IN RE: CELEXA AND LEXAPRO MARKETING AND SALES PRACTICES LITIGATION
Nos. 18-1146, 18-1147
United States Court of Appeals For the First Circuit
January 30, 2019
PAINTERS AND ALLIED TRADES DISTRICT COUNCIL 82 HEALTH CARE FUND; DELANA S. KIOSSOVSKI; RENEE RAMIREZ, on behalf of herself and all others similarly situated; MARLENE T. LOCONTE, Plaintiffs, Appellants, MARTHA PALUMBO, individually and on behalf of all other persons similarly situated; PETER PALUMBO, individually and on behalf of all other persons similarly situated; JAYNE EHRLICH, individually and on behalf of all other persons similarly situated; ANNA MURRET, individually and on behalf of all other persons similarly situated; UNIVERSAL CARE, INC.; ANGELA JAECKEL; MELVIN M. FULLMER, on behalf of himself and all others similarly situated; NEW MEXICO UFCW UNION‘S AND EMPLOYER‘S HEALTH AND WELFARE TRUST FUND, on behalf of itself and all others similarly situated; ALLIED SERVICES DIVISION WELFARE FUND, on behalf of itself and all others similarly situated; TARA JOHNDROW, individually and on behalf of all other persons similarly situated; BRIAN ANSON, individually and on behalf of all others similarly situated; SCOTT A. WILCOX, on behalf of himself and all others similarly situated; MUNICIPAL REINSURANCE HEALTH INSURANCE FUND; RANDY MARCUS; BONNIE MARCUS; RUTH DUNHAM; TANYA SHIPPY; JILL POWELL, Plaintiffs, v. FOREST PHARMACEUTICALS, INC.; FOREST LABORATORIES, INC.; FOREST LABORATORIES, LLC, successor in interest to Forest Laboratories, Inc., Defendants, Appellees, PFIZER, INC.; WARNER LAMBERT COMPANY, Defendants.
APPEALS FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS
[Hon. Nathaniel M. Gorton, U.S. District Judge]
Before Howard, Chief Judge, Torruella and Kayatta, Circuit Judges.
R. Brent Wisner, with whom Michael L. Baum, Baum, Hedlund, Aristei & Goldman, P.C., Christopher L. Coffin, and Pendley, Baudin & Coffin, LLP were on brief, for appellants.
Andrew J. Ceresney, with whom Edwin G. Shallert, Kristin D. Kiehn, J. Robert Abraham, Debevoise & Plimpton LLP, John G. O‘Neill, and Sugarman, Rogers, Barshak & Cohen, P.C. were
KAYATTA, Circuit Judge. These consolidated appeals arise out of two so-called “off-label” prescription-drug-marketing cases aggregated for pretrial proceedings in the District of Massachusetts by order of the multidistrict litigation panel. Plaintiffs claim that the defendants, Forest Pharmaceuticals, Inc. and Forest Laboratories, Inc. (collectively “Forest“), engaged in fraud to push their antidepressant drugs on unsuspecting minors for whom the FDA had not approved the use of these medications. As we will explain, we reverse the dismissal of the claims brought by two of the four plaintiffs, and we vacate the denial of plaintiffs’ motion to compel the production of additional documents by Forest. We otherwise affirm the challenged district-court rulings, including the denial of class certification.
I.
We begin by summarizing the relevant statutory and regulatory framework and by reciting the facts relеvant to the plaintiffs’ summary-judgment appeal in the light most favorable to the plaintiffs. See Boudreau v. Lussier, 901 F.3d 65, 71 (1st Cir. 2018).
A.
The Federal Food, Drug, and Cosmetic Act (“FDCA“) requires drug manufacturers to obtain approval from the U.S. Food and Drug Administration (“FDA“) before marketing a drug for a particular medical use.
B.
Forest manufactures and markets prescription drugs, including the antidepressant
The record in this case nevertheless strongly suggests that Forest engaged in a comprehensive off-label marketing scheme from 1998 through 2009 aimed at fraudulently inducing doctors to write pediatric prescriptions of Celexa and Lexapro when Forest had insufficient reason to think that these drugs were effective for the treatment of depression in children and adolescents. Plaintiffs have pointed to substantial evidence that Forest sought to achieve this illicit aim by: (1) promoting Celexa‘s efficacy for the treatment of pediatric depression at medical conferences, at continuing-medical-education programs, and in press releases; (2) concealing negative clinical studies concerning Celexa‘s efficacy and safety; and (3) directly encouraging physicians to prescribe Celexa and Lexapro for the treatment of pediatric depression.
