Full opinion text
MEMORANDUM OPINION AND ORDER BARBARA M.G. LYNN, District Judge. Before the Court are Motions to Dismiss filed by Boston Scientific Corporation [Docket Entry # 110], Cordis Corporation and Johnson & Johnson (collectively, “Cor-dis”) [Docket Entry # 112], and Abbott Laboratories and Abbott Vascular Solutions, Inc. (collectively, “Abbott”) [Docket Entry # 115]. For the reasons stated below, the Motions to Dismiss filed by Boston Scientific and Cordis are GRANTED, and the Motion to Dismiss filed by Abbott is GRANTED in part and DENIED in part. As explained below, the Relator is granted leave to amend some of the dismissed claims. I. BACKGROUND.........................................................504 A. The Parties .........................................................505 B. Colquitt’s Allegations ................................................505 1. False Statements to the FDA .....................................505 a. FDA Regulation of Medical Devices ............................505 b. Alleged False Statements .....................................507 2. Off-Label Promotion and Marketing................................507 a. Colquitt’s Experiences as an Abbott Territory Manager ...........507 b. Off-Label Marketing in Vascular Journals and on the Internet.....510 3. Inducement of Claims for Reimbursement ..........................510 4. Kickback Allegations..............................................511 C. Colquitt’s Legal Theories .............................................511 D. Procedural Posture ..................................................512 II. ANALYSIS ............................................................513 A. Lack of Subject Matter Jurisdiction — Public Disclosure Bar...............513 1. Alleged Public Disclosures ........................................514 2. Legal Standard ..................................................516 3. Analysis ........................................................517 a. Public disclosure of allegations or transactions ...................517 i. Statutorily specified form ...............................517 ii. Allegations or transactions ..............................519 (1) False statements to FDA ............................519 (2) Evidence of off-label promotion.......................521 iii. Conclusion — Public disclosure of allegations or transactions .........................................523 b. “Based upon” public disclosure of allegations.....................523 c. Original Source...............................................524 d. Conclusion — Public Disclosure Bar..............................529 B. Failure to State a Claim or Plead Fraud with Particularity................529 1. Off-Label-Promotion Claims.......................................530 a. Claim Falsity................................................530 b. Failure to Plead with Particularity .............................533 c. Conclusion — Off-Label Promotion Claims........................535 2. Kickback Claims .................................................536 C. State Law Claims ...................................................537 III. CONCLUSION .........................................................537 I. BACKGROUND Relator Kevin Colquitt brings this qui tarn action, under the federal False Claims Act (“FCA”) and several analogous state false claims statutes, against the Defendants, who are medical device manufacturers. The crux of Colquitt’s suit is that the Defendants engaged in a scheme to thwart the FDA approval process for vascular stents by fraudulently obtaining FDA clearance for their devices as biliary stents, when in fact the Defendants intended to and did market and promote them as vascular stents. Colquitt argues that this scheme led or was material to false claims for reimbursement submitted to federal payer programs, such as Medicare and Medicaid. The Defendants move to dismiss Colquitt’s claims under Rules 12(b)(1) and 12(b)(6), arguing that the FCA’s public disclosure jurisdictional bar deprives the Court of jurisdiction over Colquitt’s claims, see 31 U.S.C. § 3730(e)(4), that Colquitt has failed to state a plausible claim for relief as required by Rule .8, and that Colquitt has not pleaded fraud with particularity as required by Rule 9(b). A. The Parties Defendants are medical device manufacturers who make and sell biliary stents. Colquitt held the position of Territory Manager for Abbott, successor-in-interest to Guidant Corporation, from February 2004 to July 2006. Colquitt alleges that during this period he witnessed and participated in a scheme through which Abbott promoted the off-label use of its biliary stents, and induced physicians and hospitals to seek reimbursement from federal payer programs for such off-label use. Although Colquitt never worked for Boston Scientific or Cordis, he alleges that through his employment with Abbott he witnessed similar off-label promotion by them as well. B. Colquitt’s Allegations The allegations in the Third Amended Complaint (“TAC”) can be divided into four categories: (1) allegations concerning false statements allegedly made by the Defendants to the FDA in obtaining market clearance for their stents; (2) allegations that the Defendants promoted and marketed their biliary stents for off-label, vascular applications; (3) allegations that the Defendants induced healthcare providers to seek reimbursement from federal payer programs for the off-label use of their biliary stents; and (4) allegations of illegal kickbacks provided by the Defendants to physicians and hospitals to use their stents for off-label uses. 1. False Statements to the FDA a. FDA Regulation of Medical Devices Under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and the amendments thereto, medical devices are classified as Class I, Class II, or Class III. 21 U.S.C. § 360c(a)(l) (2006). Which class a particular device is placed in is determined by the level of regulatory review necessary to provide assurance of the device’s “safety and effectiveness.” Id. § 360c(a)(l)(A)(i), (B), (C)(i). Class I devices, such as tongue depressors and elastic bandages, are those that present no unreasonable risk of illness and injury and therefore require only general manufacturing controls. Id. § 360c(a)(l)(A); Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 344, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). Class II devices are those that require “special controls” to provide assurance of their safety and effectiveness. 21 U.S.C. § 360c(a)(l)(B); see Buckman, 531 U.S. at 344, 121 S.Ct. 1012. Finally, Class III devices are those whose uses are purported or represented to support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. 21 U.S.C. § 360c(a)(l)(C). Therefore, Class III devices receive the FDA’s strictest regulation. Buckman, 531 U.S. at 344, 121 S.Ct. 1012. Generally, all new devices introduced into interstate commerce for commercial distribution after May 28, 1976, are classified as Class III devices. 