United States ex rel. Ge v. Takeda Pharm. Co.
| Decision Date | 06 December 2013 |
| Docket Number | Nos. 13–1088,13–1089.,s. 13–1088 |
| Citation | 737 F.3d 116 |
| Parties | UNITED STATES ex rel. Helen GE, M.D., Relator, Appellant, State of California; State of Delaware; State of Florida; State of Georgia; State of Hawaii; State of Illinois; State of Louisiana; State of Indiana; State of Michigan; State of Minnesota; State of Montana; State of Nevada; State of New Hampshire; State of New Jersey; State of New Mexico; State of New York; State of North Carolina; State of Oklahoma; State of Rhode Island; State of Tennessee; State of Texas; State of Wisconsin; Commonwealth of Massachusetts; Commonwealth of Virginia; District of Columbia, Plaintiffs, v. TAKEDA PHARMACEUTICAL COMPANY LIMITED; Takeda Pharmaceutical North America, Inc., Defendants, Appellees. United States ex rel. Helen Ge, M.D., Relator, Appellant, State of California; State of Delaware; State of Florida; State of Georgia; State of Hawaii; State of Illinois; State of Louisiana; State of Indiana; State of Minnesota; State of Montana; State of Nevada; State of New Hampshire; State of New Jersey; State of New Mexico; State of New York; State of North Carolina; State of Oklahoma; State of Rhode Island; State of Tennessee; State of Texas; State of Wisconsin; Commonwealth of Massachusetts; Commonwealth of Virginia; District of Columbia, Plaintiffs, v. Takeda Pharmaceutical Company Limited; Takeda Pharmaceutical North America, Inc., Defendants, Appellees. |
| Court | U.S. Court of Appeals — First Circuit |
OPINION TEXT STARTS HERE
Michael Sullivan, with whom The Ashcroft Group, Michael L. Baum, Bijan Esfandiari, R. Brent Wisner, and Baum, Hedlund, Aristei & Goldman, P.C. were on brief, for appellant.
Brian J. Murray, with whom Morgan R. Hirst, Marron A. Mahoney, Christopher M. Morrison, Joseph B. Sconyers, and Jones Day were on brief, for appellees.
Melissa N. Patterson, Attorney, Appellate Staff, Civil Division, with whom Stuart F. Delery, Acting Assistant Attorney General, Carmen M. Ortiz, United States Attorney, and Michael S. Rabb, Attorney, Appellate Staff, Civil Division, were on brief, for the United States of America as Amicus Curiae.
Before LYNCH, Chief Judge, STAHL and HOWARD, Circuit Judges.
In June 2010 Dr. Helen Ge originally filed these two qui tam actions against her former employer, Takeda Pharmaceutical Company Ltd. and its subsidiary Takeda Pharmaceutical North America, Inc. (collectively, “Takeda”), under the federal False Claims Act (“FCA”), 31 U.S.C. § 3729 et seq., and various analogous state statutes. The two actions concern different drugs. She has since amended each of her complaints twice. The United States has declined to enter the case as a party. In a successful qui tam action, the relator collects a portion of the award to the government regardless of whether the government intervenes. See United States ex rel. Duxbury v. Ortho Biotech Prods., L.P. (“ Duxbury I ”), 579 F.3d 13, 16 (1st Cir.2009).
Dr. Ge has alleged in her second amended complaints that Takeda had failed to disclose adequately the risks associated with four of its drugs and generally that this failure resulted in the submission of false claims by various third-party patients and physicians for government payment through, for example, Medicare or Medicaid reimbursement.
On Takeda's motions to dismiss, the district court dismissed both of Dr. Ge's actions under Federal Rule of Civil Procedure 9(b) for failure to plead fraud with particularity and, in addition, under Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim. United States ex rel. Ge v. Takeda Pharm. Co. Ltd., Nos. 10–11043–FDS, 11–10343–FDS, 2012 WL 5398564 (D.Mass. Nov. 1, 2012). Dr. Ge proposed to amend the second amended complaint yet again, asserting still more theories of FCA liability. The district court declined to allow further amendment.
