MEMORANDUM

LAWRENCE F. STENGEL, District Judge.

Relator Yoash Gohil brings this False Claims Act lawsuit on behalf of the United States against his former employer Sanofi-Aventis U.S., Inc. (Aventis) and its subsidiaries. Mr. Gohil alleges that Aventis engaged in a fraudulent pharmaceutical marketing scheme, which caused numerous healthcare providers to submit false claims to federally-funded health insurance programs. Aventis has moved for a partial judgment on the pleadings, asserting a statute of limitations bar and a First Amendment defense. I will deny this motion.

I. BACKGROUND1

Mr. Gohil was employed by Aventis and its predecessor companies from February 1982 until his resignation in June 2002. At all relevant times, Mr. Gohil was a Senior Oncology Sales Specialist whose duties included the marketing, promotion, and sale of pharmaceuticals manufactured by Aventis. This case concerns the marketing of Taxotere, a chemotherapy agent manufactured by Aventis which Mr. Gohil was assigned to promote and sell in the Philadelphia region.

Originally, the Food and Drug Administration (FDA) approved Taxotere for the treatment of patients with Non-Small Cell Lung Cancer and Breast cancer, but only after the failure of prior platinum based chemotherapy. This is also known as second line treatment. In November 2002, the FDA approved Taxotere for first line treatment of Non-Small Cell Lung Cancer. There were no other approved medical indications. Between 1996 and 2004, Taxotere was the most expensive taxane on the market. A substantial portion of individuals who are treated with Taxotere are participants in a federal insurance program including Medicare, Medicaid, CHAMPUS/Tricare, and the Federal Employee Health Benefit Plan (FEHBP).2

In 2000, Aventis was formed through the merger of RPR and Hoechst Marion Roussel. Rhone-Poulenc Rorer Pharmaceuticals, Inc. (RPR) had manufactured and marketed Taxotere. The plaintiff was an employee of Hoechst and then became an employee of Aventis. After the merger, he was assigned to market Taxotere.

The plaintiff alleges that, from 1996 until 2004, Aventis engaged in a marketing plan which promoted Taxotere for off-label uses. Gohil alleges that Aventis trained and directed its employees to misrepresent the safety and effectiveness of the off-label use of Taxotere to expand the market for Taxotere into unapproved settings. He claims Aventis also paid healthcare providers illegal kickbacks—i.e., sham unrestricted grants, speaking fees, travel, entertainment, sports and concert tickets, preceptorship fees, and free samples and free reimbursement assistance—to incentivize providers to prescribe Taxotere for off-label uses. By the means of this fraudulent marketing scheme, Aventis dramatically increased revenue on sales of Taxotere from $424 million in 2000 to $1.4 billion in 2004.

Federal Insurance Programs will pay for an off-label use of a prescription drug if the drug is used for a medically accepted indication or the drug is medically necessary. Aventis marketed Taxotere for off-label use in the first line treatment of Breast Cancer and Non-Small Cell Lung Cancer, for the second line treatment of Ovarian Cancer, and for the treatment of other unspecified medical indications. According to Gohil, the prescription of Taxotere in these settings would not be eligible for reimbursement. Additionally, prescriptions of Taxotere which were "produced through the payment directly or indirectly of a kickback" were ineligible for reimbursement. As a result, Aventis' fraudulent marketing scheme allegedly caused a substantial number of healthcare providers to submit claims for reimbursement to Governmental medical reimbursement systems for the use of Taxotere, which would not have otherwise been paid had the Government reimbursement programs known of Aventis' fraudulent marketing scheme.

II. RELEVANT PROCEDURAL HISTORY

Mr. Gohil filed his original False Claims Act (FCA) qui tam complaint under seal on May 17, 2002.3 He filed his First Amended Complaint on July 19, 2002 under seal. In June 2002, Mr. Gohil resigned from Aventis, and he initiated a wrongful termination action against Aventis in New Jersey Superior Court pursuant to New Jersey's Conscientious Employee Protection Act and New Jersey's Law Against Discrimination. In the state court lawsuit, Mr. Gohil alleged that Aventis retaliated against him because he objected to sales activities which violated federal and state laws, including FDA regulations.

