Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc.
808 F.3d 281
6th Cir.2015Background
- Stephanie Yates, using the ORTHO EVRA® birth-control patch in April 2005, suffered a stroke seven days after first use and sued the patch’s manufacturers in New York state court; the case was removed and consolidated in MDL 1742 and later in the Northern District of Ohio.
- Yates pleaded five claims: strict products-liability (failure to warn), strict liability (manufacturing defect), negligence, breach of implied warranty, and breach of express warranty; district court granted summary judgment to defendants on all claims and entered final judgment.
- The ORTHO EVRA® physician package insert and patient insert in effect at the time explicitly warned prescribers and patients about an increased risk of stroke and thromboembolism associated with hormonal contraceptives. Yates admits her prescriber (PA Smith) counseled her about stroke risk and she received sample patches with a patient flyer.
- Yates’s experts attributed her stroke to the patch; she also produced an expert affidavit alleging manufacturing scale-up problems (inter-lot variability) and a post-approval FDA labeling change is noted in the record.
- The court framed the dispute under New York substantive law and federal preemption doctrine (impossibility preemption), applying Supreme Court precedents on drug-labeling and design/preemption (Levine, Mensing, Bartlett).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Failure to warn (adequacy) | Label failed to convey the magnitude of stroke risk (e.g., higher risk vs. oral contraceptives) | Label and inserts expressly warned of stroke risk to prescribers; PA Smith was aware and counseled Yates | Warning was adequate as a matter of law; summary judgment for defendants |
| Learned-intermediary / FDA exception | FDA regulations requiring patient inserts mean defendants had a duty to warn the patient directly | Learned-intermediary doctrine applies; PA Smith functioned as informed intermediary and patient was meaningfully counseled | No FDA-based exception; learned-intermediary doctrine applies here |
| Design-defect / preemption (pre- and post-approval) | Defendants had a state-law duty to design a safer drug pre-approval and could have adopted a safer formulation | Federal law and FDA regulations make post-approval formulation changes major and require FDA approval; pre-approval alternatives are speculative and would still require FDA approval — impossibility preemption applies | Design-defect claims (pre- and post-approval theories) are preempted under impossibility preemption (Bartlett/Mensing/Levine framework) |
| Manufacturing defect (circumstantial proof) | Evidence of manufacturing scale-up problems and expert affidavit create inference of defective lots | No proof the patches Yates used differed from approved specifications or other lots; known side effects do not alone show a manufacturing defect | No genuine dispute; insufficient evidence of a manufacturing defect — summary judgment for defendants |
| Express/implied warranty & negligence | Implied/express warranty and negligence arising from alleged design/manufacturing failures | Overlap with preempted design claims; no direct representations to Yates; warnings were provided to prescriber | Warranty and negligence claims dismissed: express warranty fails for lack of specific representations relied upon; implied warranty and negligence fail given preemption and absence of defect/warning failures |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (2009) (brand-name manufacturer can in some cases strengthen warnings under the CBE regulation; impossibility preemption is a demanding defense)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (generic manufacturers constrained by labeling sameness rule; failure-to-warn claims preempted where federal law forbids independent label changes)
- Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013) (applying Mensing/Levine to preemption of design-defect claims where federal requirements make compliance with state-law duties impossible)
- Voss v. Black & Decker Mfg. Co., 59 N.Y.2d 102 (1983) (New York uses risk-utility factors in design-defect analysis)
- Denny v. Ford Motor Co., 87 N.Y.2d 248 (1995) (recognizes product-liability claims against manufacturers including for drugs; discusses design-defect principles)
- Lindsay v. Ortho Pharm. Corp., 637 F.2d 87 (2d Cir. 1980) (learned-intermediary doctrine: manufacturer’s duty to warn runs to prescribing physician absent FDA regulations to the contrary)