Dr. Ge now appeals, making three levels of arguments: (1) as to the Rule 9(b) dismissal, that her complaints contain sufficient allegations concerning “the who, what, where, and when” of Takeda's misconduct to satisfy Rule 9(b)'s particularity requirement, see Duxbury I, 579 F.3d at 30 ) (internal quotation mark omitted), (2) the district court abused its discretion in rejecting without opinion two requests, one prejudgment and one post-judgment, by Dr. Ge to amend her complaints again, and (3) as to Rule 12(b)(6), that the district court's analysis relies on an overly restrictive conception of FCA liability.
This opinion concerns the first two arguments. We affirm the district court on its Rule 9(b) and denial of amendment rulings, and do not reach the 12(b)(6) issue.
In September 2008, Dr. Ge took a position with Takeda as a contract physician, contracting to perform medical reviews of adverse event reports. Dr. Ge was responsible for reports of adverse events, including those concerning four specific drugs for specific diseases: Actos (type 2 diabetes), Uloric (gout), Kapidex/Dexilant (gastroesophageal reflux disease), and Prevacid (same). Takeda sells all four drugs and each required Food and Drug Administration (“FDA”) approval for these uses. Dr. Ge's tasks included ascertaining the seriousness of a reported event, determining whether the associated drug was causally responsible for that event, and determining whether that event constituted a “safety signal,” that is whether the reported event signaled the need for additional safety warnings. Dr. Ge worked for Takeda until January 2010. She asserts that when she complained about improper reporting at Takeda, her contract was summarily terminated.
On June 18, 2010, Dr. Ge filed an FCA complaint under seal against Takeda pertaining to Actos. United States ex rel. Helen Ge v. Takeda Pharmaceutical Co., et al, 10–11043–FDS. On March 1, 2011, Dr. Ge filed a second complaint under seal pertaining to Uloric, Kapidex/Dexilant, and Prevacid. United States ex rel. Helen Ge v. Takeda Pharmaceutical Co., et al, 11–10343–FDS. In Dr. Ge's complaints, she alleged on behalf of the United States 1 that three FCA sections were violated: (a) 31 U.S.C. § 3729(a)(1)(A), which imposes liability on any person who “knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval,” (b) § 3729(a)(1)(B), which imposes liability on 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,” and (c) § 3729(a)(1)(C), which imposes liability on any person who conspires to commit a violation of, among other things, § 3729(a)(1)(A) or § 3729(a)(1)(B).
In late 2011 and early 2012, Dr. Ge filed amended complaints in both cases while both complaints were still under seal. Between late March and early April 2012, Dr. Ge filed a second set of amended complaints after the complaints were unsealed. Dr. Ge's second amended complaints are the ones directly at issue on appeal.
Dr. Ge alleged Takeda had failed to report promptly and accurately to the FDA a number of post-approval adverse events associated with the four subject drugs. The FDA is responsible for the approval of drugs for commercial marketing. See21 U.S.C. § 355. The FDA is authorized after approval to continue to evaluate the safety and effectiveness of the drug and, where appropriate, to withdraw approval or require a change in labeling. See id. § 355(k). FDA regulations require prompt, accurate reports of adverse drug events by drug manufacturers. 21 C.F.R. §§ 314.80, 314.81. The receipt of an adverse report does not in and of itself show a causal relationship between a drug and the illness mentioned in a report. N.J. Carpenters Pension & Annuity Funds v. Biogen Idec, Inc., 537 F.3d 35, 53 (1st Cir.2008).
It is undisputed that Takeda did submit adverse event reports and there is no specific allegation that any of the events which are the subject of the complaint were not eventually reported in some form to the FDA. As to the drug Actos, Dr. Ge alleged that she was asked by Takeda to misreport adverse events including incidences of heart failure, renal failure, pancreatic cancer, and, most notably, bladder cancer. Dr. Ge alleged that she complied with those directions on certain occasions after having made known her objections. In addition, Dr. Ge alleged that she had discovered systematic under-reporting by Takeda of the incidence of bladder cancer in adverse event reports.
