### In the 

# United States Court of Appeals For the Seventh Circuit

____________________ No. 19-2547

W ENDY B. D OLIN , Individually and as Independent Executor of the Estate of S TEWART D OLIN , Deceased, Plaintiff-Appellant,

v.

G LAXO S MITH K LINE LLC, Formerly Known as S MITH K LINE B EECHAM C ORPORATION , Defendant-Appellee

.

____________________ Appeal from the United States District Court for the Northern District of Il linois, Eastern Division.

No. 1:12-cv-6403 — William T. Hart, Judge

.

____________________

A RGUED J ANUARY 22, 2020

— D ECIDED M ARCH 6, 2020

____________________

Before W OOD , Chief Judge, and S YKES and H AMILTON , Circuit Judges

. H AMILTON , Circuit Judge . This appeal presents two questions: fi rst, whether we should reopen our court’s prior judgment in this case, see Dolin v. GlaxoSmithKline LLC , 901 F.3d 803 (7th Cir. 2018) (“ Dolin I”), and second, whether we should impose sanctions against appellant Wendy Dolin or her2 No. 19-2547

counsel for pursuing this appeal . Our decisions are not to reopen the judgment and not to impose sanctions on Mrs. Dolin or her counsel.

I. Factual and Procedural Background This case stems from a tragic suicide. In June 2010, Stewart Dolin was prescribed Paxil, the brand-name version of the drug paroxetine, to treat his depression. The prescription was fi lled not with brand-name Paxil but with a generic paroxetine product. Six days after beginning to take the medication, Mr. Dolin died by suicide. Federal law would have preempted a state-law claim against the generic manufacturer of the pills Mr. Dolin actually took on the theory that the federally approved label was inadequate because it failed to warn of the danger of adult suicide associated with the drug. See PLIVA, Inc. v. Mensing, 564 U.S. 604, 609 (2011). Mrs. Dolin sued GlaxoSmithKline (GSK), the manufacturer of brand-name Paxil, on the theory that GSK was legally responsible for the content of the labeling for all paroxetine; no ma tt er who made and sold it; that GSK had negligently omi tt ed an adult suicide risk on the drug label, and that the negligent omission had caused her husband’s death. Mr s. Dolin won a $3 million jury verdict in federal district court. On appeal, we reversed the judgment. The appeal raised several issues, including whethe r Illinois law might hold GSK responsible for harm caused by paroxetine that someone else manufactured and sold, based on the contents of the label. We did not reach that issue. Instead, we found that Mrs. Dolin’s claim was preempted by federal law governing the contents of the label for paroxetine. Dolin I, 901 F.3d at 803. Our opinion provided background on the complex regulation of drug labels in general and Paxil/paroxetine’s label in particular. 901No. 19-2547 3

F.3d at 806–10. We will not repeat it except to highlight that under the “changes being e ff ected” or CBE regulation, 21 C.F.R. § 314.70(b)(2)(v)(A), “GSK needed FDA permission to change the paroxetine label unle ss three things were true: (1) GSK had newly acquired information about paroxetine (2) that showed a causal association (3) between the drug and an

e ff ect that warranted a new or st ronger warning.” 901 F.3d at806. Further, the “FDA reviews CBE submissions and can reject label changes even afte r the manufacturer has made them.” Id. , citing 21 C.F.R. § 314.70(c)(6) & (7). GSK a tt empted to change the Paxil label under the CBE regulation in 2007 to add an adult suicide warning. The FDA rejected that change.GSK had additional communications with FDA about the accuracy of the label’s suicide risk warnings between 2007 and 2010, when Mr. Dolin died, but had not added a warning of adult suicide risk. Under controlling precedent, “state-law claims based on labeling de fi ciencies are not preempted if the manufacturer could have added the warning unilaterally under the CBE regulation.” Dolin I , 901 F.3d at 811, citing Wyeth v. Levine, 555 U.S. 555, 573 (2009). Applying Wyeth , we held in Dolin I that, “as a ma tt er of law, (1) there is clear evidence that the FDA would have rejected the warning in 2007 [when it ordered GSK to remove its Paxil-speci fi c adult-suicidality warning and instead use a class-wide SSRI warning], and (2) GSK lacked new information after 2007 that would have allowed itto add an adult-suicidality warning under the CBE regulation.” Dolin I , 901 F.3d at 812. We therefore held that Mrs. Dolin’s state-law claims against GSK were preempted. Mrs. Dolin fi led a petition for certior ari at the Supreme Court, which was denied on May 28, 2019. 139 S. Ct. 2636 (2019).4 No. 19-2547