For years, Forest nevertheless denied that it was engaged in the off-label promotion of these drugs. Forest Laboratories’ Executive Vice President, Dr. Lawrence Olanoff, testified before Congress in 2004 that “because the FDA has not approved pediatric labeling for our products, Forest has always been scrupulous about not promoting the pediatric use of our antidepressant drugs, Celexa and Lexapro. That is the law, and we follow it.” Publication and Disclosure Issues in Antidepressant Pediatric Clinical Trials: Hearing Before the Subcomm. on Oversight & Investigations of the Comm. on Energy & Commerce, 108th Cong. 82 (2004) (statement of Dr. Lawrence Olаnoff).
Even before Dr. Olanoff assured Congress of Forest‘s scrupulousness, a whistleblower had commenced a qui tam action, alleging that Forest had violated the False Claims Act (“FCA“),
C.
Within the following four years, over a dozen consumers and entities who paid for prescription drugs filed the lawsuits that led to this appeal. Initially, four plaintiffs joined in the notice of appeal. Only two, Renee Ramirez and the Painters and Allied Trades District Council 82 Health Care Fund (“Painters“) have presented any argument on appeal. We refer to these two collectively as “plaintiffs.”1 Ramirez purchased Celexa and Lexapro for her young son from February 2003 through March 2010 on the recommendation of her son‘s neurologist. Painters has reimbursed its pediatric insureds for off-label prescriptions of Celexa and Lexapro since early 1999. Plaintiffs together seek recovery under the Racketeer Influenced and Corrupt Organizations Act (“RICO“),
In June 2016, the district court denied Painters’ motion to certify two nationwide classes of similarly situated health-insurance companies and health plans that had paid for or reimbursed off-labеl pediatric prescriptions of Celexa or Lexapro. In re Celexa & Lexapro Mktg. & Sales Practices Litig. (Painters I), 315 F.R.D. 116, 131 (D. Mass. 2016).2 In rejecting class certification, the court reasoned that while Painters had satisfied the Rule 23(a) numerosity, commonality, typicality, and adequacy requirements, Painters had failed to establish that common questions of fact or law predominated over individual issues as required by Rule 23(b)(3). Id. at 123–31.
Subsequently, in March 2017, a dispute arose as a result of Forest‘s apparently belated production of two internal memoranda in advance of a deposition conducted by agreement after discovery had otherwise closed. The two documents contained details regarding a study of Celexa‘s effectiveness. Forest revealed that it had not sought any responsive documents from its Clinical Supply Group in responding to Painters’ discovery requests. The district court nevertheless denied Painters’ motion to compel Forest‘s supplemental production of documents from this group, concluding that any such production would be cumulative. In re Celexa & Lexapro Mktg. & Sales Practices Litig. (Painters II), 288 F. Supp. 3d 483, 486–87 (D. Mass. 2018).
In due course, after deeming discovery complete and ruling on various interim motions, the district court entered summary judgment for Forest on plaintiffs’ RICO claims, holding that neither Painters nor Ramirez could demonstrate injury. In re Celexa & Lexapro Mktg. & Sales Practices Litig. (Painters III), 289 F. Supp. 3d 247, 253–56 (D. Mass. 2018). The court then proceeded to dismiss plaintiffs’ state-based allegations as deriving from their
II.
Summary judgment is appropriate “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.”
A.
Prevailing on a RICO сlaim requires proof of an economic injury. See
Starting in 1997, Lundbeck -- the developer of Celexa -- began conducting Study 94404, which focused on Celexa‘s efficacy in treating depression in adolescents. The study produced across-the-board negative results. Forest then conducted Study MD-18 in an attempt to demonstrate Celexa‘s effectiveness in both сhildren and adolescents. The efficacy results of MD-18 are difficult to assess because Forest bungled the study: Some participants randomized into the active treatment group were dispensed nongeneric, pink tablets in one portion of the trial, potentially unblinding both the individuals who received these pills and the researchers conducting the study. The MD-18 study only demonstrated statistically positive results when these potentially unblinded participants were included. Finally, in 2002–2004 and 2005-2007, Forest conducted two additional clinical trials. Study MD-15 examined Lexapro‘s efficacy in children and adolescents and achieved negative results. Study MD-32 set out to test Lexapro‘s effectiveness in treating only adolescents and achieved statistically significant positive results.
