PRATTER, District Judge.
Mr. Galmines brings this qui tam action against Novartis Pharmaceuticals Corporation ("Novartis") under the False Claims Act, 31 U.S.C. §§ 3729 et seq., and the laws of several states. Mr. Galmines asserts that Novartis engaged in "off-label" marketing for the drug Elidel, encouraging
The Court now must consider Mr. Galmines's Motion for Leave to File a Fourth Amended Complaint (Doc. No. 106). The need or at least the stated justification for the request for this Fourth Amended Complaint allegedly arises out of a February 2014 discovery dispute between the parties. Mr. Galmines sought discovery relating to Novartis's conduct following the filing of the initial complaint on July 21, 2006. Novartis opposed this discovery request, and the Court ruled that, in order to obtain discovery for conduct after the date of the filing of the initial complaint, Mr. Galmines would need to allege wrongful conduct continuing after July 21, 2006. See Feb. 26, 2014 Order (Doc. No. 104). Mr. Galmines now seeks leave to file a Fourth Amended Complaint that alleges continuing wrongful conduct by Novartis through at least 2009. Novartis opposes permitting Mr. Galmines to amend his complaint a fourth time. Novartis argues that Mr. Galmines unduly delayed in proposing this amendment and that, in any case, the amendment is futile. Specifically, Novartis argues that the amendment is futile not only because the new allegations are not well-pleaded, but also because Mr. Galmines is not an "original source" of the publicly disclosed allegations, which status would bar his claims under the False Claims Act. The Court disagrees, however, and will allow Mr. Galmines file a Fourth Amended Complaint.
The primary point of contention among the parties is whether Mr. Galmines must meet the "original source" requirements for the new allegations and, if so, whether he does meet those requirements. The False Claims Act allows citizens to sue those making false claims to the federal government, though it bars such actions that are "based upon the public disclosure of allegations ... unless ... the person bringing the action is an original source of the information." See 31 U.S.C. § 3730(e)(4)(A) (2006).
The Court has already grappled with the original-source exception to the public-disclosure bar in this case. In June of 2013, the Court held that Mr. Galmines could qualify as an original source under the False Claims Act even though his direct and independent knowledge concerned only Novartis's practices that caused the false claims and not the false claims themselves. See generally June 13, 2013 Memorandum (Doc. No. 68) available at 2013 WL 2649704. The Court found this case to be distinguishable from the Third Circuit Court of Appeals's opinion in United States ex rel. Mistick PBT v. Housing Authority, 186 F.3d 376 (3d Cir.1999), in which the Third Circuit Court of Appeals held that a relator was not an original source where the relator lacked direct and independent knowledge of the defendant's false submissions to the Government, "the most critical element of its claims." See id. at 388. The Court determined that because the allegations of Mr. Galmines are merely that Novartis caused others to submit false claims and did not submit false claims itself, the ruling in Mistick did not apply. The False Claims Act does allow claims where the defendant only "causes to be presented" a false claim, see 31 U.S.C. § 3729, and for such claims, the "most critical element of [the] claims" is not the submission to the Government but the conduct causing the false submissions.
The parties dispute whether the new allegations are based upon public disclosures. The Court agrees with Novartis that they are. Mr. Galmines argues that "[m]any details in Mr. Galmines [sic] Fourth Amended Complaint were provided by Novartis in non-public documents to the U.S. [A]ttorney in the Eastern District of Pennsylvania and/or the state of Texas in response to Civil Investigative Demands." Mot. at 6. However, Novartis points out that Mr. Galmines has already conceded that the fraudulent scheme underlying his claims were publicly disclosed. See Mem. in Opposition 8 (citing Relator's Response in Opposition to Mot. to Dismiss 26-27 (Doc. No. 45)). The question, then, which resonates throughout this present procedural dispute, is whether it is correct to conclude that because the original claims were based on public disclosures, the new allegations are also based on those same public disclosures. To answer this question, the Court has to consider whether the new allegations are "substantially similar" to those which have been publicly disclosed. U.S. ex rel. Paranich v. Sorgnard, 396 F.3d 326, 334-35 (3d Cir.2005). Here, they are substantially similar, as they allege the same underlying scheme, but as applied to a new time period. See id. at 335 ("[A] qui tam action is `based upon' a qualifying disclosure if the disclosure sets out either the allegations advanced in the qui tam action or all of the essential elements of the qui tam action's claims." (citation omitted)); cf. U.S. ex rel. Tahlor v. AHS Hosp. Corp., No. 2:08-02042, 2013 WL 5913627, at *8 (D.N.J. Oct. 31, 2013) ("Finally, a claim can be `based upon' a public disclosure if the public disclosure concerned similar conduct that occurred in a different time period."). Therefore, the Court finds that the public disclosure bar applies to the new allegations, and Mr. Galmines will need to qualify as an original source for these new allegations.
