*1 Before GREGORY, Chief Judge, AGEE, and DIAZ, Circuit Judges.
Reversed and remanded with instructions by published opinion. Judge Agee wrote the opinion, in which Chief Judge Gregory and Judge Diaz joined.
ARGUED: Sarah Virginia Bondurant Price, MCGUIREWOODS LLP, Richmond, Virginia, for Appellant. L. Steven Emmert, SYKES, BOURDON, AHERN & LEVY, PC, Virginia Beach, Virginia, for Appellee. ON BRIEF: Michael W. Stark, MCGUIREWOODS LLP, Richmond, Virginia; Martin A. Conn, Matthew J. Hundley, Lisa M. McMurdo, MORAN REEVES & CONN PC, Richmond, Virginia, for Appellant. Peter C. Grenier, GRENIER LAW GROUP PLLC, Washington, D.C.; Andrew G. Slutkin, Ethan Nochumowitz, SILVERMAN THOMPSON SLUTKIN & WHITE, Baltimore, Maryland, for Appellee. Robert L. Wise, Jason R. Hodge, Richmond, Virginia, Susan E. Burnett, BOWMAN AND BROOKE LLP, Austin, Texas, for Amicus Curiae.
AGEE, Circuit Judge:
Federal Rule of Evidence 702 appoints trial judges as “gatekeepers of expert
testimony” to protect the judicial process from “the potential pitfalls of junk science.”
United States v. Bonner
,
Appellee Andrea Sardis, in her capacity as the Administrator of the Estate of her late husband, Evangelos Sardis (“the Estate”), asserted various products liability claims against Appellant Overhead Door Corporation (“ODC”) relating to Mr. Sardis’ tragic death in a work-related accident in June 2016. But the only probative evidence supporting the Estate’s claims came from two expert witnesses, neither of whom offered relevant or reliable opinions. Nonetheless, the district court permitted the jurors to hear their testimony, finding that cross-examination was the proper, and only, tool to vet any relevance or reliability factors. On the basis of that testimony, the jury awarded the Estate a multi-million-dollar verdict.
That verdict is the result of the district court’s abuse of discretion in admitting the Estate’s expert testimony. Without it, the Estate offered insufficient admissible evidence as a matter of law to prevail on any of the four claims submitted to the jury. We therefore reverse the judgment in this case, and remand with instructions that judgment be entered in favor of ODC as to each of the Estate’s claims.
I.
A. ODC designs and manufactures garage doors and the metal hoods those doors are installed in, and then sells these products through a network of independent distributors. ODC also designs and manufactures the packaging used for shipping these products. The packaging––not the garage doors or hoods––is the focus of this case.
For thirty years, until 2014, ODC shipped its garage door hoods in rectangular prism-shaped containers. The entire container was made of a double-wall corrugated material, and the two “ends” of the container (the two square ends to which all four of the rectangular “sides” connected) contained handhold “punchouts” in the material. ODC intended for workers to use, and workers in fact used, these handholds to push and pull the containers as necessary for storage and transit. ODC never received a report of a worker ripping a handhold, but it did receive complaints that the corrugated material would collapse during transit, damaging the hoods inside.
In response to these complaints, ODC redesigned its garage door hood containers in December 2014. It kept the same rectangular prism shape, but made two important modifications. First, it replaced the double-wall corrugated material on the sides with triple-wall corrugated material. Second, it replaced the double-wall corrugated material on the ends with wood slats. Staples connected each of the four triple-wall corrugated sides to two vertical pieces of wood on either “end.” The square “ends” were comprised of several horizontal pieces of wood that were nailed into the two vertical wood slats. ODC incorporated the “handhold” design from its old container design by omitting one horizontal wood piece on each end. A photograph of an exemplar container, J.A. 1243, is reproduced below.
Prior to using this new container design for shipping its goods, ODC performed some field testing. According to Bradley Knable, ODC’s corporate designee, the testing included workers pushing and pulling the containers using those handholds, although there was no specific test of the maximum strength of the new handholds. The new design overall performed to ODC’s satisfaction. ODC then shipped garage door hoods in these new containers to select customers. ODC asked for feedback on the containers, and received no complaints about the new container or its handholds.
B.
Mr. Sardis began working for Washington Overhead Door, Inc. (“WOD”), an ODC distributor, in June 2016. On June 6, 2016, he and his training supervisor, Keith Lawrence, were asked to transport an ODC garage door hood to a work site. The hood was shipped in a post-2014 ODC container (hereinafter “the Container”), which was loaded onto a ladder rack in the bed of a WOD service truck that Lawrence operated. At the work site, Lawrence tried to remove the Container from the truck with a forklift, but the Container became unbalanced on the forklift’s tines, making it unsafe to unload. Mr. Sardis then climbed onto the ladder rack and tried to adjust the Container on the forklift tines by pulling on one of its handholds. Lawrence recalled seeing Mr. Sardis standing in a “C position,” in which his hands were directly over his feet, and his body was curved in a “C”-shape. J.A. 665–66. When Mr. Sardis pulled, the wood slat constituting the handhold broke off, causing him to fall off the ladder rack and hit his head on the pavement nine feet below. He succumbed to his injuries two weeks later. The Container was photographed immediately after the accident, but it was not preserved, to the fault of neither party. Thus, neither party could test or otherwise examine the Container involved in Mr. Sardis’ accident. [1]
C.
