S.C. § 3730.

The FCA prohibits “false or fraudulent claim[s]” submitted to

the government “for payment.”                    See 31 U.S.C. § 3729(a).                Here,

there   is   absolutely           no   evidence        that    a   physician       wrote     a

prescription      for       Kadian,     which       was    then     submitted       to    the

government       for    reimbursement,            based       on   the    Switch     Study,

Coventry     presentation,             dose-dumping            study,      or      internet

surveillance study.           See Hopper v. Solvay Pharms., Inc. 588 F.3d

1318,     1326    (11th      Cir.      2009)      (affirming        dismissal       of     FCA

complaint where it failed to identify “a single physician who

wrote a prescription with [] knowledge [that the cost of filling

the prescription would be borne by the government],” “a single

pharmacist who filled such a prescription,” or “a single state

healthcare program that submitted a claim for reimbursement to

the federal government”); Parke-Davis, 147 F. Supp. 2d at 52

(“[An] alleged FCA violation arises – not from unlawful off-

label marketing activity itself – but from the submission of

Medicaid     claims         for    uncovered        off-label       uses        induced     by

Defendant’s fraudulent conduct.”).

                                             25
            Moreover, Parks failed to adduce any evidence that the

off-label     promotion      would      inevitably    lead    to    such        false

submissions.        Indeed, Parks offered no more than speculation,

which at summary judgment, is insufficient.                  See Othentec Ltd.

v. Phelan, 526 F.3d 135, 140 (4th Cir. 2008) (observing that

non-moving     party      must   come    forward     with    more   than        “mere

speculation    or    the    building     of   one   inference   upon    another”

(internal quotation marks omitted)).

            Accordingly, we hold that Parks did not satisfy the

notice prong of her FCA retaliation prima facie claim, and we

therefore affirm the district court on that ground.

                                        IV.

            For     the    foregoing     reasons,    the     judgment      of    the

district court is

                                                                        AFFIRMED.

                                         26