VIRGINIA M. HERNANDEZ COVINGTON, District Judge.
This matter comes before the Court pursuant to Defendants RS Compounding LLC and Renier Gobea's Motion to Dismiss Relator's First Amended Complaint (Doc. # 48), filed on September 20, 2017, and Defendant Stephen Caddick's Motion to Dismiss Relator's First Amended Complaint (Doc. # 70), filed on October 11, 2017. Relator McKenzie Stepe responded on October 4 and 25, 2017. (Doc. ## 65, 73). For the reasons that follow, the Motions are granted and Stepe's Amended Complaint is dismissed with leave to amend by December 7, 2017.
Defendants Renier Gobea and Stephen M. Caddick, Pharm. D., co-founded Defendant RS Compounding LLC in 2004. (Doc. # 39 at ¶ 35). RS Compounding, which does business as Zoe Scripts Laboratory Services, LLC, and Westchase Compounding Pharmacy, is a compounding pharmacy that "distribute[s] massive quantities of pre-made compounds for both humans and animals throughout the country in a fashion similar to a large pharmaceutical manufacturing company." (
Caddick is a licensed pharmacist, but Gobea is not. (
Plaintiff relator McKenzie Stepe worked for RS Compounding as a sales representative in New York and New Jersey between November of 2011 and February of 2013. (
The first was a marketing scheme, which Defendants called the "1, 2, 3 strategy." (
Stepe alleges that, as a result of these pre-printed script pads, "Defendants automatically ship refills to patients — often of the most expensive products if the physician did not cross out the check mark and check off a different compound — and seek TRICARE, Medicare, Medicaid, and private insurance reimbursements for those refills despite questionable (and unsupervised by a doctor) medical necessity." (
In addition to the pre-printed script pads, "[u]nder the `1, 2, 3 strategy,' Defendants' sales representatives `coach' physicians to number three products on the pre-printed script." (
Another scheme involved disparate pricing of the compounds and gels sold by Defendants, in which different patients were charged different amounts for the same substances. According to Stepe, "the Company charged vastly different prices for individuals who were uninsured, who had private insurance, and who were covered by TRICARE, Medicare, and Medicaid." (
Also, Stepe alleges Defendants "do not train their sales representatives regarding proper and improper use, or potential contra-indications or warnings." (
As a result of these various schemes, Stepe alleges Defendants have submitted fraudulent claims to the Government and have made false records and statements material to such claims. (
On December 16, 2013, Stepe filed her Complaint against RS Compounding and John Doe Corporations 1-10 under seal, alleging violations of the False Claims Act (FCA), 31 U.S.C. § 3729(a), and Florida's state equivalent of the FCA. (Doc. # 1). On April 28, 2017, the Government elected to intervene in part as to the fraudulent pricing allegations, but not as to the "remaining allegations (including [Stepe's] fraudulent marketing and promotional allegations)." (Doc. # 33). The Government filed its Complaint in partial intervention on June 30, 2017, and subsequently filed its Amended Complaint in partial intervention on September 9, 2017, against RS Compounding and Gobea. (Doc. ## 36, 42).
Stepe filed her Amended Complaint on July 12, 2017, again alleging violations of the FCA and various States' equivalent statutes against RS Compounding, Gobea, Caddick, and John Doe Corporations 1-10. (Doc. # 39). Stepe alleges claims under the state equivalents of the FCA for Florida, Virginia, Massachusetts, California, Colorado, Delaware, Georgia, Illinois, Indiana, Louisiana, Maryland, Nevada, New Jersey, New Mexico, Oklahoma, Tennessee, and Texas. (
RS Compounding and Gobea filed their Motion to Dismiss Stepe's Amended Complaint on September 20, 2017. (Doc. # 48). Caddick filed his Motion to Dismiss Relator's First Amended Complaint on October 11, 2017.
On a motion to dismiss, this Court accepts as true all the allegations in the complaint and construes them in the light most favorable to the plaintiff.
However, the Supreme Court explains that:
Rule 9(b) of the Federal Rules of Civil Procedure imposes more stringent pleading requirements on claims alleging fraud.
Enacted in 1863, the FCA "was originally aimed principally at stopping the massive frauds perpetrated by large contractors during the Civil War."
The FCA may be enforced by the government or by a relator through a qui tam action brought "in the name of the Government." 31 U.S.C. § 3730(b). Thus, the FCA permits private persons to file qui tam actions on behalf of the United States against any person who:
31 U.S.C. § 3729(a). Stepe alleges violations of these four subsections.
Defendants argue that Stepe has failed to state claims under any of these subsections because her allegations fail to meet either the Rule 12(b)(6) or Rule 9(b) standards, as well as failing to establish the allegations were material to the Government's decision to pay claims. (Doc. # 48 at 3, 6-7).
