Ridings v. Maurice
444 F.Supp.3d 973
W.D. Mo.2020Background
- Plaintiff Max Ridings (and spouse) sued Boehringer over injuries from taking the anticoagulant Pradaxa, alleging design-defect and failure-to-warn claims under Missouri law.
- The court earlier found Ridings’ design-defect claims preempted; the remaining dispute concerned failure-to-warn preemption.
- FDA had approved Pradaxa in 2010 based on RE-LY trial data showing an exposure–response tradeoff (higher plasma levels: fewer strokes but more major bleeding); FDA-approved U.S. labeling did not mandate routine plasma monitoring or a lower 110 mg U.S. dose.
- Post-approval materials at issue included the EU (“Euro”) label (more monitoring guidance), a 2011 Boehringer Clinical Overview Statement, 2012 company simulations, the Reilly paper (submitted July 2013, published Feb. 2014), and 2014 BMJ “Cohen” articles.
- After Merck v. Albrecht, the court (sitting as factfinder) held a bench hearing to decide two-step preemption: (1) whether there was “newly acquired information” enabling a unilateral CBE label change; and (2) if so, whether defendant showed by “clear evidence” the FDA would have rejected the proposed warnings.
- The court concluded Ridings failed to prove “newly acquired information,” and alternatively found Boehringer offered clear evidence the FDA would have rejected the proposed label changes; judgment: all remaining claims preempted.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Ridings showed "newly acquired information" under the FDA CBE rule enabling unilateral label warning changes | Reilly paper, Euro label, 2011 COS, company simulations and BMJ articles supplied new analyses/data showing plasma-concentration risks that warranted stronger warnings | Most contested information derived from RE-LY and had been submitted to FDA pre-approval; post-approval materials either replicate existing data, are unreliable, or were known to FDA | Court: Ridings failed to meet burden; the materials do not constitute "newly acquired information" sufficient to trigger CBE |
| Whether FDA inaction or foreign labels defeat preemption (i.e., whether differences in EU label show U.S. label inadequate) | Existence of more detailed EU label and Euro guidance shows reasonable evidence that U.S. label could and should have been changed | Foreign regulatory standards differ; EU label based on similar/same data already before FDA, so it is not newly acquired evidence | Court: Foreign label alone is insufficient; EU label does not show different/new risks not previously submitted to FDA |
| Whether defendant proved by "clear evidence" the FDA would have rejected the specific warnings Ridings sought | Ridings assumes if information were presented the FDA would have allowed CBE changes; absence of formal rejection is not dispositive | Boehringer pointed to the FDA’s prior review, repeated exchanges rejecting certain proposals (e.g., dose/monitoring), and longstanding FDA stance against routine monitoring | Court (alternative holding): Boehringer offered clear evidence FDA would have rejected the proposed warnings; thus impossibility preemption applies |
| Admissibility/lateness of certain deposition testimony and undisclosed witness (Dr. Oakes) | Ridings moved to exclude depositions taken in other cases and late-disclosed live testimony; argued unfair surprise and hearsay/Rule 804 issues | Boehringer relied on Rule 32 and court discretion for bench hearing; argued prior depositions and late testimony were permissible and not prejudicial | Court: Denied the motion; in a bench preemption hearing court relaxed exclusionary rules, found no unfair surprise and no deliberate sandbagging |
Key Cases Cited
- Block v. Toyota Motor Corp., 665 F.3d 944 (8th Cir. 2011) (fraudulent-joinder standard for removal)
- Brinkley v. Pfizer, Inc., 772 F.3d 1133 (8th Cir. 2014) (impossibility preemption analysis in pharmaceutical design/labeling claims)
- Wyeth v. Levine, 555 U.S. 555 (2009) (CBE regulation and manufacturer duty to update label for newly acquired information unless FDA would have rejected change)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (preemption principles in drug-labeling cases)
- Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019) (preemption is a legal question for the judge; framing of "clear evidence" and CBE analysis)
- Geier v. American Honda Motor Co., 529 U.S. 861 (2000) (state tort law can be preempted by federal law)
- Utts v. Bristol-Myers Squibb Co., 251 F. Supp. 3d 644 (S.D.N.Y. 2017) (interpreting "newly acquired information" and CBE regulatory meaning)