ORDER
In this qui tam action, Relator alleges that Defendant violated the False Claims Act (“FCA”), 31 U.S.C. § 3729 et seq., by engaging in a fraudulent billing scheme in which Defendant received a certain portion of the medication it ordered from manufacturers for free, it administered that allegedly free medication to dialysis . patients, and then it sought reimbursement from Medicare for the free medication it administered. '.Defendant moves to dismiss the lawsuit under two statutory provisions that circumscribe the Court’s jurisdiction.
Defendant has styled its Motion as a Motion to Dismiss for lack of subject matter jurisdiction [Doc. 215]. Defendant filed a very similar motion back in July of 2011. The Court dismissed it and found jurisdiction to be proper based on the allegations in the Complaint. (Doc. 57.) The parties then engaged in discovery, during which Relator’s deposition was taken on November 16,. 2012. Almost two and a half years have lapsed between Relator’s deposition and Defendant’s filing this Motion, which is a factual challenge to the Court’s jurisdiction based mostly on the November 2012 deposition.
Defendant argues that both the Public Disclosure Bar and the First-to-File Bar apply to Relator’s claims, thereby depriving the Court of subject matter jurisdiction
1. LEGAL STANDARD
A motion to dismiss for lack of subject matter jurisdiction may be based on either a facial or factual challenge to the complaint. See McElmurray v. Consol. Gov’t of Augusta-Richmond County,
the trial court may proceed as it never could under 12(b)(6) or Fed.R.Civ.P. 56. Because at issue in a factual 12(b)(1) motion is the trial court’s jurisdiction its very power to hear the case there is substantial authority that the trial court is free to weigh the evidence and satisfy itself as to the existence of its power to hear the case. In short, no presumptive truthfulness attaches to plaintiffs allegations, and the existence of disputed material facts will not preclude the trial court from evaluating for itself the merits of jurisdictional claims. [In addition], the plaintiff [bears] the burden of proof that jurisdiction does in fact exist.
Lawrence,
II. BACKGROUND
The facts most relevant
Sometime in August, September, or October
In September 2009, Relator began doing the inventory for Epogen as well. (Id. at 30:11-15.) The Epogen inventory form also included an overfill calculation, though Relator was only responsible for inputting the beginning and ending vial counts. (Id. at 150:20-151:8.) Relator knew that someone else — either a clinic manager, a secretary, or a nurse — was responsible for plugging in the number of doses administered. (Id. at 150:15-151:8.)
All told, Relator completed Zemplar inventory forms containing overfill calculations from August 2007 to December 2008, and he completed Epogen inventory forms from August or September of 2009 until his termination in December 2009. Two different supervisors told Relator that it was very important that he not make a mistake on those inventory forms because they were the basis of billing Medicare. (Id. at 39:17-40:6; 83:22-84:9.)
Inventory forms were not Relator’s only job responsibilities related to, or his only interface with, overfill billing. In March 2008 — one year into his almost 3-year tenure at Fresenius — Relator was promoted from equipment technician to chief technician. (Id. at 14:22-15:1.) In Saldivar’s chief technician role, he was tasked with “achieving” the right amount of overfill, and his colleagues assured him they would assist him in his charge. (Id. at 161:6-9.)
Relator was also well aware of Freseni-us’s overfill policy because it was openly talked about in the office:
The use of overfill was openly discussed by managers and nurses at Fre-senius. It was a topic of conversation in part because the clinics were ranked nationwide on overfill collection, and employees at clinics with the highest percentages of overfill with Fresenius’ prescribed ranges were given bonuses.
(Saldivar Deck ¶ 8; see also Saldivar Dep. at 165:6-12 (“[0]ur goal [wa]s to achieve that overfill mark. Remember, we’re competing in the ultra score [bonus structure]. We’re trying to get that bonus. All clinics are trying to get that bonus. There’s a ranking.”).)
Relator was privy to the specifics of Fresenius’s overfill policy by virtue of his chief technician position and his inventory duties. Relator explained that he and other; Fresenius employees talked about the overfill policy “in clinical meetings. We talked about it in one-on-one conversations with managers. We talked about the monthly and quarterly report coming from corporate about the overfill.” (Id. at 48:12-17.) Relator understood how effectively the policy was implemented across Fresenius’s clinics nationwide because he was shown national reports as a result of his inventory-related functions:
During my employment, Fresenius’ corporate headquarters regularly sent monthly and quarterly reports to clinic supervisors reminding them of the company’s overfill percentage goals and listing clinic performance nationwide in terms of overfill percentage for Epogen and Zemplar administered to patients. Became I was charged with accounting for Zemplar and Epogen vials, I was shown these reports each month and quarter.
