Another Pretty Potent Painkiller Preemption Decision

Even though lawyers who bill for their time defending product liability cases might favor those cases sticking around and plaintiffs getting many chances before inevitable dismissals with prejudice, we have been clear that we think plaintiffs should not get to re-plead around preemption once courts have defined the preempted path.  There seems to be an unwritten three strike rule when it comes to complaints, meaning it is often not until a second amended complaint that asserted claims are dismissed with prejudice in response to 12(b)(6) motions. See here, here, and here.  When it comes to motions to dismiss on preemption—which is a way in which a plaintiff can fail to state a viable claim—one strike should usually be enough unless the plaintiff avails herself of Fed. R. Civ. P. 15(a)(1)(B) or a state equivalent to put in an amended complaint in response to a motion to dismiss.  Given the availability of the opportunity to amend a complaint as of right, the first time a court dismisses claims as preempted the dismissal should be with prejudice.

Almost nineteen months ago, we detailed a pretty good decision finding all the product liability claims asserted as to a prescription drug to be preempted, although only some of the claims were dismissed with prejudice.  It should not have taken much more time for plaintiff to try and fail to re-plead non-preempted claims.  Yet, plaintiff here got the leeway a plaintiff often gets and it ultimately took more than thirty-three months from filing for the defendants to get a complete dismissal with prejudice.  Brashear v. Pacira Pharms., Inc., No. 1:21-cv-700, 2024 WL 380465 (S.D. Ohio Aug. 19, 2024).  We say defendants because plaintiff served two additional related entities after the manufacturer largely won its first motion to dismiss.  Those additional defendants offered a range of grounds for dismissal, but we will focus on preemption.  After its original order, the court also granted plaintiff’s motion to change the dismissal of one of the claims from with prejudice to without prejudice.  Then the plaintiff missed her deadline to file an amended complaint, which ended up being largely a re-hash of her prior complaint.

Ultimately, three asserted claims were at issue in Brashear II.  Plaintiff alleged that the drug’s label was inadequate because it was not changed after approval to add a warning about a purported risk of injury to the diaphragm.  Consistent with the refreshing change in the drug product liability litigation landscape from Levine to Albrecht, the court stated “most failure-to-warn claims are preempted because drug labeling is highly federally regulated.”  2024 WL 380465, *5.  As before, plaintiff could not base a claim on the defendants’ alleged failure to seek approval for a labeling change because such a claim would be based on an obligation that exists only because of the FDCA.  Id.  It would also run afoul of the independence principle from Mensing because the court cannot presume that FDA would have approved the labeling change if requested.  Plaintiff also got a chance to articulate why defendants should have utilized a CBE to make a labeling change based on new information of a risk, but her amended complaint did not come close:

Despite claiming in an earlier filing that she could provide new allegations to that effect, Brashear has pointed to no facts that plausibly suggest such new information exists.

Id. at *6 (emphasis in original and internal citation omitted).  Although not mentioned in the amended complaint, plaintiff tried to point to a case report involving one patient who took a different drug.  Not only could this “evidence” not in the pleadings not be considered at this stage—it was certainly not judicial notice material—it “does not permit of a plausible inference that such a paper constitutes newly acquired information serving as evidence establishing a causal link between the drug in question and the alleged risk of harm.”  Id. at *6 & n.8 (emphasis in original).  That meant dismissal of the warnings claim with prejudice as to all the defendants.

Next up was a “false marketing claim,” which was really an attempt to assert a failure to warn claim based on something other than the content of the label.  Despite Brashear I making it clear that the alleged misrepresentation had to be outside the label to have a chance at not being preempted, plaintiff “cites only representations Defendants made on Exparel’s label as the basis for her claims that she was misled into believing that the drug was safe and effective for pain management.”  Id. at *6.  Dismissal with prejudice on that one too (but no costs for wasting everyone’s time).  Given the drug’s approved indications—that is, the local and regional analgesic uses for which FDA has determined the drug is safe and effective—plaintiff would have had to have some extra-label false promise of efficacy for an off-label use.

Last was a “supplier liability claim.”  Again, this was really a slightly re-packaged design defect claim, which the manufacturer had already gotten dismissed with prejudice in Brashear I.  The court saw this particular formulation as a “stop-selling” claim preempted by Bartlett.

As Brashear fails even to address the preemption issue latent in this stop-selling argument, the Court adheres to its previous determination that Brashear may not challenge the “dangerousness” of Exparel to maintain her supplier liability claim.

Id. at *6 (internal citation omitted).  Another dismissal with prejudice (but no costs for wasting everyone’s time).

If we have been too subtle—a rarity, for sure—we think there should be some penalty to deter this kind of litigating by the plaintiff.  When a plaintiff takes a voluntary dismissal and re-files, Fed. R. Civ. P. 41(d) authorizes the court to “order the plaintiff to pay all or part of the costs of that previous action” and “stay the proceedings until the plaintiff has complied.”  Maybe amending complaints in response to 12(b)(6) motions or orders on 12(b)(6) motions should involve the same dynamic, with the Rules specifically authorizing courts to impose a sort of user fee from the plaintiff if she insists on taking another swing.