Defendants also argue "the companion state FCA claims (Fifth through Twenty-Third Claim) should be dismissed for the same reason since the state FCAs are modeled on the federal False Claims Act." (
Defendants argue that Stepe cannot base her claims on the alleged disparate pricing scheme because the Government has intervened as to those allegations. (Doc. # 48 at 7-8). Indeed, as another court has explained, "[w]hen the government has intervened, that portion of the relator's complaint effectively ceases to exist because it has been superseded."
The Court need not dismiss Stepe's disparate pricing allegations. "[T]he appropriate action for the Court to take when a defendant moves to dismiss those portions of a relator's complaint that have been superseded by government intervention is to deny the motion as moot as it relates to the intervened claims."
In Count I, Stepe alleges "Defendants have knowingly presented or caused to be presented false or fraudulent claims for payment or approval in violation of 31 U.S.C. § 3729(a)(1)(A)." (Doc. # 39 at 28). Section 3729(a)(1)(A) imposes liability on any person who "knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval." 31 U.S.C. § 3729(a)(1)(A).
The key issue under § 3729(a)(1)(A) is whether the defendant "presented or caused to be presented" a false claim.
"Providing exact billing data — name, date, amount, and services rendered — or attaching a representative sample claim is one way a complaint can establish" presentment of a false claim.
Defendants argue that the Amended Complaint fails to plead fraud with particularity as to any false claims being submitted to the Government. (Doc. # 48 at 3; Doc. # 70 at 6-7, 10). Defendants highlight that Stepe worked for RS Compounding in the New York area, "far from RS Compounding's office in Tampa" and that Stepe "lacked any direct, first-hand knowledge of RS [Compounding]'s submission of claims to federal health care programs." (Doc. # 48 at 3). As to the presentation of false claims, Defendants note that "[n]o actual or example false claims or reverse false claims are pled" and Stepe "fails to explain the basis for her assertion that fraudulent claims were actually submitted to federal health care programs." (
Stepe insists the Amended Complaint presents sufficient indicia of reliability. According to Stepe, her role as a sales representative for RS Compounding in New York and New Jersey gave her "first-hand knowledge" supporting her belief that false claims were submitted to the Government. (Doc. # 65 at 12-13; Doc. # 73 at 12). She argues that her detailed allegations about the various schemes, which she alleges were targeted to TRICARE and Medicare patients, "support[] a reasonable inference that Defendants' claims were submitted to Government healthcare programs, since the sine qua non of the scheme was to get paid exorbitant amounts for their compounds." (Doc. # 65 at 12).
True, Stepe has provided detailed allegations regarding marketing schemes and allegedly inadequate training by Defendants. The statement by her superior, Mr. Taylor, encouraging sales representatives to "coach" physicians on how to rank their prescription preferences supports that the "1, 2, 3" marketing scheme exists. And the comments by physicians about upset patients receiving superfluous refills implies that doctors may have mistakenly prescribed a higher number of refills because of the pre-printed script pads. Nevertheless, it is not plainly alleged that the physicians were confused about how many refills they had prescribed, or whether they would have prescribed a lower number of refills if they had not been confused by the pre-printed script pad. And it is unclear whether the patients who complained about receiving unwanted refills were covered by Medicare or TRICARE. Nor is the Court certain on how Defendants' inadequate training of its sales representatives about drug warnings makes the prescriptions submitted by physicians for Defendants' drugs false or fraudulent.
In short, the Court agrees with Defendants. The sine qua non of an FCA case is the submission of a false claim for payment to the Government.
Although Stepe focuses on her status as an insider of RS Compounding, that status, without more, does not provide sufficient indicia of reliability to satisfy Rule 9(b).
Courts cannot draw inferences in favor of relators concerning the submission of fraudulent claims because doing so would strip "all meaning from Rule 9(b)'s requirements of specificity."
Defendants also argue that the Amended Complaint fails to show that allegations regarding the "1, 2, 3 strategy," the automatic refills, and the failure to warn patients are material to the Government's decision to pay claims. (Doc. # 48 at 5-6). Defendants cite
Because the Court has already determined that Stepe's § 3729(a)(1)(A) claim fails to meet the Rule 9(b) standard, the Court need not address the materiality argument at this juncture. But Stepe is advised that, in amending this claim, she should consider the importance of alleging facts supporting materiality — i.e. why the "1, 2, 3 strategy," pre-printed script pads with high refill numbers, and inadequate training regarding drug warnings would influence the Government's decision to pay such claims. And she should remember that her disparate pricing allegations, because they have been superseded, cannot be used to meet the materiality requirement.
