Full opinion text
MEMORANDUM AND ORDER DOUGLAS P. WOODLOCK, District Judge. Relators Trida Nowak and Enda Dodd (the “relators”) bring this qui tam action against Medtronic, Inc., on behalf of the United States, twenty-two states, and the District of Columbia. The relators allege that Medtronic knowingly and intentionally made false statements - and caused to be submitted false claims in violation of the False Claims Act (“FCA”), 31 U.S.C. § 3729(a), and similar state statutes and that it wrongfully terminated Nowak in violation of the anti-retaliation provision of the FCA, 31 U.S.C. § 3730(h) and related California laws. Medtronic has moved to dismiss the relators’ claims. I will grant in part and deny in part Medtronic’s motion to dismiss. I. STATUTORY FRAMEWORK A. False Claims Act The False Claims Act, 31 U.S.C. § 3729 et seq., permits an individual, or relator, to file a qui tarn action on behalf of the United States against persons or entities who knowingly submit or cause to be submitted false claims to the government or who knowingly make, use, or cause to be made false records or statements to get a false claim paid by the government. 31 U.S.C. § 3729(a)(1); 31 U.S.C. § 3730(a)(2). Complaints filed in qui tarn actions are filed under seal and first served upon the government, which has sixty days to decide whether to intervene and assume primary responsibility over the action. 31 U.S.C. § 3730(b)(2), (b)(4), (c). The complaint may be unsealed and served on the defendant only at the court’s direction. 31 U.S.C. § 3730(b)(2).- The relator is eligible to collect as much as thirty percent of any damages awarded in such an action regardless of whether the government intervenes. 31 U.S.C. § 3730(d). The FCA also provides whistle-blower protection to employees who take action to prevent FCA violations. 31 U.S.C. § 3730(h). An employee terminated because she attempts to stop a violation of the False Claims Act is entitled to reinstatement, back pay, and other appropriate compensation. 31 U.S.C. § 3730(h)(2). The considerable financial incentive to bringing a False Claims Act action both “encourages would-be relators to expose fraud” and “serves to attract those looking to capitalize on fraud already exposed by others.” United States ex rel. Poteet v. Bahler Med., Inc., 619 F.3d 104, 107 (1st Cir.2010). Consequently, there are several statutory limitations to filing qui tam actions under the FCA. Once a relator files a qui tam action against a defendant, “no person other than the Government may intervene or bring a related action based on the facts underlying the pending action.” 31 U.S.C. § 3730(b)(5). In addition to this “fírst-to-fíle” bar, no person may bring a False Claims Act action against a defendant based on prior public disclosures of the alleged fraud “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). When this public disclosure bar applies, only the Attorney General or an “original source of the information” may bring such an action. 31 U.S.C. § 3730(e)(4)(A). A relator claiming to be an “original source” must (1) “ha[ve] ‘direct and independent knowledge’ of the information supporting her claims and (2) [must have] ‘provided the information to the Government before filing an action.’ ” United States ex rel. Duxbury v. Ortho Biotech Prods., L.P., 579 F.3d 13, 16 (1st Cir.2009), cert. denied, — U.S.-, 130 S.Ct. 3454, 177 L.Ed.2d 1054 (2010) (quoting 31 U.S.C. § 3730(e)(4)(B)). B. Federal Regulation of Medical Devices The Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq., regulates the approval and marketing of medical devices. No medical device may be marketed in the United States without prior approval by the Food and Drug Administration (“FDA”) for its intended use. 21 U.S.C. § 360. The FDCA creates three categories of devices that are subject to increasing levels of regulatory oversight: Class I (low risk, general controls), Class II (medium-risk, special controls), and Class III (high-risk, premarket approval). 21 U.S.C. § 360c(a)(l). Class III devices include those for which it is impossible to establish special regulations that assure safety, those “purported or represented to be for use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health,” and those that “presentí ] a potential unreasonable risk of illness or injury.” 21 U.S.C. § 360c(a)(l)(C). In order to market a Class III device, a manufacturer must submit a comprehensive application to the FDA for premarket approval. 21 U.S.C. § 360e(c). The device is approved only for its “intended uses” or “the objective intent of the persons legally responsible for the labeling of the devices.” 21 C.F.R. § 801.4. The FDA must also approve any changes to the intended uses of a Class III device. 21 C.F.R. §§ 801.4, 807.81. There are two ways in which to avoid the costly and time-consuming premarketapproval process: the investigational device exception, 21 C.F.R. § 812.1 et seq., and “510(k)” clearance based upon prior approval of a substantially equivalent device, 21 U.S.C. § 360; 21 C.F.R. § 807.87(k). To obtain 510(k) clearance to market a device, the manufacturer must submit a premarket notification, including a certified “statement that the submitter believes, to the best of his or her knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.” 21 C.F.R. § 807.87(k). The notification must include the intended uses of the device, the conditions the device is designed to treat, and the relevant patient population. 21 C.F.R. § 807.92(a)(5). Clearance through the 510(k) process does not constitute FDA “approval” of the device; it limits the cleared use of the device to those indications listed in the application as the intended uses. 21 U.S.C. § 352(f); 21 C.F.R. § 801.5; 21 C.F.R. § 807.97. These limited indications must be listed on the label, and a manufacturer may only promote a device for cleared or approved indications. 21 U.S.C. § 352(f); 21 C.F.R. § 807.81(a)(3). Any promotion of a device for any indication not approved or cleared by the FDA and indicated on the label is considered an “off-label” promotion and is unlawful. See 21 U.S.C. § 331(d). However, off-label use of devices by physicians is not per se unlawful. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) (recognizing that “‘off-label’ usage of medical devices ... is an accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine” (citations omitted)). Courts have also recognized that “off-label use of a drug or medical device is not the same as a medically unnecessary use of that drug or device.” United States ex rel. Bennett v. Medtronic, Inc. (“Bennett I”), 747 F.Supp.2d 745, 751 (S.D.Tex.2010) (collecting cases); see also Svidler v. U.S. Dep’t of Health & Human Servs., No. C OS-3593, 2004 WL 2005781, at *5 (N.D.Cal. Sept. 8, 2004) (“[T]he FDA can restrict a company from marketing off-label uses, but cannot prevent a doctor from prescribing a device for an off-label use for any purpose she deems medically necessary.” (citing Wash. Legal Found, v. Friedman, 13 F.Supp.2d 51 (D.D.C.1998))). C. Federal Reimbursement for Medical Devices Medicare is the federally subsidized health insurance program for the elderly and disabled established under the Social Security Act (“Medicare Act”), 42 U.S.C. § 1395 et seq. Whereas Medicare coverage for off-label uses of pharmaceuticals is highly restricted, “Medicare reimbursements for off-label uses of medical