21 U.S.C. § 360c(f)(l). However, a new device is not classified as Class III if it is “substantially equivalent” to a type of device that has previously been classified in Class I or II. Id. § 360c(f)(l)(A). In that case, the device is placed in the same class as the substantially equivalent device type. Id. The difference in the level of regulatory review required for Class II and Class III devices is substantial. Class III devices are subject to a premarket approval process, which is the most stringent level of device regulation imposed by the FDA, usually requiring the manufacturer to conduct costly clinical studies to demonstrate the safety and effectiveness of the device. See id. § 360e. Class II devices, on the other hand, are subject to a less arduous process, commonly known as § 510(k) certification. Medtronic, Inc. v. Lohr, 518 U.S. 470, 478, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). Under the § 510(k) certification process, a manufacturer must submit to the FDA a premarket notification submission, commonly known as a 510(k) notice, before a device may be introduced into interstate commerce. 21 U.S.C. § 360(k); 21 C.F.R. § 807.81 (2010). The 510(k) notice must include, among other things, proposed labeling sufficient to describe the device, its intended use, and the directions for its use; a statement indicating the device is similar to or different from other products of comparable type in commercial distribution; and a statement that the submitter believes, to the best of the submitter’s knowledge, that all information in the 510(k) notice is truthful and accurate, and that no material fact has been omitted. 21 C.F.R. § 807.87(e)-(h), (k). Along with the 510(k) notice, a manufacturer must submit a “510(k) summary,” which “shall be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence [to previously cleared devices].” Id. § 807.92(a). Among the information that must be contained in a 510(k) summary is “[a] description of the device ..., including ... the significant physical and performance characteristics of the device, such as device design, material used, and physical properties.” Id. § 807.92(a)(4). The 510(k) summary must also include “[a] statement of the intended use of the device ... including a general description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate.” Id. § 807.92(a)(5). Biliary stents are Class II devices intended for use in the bile ducts of patients with biliary cancer. See 21 C.F.R. § 876.5010. Patients with biliary cancer can develop cancerous growths that restrict the flow of bile through the bile ducts, so the stents are used to keep the bile ducts open, allowing bile to drain freely from the liver and gallbladder. Biliary stents are classified as Class II devices, partly because of the short life expectancy of patients who use them. See Dorothy B. Abel, Off-Label Medical Device Use, Endovascular Today, March 2003, at 60 (“Given the terminal status of ... patients [requiring biliary stenting due to malignant biliary cancer], any long-term risks associated with these devices are not a significant concern.”); see also 21 U.S.C. § 360c(a)(2) (“[T]he safety and effectiveness of a device are to be determined ... weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.”). Vascular stents are Class III devices. (Relator’s Third Am. Compl. ¶ 64, ECF No. 68 [hereinafter TAC].) A vascular stent is used to treat peripheral vascular disease by providing structural support to the blood vessel in which it is implanted. (M) Unlike biliary stents, vascular stents are implanted in patients with long life expectancies, and thus, the stents are considered permanent implants. (TAC ¶ 65.) Vascular stents must undergo the premarket approval process in order to establish their safety and effectiveness, and cannot be cleared for marketing through the 510(k) certification process. (TAC ¶ 66.) b. Alleged False Statements Colquitt alleges the Defendants falsely represented in their 510(k) notices that their stents were intended for use in the biliary system when in fact they were intended for use in the vascular system. In other words, Colquitt charges that the Defendants misrepresented their stents as biliary stents in order to circumvent the costly premarket approval process, and instead to take advantage of the less stringent § 510(k) certification process. In particular, the TAC alleges that the Defendants made false statements and omitted material information regarding the stents’ classification, type, predicate devices, substantial equivalence, intended use, appropriate labels, and risk to patients. (TAC ¶ 77.) In support of these allegations, Colquitt points to the physical dimensions of the stents, asserting that 99% of the Defendants’ devices “are too large or too small to fit the biliary tree and/or are marketed and sold to healthcare providers premounted on delivery catheters that are incorrectly sized to place the stents in the biliary tree.” (TAC ¶ 72.) The devices were, Colquitt alleges, appropriately sized for use in vasculature. To demonstrate this argument, Colquitt attached as Exhibit 1 to the TAC a table that lists the Defendants’ stents and a variety of physical characteristics of each. (TAC, Ex. 1.) Additionally, the table contains a column labeled “Biliary Use Probability,” which for each device states, “Y,” “N,” or “Y/N.” (Id.) Colquitt also relies on the significant increase in the number of biliary stents cleared for marketing in recent years in comparison to the steady and relatively small number of patients requiring stenting of the biliary tree. (Id.) Colquitt alleges that “[t]he obvious explanation is that Defendants intended the devices to be used for vascular procedures, which is a vastly larger market.” (Id.) In summary, Colquitt alleges that the dimensions of the devices the Defendants submitted for 510(k) clearance, and the quantity produced, demonstrates that the stents were intended to be used as vascular stents, despite the statements in the 510(k) notices. Had the Defendants been truthful about the stents’ intended use, Colquitt asserts, they would have been required to complete the premarket approval process for Class III devices. Thus, according to Colquitt, the Defendants obtained market clearance of their stents through fraud. 2. Off-Label Promotion and Marketing The bulk of Colquitt’s factual allegations relate to the Defendants’ alleged off-label promotion and marketing of biliary stents for vascular use. a. Colquitt’s Experiences as an Abbott Territory Manager Colquitt worked for Abbott from February 2004 to July 2006. Colquitt alleges that he was trained to promote the off-label vascular use of several of Abbott’s devices that had been cleared by the FDA only as biliary stents. His initial training sessions in Abbott’s endovascular headquarters were allegedly centered on increasing Abbott’s share of the vascular stent market, although Abbott had no FDA-approved vascular stents. Colquitt alleges that he and other attendees at the training sessions practiced deploying Abbott’s biliary stents in anatomic models of the vascular system, under the supervision of Abbott instructors. Colquitt alleges that this training was provided so that he and other sales representatives could demonstrate to physicians how to use Abbott’s biliary stents in the vascular system. According to Colquitt, the anatomic models did not include biliary anatomy, and no laboratory training was provided for placement of stents in the biliary tree. Colquitt also alleges that the other Defendants utilized similar training methods. According to the TAC, shortly after Colquitt completed his training with Abbott in the spring of 2004, he learned