(Saldivar Deck ¶ 10 (emphasis added).)
Eventually, on December 18, 2009, Relator Chester Saldivar was terminated. Some months thereafter, he brought this lawsuit against Fresenius. The Third Amended Complaint, the operative com
• Count 1: Violation of the FCA for submitting false or fraudulent claims with respect to Zemplar overfill reimbursement and making false records or statements material to such claims.
• Count 2: Violation of the FCA by-concealing or improperly avoiding or decreasing its own obligation to reimburse the Government for Zemp-lar overfill reimbursement as described in Count 1.
• Count 3: Violation of the FCA for submitting false or fraudulent claims with respect to Epogen overfill reimbursement and- making false records or statements material to” such claims.
• Count 4: Violation of the FCA by concealing or improperly avoiding-or decreasing its own obligation to reimburse the Government for Epogen overfill reimbursement as described in Count 3.
Fresenius contends that its practice of utilizing overfill has been disclosed multiple times in multiple forms. Defendant points to three prior lawsuits, a 2004 Office of the Inspector General (“OIG”) Report, a 2005 Department of Justice (“DOJ”) subpoena, Fresenius’s own SEC filings from 2005 through 2009, a 2008 article in a trade publication, and a number of financial analyst reports. These publications, and exactly what information they contained, will be addressed in more detail below as required.
III. DISCUSSION
A. Public Disclosure Bar
Defendant argues that the Court lacks subject matter jurisdiction to hear this case because the allegations upon which Relator’s claims are based had been publicly disclosed before Relator filed his Complaint. Defendant also argues that Relator , is not an original source for any of that information. Relator disagrees, contending not only that the specific allegations that Fresenius billed Medicare for free overfill had not been disclosed, but also that Relator is an original source of the information.
The FCA’s Public Disclosure Bar (“PDB”) was designed to “strike a balance between encouraging .private persons to root out fraud and stifling parasitic lawsuits. ...” Graham Cnty. Soil & Water Conservation Dist. v. U.S. ex rel. Wilson,
The PDB that applies to Relator’s claims
(A) No court shall have jurisdiction over an action under this section based upon the public disclosure of allegations or transactions in a criminal, civil, or administrative hearing, in a congressional,*1317 administrative, or Government Accounting Office report, hearing, audit, or investigation, or from the news -media, unless the action is brought by the Attorney General or the person bringing the action is an original source of the information.
(B) For purposes of this paragraph, “original source” means an individual who has direct and independent knowledge of the information on which the allegations are based and has voluntarily provided the information to the Government before filing an action under this section which is based on the information.
The Eleventh Circuit dictates a three-step inquiry under the PDB: “(1) have the allegations made by the plaintiff been publicly disclosed; (2) if so, is the disclosed information the basis of the plaintiffs suit; (3) if yes, is plaintiff an ‘original source’ of that information.” McElmurray v. Consol. Gov’t of Augusta-Richmond County,
1. Publicly disclosed
Step 1 of the Cooper test requires the Court to determine whether the allegations in the Complaint were publicly disclosed. There is little question in this case that some similar factual allegations have been disclosed, at least in part.