After Mr. Sardis’ death, the Estate sued ODC in federal court, invoking the district court’s diversity jurisdiction. [2] The Estate asserted four causes of action under Virginia products liability law: (1) a general negligence claim; (2) a design defect claim; (3) a breach of implied warranty claim; and (4) a failure to warn claim. [3] Essentially, the Estate alleged that ODC was negligent in designing the Container’s handholds, and that this defective design caused Mr. Sardis’ injuries. Alternatively, the Estate alleged that ODC had a duty to warn foreseeable users of the Container to not rely on the handholds for pulling it, and that had Mr. Sardis been warned, he would not have been injured. The Estate offered Sher Paul Singh, Ph.D., as its sole expert for the design defect claim; and Michael S. Wogalter, Ph.D., as the sole expert for the failure to warn claim.
Dr. Singh, a packaging design engineer, opined that the Container should have been designed according to what he claimed was the relevant industry standard, American Society of Testing and Materials Standard #D6039 (“ASTM D6039”). He opined that the Container failed to satisfy this standard in two ways: (1) the handholds should not have been included in the design; and (2) the Container should have been designed with end “cleats,” or pieces of lumber or plywood vertically nailed onto the wood end pieces on the outside of the Container. Dr. Singh also testified that ODC breached industry standards by failing to test the Container prior to placing it in the stream of commerce. Finally, without performing any testing or citing to any published literature, he opined that these failures proximately caused Mr. Sardis’ death.
The Estate also offered the expert testimony of Dr. Wogalter for its failure to warn claim. Dr. Wogalter described himself as an expert on “human factors,” which he said was “a discipline of study that deals with the design of products and systems based on people’s abilities and limitations to promote productivity, satisfaction, and safety.” J.A. 96, 555. He offered three opinions: (1) ODC should have done a “hazard analysis” (which entails, inter alia , field and laboratory testing and soliciting feedback from consumers) to ascertain if its new handhold design created new dangers that would require warnings; (2) the lack of warnings about the hazards of pulling on the wooden handholds made it unreasonably dangerous; and (3) ODC’s failure to perform a hazard analysis and to warn consumers not to pull on the Container’s handholds proximately caused Mr. Sardis’ death.
Before trial, ODC filed a motion in limine to exclude both experts’ testimony as
irrelevant and unreliable.
See Daubert v. Merrell Dow Pharms.
,
D.
After the jury rendered a $4.84 million verdict in the Estate’s favor on all four claims for relief, ODC filed a renewed motion for judgment as a matter of law under Federal Rule of Civil Procedure 50(b). ODC reasserted that both Drs. Singh and Wogalter provided irrelevant and unreliable opinions, and that the district court should have stricken their testimony at trial. In ODC’s view, with or without their testimony, the Estate could not prevail on its claims as a matter of law.
Beginning with Dr. Singh and the Estate’s design defect claim, the district court rejected ODC’s renewed Daubert challenges to Dr. Singh’s testimony as only “‘affect[ing] the weight of the evidence,’ not its admissibility.” J.A. 1179 (citation omitted); J.A. 1182. On the merits of the design defect claim, the court concluded that Dr. Singh provided sufficient testimony to show that ASTM D6039 was the applicable industry standard for the Container’s design, and that “the [C]ontainer fell short of that standard’s specifications.” J.A. 1181. It further found that despite “some flaws” in Dr. Singh’s proximate causation opinion, his testimony “gave the jury sufficient evidence to conclude that the container’s defective design proximately caused [Mr.] Sardis’ death.” J.A. 1182.
ODC also argued that Dr. Wogalter’s testimony was inadmissible under because his opinions all relied on the irrelevant point that ODC should have known of the dangers that its handhold design posed. According to ODC, in order to prevail on a failure to warn claim, Virginia law required ODC to have reason to know of the dangers, but Dr. Wogalter provided no such testimony addressing that standard.
The district court made no explicit findings as to Dr. Wogalter, concluding only that there was sufficient evidence to support the jury’s failure to warn verdict. Citing Mr. Knable’s testimony that ODC did not “ever consider the potential dangers that its packaging or crates can pose to others,” and Dr. Wogalter’s testimony that ODC had to “solicit feedback” from users of the Container about the handhold’s dangers, the court found that a reasonable jury could conclude that ODC “violated its ‘general duty to make reasonable inferences from relevant and reasonably available facts.’” J.A. 1185 (citation omitted). This testimony, the court explained, sufficiently supported the finding that ODC “had a ‘reason to know’ of the [C]ontainer’s dangers.” J.A. 1185–86. The court did not, however, address the issue of proximate causation.
ODC lastly challenged the sufficiency of the evidence supporting the jury’s verdicts on the other two claims for relief, the general negligence claim and the breach of the implied warranty of merchantability claim. The district court rejected both arguments, however, deeming the evidence sufficient to support both verdicts. ODC thereafter timely filed a notice of appeal, and we have jurisdiction pursuant to 28 U.S.C. § 1291.
II.
Rule 50(b) permits a party to bring a renewed motion for judgment as a matter of
law after the jury has rendered its verdict. If that motion is denied, the moving party is
entitled to assert those same arguments on appeal, Fed. R. Civ. P. 50(e), and our subsequent
review is de novo,
Sloas v. CSX Transp., Inc.
,
III.
