JHP Pharmaceuticals, LLC v. Hospira, Inc.
52 F. Supp. 3d 992
C.D. Cal.2014Background
- Par Sterile Products (Par) manufactures FDA-approved injectable epinephrine (ADRENALIN) for a 1 mL product; competitors American Regent, Hospira, and IMS sell unapproved injectable epinephrine products.
- Par alleges competitors falsely market their unapproved products as FDA-approved, as "generics" or interchangeable with Par’s NDA product, and advertise conformity with law; Par asserts Lanham Act and parallel state false-advertising claims.
- Defendants moved to dismiss, arguing FDCA preclusion, failure to exhaust administrative remedies, and that primary jurisdiction/FDA expertise precludes court resolution of disputed issues.
- The district court stayed earlier briefing pending POM Wonderful and, after that decision, reconsidered Defendants’ motions.
- The court analyzed whether Lanham Act claims touching FDA-regulated drug approval/labeling are precluded or require referral to the FDA, and evaluated the sufficiency of Par’s pleadings.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Exhaustion of administrative remedies | No citizen-petition to FDA required because Par sues competitors, not FDA | American Regent: Par should have filed a Citizen’s Petition before suit | Denied as a basis for dismissal — exhaustion not required here |
| False representation of FDA approval | Par: competitors imply or state FDA approval or ‘‘generic’’ equivalence, harming Par | Defs: FDCA/agency expertise precludes court; pleadings insufficient to show overt false statements | Survives 12(b)(6): claim not precluded; pleadings adequate (specific allegation against Hospira; plausible implied claims against others) |
| Claims that products are "safe" or "effective" | Par pleads defendants advertise safety/effectiveness as misleading | Defs: safety/effectiveness determinations implicate FDA expertise and may be precluded | Dismissed for lack of factual sufficiency and because safety/effectiveness implicate FDA expertise |
| Claims that defendants’ products are unlawful under the FDCA (comply-with-law statements) | Par: defendants represent compliance while selling unlawful, unapproved drugs | Defs: legality questions require FDA determination and involve exempted/"grandfathered" status and complex agency expertise | Dismissed without prejudice: resolution falls within FDA primary jurisdiction; Par may seek FDA petition first |
| Alleged misleading omission in labeling (failure to carry Par’s warnings) | Par: competitors omit warnings Par must carry, implying Par is less safe | Defs: implication is ambiguous and requires proof of actual consumer deception; drug labeling is FDA-regulated | Dismissed for failure to plead facts showing actual conveyed message and because resolving comparative safety implicates FDA expertise |
Key Cases Cited
- Somers v. Apple, Inc., 729 F.3d 953 (9th Cir. 2013) (Rule 12(b)(6) pleading standard overview)
- Williams v. Gerber Prods. Co., 552 F.3d 934 (9th Cir. 2008) (contextual consumer impression controls deceptive-labeling claims)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (plausibility standard for pleadings)
- PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010) (Lanham Act claims may be barred where resolution requires litigating an underlying FDCA violation absent FDA determination)
- POM Wonderful LLC v. Coca-Cola Co., 134 S. Ct. 2228 (2014) (FDCA does not generally preclude Lanham Act claims; agency expertise may preclude some suits)
- Geier v. American Honda Motor Co., 529 U.S. 861 (2000) (preemption where agency allowed choice among regulatory options)
- Reiter v. Cooper, 507 U.S. 258 (1993) (primary jurisdiction doctrine overview)
- United States v. Gen. Dynamics Corp., 828 F.2d 1356 (9th Cir. 1987) (factors for applying primary jurisdiction)
- Mylan Labs., Inc. v. Matkari, 7 F.3d 1130 (4th Cir. 1993) (mere marketing does not necessarily imply FDA approval)
- William H. Morris Co. v. Grp. W, Inc., 66 F.3d 255 (9th Cir. 1995) (need to plead actual conveying of implied message for deceptive implication claims)
- Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609 (1973) (FDA has authority to determine which drugs require NDA approval)