from a Cordis sales representative that Cordis’s representatives were trained in a vascular laboratory where a physician taught them how to read vascular angiograms and let them watch live “peripheral vascular cases.” The TAC does not contain any similar specific allegations about the training of Boston Scientific employees. Colquitt alleges that he was trained on Abbott’s Peripheral Preceptorship Program (the “Program”), the objective of which was to build a stent market share by soliciting interventional cardiologists and vascular surgeons to perform peripheral vascular stenting procedures using Abbott’s bilary stents thereby promoting off-label usage. Abbott funded and sponsored the Program’s courses through grants to Medical Media Communications (“MMC”), a for-profit company financed by the Defendants. According to Colquitt, Abbott established the timing and location of the Program courses, selected the vascular physician instructors, selected other vascular specialists to be trained, and negotiated payment to the instructors. In connection with these courses, Colquitt alleges that he was tasked with identifying cardiologists and vascular surgeons who were likely to prescribe large numbers of Abbott’s biliary stents for vascular use. Once identified, these “target” physicians would be invited by Abbott’s training department, through MMC, to attend one of the courses, which were conducted in the catheterization lab of the hospitals where the vascular specialists worked. Colquitt alleges that Cordis and Boston Scientific also sponsored peripheral endovascular stenting courses to instruct physicians how to utilize Cordis’s and Boston Scientific’s biliary stents for off-label vascular uses. According to Colquitt, the Defendants “conducted dozens of these courses annually, each of which promoted and marketed biliary stents for vascular procedures,” and thus, “Defendants have sponsored the training of thousands of vascular specialist physicians on the off-label use of biliary stents for vascular purposes.” (TAC ¶ 131.) Furthermore, Colquitt alleges that Abbott induced off-label use of its stents through its “practice building program.” As part of this program, Abbott allegedly compiled a package of information for distribution to vascular specialists that contained letters to physicians, patient questionnaires, and patient “advisory” letters. Colquitt claims that the patient advisory letters were prepared for the vascular specialist to send to his or her own patients to warn them of serious health risks of undiagnosed and untreated peripheral vascular disease, and that the physician letters provided information about the design specifications of Abbott’s biliary stents. The TAC also states that Abbott coordinated and funded dinners for “referring physicians.” Additionally, Colquitt alleges that as part of the practice building program, he accompanied another Abbott territory manager, who was also the “field sales trainer,” on visits to healthcare providers. During the visits, Colquitt allegedly witnessed numerous vascular procedures involving the placement of biliary stents in the vascular anatomy, but never witnessed any procedures in which biliary stents were implanted in the biliary tree. The Abbott field sales trainer also allegedly trained Colquitt on how to market Abbott’s stents against the biliary stents of Cordis and Boston Scientific, which Colquitt alleges also were marketed for vascular purposes. Colquitt claims that during his time as a territory manager for Abbott, his entire focus was on promoting the off-label use of Abbott’s biliary stents in the vascular system. He alleges that he was never instructed or trained to market the devices to gastroenterologists — the physicians who would actually use stents in the biliary tree. According to the TAC, Colquitt and his managers participated in sales presentations that focused exclusively on soliciting vascular physicians for off-label use of Abbott’s devices. Further, Colquitt alleges that he attended trade shows on peripheral vascular disease, where he witnessed identified sales representatives from Cordis and Boston Scientific promote their employers’ biliary stents to vascular specialists for vascular procedures. The trade shows are not the only occasion at which Colquitt claims to have witnessed sales representatives from Cordis and Boston Scientific promoting their biliary stents for vascular use. According to the TAC, Colquitt witnessed a Cordis sales representative attend live vascular stenting where off-label use of Cordis’s stents was “successfully promoted.” (TAC ¶ 142.) The TAC contains similar allegations regarding Boston Scientific, stating that Colquitt witnessed one of Boston Scientific’s sales representatives promote the off-label use of its biliary stents to identified physicians in the hospital’s catheterization lab. According to the TAC, Abbott further induced off-label use of its stents by providing Abbott territory managers with compensation incentives to reward off-label promotion. Colquitt claims that the majority of his earnings came from commissions for off-label sales of Abbott’s biliary stents, and that Abbott established biliary-stent sales quotas that “greatly exceeded” the number of potential on-label biliary uses. (TAC ¶ 153.) Colquitt thus asserts that Abbott’s compensation structure “created a culture ... that rewarded representatives for illegally promoting and marketing the biliary stents off-label.” (TAC ¶ 154.) As for Cordis and Boston Scientific, the TAC alleges that they “similarly instituted compensation structures, quotas, and bonuses that rewarded and incentivized sales representatives to promote and sell the biliary stent systems to vascular specialists and required representatives to promote the devices off-label.” (TAC ¶ 156.) Colquitt alleges that the Defendants also used consignments to promote and induce off-label use. According to Colquitt, the Defendants stocked hospitals with their biliary stents but did not charge the hospital for any stent until it was actually used, and that the majority of consigned stents were allocated to hospital departments where biliary procedures were not performed, but vascular surgery was. Colquitt estimates that at least half of all biliary stents are sold through consignment to hospital departments that do not perform biliary procedures. According to the TAC, Abbott also kept records and collected data concerning these consigned devices to measure off-label usage by physicians and overall vascular market share. Colquitt alleges that Cordis’s recordkeeping involved a sophisticated system of handheld scanners, which he allegedly witnessed a Cordis representative use in departments that did not perform biliary procedures. Colquitt further claims to have witnessed Boston Scientific and Cordis sales representatives manage their consignment inventories in the catheterization labs of various hospitals. Finally, the TAC contains allegations that the Defendants’ sales representatives performed laboratory demonstrations of off-label use of the Defendants’ biliary stents. According to the TAC, sales representatives of each Defendant were assigned exclusive days in catheterization labs during which they would attend live vascular cases, demonstrate the off-label use of biliary stents, and provide technical advice on how