This post is from the non-Reed Smith side of the blog.
It’s been a year and a half since we last talked about Dolin v. GlaxoSmithKline, which is when we posted about the Seventh Circuit overturning the district court and holding that plaintiff’s claims were preempted under Wyeth v. Levine, 555 U.S. 555 (2009). Since then, plaintiff filed a motion for certiorari to the Supreme Court which was denied. That denial came eight days after the Supreme Court decided Merck Sharp & Dohme Corp. v. Albrecht, – U.S. ––, 139 S. Ct. 1668 (2019). That decision prompted plaintiff to file a motion under Federal Rule of Civil Procedure 60(b)(6) asking that the final judgment against her be overturned. Her argument was that Albrecht had changed the law of impossibility preemption and under the new law, GSK was not entitled to the defense.
The district court denied the motion. Plaintiff appealed. The Seventh Circuit denied her appeal. Which is what brings us back to this case 19 months later. The Seventh Circuit was asked to decide whether the district court abused its discretion in denying plaintiff’s Rule 60(b) motion. The Seventh Circuit ruled that it had not. Dolin v. GlaxoSmithKline LLC, 2020 WL 1074812 (7th Cir. Mar. 6, 2020).
First, it’s worth pointing out, as the court did, that plaintiff moved to overturn the judgment under Rule 60(b)(6). Paragraphs 1 through 5 of Rule 60(b) provide specific grounds for granting relief from a final judgment such as mistake, fraud, or new evidence. Paragraph 6, however, is a catch-all. It allows a court to overturn a judgment for “any other reason that justifies relief.” That’s sort of like saying, if you don’t have one of these clear reasons for relief, whatever you’re arguing better be pretty darn compelling. And, in a catch-all type of case, the court’s discretion is fairly liberal. That’s not to say that a court should fail to exercise its discretion where it is given, but where a district court is aware of its options, examines the, and prepares a reasoned analysis, it is unlikely the appellate court is going to overturn. Id. at *4.
That brings us to the substance of the ruling. First a quick reminder of the underlying issue. Plaintiff’s husband was prescribed Paxil and was dispensed generic paroxetine. Shortly after taking the drug, plaintiff’s husband committed suicide. Plaintiff sued the brand-name manufacturer arguing that it failed to include an adequate warming about the risk of adult suicide on the drug’s label. After a jury verdict for plaintiff, the Seventh Circuit ruled that the case should have been dismissed on preemption grounds because the defendant was unable to unilaterally change the drug’s label under the “changes being effected” (“CBE”) regulations. (As an aside, the court chose not to rule on the issue of innovator liability which we also believe should have been fatal to this case.) Prior to plaintiff’s husband’s suicide, the defendant attempted to change its label to add an adult suicide warning, but the FDA rejected that change. Id. at *1. The Seventh Circuit ruled that the rejection was “clear evidence” under Levine that the defendant could not have changed is label and therefore that the failure to warn claims were preempted. Id.
Plaintiff argued that Albrecht was a change in the law that should change the outcome of her case. The Seventh Circuit disagreed finding that Albrecht was a “clarification” of Levine, not a “repudiation” of it. Id. at *5. We’ve talked about this before on this blog. Albrecht provides guidance as to what will satisfy the “clear evidence” standard. In fact, the principal holding of Albrecht is that the preemption issue is a question of law for the court to decide, not a jury. Id. at *6. “To the extent the Supreme Court modified the [Levine] standard, the Court itself did not try to apply that modified standard,” leaving that to the lower courts. Id. The Seventh Circuit notes that Albrecht “explicitly grounds its analysis in the Court’s holdings in [Levine].” Id. at *5. Call it an elaboration or a clarification, the point is Albrecht provided guidance, but “did not break new ground.” Id. at *6.
And in the context of Dolin, Albrecht offered nothing that warranted a change in the court’s prior ruling. Albrecht’s guidance is that the clear evidence standard is met if defendant shows that the 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.” Albrecht, 139 S. Ct. at 1672. Here, the defendant made the necessary disclosure to the FDA and the FDA “unambiguously rejected” defendant’s proposed label change. Dolin, at *6. Further, Albrecht has no bearing on the issue of whether defendant had “newly acquired evidence” to support a CBE label change. In this case, the court had already found that defendant had not. Neither the law nor the facts had changed on that score. Id.
So, the Dolin decision from 2018 stands and this should mark the end of the case as the court noted that even if Albrecht “more dramatically” changed the law (which it didn’t), intervening legal developments rarely constitute the “extraordinary circumstances” needed for Rule 60(b) relief. The decision is final. Claims are barred by impossibility preemption.