US ex rel. Debra Parks v. Alpharma, Incorporated , 493 F. App'x 380 ( 2012 )

UNPUBLISHED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Affirmed by unpublished per curiam opinion.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Unpublished opinions are not binding precedent in this circuit.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
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• “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
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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.”).
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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.
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