In Count II, Stepe alleges Defendants made or used, or caused to be made or used, false records and statements that were material to false or fraudulent claims in violation of 31 U.S.C. § 3729(a)(1)(B). (Doc. # 39 at 28). These false records or statements were "false certifications and representations made or caused to be made by RS Compounding." (
Section 3729(a)(1)(B) creates liability for any person who "knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim." 31 U.S.C. § 3729(a)(1)(B). Thus, "[t]o prove a claim under § 3729(a)(1)(B), a relator must show that: (1) the defendant made (or caused to be made) a false statement, (2) the defendant knew it to be false, and (3) the statement was material to a false claim."
For this provision, the FCA defines "material" as "having a natural tendency to influence, or be capable of influencing, the payment or receipt of money or property." 31 U.S.C. § 3729(b)(4). "Under this version of the statute, a relator is not required to allege presentment because the statutory language includes no express presentment requirement."
Defendants argue this claim should be dismissed because the Amended Complaint "fails to specify what precisely the `false certifications and representations' made by RS Compounding are, as required by Rule 9(b)." (Doc. # 48 at 6; Doc. # 70 at 7-9). Additionally, they contend the Amended Complaint "fails to provide a plausible factual basis to support the allegation that these unidentified certifications and representations were in fact `material' to payment" and "does not contain sufficient facts regarding this claim to meet the
In response, Stepe argues Defendants made a "demonstrably false" certification when they "falsely certified under their provider agreement with TRICARE that they were charging the Government the same prices they charged cash buyers." (Doc. # 65 at 18). But, as the disparate pricing allegations are superseded, the allegation that Defendants falsely certified their pricing was flat cannot support Stepe's claims, which may be based only on the fraudulent marketing and inadequate training allegations. (Doc. # 65 at 18).
The Amended Complaint does not explicitly identify false statements or certifications made, or caused to be made, by Defendants relating to the non-superseded allegations. While the Amended Complaint identifies sales representatives' encouragement of physicians to prescribe more expensive medications, Stepe does not explain how those statements are false. And, although she alleges Defendants placed a number "6" on the refill line of the pre-printed script pads, physicians were free to mark that number out and write the refill number they believe is appropriate. Essentially, Stepe has alleged that Defendants pre-filled the refill section of the script pads to set a default position of numerous automatic refills. But, again, Stepe fails to allege with particularity what part of this action constitutes a false statement under the FCA. The same is true for the inadequate training and drug warning allegations — no false statements or certifications related to these allegations are identified with particularity. Therefore, this claim is dismissed for failure to satisfy Rule 9(b).
Because the § 3729(a)(1)(B) claim does not satisfy Rule 9(b) for the false statement requirement, it is unnecessary to deal with the materiality requirement. Nevertheless, the Court notes that Defendants argue the
Regarding Count III for violation of 31 U.S.C. § 3729(a)(1)(G), Stepe alleges
(Doc. # 39 at 29). "As a result, the Government has suffered damages in the form of millions of dollars in unearned TRICARE, Medicare, and Medicaid payments made to Defendants." (
Section 3729(a)(1)(G) creates liability for a person who "knowingly makes, uses, or causes to be made or used, a false record or statement material to an obligation to pay or transmit money or property to the Government," or who "knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay or transmit money or property to the Government." 31 U.S.C. § 3729(a)(1)(G). "This is known as the `reverse false claim' provision of the FCA because liability results from avoiding the payment of money due to the government, as opposed to submitting to the government a false claim."
"Importantly, to establish a reverse false claim cause of action, a relator must show that the defendant owed a definite and clear `obligation to pay money to the United States at the time of the allegedly false statements.'"
Defendants argue Stepe "fails to specify precisely what [] both the `false certification made or caused to be made by Defendants' and the `obligation' was, as required by Rule 9(b)." (Doc. # 48 at 7; Doc. # 70 at 7, 9). They also argue the Amended Complaint "fails to provide a plausible factual basis to support the allegation that these unspecified certifications were in fact `material' to the unidentified obligations." (Doc. # 48 at 7). In her response, Stepe insists she has identified the false certification made and obligation owed to the Government: "Defendants were obligated but failed to return their `ill-gotten gains' to the Government," specifically the money they received from charging higher prices to the Government and by "ship[ping] unsuspecting patients six automatic refills of its creams and gels that were medically unnecessary." (Doc. # 65 at 18).
