Rule 702 Requires Field-Specific Expertise: A Treating Surgeon’s Product Use Cannot Supply Design/Manufacturing Causation; Georgia Negligent Manufacturing Needs More Than a Malfunction

Introduction

In Maryann Rudzinskas v. Retractable Technologies, Inc. (11th Cir. Aug. 28, 2026) (unpublished), the Eleventh Circuit affirmed (1) the exclusion of the plaintiff’s proposed expert testimony under Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., and (2) summary judgment for the manufacturer on Georgia-law negligence claims.

The plaintiff, a Georgia resident, alleged she suffered two needle-retention injuries when her husband administered injections using allegedly defective “VanishPoint” syringes manufactured by Retractable Technologies, Inc., a Texas corporation. The key litigation problems were evidentiary and causal: the allegedly injuring syringes were not available for inspection, the plaintiff had no evidence of similar incidents in other units, and her only proffered defect-causation expert was her treating surgeon (Dr. John Odom), whom she stipulated was not a manufacturing or design expert.

The appeal centered on two issues: (1) whether the district court abused its discretion by excluding Dr. Odom’s design/manufacturing opinions; and (2) whether, without admissible defect evidence, the plaintiff could reach a jury on negligent manufacturing and negligent failure-to-warn under Georgia law.

Summary of the Opinion

  • Expert exclusion affirmed: The Eleventh Circuit held the district court did not abuse its discretion in finding Dr. Odom unqualified to opine that the syringe needles separated “due to manufacturing issues and a defective product/design.” A physician’s clinical and surgical experience and product familiarity, without specialized design/manufacturing expertise, does not satisfy Rule 702’s qualification requirement for defect causation.
  • Summary judgment affirmed: Applying Celotex Corp. v. Catrett and Georgia negligence principles, the court held the plaintiff failed to create a triable issue that the syringes had a manufacturing defect when they left the manufacturer. Georgia law allows circumstantial proof and does not require production of the specific item, but the plaintiff offered only her assertion of malfunction—insufficient under Miller v. Ford Motor Co..
  • Failure-to-warn claim fails derivatively: Because the plaintiff could not show a defect or danger known or knowable to the manufacturer, she could not prove breach of a duty to warn under Chrysler Corp v. Batten.

Analysis

Precedents Cited

1) Expert admissibility, qualifications, and appellate deference

  • Daubert v. Merrell Dow Pharmaceuticals, Inc.
    The opinion situates Rule 702 within Daubert’s gatekeeping framework—district courts consider (i) expert qualifications, (ii) reliability of methodology, and (iii) helpfulness to the factfinder. The panel relied on Daubert primarily to emphasize the gatekeeping role and the threshold requirement that expertise match the subject matter.
  • City of Tuscaloosa v. Harcos Chems., Inc.
    Cited for the requirement that an expert be “qualified to testify competently regarding the matters he intends to address.” This is the central lens the court used to evaluate Dr. Odom: competence must align with the design/manufacturing questions at issue, not merely with clinical treatment of the plaintiff.
  • McCorvey v. Baxter Healthcare Corp.
    Used to allocate the burden: the party offering the expert must establish qualifications by a preponderance of the evidence. The court treated the plaintiff’s stipulation that Dr. Odom was not a manufacturing/design expert as fatal to that burden.
  • Gen. Elec. Co. v. Joiner
    Provides the standard of review and the high level of deference to exclusion decisions: reversal only if “manifestly erroneous.” This deference was outcome-determinative on appeal; the panel did not reweigh Dr. Odom’s experience, but assessed whether the district court’s qualification ruling fell within its permissible discretion.
  • United States v. Frazier
    Supports the proposition that experts may be qualified by knowledge, education, or experience, but that experience must still fit the opinion offered. The case underpins the idea that “experience” is not a universal passport; it must be experience in the relevant technical field.
  • Lebron v. Sec'y of Fla. Dep't of Child. & Fams.
    Cited for the rule that “expertise in one field does not qualify a witness to testify about others.” The panel analogized Dr. Odom to an expert who is credentialed in a domain (medicine) but seeks to testify to a different technical domain (product design/manufacturing causation).
  • United States v. Brown
    Used as an analogy: even a highly educated scientist with some contact with a subject may be unqualified to opine on a specialized question if his experience is limited or “isolated.” The panel used Brown to reinforce that “using” a product (or working with a subject occasionally) does not establish expertise in its design/manufacturing characteristics.

