Rivera v. Wyeth-Ayerst Laboratories

REVISED FEBRUARY 22, 2002 IN THE UNITED STATES COURT OF APPEALS FOR THE FIFTH CIRCUIT _______________ m 01-40122 _______________ ELIZABETH RIVERA; ARKANSAS CARPENTERS HEALTH AND WELFARE FUND, ON BEHALF OF THEMSELVES AND OTHERS SIMILARLY SITUATED, Plaintiffs-Appellees, VERSUS WYETH-AYERST LABORATORIES, A DIVISION OF AMERICAN HOME PRODUCTS CORPORATION; AMERICAN HOME PRODUCTS CORPORATION, Defendants-Appellants. _________________________ Appeal from the United States District Court for the Southern District of Texas _________________________ February 15, 2002 Before SMITH and EMILIO M. GARZA, Pursuant to FED. R. CIV. P. 23(f), defen- Circuit Judges, and CUMMINGS,* dants Wyeth-Ayerst Laboratories (“Wyeth”) District Judge. and American Home Products Corporation ap- peal the certification of a nationwide class of JERRY E. SMITH, Circuit Judge: drug purchasers and their insurance compa- nies. Because we conclude that this suit does not present a justiciable case or controversy * District Judge of the Northern District of under Article III of the Constitution, we re- Texas, sitting by designation. verse and render a judgment of dismissal. II. Elizabeth Rivera and the Arkansas Carpen- I. ters Health and Welfare Fund (the “Fund”) In July 1997, Wyeth began distributing filed this nationwide class action suit. Rivera Duract, a non-steroidal anti-inflammatory drug seeks to represent all patients who were pre- (“NSAID”) prescribed for short-term man- scribed, had purchased, and had ingested Dur- agement of acute pain. Although all NSAID’s act but suffered no physical or emotional1 in- carry certain risks of liver and gastrointestinal jury. In fact, the class explicitly excludes any damage, clinical trials revealed that Duract had patients who have been injured by Duract. additional negative effects. Wyeth included a Nor do plaintiffs claim Duract was ineffective package insert in each box of Duract detailing as a pain killer or has any future health conse- these dangers, reporting the results of the clini- quences. cal trials, recommending Duract be used for only short periods (“generally less than ten Although the class includes citizens of all days”), and warning that Duract may not be fifty states and the District of Columbia, plain- appropriate for those with preexisting liver tiffs state their complaint under Texas law. conditions. The Food and Drug Administra- They allege that Wyeth failed to warn of Dur- tion (“FDA”) approved Duract, its labeling, act’s dangers and that Duract was defective in and its package insert. violation of (1) the Texas Deceptive Trade Practices Act (“DTPA”), TEX. BUS. & COM. In December 1997, Wyeth received three CODE ANN. §§ 17.50, 17.46 (Vernon Supp. reports of liver failure by patients who had tak- 1998), (2) the implied warranty of merchant- en Duract for long-term relief without un- ability, TEX. BUS. & COM. CODE ANN. dergoing liver testing. In February 1998, after § 2.314(a) (Vernon 1994), and (3) common receiving FDA approval, Wyeth issued a new, law unjust enrichment, and thus Wyeth owes revised package insert reporting these cases of them economic damages. The Fund asserts a liver failure and reemphasizing that Duract was derivative claim: It seeks to represent all intended “only for the short term (10 days or third-party payers who have reimbursed these less).” After receiving new reports of liver patients for Duract. failure among long term users, Wyeth volun- tarily withdrew Duract from the market in June 1998. 1 The plaintiffs have never allegedSSin their ori- ginal complaint, their second amended complaint, Wyeth explained that of the twelve patients or their brief to this courtSSthat they suffered emo- injured by Duract, eleven had taken the drug tional distress. Yet, in its November 8 order for over ten days, and one had preexisting liver denying Wyeth’s motion to dismiss, the district court based its holding on this fact. It concluded disease. Wyeth stated that because no change that “even if the medicine does not cause physical in Duract’s package insert could guarantee injury, the user may spend months or years worry- physicians would stop prescribing the drug for ing about potential illness caused by the medicine,” long-term use, it was withdrawing Duract and this stated a claim under Texas law. Rivera v. from the market. Wyeth established a program Wyeth-Ayerst Labs., 121 F. Supp. 2d 614, 619 to refund Duract users for any unused portion (S.D. Tex. 2000). To eliminate all confusion, the of their prescription. plaintiffs repudiated the district court’s claim in their brief to this court. 