This leads to the crux of this dispute — is Mr. Galmines an original source of the allegations that Novartis continued to unlawfully market Elidel after the filing
Novartis asserts that Mr. Galmines does not have direct and independent knowledge of any unlawful conduct relating to the marketing of Elidel after he left Novartis's employ in May 2006, and that he is not, therefore, an original source of the new allegations. This, Novartis asserts, should prevent Mr. Galmines from amending his complaint to allege that the underlying scheme continued after his employment at Novartis ended. Defendant relies primarily on three cases in support. Novartis would have the Court read a strict time limitation into the original source exception, such that a relator's status as an original source begins and ends strictly when her direct and independent knowledge begins and ends. However, such a reading comports neither with the law nor the policy behind the False Claims Act.
While there is no controlling Third Circuit case law directly on point, the Court perceives some guidance from the language of the Third Circuit Court of Appeals in Mistick, in which the court held that a qui tam plaintiff must have "direct and independent knowledge of the most critical element of its claims," but "it is not necessary for a relator to have all the relevant information in order to qualify as independent." 186 F.3d at 388-89 (quotation marks and citations omitted); see also June 13, 2013 Memorandum available at 2013 WL 2649704, at *9 ("Here, however, the centerpiece of Mr. Galmines's claim is Novartis's off-label marketing and kickback scheme. Given that Mr. Galmines has direct and independent knowledge of that scheme, and bearing in mind that Third Circuit appellate precedent does not require Mr. Galmines to have firsthand knowledge of `all the relevant information' on which his allegations are based, the Court holds that Mr. Galmines is an original source and that the [False Claims Act's] public disclosure bar does not prohibit his suit." (citation omitted)). In other words, a relator's allegations need not be strictly limited to the information as to which she has direct and independent knowledge, provided that the relator has direct and independent knowledge of the critical elements of the alleged fraudulent scheme. The precise start and end dates of a fraudulent scheme are not "critical elements" of a False Claims Act claim. See U.S. ex rel. Judd v. Quest Diagnostics Inc., No. 10-4914, 2014 WL 2435659, at *8 (D.N.J. May 30, 2014) ("Indeed, time, place, and manner allegations do not, in themselves, constitute the essential elements of a fraudulent scheme."). The precise duration of a fraudulent scheme goes not to liability but to damages — and not even to the existence of damages, but to the quantum of damages. Cf. Zenith Radio Corp. v. Hazeltine Research, Inc., 395 U.S. 100, 114 n. 9, 89 S.Ct. 1562, 23 L.Ed.2d 129 (1969) ("Zenith's burden of proving the fact of damage ... is satisfied by its proof of some damage flowing from the unlawful conspiracy; inquiry beyond this minimum point goes only to the amount and not the fact of damage."). One would expect that a relator with direct and independent knowledge of the critical elements of the fraud might not know when the fraudulent scheme began or ended, and it would make little sense not to allow a relator to obtain these details during discovery and amend her complaint accordingly.