Under the statute, a disclosure is public if it occurs “in a congressional, administrative, or Government Accounting Office report, hearing, audit, or investigation, or from the news media.” 31 U.S.C. § 3730(e)(4)(A). The sources of the information at issue here are unsealed filings in prior federal court litigation, federal government reports available to the public online; publicly aváilable Securities and Exchange Commission (“SEC”) filings, and publicly available industry reports. To the extent those documents are not marked as “confidential,”
a. Woodard
Defendant argues that Relator’s allegations were disclosed in the second amended complaint in U.S. ex rel. Ivey Woodard v. Fresenius Medical Care, AG., DaVita, Inc., and John Does 1-20, No. 1:02-CV-00252, Doc. 42 (E.D.Tex.2002). According to the Woodard docket, the second amended complaint was filed on March 3, 2005 and was unsealed on February 2, 2010
• Administering Epogen without regard to medical necessity or patient need, and in an off-label manner, by allowing Amgen salespeople, in violation of federal regulations, to view patient charts without patient consent and direct the clinic staff to administer Epogen in excess of the maximum amount permitted by the product information sheet, (id. ¶¶ 30-31);
• Maintaining a practice in which physicians would approve the above dosage alterations ■ without consulting patients’ charts, (id. ¶ 34);
• Reporting to Medicare potentially false reasons- why excess Epogen was administered to a particular patient, (id. ¶ 36);
• Intravenous (rather than subcutaneous) administration of Epogen in a scheme to minimize the drug’s efficiency and thus maximize the amount for which the companies could bill Medicare, (id. ¶¶ 39-49);
• Administering Epogen in an off-label and illegal manner by making multiple entries into single-entry Epogen vials to capture overfill, and then administering the overfill and billing Medicare for those additional doses “as if [the doses] came from new vials,” (id. ¶ 56.);
• Billing Medicare for more Epogen than was actually administered, (id. ¶ 62);
• Obtaining rebates on Epogen orders from their Epogen supplier, Amgen, yet billing Medicare for the full amount paid, (id. at 24-25);
• Receiving kickbacks from Amgen including free anemia management and training support, free clinical and sales staff, and free entertainment funds, (id. ¶¶ 70-74);
• Obtaining rebates on Zemplar orders from their Zemplar supplier, Abbot Laboratories, yet billing Medicare for the full amount paid, (id. ¶¶ 78, 84);
• Making false representations to physicians in order to convince them to*1319 switch patients off other Vitamin D analogs and onto Zemplar, (id. ¶¶ 82-83); and
• Submitting claims for “unnecessary doses of Zemplar.” (Id. ¶ 85.)
The Woodard allegations related to Zemp-lar do not disclose the allegations in this case. They do not discuss overfill at all. The Woodard allegations related to Epo-gen, and particularly the following paragraphs, come much closer, although they focus on Fresenius’s violation of medical standards:
56. Since on or about 1992, Defendants instructed their employees to make multiple entries into single-use vials of Epo-gen to capture the overfill and these instructions may have been reduced to writing. Defendants combined the overfill from multiple vials to form additional doses of Epogen, and the additional doses were billed to Medicare as if it came from new vials.
57. Such multiple entries into single-use vials are a violation of standard medical practice, state law, and Medicare conditions of coverage for such, which require use of medications according to their labels and consistent with good medical practice. Multiple entries also pose a significant risk of infection to patients.
64. As a result of the above practices, [Fresenius] and DaVita have submitted and have continued to submit false claims for EPO to Medicare in substantial amounts per year.
(Id. (emphasis added).) If the context of the allegations provided by paragraph 57 and the remainder of the Complaint is stripped away or ignored, the italicized portion of paragraph 56 as well as paragraph 64 can be read to allege simply that such Medicare overfill billing violated the FCA and continued through March 3, 2005, when the second amended complaint was filed.
b. OIG Investigation — Epogen
Other public disclosures of billing Medicare for Epogen overfill are found in written communications relayed pursuant to a Corporate Integrity Agreement (“CIA”) between Fresenius and the Office of the Inspector General (“OIG”). Qn January 18, 2000, Fresenius entered into the CIA, which lasted from 2000 through 2008 and was “designed to ‘ensure compliance’ by Fresenius and its subsidiaries, employees, contractors, and agents, ‘with the re- ' quirements of Medicare, Medicaid and all other Federal health care programs.” (Doc. 221-20 at 25-26.) The OIG Associate Counsel assigned to monitor Freseni-us’s compliance with the CIA was Nicole Caucci (formerly Nicole Hall).
Communications between Fresenius and Caucci, and Caucci’s deposition testimony, show that Fresenius did not hide its overfill billing practicés. For example, in an October 5, 2001 letter, Fresenius stated, “[i]nsofar as Epogen is billed to the Medicare program on the basis of units actually administered, the utilization of overfill amounts has no effect on facility reimbursement.” (Doc. 221-21 at 5.)