On appeal, ODC asserts that the district court reversibly erred in admitting the expert testimony of Drs. Singh and Wogalter under Federal Rule of Evidence 702. It argues that the district court first erred by delegating the determination of expert witness relevance and reliability to the jury without performing any Daubert analysis. On the merits, ODC contends that both experts’ opinions were irrelevant because Dr. Singh offered no relevant industry standard, and Dr. Wogalter’s testimony was incompatible with Virginia’s failure to warn jurisprudence. Further, ODC posits that both experts’ failure to test or otherwise authenticate their proximate causation opinions rendered them unreliable. Since the experts’ testimony was inadmissible, according to ODC, the Estate cannot establish any design defect or reason for ODC to have known of the Container’s alleged dangers.
The Estate counters that the district court properly allowed the jury to consider ODC’s challenges to Drs. Singh’s and Wogalter’s testimony. And even if those experts’ testimony was inadmissible, the Estate maintains that the other admissible evidence at trial sufficiently supported the jury’s verdict on each claim for relief.
We agree with ODC. The district court erred at the motion in limine stage when it improperly abdicated its critical gatekeeping role to the jury and admitted Drs. Singh’s and Wogalter’s expert testimony without engaging in the required Rule 702 analysis. That error was harmful. Had the district court faithfully executed its Daubert responsibilities before or after the jury’s verdict, our precedent would have compelled it to exclude both experts’ testimony. And without that expert testimony, the Estate failed to meet its evidentiary burden on each cause of action submitted to the jury.
A.
Before addressing the merits of the arguments on appeal, it is helpful to provide an overview of Virginia products liability law.
“Virginia has not adopted a strict liability regime for products liability.”
Evans v.
Nacco Materials Handling Grp., Inc.
,
To prevail on a design defect claim, a plaintiff must show that the manufacturer
“owes a legally recognized duty to design” a product in a certain way to ensure that the
product “is reasonably safe for the purpose for which it is intended.”
Holiday Motor Corp.
v. Walters
,
If a plaintiff successfully establishes a duty to construct a product in a particular
manner, the manufacturer breaches that duty if the product does not conform to that
standard.
Holiday Motor
,
Distinctly, failure to warn claims recognize that “[a] product may . . . suffer from no design defect, but nevertheless require a warning to consumers about a hidden danger.” Evans , 810 S.E.2d at 472. To prevail on such a claim, a plaintiff must prove that the manufacturer:
(a) knows or has reason to know that the [product] is or is likely to be dangerous for the use for which it is supplied, and (b) has no reason to believe that those for whose use the [product] is supplied will realize its dangerous condition, and (c) fails to exercise reasonable care to inform them of its dangerous condition or of the facts which make it likely to be dangerous.
Funkhouser v. Ford Motor Co.
,
B.
We begin with ODC’s argument that the district court abused its discretion in
admitting Drs. Singh’s and Wogalter’s expert testimony. We review a district court’s
decision to admit expert testimony for an abuse of discretion.
McKiver v. Murphy-Brown,
LLC
,
Rule 702 permits expert testimony if that testimony is (1) helpful to the jury in
understanding the evidence or determining a fact at issue, (2) “based on sufficient facts or
data,” (3) “the product of reliable principles and methods,” and (4) the product of a
“reliabl[e] appli[cation] of th[ose] principles and methods to the facts of the case.” Rule
702 thus “imposes a special gatekeeping obligation on the trial judge” to “ensur[e] that an
expert’s testimony both rests on a
reliable
foundation and is
relevant
to the task at hand.”
Nease
,
An expert’s opinion is relevant if it has “a valid scientific connection to the pertinent
inquiry.”
Belville v. Ford Motor Co.
,
But even if relevant, an opinion must also be sufficiently reliable. Reliability is a
“flexible” inquiry that focuses on “the principles and methodology” employed by the
expert.
Daubert
, 509 U.S. at 594–95. Specifically, district courts must ensure that an
expert’s opinion is “based on scientific, technical, or other specialized
knowledge
and not
on belief or speculation.”
Oglesby v. Gen. Motors Corp.
,
Daubert
provides four, non-exhaustive “guideposts” to aid in the required reliability
analysis: (1) whether the expert’s theory or technique “can be (and has been) tested”; (2)
“whether the theory or technique has been subjected to peer review and publication”; (3)
“the known or potential rate of error” inherent in the expert’s theory or technique; and (4)
whether the expert’s methodology is generally accepted in his field of expertise.
Nease
,
As we explain below, the district court abused its discretion initially when it failed to perform any Daubert analysis and ruled that the issues of relevance and reliability impacted only the weight of the experts’ testimony, not their admissibility. That error was harmful for two independent reasons. First, without Drs. Singh’s and Wogalter’s testimony, the Estate could not have prevailed on any of its claims as a matter of law. And second, assuming that the court had considered the merits of ODC’s Daubert challenges in ruling on ODC’s post-trial Rule 50(b) motion, it abused its discretion in refusing to strike Drs. Singh’s and Wogalter’s testimony for both offered irrelevant and unreliable opinions.
1.
a. We begin with ODC’s argument that the district court failed to perform its gatekeeping function as to both experts.
After the Supreme Court’s seminal decisions in
Daubert
and
Kumho Tire
, Rule 702
was amended specifically to “affirm[] the trial court’s role as gatekeeper.” Fed. R. Evid.
702 advisory committee’s note to 2000 amendments. So when a party challenges an
opposing expert’s testimony as irrelevant, the court must satisfy itself that the proffered
testimony is relevant to the issue at hand, for that is “a
precondition
to admissibility.”
