Czimmer v. Janssen Pharmaceuticals, Inc.
122 A.3d 1043
| Pa. Super. Ct. | 2015Background
- April Czimmer took Topamax (brand-name by Janssen) for migraines in Aug 2006; she became pregnant in Dec 2006 and gave birth in Sept 2007 to son Blake with cleft lip/palate.
- April sued Janssen (writ filed May 31, 2011) alleging negligent failure to warn prescribers of Topamax’s risk of oral birth defects; trial proceeded on the negligence/failure-to-warn claim.
- Jury returned verdict for plaintiff (guardian for Blake) awarding damages for pain and suffering and future medical costs; trial court denied Janssen’s post-trial JNOV/new-trial motion and entered judgment (with delay damages); Janssen appealed.
- Janssen raised preemption (impossibility and FDA would not have approved the proposed warning), Virginia causation standard (objecting to "substantial factor" language), learned-intermediary / prescriber-knowledge arguments, and statute-of-limitations issues for future minor medical costs.
- The trial court and Superior Court applied Pennsylvania procedural rules (including choice-of-law rules concluding Virginia law governs the negligence claim), but Pennsylvania substantive limitations/tolling rules controlled the statute-of-limitations question.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| 1. Federal preemption of state failure-to-warn claim | Janssen could have warned; brand-name manufacturer can be liable under state law (plaintiff contended no preemption). | Janssen: impossibility preemption (PLIVA/Mensing) and Wyeth-type argument that FDA would not have approved the proposed warning. | Preemption rejected: PLIVA inapplicable to brand-name; Janssen’s FDA-history evidence did not show clear proof FDA would have disapproved the specific cleft warning. |
| 2. Causation instruction — use of "substantial factor" under Virginia law | Charge correctly required proof by preponderance that Janssen’s negligence caused Blake’s cleft; definition clarified. | Janssen: Virginia rejects "substantial factor" language (Boomer) and court should have used factual-cause formulation. | No reversible error: charge, read as a whole, defined "substantial factor" as factual/but-for causation and required preponderance, so jury was properly guided. |
| 3. Prescriber knowledge and excluded impeachment evidence | Plaintiff relied on PA learned-intermediary doctrine and Basye’s testimony that an adequate warning would have changed her prescribing. | Janssen: Basye already knew risk (Cat. C) and would have prescribed anyway; excluded evidence (prescribing Paxil, refusal to refill after pregnancy) would show Basye’s knowledge. | Denial of JNOV upheld: Basye testified she would not have prescribed if warned; exclusion of Paxil/refill evidence was within trial court’s discretion and not prejudicial. |
| 4. Recovery of future medical costs for minor despite parents’ time-barred claim | Blake (through guardian) may recover future/pre-majority medical costs in his own right; public policy disfavors giving tortfeasor windfall when parents’ suit is time-barred. | Janssen: parents’ claim for pre-majority medical expenses is time-barred; minor cannot recover those same expenses when parents’ claim is barred. | Court held Pennsylvania law (tolling for minor) allows the minor an independent right to recover pre-majority medical expenses (parents’ separate claim was time-barred but did not bar Blake’s recovery). |
Key Cases Cited
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (preemption decision addressing generic manufacturers and "impossibility" defense)
- Wyeth v. Levine, 555 U.S. 555 (2009) (brand‑name manufacturer liability and federal preemption principles)
- Gurley v. Janssen Pharm., Inc., 113 A.3d 283 (Pa. Super. 2015) (Superior Court rejection of Janssen’s preemption and related arguments in similar Topamax litigation)
- Ford Motor Co. v. Boomer, 285 Va. 141 (Va. 2013) (Virginia Supreme Court disapproving unqualified "substantial contributing factor" causation language)
- E.D.B. ex rel. D.B. v. Clair, 605 Pa. 73 (Pa. 2009) (Supreme Court opinion addressing Medicaid reimbursement and casting doubt on the old common-law bar that minors cannot recover pre‑majority medical expenses)
- Braun v. Wal‑Mart Stores, Inc., 24 A.3d 875 (Pa. Super. 2011) (standards for reviewing JNOV and evidence inferences)
- ACE American Ins. Co. v. Underwriters at Lloyds and Cos., 939 A.2d 935 (Pa. Super. 2007) (standard of review for denial of a new trial)