Dolin v. GlaxoSmithKline LLC, 19-2547

• Decision Date: 06 March 2020
• Docket Number: No. 19-2547,19-2547
• Citation: 951 F.3d 882
• Parties: 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.
• Court: U.S. Court of Appeals — Seventh Circuit

951 F.3d 882

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.

No. 19-2547

United States Court of Appeals, Seventh Circuit.

Argued January 22, 2020

Decided March 6, 2020

Bijan Esfandiari, Attorney, BAUM, HEDLUND, ARISTEI & GOLDMAN, PC, Los Angeles, CA, for Plaintiff-Appellant.

Andrew T. Bayman, Attorney, KING & SPALDING LLP, Atlanta, GA, Sarah M. Harris, Attorney, John Pararas, Attorney, WILLIAMS & CONNOLLY LLP, Washington, DC, Alan Scott Gilbert, Attorney, DENTONS US LLP, Chicago, IL, for Defendant-Appellee.

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 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, 131 S.Ct. 2567, 180 L.Ed.2d 580 (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 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, 129 S.Ct. 1187, 173 L.Ed.2d 51 (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. ––– U.S. ––––, 139 S. Ct. 2636, 204 L.Ed.2d 282 (2019).

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. ––– U.S. ––––, 139 S. Ct. 1668, 203 L.Ed.2d 822 (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.

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. 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 (appellant-defendant 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...