2) Summary judgment framework

  • Celotex Corp. v. Catrett
    Supplies the governing principle: summary judgment is required when the nonmovant fails to make a sufficient showing on an essential element on which it bears the burden at trial. Here, the missing element was proof of a manufacturing defect existing when the product left the manufacturer, and causation tied to that defect.

3) Georgia negligence and product-defect proof

  • R & R Insulation Servs., Inc. v. Royal Indem. Co.
    Cited for Georgia negligence elements (duty, breach, injury, causation) and later for the failure-to-warn duty framed as warning of “foreseeable dangers arising from the reasonable use for which the product is intended.” The panel used it to show that a warning duty presupposes an identifiable danger.
  • Sheats v. Kroger Co.
    Cited for the elements of negligent manufacturing and for the limits of circumstantial evidence where the injuring unit is unavailable and there is no proof of similar issues in comparable units. The opinion uses Sheats to illustrate that absence of the product is not necessarily fatal, but absence of corroborating defect evidence is.
  • Rose v. Figgie Int'l, Inc.
    Used to emphasize Georgia’s flexibility: plaintiffs need not produce the specific injury-causing item; a defect may be inferred from circumstantial evidence, especially when products are destroyed. The panel treated Rose as the plaintiff-friendly rule that still requires meaningful circumstantial support—e.g., evidence of other similar incidents in the same model line.
  • Skil Corp. v. Ludgsdin
    Cited for another route to circumstantial proof: expert manufacturing testimony establishing that the only reasonable explanation for the incident is a defect present when the product left the manufacturer. The exclusion of Dr. Odom’s defect opinions meant the plaintiff lacked this pathway.
  • Miller v. Ford Motor Co.
    Key limiting principle: “the mere failure” of a product is not evidence of an original defect because failure can occur for many reasons unrelated to manufacturing. The panel relied on Miller to reject the plaintiff’s attempt to reach a jury based on malfunction assertions alone.
  • Chrysler Corp v. Batten
    Cited for the proposition that a duty to warn arises when the manufacturer knows or reasonably should know of the danger arising from use of its product. The panel used Batten to conclude that, without defect evidence, the plaintiff could not show a known/knowable danger requiring a warning.

Legal Reasoning

1) Rule 702 “fit” at the qualification step: clinical experience ≠ manufacturing/design expertise

The court’s Rule 702 analysis turned on qualifications, not methodology. Even though Dr. Odom was a treating surgeon who used VanishPoint syringes in practice, the court drew a sharp line between: (a) clinical competence to treat an injury and recognize that a retained needle is harmful, and (b) technical competence to opine that the needle separation occurred “due to manufacturing issues and a defective product/design.”

The panel emphasized two practical points:

  1. Field mismatch: Under Lebron v. Sec'y of Fla. Dep't of Child. & Fams., expertise is not transferable simply because the witness is a professional; the opinion must be grounded in the relevant field (manufacturing/design engineering).
  2. “Common sense” is not specialized knowledge: The court rejected the idea that it is enough to say “a needle should not break off” and infer manufacturing defect. That inference is precisely what Rule 702 polices, because alternative causes—such as user error—are plausible and require specialized analysis to rule in or out.

Importantly, the standard of review (Gen. Elec. Co. v. Joiner) made the district court’s gatekeeping decision difficult to overturn: the question on appeal was not whether Dr. Odom could have been admitted, but whether excluding him was “manifestly erroneous.”