Based upon the results of MD-32 and the Celexa MD-18 study, Forest submitted an sNDA to the FDA in 2008. In 2009, the FDA approved the application, allowing Forest to market Lexapro for use in adolescents. Forest did not seek such approval for Celexa.
Plaintiffs’ evidence that Celexa and Lexapro were ineffective for the pertinent indications consisted of the following: The FDA has neither approved Celexa for treating depression in children or adolescents nor has it approved Lexapro for use in children; Study 94404 demonstrated only a detrimental effect of Celexa in treating depression in adolescents; Study MD-18 was corrupted and showed no beneficial effect in children and adolescents unless the potentially unblinded participants
There is also evidence in the record before us, however, that cuts the other way. In September 2002, the FDA accepted Study MD-18 as a positive trial that would support a determination of Celexa‘s effectiveness for the treatment of MDD in adolescent patients. And in January 2003, the FDA also stated that MD-18 could be employed to support an application for FDA approval “for both Celexa and Lexapro, in pediatric patients with [MDD].” The FDA relied in part on these findings in approving Lexapro for the treatment of depression in adolescents in March 2009. Further, Forest points out that neither Painters nor Prime Therapeutics (“Prime“), Painters’ pharmacy-benefits manager, has taken any effort to limit or remove from its formulary pediatric prescriptions of Celexa and Lexapro.
This record raises two questions. First, do the FDA‘s various pronouncements or actions close the door on any effort to convince a jury that either Celexa or Lexapro was ineffective? Second, to the extent that the FDA‘s pronouncements and actions are not preclusive, is the evidence in this case nevertheless insufficient to support a jury finding of ineffectiveness?
1.
Forest claims that two of our recent decisions -- D‘Agostino v. ev3, Inc., 845 F.3d 1 (1st Cir. 2016), and In re Celexa & Lexapro Mktg. & Sales Practices Litig. (Marcus), 779 F.3d 34 (1st Cir. 2015) -- answer the first question in the affirmative by deeming FDA approval dispositive. Even were we to find it convincing, this argument would not cover all the challenged uses at issue in this appeal. The FDA has never approved Celexa for any of the off-label uses for which Forest рromoted it. Nor has it approved Lexapro for the treatment of MDD in children under the age of twelve. So Forest‘s reliance on actual FDA approval to foreclose a jury determination of inefficacy must be limited to Forest‘s marketing of Lexapro for adolescent use and, perhaps as well, to the question of how to construe MD-18.
In any event, even as thus limited, we do not find Forest‘s reliance on D‘Agostino convincing. The claim in D‘Agostino concerned the sale of medical devices after the FDA had approved the devices for the uses for which they were sold. D‘Agostino, 845 F.3d at 3, 7–9. In rejecting a challenge to those post-approval sales under the False Claims Act based on alleged pre-approval fraud on the FDA, we reasoned that “[t]o rule otherwise would be to turn the FCA into a tool with which a jury of six people could retroactively eliminate the value of FDA аpproval and effectively require that a product largely be withdrawn from the market even when the FDA itself sees no reason to do so.” Id. at 8. Here, by contrast, plaintiffs challenge only the promotion of Celexa and Lexapro for uses that were off-label (i.e., not FDA-approved) at the time Forest promoted and sold the drugs.4 When Forest is said to
Nor does our opinion in Marcus aid Forest in this case. In Marcus, we rejected a challenge to a drug label based on information that was “plainly known to the FDA prior to approving the label.” 779 F.3d at 43. We made clear in doing so, however, that we were merely applying the state-law preemption principles the U.S. Supreme Court laid out in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Wyeth v. Levine, 555 U.S. 555 (2009). See Marcus, 779 F.3d at 40–43 (explaining that a drug manufacturer can only be held liable under state law for inadequate warning in an FDA-approved label when the drug manufacturer can, “of its own volition, . . . strengthen its label in compliance with its state tort duty” (quoting PLIVA, Inc., 564 U.S. at 624)). Marcus, accordingly, is inapposite.
