333 F. Supp. 3d 111
N.D.N.Y.2018Background
- Plaintiff Shaquil Byrd sued Janssen Pharmaceuticals and Johnson & Johnson claiming Risperdal caused gynecomastia and that defendants failed to warn; jury returned verdict for Plaintiff on failure-to-warn and awarded $1,000,000 for pain and suffering.
- Defendants moved under Fed. R. Civ. P. 50(b) for judgment as a matter of law, or alternatively for a new trial under Rule 59, arguing (inter alia) federal preemption, insufficient causation proof, and attorney misconduct.
- Central factual time frame: Plaintiff took Risperdal from ~2002–2006; dispute focused on whether gynecomastia was a "serious" adverse event under the then-applicable FDA regulations and whether defendants could have unilaterally added a warning via the CBE process.
- At trial, Plaintiff offered regulatory and medical experts to show Risperdal causes gynecomastia and that different warnings would have changed prescribing; defendants countered with regulatory testimony and literature challenging causation and regulatory permissibility.
- The court concluded (1) Defendants showed "clear evidence" FDA would not have approved the proposed labeling change because gynecomastia was not a regulatory "serious" adverse event during the period at issue and sponsors/investigators and Plaintiff’s own regulatory expert acknowledged that; (2) Plaintiff failed to prove general and specific causation—experts either disclaimed causation expertise or relied on association/weak studies; and (3) Plaintiff’s counsel engaged in repeated misconduct before the jury, warranting a new trial at minimum.
- Court granted Defendants’ motion, vacated the jury verdict and judgment for Plaintiff, and entered judgment for Defendants.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Preemption: Could Janssen have unilaterally added a pediatric gynecomastia warning (CBE) or is state failure-to-warn preempted? | Byrd: Regulations and some state courts allow adding safety info; gynecomastia was newly known and serious, so a CBE was permissible. | Janssen: 21 C.F.R. structure and agency practice required FDA control for off‑label safety info; clear evidence FDA would not have approved such a change because gynecomastia was not a "serious" event then. | Held for Defs.: Preempted. Court found clear and convincing evidence FDA would have rejected the labeling change because gynecomastia was not a regulatory "serious" adverse event in the relevant period. |
| Causation (general and specific): Did Plaintiff prove Risperdal can cause gynecomastia and that it caused Byrd’s condition? | Byrd: Experts testified Risperdal can cause gynecomastia and Dx expert performed differential diagnosis linking drug to Byrd. | Janssen: Plaintiff's regulatory expert disclaimed causation expertise; cited literature shows association not causation, studies lacked controls; treating experts would have prescribed regardless. | Held for Defs.: Insufficient proof of general causation (experts relied on association/unreliable data) and specific causation; judgment granted on alternative ground. |
| Altered-prescribing causation (physician reliance): Would alternative warnings have changed prescribing/consent? | Byrd: Treating physicians and mother would have acted differently if frequency risk disclosed. | Janssen: Testimony showed some prescribers would have prescribed anyway; no evidence alternative label would have changed decisions of non-testifying prescribers. | Held for Defs.: Plaintiff failed to show an alternative warning would have altered prescribing for the relevant physicians as a matter of law. |
| Attorney misconduct: Did counsel’s in-court conduct unfairly prejudice Defendants and warrant a new trial? | Byrd: Conduct was zealously advocacy; objections and one curative instruction cured any harm; juror affidavit supports verdict based on evidence. | Janssen: Repeated personal appeals, vouching, and improper testimony before jury repeatedly prejudiced defendants and influenced verdict. | Held for Defs.: Misconduct was prejudicial; even absent other grounds a new trial would be warranted. Court also excluded juror affidavit under Fed. R. Evid. 606(b). |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (2009) (establishes demanding standard for impossibility preemption in failure-to-warn drug claims)
- Pliva, Inc. v. Mensing, 564 U.S. 604 (2011) (preemption analysis for labeling and communications to physicians)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001) (state-law fraud-on-the-FDA claims conflict with federal regulatory scheme)
- Gen. Elec. Co. v. Joiner, 522 U.S. 136 (1997) (expert opinion must be grounded in and connected to reliable data; courts may exclude opinions with analytical gaps)
- In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., 852 F.3d 268 (3d Cir. 2017) (clarifies "clear evidence" means clear and convincing proof that FDA would have rejected label change)
- Kirsch v. Fleet Street, Ltd., 148 F.3d 149 (2d Cir. 1998) (Rule 50(b) judgment n.o.v. limited unless required to prevent manifest injustice)