287 F.R.D. 357
D. Maryland2012Background
- Aredia and Zometa are FDA-approved drugs sold by Novartis; court previously granted punitive damages preclusion.
- Plaintiff Phyllis Newman pursued strict liability and negligence claims in Maryland-related litigation arising from ONJ after using Aredia/Zometa for cancer treatment.
- Case posture moved from MDL proceedings to this court; remanded for trial with pending summary-judgment motions.
- Newman died in 2007; Stacy Zimmerman, as personal representative, continued the action against Novartis in 2007 in the Middle District of Tennessee before transfer/remand.
- Plaintiff abandoned the “drug holiday” causation theory and advanced two new proximate-causation theories regarding prior extraction and physician knowledge.
- Court grants Novartis’s renewed motion for summary judgment on proximate causation, citing lack of evidence that warnings would have altered Ms. Newman’s treatment and that tooth #16’s extraction was medically required regardless of warnings.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Proximate causation for failure to warn in drug-induced ONJ | Plaintiff argues warnings could have changed dental decisions pre- or post-ONJ onset | Warning would not have prevented extraction decisions; causation cannot be shown | Proximate causation not proven; summary judgment for Novartis granted |
| Post-hearing affidavits and discovery requests compatibility with summary judgment | New expert affidavit creates genuine dispute; discovery needed | Affidavit contradicts deposition and is insufficient; discovery not warranted | Sham affidavit doctrine applied; additional discovery denied |
| Rule 56(d) discovery standards applicability | Rule 56(d) permit discovery to obtain necessary facts | Discovery sought was untimely; available earlier; not showable as needed | Rule 56(d) motion denied; no need for further discovery |
Key Cases Cited
- Celotex Corp. v. Catrett, 477 U.S. 317 (1986) (summary judgment standard; burden shifting)
- Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (1986) (material facts must be viewed in the light most favorable to the nonmoving party)
- Ames v. Apothecon, Inc., 431 F.Supp.2d 566 (D.Md.2006) (causation in failure-to-warn cases)
- Beale v. Hardy, 769 F.2d 213 (4th Cir.1985) (genuine issue of material fact standard)
- Bouchat v. Baltimore Ravens Football Club, Inc., 346 F.3d 514 (4th Cir.2003) (summary judgment burden on opposing party)