Contrary to Novartis's contention, the Supreme Court's decision in Rockwell International Corp. v. United States, 549 U.S. 457,
The holding in Rockwell was not — as Novartis contends — that the relator categorically could not be an original source for any allegations extending past the date of his employment. Rather, the Court held merely that the relator had no direct and independent knowledge of the facts underlying the fraudulent scheme. See U.S. ex rel. Hockett v. Columbia/HCA Healthcare Corp., 498 F.Supp.2d 25, 54 (D.D.C.2007) ("Under Rockwell, a relator must qualify as an original source for each distinct kind of claim or scheme she alleges."). The relator predicted that the pondcrete would fail for one reason, then the relator was laid off, and then the pondcrete failed — but for an entirely different reason than the one the relator had predicted. Here, Mr. Galmines observed the off-label marketing and illegal kickbacks firsthand, then he left Novartis and filed this lawsuit, but the off-label marketing and illegal kickbacks continued as they had before he left Novartis. The analogous situation would have been if the relator in
However, there are at least two cases that appear to come to the contrary conclusion. A 2013 District of New Jersey case, Tahlor, did hold that:
2013 WL 5913627, at *11 (quotation marks and citations omitted).
The Court here does not reach the same conclusion as the Tahlor court. For one, the Tahlor court provides little explanation for its conclusion that the relators could not pursue alleged fraudulent conduct that occurred post-termination, even though the conduct emanated from the same fraudulent scheme. This suggests to the Court that the context in Tahlor partially drove the outcome, given that since the Government had settled the claims for the time period during which the relators had been employed, the relators' services in pursuing the later time period would be of little use since their direct and independent knowledge went exclusively to a time period that was no longer at issue (unlike here where Mr. Galmines is not exclusively pursuing conduct that occurred after he left Novartis). Additionally, the Tahlor court appears to have concluded that, after several years of litigation and a settlement, allowing the case to reopen as to new allegations for a scheme for which the Government had already reached a settlement would not serve the purposes of the False Claims Act. Here, however, there has been no settlement with the Government — the allegations about the scheme remain active. Thus, the Court does not find the result in Tahlor to be persuasive for the facts of this case.
A District of Massachusetts court concluded in United States ex rel. Duxbury v. Ortho Biotech Prods., L.P., No. 03-12189, 2010 WL 3810858, at *2-3 (D.Mass. Sept. 27, 2010), that a relator could only serve as an original source for the period of time during which he was employed by the defendant and that the relator would be limited in recovery to that discrete period. The Court is not persuaded by Duxbury,
U.S. ex rel. Duxbury v. Ortho Biotech Products, L.P., 719 F.3d 31, 39 (1st Cir. 2013) (citations omitted). This language implies that, when determining the extent to which an original source can allege and seek discovery for additional aspects of the same underlying scheme, the limiting principle is the sufficiency of the allegations and the evidence — not the ability of the relator to demonstrate that she has direct and independent knowledge of the extent of the fraudulent scheme. See id. ("Thus, this was not a case in which evidence was discovered of a nationwide scheme, which might then have been the basis for widening discovery."); see also U.S. ex rel. Rost v. Pfizer, Inc., 253 F.R.D. 11, 17 (D.Mass. 2008) (holding that where an original source of a fraudulent scheme had only provided particularity as to false claims in Indiana, "the Court will permit discovery only relating to the sales and marketing region that includes Indiana. If the discovery shows that kickbacks were paid to the doctors who then made off-label prescriptions, and that this sales region was following national directives, the Court will expand the scope of discovery nationwide."). This principle should apply with equal force to the factor of time — the limitation on a relator's ability to recover for
The applications of the public disclosure bar and the first-to-file rule demonstrate just how extraordinary a position it would be for the Court to adopt Novartis's proposal. Courts, when considering whether a case is based upon allegations that have been publicly disclosed, regularly conclude that a plaintiff is barred from bringing a lawsuit alleging the same scheme as that which was publicly disclosed, but for a different time period. See, e.g., Judd, 2014 WL 2435659, at *8 ("[N]ot a single circuit has held that a complete identity of allegations, even as to time, place, and manner is required to implicate the public disclosure bar. Indeed, time, place, and manner allegations do not, in themselves, constitute the essential elements of a fraudulent scheme.... Thus, allegations of different time periods of virtually the same scheme do little to take away from their similarity under the public disclosure bar." (citations omitted)); Tahlor, 2013 WL 5913627, at *8 ("Finally, a claim can be `based upon' a public disclosure if the public disclosure concerned similar conduct that occurred in a different time period.").
