In the 

United States Court of Appeals 

For the Seventh Circuit ____________________ 

No. 19-2547 

WENDY B. DOLIN, Individually and as Independent 

Executor of the Estate of STEWART DOLIN, Deceased, 

Plaintiff-Appellant, 

v.

GLAXOSMITHKLINE LLC, 

Formerly Known as SMITHKLINE BEECHAM CORPORATION, 

Defendant-Appellee. 

____________________ 

Appeal from the United States District Court for the 

Northern District of Illinois, Eastern Division. 

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

____________________ 

ARGUED JANUARY 22, 2020 — DECIDED MARCH 6, 2020 

____________________ 

Before WOOD, Chief Judge, and SYKES and HAMILTON, Circuit Judges. 

HAMILTON, Circuit Judge. This appeal presents two questions: first, 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 her 
2 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 

filled 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 matter who made 

and sold it; that GSK had negligently omitted an adult suicide 

risk on the drug label, and that the negligent omission had 

caused her husband’s death. Mrs. Dolin won a $3 million jury 

verdict in federal district court. 

On appeal, we reversed the judgment. The appeal raised 

several issues, including whether 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. 901 
No. 19-2547 3

F.3d at 806–10. We will not repeat it except to highlight that 

under the “changes being effected” or CBE regulation, 21 

C.F.R. § 314.70(b)(2)(v)(A), “GSK needed FDA permission to 

change the paroxetine label unless three things were true: (1) 

GSK had newly acquired information about paroxetine (2) 

that showed a causal association (3) between the drug and an 

effect that warranted a new or stronger warning.” 901 F.3d at 

806. Further, the “FDA reviews CBE submissions and can reject label changes even after the manufacturer has made 

them.” Id., citing 21 C.F.R. § 314.70(c)(6) & (7). GSK attempted 

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 deficiencies 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 matter 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-specific adult-suicidality warning 

and instead use a class-wide SSRI warning], and (2) GSK 

lacked new information after 2007 that would have allowed it 

to 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 filed a petition for certiorari 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 off, further 

explaining Wyeth’s “clear evidence” standard for impossibility preemption for prescription drug labels. 139 S. Ct. 1668 

(2019). After Albrecht was decided, Mrs. Dolin returned to the 

district court and filed a motion under Federal Rule of Civil 

Procedure 60(b)(6). Her motion argued that the 2018 final 

judgment should be set aside on the ground that Albrecht 

changed the law so that GSK could not establish its defense of 

impossibility 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-matter 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 also 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 filed 

her Rule 60(b)(6) motion in June 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 written order to that 

effect on July 11, 2019. Mrs. Dolin appealed, and during the 

briefing, GSK filed a motion for sanctions, asserting that the 

appeal is frivolous. We deferred ruling on that motion until 

briefing 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 first 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 filed 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 efforts to convince the courts 

to extend, modify, or even reverse 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 filing); Nisenbaum v. Milwaukee County, 333 F.3d 804, 809 (7th Cir. 2003) 

(“[C]ourts do not penalize litigants who try to distinguish adverse precedents, argue for the modification 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 significant impact beyond the merits of the individual 

case and can affect the reputation and creativity of counsel.”) 

(cleaned up); In re Drexel Burnham Lambert Group Inc., 995 F.2d 

1138, 1147 (2d Cir. 1993) (“Sanctions 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. Even 

in its more expansive form as amended in 1983, it was not designed to penalize litigants because they choose to fight uphill 

battles[.]”); Fed. R. Civ. P. 11 Advisory Committee’s Note to 

1983 Amendment (“The rule is not intended to chill an attorney’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 inquiring 

what was reasonable to believe at the time the pleading, motion, or other paper was submitted.”). 

By contrast, appeals that are hopeless efforts to harass the 

opposing 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 offered no plausible reason to set aside district-court judgment enforcing 

eight-figure 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 attacks 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 first consider 

whether the appeal is frivolous. “Frivolous,” we stress, is not 
No. 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 something more to us than an unsuccessful appeal.”). GSK suggests that because Mrs. Dolin 

lost her Rule 60(b) motion in the district court, and because 

our review of such a denial is “extraordinarily deferential,” it 

was almost by definition 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 utterly 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 clarified the Wyeth standard. There are reasonable, 

and certainly colorable, arguments on both sides. We ultimately agree with the district court that Albrecht is better 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.3d 
8 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 here. 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 face of a deferential standard of 

review were filed in bad faith. See, e.g., Smeigh v. Johns Manville, Inc., 643 F.3d 554, 566 (7th Cir. 2011) (denying Rule 38 

sanctions: “We find 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 attorneys’ 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 afforded under the circumstances. The district judge was aware of the range of options 

available to him and justified 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 finality. 