, 509 U.S. at 592 (emphasis added). And if that expert’s proffered evidence is
further alleged to be unreliable, then “the trial judge must determine whether the testimony
has ‘a reliable basis in the knowledge and experience of the relevant discipline.’”
Kumho
Tire
,
The district court’s ruling on ODC’s motion in limine cursorily dismissed each of ODC’s reliability and relevance arguments as only going to weight, not admissibility. Although the court recognized “ legitimate concerns ” with Dr. Wogalter’s proffered testimony, it nonetheless deemed those concerns solely a subject for cross-examination. J.A. 287–88 (emphasis added). Despite ODC’s request, the district court failed to undertake any analysis. Just as in Nease , “[t]he court did not use Daubert ’s guideposts or any other factors to assess the reliability of [Drs. Singh’s and Wogalter’s] testimony, and the court did not make any reliability findings.” 848 F.3d at 230. Instead, it reflexively “[found] that [ODC]’s arguments go to the weight the jury should afford [Dr. Singh’s] testimony, not its admissibility.” Id. at 230–31 (first alteration in original). By doing so, the court “abandoned its gatekeeping function,” thereby abusing its discretion. Id. at 230.
The court similarly erred in ruling on ODC’s post-trial Rule 50(b) motion. As to Dr.
Singh, the district court doubled down, again finding that ODC’s challenges went to the
weight of the testimony, not admissibility. It pointed out that ODC “vigorously cross-
examined Dr. Singh” on his failure to test his theories, but “the jury apparently found Dr.
Singh’s opinions credible.” J.A. 1180, 1182. But credibility is entirely distinct from
reliability and relevancy, which are
preconditions
to the admissibility of expert testimony.
Nease
,
At oral argument, the Estate posited that to the extent the district court did not make
explicit its relevance and reliability findings, those were implicit in the ultimate ruling that
both experts could testify. That is plainly insufficient. Where the admissibility of expert
testimony is specifically questioned, Rule 702 and require that the district court
make explicit findings, whether by written opinion or orally on the record, as to the
challenged preconditions to admissibility.
United States v. Ruvalcaba-Garcia
, 923 F.3d
1183, 1190 (9th Cir. 2019) (“[T]he district court’s ruling at most suggests an implicit
finding of reliability, which is not sufficient. To satisfy its gatekeeping duty under
Daubert
,
the court must make an explicit reliability finding.” (citations and internal quotation marks
omitted));
Carlson v. Bioremedi Therapeutic Sys., Inc.
,
The district court did none of this, despite voicing its concerns with both experts
during trial.
See, e.g.
, J.A. 501, 504 (pointing out that Dr. Singh’s reliance on ASTM D6039
might be “comparing apples and oranges,” but nonetheless deciding to “leave [the parties]
to fight that out” in front of the jury); J.A. 573–74 (demanding that Dr. Wogalter provide
“more detail” into the hazard analysis process “so that we can figure out whether there is a
likelihood of good results,” but then discovering that there is no “existing literature” on the
subject, and no analogous example of a hazard analysis performed on a similar container).
Without the explicit findings required under , “it is impossible on appeal to
determine whether the district court carefully and meticulously reviewed the proffered
evidence or simply made an off-the-cuff decision to admit the expert testimony.”
Smith v.
Jenkins
,
We conclude with one final observation. Our insistence on district courts’ compliance with Rule 702’s plain gatekeeping requirement stems not from an arbitrary adherence to a procedural formality. Rather, because Rule 702 grants experts “wide latitude to offer opinions, including those that are not based on firsthand knowledge or observation,” “[e]xpert evidence can be both powerful and quite misleading.” , 509 U.S. at 592, 595 (citations and internal quotation marks omitted). As such, “the importance of [the] gatekeeping function cannot be overstated.” United States v. Barton , 909 F.3d 1323, 1331 (11th Cir. 2018) (citation and internal quotation marks omitted).
That much is confirmed by the Advisory Committee on Evidence Rules’ current proposal to amend Rule 702. On April 30, 2021, the Committee unanimously approved a proposal to amend Rule 702, part of which is motivated by its observation that in “a number of federal cases . . . judges did not apply the preponderance standard of admissibility to [Rule 702’s] requirements of sufficiency of basis and reliable application of principles and methods, instead holding that such issues were ones of weight for the jury.” Advisory Comm. on Evidence Rules, Agenda for Committee Meeting 17 (Apr. 30, 2021) [saved as ECF opinion attachment]. In order to address this “pervasive problem,” id. at 18, both of the current draft amendments to Rule 702 would contain the following language in the advisory committee’s notes:
[U]nfortunately many courts have held that the critical questions of the sufficiency of an expert’s basis [for his testimony], and the application of the expert’s methodology, are generally questions of weight and not admissibility. These rulings are an incorrect application of Rules 702 and 104(a) and are rejected by this amendment.
Id. at 105, 107. That clearly echoes the existing law on the issue. See, e.g. , Daubert , 509 U.S. at 589 (“[U]nder the Rules the trial judge must ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable.”); Kumho Tire , 526 U.S. at 147 (extending to “all expert testimony”); Fed. R. Evid. 702 advisory committee’s note to 2000 amendments (“The trial court’s gatekeeping function applies to testimony by any expert.”). Consistent with that existing law––and in accordance with the Committee’s pending rule––we confirm once again the indispensable nature of district courts’ Rule 702 gatekeeping function in all cases in which expert testimony is challenged on relevance and/or reliability grounds.
b.