More problematic, the first-to-file rule, which provides that "[w]hen a person brings [a qui tam action], 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.A. § 3730(b)(5), has also been interpreted to bar lawsuits based on the same essential facts but different time periods. See, e.g., 10A Fed. Proc. Forms § 34:550 ("If the later-filed complaint alleges the same type of wrongdoing as the first, therefore, and the first adequately alleges a broad scheme encompassing the time and location of the later filed, the fact that the later complaint describes a different time period or geographic location that could theoretically lead to a separate recovery does not save it from the [False Claims Act's] absolute first-to-file bar."). The purpose of this broad interpretation of the first-to-file bar is multifold. For one, it "encourage[es] qui tam plaintiffs to report fraud promptly." U.S. ex rel. LaCorte v. SmithKline Beecham Clinical Labs., Inc., 149 F.3d 227, 234 (3d Cir.1998). "Also, as a matter of fairness claimants alleging the same material facts as prior relators should not share in a qui tam award, because their allegations are unlikely to increase the total recovery. In addition, such duplicative claims do not help reduce fraud or return funds to the federal fisc, since once the government knows the essential facts of a fraudulent scheme, it has enough information to discover related frauds." Id. The first-to-file bar has also applied to bar suits relating to conduct occurring after the filing of the original complaint where, as here, a relator merely alleges that a particular scheme is continuing or ongoing. See U.S. ex rel. Chovanec v. Apria Healthcare Group, Inc., 606 F.3d 361, 365 (7th Cir.2010) (Easterbrook, J.).
The implication of these broad interpretations of the public disclosure and first-to-file rules is twofold. First, in interpreting whether the time period of the alleged fraud is a "critical element" of which an original source must have direct and independent knowledge, a court can reason by analogy and conclude that it is not a critical element, but rather part of the "relevant information" of which a relator need not have direct and independent knowledge of every detail. After all, if the time period of the fraud is not a "material fact" for purposes of the first-to-file rule, it would bedevil judicial reasoning to conclude
Second, because of the broad interpretations of the public disclosure and first-to-file rules, if the Court were to interpret that a relator need direct and independent knowledge as to the entire time period alleged, there might well be a situation where no relator can bring a lawsuit for a certain time period of fraud. This would be because the original source who filed first might lack direct and independent knowledge of a later time period (perhaps of the fraud that continued after the filing of the complaint), but no other relator can bring a lawsuit because they will be barred under the first-to-file rule, even if they do have direct and independent knowledge of later fraud.
Consider the hypothetical of a woman who starts work at a hospital and, on her first day of work, obtains direct and independent knowledge of every critical element of a scheme to defraud the Government (admittedly a tall premise). After only the one day of work, this woman quits her job and sues under the False Claims Act. But, it turns out, this fraud had been going on for 10 years and was publicly disclosed in a newspaper story the day before this woman began work. Under Novartis's interpretation of the original source requirement, (a) this woman can sue for only the one day of fraud for which she has direct and independent knowledge; and (b) no other putative relator could sue for the rest of the time period of this fraudulent scheme, because they would be barred under the first-to-file and public disclosure rules. Is this result consistent with the scheme of the False Claims Act's public disclosure and original source requirements? What public policy is served by such a result? Why should the potential for mischief to benefit a potential wrongdoer be embraced by the rule Novartis seeks?
To address these questions, the Court needs to consider the policy behind these provisions. As the Third Circuit explained in LaCorte, "The 1986 amendment, which introduced the current version of section 3730(b)(5), sought to achieve the golden mean between adequate incentives for whistle-blowing insiders with genuinely valuable information and discouragement of opportunistic plaintiffs who have no significant information to contribute of their own. In construing section 3730, we are mindful of the need to preserve a balance between the amendment's two competing goals." 149 F.3d at 234 (quotation marks and citation omitted).