2 Wyeth asked the district court to deny the moved the district court to issue an order “ex- motion to certify the class on the pleadings or, pressing the court’s intent to vacate the class in the alternative, to allow class discovery and certification order and to reconsider the class an evidentiary hearing. The plaintiffs agreed certification issue upon remand.” The plain- that discovery would be appropriate; accord- tiffs noted that the district court had erred in ingly, on November 28, 2000, the parties sub- failing to conduct a choice-of-law analysis and mitted a proposed discovery plan to the dis- failing to demand plaintiffs submit a subclass trict court. That same day, despite the plain- plan before certification; plaintiffs requested tiffs’ concession in favor of discovery, the the court to assure that it would do so on re- court denied Wyeth’s request for discovery mand; nonetheless, the court denied the mo- and an evidentiary hearing and certified the tion on the stated ground of lack of jurisdic- class under FED. R. CIV. P. 23(b).2 tion. Even though FED. R. CIV. P. 26(d) prohibits III. discovery and evidentiary hearings in advance Rarely on appeal does the appellee concede of the pretrial conference, and the pretrial con- that the district court’s order is so fatally ference had been held only thirteen days ear- flawed that it cannot stand. Yet, at oral argu- lier, the district court rebuked Wyeth for not ment, the attorney for Rivera and the Fund did having pursued discovery over the past four just that, admitting that only a “feeling of ob- months and decided it could certify the class ligation to support the district court order” without any discovery. Accordingly, although moved him to argue when it was “crystal the record contained no evidence on Rivera’s clear” we would have to vacate and remand. 3 purchase or use of Duract or on the Fund’s re- Counsel was only half right, however: Be- imbursement of Duract patients, the court held cause this suit does not even present a justicia- that the claims of Rivera and the Fund “appear ble case or controversy under Article III, we to be typical” of the class members. vacate and render a judgment of dismissal. Similarly, the district court dismissed Wy- IV. eth’s argument that variations in the fifty Article III limits the judicial power of the states’ laws would swamp any common issues. federal courts to “Cases” and “Controversies” There was no need to analyze different states’ but does not define those terms. Instead, “the laws or even to decide which laws applied, the Constitution’s central mechanism of separation district court held, because plaintiffs had of powers depends largely upon common un- promised eventually to provide a workable derstanding of what activities are appropriate subclass plan that would solve any problems. to legislatures, to executives, and to courts.” Lujan v. Defenders of Wildlife, 504 U.S. 555, Wyeth timely filed, and this court granted, 559-60 (1992). An “essential and unchanging an application for interlocutory appeal pursu- ant to rule 23(f). Apparently estimating that their odds on appeal were bleak, plaintiffs 3 We are sympathetic to counsel’s plight on appeal, and we appreciate his candor, in his role as an officer of the court, in acknowledging the 2 Rivera v. Wyeth-Ayerst Labs., 197 F.R.D. weakness of the position thrust on him and his 584 (S.D. Tex. 2000). clients by the district court. 3 part” of this common understanding is the Though rule 23(f) allows a party to appeal doctrine of standing. Id. at 560. only the issue of class certification, “[s]tanding is an inherent prerequisite to the class cer- The “irreducible constitutional minimum of tification inquiry.” Bertulli v. Indep. Ass’n of standing contains three elements”: “[T]he Cont’l Pilots, 242 F.3d 290, 294 (5th Cir. plaintiff must have suffered an injury in fact,” 2001). Accordingly, standing maySSindeed “there must be a causal connection between mustSSbe addressed even under the limits of a the injury and the conduct complained of,” and rule 23(f) appeal. Id.6 “it must be likely . . . that the injury will be redressed by a favorable decision.” Id. at 560- Standing is a question of law that we re- 61 (internal quotations omitted).4 The plain- view de novo. Pederson v. La. State Univ., tiffs, as the party invoking federal jurisdiction, 213 F.3d 858, 869 (5th Cir. 2000). We review bear the burden of establishing these elements. for clear error all facts expressly or impliedly Steel Co. v. Citizens for a Better Env’t, 523 found by the district court. Id. U.S. 83, 103 (1998). Failure to establish any one deprives the federal courts of jurisdiction B. to hear the suit. Id. To establish an injury in fact, plaintiffs must demonstrate “an invasion of a legally protected The district court erred by not demanding interest which is . . . concrete and particular- such a showing before it certified the class.5 ized.” Defenders of Wildlife, 504 U.S. at 560. Had it done so, it would have found that plaintiffs had demonstrated neither injury nor causation. 