The FDA did receive information on bladder cancer risk because in June 2011, the FDA issued an official warning “that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.” FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer (June 15, 2011), http:// www. fda. gov/ Drugs/ Drug Safety/ ucm 259150. htm. The FDA also mandated a label change. FDA Drug Safety Communication: Updated drug labels for pioglitazone-containingmedicines
(Aug. 4, 2011), http:// www. fda. gov/ drugs/ drugsafety/ ucm 266555. htm. But it also issued a supplemental approval of Actos after knowing of the bladder cancer risk. Dr. Ge alleges that after the labeling change the sales of Actos plummeted.
As to the drugs Uloric, Kapidex/Dexilant, and Prevacid, Dr. Ge alleged that Takeda pressured her to falsify her medical conclusions, asking her to classify events as “non-serious” or to change her causality assessment to “unrelated” so as to avoid “reporting within 15 days” as required by FDA regulation. See21 C.F.R. § 314.80(c)(1)(i) (). Specifically, Dr. Ge alleged that she was directed to alter her analysis of reported adverse events involving the interactions between the three drugs and other medications likely to be taken by senior citizens. Dr. Ge did not clearly allege that she complied with Takeda's directions. Dr. Ge did allege, however,...
To continue reading
Request your trial
-
Ayyadurai v. Floor64, Inc., Civil Action No. 17–10011–FDS
...an opposition to a motion to dismiss does not constitute a motion to amend for purposes of Rule 15(a)." United States ex rel Ge v. Takeda Pharm. Co. , 737 F.3d 116, 128 (1st Cir. 2013) (quoting Gray v. Evercore Restructuring LLC , 544 F.3d 320, 327 (1st Cir. 2008) ). "[W]here, as here, a re......
-
Capron v. Office of the Attorney Gen. of Mass.
...amend their complaint pursuant to Rule 15(a). We review denials of both motions for abuse of discretion. United States ex rel. Ge v. Takeda Pharm. Co., 737 F.3d 116, 127 (1st Cir. 2013). We find none.The plaintiffs can succeed on a Rule 59(e) motion for reconsideration -- relief for which, ......
-
Salmon v. Lang
...rule under Federal Rule of Procedure 15(c)(1)(C). We review both orders for abuse of discretion. See U.S. ex rel. Ge v. Takeda Pharm. Co. Ltd., 737 F.3d 116, 127 (1st Cir. 2013). In so doing, we are mindful that "[t]he granting of a motion for reconsideration is an extraordinary remedy whic......
-
United States ex rel. Gardner v. Vanda Pharm., Inc.
...id. at 20-21 (citing Booker, 847 F.3d 52; Nathan, 707 F.3d 451; Rost, 507 F.3d 720; Lawton, 842 F.3d 125; United States ex rel. Ge v. Takeda Pharm. Co., 737 F.3d 116 (1st Cir. 2013); United States ex rel. Kelly v. Novartis Pharms. Corp., 827 F.3d 5 (1st Cir. 2016); King, 871 F.3d 318). This......
-
Fourth Circuit Holds cGMP Violations Do Not Create False Claims Under Medicare And Medicaid
...the FCA.20 The government's position in Rostholder parallels the position it took last year in United States ex rel. Ge v. Takeda Pharm., 737 F.3d 116 (1st Cir. 2013), where it acknowledged in an amicus brief that "[s]imply alleging that a company failed to comply with FDA's adverse event r......
-
False Claim Act: 2013 Year In Review
...of a contract, and (3) alleged that the government made payment under the contracts. US ex rel. Ge v. Takeda Pharmaceutical Co. Ltd., 737 F.3d 116 (1st Cir. In an interesting move, on December 6, the First Circuit dismissed US ex rel. Ge v. Takeda Pharmaceutical Co. Ltd. on 9(b) grounds, ci......