Likewise, in a November 4, 2002 letter, Fresenius notified Ms. Caucci that it had “noted an increase in the reported amount of overfill recovered from Epogen vials by [its] dialysis clinics.” (Doc. 221-23 at 171.) In particular, some clinics were reporting an average overfill of more than 16.8%— the target on average overfill contained in Epogen vials. “By itself,” Fresenius explained, “an improvement in the Compa
Fre'senius sent Ms. Caucci a follow-up letter in February 2003; The letter explained that Fresenius had not yet completed its analyses or reached any final conclusions regarding the reported overfill discrepancy. However, Fresenius notified Caucci that it established the escrow account for estimated revenue attributable to Epogen overfill in excess of 16,8% and was in the process of developing a procedure for monitoring the accuracy of overfill utilization using scientific scales. (Doc. 221-23 at 190-192.)
The next letter to Caucci, dated March 3, 2003, further confirmed Fresenius’s utilization and .billing for overfill. Freseni-us’s Senior Vice President John Markus explained the new Epogen monitoring program Fresenius had instituted and enclosed material describing this program. (Doc. 221-24 at 2-10.) A critical aspect of the new program involved reducing the amount Fresenius billed Medicare for Ep-ogen overfill amounts if the reported overfill amount exceeded 17%, which was below the 17.6 percent average overfill recently reported by Amgen. Markus explained, “Should the reported overfill exceed the maximum amount calculated from the measured sample, all billing for Epogen amounts from that facility for that day will be reduced on a pro rata basis prior to billing.” (Id.) Caucci assumed, based on this disclosure, that Fre-senius would continue this program throughout the life of the CIA — ie., though 2008 — unless Fresenius notified her to the contrary. (Caucci Dep. at 79-80.) She did not recall Fresenius ever notifying her that it was discontinuing the program. (Id. at 79.) Under Step 1 of the Cooper test, the Woodard second amended complaint and the CIA communications publicly disclose the Epogen allegations.
c. OIG Investigation — Zemplar
Billing Medicare for Zemplar was also publicly disclosed in the OIG investigation. Another March 2003 letter to Ms. Caucci addressed billing Medicare for Zemplar overfill. (Doc. 221-24 at 12-13.) Here, David Kembel, Fresenius’s Assistant General Counsel, explained that there was a “potential overpayment involving billings for Zemplar.” (Id. at 12.) “In June, 2002,” Kembel explained, “we became aware that a small number of FMCNA facilities were utilizing the overfill contained in vials of Zemplar. Upon further review, we determined that in some in
Specifically, in instances where the physician ordered between 5 and 6 meg. of Zemplar the clinic' staff could at times obtain the full dose from a single 5 meg. vial. Our billing system was at the time programmed to bill for Zemplar in 5 meg. increments based on the Medicare HCPCS code available at the time. Therefore, if the clinician were able to obtain the full dose from one vial of Zemplar, the billing system would still bill the administration as 10 meg. even though only one vial was used. The same issue arises if the physician, ordered between 10. and 11 meg., since Zemplar is sold in 10 meg vials as well and the overfill could have been used, to complete the prescribed dose. A June 25, 2002 memorandum directed the facilities to discontinue utilizing Zemplar overfill until billing software changes could be made.
(Id. at 12-13 (emphasis'added) (footnote omitted).) In other words, Fresenius disclosed to OIG (through Caucci) that its clinics were utilizing and billing Medicare for Zemplar overfill, but at times, inadvertently billing for more than was actually administered. According to Caucci, this letter confirmed that Fresenius had disclosed that it was both using Zemplar overfill and billing the government for it, (Caucci Dep. at 67), and Caucci understood that Fresenius’s overfill utilization policy would continue throughout the life of the CIA — through 2008 — unless she was notified otherwise. (Caucci. Dep. at 89.) Caucci did not indicate that Fresenius ever notified her otherwise. (See id. at 147:20-25 “Q. Do you agree that Fresenius fully disclosed to you that it used and billed for Epogen and Zemplar ovérfíll at all times from 2008 through [2008]? A. They did disclose to me that they were using and billing for overfill Epogen and Zemplar.”) Under 31 U.S.C. § 3730(e)(4)(A), a disclosure in an “administrative ... report, hearing, audit, or investigation” is public, so Step 1 of the Cooper test is satisfied for all of Relator’s claims involving both Epogen and Zemplar.