This is not to say that the FDA‘s 2009 approval of Forest‘s sNDA for Lexapro is irrelevant to this case. Certainly the approval and the FDA‘s reliance on MD-18 provide what many jurors may view as strong evidence confirming that Lexapro, and perhaps Celexa as well, have always been efficacious in treating pediatric depression. The common law has long recognized that agency approval of this type is relevant in tort suits. See Restatement (Third) of Torts: Prod. Liab. § 4 (Am. Law Inst. 1998) (“[C]ompliance with an applicable product safety statute . . . is properly considered in [a product defect case].“). But the common law also recognizes that such evidence is not always preclusive. Id. (“[S]uch compliance does not preclude as a matter of law a finding of product defect.“). And while there are strong reasons for treating such evidence as preclusive when the challenged sales are made in reliance on agency approval, those same reasons cut the other way when the sales are made without approval, and certainly when made unlawfully, as we must assume they were here.
2.
Having decided that the FDA‘s subsequent approvаl of Lexapro does not preclude proving that pre-approval uses of these drugs were ineffective, we turn to addressing whether plaintiffs may proceed with a claim based on product ineffectiveness when the evidence of efficacy is conflicting. This is more or less the question we left unanswered in Kaiser. See Kaiser, 712 F.3d at 49 (declining to address what evidentiary standard would be needed to demonstrate efficacy “if the results of DBRCTs were equivocal” or “if there were
Generally speaking, “conflicting evidence” is the hallmark of an issue that calls for factfinding, not summary judgment. See, e.g., Adria Int‘l Grp. v. Ferre Dev., Inc., 241 F.3d 103, 111 (1st Cir. 2001) (finding summary judgment inappropriate when evidence presented was “contested and contradictory“); see also 10A Charles Alan Wright et al., Federal Practice and Procedure § 2712 (4th ed. 2018) (“[S]ummary judgment is not a substitute for the trial of disputed fact issues.“). We see no reason to deviate from that gеneral rule merely because the product marketed illegally is one that was later approved for lawful sales.7 In short, why should we forgo customary factfinding by the jury so as to reward unlawful conduct aimed at getting children to consume unapproved drugs?
Forest also argues that plaintiffs’ evidence of ineffectiveness falls short of proving injury because Painters has not produced “individualized” proof that Celexa or Lexapro was ineffective for any particular insured. By “individualized” proof, Forest appears to mean testimony from a patient (or from a doctor concerning that patient) that the patient experienced no beneficial effects from the drug. While evidence of that type could be probative, certainly it is not the only way to prove that a drug is ineffective. Indeed, given that (1) an ineffective drug may trigger a placebo effect in a given individual and (2) an effective drug may not benefit all users, individualized proof might well be less probative than the type of expert, study-based testimony that plaintiffs have offered. In any event, as we already held, such individualized proof is certainly not required. See In re Neurontin Mktg. & Sales Practices Litig. (Harden), 712 F.3d 60, 69 (1st Cir. 2013) (“[W]e reject Pfizer‘s position that these plaintiffs must prove the individual, subjective ineffectiveness of each off-label prescription in order to establish injury. . . . The Harden plaintiffs have proffered clinical trial evidence that Neurontin is ineffective . . ., which is certainly enough to raise a genuine issue of fact on the effectiveness issue.” (citation omitted)); In re Neurontin Mktg. & Sales Practices Litig. (Aetna), 712 F.3d 51, 59–60 (1st Cir. 2013).
In sum, we hold that the FDA‘s 2009 approval of Lexapro does not preclude a jury from concluding that the off-label uses of Celexa and Lexapro at issue in this case were ineffective in treating pediatric depression. Moreover, plaintiffs have provided competent and sufficient evidence -- through DBRCTs, expert testimony, and peer-reviewed literature -- to raise a genuine issue of material fact as to the efficacy of these drugs for pediatric use. Accordingly, the district court erred in
B.
In addition to demonstrating economic injury, a RICO plaintiff must prove that the defendant‘s racketeering conduct caused her injury.
