United States of America v. Takeda Pharmaceuticals America, Inc.

District Court, N.D. Illinois·Decided August 2, 2022·No. 1:14-cv-09412·Unknown

Opinion

UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ILLINOIS UNITED STATES OF AMERICA et al. ex rel. RONALD J. STRECK,

Plaintiffs-Relator, Case No.: 1:14−cv−09412 v.

TAKEDA PHARMACEUTICALS Judge Harry D. Leinenweber AMERICA, INC., et al.,

Defendants. RELATOR’S MOTION FOR JUDGMENT AS A MATTER OF LAW UNDER FEDREAL RULE OF CIVIL PROCEDURE 50(a) Pursuant to Federal Rule of Civil Procedure 50(a), Relator respectfully moves for judgment as a matter of law with respect to causation, materiality, and scienter.1 Federal Rule of Civil Procedure 50(a) provides that once “a party has been fully heard on an issue during a jury trial and the court finds that a reasonable jury would not have a legally sufficient evidentiary basis to find for the party on that issue, the court may (A) resolve the issue against the party; and (B) grant a motion for judgment as a matter of law against the party on a claim or defense that, under the controlling law, can be maintained or defeated only with a favorable finding on that issue.” In considering Rule 50(a) motions, “[t]he standard for granting judgment as a matter of law mirrors that for the granting of summary judgment.” Orlowski v. Eriksen, 2009 WL 5183226, at *1 (N.D. Ill. Dec. 30, 2009) (quotations omitted). For the reasons described below, even viewing the evidence in the light most favorable to Lilly, the trial record establishes that the Court should enter judgment as a matter of law for Relator

1 All references to trial transcript are in the form of “Tr. __.” All references to admitted exhibits are in the form of “RX-____” for Relator’s exhibits and “DX-___” for Lilly’s exhibits. on causation, materiality, and scienter. I. The Undisputed Evidence Establishes Causation The Seventh Circuit’s most recent decision on causation in an FCA case provides that “the plaintiff must establish that the defendant's fraud was a material element and a substantial factor in bringing about the injury.” U.S. v. Molina Healthcare of Illinois, Inc., 17 F.4th 732, 745 (7th Cir. 2021) (quotations omitted). Citing the Seventh Circuit’s earlier decision in U.S. v. Luce, 873

F.3d 999 (7th Cir. 2017), Lilly contends that in addition to satisfying this test from Molina, Relator must also establish proximate cause. (Dkt. 391 at 13-14). Lilly describes this test as requiring Realtor to prove that the Government’s loss “was reasonably foreseeable or anticipated as a natural consequence of defendants’ conduct.” Id. at 14. Relator preserves his argument that Molina governs the causation inquiry. But, even under Lilly’s formulation of the causation inquiry, the trial record establishes that Lilly’s false AMPs and false certifications were both (1) a material element and a substantial factor in bringing about the Government’s injury and (2) the Government’s injury was a reasonably foreseeable and anticipated consequence of Lilly’s conduct. Lilly has not seriously argued otherwise – indeed, in opening statements, Lilly’s counsel said that the case was about scienter and materiality without

even mentioning causation. Tr. 183:13-184:1. This is just as well, since the below-discussed evidence firmly establishes causation. Simply put, the facts in this case are as far as you can get from the unforeseeability of a guard assisting an unsteady passenger aboard a train, and in the course of doing so, unwittingly causing the passenger to drop a package of fireworks, which, in turn, causes scales to fall on the opposite end of the train platform, injuring a passerby. Cf. Palsgraf v. Long Island R. Co., 248 N.Y. 339, 341 (1928). First, CMS provided two lengthy declarations that, in painstaking detail, explain how a manufacturer’s submission of false AMPs directly leads to the manufacturer’s underpayment of Medicaid rebates. RX-1358, RX-1359. To summarize, “based on the statutory design of the MDRP, higher AMPs result in higher rebates, and lower AMPs result in lower rebates,” and thus,

“[i]f a drug manufacturer incorrectly reports AMPs that are lower than they should be based on program requirements, the manufacturer will underpay the amount of MDRP rebates it owed to the government.” RX-1359 ¶ 19. Second, Lilly witnesses testified in a materially identical fashion. For example, Heather Dixson explained: Q. So let's talk just briefly process for a moment. Would you agree with this: Lilly calculates its AMPs, right, internally? A. Yes. Q. And the government has nothing to do with that, right, like the calculation? A. The calculation, no. Q. Okay. Lilly then sends its AMPs to the government? A. Correct. Q. Through the DDR system? A. Yes. Q. Okay. And then CMS calculates the unit rebate amount, right? A. Both CMS and the manufacturer have the responsibility to calculate the rebate amount. Q. Okay. And then CMS sends the unit rebate amount to all 50 states, right? A. Yes. Q. And the District of Columbia, let's not forget good old Washington? A. Absolutely. Q. Then each state and Washington, D.C. prepare these invoices that multiply the URA, the unit rebate amount, by the utilization for each individual Lilly product? A. That's typically how it works, yes. Q. Okay. So if the AMP is wrong for one individual Lilly product, one individual drug, the rebate amount sought by the invoice will be incorrect, right? A. Yes. Tr. 766:7-767:10. Third, Lilly’s own internal documents show that the company was keenly aware that its submission of AMPs directly affected its rebate amounts (which of course is doing little more than stating the obvious since this is the result of the operation and design of the rebate program). For example, one Lilly document describes: Each calendar quarter, Lilly calculates an AMP for each product and a Best Price for those products that are classified as innovators, and AMP for any non- innovator products. Lilly submits the AMP and Best Price information for each product family to CMS within 30 days of the end of the quarter. Using that information, baseline information, and the CPI-U, CMS calculates the URA for each drug and disseminates those values to the States generally within 40 to 45 days of the end of the quarter. The States send rebate invoices to Lilly based on claims paid by the State and the URA information received from CMS, generally beginning 50 to 60 days from the end of the quarter. RX-0067 at 0007-0008. Fourth, Relator’s damages expert (Eric Kimelblatt) similarly explained that “if an AMP was underreported, again, that's going to translate to an underpayment of Medicaid rebates from the manufacturer to the state and Medicaid programs.” Tr. 574:5-10. Likewise, Mr. Kimelblatt’s unrebutted calculation that Lilly’s underreported AMPs led to underpayment of its rebates by $61 million further corroborates causation. In short, whatever the parties’ areas of disagreement, the trial record only permits one conclusion: that Lilly’s false AMPs and false certifications caused Lilly’s underpayment of its Medicaid rebates. This is true under both Relator’s view of causation (only requiring that conduct play a material element and a substantial factor) and under Lilly’s view of causation (also requiring that the Government’s injury was a reasonably foreseeable and anticipated consequence). As such, the Court should enter judgment as a matter of law for Relator on causation. II. The Undisputed Evidence Establishes Materiality A defendant’s conduct is material under the FCA if it had “a natural tendency to influence, or be capable of influencing, the payment or receipt of money.” 31 U.S.C.

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United States of America v. Takeda Pharmaceuticals America, Inc., (N.D. Ill. 2022).

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