devices are not addressed within the Medicare Act itself.” Bennett I, 747 F.Supp.2d at 752 (citing Yale-New Haven Hosp. v. Leavitt, 470 F.3d 71, 73 (2d Cir.2006)). The Medicare Act provides only “[bjroad wording,” Yale-New Haven Hosp., 470 F.3d at 73, excluding “any expenses incurred for items or services [which] are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member,” 42 U.S.C. § 1395y(a)(l)(A). The Secretary for the Department of Health and Human Services (“DHHS”) has “wide discretion” in “specifying those services that are covered under the ‘reasonable and necessary’ standard.” Yale-New Haven Hosp., 470 F.3d at 74 (citing 42 U.S.C. § 1395ff(a)). Before 1995, the DHHS manuals prohibited Medicare reimbursement “for devices not approved by the FDA for commercial distribution because they were not considered ‘reasonable and necessary1 under 42 U.S.C. § 1395y(a)(l).” See Bennett I, 747 F.Supp.2d at 752 (citations and internal quotation marks omitted); see also In re Cardiac Devices Qui Tam Litig., 221 F.R.D. 318, 329 (D.Conn.2004) (“Between July 1986 and November 1995, payment by Medicare for any medical procedure in which a medical device was used was expressly predicated upon the FDA’s approval of the medical device for marketing.”). In 1995, the DHHS Secretary published superseding regulations “allowing Medicare coverage for Category B investigational devices under the ‘reasonable and necessary’ standard,” but maintaining a categorical prohibition on off-label use of Category A investigational devices. See Bennett I, 747 F.Supp.2d at 752 (quoting In re Cardiac Devices Qui Tam Litig., 221 F.R.D. at 325). Devices “believed to be in ... Class II” — such as Medtronic’s biliary stents at issue in this case — are Category B, “nonexperimental/investigational” devices, 42 C.F.R. § 405.201(b), which Medicare contractors “may approve ... if all other coverage requirements are met,” 42 C.F.R. § 405.211(b) (emphasis added). See also Bennett I, 747 F.Supp.2d at 753. In considering whether to cover a particular Category B device, “Medicare contractors must consider whether any restrictions concerning site of service, indications for use, or any other list of conditions for coverage have been placed on the device’s use.” 42 C.F.R. § 405.211(c) (emphasis added). TRICARE (formerly CHAMPUS) and CHAMPVA are also federal healthcare programs. Administered by the Department of Defense, TRICARE is “a comprehensive managed health care program for the delivery and financing of health care services in the Military Health System” covering qualifying retired military personnel and military dependents and spouses. 32 C.F.R. §§ 199.17(a), 199.3. As of September 2010, TRICARE had 5.8 million enrolled users and 3.8 million non-enrolled users. See http://www.tricare.mil/ mediacenter/press_facts.aspx. Much like Medicare, TRICARE coverage for medical devices depends on the medical necessity of the procedure. TRI-CARE “will pay for medically necessary services and supplies required in the diagnosis and treatment of illness or injury.” 32 C.F.R. § 199.4(a)(l)(I) (emphasis added). TRICARE coverage of off-label medical devices has also changed in the recent past, although in the case of TRICARE, the coverage has become more restrictive. The 2002 TRICARE Policy Manual, ch. 8, § 5.1, states that the “[u]se of FDA-approved devices for off-label or non-FDA approved applications may be covered if documented by reliable evidence as safe, effective, and in accordance with nationally accepted standards of practice in the medical community.” The superseding 2007 TRICARE Policy Manual, ch. 8, § 5.1(III)(B), however, excludes “off-label uses of devices.” CHAMPVA is administered by the Department of Veterans Affairs (“VA”) and provides health care to qualified veterans of the U.S. Armed Forces. See http:// www.va.gov/hac/forbeneficiaries/ehampva/ champva.asp. CHAMPVA coverage of off-label medical devices is similar to the 2002 TRICARE Policy Manual’s coverage; under chapter 2, § 17.2(III)(C), of the 2005 CHAMPVA Policy Manual, “use of FDA-approved devices for off-label or non-approved FDA applications may be covered if documented by reliable evidence as safe, effective, and in accordance with nationally accepted standards of practice in the medical community.” II. FACTUAL AND PROCEDURAL BACKGROUND As I must, when considering a motion to dismiss, I recount the facts as alleged in the complaint as true: A. The Parties Medtronic is one of the world’s largest medical technology companies and employs approximately 38,000 people worldwide. (Consol. Compl. ¶ 3) A Fortune 200 company, Medtronic saw nearly $15 billion in revenue for fiscal year 2009. (Consol. Compl. ¶ 3) Both relators, Tricia Nowak and Enda Dodd, are former employees of Medtronic. (Consol. Compl. ¶¶ 11-12.) Nowak was a sales representative in Medtronic’s Endovascular sales group from May 2005 until her termination on August 7, 2009. (Con-sol. Compl. ¶ 11.) In 1987, Dodd began working as a senior engineer for a medical device company in Ireland. (Consol. Compl. ¶ 12.) Medtronic eventually acquired Dodd’s company in 1999, and, in 2003, Dodd moved to California to be a senior research manager tasked with overseeing the development of peripheral vascular products for Medtronic, including Medtronic’s line of biliary stents. (Consol. Compl. ¶ 12.) Medtronic terminated Dodd in 2008, at which time Dodd and Medtronic entered into a termination agreement that included a release of legal claims. (Nemirow Deck, Ex. S.) B. Medtronic’s Line of Biliary Stents Medtronic develops and produces a line of biliary stents, including the Bridge, Aurora, Assurant, Racer, and Complete SE stent lines. (Consol. Compl. ¶¶ 69, 72, 74.) A stent is a tubular device that can be implanted in tubular structures of the body such as blood vessels (vascular stents) and bile ducts (biliary stents) and is used to relieve or prevent blockages. (Consol. Compl. ¶ 31.) A biliary stent is defined by federal law as a “tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, and for preventing stricture of the bile duet.” 21 C.F.R. § 876.5010(a). Biliary stents are generally used to relieve the pain caused by bile blockages experienced by a limited number of late-stage cancer patients. (Consol. Compl. ¶ 33.) As such, their intended use is palliative and short-term. (Consol. Compl. ¶¶ 33, 58.) Biliary stents are considered medium-risk, Class II devices and are classified under federal law as gastro-enterological. (Consol. Compl. ¶¶ 33, 60.) See 21 C.F.R. § 876.5010(b). Medtronic’s biliary stents were cleared by the FDA for entry into the market through the less-costly and less-comprehensive 510(k) process. (Con-sol. Compl. ¶ 60.) Because the biliary stents are short-term and not life-sustaining, less rigorous clinical studies are considered sufficient to assure their safety for their intended use in the biliary tree only. (Consol. Cómpl. ¶ 33.) C. Vascular Stents In contrast to biliary stents, the FDA considers stents used in the vascular system to be high-risk devices subject to regulation as Class III devices. (Consol. Compl. ¶34.) The vascular system consists of the body’s blood vessels, and the peripheral vascular system (or “periphery”) includes the renal, iliac, and superficial femoral arteries — all blood vessels not located within or near the heart. (Consol. Compl. ¶¶ 34, 93.) Stents are used in the