Theresa Huck v. Wyeth, Inc. D/B/A Wyeth Schwarz Pharma, Inc. and Pliva, Inc.
850 N.W.2d 353
Iowa2014Background
- Theresa Huck was prescribed metoclopramide (Reglan) in 2004; her pharmacy filled the prescription with PLIVA’s generic. She later developed tardive dyskinesia and sued PLIVA (generic manufacturer) and the branded manufacturers (Wyeth/Schwarz).
- In July 2004 the FDA approved stronger Reglan label language: “Therapy should not exceed 12 weeks in duration.” PLIVA did not put that language on its generic label. Huck alleges she would not have taken the drug if warned.
- Lower courts granted summary judgment for the brand defendants (Huck had ingested only the generic) under Iowa’s product-identification rule (Mulcahy). The district court also granted summary judgment to PLIVA based on Mensing preemption; the court of appeals affirmed. The Iowa Supreme Court granted review.
- The legal issue centers on conflict preemption under federal drug labeling law (Hatch‑Waxman framework), and whether Mensing bars state-law failure-to-warn and related claims against a generic when the generic failed to adopt an FDA‑approved brand label update.
- The Iowa Supreme Court held Huck’s state common‑law claims against PLIVA survive to the extent they are based on PLIVA’s failure to adopt the 2004 FDA‑approved warning; but claims against the brand defendants were properly dismissed because Huck never used Reglan and Iowa law requires plaintiff to prove the defendant manufactured or supplied the injury‑causing product.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Mensing preempts Huck’s failure‑to‑warn and related state claims against the generic (PLIVA) | Huck: Mensing only preempts claims that would force a generic to deviate from the brand label; here PLIVA failed to adopt a 2004 FDA‑approved brand warning, so state claims are viable | PLIVA: Mensing bars any state-law warning claims because federal law requires label sameness and prohibits unilateral strengthening by generics | Court: Mensing does not preempt claims premised on a generic’s failure to adopt an FDA‑approved change (the 2004 language); those claims may proceed; other label‑variance claims remain preempted |
| Whether Huck’s other tort/warranty claims (negligent testing/post‑market surveillance, implied warranty, fraud/misrepresentation) are preempted or barred as attempts to enforce the FDCA | Huck: These claims can be pleaded on traditional state‑law grounds and, insofar as they concern PLIVA’s failure to adopt the 2004 warning, are not preempted | PLIVA: These are disguised attempts to enforce the FDCA and are preempted or barred by §337(a) (no private FDCA enforcement) | Court: Claims based on PLIVA’s failure to implement the 2004 FDA‑approved warning escape preemption and are not a forbidden private FDCA enforcement; traditional state‑law theories may proceed limited to that theory |
| Whether brand manufacturers (Wyeth/Schwarz) can be liable to a patient who used only the generic | Huck: After Mensing, liability should shift to the brand where the generic was constrained by federal law and used the brand label as the standard | Brands: Iowa law (Mulcahy) requires plaintiff to prove the defendant manufactured or supplied the product that caused injury; Huck used only PLIVA’s product so brands are not liable | Court: Affirmed dismissal of brands — plaintiff must show defendant manufactured/supplied the injuring product; courts will not expand Iowa products‑liability law to impose liability for a competitor’s product |
| Whether public‑policy/purposes‑and‑objectives preemption supports dismissal | Huck: Allowing state claims aids safety and complements FDA oversight; permitting limited state suits does not frustrate federal objectives | PLIVA/Brands: Allowing state suits undermines Hatch‑Waxman objectives (promote generics, lower costs) and conflicts with FDA regulatory scheme | Court: Purposes-and-objectives preemption does not bar Huck’s limited claims against PLIVA; state tort law can complement FDA regulation and is presumptively not preempted |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (2009) (federal drug labeling regulations do not categorically preempt state-law failure-to-warn claims against brand manufacturers)
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (state-law failure-to-warn claims against generic manufacturers are preempted when they would require a generic to unilaterally strengthen its label in conflict with federal duty of sameness)
- Mulcahy v. Eli Lilly & Co., 386 N.W.2d 67 (Iowa 1986) (Iowa rule requiring plaintiff to prove the defendant manufactured or supplied the product that caused the injury)
- Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013) (holds Mensing does not preempt claims based on a generic’s failure to adopt a brand’s FDA‑approved label change)
- Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013) (Supreme Court refused “stop‑selling” escape to avoid impossibility preemption analysis in generic drug context)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (state damages remedies that parallel federal requirements are sometimes permissible despite federal regulation)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (claims that exist solely by virtue of federal regulatory scheme are preempted; no private cause of action to enforce FDA’s authority)