Forest therefore urges that, even if we disagree with the district court on the issue of injury/efficacy, we should still affirm the entry of summary judgment due to Painters’ lack of proof of but-for causation. While the district court did not consider the issue of causation in its summary-judgment ruling, it did earlier assay Painters’ causation evidence in ruling on Painters’ motion for class certification. The district court labeled the proof so “insubstantial” and “fundamentally flawed” “as to preclude class certification.” Painters I, 315 F.R.D. at 126–28. Forest would have us interpret these pronouncements as a finding that the evidence was insufficient as a matter of law to prove but-for causation.
We disagree. In the first place, it is unclear why the district court gauged the substantiality or merit of plaintiffs’ proof in the context of a Rule 23 motion. The central issue in that context is not whether the method of proof would or could prevail. Rather, it is whether the method of proof would apply in common to all class members. See, e.g., Tyson Foods, Inc. v. Bouaphakeo, 136 S. Ct. 1036, 1047 (2016) (“When . . . ‘the concern about the proposed class is not . . . some fatal dissimilarity but, rather, a fatal similarity -- [an alleged] failure of proof as to an element of the plaintiffs’ cause of action -- courts should engage that question as a matter of summary judgment, not class certification.‘” (alteration in original) (quoting Richard A. Nagareda, Class Certification in the Age of Aggregate Proof, 84 N.Y.U. L. Rev. 97, 107 (2009))).
More substantively, Painters’ evidеnce does not seem clearly insufficient. There is ample evidence that Forest spent money inducing doctors to prescribe its drugs to pediatric patients and that it would not have done so had the effort not been worth the money. Two experts, Dr. Meredith Rosenthal and Dr. Christopher Baum, also opined that Forest‘s spending on promotions in general correlated positively with sales. As the district court pointed out, Painters’ experts then assumed that this same approximate correlation applied to off-label promotional spending and off-label sales. Painters I, 315 F.R.D. at 127. The district court thought this assumption to be a “fundamental flaw” in the analysis. Id. Why, exactly, we are not sure. After all, why would Forest, which knew its markets better than anyone, have spent money on off-label marketing
If the jury accepts this assumption as reasonable, and if it finds that the prescriptions that Painters paid for were typical of those that the experts analyzed, jurors would then have a fair path to finding that Forest‘s off-label marketing caused Painters to pay for ineffective drugs. The experts’ interpretation of the data indicated that Forest‘s off-label promotions caused 76% and 54% of all pediatric prescriptions of Celexa and Lexapro, respectively. Dr. Rosenthal estimated that if Painters paid for as few as five independent prescriptions, there would be a 98% chance that at least one was the result of off-label marketing. In fact, Painters likely paid for the Celexa or Lexapro prescriptions of more than five different patients.8 So the odds that Painters was not harmed if the drugs were, indeed, ineffective was likely infinitesimal (assuming the prescriptions were independent of one another).9
Nor is Painters’ evidence limited to the thrust of its statistics. Painters also has evidence that Forest sales representatives called or visited at least two physicians who subsequently ordered pediatric prescriptions of Celexa and Lexapro that Painters reimbursed. In addition, Painters produced evidence suggesting that Forest specifically targeted Painters’ pharmacy-benefits manager, Prime, and that Prime relied upon a misleading report by Forest of Study MD-18 in managing Painters’ formulary. All together, this is surely enough to raise a triable issue of fact as to whether Forest‘s off-label marketing caused Painters to pay for a prescription for which it would not have otherwise paid.
This is not to say that Painters will ultimately prevail on the issue of causation. The district court has not conducted a Daubert analysis. And there may be other potential bones to pick with the sufficiency of Painters’ proof of causation. As the record now stands, though, we agree with Painters that we cannot affirm the summary judgment finding that its causation proof is insufficient as a matter of law.
As for Ramirez, Forest did not challenge her standing on the basis of causation in its memorandum in support of its motion for summary judgment. Accordingly, we express no opinion as to whether Ramirez has raised a triable issue on RICO causation.
As for proximate causation, it is of no moment that pediatricians were the immediate target of Forest‘s fraudulent marketing. Here, as in Kaiser, a jury could find that Painters and Ramirez wеre “the primary and intended victims of [Forest‘s] scheme to defraud.” Kaiser, 712 F.3d at 37 (quoting Bridge v. Phx. Bond & Indem. Co., 553 U.S. 639, 650 (2008)). Moreover, Painters’ and Ramirez‘s alleged harm (i.e., reimbursing or purchasing more pediatric prescriptions than they otherwise would have) was a “foreseeable and natural consequence” of Forest‘s scheme. Bridge, 553 U.S. at 658. Indeed, it was precisely the point.