peripheral vasculature to treat vascular disease by relieving blockages in the blood vessels; as such, their use is not palliative. (Consol. Compl. ¶ 34.) Peripheral vascular stents are implanted for permanent use and undergo far longer-term and variable stresses than biliary stents due to their location in the body. (Consol. Compl. ¶ 34.) As Class III devices, vascular stents require premarket approval, including clinical tests and institutional board review. (Consol. Compl. ¶¶ 34, 36.) D. Stent Markets There are vastly different potential markets for biliary and vascular stents. Biliary stents are generally intended for use in treating those with pancreatic and bile-duct cancer, a population estimated at slightly more than 40,000 in 2007. (Consol. Compl. ¶ 35.) By contrast, the number of Americans suffering from peripheral vascular disease numbers in the millions. (Consol. Compl. ¶ 35.) Nevertheless, there are very few stents approved for use in the peripheral vasculature, whereas there are dozens of biliarystent models with annual sales totaling billions of dollars. (Nemirow Deck, Ex. O.) The New York Times has estimated that off-label uses of biliary stents constitute ninety percent of the biliary-stent market, and other estimates put the ratio of on- to off-label uses at 1:250. (Nemirow Deck, Ex. O; Consol. Compl. ¶ 92.) Barnaby Feder, Little Data on Stent’s Most Common Use, N.Y. Times, Jan. 21, 2008, at C2. Not surprisingly, as a result, off-label use of biliary stents for treating peripheral vascular disease has become commonplace. By 2001, cardiologists and other physicians were discussing the difficulty of conducting clinical trials for peripheral stents because of the-, “rampant off-label use of [biliary] stents.” (Nemirow Deck, Ex. I, Tr. at 204.) An industry journal declared, in 2001, that “[p]eripheral stenting ... is already regarded as the standard of care, even though the procedure is off-label.” (Nemirow Deck, Ex. J.) The relators allege facts suggesting that there is some doubt regarding the safety and effectiveness of off-label use of biliary stents in the vascular periphery. During the research and development of both the Racer and Complete SE biliary stents, Dodd voiced concerns to his supervisors that the biliary stents would crack or malfunction when used in the vasculature, where increased pulsation of the veins puts more stress on the stents. (Consol. Compl. ¶¶ 66, 126.) The FDA reported that, as off-label use of biliary stents has increased, the number of adverse events involving those devices has increased substantially. (Consol. Compl. ¶ 128.) In 2008, an article in the American Journal of Therapeutics reported that there is little “clinical data” to support “clinical effectiveness and safety” of biliary stents used in the periphery and that eighty-one percent of malfunctions and more than eighty-seven percent of adverse events involving biliary stents occurred when the biliary stents were used off-label in the vascular system. (Consol. Compl. ¶ 137 (quoting Jonathan Bridges & William H. Maisel, Malfunctions and Adverse Effects Associated with Off-Label Use of Biliary Stents in the Peripheral Vasculature, 15 Am. J. Therapeutics 1 (2008)).) These adverse events can lead to a “need for surgery to retrieve retained device materials, or to repair a ruptured vessel, to serious vascular injury (vessel perforation, dissection, and thrombosis), stroke, heart attack, and death.” (Consol. Compl. ¶ 138.) E. FDA Regulation of Stent Marketing In response to the increased use of off-label biliary stents and reporting of adverse complications from that use, the FDA increased its vigilance and regulation of biliary-stent sales and promotion. (Consol. Compl. ¶ 37; Nemirow Deck, Ex. K at 1.) In 1999, for example, the FDA required biliary stents to carry a contraindication stating that biliary stents are not approved or tested for use in the vascular system. (Consol. Compl. ¶ 37.) The FDA reminded biliary-stent manufacturers of these additional labeling requirements again in 2003. (Nemirow Deck, Ex. K at 2.) In 2004, the FDA issued a recall of a biliary stent product manufactured by Cor-dis because the FDA had not approved the instructions. (Nemirow Deck, Ex. K at 2.) The FDA also recalled Medtronic’s Assurant system in 2003 because of dangers arising from its use in the vasculature. (Consol. Compl. ¶ 126.) In March 2007, the FDA took the unusual step of calling a meeting of biliary-stent manufacturers to convey the government’s concerns regarding off-label use and promotion of biliary stents in the peripheral vascular system. (Consol. Compl. ¶ 38; Nemirow Deck, Ex. K at 1.) This meeting was reported by industry and national media outlets. (Nemirow Deck, Exs. K, M, O, P.) Medtronic representatives attended the March 2007 meeting, at which the FDA announced that, as of that time, it was foregoing compliance action relating to the off-label use and promotion of biliary stents in the hope that the manufacturers would come into self-compliance. (Consol. Compl. ¶ 38) F. Relators' Allegations of Fraud by Medtronic The Consolidated Complaint appears to outline two interrelated allegations of fraud under the FCA. Although the relators do not clearly define these two allegations, the Consolidated Complaint can be read to describe a fraudulent scheme of “false certification” and a fraudulent scheme of “off-label promotion.” {See Consol. Compl. ¶¶ 5-9.) First, the relators allege that Medtronic knowingly submitted false certifications to the FDA, in order to obtain 510(k) clearance, of their stents as biliary stents despite the fact that the stents were designed, intended, and promoted as vascular stents. (Consol. Compl. ¶ 140.) Therefore, the relators contend, any claim for reimbursement submitted to the government for use of those stents was fraudulent — whether on-or off-label — because it necessarily would have been based on a fraudulent clearance. (Consol. Compl. ¶ 144.) Second, the relators allege that Medtronic knowingly promoted off-label use of its biliary stents in the vascular system, thereby causing third parties to submit fraudulent claims for reimbursement to the government for unlawful and nonreimbursable off-label uses. (Consol. Compl. ¶¶ 140,174.) 1. False Certification Scheme The relators allege that, although Medtronic cleared its biliary stents through the 510(k) process as Class II devices, the defendant designed the devices as vascular stents and intended to market them exclusively as such. (Consol. Compl. ¶ 57.) Because the 510(k) process requires certification that the device is intended for its indicated use and is “substantially similar” to prior devices, Medtronic allegedly made false statements to FDA by mischaracterizing the vascular stents as biliary stents. (Consol. Compl. ¶ 62.) The relators recount the design and approval process for two of Medtronic’s biliary stents: the Racer and the Complete SE. Dodd, a senior research manager, was brought in to finalize the Racer stent for its market release. (Consol. Compl. ¶ 64.) He worked on problems surrounding the integrity of the stent when used in renal arteries. (Consol. Compl. ¶ .64) Although the design process followed guidelines for biliary stents, “the sole and only commercial intent, as articulated by [other senior project managers], was the treatment of stenosed (blocked) renal (kidney) arteries, a blood