The denial of certiorari in Dolin I came eight days after the Supreme Court decided another case, Merck Sharp & Dohme Corp. v. Albrecht, that picked up where Wyeth left o ff , further explaining Wyeth ’s “clear evidence” standard for impossibility preemption for prescription drug labels. 139 S. Ct. 1668 (2019). After Albrechtwas decided, Mrs. Dolin returned to the district court and fi led a motion under Federal Rule of Civil Procedure 60(b)(6). Her mo tion argued that the 2018 fi nal judgment should be set as ide on the ground that Albrecht changed the law so that GSK could not establish its defense ofimpossibility preemption. The district court denied that motion. Mrs. Dolin has appealed. We have jurisdiction of this appeal under 28 U.S.C. § 1291. The district court originally had subject-ma tt er jurisdiction over the case under 28 U.S.C. § 1332(a)(1). Mrs. Dolin is a citizen of Illinois, and to the extent she is suing as representative of Mr. Dolin’s estate, he was al so a citizen of Illinois. See 28 U.S.C. § 1332(c)(2) (citizenship of legal representative of estate). GSK’s only member is a corporation organized under Delaware law with its principal place of business in Delaware. The amount in controversy exceeds $75,000. The district court had jurisdiction when Mrs. Dolin fi led her Rule 60(b)(6) motion in Jun e 2019. We had returned jurisdiction to the district court when we issued our 2018 mandate to that court to enter judgment in GSK’s favor. The district court denied the motion and entered a wri tt en order to that

e ff ect on July 11, 2019. Mrs. Dolin appealed, and during the brie fi ng, GSK fi led a motion for sanctions, asserting that the appeal is frivolous. We deferred ruling on that motion until brie fi ng and argument on the merits.No. 19-2547 5

We review a district court’s Rule 60(b) decision for abuse of discretion. LAJIM, LLC v. General Electric Co. , 917 F.3d 933,949 (7th Cir. 2019). “[R]elief under that rule has been described as ‘an extraordinary remedy ... granted only in exceptional circumstances.’” Davis v. Moroney, 857 F.3d 748, 751 (7th Cir. 2017), quoting Bakery Machinery & Fabrication, Inc. v. Traditional Baking, Inc. , 570 F.3d 845, 848 (7th Cir. 2009).

II. Sanctions

We fi rst address the question of sanctions, however. Federal Rule of Appellate Procedure 38 provides: “If a court of appeals determines that an appeal is frivolous, it may, after a separately fi led motion or notice from the court and reasonable opportunity to respond, award just damages and single or double costs to the appellee.” GSK’s motion argues that Mrs. Dolin’s appeal is frivolous. Its Rule 38 motion seeks fees and costs. We deny this motion. “We do not invoke Rule 38 lightly.” Harris N.A. v. Hershey, 711 F.3d 794, 801 (7th Cir. 2013). As we have often explained,our business is deciding appeals brought by reasonable lawyers and parties who disagree in good faith on the application of law in a particular case. Federal courts exist to decide such disputes, including good-faith e ff orts to convince the courts to extend, modify, or even revers e existing law. See, e.g., Fed.R. Civ. P. 11(b)(2) (explicitly endorsing “nonfrivolous argument[s] for extending, modifying, or reversing existing law or for establishing new law” as proper subject of legal fi ling); Nisenbaum v. Milwaukee County, 333 F.3d 804, 809 (7th Cir. 2003) (“[C]ourts do not penalize litigan ts who try to distinguish adverse precedents, argue for the modi fi cation of existing law, or preserve positions for presentation to the Supreme Court.”); Hartmarx Corp. v. Abboud, 326 F.3d 862, 867 (7th Cir.6 No. 19-2547