to prepare and deploy the biliary stents for use in the vascular system. Colquitt alleges that these live demonstrations were important because they allowed the Defendants’ sales representatives to give instructions and advice that they were prohibited from putting in writing due to labeling restrictions and the risk of misbranding the devices. b. Off-Label Marketing in Vascular Journals and on the Internet Outside of the activities and duties of the Defendants’ sales teams, Colquitt alleges that the Defendants marketed their devices for off-label use on them websites, in press releases, and in journals focused on vascular medicine. Colquitt alleges that Cordis’s website represented that its biliary stents were used for “endovascular interventional procedures.” (TAC ¶ 166.) Likewise, Boston Scientific allegedly promoted its biliary stents as part of a treatment option for addressing peripheral artery disease, and on its website promoted one biliary stent in particular as a vascular stent, though that stent had not been approved by the FDA for vascular indications. Furthermore, the TAC alleges that Cordis twice issued press releases promoting the effectiveness of its biliary stents in treating vascular disease. Finally, the TAC contains numerous allegations regarding the Defendants’ placement of advertisements in vascular journals to promote their biliary stents. The TAC identifies the specific journals and dates for three ads announcing the launch of Boston Scientific devices, four announcing Cordis products, and one announcing an Abbott product. Colquitt alleges that in contrast to the Defendants’ advertising in vascular journals, the Defendants did “little to no” advertising of their biliary stents in publications directed to biliary clinicians. (TAC ¶ 180.) 3. Inducement of Claims for Reimbursement Colquitt claims that the Defendants not only induced the off-label use of their biliary stents, but also induced physicians to seek reimbursement for that off-label use from federal payer programs. Professional services rendered by physicians are reimbursed by Medicare and Medicaid on a fee-for-service basis, using a system of Current Procedural Terminology (“CPT”) codes. (PL’s Br. Opp’n 76.) There are four CPT codes associated with the placement of a vascular stent. Colquitt alleges that the Defendants distributed to healthcare providers “reimbursement guides” containing instructions to use these four CPT codes when seeking reimbursement from Medicare and Medicaid for off-label placement of biliary stents in the vascular system. Colquitt claims that these guides did not disclose that the safety and effectiveness of using biliary stents in the vasculature was not established, and that the Defendants expressly, or impliedly, made false representations that the biliary stents would safely and effectively treat peripheral vascular disease. Specifically, Colquitt alleges that Cordis prepared and disseminated to healthcare providers “Endovascular Payment and Reimbursement Guidelines” that purported to “assist [healthcare providers] in obtaining the appropriate hospital reimbursement for services rendered to patients having peripheral vascular disease.” (TAC ¶ 195.) The Guidelines allegedly instructed physicians to use the CPT code for “transcatheter placement of intravascular stent (non-coronary).” (Id.) Colquitt further alleges that Cordis gave healthcare providers a catalog that identified its biliary stent systems as endovascular stents. The TAC contains similar allegations regarding Abbott. Colquitt alleges that Abbott also distributed guides to healthcare providers, instructing them to use vascular-procedure CPT codes to obtain reimbursement for procedures using Abbott’s stents, when Abbott had no stents that were FDA-approved for such procedures. The TAC contains no similar allegations specific to Boston Scientific, although some of Colquitt’s allegations apply generally to “Defendants.” 4. Kickback Allegations The TAC also alleges that the Defendants paid certain healthcare providers kickbacks, to induce them to use the Defendants’ biliary stents for off-label, vascular applications. Colquitt names certain hospitals to which Abbott allegedly granted rebates based on specific market share criteria, such as the percentage of the hospital’s stents purchased from Abbott in a given quarter. According to Colquitt, these percentages were so high that the small number of biliary stenting procedures performed by the providers would not justify them. Colquitt further alleges that Abbott paid for dinners for physicians to encourage them to refer patients to vascular specialists who used Abbott’s stents. As for the other Defendants, the TAC alleges that Cordis and Boston Scientific offered similar discounts on their stents, and paid an identified doctor, $80,000 for a vascular fellowship program, and $15,000 per peripheral training course he taught, to induce him to recommend and prescribe off-label use of their biliary stents. C. Colquitt’s Legal Theories The FCA creates liability for any person who knowingly presents, or causes to be presented to the United States government, a false or fraudulent claim for payment or approval. 31 U.S.C. § 3729(a)(1) (2006). Claims under this provision are often termed “presentment claims,” because they require proof that a false claim was presented to the government. The FCA also 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) (Supp. Ill 2009). Claims seeking to impose this type of liability are often referred to as “false-statement claims.” Relying on the factual allegations summarized above, Colquitt asserts three theories of liability under the FCA. First, Colquitt asserts a fraudulent inducement theory of liability. This theory is properly characterized as a false-statement claim. Colquitt alleges that the Defendants’ false statements to the FDA were material to false or fraudulent claims because those statements induced the government to clear the stents for introduction into interstate commerce, which is a prerequisite for reimbursement by the healthcare payer programs. Importantly, the underlying principle of the fraudulent inducement theory is that the initial fraud taints all future claims presented, whether or not they are literally false or fraudulent. United States ex rel. Longhi v. Lithium Power Techs., Inc., 575 F.3d 458, 467-68 (5th Cir.2009). Thus, in the classic example of a government contractor who procures a government contract by fraud, the fact that the contract itself was procured by fraud creates FCA liability for every claim for payment made under the contract, even if all of the claims the contractor makes are otherwise free of falsity or fraud. United States ex rel. Laird v. Lockheed Martin Eng’g & Sci. Servs. Co. (Laird II), 491 F.3d 254, 259 (5th Cir.2007) (citing United States ex rel. Marcus v. Hess, 317 U.S. 537, 63 S.Ct. 379, 87 L.Ed. 443 (1943)). Colquitt’s second theory of liability, which he terms his “off-label promotion theory,” focuses on the Defendants’ alleged activities in promoting off-label use of their biliary stents in the vascular system. Colquitt frames this theory as both a presentment claim and a false-statement claim. As a presentment claim, Colquitt alleges that the Defendants knowingly caused the submission of false or fraudulent claims by promoting their stents