2. Disclosed information as the basis of Relator’s suit
Step 2 of the Cooper test asks whether the Relator’s lawsuit is “based in any part on publicly disclosed information.” Battle,
The Court previously found that Relator’s lawsuit could not be “based on” the second amended complaint in Woodard because the second amended complaint alleged fraud based on a distinct theory of liability. (Doc. 57 at 16.)
Under the quick trigger of Step 2, as interpreted anew in Osheroff, Epogen overfill billing was likely sufficiently disclosed in the Woodard second amended complaint. The allegations that Fresenius “combined the overfill from multiple vials to form additional doses of Epogen” and that those additional doses “were billed to Medicare,” (Doc. 42-4 ¶ 56), likely overlap with the Epogen claims in this case in a significant enough way that they count under Osheroff’s analysis.
That date matters, because Relator persuasively argues that the Court should disregard any of the disclosures that pre-date CMS’s the adoption of the Average Acquisition Cost methodology in January 1, 2005. This argument has some appeal, for a disclosure that a company is performing a legal activity does not obviously equate to a public disclosure that a company is still proceeding with that same activity after the activity becomes illegal. Common sense dictates that the initial disclosure would be stale as of the change in the law, thereby requiring a new public disclosure that, yes, the company was still doing it even though the practice has become unlawful. But see U.S. ex rel. Fine v. Sandia Corp.,
The disclosure timing issue is further complicated in this case, where the only obvious disclosure of billing Medicare for Zemplar overfill comes, essentially, from Fresenius’s silence. Specifically, as described in detail above, Fresenius disclosed to the government, pursuant to the CIA, that it was billing for Zemplar overfill in 2003. And, pursuant to the government’s understanding of the CIA, Fresenius would inform the government if it stopped billing for Zemplar overfill anytime before the CIA ended in 2008. So, according to Caucci, the OIG Associate Counsel assigned to monitor Fresenius’s compliance with the CIA, the government understood or assumed that Fresenius was still billing for Zemplar overfill until sometime in 2008.
True, the purpose of the public disclosure bar is to “discourage opportunistic plaintiffs who have no significant information to contribute of their own,” Graham Cnty.,
3. Original Source
The third and final — and more, exacting — inquiry under the Cooper test is whether Relator was an original source of the information alleged. Relator’s knowedge “must have been direct and independent for the [relator] to qualify as an original source.” Osheroff,
In Cooper, the relator, an employee of the defendant, was an original source -because he acquired his information through years of experience in processing claims with Blue Cross Blue Shield of Florida.
In McElmurray v. Consolidated Government of Augusta-Richmond County,
Finally, in Osheroff, the relator also was not an employee and also was not an original source. The relator there had done his own “market research” and his allegations substantially overlapped with information available in the public media. Those news . media disclosures portrayed that “the clin•ics offered many free services to their patients,”
This case is more like Cooper than Osheroff or McElmmray, and Relator — an employee of Defendant — has presented sufficient facts to convince the Court that he has direct and independent knowledge that provides more than mere background information. Chester Saldivar. began working for Fresenius in April of 2007. Starting in August or so of 2007, Relator was in charge of ordering both Epogen and Zemplar for his two Fresenius clinics, and he also transferred orders to and between the clinics. He continued to perform this ordering and transferring function for both drugs until his termination in December 2009.