Thus, the Court must balance these two goals in construing the original source requirement: (a) preventing parasitic lawsuits; and (b) providing adequate incentives for whistle-blowing insiders with valuable information to bring qui tam actions. The Court concludes that the position that strikes the best balance between those competing goals is to allow original-source relators to pursue the entire fraudulent scheme for which they have direct and independent knowledge of the operative substantive facts, and not to limit relators to the specific time periods for which they have direct and independent knowledge, particularly where the relator has alleged the scheme was "continuing" as of the day they lost their direct and independent knowledge by reason of a cessation of employment or equivalent development. This interpretation of the original-source requirement does little to encourage parasitic lawsuits, since only the first-to-file can bring a qui tam suit for the scheme. True, this interpretation allows a relator to recover for a period of time for which she does not have direct and independent personal knowledge, making her perhaps less
Here, Mr. Galmines should qualify as an original source for the entire fraudulent scheme to market Elidel off-label and provide illegal kickbacks, even if that scheme extended past his dates of employment or continued past the date of the filing of his complaint. Mr. Galmines alleged that this same operative fraudulent scheme was continuing when he filed his complaint, and his proposed amendments merely provide sufficiently pleaded allegations of the fact that the scheme has continued past the date of the filing of the original complaint.
Just because Mr. Galmines qualifies as an original source for the entire scheme does not mean he can obtain discovery ad infinitum. Rather, he must meet the pleading requirements and sufficiently allege that the scheme occurred past the date of his filing of his complaint. See Feb. 25, 2014 Order (requiring plaintiff to submit "a Proposed Fourth Amended Complaint with well-pleaded factual allegations sufficient to show that Novartis's alleged wrongful conduct continued after July 21, 2006, as well as more specific timeframes for those allegations currently alleging that conduct occurred `to the present' or were otherwise made out in the present tense."). By requiring Mr. Galmines to amend his complaint in order to
Mr. Galmines has sufficiently alleged that the off-label marketing continued until at least April 2009 and the illegal kickbacks continued until at least mid-2007. His supplemental allegations include allegations about how Novartis instructed its employees to market Elidel off-label using a visual aid in 2007, see Proposed Fourth Am. Compl. ¶ 79, how the marketing of Novartis continued to be targeted at off-label uses beyond the date of the original complaint, see, e.g., id. ¶ 83 (use of the phrase "steroid-free"), ¶ 103 (focus on sensitive skin messaging), ¶ 108 (website implicitly advocating use of Elidel as first-line treatment for eczema), ¶ 109 (availability of Eczema Survival Guide through March 16, 2008), how off-label uses of Novartis have continued through at least April 2009, see id. ¶ 128, and how Novartis continued to pay speaking fees to doctors who prescribed Elidel and to provide them with other kickbacks like golf trips, see id. ¶¶ 156-58. These new allegations, while perhaps not sufficient in isolation to adequately allege a violation of the False Claims Act, are, when considered together with the original allegations, sufficient to meet even the heightened requirements of Rule 9(b) and are sufficient to convince the Court that, by allowing the amendments, it is not encouraging unrestrained discovery.
Finally, before allowing Mr. Galmines to amend (or "supplement") his complaint, the Court must consider whether the supplemental pleading should be denied because of undue delay or bad faith. Arthur v. Maersk, Inc., 434 F.3d 196, 204 (3d Cir.2006). The touchstone of this analysis is prejudice to the defendant. Id.
Although it is a fair question whether Mr. Galmines's years of delay before supplementing his pleading with well-pleaded allegations as to the post-2006 conduct warrant a denial of his motion to amend, the Court concludes that the delay does not warrant denying leave to amend. Although a more diligent approach would have been to seek leave to amend immediately upon uncovering the underlying facts of the new allegations, the delay here was not undue or a result of bad faith. Mr. Galmines apparently believed that his bald assertions of "ongoing" conduct would allow for discovery past the date of the filing of the original complaint. While case law contradicts this view, the Court does not find that Mr. Galmines had a dilatory motive. Novartis argues that it will be prejudiced by a Fourth Amended Complaint, given the immense discovery costs it will have to incur given the expanded time period. But Novartis has not persuaded the Court that the delay itself has prejudiced Novartis. Of course more discovery will cost more money — that is a fundamental law of litigation. The appropriate inquiry is not whether it will be costly to defend against the allegations because of the nature of the allegations but whether the delay "impaired [Novartis's] ability to defend against the suit or that it was unfairly disadvantaged or deprived of the opportunity to present facts or evidence which it would have offered had the amendment been timely." Id. at 206 (quotation marks, alterations, and citation omitted). Here, Novartis's ability to defend
For all the foregoing reasons, the Court will permit Mr. Galmines to submit a Fourth Amended Complaint. An order consistent with this Memorandum follows.