Tamanchia Moore v. Intuitive Surgical, Inc.
995 F.3d 839
| 11th Cir. | 2021Background
- Moore underwent a robotically-assisted laparoscopic hysterectomy using Intuitive Surgical’s da Vinci system and Endowrist Hotshears Monopolar Curved Scissors (MCS); post-op she suffered a thermal injury to her left ureter. Intuitive later recalled the MCS for potential microcracks that could leak electrosurgical energy.
- Moore sued Intuitive for defective design, failure to warn, and related claims; she retained Dr. Michael Hall (board‑certified OB/GYN, 40+ years, >4,000 hysterectomies) as her causation expert. Dr. Hall had not performed robotic hysterectomies but had observed them, taken preliminary training, and served on QA committees reviewing ureteral injuries.
- At a two‑day Daubert hearing, Intuitive argued Dr. Hall was unqualified because he had not used the specific robotic instruments; the district court excluded Dr. Hall’s causation testimony on qualifications grounds and entered summary judgment for Intuitive (Dr. Hall was Moore’s only causation expert).
- The district court focused on Dr. Hall’s inability to describe (to its satisfaction) differences in robotic vs. traditional instrumentation, port placement, or instrument trajectories; it did not rule on reliability.
- On appeal, the Eleventh Circuit reversed: it held the district court conflated qualifications with reliability, set the admissibility bar too high (requiring product use), and abused its discretion; the case was remanded for further proceedings and reassigned to a different judge.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Dr. Hall was qualified to testify on causation of the ureteral thermal injury | Dr. Hall’s decades of gynecologic surgery, QA review experience, and differential‑etiology work qualify him to opine on cause | Dr. Hall lacked necessary qualifications because he had not used the da Vinci/MCS and had not performed robotic hysterectomies | Reversed: Dr. Hall was qualified; experience performing and reviewing many hysterectomies sufficed for causation opinion |
| Whether an expert must have used the specific product to be qualified | No; Rule 702 allows qualification by experience, training, education—product use not required | Yes; product‑specific familiarity is critical for reliable causation opinions | Rejected: Court refused to adopt bright‑line rule requiring personal use of defendant’s product |
| Whether the district court properly applied an “exacting analysis” of foundations when assessing qualifications | The district court improperly conflated reliability with qualifications | The court’s inquiry into foundation and specifics (port placement, trajectory) was necessary to test qualification | Reversed: district court conflated distinct Daubert prongs and applied the wrong standard |
| Whether appellate court should decide reliability in the first instance | Reliability was not decided below and should be left to the district court | Intuitive asked appellate court to decide unreliability now | Court declined to address reliability; remanded for district court to assess reliability in first instance |
Key Cases Cited
- Daubert v. Merrell Dow Pharm., 509 U.S. 579 (1993) (establishes federal gatekeeping standard for expert admissibility)
- Gen. Elec. Co. v. Joiner, 522 U.S. 136 (1997) (abuse‑of‑discretion review of Daubert rulings)
- Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999) (Daubert applies to non‑scientific expert testimony)
- United States v. Frazier, 387 F.3d 1244 (11th Cir. 2004) (articulates Eleventh Circuit’s three‑part Daubert inquiry: qualification, reliability, helpfulness)
- Quiet Tech. DC‑8, Inc. v. Hurel‑Dubois UK Ltd., 326 F.3d 1333 (11th Cir. 2003) (distinguishes expert qualification from methodological reliability)
- Adams v. Lab. Corp. of Am., 760 F.3d 1322 (11th Cir. 2014) (rejects requirement that medical experts recreate conditions or be users of defendant’s product)
- Allison v. McGhan Med. Corp., 184 F.3d 1300 (11th Cir. 1999) (caution against setting Daubert admissibility bar too high)
- McCorvey v. Baxter Healthcare Corp., 298 F.3d 1253 (11th Cir. 2002) (proponent’s burden to show expert is qualified)