for off-label use by healthcare providers, who in turn used the stents off-label and sought reimbursement from the government for such use. According to Colquitt, the requests for reimbursement were false claims because the off-label use caused by the Defendants’ promotional activities was not properly reimbursable. Additionally, Colquitt alleges that some of the Defendants’ promotional activities— the distribution of reimbursement guides in particular — misrepresented to healthcare providers that the Defendants’ biliary stents were approved for vascular use and that such use was thus reimbursable by the government. Thus, under the rubric of false-statement liability, Colquitt alleges that these promotional activities constituted knowingly false statements that were material to false or fraudulent claims. Colquitt’s third theory of liability relies on the federal Anti-Kickback Statute (AKS). Colquitt alleges that the Defendants paid kickbacks to healthcare providers in exchange for those providers using the Defendants’ biliary stents off-label. According to Colquitt, these providers falsely certified their compliance with the AKS to be eligible to receive reimbursement from Medicare and other healthcare payer programs, and therefore, claims for reimbursement made by these providers were false or fraudulent. D. Procedural Posture Colquitt initiated this suit on September 26, 2006, by filing the Complaint ex parte and under seal pursuant to 31 U.S.C. § 3730(b)(2). On motion of the Government, the Court extended the time for the Government to elect to intervene, giving the Government until January 21, 2008 to do so. On October 25, 2007, Colquitt filed his First Amended Complaint, and on December 5, 2007, after obtaining leave of Court, filed his Second Amended Complaint. Through a series of extensions sought by the Government and granted by the Court, the case remained under seal until January 11, 2010, while the Government considered whether to intervene. On January 11, the Government filed notice that it was not intervening at that time. Shortly thereafter, the States of Florida, Louisiana, Tennessee, California, Illinois, and Texas also filed notices of their decisions not to intervene. On May 6, 2010, after receiving leave of Court, Colquitt filed the TAC, which is the subject of the Motions to Dismiss before the Court. II. ANALYSIS The Defendants’ Motions to Dismiss attack Colquitt’s federal FCA claims on essentially two grounds: (1) lack of subject matter jurisdiction under the FCA’s public disclosure bar; and (2) failure to state a claim. The Defendants further argue that Colquitt’s claims under state false claims statutes should be dismissed, both on jurisdictional grounds and on the merits. Both the Government and the State of Texas have filed Statements of Interest opposing the Defendants’ Motions. A. Lack of Subject Matter Jurisdiction— Public Disclosure Bar Congress has limited the subject matter jurisdiction of federal courts over qui tam actions under the FCA: 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, 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. 31 U.S.C. § 3730(e)(4)(A). An “original source” is “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 Govfernment before filing an action under this section which is based on the information.” Id. Thus, if this qui tarn’ action is based upon publicly disclosed allegations or transactions, the Court has subject matter jurisdiction only if Colquitt has direct and independent knowledge of the information on which his allegations are based. The Supreme Court held in Rockwell International Corp. v. United States, 549 U.S. 457, 127 S.Ct. 1397, 167 L.Ed.2d 190 (2007), that when determining if a relator is an original source of the “information on which the allegations are based,” the “allegations” courts are to examine are those in the relator’s complaint, as amended. Id. at 473, 127 S.Ct. 1397. Noting that an amended complaint that withdraws jurisdiction-giving allegations will defeat jurisdiction unless those allegations are replaced by others that establish jurisdiction, the Court stated that “when a plaintiff files a complaint in federal court and then voluntarily amends the complaint, courts look to the amended complaint to determine jurisdiction.” Id. at 473-74, 127 S.Ct. 1397. However, on August 5, 2011, as this Court was finalizing and preparing to issue this Opinion, the Fifth Circuit decided United States ex rel. Jamison v. McKesson Corp., 649 F.3d 322 (5th Cir.2011). In Jamison, the Fifth Circuit held that the district court lacked jurisdiction under the FCA’s public disclosure bar because the allegations in the relator’s original complaint were based on publicly disclosed allegations or transactions. Id. at 330-32. Relying on Rockwell, the relator argued that the court should look instead to his amended complaint to determine the scope of his claims and whether they were based on publicly disclosed allegations or transactions. Id. at 327-28. Rejecting that argument, the Fifth Circuit interpreted Rockwell as holding only that “the court can lose jurisdiction over an otherwise sound action if the relator amends his complaint to remove the basis of the jurisdiction.” Id. at 328. As the Fifth Circuit interpreted it, Rockwell does “not hold ... that the original complaint is irrelevant to jurisdiction,” nor does it “speak to the question whether a relator can use an amended complaint to establish jurisdiction when the original complaint is lacking.” Id. Relying on “the longstanding rule that the amendment process cannot ‘be used to create jurisdiction retroactively where it did not previously exist,’” the court concluded that if the relator’s original complaint did not establish jurisdiction, the amended complaint could not save it. Id. (quoting Aetna Cas. & Sur. Co. v. Hillman, 796 F.2d 770, 775 (5th Cir.1986)). Here, the Defendants have directed their jurisdictional arguments to the TAC, rather than Colquitt’s original Complaint. In other words, the Defendants’ Motions to Dismiss contend that the allegations in the TAC are such that this Court lacks jurisdiction, regardless of whether the original Complaint fails to provide a basis for jurisdiction in the first instance. Nothing in either Rockwell or Jamison precludes this argument. To the extent that the allegations in the original Complaint generate jurisdictional impediments not present in the TAC, the Defendants are not precluded from later raising jurisdictional arguments based on the original Complaint, as such arguments are not resolved here and cannot be waived. At this juncture, the Court focuses only on the TAC, to which the Motions to Dismiss are directed, to analyze whether it has jurisdiction under the FCA’s public disclosure bar. 1. Alleged Public Disclosures The Defendants have filed a Joint Defense Appendix containing 929 pages of documents that allegedly demonstrate the public disclosure of the allegations or transactions on which Colquitt’s claims are based. (Joint Defense Appendix (JDA), ECF No. 114.) The forty-nine documents in the Appendix fall into three basic categories: (1) 510(k) summaries filed with the FDA; (2) articles published in medical journals and trade publications; and (3) letters sent to the Defendants from the FDA. The Defendants also rely on advertisements for their biliary