6 See also Steel Co., 523 U.S. at 94 (“‘On every writ of error or appeal, the first and funda- A. mental question is that of jurisdiction’” (quoting Even though the certification inquiry is Great S. Fire Proof Hotel Co. v. Jones, 177 U.S. more straightforward, we must decide standing 449, 453 (1900))). first, because it determines the court’s funda- Although there is a limited exception for suits in mental power even to hear the suit. Id. at 94. which the class certification issues are “logically The procedural posture of this case does not antecedent to the existence of any Article III is- alter our conclusion. sues,” Amchem Prods., Inc. v. Windsor, 521 U.S. 591, 612 (1997); accord Ortiz v. Fibreboard Corp., 527 U.S. 815, 831 (1999) (citations omit- ted), this exception is not applicable here. In the 4 instant case, in contrast to Ortiz and Amchem, the Accord Pub. Citizen, Inc. v. Bomer, 274 F.3d 212, 217 (5th Cir. 2001). standing question would exist whether Rivera filed her claim alone or as part of a class; class certifica- 5 Although Wyeth argued that plaintiffs lacked tion did not create the jurisdictional issue. Nor are standing, the district court refused to address the we precluded from addressing standing by the fact question, insisting it had done so in its November that the district court did not discuss it. “[B]ecause 8 denial of a motion to dismiss. Rivera v. Wyeth- ‘standing is a jurisdictional requirement, [it] may Ayerst Labs., 197 F.R.D. 584, 588 (S.D. Tex. always be addressed for the first time on appeal.’” 2000). The November 8 order, however, does not Pub. Citizen, 274 F.3d at 217 (quoting Sierra Club mention standing. Rivera v. Wyeth-Ayerst Labs., v. Cedar Point Oil Co., 73 F.3d 546, 555 n.22 (5th 121 F. Supp. 2d 614 (S.D. Tex. 2000). Cir. 1996)). 4 Rivera’s claim to injury runs something like F.3d at 295. this: Wyeth sold Duract; Rivera purchased and used Duract; Wyeth did not list enough The plaintiffs’ most plausible argument for warnings on Duract, and/or Duract was defec- finding they have suffered “invasion of a le- tive; other patients were injured by Duract; gally protected interest” is their claim they Rivera would like her money back. The plain- were denied “the benefit of the bargain” due to tiffs do not claim Duract caused them physical them under general, contract law type princi- or emotional injury, was ineffective as a pain ples. The plaintiffs do not actually argue killer, or has any future health consequences to breach of contractSSlikely a smart decision, users. Instead, they assert that their loss of given that there was no contract. Instead, they cash is an “economic injury.” invoke Coghlan v. Wellcraft Marine Corp., 240 F.3d 449 (5th Cir. 2001), a bold move The plaintiffs never define this “economic given that Coghlan explicitly distinguishes injury,” but, instead, spend most of their brief valid, contract law suits from the “no-injury listing helpful suggestions on how a court products liability law suit” plaintiffs bring. could calculate damages. These arguments are relevant (if at all) to redressability, not injury. The Coghlan plaintiffs had contracted to Merely asking for money does not establish an buy an all fiberglass boat but instead received injury in fact. a less valuable, wood-fiberglass hybrid. They sued for breach of contract, requesting dam- Notably, the wrongs Rivera and the class ages equal to the difference in value between allege are those suffered by other, non-class what they were promised (an all fiberglass member patients. The plaintiffs claim that Wy- boat) and what they received (the fiberglass- eth violated the implied warranty of merchant- wood hybrid). In holding that the Coghlans ability by selling a defective drug, but then had suffered an injury, we explained that aver that the drug was not defective as to them. Similarly, the plaintiffs claim Wyeth vi- [t]he key distinction between [the Cogh- olated the DTPA by failing to issue warnings lans’] case and a “no-injury” products sufficient to advise injured users, but then con- liability suit is that the Coghlans’ claims cede they were not among the injured. Such are rooted in basic contract law rather wrongs cannot constitute an injury in fact. than the law of product liability: the Coghlans assert they were promised one “[T]he ‘injury in fact’ test requires more thing but were given a different, less than an injury to a cognizable interest. It re- valuable thing. The core allegation in a quires that the party seeking review be himself no-injury product liability class action is among the injured.” Sierra Club v. Morton, . . . the defendant produced or sold a 405 U.S. 727, 734-35 (1972); accord Defend- defective product and/or failed to warn ers of Wildlife, 504 U.S. at 563. It is not of the product’s dangers. enough that Wyeth may