contact vascular indication.” (Con-sol. Compl. ¶ 65.) The Racer Integrated Business Plan also “set out the business-directed process of a non-vascular FDA cleared indication while promoting the new product offering exclusively for the treatment of renal artery disease.” (Consol. Compl. ¶ 67.) The target physician-audience was cardiologists. (Consol. Compl. ¶ 67.) Surprised by this promotion strategy, Dodd reviewed the records on the development of previous biliary stents and found a similar pattern in the approval processes of the Bridge, Aurora, and Assurant stents. (Consol. Compl. ¶¶ 68-69.) Dodd expressed his concerns to his supervisors but was warned not to delay Racer’s market release. (Consol. Compl. ¶ 71.) The FDA cleared Racer in November 2003 for a biliary indication only. (Consol. Compl. ¶ 72.) Medtronic product launch materials, however, announced that “Racer is Medtronic Vascular’s fourth entry into the renal stenting segment” and is “forecasted to generate $4.25M in revenue for FY04 and $13.44M for FY05.” (Consol. Compl. ¶ 73.) The Racer replaced — and was promoted as replacing — a Medtronic stent that had obtained premarket approval as a peripheral vascular stent. (Consol. Compl. ¶ 73.) The Consolidated Complaint outlines a similar development and clearance process for the Complete SE stent, which the FDA cleared for the market as a biliary stent in November 2007. (Consol. Compl. ¶ 74.) In late 2003, Dodd began working on the development of the Complete SE, which he was originally told would be submitted to the FDA for premarket approval as a peripheral stent as well as for clearance as a biliary stent. (Consol. Compl. ¶ 75.) By summer 2005, however, Dodd’s supervisor informed Dodd that no such premarket approval would be sought, and “[t]he management team developed Product Launch Plans for the launch of COMPLETE SE that were predicated entirely upon revenue forecasts from off-label sales.” (Con-sol. Compl. ¶ 78.) In advance of the 2006 Vascular Interventional Advances Conference, at which Medtronic promoted off-label use of the Complete SE, Medtronic’s chief executive officer, William Hawkins, congratulated Dodd’s superiors for eliminating resistance to clearing the Complete SE via the 510(k) process. (Consol. Compl. ¶ 82.) Ultimately, Medtronic pursued — and obtained — 510(k) clearance despite concerns raised by its own regulatory director. (Consol. Compl. ¶ 84.) 2. Off-Label Promotion Scheme The relators outline in great detail various means by which Medtronic promoted off-label use of its biliary stents. In addition to promoting off-label uses to cardiologists and other physicians at industry conferences and advisory training sessions at its research facility, the Consolidated Complaint alleges that Medtronic sent engineers and project managers to clinical sites to observe implantation of biliary stents in the vascular system. (Consol. Compl. ¶ 86.) Promotional materials and annual revenue projections routinely characterized biliary stents as peripheral products. In 2005, annual financial operating plans projected millions of dollars in off-label sales, and promotional materials entitled “Medtronic Peripheral Solutions” described each biliary stent, including the yet-to-be marketed Complete SE. (Consol. Compl. ¶ 104.) An early Racer brochure announced Racer as “the first cobalt chromium stent launched for peripheral applications,” and a Peripheral Product Catalog included biliary stents. (Consol. Compl. ¶ 106.) Medtronic does not promote the use of the biliary stents to gastroenterologists or for their intended use in the biliary tree. (Consol. Compl. ¶¶ 101,105.) Medtronic instructed its salespeople to promote off-label use directly to hospitals and other health professionals. Medtronic originally promoted use of biliary stents in the peripheral vasculature through its Peripheral Products Group. (Consol. Compl. ¶ 93.) However, after the FDA’s March 2007 industry-wide meeting, Medtronic dissolved this sales group. (Consol. Compl. ¶ 93.) Off-label promotion of biliary stents was then absorbed into a new Carcho Vascular Division (‘Vascular Division”). (Consol. Compl. ¶ 94.) The Vascular Division includes two groups: the Endovascular Group, which primarily promotes the AneuRx AAAdvantage Stent Graft System (“AneuRx”) and the Talent Abdominal Stent Graft to combat abdominal aortic aneurysms; and the Coronary Group, which promotes a variety of coronary stents, catheters, and guidewires. (Consol. Compl. ¶¶ 96-97.) Medtronic required sales representatives in the Endovascular and Coronary Groups, as part of their duties, to sell “peripheral products,” of which biliary stents — for use in the vasculature — are the primary, if not only, products. (Con-sol. Compl. ¶ 99.) Sales representatives’ compensation packages also depended on peripheral sales, including peripheral commissions, peripheral bonuses, and an incentive “Summit Quest Contest” that included a peripheral quota for eligibility. (Consol. Compl. ¶¶ 109-10, 121.) Medtronic also kept track of peripheral sales, distributed rankings of top sellers of peripheral products, and pressured Nowak to sell peripheral products even though she refused to sell for off-label use. (Con-sol. Compl. ¶¶ 109, 111-15.) Quarterly sales reports listed the number of peripheral devices sold by each sales representative, as well as the details of each sale (product number, buyer, price, date). (Consol. Compl. ¶¶ 115-16.) Nowak received pressuring emails when she refused to sell the biliary stents off label. (Consol. Compl. ¶¶ 116-19.) In one 2008 quarterly evaluation, Nowak’s high sales were praised, but the evaluation noted that her “peripheral business was non existent [sic ]. There is an expectation to sell the peripheral portfolio and that will be an area of focus in FY09.” (Consol. Compl. ¶ 118.) A November 2008 email stated that “[t]he expectation is 10K [of peripheral sales] per rep per qtr” and listed available products as “a selection of Biliary stents: Racer, Assurant and Complete SE.” (Consol. Compl. ¶ 120.) Medtronic also encouraged sales representatives to attend vascular procedure trainings explaining “common peripheral interventions, ie., renal, iliac, SFA” and “what size devices to use along with ancillary equipment selection.” (Consol. Compl. ¶ 123.) A September 11, 2007, email from a regional sales manager characterized these trainings as a “great opportunity for YOU, yes YOU, to get some hands on peripheral training” to “enhance your ability to talk with your customers about the details of this type of procedure.” (Consol. Compl. ¶ 123.) Medtronic was aware of FDA scrutiny and took steps to conceal its off-label promotional activities. At the same time Medtronic was rearranging its sales force in light of FDA’s March 2007 meeting, it instructed sales representatives to “destroy” promotional materials listing biliary stents as “peripheral devices.” (Consol. Compl. ¶ 106.) In September 2007, an email sent to the entire U.S. sales force warned that, “[a]s you know, the industry’s sales practices of [sic] biliary stents have been under intense scrutiny by the FDA.” (Consol. Compl. ¶ 134.) The email included an attachment outlining “Do’s and Don’ts” that instructed sales representatives how to promote off-label use subtly. (Consol. Compl. ¶ 134.) G. Nowak’s Termination by Medtronic Nowak had joined Medtronic’s sales force in 2005 after seven years in the medical sales industry. (Consol. Compl. ¶ 141.) As a member of the Endovascular Group, Nowak primarily sold the AneuRx system. (Consol. Compl. ¶ 142.) She consistently exceeded her targets, was ranked among the top sales representatives in the country, and routinely received praise from her superiors. (Consol. Compl. ¶¶ 146, 153-55, 158.) However, she disagreed with the requirement — after the Peripheral Sales Group was dissolved — that she sell peripheral products off-label. (Consol. Compl. ¶¶ 147-48.) On March 7, 2007, Nowak emailed her sales manager after attending legal training and viewing a DVD presentation that warned that off-label promotion was unlawful, that sales representatives could be held personally responsible for off-label promotion, and that there was “no ‘Nuremberg defense.’ ” (Consol. Compl. ¶¶ 125, 149-50.) Nowak expressed concern and asked how the Endovascular Group could be asked to sell peripheral products off-label given the legal restrictions and potential personal liability for sales representatives. (Consol. Compl. ¶¶ 125, 149-50.) Her sales manager did not reply to her email in writing, but orally told her that selling peripheral products was part of the job. (Consol. Compl. ¶¶ 125, 149-50.) Nowak was also asked to participate in a teleconference with independent and in-house legal counsel. (Con-sol. Compl. ¶ 150.) After the meeting, Nowak continued to excel, ranking eleventh and thirteenth in the country in successive quarters. (Consol. Compl. ¶ 154.) However, her continued refusal to sell biliary stents off-label attracted attention and pressure from her superiors and teasing by her colleagues. (Consol. Compl. ¶¶ 156-57.) On March 5, 2008, Nowak filed a False Claims Act action against Medtronic, and, on April 17, 2008, she filed an amended complaint. (Consol. Compl. ¶ 157.) On June 5, 2008, Nowak again received praise for her continued excellent sales performance. (Consol. Compl. ¶ 158.) On July 2, 2008, Medtronic circulated a document-preservation notice and made public the FDA’s investigation into Medtronic’s off-label promotion practices. (Consol. Compl. ¶ 159.) At this point, Nowak alleges, Medtronic began to establish a pretext for terminating her. Despite ranking second highest in her region at the end of October 2008, Nowak was told by Medtronic on February 6, 2009, that she would be placed “on probation” and put on a Performance Improvement Plan that required her to achieve certain deliberately unachievable targets or risk termination. (Consol. Compl. ¶¶ 161, 163.) After receiving the plan for signature on March 11, 2009, half way into the fourth quarter, Nowak protested the implementation of the plan to a superior, who assured her that Medtronic would not terminate a “ ‘top performer’ who ‘never missed an annual number since being at Medtronic.’ ” (Consol. Compl. ¶ 165.) Medtronic nevertheless placed Nowak on a second Performance Improvement Plan on May 8, 2009, and split her most lucrative territory with a sales representative who had been praised for his off-label promotion of biliary stents. (Consol. Compl. ¶ 166.) On August 4, 2009, the sales team was notified that overall revenue had fallen during the last quarter and that most sales representatives had not met their targets. (Consol. Compl. ¶ 169.) Nowak was terminated on August 7, 2009, and was told that her termination was due to a “lack of intensity.” (Consol. Compl. ¶ 170.) She refused to sign a severance agreement or agree to voluntary termination. (Consol. Compl. ¶ 170.) H. Procedural History Nowak had filed her original complaint — under seal — against Medtronic in this court on March 5, 2008. (Consol. Compl. ¶ 157.) She filed an amended complaint — also under seal — on April 17, 2008. (Nowak Compl. (Doc. No. 7).) Dodd filed a similar complaint against Medtronic under the FCA in the United States District Court for the Northern District of California in April 2009. On September 28, 2009, that case was removed to this court and consolidated with Nowak’s action. The United States chose not to intervene at the time but has, along with the states of Florida and Texas, submitted statements of interest in response to Medtronic’s motion to dismiss this action for failure to state a claim. The two relators reached a relator-share agreement and, on February 19, 2010, filed a Consolidated Complaint against Medtronic on behalf of themselves, the United States, twenty-two states, and the District of Columbia. In the Consolidated Complaint, Nowak and Dodd allege twenty-seven counts against Medtronic. (Consol. Compl. at 63-90.) Count I asserts a claim for treble damages and penalties under the FCA. The relators claim that Medtronic “knowingly presented or caused to be presented, false or fraudulent claims to the United States Government for payment or approval, and made, used and caused to be made and used false records and statements material to false claims” for each claim for reimbursement for a biliary stent fraudulently approved by the FDA based on false statements and certifications and for each claim for reimbursement for a biliary stent promoted off-label and used in an unapproved manner. (Consol. Compl. ¶¶ 172-74.) The relators also alleged similar claims under the analogous false-elaims statutes of twenty-two states and of the District of Columbia. Nowak also brought separate claims— under the federal False Claims Act, 31 U.S.C. § 3730(h), the California False Claims Act, Cal. Gov’t Code § 12653(B), and California common law — alleging that Medtronic unlawfully terminated her in retaliation for filing the instant action. (Consol. Compl. at 88-90.) In their prayer for relief, the relators seek up to treble damages for each violation under the federal and state statutes for fraudulently submitted reimbursement claims, an injunction ordering Medtronic to cease its fraudulent activity, and reinstatement of Nowak with appropriate back pay and damages. (Consol. Compl. at 90-94.) Medtronic moved to dismiss the Consolidated Complaint for lack of subject matter jurisdiction, lack of standing as to relator Dodd, and failure to state a claim. See Fed.R.Civ.P. 12(b)(1) and (6). Medtronic also seeks dismissal for failure to comply with the particularity requirement of Federal Rule of Civil Procedure 9(b). I will address each challenge in turn. III. ANALYSIS A. Dismissal for Lack of Jurisdiction At the outset, “[t]he threshold question in a False Claims Act case is whether the statute bars jurisdiction.” Duxbury, 579 F.3d at 20 (quoting United States ex rel. Rost v. Pfizer, Inc., 507 F.3d 720, 727 (1st Cir.2007)). Whether a relator is qualified to bring a qui tam action under the FCA is a question of subject matter jurisdiction. Rockwell Int’l Corp. v. United States, 549 U.S. 457, 468, 127 S.Ct. 1397, 167 L.Ed.2d 190 (2007). The relators, “as the proponents] of federal jurisdiction, bear[ ] the burden of proving its existence by a preponderance of the evidence.” Poteet, 619 F.3d at 109. A relator’s eligibility to assert each claim alleged in the complaint must be examined separately, with only those claims that a relator is eligible to bring surviving the motion to dismiss on these grounds. Rockwell Int’l Corp., 549 U.S. at 476, 127 S.Ct. 1397. In determining whether subject matter jurisdiction lies, I look to the Consolidated Complaint. Id. at 473-74, 127 S.Ct. 1397. However, “[wjhen