stents published in medical journals and trade publications that are described in the TAC. Regarding the first category, the Defendants argue that the 510(k) summaries publicly disclose the misstatements Colquitt alleges were made to the FDA during the clearance process for their biliary stents. These summaries are prepared and submitted by device manufacturers as part of the 510(k) clearance process, and are later made public by the FDA. 21 C.F.R. § 807.95(d) (2010). The 510(k) summaries contain a variety of information, including “the significant physical and performance characteristics of the device, such as device design, material used, and physical properties.” Id. § 807.92(a)(4). Although the Joint Defense Appendix contains copies of only three 510(k) summaries, all of which relate to stents manufactured by Abbott, federal regulations require that these summaries be submitted as part of a manufacturer’s 510(k) premarket notification submission to obtain Class II clearance. Colquitt has alleged that the Defendants obtained Class II certification for all of the stents underlying his claims; therefore, the Court can and does assume, and Colquitt does not dispute, that similar summaries were submitted and made public by the FDA for each of the Defendants’ biliary stents. Various articles published in medical journals and trade publications make up the second type of evidence provided by the Defendants. Some of these are scholarly articles published in medical journals, and others are non-scholarly articles published in trade journals focused on vascular medicine or on medical device regulation. For the most part, the Defendants cite these articles to argue that off-label use of biliary stents has been widely reported and was known to the public before Colquitt filed this suit. The third type of evidence the Defendants rely on consists of two letters from the FDA. One of these letters is a “warning letter” sent to Cordis by the FDA in April 1999. An FDA warning letter “is a correspondence that notifies regulated industry about violations that [the] FDA has documented during its inspections or investigations.” (Pl.’s Br. Opp’n App. 7.) The April 1999 warning letter sent to Cor-dis involved an advertisement placed for Cordis’s S.M.A.R.T. stent, which was cleared only for biliary use. (JDA 392.) The ad in question appeared in an issue of Endovascular Surgery, an interdisciplinary journal for vascular specialists, and referred to the S.M.A.R.T. stent as being from “Cordis Endovascular.” (Id.) The FDA warning letter states that “the ad makes an implied claim for vascular use for the stent because it appears in a journal intended for vascular specialists.” (Id.) The letter also states that the implied claim for vascular use demonstrated the device was not intended for biliary use, as Cordis had stated during the clearance process, but was instead “a class III [vascular stent] for which there [was] not in effect an approved premarket approval application, as required by [the FDCA].” (Id.) The other FDA letter that the Defendants rely on is known as an “untitled letter.” An untitled letter “cites [regulatory] violations that do not meet the threshold of regulatory significance for a Warning Letter.” Food and Drug Administration, Regulatory Procedures Manual, “Untitled Letters,” § 4-2 (March 2010). The warning letter in this case was received by Abbott and Boston Scientific, as well as other biliary stent manufacturers, and outlines the FDA’s concerns about off-label marketing of biliary stents for vascular uses. (JDA Exs. EE & FF.) The letter does not identify any particular manufacturer, instead stating generally, “[I]t has come to our attention that many expandable metal biliary stents continue to be marketed for vascular use.” (JDA 404, 406.) The letter continues, “It is clear that many more of these stents are used in the vasculature, for which they are not indicated, than the biliary tree, for which they are indicated.” (Id.) The letter also states that biliary stents are approved through the 510(k) process, rather than the premarket approval process required for vascular stents, and that many of the characteristics of recently cleared biliary stents “appear to be made to optimize performance in vasculature.” (Id.) Among the characteristics mentioned in the letter are the dimensions of the stents and the length of the attached catheters. In addition to the three types of evidence included in the Joint Defense Appendix, the Defendants rely on allegations in the TAC to argue that the public disclosure bar applies. The TAC alleges that the Defendants “routinely marketed their biliary stent systems for vascular use in vascular journals,” and identifies several specific advertisements admittedly placed by each of the Defendants in such journals. (See TAC ¶¶ 169-80.) The Defendants argue that these allegations, if true, publicly disclose their alleged off-label marketing efforts. 2. Legal Standard Usually, when a Court is confronted with a motion to dismiss for lack of subject matter jurisdiction, it “may evaluate ‘(1) the complaint alone; (2) the complaint supplemented by the undisputed facts in the record; or (3) the complaint supplemented by undisputed facts plus the court’s resolution of disputed facts.’ ” United States ex rel. Barrett v. Johnson Controls, Inc., No. 3:01-cv-1641-M, 2003 WL 21500400, at *3 (N.D.Tex. Apr. 9, 2003) (Lynn, J.) (quoting Williamson v. Tucker, 645 F.2d 404, 413 (5th Cir.1981)). However, the Fifth Circuit has held that a challenge to jurisdiction under the public disclosure bar is “ ‘necessarily intertwined with the merits’ [sic] and is, therefore, properly treated as a motion for summary judgment.” Jamison, 649 F.3d at 326 (quoting United States ex rel. Reagan v. E. Tex. Med. Cent. Reg’l Healthcare Sys., 384 F.3d 168, 173-74 (5th Cir.2004)). Therefore, in deciding whether the Court has jurisdiction, the Court must view the evidence and inferences drawn from that evidence in the light most favorable to the non-moving party, and find the absence of jurisdiction only if there is no genuine issue of material fact. Reagan, 384 F.3d at 173-74. In the context of an FCA claim, a defendant asserting a jurisdictional argument under the public disclosure bar must “first point to documents plausibly containing allegations or transactions on which [the relator’s] complaint is based.” Jamison, 649 F.3d at 327. “Then, to survive summary judgment, [the relator] must produce evidence sufficient to show that there is a genuine issue of material fact as to whether his action was based on those disclosures,” or that he is an original source of the complaint’s allegations. Id. As with any summary judgment motion, in deciding jurisdiction under the public disclosure bar, the Court may not weigh the evidence or evaluate the credibility of witnesses, and all justifiable inferences will be made in the non-moving party’s favor. Id. Here, Colquitt does not challenge any of the facts asserted by the Defendants in support of their jurisdictional-bar argument; that is, Colquitt does not dispute the authenticity of the evidence in the Joint Defense Appendix. Rather, Colquitt argues that the evidence is insufficient to trigger the jurisdictional bar. In other words, Colquitt argues that Defendants’ evidence does not plausibly disclose allegations or