Carlson v. Bioremedi Therapeutic Systems, Inc.
822 F.3d 194
| 5th Cir. | 2016Background
- David Carlson, a diabetic with peripheral neuropathy, received ProNeuroLight infrared treatment at Dr. Lance Durrett’s clinic and developed heel ulcers within 48 hours that were later diagnosed as burns, leading to infection and amputations.
- The Carlsons sued the device manufacturer and distributor on design-defect, manufacturing-defect (later withdrawn), and failure-to-warn theories.
- Defendants’ sole trial witness was Dr. Durrett, a chiropractor and alternative-medicine practitioner who had used similar devices but is not a medical doctor; he testified the device could not have caused burns and that the injuries looked like diabetic ulcers.
- The Carlsons moved pretrial to exclude Dr. Durrett’s medical testimony; the district court denied the motion without on-the-record Daubert findings and admitted his testimony in front of the jury.
- The jury returned a verdict for the defendants on design-defect and failure-to-warn; the Carlsons appealed only the admission of Dr. Durrett’s expert testimony.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Dr. Durrett’s medical testimony was expert opinion requiring Rule 702 screening | Durrett lacked medical qualifications to opine on wound care, podiatry, neurology, nephrology, diabetic medicine, or device causation | Testimony was either non-expert/lay or, if expert, sufficiently qualified by experience with device | Testimony was expert in nature and district court should have assessed under Rule 702; admitting without a Daubert inquiry was an abuse of discretion |
| Whether the objection to Durrett’s testimony was preserved for appeal | Pretrial motion to exclude plus two in-trial objections preserved the issue | Defendants implied lack of proper designation or procedural defect | Preserved: pretrial objection and trial objections sufficed under precedent (Mathis) |
| Whether the district court satisfied its Daubert gatekeeping duty without a formal hearing | Court may sometimes avoid formal hearing but must at least perform and record a Daubert inquiry and qualification findings | District court’s brief on-the-record statement left admissibility to jury, treating credentials as weight issue | Court failed to conduct any Daubert inquiry or make findings; that omission was reversible error |
| Whether the error was harmless | Durrett was the defense’s only witness and his opinions were emphasized in closing; other experts had testified for plaintiffs | Defendants argued other admissible evidence supported verdict | Error affected substantial rights and was not harmless; reversal and remand required |
Key Cases Cited
- Daubert v. Merrell Dow Pharm., 509 U.S. 579 (1993) (trial court’s gatekeeping role for scientific testimony)
- Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999) (Daubert gatekeeping applies to all expert testimony)
- Pipitone v. Biomatrix, 288 F.3d 239 (5th Cir. 2002) (preliminary assessment of methodology and application to facts)
- Smith v. Goodyear Tire & Rubber Co., 495 F.3d 224 (5th Cir. 2007) (Rule 702’s three-part reliability framework)
- Knight v. Kirby Inland Marine Inc., 482 F.3d 347 (5th Cir. 2007) (expert testimony must be reliable at each step)
- Mathis v. Exxon Corp., 302 F.3d 448 (5th Cir. 2002) (pretrial objection preserves evidentiary error under Rule 103)
- Bocanegra v. Vicmar Servs., Inc., 320 F.3d 581 (5th Cir. 2003) (abuse-of-discretion review for expert-admission rulings)
- Edmonds v. Ill. Cent. Gulf R.R., 910 F.2d 1284 (5th Cir. 1990) (non-physician excluded from medical causation testimony beyond expertise)
- Ueland v. United States, 291 F.3d 993 (7th Cir. 2002) (district court must conduct Daubert inquiry before admitting questionable medical testimony)