evaluating a 12(b)(1) motion to dismiss, the court may conduct a ‘broad inquiry’ and may consider extrinsic materials, including exhibits attached to the pleadings and the evidentiary materials submitted by the parties.” In re Pharm. Indus. Average Wholesale Price Litig., 538 F.Supp.2d 367, 375 (D.Mass.2008) (quoting Hemandez-Santiago v. Ecolab, Inc., 397 F.3d 30, 33 (1st Cir.2005)). Furthermore, “[t]he basis for jurisdiction must be apparent from the facts existing at the time the complaint is brought.” United States ex rel. Poteet v. Medtronic, Inc., 552 F.3d 503, 510 (6th Cir.2009) (citing Steel Co. v. Citizens for Better Env’t, 523 U.S. 83, 94-95, 118 S.Ct. 1003, 140 L.Ed.2d 210 (1998)). I must accept as trae all well-pleaded facts and resolve all reasonable inferences in the relators’ favor. Cooperman v. Individual, Inc., 171 F.3d 43, 46 (1st Cir.1999). Accordingly, I will consider the consolidated complaint, the relators’ original complaints where relevant, and materials submitted by the parties in relation to the motion to dismiss. Medtronic argues that this court lacks jurisdiction over the relators’ FCA claims on several grounds. Medtronic first contends that the FCA’s public disclosure bar, 31 U.S.C. § 3730(e)(4), precludes this court from exercising subject matter jurisdiction over this action. Medtronic then argues that Dodd’s False Claims action, which was filed one year after Nowak’s, is barred by the FCA’s first-to-file requirement, 31 U.S.C. § 3730(b)(5). Finally, Medtronic argues that Dodd lacks standing to bring an FCA claim against Medtronic in this matter because he signed a termination agreement that contained an expansive release of claims. As discussed below, I find that prior disclosures of the fraud allegations triggered the public disclosure bar but that relator Nowak qualifies as an original source with respect to the alleged off-label promotion scheme. By contrast, I find that relator Dodd does not qualify as an original source regarding any claim asserted in the Consolidated Complaint. Moreover, Dodd’s FCA action is barred by the FCA’s first-to-file rule and by the release of claims he signed prior to filing his complaint. 1. Public Disclosure Bar As previously noted, the FCA mandates that a court has no jurisdiction over “an action ... based upon the public disclosure of allegations or transactions” in various proceedings, reports, investigations, or the news media. 31 U.S.C. § 3730(e)(4) (A). In determining whether the public disclosure bar precludes a given claim, I must engage in a three-part inquiry focusing on “(1) whether there has been a prior, public disclosure of fraud; (2) whether that prior disclosure of fraud emanated from a source specified in the statute’s public disclosure provision; and (3) whether the relator’s qui tarn action is ‘based upon’ that prior disclosure of fraud.” Poteet, 619 F.3d at 109 (citing United States ex rel. Ondis v. City of Woonsocket, 587 F.3d 49, 53 (1st Cir.2009)). A negative answer to any one of these inquiries renders the public disclosure bar inapplicable. Id However, “if all three questions are answered in the affirmative, the public disclosure bar applies unless the relator qualifies under the ‘original source’ exception” as defined by 31 U.S.C. § 3730(e)(4)(B). Id. at 109-10. a. Public Disclosures The First Circuit has held that “[a] prior, public disclosure of fraud occurs ‘when the essential elements exposing the particular transaction as fraudulent find their way into the public domain.’ ” Id. at 110 (quoting Ondis, 587 F.3d at 54). This is because, once “the materials necessary to ground an inference of fraud are generally available to the public, ... there is nothing to prevent the government from detecting it” and pursuing it. Id. at 111. A “public” disclosure is one “generally available to the public,” id., meaning “the public outside of the government,” Ondis, 587 F.3d at 55 (citation omitted). To be considered a disclosure “ ‘of fraud’ the public disclosure must contain either (1) a direct allegation of fraud, or (2) both a misrepresented state of facts and a true state of facts so that the listener or reader may infer fraud.” Poteet, 619 F.3d at 110 (citations omitted). In the second option, “[t]he two states of facts may come from different sources, as long as the disclosures together lead to a plausible inference of fraud.” Ondis, 587 F.3d at 54. However, there is no public disclosure when the “essential background information” is publicly available but no allegation of fraud or true state of facts has been made publicly available. United States ex rel. Ven-A-Care of Fla. Keys, Inc. v. Actavis Mid Atl. LLC, 659 F.Supp.2d 262, 266-68 (D.Mass. 2009). Medtronic has produced sufficient evidence of public disclosure in the news media and by the government of the allegations of fraud by Medtronic to establish that there was prior public disclosure. The sources disclose “direct allegation[s] of fraud” as well as both a “true state of facts” and a “false state of facts” sufficient to infer the fraudulent schemes of both false certification and off-label promotion by Medtronic. First, it is clear that the government, the medical community, and the media were aware of off-label promotion of biliary stents for use in the vascular system prior to the filing of both relators’ complaints. The Consolidated Complaint itself relies heavily on a 2008 article in the American Journal of Therapeutics that discusses the dangers of the widespread off-label use of the biliary stents in the vasculature. (Consol. Compl. ¶¶ 137-38.) The government’s concern and investigation was also public knowledge. The DHHS issued a Warning Letter to Cordis for off-label advertising of its biliary stent in 1999, and Medtronic recalled its Assurant biliary stent in 2003 due to concerns arising from off-label use in the vasculature. (Consol. Compl. ¶ 126; Nemirow Deck, Ex. H.) The FDA called a meeting of all biliary-stent manufacturers in March 2007 to warn against off-label use and promotion of biliary stents. (Nemirow Deck, Ex. K.) According to one media report of the meeting, “[o]n its web sit[e], the FDA stated that the March [2007] meeting was the result of an investigation ‘prompted by the promotion of metal biliary stents for vascular indications.’ ” (Nemirow Deck, Ex. K.) Another industry publication reported in March 2007 that the “FDA says that manufacturers have encouraged off-label implants by marketing biliary stents for vascular indications on their Web sites and at meetings.” (Nemirow Deck, Ex. L.) News media also reported that the FDA was investigating biliary-stent producers for off-label promotion: “The U.S. Department of Justice is conducting a civil investigation of allegations that Boston Scientific and other suppliers improperly promoted biliary stents for off-label uses.” (Nemirow Deck, Ex. M.) Both the publications by the FDA on its website and the media coverage of the meeting constitute public disclosures. Second, the news media raised direct allegations of fraud with respect to both the off-label promotion of biliary stents and the misuse of the 510(k) clearance process to enable off-label use. A May 16, 2007, article in Lawyers & Settlements stated that “the FDA has known about the rampant off-label sales of bile stents for years and this is another example of how the nation’s regulatory watchdog has failed to protect consumers from the profit driven pharmaceutical industry.” (Nemirow Deck, Ex. K.) The article continued, “[T]he profit-driven sales of devices for unapproved uses may be nearing the end because law enforcement agencies are warning that off-label marketing will continue to be a focus of anti-fraud enforcement efforts over the next two years.” (Nemirow Deck, Ex. K.) A New York Times article provided facts that give rise to an inference that, given the market realities, biliary stents were intended and cleared for off-label use. (Nemirow Deck, Ex. 0.) The article reported that off-label uses of biliary stents account for ninety percent of the market for those devices and that, whereas the off-label use is a multi-billion dollar industry, the market for on-label use is relatively small. (Nemirow Deck, Ex. 0.) The article also stated that a new device by Medtronic (the Complete SE) was cleared in November 2007, despite concerns regarding off-label use and promotion. (Nemirow Deck, Ex. 0.) These facts, inter alia, certainly “contained enough information to enable the government to pursue an investigation against [Medtronic]” for both the false-certification and off-label promotion schemes. United States v. Alcan Elec. & Eng’g, Inc., 197 F.3d 1014, 1019 (9th Cir.1999). The relators argue that industry-wide suspicion alone is not sufficient to constitute a public disclosure with respect to Medtronic. This argument fails for several reasons. First, several of the disclosures identify Medtronic. Media reports of the March 2007 FDA-called meeting state that Medtronic was in attendance. (Nemirow Deck, Ex. L.) Other media reports on off-label promotion recognize Medtronic as a significant biliary-stent manufacturer. (Nemirow Deck, Ex. M.) The New York Times identified Medtronic’s Complete SE device as the latest device cleared in relation to the off-label promotion and off-label use issue. (Nemirow Deck, Ex. O.) Second, even though the New York Times article is the only media source entered into the record that suggests impropriety specifically by Medtronic, the repetitive mention of Medtronic in these public disclosures of uniform off-label promotion provides enough evidence to identify Medtronic as a perpetrator of the allegedly industry-wide fraud. See United States ex rel. Gear v. Emergency Med. Assocs. of Ill., Inc., 436 F.3d 726, 729 (7th Cir.2006) (“Industry-wide public disclosures bar qui tarn actions against any defendant who is directly identifiable from the public disclosures.”); United States ex rel. Findley v. FPC-Boron Emps.’ Club, 105 F.3d 675, 688 (D.C.Cir.1997) (finding the disclosure bar to apply when the “relator[’s] complaint merely echoes publicly disclosed, allegedly fraudulent transactions that already enable the government to adequately investigate the case and to make a decision whether to prosecute, the public disclosure bar applies” even when the defendant-in-suit was not named in the disclosures); see also Ven-A-Care of Fla. Keys, 659 F.Supp.2d at 268 (recognizing a permissible inference that industry-wide public disclosure bars a defendant-member of that industry when there is a “narrow class of suspected wrongdoers” (citation and internal quotation marks omitted)). Additionally, as the Consolidated Complaint alleges, one of Medtronic’s biliary stents was recalled in 2003 due to off-label use. (Consol. Compl. § 126.) The public disclosures, therefore, explicitly link Medtronic to both the allegedly fraudulent off-label promotion and false-certification schemes. And, consequently, public disclosures predating Nowak’s original March 5, 2008, complaint fairly encompass the relators’ allegations. Although the relators’ complaints undoubtedly provide more detailed information than do the public disclosures, the allegations disclosed publicly need not be identical to or as detailed as the allegations contained in the complaint. Dingle v. Bioport Corp., 388 F.3d 209, 214-15 (6th Cir.2004) (“So long as the government is put on notice to the potential presence of fraud, even if the fraud is slightly different than the one alleged in the complaint, the qui tam action is not needed.”). In Dingle, the Sixth Circuit found that a single congressional witness’s testimony that the defendant fraudulently modified production of a drug, albeit on different grounds than those asserted by the relators, constituted public disclosure of fraud. Id. at 214. This is not a case in which the public disclosures asserted only “essential background information” or “lack[ed] any suggestion of fraudulent activity by drug manufacturers or anyone else ... or any indication of how the scheme works.” Ven-A-Care of Fla. Keys, 659 F.Supp.2d at 266-68 (declining to find public disclosure when neither the defendants nor the drugs at issue were revealed in the published government reports at issue). Public disclosures here described an industry-wide practice of off-label promotion and misuse of the 501(k) certification process relating to biliary stents and specifically identified Medtronic — and more than one of its biliary stent products — as complicit in this scheme. b. Statutorily Recognized Sources of Public Disclosure The public disclosure bar applies to public disclosures that occur “in a criminal, civil, or administrative hearing, in a 39 congressional, administrative, or Government Accounting Office report, hearing, audit, or investigation, or from the news media.” 31 U.S.C. § 3730(e)(4)(A). On its face, the statute encompasses government investigations such as the FDA’s. Additionally, the majority of the public disclosures of fraud in this case appear in industry or national news media. (See Nemirow Deck, Exs. J-P.) Because “[a]ny transactions and allegations discussed in the news media would seem to qualify as public disclosures,” Poteet, 619 F.3d at 110, I answer the second inquiry in the public-disclosure-bar analysis in the affirmative. c. “Based Upon” Public Disclosure I must next determine whether the relators’ action is “based upon” the public disclosures. See 31 U.S.C. § 3730(e)(4)(A). An action is “‘based upon’ prior disclosures if the relator’s complaint contains allegations that are ‘substantially similar to’ those disclosures.” Poteet, 619 F.3d at 114 (quoting Ondis, 587 F.3d at 58). Even if it is clear from the record that the allegations made in the Consolidated Complaint did not derive from the public disclosures but from information gained from the relators’ own experiences, First Circuit case law holds that their claims were “based upon” the public disclosures if they were “substantially similar.” Ondis, 587 F.3d at 58. When making this determination, I “must compare the substance of the prior disclosures with the substance of the relator[s’] complaint[s].” Poteet, 619 F.3d at 114. The First Circuit has not particularized how similar the claims must be to the disclosures to render them “substantially similar.” In the court’s two cases addressing this question, the prior disclosures were nearly identical to the claims: in Poteet, the disclosures consisted of prior FCA actions against the same defendant by the same relator and by another relator alleging the same fraudulent scheme, 619 F.3d at 114-15 (noting that “[t]he only notable difference between the two allegations” is that in the latest complaint, the relator identifies a specific device and the exact means by