In Re: Risperdal Litigation, MA.J.L. v. Janssen
577 EDA 2015
| Pa. Super. Ct. | Nov 28, 2017Background
- Plaintiffs (multiple juvenile male plaintiffs, residents of Michigan when treated) sued Janssen/Johnson & Johnson in Philadelphia alleging Risperdal caused weight gain and gynecomastia.
- Plaintiffs filed claims derived from the In re Risperdal mass-tort master complaint asserting negligence, strict liability (design/failure to warn), fraud, breach of warranties, consumer-protection claims, punitive damages, and related claims.
- Defendants moved for summary judgment arguing Michigan law (the Michigan Product Liability Act, MPLA) governs and provides statutory immunity because Risperdal had FDA approval and labeling compliance.
- Plaintiffs argued Pennsylvania law should apply or, if Michigan law governs, the MPLA’s fraud exception and/or the off-label use of Risperdal by plaintiffs removes MPLA immunity.
- The trial court applied Michigan law, concluded the MPLA barred plaintiffs’ common-law claims, found the fraud exception inapplicable, and entered summary judgment for defendants; the Superior Court affirmed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does the MPLA bar product-liability claims where the drug had FDA approval? | MPLA immunity shouldn’t apply to these plaintiffs because Risperdal was prescribed "off-label" and not FDA-approved for their specific use. | MPLA immunity applies so long as the drug received any FDA approval and labeling complied with FDA standards. | Held: MPLA bars the claims; FDA approval for the drug generally triggers MPLA immunity regardless of the specific population. |
| Does "approved" in the MPLA require approval for the specific population using the drug? | Plaintiffs: approval must be population-specific; otherwise off-label administrations fall outside MPLA. | Defendants: statute requires only drug-level FDA approval; no population limitation. | Held: "Approved" refers to FDA approval of the drug generally; no population-specific requirement. |
| Does the MPLA fraud-on-the-FDA exception apply based on allegations defendants misrepresented data regarding gynecomastia? | Plaintiffs: evidence raises genuine issues whether defendants intentionally withheld/misrepresented information and whether accurate submission would have prevented approval. | Defendants: plaintiffs offer no proof FDA would not have approved (and FDA declined to withdraw pediatric approval); no federal finding of fraud. | Held: Fraud exception inapplicable—plaintiffs produced no evidence FDA would have denied or withdrawn initial 1993 approval; no genuine issue of material fact. |
| Is the MPLA fraud exception preempted by federal law (circuit split)? | Plaintiffs cited Desiano (2d Cir.) to argue exception not preempted. | Defendants cited Garcia (6th Cir.) and Lofton (5th Cir.) supporting preemption or rejectability of exception. | Held: Court did not decide preemption outcome; found resolution unnecessary because plaintiffs failed to meet the statutory showing that FDA would not have approved/retain approval. |
Key Cases Cited
- E.R. Linde Const. Corp. v. Goodwin, 68 A.3d 346 (Pa. Super. 2013) (summ. judgment standard and review)
- Taylor v. SmithKline Beecham Corp., 658 N.W.2d 127 (Mich. 2003) (MPLA provides an absolute defense for FDA‑approved drugs unless exceptions apply)
- Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004) (fraud-on-the-FDA exception preemption analysis)
- Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006) (contrasting view on preemption; fraud exception not preempted)
- Lofton v. McNeil Consumer & Specialty Pharm., 672 F.3d 372 (5th Cir. 2012) (rejects Desiano and aligns with Garcia on preemption)
- White v. SmithKline Beecham Corp., 538 F. Supp. 2d 1023 (W.D. Mich. 2008) (MPLA immunity covers off-label use when drug has FDA approval and compliant labeling)