have violated a legal duty owed to some other patients; the plain- Id. at 455 n.4. tiffs must show that Wyeth violated a legal duty owed to them. “What courts require . . . Even if we were to ignore the fact that is that the injury be personal.” Bertulli, 242 plaintiffs have no contract, the general princi- 5 ples they invoke do not help them. By plain- Rivera has not even indicated what additional tiffs’ own admission, Rivera paid for an effec- warnings Wyeth should have included or tive pain killer, and she received just thatSSthe which of Duract’s defects Wyeth should have benefit of her bargain. “An award of damages curedSSperhaps because as one not injured by for breach of contract is supposed to place the the drugs, she does not know. injured party as nearly as po ssible in the po- sition that he would have occupied had the C. defaulting party performed the contract.” Id. In addition to their failure to demonstrate at 453-54. Duract worked. Had Wyeth pro- an injury in fact, plaintiffs fail to plead facts vided additional warnings or made Duract saf- essential to establish causation. Standing re- er, the plaintiffs would be in the same position quires “a causal connection between the injury they occupy now. Accordingly, they cannot and the conduct complained ofSSthe injury has have a legally protected contract interest. to be fairly traceable to the challenged action of the defendant, and not the result of the The confusion arises from the plaintiffs’ independent action of some third party not attempt to recast their product liability claim in before the court.” Defenders of Wildlife, 504 the language of contract law. The wrongs U.S. at 560 (internal quotations and alterations they allegeSSfailure to warn and sale of a omitted). defective productSSare products liability claims. Id. at 455 n.4. Yet, the damages they The facts provide plaintiffs an additional assertSSbenefit of the bargain, out of pocket hurdle in demonstrating causation. Duract expendituresSSare contract law damages. The was a prescription drug; before a patient could plaintiffs apparently believe that if they keep take Duract, his physician had to make an in- oscillating between tort and contract law dependent medical judgment to prescribe it.7 claims, they can obscure the fact that they have Where an element of standing “depends on the asserted no concrete injury. Such artful plead- unfettered choices made by independent actors ing, however, is not enough to create an injury not before t he courts and whose exercise of in fact. broad and legitimate discretion the courts cannot presume either to control or to predict These are not merely pleading exercises; . . . it becomes the burden of the plaintiff to Article III’s standing requirements assure that adduce facts showing that those choices have “‘the dispute . . . will be presented in an adver- been or will be made in such a manner as to sary context and in a form historically viewed produce causation.” Id. at 562. Thus, to es- as capable of judicial resolution.’” Sierra tablish causation, plaintiffs must show that had Club, 405 U.S. at 732 (quoting Flast v. Co- Wyeth acted “lawfully” (produced a safer drug hen, 392 U.S. 83, 101 (1968)). Courts should or provided more extensive warnings), the not be deciding legal questions in the abstract, physicians would not have prescribedSSand but based on a fully developed factual record. 7 See Burton v. Am. Home Prods. (In re Nor- By definition, Rivera’s no-injury “damages” plant Contraceptive Prods. Liab. Litig.), 955 F. will not vary with Wyeth’s degree of negli- Supp. 700, 703 (noting the applicability of the gence or the drug’s propensity for harm. “learned intermediary doctrine”), aff’d, 165 F.3d 374 (5th Cir. 1999). 6 the plaintiffs would not have purchasedSSDur- act. Rivera and the class do not even assert this conclusion, much less adduce any facts sup- porting it. One logically could assume that if Duract had been safer, physicians would have been more willing to prescribe it. And even if Wyeth had issued more warnings (plaintiffs do not indicate which warnings were missing), plaintiffs never assert that they were part of a risk group that should have been warned. To find causation, we would have to infer the absurdSSfor example, that an extra warning, though inapplicable to Rivera, might have scared her and her doctor from Duract. Such reasoning is too speculative to establish Article III standing.8 Because this suit does not present a justi- ciable case or controversy under Article III, we do not reach the class certification question and intimate no view on its merits. We RE- VERSE and RENDER a judgment of dis- missal. 8 See Defenders of Wildlife, 504 U.S. at 566 (stating that “[s]tanding is not an ingenious aca- demic exercise in the conceivable” (internal quo- tations and citation omitted)). 7