The same month Relator began ordering both drugs — approximately August of 2007 — he was also assigned to report on Zemplar inventory. As part of doing the inventory, Relator personally counted the number of vials on hand at the beginning and end of the month, and personally filled out inventory forms containing this information and the number of doses administered that month. Relator performed this function for his two clinics’ Zemplar inventory from August 20G7 to December 2008,
Relator’s allegations covered not only his actual knowledge, based on his job duties as Chief Technician at two labs, of billing Medicare for overfill, but also his personal familiarity, again as a result of his Chief Technician position, with Fresenius’s .national remuneration regime in which employees were both driven and incentivized by the head corporate office' to maximize Fresenius’s profit from the administration and billing of Epogen and Zemplar overfill. Relator had direct, independent evidence that Fresenius incentivized- its employees as such and had direct, independent knowledge of the incentive structure through the reports he regularly received from corporate headquarters. The “Internal Memo” regarding “Monthly Scorecard and Leader Board — Measurements and Calculations” supplied by Defendant, while, it is somewhat difficult to understand,
Relator similarly testified that he.partic- • ipated in company discussions regarding maximizing the administration of overfill around the office, in clinical meetings, and ’ in one-on-one conversations with managers. And because Relator was tasked with accounting, for Epogen and Zemplar vials, he was shown monthly and quarterly reports “listing clinic performance hation-wide in terms of overfill percentage for Epogen and Zemplar administered-to patients.” (Saldivar Deck ¶ 10.) Taken together, all of the above leaves little doubt that Relator was an original source for his claims for at least some period of time. While Relator may not have actually -filed any reimbursement-forms with Medicare,(id. at 40:18-24), and may not have worked in the billing department, (id. at 68:5-9.), Relator’s first-hand experience filling out inventory forms which were used to bill Medicare, and his first-hand experience with Fresenius’s national policies tó maximize billing for utilization of overfill, is sufficient to constitute specific, direct, independent evidence of potential fraud. See U.S. ex rel. Westfall v. Axiom Worldwide, Inc., No. 8:06-cv-571-T-33TBM,
Defendant would have the Court disqualify Relator as an original source because he did not fill out the actual form that was submitted to Medicare, but only an inventory form on which-the numbers in the actual Medicare reimbursement form were based. That exceedingly granular argument is unpersuasive. Relator was advised by two of his supervisors -that . the forms he -personally filled out were used to bill'Medicare — which was why it was so important that he get the information right. His direct relationship to the . drug billing and utilization process is a far cry from the facts presented -in cases cited by Defendants, where the- relators’ information came from Freedom of Information Act requests, U.S. ex rel. Mistick PBT v. Hous. Auth. of City of Pittsburgh,
At the very least, Relator is an original ' source for at least some time period for both .of the drugs at issue. While the precise time period, or other factors could -affect a damages calculation, it is clear that the Court has jurisdiction to hear claims related to the billing of Medicare for overfill in vials of both drugs. Accordingly, Defendant’s Motion to Dismiss for lack of subject matter jurisdiction based on the ■Public Disclosure Bar is DENIED.
Defendant also argues that the Court lacks jurisdiction to hear Relator’s claim due to the FCA’s first-to-file rule. That rule states, “When a person brings an action under this subsection, no person other than the Government may intervene or bring a related action based on the facts underlying the pending action.” 31 U.S.C. § 3730(b)(5) (emphasis added). While Defendant’s Motion was pending, the U.S. Supreme Court held that an earlier-filed action “ceases to be ‘pending once it is dismissed.” Kellogg Brown & Root Serv., Inc. v. United States ex rel. Carter, — U.S. —,
1. Pending
Defendant argues that Woodard was indeed still pending at the time Relator’s Complaint was filed because certain claims against other Woodard defendants were proceeding at, that time — even though all claims against Fresenius had been dismissed. Relator argues that it is the dismissal of all claims against Fresenius that matters.
The U.S. Supreme Court recently held, in no uncertain terms, “[t]he FCA’s first-to-file bar keeps new claims out of court only while related claims are still alive, not in perpetuity.” Carter,
It wouldn’t. Thus, when a defendant is dismissed from a qui tam suit, that action is no longer “pending” as against that defendant. Woodard abandoned his claims against Fresenius and voluntarily dismissed Fresenius from the lawsuit, with the Government’s consent, in January 2010. Relator’s original Complaint in this action was filed in March 2010. Accordingly, when Relator’s complaint was filed, there was no action pending against Fre-senius, so the first-to-file bar does not bar this suit.
2. Related
Even if Woodard were deemed still “pending” as against Fresenius, the Court also finds it unrelated. A second action is “related” if it is “based on the facts underlying the pending action.” 31 U.S.C. § 3730(b)(5) The Eleventh Circuit’s only explicit instruction on this prong of the first-to-file bar is “once one suit has been filed by a relator or by the government, all other suits against the same defendant based on the same kind of conduct would be barred.” Cooper,
A comparison of the second amended complaint in Woodard to Relator’s Complaint makes clear that the actions are not related. See In re Natural Gas Royalties Qui Tam Litig. (CO2 Appeals),
54. Defendants’ dialysis clinics • soon learned that they could collect the overfill in the single-use vials and use it as a source of substantial amounts of “free” Epogen, which they could nevertheless bill to Medicare as though it came from new vials. However, the single-use vials are labeled as single-use and, 'many states prohibit multiple entries into single use [sic] vials. Multiple entries into EPO single-use vials are considered “off-label” and violations of good medical practice.