The parties engaged in discovery in the New Jersey action. Aventis produced tens of thousands of pages of training materials, manuals, and journal abstracts about Taxotere. Mr. Gohil took depositions of several current and former Aventis employees. After the close of discovery but before any judgment was entered, the parties settled the New Jersey action on October 19, 2005. The settlement agreement included a broad release of liability in favor of Aventis.

On August 15, 2006, the Government declined to intervene in this qui tam case. The case was unsealed and a summons issued to Aventis on September 11, 2006. With leave of court, Mr. Gohil filed the Second Amended Complaint under seal on February 9, 2007; the Government again declined to intervene. The Second Amended Complaint was unsealed on February 29, 2008.

The First Amended Complaint outlined facts regarding FCA violations for sales of both Taxotere and Anzemet (another oncological drug product marketed by Gohil while working for Aventis). The Second Amended Complaint deleted the majority of facts and claims related to the sale of Anzemet, leaving claims and facts regarding the sale of Taxotere as the primary focus.4 The Second Amended Complaint also added more detail about the Taxotere claims laid-out in the First Amended Complaint. The Second Amended Complaint defined the applicable timeframe as 1996 to 2004.

After a contentious jurisdictional discovery period (which included an interlocutory appeal), the defendants moved to dismiss the Second Amended Complaint based on several theories: the general release the plaintiff executed in connection with the settlement of the New Jersey lawsuit, the original source requirements of the FCA, and the plaintiff's failure to allege Aventis' supposed fraudulent conduct with particularity as required under Rule 9(b). I denied that motion in part and granted it in part. I dismissed Counts III and IV of the plaintiff's Second Amended Complaint without prejudice because those Counts were factually deficient.5

The defendants filed a motion for reconsideration of my decision regarding the public disclosure bar's effect on claims related to years 1996-1999 and 2002-2004. I denied that motion.6

I granted the plaintiff leave to file a Third Amended Complaint. The defendants again moved to dismiss Counts III and IV of that complaint, arguing again that these claims were factually deficient and did not meet the heightened pleading standard of Rule 9(b), required of qui tam pleading. See U.S. ex rel. LaCorte v. SmithKline Beecham Clinical Labs., Inc., 149 F.3d 227, 234 (3d Cir. 1998). I denied this motion and placed the parties on a discovery schedule.7

The defendants now move once more for the dismissal of Counts III and IV under Rule 12(c)(i.e., a motion for judgment on the pleadings), based on two legal defenses not previously presented.8

III. STANDARD OF REVIEW UNDER RULE 12(C)

"After the pleadings are closed—but early enough not to delay trial—a party may move for judgment on the pleadings." FED. R. CIV. P. 12 (c). When a defendant moves to dismiss a claim because it fails to offer a basis upon which relief can be granted under Rule 12(c), the same standard used in deciding motions under Rule 12(b)(6) is applied to motions brought under Rule 12(c). See, e.g., Turbe v. Gov't of V.I., 938 F.2d 427, 428 (3d Cir. 1991); United States v. Cephalon, ___ F. Supp. 3d ___, No. 08-287, 2016 WL 398014, at *2 (E.D. Pa. Feb. 2, 2016). District courts may grant a motion for judgment on the pleadings under Rule 12(c) "only if, viewing all the facts in the light most favorable to the nonmoving party, no material issue of fact remains and the moving party is entitled to judgment as a matter of law." Knepper v. Rite Aid Corp., 675 F.3d 249, 257 (3d Cir. 2012)(citing Rosenau v. Unifund Corp., 539 F.3d 218, 221 (3d Cir. 2008)). See also Sikirica v. Nationwide Ins. Co., 416 F.3d 214, 220 (3d Cir. 2005); Society Hill Civic Ass'n v. Harris, 632 F.2d 1045, 1054 (3d Cir. 1980). "[I]f the pleadings do not resolve all of the factual issues in the case, a trial on the merits would be more appropriate than an attempt at resolution of the case on a Rule 12(c) motion." 5A C. Wright & A. Miller, Federal Practice and Procedure § 1367, at 515 (1990).