The Court finds that Stepe has not identified with particularity the false certification that was allegedly made or caused to be made by Defendants. As already discussed, the disparate pricing allegations are superseded. So, the allegation that Defendants falsely certified to TRICARE that "they were charging the Government the same prices they charged cash buyers" cannot support Stepe's claims, which may be based only on the fraudulent marketing, automatic refills, and inadequate training/warning allegations. (Doc. # 65 at 18). No false certifications related to the non-superseded allegations, such as the automatic refills, are identified in the Amended Complaint. Similarly, the Court is unsure what obligation Defendants had to pay the Government, as Stepe also fails to identify this beyond stating Defendants "failed to return their `ill-gotten gains'." (
Furthermore, because neither the false certification nor the obligation have been alleged with particularity, the Court cannot determine whether the false certification was "material" to the obligation. This claim is dismissed for failure to comply with the particularity requirement of Rule 9(b).
In Count IV, Stepe alleges Defendants violated 31 U.S.C. § 3729(a)(1)(C), which creates liability for any person who "conspires to commit a violation of subparagraph (A), (B), (D), (E), (F), or (G)." According to Stepe, Defendants violated this section by "conspir[ing] to make or present false or fraudulent claims and performed one or more acts to effect payment of false or fraudulent claims." (Doc. # 39 at 29). Defendants argue the Amended Complaint fails to allege the existence of a conspiracy plausibly, as required under Rule 12(b)(6), or with the particularity required under Rule 9(b). (Doc. # 48 at 7).
Complaints alleging a conspiracy to violate the FCA are also subject to Rule 9(b)'s heightened pleading standard.
District courts in the Eleventh Circuit — and at least one other circuit court — have held that a failure to adequately allege the existence of a false claim is fatal to a conspiracy claim.
Regardless, the Court finds that Stepe has not pled with particularity that a conspiracy existed between Defendants RS Compounding, Gobea, and Caddick. Stepe emphasizes her allegations that "Gobea and [] Caddick worked together, through and with RS Compounding, to set the disparate prices at issue, devise and implement the `1, 2, 3' marketing scheme and automatic refills, and to provide insufficient warnings to patients and inadequate training to RS Compounding's sales representatives." (Doc. # 65 at 18).
But the allegations she points out are conclusory and insufficient to support that Defendants entered a specific agreement to submit fraudulent claims to the Government or that they took any overt act to fulfill that agreement.
Both Caddick and Gobea argue that the allegations about their personal involvement in any scheme or submission of false statements or claims are conclusory and must be dismissed. (Doc. # 48 at 4-5; Doc. # 70 at 7-8). Indeed, the Amended Complaint includes numerous conclusory allegations, such as: "pursuant to [] Gobea's and [] Caddick's directives, [] Defendants instructed their sales representatives to write in the physician's name and address, and the number `6' on each refill line." (Doc. # 39 at ¶ 63). As Gobea points out, the Amended Complaint "neither quotes nor cites any statements by [] Gobea to [Stepe] or any others to direct or encourage FCA violations." (Doc. # 48 at 4). Similarly, the Amended Complaint fails to allege details about Caddick's supposed directives.
Stepe retorts that she has made specific allegations about Gobea and Caddick's personal involvement in the alleged fraud. (Doc. # 65 at 13-14; Doc. # 73 at 13-14). Stepe emphasizes that Mr. Taylor, the Vice President of Sales and Marketing, told her that the disparate pricing decision came from "the top" of RS Compounding. (Doc. # 65 at 14). Stepe interprets this statement to mean that Caddick and Gobea themselves crafted the scheme. (
Lumping two Defendants together without any supporting factual allegations to suggest the actions were taken jointly is insufficient.
The lumping together of Caddick and Gobea is especially problematic because it is unclear if Gobea was even associated with RS Compounding during Stepe's employment. The Amended Complaint states Gobea and Caddick co-founded RS Compounding in 2004, but Gobea left "[a]t some point after founding the company," without a date specified. (Doc. # 39 at ¶ 35). Stepe alleges Gobea returned to buy out Caddick's ownership interest in February of 2014 — after Stepe's employment (and, thus, her insider knowledge about RS Compounding's practices) ended. Greater particularity about the conduct of the individual Defendants, Gobea and Caddick, is required under Rule 9(b).
Counts I, II, III, and IV under the FCA, as well as the parallel claims under the States' false claims laws, are dismissed. Stepe requests leave to amend her claims. (Doc. # 65 at 20). Pursuant to Fed. R. Civ. P. 15(a)(2), "[t]he court should freely give leave [to amend] when justice so requires." "In light of the liberal policy favoring amendment, and because this Court has not previously issued any substantive ruling in this action, the Court will grant [Stepe] one — and very likely only one — opportunity to amend."
Accordingly, it is now