Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Lawton ex rel. United States v. Takeda Pharmaceutical Co., Ltd.

United States Court of Appeals, First Circuit

November 22, 2016

PETER P. LAWTON, ex rel. UNITED STATES OF AMERICA; and THE STATES OF CALIFORNIA, COLORADO, CONNECTICUT, DISTRICT OF COLUMBIA, DELAWARE, FLORIDA, GEORGIA, HAWAII, IOWA, ILLINOIS, INDIANA, LOUISIANA, MASSACHUSETTS, MARYLAND, MICHIGAN, MINNESOTA, MONTANA, NORTH CAROLINA, NEW JERSEY, NEW MEXICO, NEVADA, NEW YORK, OKLAHOMA, RHODE ISLAND, TENNESSEE, TEXAS, VIRGINIA, WASHINGTON, WISCONSIN, Plaintiffs, Appellants,
v.
TAKEDA PHARMACEUTICAL COMPANY, LTD.; TAKEDA PHARMACEUTICALS U.S.A., INC., f/k/a Takeda Pharmaceuticals North America, Inc.; TAKEDA PHARMACEUTICALS INTERNATIONAL INC.; TAKEDA DEVELOPMENT CENTER AMERICAS, INC., f/k/a Takeda Global Research & Development Center Inc.; ELI LILLY AND COMPANY, Defendants, Appellees.

         APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS [Hon. Mark L. Wolf, U.S. District Judge]

          David E. Kovel, with whom John R. Low-Beer, Of Counsel, and Kirby McInerney LLP were on brief, for appellants.

          R. Jeffrey Layne, with whom Jonathan S. Franklin, Sarah M. Cummings, and Norton Rose Fulbright U.S. LLP were on brief, for appellees.

          Before Lynch, Stahl, and Barron, Circuit Judges.

          STAHL, Circuit Judge.

         Relator-Appellant Peter Lawton ("Lawton") brought a qui tam action against Appellees Takeda Pharmaceutical Company, Ltd. and its affiliates ("Takeda") and Eli Lilly and Company ("Eli Lilly") (collectively, "Defendants") under the False Claims Act ("FCA"), 31 U.S.C. § 3729 et seq., and the False Claims Acts of 28 different states and the District of Columbia.[1] Lawton alleges that Takeda and Eli Lilly conspired in a fraudulent marketing campaign that caused third-parties to submit false reimbursement claims to government entities for off-label uses of Actos, a treatment for Type 2 diabetes.[2]

         The district court dismissed all of Lawton's claims, holding that Lawton had not pled his claims with the particularity required by Federal Rule of Civil Procedure 9(b). Lawton contests this ruling on appeal, and maintains that his allegations sufficiently plead that false claims were submitted to both federal and state government programs. After thoroughly reviewing these allegations, we affirm.

         I. Facts & Background

         Since this appeal follows the granting of a motion to dismiss, we recite the relevant facts as they appear in Lawton's Second Amended Complaint. See Hochendoner v. Genzyme Corp., 823 F.3d 724, 728 (1st Cir. 2016).

         Actos is a brand name drug approved by the FDA for improving blood sugar control in adults with Type 2 diabetes. The drug is manufactured, promoted, marketed, and sold by Takeda.[3]

         In May 2012, Peter Lawton filed a qui tam complaint against Takeda alleging that it had engaged in an illegal off-label marketing campaign for Actos in violation of 21 U.S.C. § 321 et seq. (the "Food, Drug & Cosmetic Act"), and used illegal kickbacks to support that campaign in violation of 42 U.S.C. § 1320a-7b(b) (the "Anti-Kickback Statute").[4] Lawton -- a former chemist and patent litigator at Takeda competitor GlaxoSmithKline -- further alleged that through this campaign, Takeda and Eli Lilly had knowingly caused third-parties to submit false or fraudulent claims for payment to federal and state government programs.[5] See, e.g., 31 U.S.C. § 3729(a); N.Y. State Fin. Law §§ 188-89.

         Lawton made his first amendment to his complaint in February 2014, and after the United States declined to intervene and the action was unsealed, his case began in earnest. In August 2015, the district court allowed Lawton to amend his complaint again ("Second Amended Complaint"), which he filed the following month and is the subject of this appeal.

         The Second Amended Complaint alleged that starting in the late 1990s and lasting until 2011, Defendants utilized a marketing scheme designed to develop and promote "quasi-scientific" bases for off-label use of Actos, specifically the treatment of prediabetes.[6] The claimed centerpiece of this campaign involved the development of dozens of pro-Actos research studies and subsequent publications substantiating these claims. The most prominent of these studies, Lawton claims, was a 2006 paper ("ACT NOW Study") on the prevention of Type 2 diabetes. Allegedly conceived and funded by Takeda but ostensibly authored by Dr. Ralph DeFronzo, the ACT NOW Study advocated for the use of Actos as an effective treatment for prediabetes. Lawton alleges that Dr. DeFronzo and other "thought leaders" and researchers like him received compensation, kickbacks, and other indirect financial inducements from Takeda for their Actos studies, related speeches, and supporting presentations. Many of these studies, however, were criticized by various academic journals, peer review panels, and the FDA.

         Takeda allegedly also established a specialized Actos sales force to parallel this campaign, and tasked it with encouraging physicians to prescribe Actos as a safe and effective treatment for prediabetes. Takeda also supposedly engaged in direct marketing to the public about the off-label use of Actos and made large contributions to several educational and research organizations to gain influence over their views on prediabetes treatments. These efforts purportedly continued even after Takeda knew that the results of many of these studies were inconclusive.

         Based on these allegations, Lawton claimed that Takeda and Eli Lilly violated the FCA and analogous state statutes by causing false claims for Actos to be presented to ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.