Wendy Dolin v. GlaxoSmithKline LLC

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, Cir-
cuit Judges.
HAMILTON, Circuit Judge. This appeal presents two ques-
tions: first, whether we should reopen our court’s prior judg-
ment 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 re-
open 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 opin-
ion 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 re-
ject 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 ac-
curacy 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 regula-
tion.” 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 impossibil-
ity 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 mo-
tion. 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 cit-
izen 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 es-
tate). 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 juris-
diction 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 de-
scribed as ‘an extraordinary remedy … granted only in excep-
tional circumstances.’” Davis v. Moroney, 857 F.3d 748, 751 (7th
Cir. 2017), quoting Bakery Machinery & Fabrication, Inc. v. Tra-
ditional Baking, Inc., 570 F.3d 845, 848 (7th Cir. 2009).
II. Sanctions
We first address the question of sanctions, however. Fed-
eral 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 reasona-
ble 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 law-
yers 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 argu-
ment[s] for extending, modifying, or reversing existing law or
for establishing new law” as proper subject of legal filing); Ni-
senbaum v. Milwaukee County, 333 F.3d 804, 809 (7th Cir. 2003)
(“[C]ourts do not penalize litigants who try to distinguish ad-
verse 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 im-
posed 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 cau-
tion, given its potential for chilling legitimate advocacy. Even
in its more expansive form as amended in 1983, it was not de-
signed 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 attor-
ney’s enthusiasm or creativity in pursuing factual or legal the-
ories. 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, mo-
tion, or other paper was submitted.”).
By contrast, appeals that are hopeless efforts to harass the
opposing parties or to delay the inevitable may warrant sanc-
tions, as in Harris N.A. v. Hershey, 711 F.3d at 803 (appellant-
defendant was sophisticated borrower who offered no plau-
sible reason to set aside district-court judgment enforcing
eight-figure loan and guaranty), and Spiegel v. Continental Illi-
nois 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 ef-
fort 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 un-
successful 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 ulti-
mately agree with the district court that Albrecht is better un-
derstood as clarifying Wyeth, but that is not the “foregone con-
clusion” 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.” Har-
ris 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 pur-
suing 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 Man-
ville, 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 war-
rant 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 circum-
stances. 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 im-
portance 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 sub-
tlety, 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 incommen-
surable 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 state-
ment 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 en-
gage in a detailed back-and-forth with counsel about the rel-
evant 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 rele-
vant procedural and substantive law. We interpret his state-
ment that “after they have spoken, I have to follow the Sev-
enth 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 cir-
cuit law and the law of the case. Because he understood Al-
brecht to be a clarification of Wyeth, the result would not
change. This was a straightforward application of the hierar-
chical and precedential principles that organize our entire le-
gal system.
Based on that legal analysis, and with no other equitable
factors weighing in favor of reopening the judgment, the dis-
trict 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 un-
derstood as a clarification of the impossibility standard in Wy-
eth 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 “ab-
sent 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 ev-
idence” for two reasons: first, it had not shown that it “sup-
plied 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 estab-
lish 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 justifica-
tions 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 warn-
ing.” 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 pre-
emption 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 in-
terpreted 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 of-
fer “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 actu-
ally requested a change and that the FDA rejected it.
In addition, further language in Albrecht can be read to sig-
nal that the FDA’s rejection must have acted “pursuant to the
FDA’s congressionally delegated authority,” citing as exam-
ples 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 un-
derstood as indicating that less formal exchanges of corre-
spondence, 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 im-
possibility 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 pre-
empted by the Federal Food, Drug, and Cosmetic Act and re-
lated 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 de-
cide the pre-emption question. And we elaborate Wyeth’s re-
quirements along the way.” Id. at 1676 (emphasis added) (cita-
tion 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” hold-
ing into sharper focus. It did not adopt a new rule of preemp-
tion 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 re-
jected its proposal to add an adult-suicidality warning to the
paroxetine label that would have justified a change in the la-
bel 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 dele-
gated 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 Re-
alty Corp., 763 F.2d at 831. The “need for the finality of judg-
ments is an overarching concern.” Cincinnati Ins. Co. v. Flan-
ders 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 cau-
tion.
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]nter-
vening developments in the law by themselves rarely consti-
tute 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 judg-
ment in this case.
* * * * *
The district court’s denial of relief under Federal Rule of
Civil Procedure 60(b)(6) is AFFIRMED. Appellee Glaxo-
SmithKline’s motion for fees and costs under Federal Rule of
Appellate Procedure 38 is DENIED.