William Bock v. Novartis Pharmaceuticals Corp
661 F. App'x 227
| 3rd Cir. | 2016Background
- Aredia and Zometa are IV bisphosphonates used to treat hypercalcemia of malignancy and to protect bones in cancer patients; studies in 2003–2004 reported a possible link between bisphosphonates and osteonecrosis of the jaw (ONJ).
- Novartis amended package inserts in 2003–2005 and sent "Dear Doctor" letters warning that ONJ had been reported, advising dental exams and avoidance of invasive dental procedures if possible.
- William Bock (decedent) received bisphosphonate therapy for myeloma; treating physicians (Drs. Islam and Agha) testified they were aware of ONJ risk in 2005, discussed it with Bock, and would still prescribe the drugs because benefits outweigh risks.
- Bock underwent dental extractions (one performed without informing his physician) and later developed ONJ; oral surgeon Dr. Kail opined the bisphosphonate therapy was a component in causing the ONJ.
- Bock’s estate sued Novartis alleging negligent failure to warn (among other claims later dismissed); the district court granted summary judgment for Novartis on the failure-to-warn claim for lack of proximate causation, and the Third Circuit affirmed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Novartis’s warnings were inadequate such that it proximately caused Bock’s ONJ | Bock’s estate: warnings lacked detail on degree/frequency/duration of risk; expert proof could show doctors would have acted differently if adequately warned | Novartis: inserts and "Dear Doctor" letters informed physicians; treating doctors testified they knew risk and would still prescribe or manage similarly | Affirmed: plaintiff failed to show proximate causation; record shows doctors were aware and would not have changed treatment |
| Whether a plaintiff can avoid summary judgment before expert testimony on what additional warnings would have changed | Estate: absence of expert discovery prevents knowing what physicians would have done with different information | Novartis: speculation unsupported by record cannot defeat summary judgment; non-moving party must point to record facts | Affirmed: speculative future expert opinions insufficient; "put up or shut up" standard applies |
Key Cases Cited
- Maya v. Johnson & Johnson, 97 A.3d 1203 (Pa. Super. Ct. 2014) (elements and proximate-cause framework for failure-to-warn claims)
- Cochran v. Wyeth, 3 A.3d 673 (Pa. Super. Ct. 2010) (learned intermediary doctrine explained)
- Celotex Corp. v. Catrett, 477 U.S. 317 (1986) (summary judgment burden-shifting principles)
- Anderson v. Liberty Lobby, 477 U.S. 242 (1986) (standard for genuine dispute of material fact)
- Leibowitz v. Ortho Pharm. Corp., 307 A.2d 449 (Pa. Super. Ct. 1973) (post-sale revelation does not automatically render prior warnings inadequate)
- Wiest v. Tyco Elecs. Corp., 812 F.3d 319 (3d Cir. 2016) (nonmoving party must rebut summary judgment with record facts; no mere speculation)