Opinion ID: 4110875
Heading Depth: 2
Heading Rank: 2

Heading: Onyx Training Program Claims

Text: That leaves, with respect to Onyx, D'Agostino's theory that the defendants caused the submission of false claims by encouraging medically unnecessary and dangerous uses of Onyx by physicians who did not attend the training program offered by the 4The whistleblower in such a scenario, as an original source of the information, would trump any copycats who tried to first file suit after the FDA publicly disclosed its actions. See 31 U.S.C. § 3730(e)(4)(A)(i)–(ii). - 19 - defendants. Undergirding this theory is the fact that Medicare excludes from coverage claims involving procedures that are not reasonable and necessary for the diagnosis or treatment of illness or injury. 42 U.S.C. § 1395y(a)(1)(A). D'Agostino's proposed complaint incorporates the statement of a neurosurgeon and leading Onyx user, who opines that it is never medically reasonable or medically necessary for an untrained physician to use Onyx in procedure [sic] involving a live human being, as such use creates an exceedingly dangerous situation for the patient. According to D'Agostino, the defendants therefore caused the submission of false claims by fail[ing] to provide the physician training that the FDA required as a condition of approval usage, and subsequently induc[ing] those untrained doctors to use Onyx anyway. This theory, rather than targeting every Onyx claim, attacks the subset of claims seeking reimbursement for procedures performed by physicians whom the defendants did not train. We evaluate the sufficiency of these allegations under Federal Rule of Civil Procedure 9(b), which provides that, [i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake. Fed. R. Civ. P. 9(b). More precisely, Rule 9(b) requires a relator to allege with particularity the who, what, when, where, and how of the fraud. United States ex rel. Ge v. Takeda Pharm. Co., 737 F.3d 116, 123 (1st Cir. 2013). Furthermore, allegations limited to - 20 - describing the defendant's scheme and intent are insufficient, [b]ecause FCA liability attaches only to false claims. Id. at 124 (citing United States ex rel. Karvelas v. Melrose-Wakefield Hosp., 360 F.3d 220, 225 (1st Cir. 2004), abrogated on other grounds by United States ex rel. Gagne v. City of Worcester, 565 F.3d 40 (1st Cir. 2009)). Thus, the allegations must also establish that the fraudulent conduct actually caused the submission of false claims to the government for payment. Id. (citing United States ex rel. Rost v. Pfizer, Inc., 507 F.3d 720, 732–33 (1st Cir. 2007), overruled in part by Allison Engine Co. v. United States ex rel. Sanders, 553 U.S. 662 (2008)). As a general matter, a relator does this by alleging with particularity examples of actual false claims submitted to the government. Karvelas, 360 F.3d at 232–33. By doing so, the relator conveys that if the facts alleged are true, the filing of a false claim is not merely a possibility, but rather, necessarily occurred. Alternatively, in appropriate circumstances, a relator may instead allege factual or statistical evidence to strengthen the inference of fraud beyond possibility. United States ex rel. Duxbury v. Ortho Biotech Prod., L.P., 579 F.3d 13, 29 (1st Cir. 2009) (quoting Rost, 507 F.3d at 733). See, e.g., United States ex rel. Escobar v. Universal Health Servs., Inc., 780 F.3d 504, 515 (1st Cir. 2015), overruled on other grounds by 136 S. Ct. 1989 (2016) (holding that particular allegations concerning one patient were sufficient - 21 - because they arose from a systematic failure that necessarily infected other claims with fraud). Applying these rules, the district court found the proposed complaint's allegations insufficient, citing their failure to identify any specific false claim submitted to the government for reimbursement. D'Agostino, 153 F. Supp. 3d at 536 n.38. In response, D'Agostino repeats the argument he made to the district court, pointing to allegations in his proposed complaint that two physicians who did not attend the defendants' training program performed a total of approximately seventy procedures using Onyx, and that well over 50% of these physicians' patients were insured under government health plans. So, reasons D'Agostino, the odds are very high that at least some bills were submitted to and paid by the government for use of Onyx by untrained physicians. And since the device label calls for use only by trained physicians, the use by untrained physicians was both off-label and, in the opinion of an expert retained by D'Agostino, not medically necessary. There are several problems with this line of reasoning. First, and most simply, while the FDA-approved label for Onyx does indeed restrict use to physicians with neurointerventional training, and refers users to MTI for information on training courses, it contains no requirement that the physician must obtain the training from MTI or ev3. Therefore, D'Agostino's allegation - 22 - that the defendants did not train these two physicians falls materially short of alleging facts showing that they were not trained at all. And if they were indeed otherwise trained,5 the use of Onyx would not have been off-label. For this reason alone, D'Agostino's training program claims fail. Additionally, even if we were to overlook this gap in the allegations, the assumption that physicians submitted claims for reimbursement merely because many of their patients in general were insured under government programs is faulty. The district court noted as much, explaining the distinction between alleging that a certain percentage of patients carried government insurance and alleging that any patient carrying government insurance underwent a procedure involving the device that resulted in a claim for government reimbursement. D'Agostino, 153 F. Supp. 3d at 536 n.38. D'Agostino's assumption is particularly faulty because seeking reimbursement here would have required the physicians knowingly to submit off-label claims if they did indeed lack the training the label plainly required. See Rost, 507 F.3d at 732– 34. For each of these reasons, we agree with the district court that D'Agostino's training program version of his Onyx 5The proposed complaint alleges that the defendants trained at least one physician at each medical facility, including presumably the facilities at which each of these two physicians worked. - 23 - claim fails because it does not sufficiently allege the submission of a false claim nor does it advance a theory and facts that together create a strong inference that false claims were actually filed. Id. at 732.