COMBS v. BAYER AG et al., 2026 OK CIV APP 17

Combs sued Bayer over Magnevist after receiving an MRI contrast injection in 2016 and alleging gadolinium retention caused serious long-term injuries. 1
She asserted strict-liability, negligence, fraud, and negligent training claims, but her summary-judgment response focused on failure to warn. 2
Bayer moved for summary judgment, arguing federal preemption, Oklahoma’s rebuttable presumption against liability for FDA-approved products, and lack of proximate cause. 3
The trial court granted summary judgment for Bayer on all claims, and Combs appealed on the accelerated docket. 4
The record showed Magnevist warned of NSF risk in kidney-disease patients, but Combs offered no evidence that FDA-approved labeling could have been changed in 2016 based on a causal association between gadolinium retention and serious injury. 5
Dr. Nelson testified he would not have changed treatment even knowing of retained gadolinium, and the FDA later stated gadolinium retention had not been directly linked to adverse effects in patients with normal kidney function. 6

Issue	Plaintiff's Argument	Defendant's Argument	Held
Failure-to-warn claims preempted by federal law 7	Combs said Bayer could have unilaterally changed warnings and preemption was for the jury.	Bayer said federal law barred unilateral label changes without newly acquired causal evidence.	Failure-to-warn claims were preempted. 8
Oklahoma rebuttable presumption under §57.2 9	Combs argued she rebutted the presumption and its applicability was jury-only.	Bayer said Magnevist’s FDA approval triggered the presumption and Combs offered no rebuttal.	Combs failed to rebut the presumption; judgment affirmed. 10
Learned intermediary and proximate cause 11	Combs argued Bayer had to warn her physician and the doctrine did not apply.	Bayer said Dr. Nelson would not have changed treatment even with more warnings.	Combs failed to show proximate cause. 12

Carmichael v. Beller, 914 P.2d 1051 (Okla. 1996) (summary judgment reviewed de novo 13)
Wyeth v. Levine, 555 U.S. 555 (U.S. 2009) (state failure-to-warn claims generally not expressly preempted, but impossibility preemption may apply 14)
Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (U.S. 2019) (preemption under this framework is a legal question for the court 15)
Edwards v. Basel Pharms., 933 P.2d 298 (Okla. 1997) (manufacturer duty to warn of known or knowable dangers; learned intermediary doctrine recognized 16)
Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (U.S. 2019) (FDA labeling change and preemption analysis turns on newly acquired information 17)
Eck v. Parke, Davis & Co., 256 F.3d 1013 (10th Cir. 2001) (learned intermediary doctrine applies to proximate causation and physician behavior 18)
State ex rel. Oklahoma State Bd. of Med. Licensure & Supervision v. Rivero, 489 P.3d 36 (Okla. 2021) (waiver applies when an argument is not raised below 19)
Copeland v. Lodge Enterprises, 4 P.3d 695 (Okla. 2000) (party opposing summary judgment must show evidence supporting trial proof 20)
Edmondson v. Pearce, 91 P.3d 605 (Okla. 2004) (statutes are construed as a whole, not by isolated words 21)
McKee v. Moore, 648 P.2d 21 (Okla. 1982) (foundation of Oklahoma’s learned intermediary doctrine 22)
Choate v. Laws Title Ins. Corp., 385 P.3d 670 (Okla. Civ. App. 2016) (petition in error defines preserved issues on accelerated-docket appeal 23)