2003) (“[S]anctions are to be imposed sparingly, as they can have signi fi cant impact beyond the merits of the individual case and can a ff ect the reputation and creativity of counsel.”) (cleaned up); In re Drexel Burnha m Lambert Group Inc. , 995 F.2d 1138, 1147 (2d Cir. 1993) (“Sanction s of course are not imposed merely because one side does not prevail in a given case.”); Fleming Sales Co., Inc. v. Bailey, 611 F. Supp. 507, 519 (N.D. Ill. 1985) (“Rule 11 should be applied with some caution, given its potential for chilling legitimate advocacy. Evenin its more expansive form as amended in 1983, it was not designed to penalize litigants because they choose to fi ght uphill ba tt les[.]”); Fed. R. Civ. P. 11 Advisory Commi tt ee’s Note to 1983 Amendment (“The rule is not intended to chill an a tt orney’s enthusiasm or creativity in pursuing factual or legal theories. The court is expected to avoid using the wisdom of hindsight and should test the signer’s conduct by inquiringwhat was reasonable to believe at the time the pleading, motion, or other paper was submi tt ed.”). By contrast, appeals that are hopeless e ff orts to harass theopposing parties or to delay the inevitable may warrant sanctions, as in Harris N.A. v. Hershey, 711 F.3d at 803 (appellantdefendant was sophisticated borrower who o ff ered no plausible reason to set aside district-court judgment enforcing eight- fi gure loan and guaranty), and Spiegel v. Continental Illinois Nat’l Bank , 790 F.2d 638 (7th Cir. 1986) (appellant brought frivolous appeal from dismissal of his civil RICO claims that were collateral a tt acks on state-court decision refusing his effort to become sole trustee of valuable trust established by his father). In deciding whether to impose sanctions, we fi rst consider whether the appeal is frivolous. “Frivolous,” we stress, is notNo. 19-2547 7

a synonym for “unsuccessful,” or “unlikely to succeed.” See NLRB v. Lucy Ellen Candy Div. , 517 F.2d 551, 555 (7th Cir. 1975) (“A frivolous appeal means someth ing more to us than an unsuccessful appeal.”). GSK suggests that because Mrs. Dolin lost her Rule 60(b) motion in th e district court, and because our review of such a denial is “extraordinarily deferential,” it was almost by de fi nition frivolous for her to challenge that denial in our court. We do not see it that way. Deferential standards of review may be hard for appellants to overcome, but they have the right to try. “An appeal can be frivolous, though, ‘when the result is obvious or when the appellant’s argument is wholly without merit.’” Harris N.A. , 711 F.3d at 801–02, quoting Spiegel , 790 F.2d at 650. We disagree with Mrs. Dolin’s argument on the merits, but that does not mean it is u tt erly without merit. One way to frame the legal question at the center of Mrs. Dolin’s Rule 60(b) motion is whether Albrecht set a new standard or merely clari fi ed the Wyeth standard. There are reasonable, and certainly colorable, argumen ts on both sides. We ultimately agree with the district court that Albrecht is be tt er understood as clarifying Wyeth, but that is not the “foregone conclusion” that GSK makes it out to be. Second, even if we thought that Mrs. Dolin’s appeal were frivolous, and we do not, we would not automatically award sanctions. “When an appeal is frivolous, Rule 38 sanctions are not mandatory but are left to the sound discretion of the court of appeals to decide whether sanctions are appropriate.” Harris N.A. , 711 F.3d at 802, citing Burlington Northern R.R. Co. v. Woods , 480 U.S. 1, 4 (1987). “How we exercise [our] discretion may turn on our perception of whether an appellant acted in bad faith.” Berwick Grain Co. v. Illinois Dep’t of Agric. , 217 F.3d8 No. 19-2547