As with any evidentiary error, we review a district court’s abdication of its
gatekeeping role for harmless error and require a new trial “only when the admission of
evidence affected the substantial rights of a party.”
Wickersham v. Ford Motor Co.
, 997
F.3d 526, 531 (4th Cir. 2021). That is, if we can say “with fair assurance, after pondering
all that happened without stripping the erroneous action from the whole, that the judgment
was not substantially swayed by the error,” then we must affirm.
Taylor v. Va. Union Univ.
,
In the ordinary run of cases, we deem the erroneous admission of expert testimony harmless if after excising the erroneously admitted expert testimony there remains sufficient admissible evidence to uphold the jury’s verdict. See Wickersham , 997 F.3d at 531–32 (deeming the admission of expert testimony harmless error because of the admission of similar testimony from other expert and non-expert witnesses). But that is not the case here. As we explain in greater detail in Part IV, infra , Drs. Singh and Wogalter were the only experts to offer the evidence necessary to establish the Estate’s causes of action. We therefore cannot say that the district court’s error here was harmless in this regard.
We had no cause to address in Nease the precise parameters of how a district court’s abdication of its gatekeeping function becomes harmful error. We do so now and look to our sister circuits for guidance. That review uncovers two different approaches to the harmless error inquiry. We need not decide which is the “proper” one to follow (assuming there is one), because the district court’s error here is harmful under either path.
First, some courts focus solely on whether the erroneously admitted expert
testimony swayed the jury’s verdict.
See, e.g.
,
Carlson
,
Without considering the merits of the plaintiff’s underlying
Daubert
challenge, the
Fifth Circuit held that the district court’s failure to fulfill its gatekeeping requirement was
not
harmless.
Id.
at 202. It pointed out that after the close of the plaintiff’s case-in-chief,
the plaintiff defeated the defendant’s motion for judgment as a matter of law, meaning that
there was “a legally sufficient evidentiary basis to find for” the plaintiff.
Id.
(citation
omitted). But after the defendant called its only witness, the challenged expert witness, Dr.
Durrett, the jury rendered a verdict for the defendant.
Id.
Because Dr. Durrett’s testimony
was the
only
evidence that could have supported the jury’s verdict for the defendant, the
court reasoned, “it is not credible to categorize the admission of Dr. Durrett’s testimony as
harmless.”
Id.
;
see also UGI Sunbury LLC
,
Carlson
is virtually indistinguishable from the case before us. Again, as we explain
in Part IV,
infra
, all of the Estate’s claims fail as a matter of law without Drs. Singh’s and
Wogalter’s testimony, so their testimony necessarily must have “substantially swayed” the
jury’s verdict for the Estate.
See Taylor
,
Other circuits allow for a more particular harmlessness review, permitting a
reviewing court to make substantive findings of relevance and reliability if the record on
appeal is sufficiently developed.
See Estate of Barabin v. AstenJohnson, Inc.
, 740 F.3d
457, 467 (9th Cir. 2014) (en banc),
overruled on other grounds by United States v. Bacon
,
Applying this approach and given the extensive examination undertaken of Drs. Singh and Wogalter during trial, we find that the record allows us to adequately review the merits of ODC’s Daubert challenges. And as explained below, that review demonstrates that the district court erred in failing to strike Drs. Singh’s and Wogalter’s testimony because both experts offered irrelevant and unreliable testimony.
Therefore, under either approach, the district court’s Daubert gatekeeping error was not harmless.
2.
We now turn our attention to the merits of ODC’s challenges beginning with Dr. Singh’s expert testimony. Before addressing the application of the relevance and reliability requirements, we pause briefly to provide additional background on his substantive testimony.
a.
As noted, Dr. Singh offered several opinions during his testimony. He first testified that the Container was required to comply with the design standards set forth in ASTM D6039. The Container’s design breached those standards, he opined, because it had handholds, and because there were no end cleats on the outside of the Container to reinforce the handholds. He further opined that ODC breached industry standards that required it to test the Container design prior to placing the Container in the stream of commerce. Finally, he stated that all of these shortcomings proximately caused Mr. Sardis’ death.
As to the first opinion, regarding the governing standard, Dr. Singh explained that the ASTM promulgates a wide variety of design standards that govern both the domestic and international packaging industries. ASTM D6039 is entitled, “Standard Specification for Open and Covered Wood Crates.” J.A. 154. It “covers five types and two styles of open and one type, and one style of covered wood crates designed for net loads not exceeding 4000 lb.” J.A. 154 (ASTM D6039 § 1.1). It defines a “crate” as “a container with structural framework fastened together to form a rigid structure enclosure, typically having an open construction concept with little or no panel support.” J.A. 155 (ASTM D6039 § 3.2.4).
Dr. Singh opined that ODC’s Container qualified as a “Type II, Style A” crate under ASTM D6039, with dimensions up to twelve-feet by four-feet by two-feet and holding up to one thousand pounds. See J.A. 155 tbl. 1. As relevant here, ASTM D6039 requires that those crates “shall” be built with the materials “as specified” in the standard; that both the ends and sides of the crate “shall be [made] of lumber or cleated-plywood”; and that “for gross weights exceeding 200 lb . . . exterior side cleats shall be used to facilitate fork truck handling of crates.” J.A. 156, 160–61 (ASTM D6039 §§ 6.1, 7.7.1, 7.7.4). The standard, however, does not specify if handholds can be built into a Type II, Style A crate.