transactions on which the TAC is based. Similarly, he argues that none of the evidence offered by the Defendants speaks to the truth of the factual allegations Colquitt relies on in arguing that he is an original source. Defendants argue that those allegations, even if true, are insufficient to confer original source status on Colquitt. Therefore, the Court’s task here is to determine whether, drawing all justifiable inferences in Colquitt’s favor, the evidence in the Joint Defense Appendix and the assumed-as-true allegations in the TAC show as a matter of law that Colquitt’s claims are based on publicly disclosed allegations and transactions, and if so, whether Colquitt was as an original source of the allegations in the TAC. 3. Analysis The Fifth Circuit has adopted the following three-part test for analyzing whether a court has subject matter jurisdiction under the public disclosure bar: “(1) whether there has been a ‘public disclosure’ of allegations or transactions, (2) whether the qui tam action is ‘based upon’ such publicly disclosed allegations, and (3) if so, whether the relator is the ‘original source’ of the information.” United States ex rel. Reagan v. E. Tex. Med. Cent. Reg’l Healthcare Sys., 384 F.3d 168, 173-74 (5th Cir.2004); accord United States ex rel. Barrett v. Johnson Controls, Inc., No. 3:01-cv-1641-M, 2003 WL 21500400, at *4 (N.D.Tex. Apr. 9, 2003) (Lynn, J.). a. Public disclosure of allegations or transactions The first element of the jurisdictional bar asks whether there has been a public disclosure of allegations or transactions. As this Court has recognized, the plain language of the statute suggests three sub-parts to this element: (1) public disclosure; (2) in a particular form specified in the statute; and (3) of allegations or transactions. Barrett, 2003 WL 21500400, at *4. The Defendants argue that the documents in the Joint Defense Appendix satisfy these requirements. Because only an analysis of the second and third sub-parts is necessary to the Court’s conclusion, the Court does not discuss the first sub-part. i. Statutorily specified form The public disclosure bar is triggered only by public disclosures “in a criminal, civil, or administrative hearing, 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). Colquitt argues that the 510(k) summaries and the stent advertisements are not in one of these specified forms. The Defendants respond that the 510(k) summaries are “administrative reports” and that the stent advertisements are “from the news media.” The Defendants argue that the 510(k) summaries constitute administrative reports. In United States ex rel. Reagan v. East Texas Medical Center Regional Healthcare System, the Fifth Circuit held that the contents of an agency’s response to a Freedom of Information Act (“FOIA”) request is an administrative report because “the response (1) ‘constitute^] official government action’ — i.e., it is administrative — and (2) ‘provides information and notification regarding the results of the agency’s search for the requested documents.’ — i.e., it is a report.” Reagan, 384 F.3d 168, 176 (5th Cir.2004) (quoting United States ex rel. Mistick v. Hous. Auth., 186 F.3d 376, 383 (3d Cir.1999)). The Supreme Court recently confirmed this view in Schindler Elevator Corp. v. United States ex rel. Kirk, defining a report as “‘something that gives information’ or a ‘notification,’ ” and the Court thus holds that a response to a FOIA request is an administrative report under the FCA. — U.S. -, 131 S.Ct. 1885, 1891, 179 L.Ed.2d 825 (2011). Thus, Reagan and Schindler suggest that, to be an administrative report within the meaning of the FCA, a document must (1) constitute official government action and (2) provide information. The 510(k) summaries are published by a government agency. See 21 C.F.R. § 807.95 (stating that “FDA shall make a 510(k) summary ... available to the public” (emphasis added)). Furthermore, they provide information in the government’s possession that is collected as part of a government administrative procedure. Colquitt argues, however, that the summaries are not administrative reports because they are prepared by the manufacturers, and are only released by the FDA. The focus of the Fifth Circuit’s analysis in Reagan is not on who created the information, but on the fact that the information is made public through official government action. Whether the information is collected from medical device manufacturers or some other third party, the important factor is that it is released by the FDA as part of its administrative clearance process for medical devices. That the 510(k) summaries are initially provided to the FDA by medical device manufacturers, then, does not detract from their status as administrative reports under the FCA. Colquitt also argues that the stent advertisements described in the TAC cannot trigger the public disclosure bar because paid advertisements in specialty journals do not fall into any of the FCA’s statutorily identified categories of disclosures. The Defendants’ contention that the ads are disclosures “from the news media” presents two questions: (1) whether specialty medical journals such as Endovascular Today are “news media” under the FCA; and (2) if so, whether paid advertisements in those publications are “from” the news media. The Fifth Circuit has not set out a specific test for determining what constitutes news media, but at least two courts have held that scholarly or technical periodicals constitute news media. United States ex rel. Radcliffe v. Purdue Pharma L.P., 582 F.Supp.2d 766, 770 (W.D.Va.2008); United States ex rel. Alcohol Found., Inc. v. Kalmanovitz Charitable Found., 186 F.Supp.2d 458, 463 (S.D.N.Y.2002), aff'd, 53 Fed.Appx. 153 (2d Cir.2002). Both district courts held that “[t]he term ‘news media’ includes scholarly, scientific, and technical periodicals, including trade journals, because, like newspapers, those sources disseminate information to the public in a periodic manner.” Radcliffe, 582 F.Supp.2d at 770 (citing Alcohol Found., 186 F.Supp.2d at 463). Although this Court is not inclined to conclude that in the age of basement blogging and ease of publishing, any medium that disseminates information to the public in a periodic manner is part of the “news media,” the Court agrees that “[n]o principle of statutory construction or public policy would compel a cramped reading of the term ‘news media’ or the imposition of a judicially created limit of ‘news media’ to encompass only the newspaper context.” Alcohol Found., 186 F.Supp.2d at 463 (emphasis added). The Court agrees that scholarly periodicals are sufficiently similar to newspapers to constitute news media. However, whether advertisements in such periodicals are, like articles, “from” the news media presents a much closer question. Nevertheless, the Court concludes that, like articles, advertisements in periodicals are “from the news media.” In two recent opinions interpreting the public disclosure bar, the Supreme Court of the United States has emphasized the “broad scope” of the statutorily specified forms of disclosure generally, and “news media” in particular. Schindler Elevator Corp. v. United States ex rel. Kirk, — U.S.