502, 505 (7th Cir. 2000). Mrs. Dolin has been vigorous in pursuing her arguments, and she has had every right to be. We see no indication of bad faith he re. The fact that she has lost on the merits does not mean that her Rule 60(b) motion and her appeal of its denial in the fa ce of a deferential standard of review were fi led in bad faith. See, e.g., Smeigh v. Johns Manville, Inc. , 643 F.3d 554, 566 (7th Cir. 2011) (denying Rule 38 sanctions: “We fi nd that this case is too close to the line to warrant monetary sanctions.”), citing Ross v. RJM Acquisitions Funding LLC , 480 F.3d 493, 499 (7th Cir. 2007). We deny GSK’s motion for a tt orneys’ fees and costs. Mrs. Dolin has already lost her husband and a $3 million jury verdict. She need not lose anything more.

III. The District Court’s Decision Under Rule 60(b) The district court did not abuse its discretion in denying Mrs. Dolin’s Rule 60(b) motion . We begin by exploring the discretion the district court was a ff orded under the circumstances. The district judge was aware of the range of options available to him and justi fi ed his ruling appropriately. We then look more closely at Albrecht and Wyeth and conclude that our decision in Dolin I would have been the same even if decided under Albrecht . We close by emphasizing the importance of fi nality.

A . The District Court’s Exercise of Discretion As noted, we review a district court’s denial of a Rule 60(b) motion for abuse of discretion. LAJIM, LLC , 917 F.3d at 949. “A motion under Rule 60(b) often puts to a court a question without a right answer,” calling on the district judge to “weigh incommensurables.” Metlyn Realty Corp. v. Esmark, Inc. , 763 F.2d 826, 831 (7th Cir. 1985). “Dealing with theseNo. 19-2547 9

intersecting planes of legal argument is a task of great subtlety, calling on all the skills of the district judges. It is not, however, a task that gives rise to ‘error’ ... unless the judge leaves something important out of his analysis. This is why we have been so deferential in Rule 60(b) cases to decisions not to reopen.” Id. Our deference here is heightened by the fact that Mrs. Dolin’s motion was fi led under Rule 60(b)(6). In paragraphs (b)(1) through (b)(5), Rule 60 speci fi es fi ve particular grounds for relief “from a fi nal judgment, order, or proceeding,” such as fraud, mistake, and newly discovered evidence. Paragraph (b)(6) provides a sixth, catcha ll ground: “any other reason that justi fi es relief.” Mrs. Dolin’s Albrecht argument falls into thiscatchall, making the district court’s task here as incommensurable as one can imagine. Nevertheless, where the law gives a court discretion that the court does not recognize and exercise, “The failure of the trial court to exercise its discretion at all ... constitutes an abuse of discretion.” Brown-Bey v. United States , 720 F.2d 467, 471 (7th Cir. 1983), quoted in Childress v. Walker, 787 F.3d 433, 443 (7th Cir. 2015). Mrs. Dolin argu es that the district judgeerred by failing to exercise discretion. She points to this statement by the judge at the hearing on her motion: I might have disagreed with the Seventh Circuit. But after they have spoken, I have to follow the Seventh Circuit. I’m a District Judge, I’m not a Court of Appeals Judge or a Supreme Court Judge. I can only do whatI’m told by the upper court. If they don’t tell me, I do the best I can without them. But now I’ve got their direction, and I am sworn to follow the law.10 No. 19-2547

