235 F. Supp. 3d 1244
N.D. Ala.2017Background
- Plaintiff Ernesteen Jones alleges Reclast (zoledronic acid) caused atypical femur fractures (AFFs) after three annual infusions (2009–2011); suit asserts AEMLD, failure-to-warn, negligence/wantonness, and breach of merchantability.
- Novartis moved to exclude five experts: retained regulatory expert Dr. Suzanne Parisian; retained scientific/medical experts Drs. William Hinshaw and Wayne Taylor; and two non-retained treating/consulting physicians Drs. James Worthen and Timothy Ricketts.
- The court applied Rule 702 and Daubert/Kumho/Joiner gatekeeping, using the Eleventh Circuit three-part test (qualification, reliability, helpfulness) and toxic-tort standards requiring both general and specific causation where medical consensus is lacking.
- The court reviewed briefing and depositions (no Daubert hearing) and limited/ excluded testimony based on expertise scope, methodology reliability, Rule 26 disclosures, and whether opinions would assist the jury.
- Rulings: Parisian admitted in part (regulatory matters, labeling, FDA communications) but excluded on causation, notice, state of mind, physician-response speculation, and ONJ/Zometa comparisons; Hinshaw and Taylor excluded in full for unreliable methodologies; Worthen and Ricketts excluded to the extent they offer causation opinions (otherwise allowed limited non-expert/treatment testimony).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of Dr. Suzanne Parisian (regulatory expert) | Parisian is qualified by FDA experience to opine on regulatory compliance, labeling, marketing, and what Novartis should have reported; she may explain FDA terms (including "causal association"). | Novartis argued she lacks medical/causation expertise, offers narrative/legal conclusions, and would improperly opine on notice, physician behavior, and intent. | Allowed: testimony on FDA regulatory process, Novartis–FDA communications (including 2008/2015 reports), and compliance with advertising/labeling rules; Excluded: any causation/"causal association" findings, notice as to causation (including Study 2202), impact on prescribing physicians, state of mind/intent, and ONJ/Zometa comparisons. |
| Admissibility of Dr. William Hinshaw (scientific/medical expert) | Hinshaw (chemist and gynecologist) says Bradford Hill and weight-of-evidence support general causation (class-wide BP→AFF) and he performed limited differential diagnosis for specific causation. | Novartis contends Bradford Hill was misapplied without an association for Reclast; improper extrapolation from class-wide studies; differential diagnosis undeveloped and disclosed late; methodology unreliable. | Excluded in full: court found Hinshaw qualified generally but his Bradford Hill and "weight of evidence" applications were unreliable (no reliable association for Reclast specifically; improper extrapolation; Rule 26 disclosure/differential-diagnosis defects), so both general and specific causation excluded. |
| Admissibility of Dr. Wayne Taylor (statistician) | Taylor used background-rate analysis and re-analysis of trial data to show Reclast rate exceeds expected AFF background, and criticized trial reporting/ power. | Novartis argues Taylor is not a medical/causation expert, misapplied statistics (cherry-picked Feldstein rate, improper reclassification of fractures, used one-tailed test, compared CI lower bound to a point estimate), and lacked review of trial case reports. | Excluded in full: court concluded Taylor lacks subject-matter qualification for causation, and his statistical methods were unreliable (flawed background-rate choice, improper re-analysis/classification of fractures, misuse of confidence-interval/testing methods, and failure to review primary case materials). |
| Admissibility of non-retained treating/consulting experts (Drs. Worthen & Ricketts) on causation | Plaintiff offers treating surgeons/physicians to testify from treatment observations that fractures were atypical and probably caused by Reclast. | Novartis argues the doctors lack relevant expertise on AFF causation, failed reliable differential diagnoses, lacked full records, and cannot establish general causation foundation. | Partially granted: testimony by Worthen and Ricketts is excluded to the extent they offer causation opinions (unqualified and unreliable differential diagnoses and no reliable general-causation foundation); they may testify to treatment/medical observations within their competence. |
Key Cases Cited
- Daubert v. Merrell Dow Pharm., 509 U.S. 579 (establishes trial-court gatekeeping for scientific expert evidence)
- Gen. Elec. Co. v. Joiner, 522 U.S. 136 (abuse-of-discretion review; courts may exclude expert evidence with analytical gaps)
- Kumho Tire Co. v. Carmichael, 526 U.S. 137 (Daubert gatekeeping applies to non-scientific expert testimony)
- McClain v. Metabolife Int'l, Inc., 401 F.3d 1233 (11th Cir.) (toxic-tort framework: need general and specific causation absent medical consensus)
- Hendrix ex rel. G.P. v. Evenflo Co., Inc., 609 F.3d 1183 (11th Cir.) (three-part Daubert test in Eleventh Circuit; differential-diagnosis guidance)
- Rider v. Sandoz Pharm. Corp., 295 F.3d 1194 (11th Cir.) (cannot extrapolate class effects to a specific drug without scientific fit)
- Allison v. McGhan Med. Corp., 184 F.3d 1300 (11th Cir.) (proponent bears burden to establish expert admissibility)
- United States v. Frazier, 387 F.3d 1244 (11th Cir.) (district court must perform exacting analysis of expert foundations)