which the improper influence was applied to induce fraudulent claims); and, in Ondis, a previously released FOIA response “[wa]s substantially similar (indeed, identical)” to the relator’s complaint, 587 F.3d at 58. In both cases, the complaints alleged more detailed facts than the disclosures, but generally described the same alleged fraud. The public disclosures here disclosed all of the essential elements of the relators’ false-certification claims, including how biliary stent manufacturers — and Medtronic in particular — used the 510(k) process to approve de facto vascular stents under the less stringent guise of Class II biliary stents. One article even refers to the FDA’s approval of a specific Medtronic device in 2007 (the Consolidated Complaint identifies this device as the Complete SE). (See Nemirow Deck, Ex. O.) As in Poteet, the Consolidated Complaint adds details— identifying the allegedly fraudulently certified devices and the means by which Medtronic allegedly misrepresented the stents to the FDA during the certification process — but alleges the same fraudulent scheme. See Poteet, 619 F.3d at 115. Consequently, under the First Circuit’s interpretation of “based upon,” the false-certification claims fall under the public-disclosure bar (unless the relators are otherwise exempted as original sources). See Ondis, 587 F.3d at 58. The differences between the public disclosures and the Consolidated Complaint’s allegations regarding off-label promotion are greater than those concerning the false-certification claims. Whereas the news articles outline precisely how biliary stent manufacturers used the 510(k) process to certify stents made for vascular usage, the articles disclosing the off-label marketing scheme make more general allegations of rampant off-label promotion by Medtronic and others and the FDA’s investigations and concerns regarding the practice. By contrast, the Consolidated Complaint provides specific allegations of fraudulent conduct by Medtronic and gives the who, when, and how regarding the workings of Medtronic’s off-label marketing operation. Nevertheless, the First Circuit’s interpretation of “based upon” is broadly defined; the public disclosures allege an intentional off-label promotion scheme and identify Medtronic as a likely perpetrator. The public disclosures, therefore, “ultimately target[ ] the alleged fraudulent scheme. That is enough to trigger the disclosure bar.” Poteet, 619 F.3d at 115; cf. United States ex rel. Baltasar, 635 F.3d 866, 869 (7th Cir.2011) (concluding that the relator’s “defendant-specific” allegation was not “substantially similar” to the public disclosures because they had reported only that “false or mistaken claims are common” but did not identify the defendant as among those submitting fraudulent claims); United States ex rel. Lisitza v. Johnson & Johnson, 765 F.Supp.2d 112, 124 (D.Mass.2011) (finding claim “based upon” disclosures that had identified best-price manipulation scheme, how it worked, and at least some of the pharmaceuticals involved, thereby “b[ringing] to light all of the ‘essential elements’ of [the relator’s] best price allegations”). Thus the FCA’s disclosure bar applies to both of the relators’ allegations here and their action must be dismissed unless the relators demonstrate that they are original sources. d. The Original-Source Exception An original source is “an individual who [ (I) ] has direct and independent knowledge of the information on which the allegations are based and [ (ii) ] has voluntarily provided the information to the Government before filing an action under [the FCA] which is based on the information.” 31 U.S.C. § 3730(e)(4)(B). I will address the second requirement first. The First Circuit has “h[e]ld that § 3730(e)(4)(B) only requires that a relator provide his or her information [to the government] prior to the filing of the qui tam suit.” Duxbury, 579 F.3d at 28. In Duxbury, the court rejected the “contention that § 3730(e)(4)(B) requires an ‘original source’ to provide his or her information before the public disclosure at issue.” Id. The relators concede that Dodd only provided the government with information “concurrent with his filing.” (Opp. at 19 n. 84.) No further details regarding what he disclosed, to whom, or how are provided. “Concurrent” is not “before” and, consequently, Dodd fails to qualify as an original source. Accordingly, all claims attributable to Dodd will be dismissed. Nowak, however, disclosed her allegations to the government on November 9, 2007, and February 29, 2008. (Stevenson Decl. ¶ 2.) She also claims that she submitted a draft of her original complaint to the government on November 16, 2007, prior to filing her qui tarn action. (Stevenson Decl. ¶ 4.) Although the details of the information provided are not alleged, provision of a draft copy of the original complaint, in addition to several conversations, complies with the strict letter of the statute, which requires only that the original source “voluntarily provide! ] the information to the Government before filing an action.” 31 U.S.C. § 3730(e)(4)(B); United States ex rel. Hutcheson v. Blackstone Med., Inc., 647 F.3d 377, 384 n. 8 (1st Cir.2011) (“Hutcheson’s complaint stated that she disclosed the allegations to the United States Attorney’s Office ... in the ‘Summer of 2006’ ‘prior to filing.’ This is more than enough.”); Baltazar, 635 F.3d at 869. The original-source exception also requires Nowak to demonstrate that she “has direct and independent knowledge of the information on which the allegations are based.” 31 U.S.C. § 3730(e)(4)(B). In order to do so, she must provide more than mere “conclusory allegations” in the complaint. Duxbury, 579 F.3d at 28. The Supreme Court has held that “the ‘information’ ... is the information upon which the relator’s allegations are based.” Rockwell Int’l Corp., 549 U.S. at 470-71, 127 S.Ct. 1397. “A relator’s knowledge is ‘direct’ if she acquired it through her own efforts without an intervening agency, and it is ‘independent’ if her knowledge is not dependent on the public disclosure.” In re Pharm. Indus. Average Wholesale Price Litig., 538 F.Supp.2d at 379 (citation omitted). Nowak’s original, amended, and consolidated complaints allege the off-label promotion scheme with great detail. She refers to specific emails, conversations, meetings, promotional materials, and sales reports to support her allegations. These are materials that she collected as a Medtronic sales representative and not from public disclosures or another source. See United States ex rel. Hutcheson v. Blackstone Med., Inc., 694 F.Supp.2d 48, 60 (D.Mass.2010), rev’d on other grounds, 647 F.3d 377 (1st Cir.2011) (finding that a relator was an original source because, as the defendant’s employee, “she observed [the defendant’s] business practices!,] ... was privy to meetings, conversations, and other internal communications!, and] ... had access to email and internal documents and data which reflected the conduct discussed in the complaint”). As to the off-label promotion scheme, Medtronic’s assertions that Nowak based her allegations on information available publicly is simply not supported by the record. Nowak’s original and amended complaints, however, do not establish that she was an original source for the alleged false-certification scheme. Although she implies that Medtronic designed its