Mrs. Dolin’s counsel then asked the court to “take a hard look at the law around Rule 60 because I think that the law actually gives you signi fi cantly more discretion than you realize.” Judge Hart replied that he had “read the cases and everything that was called out to my a tt ention,” and he proceeded to engage in a detailed back-and-forth with counsel about the relevant precedents. See, e.g., E.E.O.C. v. Sears, Roebuck & Co. , 417 F.3d 789, 796 (7th Cir. 2005); LSLJ Partnership v. Frito-Lay, Inc. , 920 F.2d 476, 478 (7th Cir. 1990). The transcript shows that Jud ge Hart knew well the relevant procedural and substantive law. We interpret his statement that “after they have spoken, I have to follow the Seventh Circuit” to indicate that he felt bound to follow our Dolin I ruling as to the interpretation of Wyeth v. Levine . Though hemay have disagreed with that interpretation, it is binding circuit law and the law of the case. Because he understood Albrecht to be a clari fi cation of Wyeth , the result would notchange. This was a straightforward application of the hierarchical and precedential principles that orga nize our entire legal system. Based on that legal analysis, and with no other equitablefactors weighing in favor of reopening the judgment, the district judge held that “this is not one of those cases where I think a District Judge should grant a 60(b) motion.” Note:

“ should not,” not “ can not.” The district judge knew that he had discretion, and he exercised it to deny the motion.

B. Albrecht and Wyeth We agree with the district court that Albrecht is be tt er understood as a clari fi cation of the impossibility standard in Wyeth rather than as a repudiation of it. We decided Dolin I onNo. 19-2547 11

the basis of the Supreme Court’s teaching in Wyeth that “absent clear evidence that the FDA would not have approved a change to [the drug]’s label, we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements.” 555 U.S. at 571. In Wyeth , the Supreme Courtheld that the drug company had not provided such “clear evidence” for two reasons: fi rst, it had not shown that it “supplied the FDA with an evaluation or analysis concerning the speci fi c dangers” underlying the appropriate warning; and second, it had not shown that it had “a tt empted to give the kind of warning required by [state law] but was prohibited from doing so by the FDA.” Id. at 572–73. Wyeth did not establish a general de fi nition of the “clear evidence” standard.

In Albrecht, the Court clari fi ed that standard, writing that “‘clear evidence’ is evidence that shows the court that the drug manufacturer fully informed the FDA of the justi fi cations for the warning required by state law and that the FDA, in turn, informed the drug ma nufacturer that the FDA wouldnot approve a change to the drug’s label to include that warning.” 139 S. Ct. at 1672. Albrecht included two other important holdings: fi rst, that the preemption question is a ma tt er of law to be decided by the judge, not the jury; and second, that “the only agency actions that can de termine the answer to the preemption question ... are agency actions taken pursuant to the FDA’s congressionally delegated authority.” Id. at 1672, 1679. There is language in Albrecht, however, that could be interpreted as a signi fi cant modi fi cation of the Wyeth standard for applying the CBE regulation to preemption of labeling claims. Wyeth framed the issue as requ iring the defense to offer “clear evidence that the FDA would not have approved a change to [the drug’s] labe l.” 555 U.S. at 571. The phrase12 No. 19-2547

“would not have approved” implies that the defendant may be able to satisfy the standard without showing that it actually requested a change for the label and that the FDA rejected it. In Albrecht, the Court wrote that th e “clear evidence” needed is “evidence that shows the cour t that the drug manufacturer fully informed the FDA of the justi fi cations for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FD A would not approve a change to the drug’s label to include that warning.” 139 S. Ct. at 1672.That language implies that the manufacturer must have actually requested a change and that the FDA rejected it. In addition, further language in Albrecht can be read to signal that the FDA’s rejection musthave acted “pursuant to theFDA’s congressionally delegated authority,” citing as examples notice-and-comment rulema king or a formal rejection pursuant to regulations or some other action “carrying theforce of law.” 139 S. Ct. at 1679. That language could be understood as indicating that less formal exchanges of correspondence, like some of the evidence in this case, are not enough to provide such “clear evidence.” The quoted language from Albrecht has helped to convince us that Mrs. Dolin’s Rule 60(b)(6) motion and appeal are not frivolous. We are not persuaded, however, that she should prevail. Albrecht explicitly grounded its analysis in the Court’s holdings in Wyeth