Accordingly, for the foregoing reasons, we reverse the district court‘s entry of summary judgment for Forest on Painters’ RICO and state-law claims and on Ramirez‘s RICO and unjust-enrichment claims.
III.
Early on in this litigation the district court denied Painters’ motion to certify this case as a class action under
A.
The parties agree that the applicable statutory limitations period is four years. See Agency Holding Corp. v. Malley-Duff & Assocs., Inc., 483 U.S. 143, 156 (1987). Thаt four-year period began to run “at the time [the] plaintiff knew or should have known of his injury.” Lares Grp., II v. Tobin, 221 F.3d 41, 44 (1st Cir. 2000) (citing Rodriguez v. Banco Central, 917 F.2d 664, 665 (1st Cir. 1990)). The injury here is the payment made on account of off-label prescriptions that Forest induced. See Kaiser, 712 F.3d at 39 (“[E]conomic injury occur[s] when [plaintiff] paid for fraudulently induced [drug] prescriptions.“). So, the key question becomes: By what date can we say, as a matter of law, that Painters knew or should have known that Forest was promoting the off-label, ineffective use of Celexa or Lexapro?
The district court found that date to be no later than March of 2009. In re Celexa & Lexapro Mktg. & Sales Practices Litig., 65 F. Supp. 3d 283, 289 (D. Mass. 2014). In February of that year, the United States unsealed its complaint against Forest in
Not surprisingly, Painters points to no case law holding that a statutory limitations period does not start to run until the potential defendant first delivers a gift-wrapped admission of its alleged wrongdoing. Were that the rule, very few limitations periods would ever commence, much less conclude. Instead, as we have explained in an analogous context, “[w]e look first to whether sufficient facts were available to provoke a reasonable person in the plaintiff‘s circumstances to inquire or investigate further. . . . Once a duty to inquire is established, the plaintiff is charged with the knowledge of what he or she would have uncovered through a reasonably diligent investigation.” McIntyre v. United States, 367 F.3d 38, 52 (1st Cir. 2004); see also Sanchez v. United States, 740 F.3d 47, 52 (1st Cir. 2014) (“The discovery rule incorporates an objective standard. To delay commencement of the running of the statute of limitations, ‘the factual basis for the cause of aсtion must have been inherently unknowable, [that is, not capable of detection through the exercise of reasonable diligence] at the time of injury.‘” (alteration in original) (quoting Gonzalez v. United States, 284 F.3d 281, 288-89 (1st Cir. 2002))). The same fundamental principle applies to RICO suits. See Rotella v. Wood, 528 U.S. 549, 555 (2000) (“Federal courts . . . generally apply a discovery accrual rule when a statute is silent on the issue, as civil RICO is here. . . . [D]iscovery of the injury . . . is what starts the clock.” (citations omitted)); Koch v. Christie‘s Int‘l PLC, 699 F.3d 141, 150-51 (2d Cir. 2012) (noting that a RICO claim does not accrue until a plaintiff has “actual or inquiry notice of the injury” (quoting In re Merrill Lynch Ltd. P‘ships Litig., 154 F.3d 56, 60 (2d Cir. 1998))).
We agree with the district court that the unsealing of the United States’ complaint and the subsequent lawsuits filed in March 2009 were more than sufficient to put a TPP like Painters on notice that Forest had likely been inducing off-label prescriptions of Celexa and Lexapro. The United States’ complaint chronicled how Forest suppressed a negative study on Celexa while promoting a positive study (which conveniently neglected to mention the earlier, negative study). United States’ Complaint
Nevertheless, we also agree with the district court thаt Painters survived Forest‘s statute-of-limitations defense because the running of the limitations period was stayed for more than eight months by the filing of the N.M. UFCW class action in March 2009. See In re Celexa & Lexapro Mktg. & Sales Practices Litig., 65 F. Supp. 3d at 291. Painters was a member of the putative RICO class action for which the N.M. UFCW complaint sought certification. Under American Pipe & Construction Co. v. Utah, 414 U.S. 538 (1974), the limitations period during which Painters might sue on its own behalf was therefore tolled until the N.M. UFCW class action was dismissed in June 2010. Forest did not cross-appeal the district court‘s application of American Pipe. Rather, Forest argues only that the limitations period began running long before March of 2009 when plaintiffs first should have suspected that Celexa and Lexapro were ineffective for pediatric use. We reject that argument because the injury here is paying for unlawfully induced off-label prescriptions, not merely physician-directed, off-label prescriptions.