At trial, Dr. Singh was questioned at length regarding whether ASTM D6039 was in fact the governing industry standard for the Container’s design. During his direct examination, Dr. Singh maintained that ASTM D6039 provided the applicable industry standard for the Container’s design, despite its sides being made of triple-wall corrugated material, because the Container’s wood ends provided the necessary “structural framework” to hold it together and “support[] the load of the product.” J.A. 453–54. On cross-examination, ODC’s counsel noted that sections 7.7.2 and 7.7.3 of ASTM D6039 required that the sides and the top members of a crate “shall” be made of lumber or pleated plywood, too. See J.A. 160–61. When asked if this could mean that the Container “just isn’t a wood crate,” Dr. Singh responded, “That is possible, yes, sir.” J.A. 523. The district court then inquired further:
THE COURT: [C]ould you use a container that had a wooden end and
the rest of it was made of cardboard?
DR. SINGH: You can, but you still have to test it.
THE COURT: Well, okay. Would that [container] be governed by this ASTM 6039?
DR. SINGH: It wouldn’t be governed by 6039 , but there would be other testing standards that would apply. . . .
THE COURT: So it would be [alright] to [build a box with cardboard sides and wooden ends] then?
DR. SINGH: It would be [alright] to do that as long as you test it with ASTM standards.
J.A. 539–40 (emphasis added).
This final point that Dr. Singh raised––that ASTM D6039 actually did not apply to the Container but “there would be other testing standards that would apply,” J.A. 539–– referred to what he characterized as another governing industry standard. Indeed, ASTM D6039 itself specifies that manufacturers may use other construction methods, so long as “the resulting packaging systems [are] of equal or better performance,” J.A. 154 (ASTM D6039 § 1.4), and (according to Dr. Singh) the procedure otherwise complies with ASTM D4169. But ASTM D4169 is not in the record. Most importantly, Dr. Singh never explained what sort of testing procedures ASTM D4169, or any other ASTM standards, if any, applied to the Container. And there was no testimony from Dr. Singh or anyone else as to any testing or scientific literature review done for compliance with the unidentified standards.
Despite his testimony that the Container as constructed “wouldn’t be governed by [ASTM] [D]6039,” J.A. 539, he nonetheless opined that the Container breached ASTM D6039’s requirements in two ways: (1) the handhold should not have been included in the design; and (2) the Container should have been designed with end cleats nailed vertically on the wood end pieces on the outside of the Container. ODC questioned his opinion regarding the handholds at length during cross-examination, asking him whether ASTM D6039 considered that a crate would have handholds built into it. Dr. Singh confirmed that ASTM D6039 said nothing about handholds––meaning that it did not preclude manufacturers from including them. As such, “[t]here is . . . nothing in [ASTM D6039] that refers to a [required] strength for pulling or pushing” a crate via a handhold. J.A. 525. When asked what, if any, handhold testing standards the ASTM generally required, Dr. Singh explained that they were “[i]n the ASTM book. I don’t remember that standard number off the top of my head. . . . You can search it on Google.” J.A. 542–43. And to determine how much more strength an end cleat would have added to a handhold, Dr. Singh acknowledged that “[y]ou would have to do some testing.” J.A. 526. He performed none and referenced none from any other source. And neither did any other witness.
Finally, Dr. Singh concluded that ODC’s failure to make the Container according to ASTM D6039’s specifications, and to test the Container prior to using it to ship goods, proximately caused Mr. Sardis’ death. Specifically, he opined only that if end cleats were present on the outside of the Container, the slat that Mr. Sardis pulled on “would have held more than not being present.” J.A. 546. But again, Dr. Singh did not cite to any tests that he performed on an exemplar Container or a computer-generated model, or to any other objective analysis, to reach this conclusion.
b.
Below and on appeal, ODC argues that Dr. Singh’s opinions were irrelevant, because his testimony insufficiently established that ASTM D6039 was a relevant industry standard that applied to the Container. It points out that the Container is not a wooden crate, which is what ASTM D6039 governs. Although both ASTM D6039 crates and the Container have wooden ends, ODC asserts that the similarities end there, making ASTM D6039 an “apples-to-oranges” comparison. Opening Br. 21.
The Estate counters that the differences that ODC cites between the Container and the requirements of ASTM D6039 “prove ODC’s failure to comply with the industry standard.” Response Br. 15. It construes Dr. Singh’s testimony as supporting the proposition that the Container’s triple-wall corrugated material, when connected to the wood ends, provided the structural framework necessary to bring it within ASTM D6039’s purview. Thus, the Estate contends, the jury was entitled to credit Dr. Singh’s opinion that ASTM D6039 governs. We find several significant flaws in the Estate’s position.
As an initial matter, whether ASTM D6039 imposed particular duties on ODC to
construct the Container in a certain manner should have never been delegated to the jury.
Virginia products liability law is clear that the question of whether a manufacturer has a
duty to design a product in a certain manner is a question of
law
for the
court
.
Holiday
Motor
,
Next, assuming that the court had deemed ASTM D6039 as the governing industry standard, that finding itself would constitute reversible legal error. Dr. Singh admitted during his testimony that a container made of “cardboard”––which the district court was using as shorthand for triple-wall corrugated material––“ wouldn’t be governed by [ASTM] [D]6039 ,” because “[t]riple-wall corrugated [material] is not considered wood.” J.A. 538– 39 (emphasis added). That admission distinguishes ASTM D6039’s requirement that a crate’s sides and ends “shall” be made of lumber or pleated plywood. See J.A. 156, 160 (ASTM D6039 §§ 6.1, 7.7.1–.2). Thus, based on Dr. Singh’s own testimony, ASTM D6039 could not be a governing standard for the Container. Yet he relied on it as the relevant benchmark, and the district court erroneously permitted him to do so before the jury.