(Doc. 42-4 at 21.) As is obvious from the remainder of the paragraph — and the rest of the second amended complaint — Woodard is not concerned with billing for overfill per, se. Woodard is concerned with billing for overfill “as though it came from new vials.” (Id.) The essence of the relevant fraud alleged in Woodard was Fre-senius certifying that it complied with Federal Drug Administration and state standard of care regulations — a condition for Medicare reimbursement — even though it was in fact impermissibly double- ■ dipping into single-use vials in violation of “standard medical practice, state law, and Medicare conditions of coverage for such, which require use of medications according to their labels and consistent with good medical practice.” (Woodard Second Amended Complaint, Doc. 42-4 ¶ 57.) It was immaterial to Woodard’s'’ claims whether Fresenius was retrieving overfill or only unused medication up to the amount labeled on the vial.
Here, on the other hand, Relator alleges a nationwide scheme of billing Medicare for administered Epogen and Zemplar overfill when Fresenius was not entitled to reimbursement for overfill after the adoption of the 2005 regulations. Relator’s claims in this case do not involve express certification of compliance with state law or medical or medication practice standards. Thus, the “type of fraud” or the “essential elements” or the “material elements” of the fraud were not the same. Under Cooper, Relator does not allege the “same kind” of fraudulent conduct alleged in Woodard.
Accordingly, this case-is not a “related action” under the material elements test. .Thus, it is not “based on the facts underlying the pending action” such that the FCA’s first-to-file bar applies. 31 U.S.C. § 3730(b)(5). And that assumes that the Woodard action is still “pending,” which the Court has already rejected.
For the forgoing reasons, Defendant’s Motion to Dismiss [Doc, 2Í5] is DENIED.
IT IS SO ORDERED this 30th day of October, 2015.
Notes
. Defendant makes the veiled argument that the Eleventh Circuit’s recent decision in U.S. ex rel. Osheroff v. Humana Inc.,
. The facts of this case are long, complex, and detailed elsewhere. (See, e.g., Doc. 144 at 3-13.)
. The exact date on which Plaintiff began performing this function is unclear. (See Sal-divar Dep. at 20:2-21:20.)
. Overfill is a varying amount of extra medicine contained in individual vials, the purpose
. The 2010 amendments to the False Claims Act altered the language of the PDB. See U.S. ex rel. Osheroff v. Humana Inc.,
. The Court therefore does not consider the 2008 Citigroup Global Markets Document. (Doc.237-3.)
. Fresenius’s Deputy General Counsel for Litigation, Ronald Castle, stated that the date of unsealing was July 2009. (Declaration of Ronald L. Castle ¶ 41, Doc. 42-2 at 18.) The docket sheet of the case shows otherwise.
. Relator does not contest that Fresenius was the defendant in Woodard.
. Other public disclosures offered by Defendant imply that Fresenius billed Medicare for Epogen overfill. In particular, the SEC filings disclosed that Fresenius billed the gov-ernmentfor administered Epogen and noted that a reduction in the amount of Epogen overfill in the vials supplied by the manufacturer could adversely affect business.
. The Court’s Order on the Parties’ Cross Motions for Summary Judgment, issued on the date of this Order, details more fully the multiple public disclosures of Fresenius’s billing of Medicare for Epogen and Zemplar overfill.
. The Court nonetheless assumed for the sake of analysis that the lawsuit was based on the public disclosures and went on to find, based on the allegations in the Complaint, that Relator was an original source of the information. (See Doc. 57 at 15-17.)
, While Relator continued to fill out Zemp-lar forms after December 2008, Fresenius stopped billing for Zemplar overfill after that time, so the forms no longer contained an input space for that information.
. The record indicates that Relator may have been slightly confused as to the precise way in which overfill factored into the calculations involved in Fresenius's bonus structure. Fre-senius makes much ado about this. But Fre-senius's'argument is much adp about nothing as the record is sufficiently clear in any event that‘employees were given bonuses based on the efficiént utilization of overfill.