IV. DISCUSSION

The defendants offer two grounds for dismissal: (1) they argue that the plaintiff's claims dating between 1996 and 2000 are barred by the statute of limitations; and (2) the parts of plaintiff's Counts III and IV of the Third Amended Complaint based on "truthful, non-misleading speech" are barred by First Amendment free speech protections.

A. The False Claims Act Statute of Limitations

Under the False Claims Act (FCA), persons who submit fraudulent applications for payment to the United States are liable to the Government in a civil action for civil penalties and treble damages. 31 U.S.C. § 3729(a)(1) (West 2015). The qui tam provisions of the act empower private individuals, like Mr. Gohil, to file lawsuits on behalf of the United States seeking damages sustained by the Government for the payment of false claims.9 31 U.S.C. § 3730(b). Relators, the citizen plaintiff in a FCA action, must file their complaints under seal and serve the Government with a copy of the complaint and disclosure of all material evidence. 31 U.S.C. § 3730(b)(2). The court cannot lift the seal until the Government investigates the claims and either decides to take over the action or notifies the court that it declines to intervene in the case. 31 U.S.C. § 3730(b)(4). If the Government declines to intervene, it retains the right to veto any settlement negotiated by the relator, and it may move to intervene at a later date upon a showing of good cause. 31 U.S.C. § 3730(b)(1);(b)(3).

The defendants argue that the "new" FCA claims dating from 1996 to 2000 appeared for the first time in the plaintiff's Second Amended Complaint and should be barred by the FCA's six-year statute of limitations because the Second Amended Complaint was filed in 2007 and unsealed in 2008. See 31 U.S.C. § 3731(b)(1).10 The plaintiff argues that the amended claims "relate back" to the claims laid out in the original complaint, filed within the statutory period, making them timely.

B. Relation Back is Appropriate Under Rule 15(c)(1)(B)

In qui tam cases where relators amend their own pleadings without Government intervention, courts have applied Rule 15(c)(1)(B) of the Federal Rules of Civil Procedure to determine whether the proposed new claims and allegations "relate back," for statute of limitations purposes, to a previously-filed complaint.11

If Rule 15(c) can be applied and later amended complaints can "relate back" to the original complaint, the amended complaint's filing is essentially treated as being filed on the date of the initial complaint, for the purpose of calculating the statute of limitations.

The hallmark of the relation back inquiry is fair notice to the defendant. See, e.g., Glover v. F.D.I.C., 698 F.3d 139, 145-47 (3d Cir. 2012)("[F]actual overlap alone is not enough, because the original complaint must have given fair notice of the amended claim to qualify for relation back under Rule 15(c).") Rule 15(c)(1)(B) only permits relation back of untimely FCA claims if they clearly arose out of the "conduct, transaction, or occurrence pled occurrence set out—or attempted to be set out—in the original pleading." FED. R. CIV. P. 15(c)(1)(B).12

Courts have liberally construed the relation back doctrine in order to comport with the general presumption favoring amendment under Rule 15. See USX Corp. v. Barnhart, 395 F.3d 161, 167 (3d Cir. 2004)("Allowing relation back under Rule 15(c) also comports with the general presumption in favor of allowing a party to amend pleadings."); Bensel v. Allied Pilots Ass'n, 387 F.3d 298, 310 (3d Cir. 2004)("In accordance with the general theory of liberalized pleading in the federal system, Rule 15(c) is premised on the notion that a party is not entitled to the protection of the statute of limitations based upon the later assertion by amendment of a claim or defense that arises out of the same conduct, transaction, or occurrence set forth in the timely filed original pleading.").13 "The relation back provision of Rule 15(c) aims to ameliorate the harsh result of the strict application of the statute of limitations." Garvin v. City of Philadelphia, 354 F.3d 215, 220 (3d Cir. 2003).

