361 F. Supp. 3d 938
D. Neb.2019Background
- Plaintiff Stephanie Ideus received a ParaGard T380 copper IUD; four years later a piece allegedly broke off and embedded in her myometrium during removal, requiring surgery.
- Ideus asserted a failure-to-warn claim against manufacturers Teva Pharmaceuticals / Teva Women’s Health, alleging patient and physician materials failed to warn that the device could break during removal or that fragments could embed deeply.
- Teva moved for summary judgment, arguing the package insert (the prescribing-physician warning) was adequate and alternatively asserting federal preemption (the court did not decide preemption).
- The Nebraska learned-intermediary doctrine (manufacturer need only warn prescribing physician) governs failure-to-warn claims for prescription products, subject to limited exceptions.
- The court predicted Nebraska would apply the learned intermediary doctrine to contraceptives, found the package insert expressly warned of embedment, breakage, difficult removals, and possible surgical removal, and credited Teva’s medical expert testimony that the warnings were adequate.
- Ideus produced no evidence that her prescribing physician would have declined to use ParaGard had the warnings been different, and she offered no expert contradicting Teva’s experts.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether learned intermediary doctrine applies to prescription contraceptives | Ideus: contraceptives are distinct; doctrine should not apply | Teva: doctrine applies because contraceptives are prescribed by physicians | Court: applies to contraceptives under Nebraska law; no exception shown |
| Whether ParaGard warnings were adequate as a matter of law | Ideus: brochure and insert failed to warn specifically of breakage during removal or fragment embedment | Teva: package insert warned of embedment, breakage, difficult removal, and need for surgery; warnings adequate | Court: package insert warnings were adequate as a matter of law |
| Whether physician’s independent knowledge breaks causation (proximate cause) | Ideus: warned risks occurred frequently; warning ambiguous/incomplete | Teva: physician knowledge and adequate labeling negate causation; plaintiff must show physician would have acted differently | Court: Ideus failed to show the prescribing physician would have declined to use ParaGard; proximate cause not established |
| Whether direct-to-consumer marketing or other exceptions defeat learned intermediary defense | Ideus: marketing/consumer materials create exception | Teva: no contemporaneous consumer marketing relevant to Ideus; exception inapplicable | Court: no evidence of relevant direct-to-consumer marketing; exception inapplicable |
Key Cases Cited
- Freeman v. Hoffman-La Roche, Inc., 260 Neb. 552, 618 N.W.2d 827 (Neb. 2000) (adopting learned intermediary rule under Restatement (Third) of Torts)
- Hill v. Searle Labs., 884 F.2d 1064 (8th Cir. 1989) (Eighth Circuit predicted contraceptives might warrant a modified rule)
- West v. Searle Co., 305 Ark. 33, 806 S.W.2d 608 (Ark. 1991) (state supreme court applied learned intermediary doctrine to IUDs)
- Terhune v. A. H. Robins Co., 577 P.2d 975 (Cal. 1978) (reasoning that physician is intermediary and patient relies on physician’s guidance)
- Brinkley v. Pfizer, Inc., 772 F.3d 1133 (8th Cir. 2014) (physician’s independent knowledge can sever causal link under learned intermediary doctrine)
- Scelta v. Boehringer Ingelheim Pharm., Inc., [citation="404 F. App'x. 92"] (8th Cir. 2010) (expert medical testimony required to assess adequacy of warnings to the medical community)