B.
Even though plaintiffs can sue, thanks to American Pipe, Painters cannot parlay that dispensation into the much-delayed filing of a class action. See China Agritech, Inc. v. Resh, 138 S. Ct. 1800 (2018). In American Pipe, the Supreme Court held that the “commencement of [a putative class action] tolls the running of the statute for all purported members of the class who make timely motions to intervene after the court has found the suit inappropriate for class action status.” 414 U.S. at 552-53. China Agritech clarified that this tolling rule has limits: While a putative class member may join an existing suit or file an individual action upon denial of class certification, a putative class member may not commence a class action anew beyond the time allowed by the untolled statute of limitations. 138 S. Ct. at 1807 (“The ‘efficiency and economy of litigation’ that support tolling of individual claims do not support maintenance of untimely successive class actions; any additional class filings should be made early on, soon after the commencement of the first action seeking class certification.” (citation omitted) (quoting Am. Pipe, 414 U.S. at 553)).
Painters argues that China Agritech is distinguishable from the case at hand because there was no substantive ruling on class certification in N.M. UFCW; the first time any district court addressed class certification was in Painters’ case. Painters’ position relies on an impermissibly narrow reading of the Court‘s decision in China Agritech. Though the Supreme Court granted certiorari in that case to answer the narrow question of whether a putative class member may commence a class action beyond the limitations period upon the district
For the foregoing reasons, the district court did not abuse its discretion in declining to certify Painters’ proposed nationwide class of TPPs.
IV.
Finally, Painters also takes issue with the district court‘s denial of its motion to compel Forest‘s supplemental production of documents related to the MD-18 Study. This court reviews a district court‘s discovery decision for abuse of discretion, intervening “only upon a clear showing of manifest injustice, that is, where the lower court‘s discovery order was plainly wrong and resulted in substantial prejudice to the aggrieved party.” Pina v. Children‘s Place, 740 F.3d 785, 791 (1st Cir. 2014) (quoting Dennis v. Osram Sylvania, Inc., 549 F.3d 851, 859 (1st Cir. 2008)).
Here, it is undisputed that Forest did not perform an exhaustive search in response to Painters’ requests for documents related to the MD-18 Study: Indeed, Forest acknowledges (employing the passive voice) that “files within the custody of the Clinical Supply Group were not searched.” Forest also does not deny that its own preliminary search within this group -- after discovery had closed -- produced two responsive memoranda regarding the packaging error in the MD-18 Study. The only excuse Forest provides is that “[p]laintiffs were fully apprised of the scope of document collection and were aware that files within the custody of the Clinical Supply Group were not searched.” Forest, however, points us to nothing in the record demonstrating that Painters acquiesced to Forest‘s limiting the scope of its document collection in this way. These admissions notwithstanding, the district court denied Painters’
The district court viewed FDA approval as being preclusive as to the validity of Studies MD-18 and MD-32. See Painters III, 289 F. Supp. 3d at 255-56. It also viewed the validity of those two studies as fatal to plaintiffs’ attempt to prove ineffectiveness with the type of evidence used in Neurontin. See id. Given those views, the district court understandably decided that further evidence on the question of effectiveness was cumulative and of no material import. See Painters II, 288 F. Supp. 3d at 487. Because we have now explained why the FDA‘s approval of Lexapro for its use in adolescents is not as preclusive as the district court might have reasonably thought, and because Painters and Ramirez have a live claim on the merits, one might reasonably expect Forest to search for responsive files within the “Clinical Supply Group.” Accordingly, we vacate the district court‘s discovery ruling so that on remand it can consider whether further discovery is called for in view of our decision in this appeal.
V. Conclusion
For the foregoing reasons, we reverse the district court‘s entry of summary judgment for Forest on Painters’ and Ramirez‘s RICO and state-law claims and vacate the district court‘s denial of Painters’