. Albrechtbegan by citing the Wyeth “clear evidence” standard and formulat ed the question for decision in terms of the Wyeth framework. Id. at 1672, 1678. The Court noted that its “conclusions fl ow from our precedents on impossibility pre-emption and the statutory and regulatory scheme that we reviewed in Wyeth .” Id. at 1678. The Court also presented its decision as a clari fi cation of Wyeth : “We statedNo. 19-2547 13

in Wyeth v. Levine that state law failure-to-warn claims are preempted by the Federal Food, Drug, and Cosmetic Act and related labeling regulations when there is ‘clear evidence’ that the FDA would not have approved the warning that state lawrequires. We here decide that a judge, not the jury, must decide the pre-emption question. And we elaborate Wyeth’s requirements along the way .” Id . at 1676 (emphasis added) (citation omi tt ed). This is the language of ordinary evolution and clari fi cation in case law, not reversal and ov erruling. In addition, the facts of both Wyeth and Albrecht o ff er relatively li tt le to work with. In Wyeth , the manufacturer had not o ff ered any evidence that might have satis fi ed the newly articulated “clear evidence” standard. And in Albrecht, the principal holding was that the “clear evidence” standard for the impossibility preemption defense is a question of law for a court to decide. To the extent the Supreme Court modi fi ed the Wyeth standard, the Court itself did not try to apply that modi fi ed standard but instead remanded the case to the lowe r courts to apply the legal standard. 139 S. Ct. at 1680–81. We agree with the district court that Albrecht brought the Wyeth “clear evidence” holding into sharper focus. It did not adopt a new rule of preemption law. More fundamental, though, our decision in Dolin I would have been the same under Albrecht . The record showed (a) that GSK disclosed the relevantdata underlying its desired adult-suicidality warning to th e FDA in 2006, and (b) that the FDA unambiguously rejected a Paxil-speci fi c warning in 2007 when it formally mandated th at all SSRIs carry a uniform, class-wide warning label. Dolin I , 901 F.3d at 813–15. We also noted in Dolin I that “Plainti ff has failed to o ff er evidence that14 No. 19-2547

GSK acquired new informatio n after 2007, when the FDA rejected its proposal to add an adult-suicidality warning to the paroxetine label that would have justi fi ed a change in the label and thus undermine GSK’s preemption defense.” Id. at 815. As we read Albrecht, the 2007 formal requirement that all SSRIs carry the same warning la bel would qualify as “agencyaction[] taken pursuant to the FDA’s congressionally delegated authority.” 139 S. Ct. at 1679. Also, the method of FDA rejection was not squarely before the Court in Albrecht and thus does not bear on that aspect of the Dolin I decision for purposes of Rule 60(b)(6). See id. at 1679–81. In short, Albrecht provided important guidance but did not break new ground that would change the result in this case.

C. Rule 60(b), Finality, and Extraordinary Circumstances Judgments “may not be reopen ed under Rule 60(b) except in compelling and extraordinary circumstances.” Metlyn Realty Corp. , 763 F.2d at 831. The “need for the fi nality of judgments is an overarching concern.” Cincinnati Ins. Co. v. Flanders Elec. Motor Service, Inc. , 131 F.3d 625, 628 (7th Cir. 1997). Rule 60(b) recognizes this concern. Its “framers ... set a higher value on the social interest in the fi nality of litigation.” Merit Ins. Co. v. Leatherby Ins. Co. , 714 F.2d 673, 682 (7th Cir. 1983). Courts therefore approach Rule 60(b) motions with great caution. Even if we agreed with Mrs. Dolin that Albrecht changed the law more dramatically than its elaboration of the Wyeth“clear evidence” standard, we would be mindful that “[i]ntervening developments in the law by themselves rarely constitute the extraordinary circumstances required for relief under Rule 60(b)(6).” Agostini v. Felton , 521 U.S. 203, 239 (1997). Mrs. Dolin presents no extraordinary circumstances here. In sum,No. 19-2547 15

we do not see a compelling reason to disturb the fi nal judgment in this case.

* * * * *

The district court’s denial of relief under Federal Rule ofCivil Procedure 60(b)(6) is AFFIRMED. Appellee GlaxoSmithKline’s motion for fees and costs under Federal Rule of Appellate Procedure 38 is DENIED.