"[T]he underlying question for a Rule 15(c) analysis is `whether the original complaint adequately notified the defendants of the basis for liability the plaintiffs would later advance in the amended complaint.'" Glover v. F.D.I.C., 698 F.3d 139, 146 (3d Cir. 2012)(citations omitted)(emphasis in original). Put another way, Rule 15(c) considers whether the facts and claims of the amended pleadings are a natural outgrowth of the original pleading, which put the defendants on notice of possible liability.

I see no reason why the amended complaints in this action would not relate back to the timely-filed original complaint.14 The allegations made in the Original and First Amended Complaints involve the same conduct detailed more fully in the Second Amended Complaint.15 Though the Second Amended Complaint no longer included FCA allegations regarding Anzemet, the basic FCA allegations regarding Taxotere remained and the additional details regarding these claims further substantiated the claims made in the First Amended Complaint.

Furthermore, as I explained in my previous decisions regarding the Second and Third Amended Complaints, the Third Amended Complaint also asserts claims that arise out of the same conduct alleged in the Original, First, and Second Amended Complaints.16 The Third Amended Complaint makes additional factual allegations that are natural offshoots of the original allegations. Aventis had fair notice of these claims and suffers no prejudice from the prosecution of these claims.17

The defendants claim that the First Amended Complaints did not put them on notice of allegations preceding 2000, because Mr. Gohil did not sell Taxotere nor work for Aventis' predecessor RPR between 1996 and 1999; as such, later complaints cannot relate back to it.18 The First Amended Complaint made clear that Mr. Gohil brings his qui tam action as an employee of Aventis and its predecessors.19 Though Mr. Gohil was technically an employee of Aventis from 2000 to 2002, he outlines events preceding the merger of Hoechst and RPR in his First Amended Complaint as part of an ongoing practice of off-label promotion.20 See Gutierrez v. Johnson & Johnson, 227 F.R.D. 255, 256-59 (D.N.J. 2005)(allowing relation back to expand statutory period to two years prior because a "pattern and practice" was alleged and conduct dating back to that timeframe was at issue in the initial pleading).

The defendants' motion regarding its statute of limitations defense is denied.21

C. First Amendment Defense is Not Ripe for Disposition

The defendants argue that dismissal of parts of the plaintiff's Counts II and IV of the Third Amended Complaint are based on allegations of truthful, non-misleading off-label promotion of Taxotere. Liability for truthful, non-misleading speech related to off-label marketing may be protected by the First Amendment. See Sorrell v. IMS Health Inc., 564 U.S. 552, 577-78 (2011). I do not read the plaintiff's allegations as asserting claims based on truthful or non-misleading speech. Throughout the Third Amended Complaint, the plaintiff asserts that the defendants' off-label promotion of Taxotere was false and/or misleading. See, e.g., Third Amended Complaint, Doc. No. 134 at ¶ 15, § 2 (pp. 6-90), ¶¶ 29, 30, 31, 38, 60-64, 67. That sort of speech is not necessarily protected by the First Amendment. See Sorrell v. IMS Health Inc., 564 U.S. 552, 583 (2011) ("[T]he Court has found that `sales practices' that are `misleading, deceptive, or aggressive' lack the protection of even this `intermediate' standard."); United States v. Caronia, 703 F.3d 149, 164 (2d Cir. 2012)("[T]o warrant First Amendment protection, the speech in question must not be misleading and must concern lawful activity."); United States v. Bell, 414 F.3d 474, 480 (3d Cir. 2005)("The threshold inquiry is whether the commercial speech involves unlawful activity or is misleading. If so, the government may restrict it and the inquiry ends." (citation omitted)).22

The parties' arguments raise the question: was the off-label promotion actually false and/or misleading.23 This is a genuine dispute which is material to the outcome of this case. Under Rule 12(c), I cannot render judgment with this dispute unresolved.24 This question is better answered by a jury. At this point, I must accept the plaintiff's allegations as true for the purpose of this motion.25 Whether a First Amendment defense is permissible is a question to be answered after fact findings have been made.26

Thus, I will deny the defendants' motion without prejudice based on their First Amendment defense.27

V. CONCLUSION

For the foregoing reasons, the defendants' motion for partial judgment on the pleadings is DENIED.

An appropriate Order follows.