-, 131 S.Ct. 1885, 1887, 179 L.Ed.2d 825 (2011); Graham Cnty. Soil & Water Conservation Dish v. United States ex rel. Wilson, — U.S. -, 130 S.Ct. 1396, 1404, 176 L.Ed.2d 225 (2010) (“The ‘news media’ referenced in Category 3 plainly have a broader sweep.”). The only other case this Court has located which has addressed this issue found no distinction between advertisements and articles, holding that the public disclosure bar requires only that the information be “from” the news media; “[i]t does not require that the information appear in any particular form or section of a [publication].” United States ex rel. Ondis v. City of Woonsocket, R.I., 582 F.Supp.2d 212, 217 (D.R.I.2008). A person who picks up a copy of Endovascular Today has just as much access to the advertisements as the edited content. Thus, the advertisements that are described in the TAC are “from the news media,” within the meaning of the FCA’s public disclosure bar. ii. Allegations or transactions Having concluded that the 510(k) summaries and the stent advertisements are within one of the statutorily specified forms, the Court turns next to whether the Defendants’ evidence discloses “allegations or transactions.” As this Court has stated before, “the key for determining whether allegations or transactions have been publicly disclosed is whether ‘the critical elements of the fraudulent transaction were in the public domain.’ ” United States ex rel. Heath v. Dall./Fort Worth Int’l Airport Bd., No. 3:99-cv-100-M, 2004 WL 1197483, at *5 (N.D.Tex. May 28, 2004) (Lynn, J.) (quoting United States ex rel. Springfield Terminal Ry. v. Quinn, 14 F.3d 645, 654 (D.C.Cir.1994)). “The critical elements have been sufficiently disclosed if the disclosures, taken together, would enable the government to draw an inference of fraud.” Id. As the D.C. Circuit explained in Springfield Terminal, “if X + Y = Z, Z represents the allegation of fraud and X and Y represent its essential elements.” Springfield Terminal, 14 F.3d at 654. “In order to disclose the fraudulent transaction publicly, the combination of X and Y must be revealed, from which readers or listeners may infer Z, i.e., the conclusion that fraud has been committed.” Id. Furthermore, the FCA is concerned with fraud on the government, and thus, public disclosure of a predicate allegation of fraud — one that does not by itself lead to an inference of a false or fraudulent claim on the government — does not disclose “allegations or transactions” for purposes of the FCA. See United States ex rel. Smart v. Christus Health, 626 F.Supp.2d 647, 653-54 (S.D.Tex.2009). Here, the Defendants argue that the alleged false statements to the FDA and their alleged off-label promotion have been publicly disclosed, and that such disclosure constitutes allegations or transactions of fraud from which the government could draw an inference of FCA liability. (1) False statements to FDA The 510(k) summaries disclose the Defendants’ alleged misstatements to the FDA because they disclose the alleged false statements and the alleged true state of affairs. First, the 510(k) summaries unambiguously contain the alleged false statements because the FDA requires that each summary contain “[a] statement of the intended use of the device ... including a general description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate.” 21 C.F.R. § 807.92(a)(5). Second, the summaries also contain information that, according to the TAC, demonstrates that those statements were false when made: the sizes and dimensions of the stents. The TAC relies heavily on the sizes of the stents in alleging that the statements of their intended use were false. Specifically, Exhibit 1 to the TAC is a table that lists the stents manufactured by each Defendant. The chart has columns for “Manufacturer,” “Stent,” “Balloon Expandable / Self Expanding,” “Wire Size,” “Stent Diameter,” “Stent Length,” “Shaft Length,” and “Biliary Use Probability.” Commenting on Exhibit 1, the TAC states, Based on accepted sizing for the biliary tree and vascular anatomy, as compared to the length and diameter of Defendants’ stents and the length of the premounted delivery catheters, Exhibit 1 demonstrates that more than 99 percent of Defendants’ devices are too large or too small to fit the biliary tree and/or are marketed and sold to healthcare providers premounted on delivery catheters that are incorrectly sized to place the stents on the biliary tree in compliance with medical standards and CGMP requirements. (TAC ¶ 72.) Furthermore, the TAC states that “[t]he size and design of the stents and delivery catheters, which are sold only as premounted systems, are intended for placement in the bloodfilled, pressurized vascular system, not the bloodless bile duct.” {Id. ¶ 11.) The same size information on which the TAC relies is disclosed in the 510(k) summaries. FDA regulations require that 510(k) summaries include “[a] description of the device ..., including ... the significant physical and performance characteristics of the device, such as device design, material used, and physical properties.” 21 C.F.R. § 807.92(a)(4). Thus, not only do the summaries disclose the alleged false statements — that the stents were intended for biliary use — but they also disclose the alleged true state of affairs — that the stents were actually intended for vascular use — because the summaries disclose size information that, according to Colquitt, “demonstrates that more than 99 percent of Defendants’ devices are too large or too small to fit the biliary.” Colquitt responds that the Defendants “cannot have it both ways,” arguing that the Defendants cannot maintain that the stents’ dimensions do not indicate the falsity of their stated intended use and simultaneously contend that the dimensions publicly disclose that alleged falsity: Abbott “denies that the design characteristics of these biliary stents are actually probative of intent to promote them for off-label use.” This statement eviscerates Abbott’s X + Y = Z equation by removing a public “Y”. Abbott tells the Court that the falsehood (X) is “that the stents were intended for biliary use” and the publicly disclosed truth (Y) is “the configurations” and “stent system design factors” allegedly disclosed in 510(k) summaries. Irreconcilably, Abbott then denies that Y (configuration and design) is “probative” in contradicting X (intended use). If Abbott denies that Y is probative in disproving X, then according to Abbott the Government had no reason to conclude Z, that Abbott was committing fraud. (Pl.’s Br. Opp’n 35-36 (citations omitted).) The Court does not share Colquitt’s interpretation of the Defendants’ argument. The Defendants can deny that the stent dimensions make the stents inappropriate for biliary use, while at the same time arguing that even if the dimensions did, as Colquitt alleges, make them appropriate only for vascular use, those dimensions were publicly disclosed in administrative reports. It is the posture of almost every motion to dismiss that the defendant denies the alleged facts, but argues that those facts, even if true, do not create liability. Although the public disclosure bar highlights the unusual rhetorical dynamics of that posture, it does not make the Defendants’ argument inappropriate or unfair. Colquitt further argues that the Defendants overstate the TAC’s reliance on the size of the stents, contending that size is only one piece of evidence of the Defendants’ false statements. Sp