2) Georgia negligent manufacturing: permissive circumstantial proof, but not “malfunction-only” proof

On the merits, the panel applied Georgia law’s nuanced approach:

  • No strict requirement to produce the exact product (Rose v. Figgie Int'l, Inc.), recognizing real-world loss/destruction scenarios.
  • But a plaintiff must still present evidence from which a defect at manufacture can be inferred, such as (i) similar incidents in other units or (ii) expert testimony demonstrating defect as the only reasonable explanation (Skil Corp. v. Ludgsdin).
  • Mere failure is insufficient (Miller v. Ford Motor Co.). Here, with the allegedly injuring syringes missing, no evidence of similar needle-separation incidents, and no admissible expert defect opinion, the plaintiff could not show a defect existed when the product left the manufacturer (Sheats v. Kroger Co.).

This evidentiary gap triggered Celotex Corp. v. Catrett: without evidence on an essential element (defect-at-manufacture), summary judgment was required.

3) Failure-to-warn treated as derivative given the record and plaintiff’s concession

The panel affirmed summary judgment on negligent failure-to-warn because the plaintiff conceded the claim was derivative of the negligent manufacturing theory. Under Chrysler Corp v. Batten, a warning duty depends on a danger the manufacturer knew or should have known. Without evidence of a defect/danger tied to the product, the plaintiff could not establish breach of a duty to warn.

Impact

  • Heightened clarity on “product user” experts: The decision reinforces that physicians (even treating surgeons) will not automatically qualify to opine on medical device design/manufacturing defect causation simply because they use the device. Litigants should expect courts to require credentials or experience specifically tethered to engineering, manufacturing processes, design controls, failure analysis, or similar technical domains.
  • Georgia manufacturing-defect cases without the product remain viable—but only with robust circumstantial proof: The opinion underscores the practical minimum: evidence of similar failures in comparable units, or admissible expert testimony that eliminates other plausible causes.
  • Derivative warning theories can collapse early: Where failure-to-warn is pleaded as dependent on proving a defect/danger, the inability to prove defect can dispose of both claims at summary judgment.
  • Litigation conduct and preservation matters: Although not framed as spoliation, the inability to locate the allegedly injuring syringes—and the earlier production of different syringes—illustrates how product retention can be central to surviving dispositive motions in manufacturing-defect litigation.

Complex Concepts Simplified

Rule 702 / Daubert gatekeeping
Before an expert can testify, the judge must ensure the witness is (1) qualified in the relevant subject, (2) using reliable methods, and (3) offering testimony that helps the jury decide an issue. Here, the case turned on (1): the surgeon was not qualified to identify a manufacturing/design defect.
“Qualified” does not mean “highly credentialed” in general
A witness can be an expert in one area (medicine) but not another (manufacturing defect analysis). Courts require a match between the expert’s actual expertise and the specific opinion offered.
Summary judgment (Rule 56)
A case can be decided without trial if the nonmoving party lacks evidence on an essential element. Under Celotex Corp. v. Catrett, the plaintiff must point to evidence that could allow a reasonable jury to find for her on each required element.
Circumstantial evidence of defect (Georgia law)
Georgia allows plaintiffs to prove a defect without the exact product, but they must still present facts supporting an inference that the defect existed when the product left the manufacturer—such as a pattern of similar failures in the same model, or expert testimony that rules out other causes.
“Mere malfunction” rule
Under Miller v. Ford Motor Co., a product’s failure by itself does not prove it was defective at manufacture; many non-defect explanations may exist (misuse, handling, intervening events).
Failure-to-warn duty
Under Chrysler Corp v. Batten, a manufacturer must warn when it knows or should know of a danger from using its product. If the plaintiff cannot prove a danger/defect associated with the product, the warning claim typically fails.

Conclusion

The Eleventh Circuit’s decision affirms two practical rules with outsized effect in product-liability negligence cases applying Georgia law: (1) under Rule 702, a treating physician’s clinical experience and product familiarity do not, without more, qualify the physician to testify about product design/manufacturing defect causation; and (2) even though Georgia permits circumstantial proof and does not require production of the specific injury-causing unit, a plaintiff must offer evidence beyond an asserted malfunction to show a manufacturing defect existed when the product left the manufacturer. Without that defect showing, derivative failure-to-warn theories will also fail.