The district court recognized as much during a sidebar with counsel. It noted that
the Container’s mostly cardboard design lacked the interconnected interior wooden
members shown in the diagramed models in ASTM D6039 and observed, “It may be this
was the wrong design to use for this [Container]. But comparing [the Container] to [ASTM
D6039]
is comparing apples and oranges
.” J.A. 501 (emphasis added). Despite these
obvious flaws in Dr. Singh’s testimony, the court decided to “leave [it to the parties] to
fight that out” in front of the jury. J.A. 504. That decision violated both Rule 702’s
gatekeeping requirement and its foundational principles of relevancy. A design standard
that “does not even apply to” the product at issue categorically “lacks ‘a valid scientific
connection to the pertinent inquiry.’”
Nease
,
The same logic applies to Dr. Singh’s testimony regarding the propriety of the Container’s handholds. While initially testifying that ASTM D6039 barred manufacturers from putting handholds on crates, Dr. Singh later admitted that ASTM D6039 said nothing one way or the other about handholds:
ODC’S COUNSEL: I want to be clear, I am not trying to play semantics, there is nothing in ASTM D 6039 for any of the styles or types . . . of crates in there that has anything [to] do with manual handles, or hand holds by any other name, anywhere in the standard; right?
DR. SINGH: Nothing referred to handles or hand holds in [ASTM] D 6039.
ODC’S COUNSEL: In fact [ASTM] D 6039 doesn’t even contemplate an option for a hand hold in an all-wood crate?
DR. SINGH: That is correct. J.A. 524. An industry standard that says nothing about the propriety of handholds––and ergo, nothing about how those handholds should be tested (if they need to be tested at all) ––is not relevant to the Estate’s claims or helpful to the jury’s breach determination.
Lastly, at first blush, Dr. Singh’s testimony that the ASTM requires manufacturers
to test a product that deviates from ASTM D6039’s requirements appears relevant. But in
reality, Dr. Singh never explained what those testing standards are or if they even exist.
Instead, Dr. Singh pointed the district court and the jury to “Google” for standards he could
not identify. J.A. 542–43. No other witness offered testimony on these unidentified
standards. That is patently insufficient to establish a duty to test a product in a certain way
and a breach of that duty. The expert must be able to identify and explain those industry
testing standards and why the product in question met or failed that test. Without such
evidence, the jury here could not properly ascertain whether ODC breached an unidentified
industry standard and was forced to speculate a guess because all that the jury had to verify
that the industry requires testing is Dr. Singh’s vague
ipse dixit
. That cannot satisfy Rule
702.
[4]
See Gen. Elec. Co. v. Joiner
,
In sum, the district court committed legal error in failing to strike Dr. Singh’s testimony under as irrelevant, because his testimony failed to establish an industry standard governing the Container, much less a breach of that alleged standard.
c.
ODC also challenged Dr. Singh’s opinion on proximate causation as unreliable, arguing that under our decision in Nease , Dr. Singh’s failure to test any exemplar or representative Container rendered his opinion unreliable. According to ODC, even if ASTM D6039 gave some insight into how much pull resistance handholds would have with end cleats on the outside, “it would not help [the Estate] here, since Dr. Singh did not do any kind of analysis to see how much force Mr. Sardis actually applied on the Container or how much force a container with exterior end cleats would have held.” Opening Br. 50.
The Estate attempts to distinguish Nease by arguing that the expert there “sought to extrapolate data relating to one model of truck to another model,” while here Dr. Singh testified as to “a product’s demonstrated failure to meet established safety standards.” Response Br. 28. Thus, the Estate contends, given Dr. Singh’s extensive credentials and “unchallenged expertise,” his testimony satisfied Daubert and Rule 702. Id. On this point, too, ODC’s argument finds stronger support in our precedent. [5]
At trial, Dr. Singh testified only in a summary fashion that the lack of vertical end cleats on the Container’s wooden ends, and ODC’s failure to test the handholds prior to placing the Container in the stream of commerce, proximately caused Mr. Sardis’ death. His only explanation of the former proposition was to opine that end cleats “would have held [the handhold slat] more than not being present.” J.A. 546.
For an expert opinion to be reliable, it must be “based on scientific, technical, or
other specialized
knowledge
and not on belief or speculation.”
Nease
, 848 F.3d at 229
(citation omitted). “One especially important factor for guiding a court in its reliability
determination is whether a given theory has been tested.”
Id.
at 231. While a lack of testing
is not dispositive,
id.
at 232, we have nonetheless recognized that “a plaintiff may not
prevail in a products liability case by relying on the opinion of an expert unsupported by
any evidence such as test data or relevant literature in the field,”
Oglesby
,
Dr. Singh’s opinions, as far as they go, are “scientific” in nature.
See
Fed. R. Evid.
702;
Daubert
,
Dr. Singh, “however, conducted no testing whatsoever to arrive at his opinion.”
Nease
,
Just as in
Nease
, “[Dr. Singh’s] failure to test his hypothes[es] renders his opinions
on the cause of [Mr. Sardis’] accident unreliable.”
