Rowland v. Novartis Pharmaceuticals Corp.
9 F. Supp. 3d 553
W.D. Pa.2014Background
- Plaintiffs allege BRONJ from NPC's Zometa (IV bisphosphonate) used for metastatic bone cancer.
- MDL pretrial proceedings in this district involve Daubert motions to exclude expert causation and related opinions.
- Court reviews experts’ admissibility under Rule 702 and Daubert, aligning with numerous prior Zometa-MDL decisions.
- Key retained and treating-expert challenges include Marx, Vogel, Ray, Parisian, Skubitz, Najjar, Atallah, and others.
- Court differentiates case-specific causation opinions from treating physicians’ benign examination/testimony, and restricts certain regulatory and procedural opinions.
- Orders grant in part and deny in part NPC’s Daubert motions across Orr, Rowland, and Machen cases.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of Dr. Marx’s BRONJ causation and mechanism testimony | Marx’s experience warrants admission on BRONJ causation and mechanism. | Testimony relies on questionable trials and non-definitive data; unreliable. | Admissible on general causation, biological mechanism, and pre-Zometa dental-prevention opinions with limits. |
| Regulatory causation and FDA regulatory testimony by Dr. Parisian | Parisian should testify on FDA regulatory framework relevant to labeling/warnings. | Parisian cannot give regulatory-causation or legal-compliance conclusions. | Generally admissible for regulatory framework; exclusion of regulatory causation opinions. |
| Professor Wayne Ray’s meta-analysis and causation opinions | Ray’s meta-analysis and Bradford Hill analysis support causation. | Certain comparisons and incidence/risk interpretations are flawed or not allowed. | Permitted on several topics; barred on Zometa vs. Aredia risk and not-rare incidence characterization. |
| Testimony of case-specific, non-retained treating physicians | Treating physicians can testify causally based on treatment and examinations. | Lack of qualifications and reliance on patient history undermine reliability. | Treating-physician causation testimony excluded; allowed to testify about care and examinations only. |
| Pre-Zometa dental treatment measures and dosing regimens testimony by Dr. Vogel | Vogel’s opinions on dental screenings and alternative dosing are relevant to risk reduction. | Opinions are not sufficiently reliable or relevant to the case’s timeline. | Qualified to testify on pre-treatment dental screenings and incidence; limited on alternative dosing testimony as to relevance. |
Key Cases Cited
- Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (Supreme Court, 1993) (gatekeeping admissibility of scientific evidence)
- Paoli R.R. Yard PCB Litig., 35 F.3d 717 (3d Cir. 1994) (reliability is about principles and methodology, not conclusions)
- Kannankeril v. Terminix Int’l, Inc., 128 F.3d 802 (3d Cir. 1997) (liberal admissibility and gatekeeping framework for expert testimony)
- Heller v. Shaw Indus., Inc., 167 F.3d 146 (3d Cir. 1999) (treating physicians’ testimony and differential diagnosis considerations)
- Deutsch v. Novartis Pharm. Corp., 768 F. Supp. 2d 420 (E.D.N.Y. 2011) (admissibility of warnings/labels and regulatory causation considerations)
- Davids v. Novartis Pharm. Corp., 857 F. Supp. 2d 267 (E.D.N.Y. 2012) (case-specific causation and expert admissibility in Zometa MDL context)