Werner v. Upjohn Company

United States Court of Appeals for the Fourth Circuit · 1980 · Evidence

628 F.2d 848 (4th Cir. 1980)

Updated August 22, 2026

EvidenceSubsequent remedial measuresFailure to warnProducts liabilityFRE 407feasibility exceptionprescription drugsstrict liability

Facts

Werner sued Upjohn and his ophthalmologist, Dr. Carbo, alleging injuries from taking Cleocin, a prescription drug manufactured by Upjohn and prescribed by Carbo. A central issue at trial was whether Upjohn's 1974 warning about Cleocin's risk of pseudomembranous colitis was adequate; over objection, the district court admitted a stronger 1975 warning revision. Plaintiff repeatedly used the 1975 warning through expert testimony and closing argument to suggest Upjohn should have given that stronger warning earlier. The jury found Upjohn negligent and in breach of warranty, found Carbo negligent, but found Upjohn not strictly liable for marketing an unreasonably dangerous drug.

Issue

Whether the district court erred by admitting and allowing use of Upjohn's 1975 revised warning under Federal Rule of Evidence 407, and whether the jury's verdicts against Upjohn for negligent failure to warn but in its favor on strict liability could stand in this prescription-drug failure-to-warn case.

Rule

Under Federal Rule of Evidence 407, evidence of subsequent remedial measures is inadmissible to prove negligence or culpable conduct, and may be admitted to show feasibility only when feasibility is genuinely and actually controverted by the defendant. The exceptions to Rule 407 are illustrative, not exhaustive, but must be narrowly construed to preserve the policy of encouraging repairs and improvements. In a failure-to-warn case involving an unavoidably dangerous prescription drug, subsequent warning changes are not admissible to prove strict liability because the adequacy inquiry under strict liability and negligence is essentially the same.

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In Phoenix, Larkspur Therapeutics sold a prescription antibiotic through physicians. After a patient developed severe intestinal complications, Larkspur added a boxed warning; at trial, Larkspur argued only that its earlier label was adequate based on the medical data it had then and never claimed it was unable to draft stronger language earlier.

May the patient introduce the later boxed warning under Federal Rule of Evidence 407 to prove the feasibility of a stronger earlier warning?

Explanation. Rule 407 permits evidence of subsequent remedial measures on feasibility only when feasibility is genuinely controverted. A defendant does not controvert feasibility merely by asserting that the earlier warning was adequate in light of what it knew at the time. Because Larkspur never argued it could not have written a stronger warning, the later warning is inadmissible for feasibility.