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The Dearinger case in the Western District of Washington provided a lot of defense friendly blog fodder. It made its way to the Washington Supreme Court for a certified question whether Washington would recognize a direct to consumer exception to the learned intermediary rule. The Washington Supreme Court answered that question with a resounding no.  Following that decision, the district court dismissed some of plaintiffs’ claims on an initial motion for summary judgement.  We blogged about that decision here.  The latest decision in Dearinger v. Eli Lilly & Co., 2024 WL 416848 (W.D. Wash. Feb. 5, 2024) serves up some nice defense nuggets applying the Washington Product Liability Act (WPLA) and refusing to let a sham affidavit create a fact issue.

Plaintiffs claimed injury from an intracranial hemorrhage allegedly caused by Cialis. After the district court’s decision dismissing the plaintiffs’ failure to warn claim, the plaintiffs filed a motion for reconsideration, and the defendant filed a second motion for summary judgment addressing the remaining design defect and loss of consortium claims.

Plaintiffs included in their motion for reconsideration a lengthy affidavit contending that the court’s decision dismissing their failure to warn claim was based on the wrong physician’s testimony.  They claimed that a primary care provider actually made the prescribing decisions.  Plaintiffs provided testimony from that physician suggesting that he would have changed his prescribing decision if presented with plaintiffs’ proposed warning language.  Plaintiffs argued these facts undermined the court’s initial ruling on summary judgment.  If accepted, the testimony may have altered the court’s analysis in the second motion for summary judgment. 

Rather than starting with the motion for reconsideration, the court began with the defendant’s arguments for summary judgment on the remaining claims (a good sign).  First up was preemption of the design defect claim, and the court made short work of this:

[I]t is uncontroverted that Cialis is an FDA-approved prescription medication which, under federal law, Defendant is prohibited from altering its formulation without prior FDA approval. Based on the plain meaning of the regulation, Defendant could not alter the medication without submission to the FDA for ‘approval prior to distribution of the product made using the change.’  Consequently, to the extent Plaintiffs’ design defect claim is based on Cialis’s formulation, it is preempted.

Id. at *2 (quoting 21 C.F.R. § 314.70(b)(2)(i)).  With that, all that remained was any design defect claim sounding in defective labeling.

Under the WPLA, a “warning-based design defect claim requires proof that a different warning would have caused a different outcome.” Id.  The prescriber (as identified by the defendant and whose testimony supported the initial grant of summary judgement on plaintiffs’ failure to warn claim) testified that (1) he was aware of the risk of hemorrhagic strokes, (2) even if he had received a stronger warning, he would not have changed his prescribing decision.  Plaintiffs did not present any evidence rebutting this physician’s testimony, so the court granted the defendant’s motion.

The court then turned to the affidavit submitted with plaintiffs’ motion for reconsideration.  The plaintiffs’ affidavit about the primary care physician being the “actual” prescriber directly contradicted the plaintiffs’ prior deposition testimony identifying a different prescribing doctor.  The court quoted good language from two Ninth Circuit decisions addressing sham affidavits.  Kennedy v. Allied Mut. Ins. Co., 952 F.2d 262, 266 (9th Cir. 1991) (“A party cannot create an issue of fact by an affidavit contradicting his prior deposition testimony.”); Russell v. Pac. Motor Trucking Co., 672 F.App’x 629, 630 (9th Cir. 2016) (“The district court did not abuse its discretion in disregarding those portions of the affidavit that directly contradicted [plaintiff’s] former deposition testimony.”).  With this support, the court denied the motion for reconsideration, and the sham affidavit had no impact on the court’s dismissal of the remaining claims. It’s a nice ending to Dearinger, and a good addition to the collection of decisions rejecting sham affidavits in prescription medical product liability litigation.