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 these 
No. 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 filed under Rule 60(b)(6). In paragraphs 

(b)(1) through (b)(5), Rule 60 specifies five particular grounds 

for relief “from a final judgment, order, or proceeding,” such 

as fraud, mistake, and newly discovered evidence. Paragraph 

(b)(6) provides a sixth, catchall ground: “any other reason that 

justifies relief.” Mrs. Dolin’s Albrecht argument falls into this 

catchall, 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 argues that the district judge 

erred 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 what I’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 significantly more discretion than you realize.” 

Judge Hart replied that he had “read the cases and everything 

that was called out to my attention,” 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 Judge 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 he 

may have disagreed with that interpretation, it is binding circuit law and the law of the case. Because he understood Albrecht to be a clarification of Wyeth, the result would not 

change. This was a straightforward application of the hierarchical and precedential principles that organize our entire legal system. 

Based on that legal analysis, and with no other equitable 

factors 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 “cannot.” 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 better understood as a clarification of the impossibility standard in Wyeth rather than as a repudiation of it. We decided Dolin I on 
No. 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 Court 

held that the drug company had not provided such “clear evidence” for two reasons: first, it had not shown that it “supplied the FDA with an evaluation or analysis concerning the 

specific dangers” underlying the appropriate warning; and 

second, it had not shown that it had “attempted 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 definition of the “clear evidence” standard. 

In Albrecht, the Court clarified that standard, writing that 

“‘clear evidence’ is evidence that shows the court that the 

drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, 

in turn, informed the drug manufacturer that the FDA would 

not approve a change to the drug’s label to include that warning.” 139 S. Ct. at 1672. Albrecht included two other important 

holdings: first, that the preemption question is a matter of law 

to be decided by the judge, not the jury; and second, that “the 

only agency actions that can determine 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 significant modification of the Wyeth standard 

for applying the CBE regulation to preemption of labeling 

claims. Wyeth framed the issue as requiring the defense to offer “clear evidence that the FDA would not have approved a 

change to [the drug’s] label.” 555 U.S. at 571. The phrase 
12 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 the “clear evidence” needed 

is “evidence that shows the court that the drug manufacturer 

fully informed the FDA of the justifications for the warning 

required by state law and that the FDA, in turn, informed the 

drug manufacturer that the FDA 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 must have acted “pursuant to the 

FDA’s congressionally delegated authority,” citing as examples notice-and-comment rulemaking or a formal rejection 

pursuant to regulations or some other action “carrying the 

force 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. Albrecht began by citing the Wyeth “clear 

evidence” standard and formulated the question for decision 

in terms of the Wyeth framework. Id. at 1672, 1678. The Court 

noted that its “conclusions flow 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 clarification of Wyeth: “We stated 
No. 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 law 

requires. 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 omitted). 

This is the language of ordinary evolution and clarification 

in case law, not reversal and overruling. In addition, the facts 

of both Wyeth and Albrecht offer relatively little to work with. 

In Wyeth, the manufacturer had not offered any evidence that 

might have satisfied 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 modified the Wyeth standard, the Court 

itself did not try to apply that modified standard but instead 

remanded the case to the lower 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 relevant data underlying its desired 

adult-suicidality warning to the FDA in 2006, and (b) that the 

FDA unambiguously rejected a Paxil-specific warning in 2007 

when it formally mandated that all SSRIs carry a uniform, 

class-wide warning label. Dolin I, 901 F.3d at 813–15. We also 

noted in Dolin I that “Plaintiff has failed to offer evidence that 
14 No. 19-2547 

GSK acquired new information after 2007, when the FDA rejected its proposal to add an adult-suicidality warning to the 

paroxetine label that would have justified 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 label would qualify as “agency 

action[] 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 reopened under Rule 60(b) except 

in compelling and extraordinary circumstances.” Metlyn Realty Corp., 763 F.2d at 831. The “need for the finality 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 finality 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 final judgment in this case. 

* * * * * 

The district court’s denial of relief under Federal Rule of 

Civil Procedure 60(b)(6) is AFFIRMED. Appellee GlaxoSmithKline’s motion for fees and costs under Federal Rule of 

Appellate Procedure 38 is DENIED.