The Estate and the district court appear to rely solely on ASTM D6039 as remedying
these defects. The district court first found that Dr. Singh’s opinions were admissible
despite his lack of testing because “where an expert is otherwise qualified to testify, a lack
of testing or failure to identify industry standards affects the weight of the evidence.” J.A.
1179 (quoting
Bilenky v. Ryobi Ltd.
, No. 2:13cv345,
First, the district court’s reliance on
Bilenky
, an unpublished decision, is misplaced.
Unlike
Bilenky
and the district court here, we do not read
Alevromagiros v. Hechinger Co.
,
Second, Dr. Singh’s reliance on ASTM D6039 cannot, as the district court appeared
to intimate, serve as a proxy for testing. Setting aside the fact that ASTM D6039 is an
irrelevant standard––which by itself is fatal to this argument––Dr. Singh admitted during
trial that “we can’t find out . . . how much strength an end cleat has to keep slats from
pulling out” by looking only at ASTM D6039. J.A. 526. Instead, “[
y
]o
u would have to do
some testing
.”
Id.
(emphasis added). Nor does ASTM D6039 “refer[] to a [handhold]
strength for pulling or pushing” generally. J.A. 525. So assuming that an industry standard
could serve as a “proxy” for testing,
see Nease
,
All of this to say: even if an expert provides relevant testimony as to how an
allegedly defective product breached a governing industry standard (which Dr. Singh did
not do here), that says nothing about whether the expert reliably opined that said breach
caused
a plaintiff’s harm. There must be some objective basis to satisfy the district court
that the conclusion reached was the product of reliable principles and methods. “Without
testing, supporting literature in the pertinent field, peer reviewed publications[,] or some
basis to assess the level of reliability, expert opinion testimony can easily, but improperly,
devolve into nothing more than proclaiming an opinion is true ‘because I say so.’”
Small
v. WellDyne, Inc.
,
3.
We now turn to ODC’s relevance and reliability challenges to Dr. Wogalter’s testimony, pausing first to provide a brief overview of the substance of his testimony.
a.
Dr. Wogalter was the Estate’s only expert to testify in support of its failure to warn claim. He described himself as an expert on “human factors,” which he described as “a discipline of study that deals with the design of products and systems based on people’s abilities and limitations to promote productivity, satisfaction, and safety.” J.A. 96, 555.
First, Dr. Wogalter testified that manufacturers have a duty to conduct a “hazard analysis” of a product, which entails considering how a product will be used at “all different stages” of its “life cycle.” J.A. 562. He opined that a proper hazard analysis entails “solicit[ing] feedback,” instead of “just wait[ing]” to hear of problems. J.A. 564. The district court questioned Dr. Wogalter about how ODC would have discovered that the handhold was dangerous, because his testimony “[was] kind of vague.” J.A. 573. Dr. Wogalter responded that ODC would have discovered this by performing additional, but unidentified, testing, as well as “go[ing] out and talk[ing] to people” to see “how they use [the Container],” see “how they move [it] around,” and “try to figure out what is going to happen to [the handhold] out in the field.” J.A. 577. Had they done this and further testing, he testified that ODC “would have found problems that the slat could come off from pulling on it.” J.A. 569. He admitted, however, that there is no existing literature on how to test human factors “that [he] know[s] of,” because “it is a general technique that cuts across products.” J.A. 574. And, he conceded that he never engaged in his own hazard analysis of any facsimile of the Container or anything comparable to it.
Second, given the handhold’s alleged dangers, Dr. Wogalter opined that some warning system was necessary. He described the general types of information that are typically contained in generic warnings, how those warnings are fashioned onto packaging, and to whom that information is distributed. However, Dr. Wogalter did not proffer what specific warnings should have been placed on the Container.
Third, despite not having opined as to what particular warnings should have been placed on the Container, Dr. Wogalter concluded that the failure to conduct a hazard analysis, and to include any warnings, proximately caused Mr. Sardis’ death. He stated that “there is plenty of research that . . . warnings are effective, and that certainly it is better than no warning,” but never explained what that research was, or why Mr. Sardis would have heeded those warnings. J.A. 585.
b.
ODC first argued in its motion in limine, and again in its post-trial Rule 50(b) motion, that Dr. Wogalter’s testimony was contrary to the Virginia standard for failure to warn claims. Reiterating those arguments on appeal, ODC asserts that Dr. Wogalter’s testimony was premised on what ODC should have done to discover any potential dangers associated with the Container’s handholds. But ODC posits that settled Virginia law only imposes liability upon a manufacturer if it had a reason to know of the danger. For that reason, ODC argued, Dr. Wogalter’s testimony on an alleged duty to warn was irrelevant.
The Estate and the district court adopted the view that Virginia’s duty to warn case law focuses on the notion “that the manufacturer should have superior knowledge of his product.” Response Br. 29 (citation omitted). And Dr. Wogalter testified that ODC failed to maintain such superior knowledge by “bury[ing] its head in the sand” and failing to consider any potential dangers. Id. (quoting J.A. 1185). But this logic rests on a flawed application of Virginia’s failure to warn jurisprudence. The proper application, which ODC presents, compels the conclusion that Dr. Wogalter’s testimony was irrelevant.
Part of a plaintiff’s burden in failure to warn cases under Virginia law is to show that the manufacturer “knows or has reason to know that the [product] is or is likely to be dangerous for the use for which it is supplied.” Featherall , 252 S.E.2d at 366 (quoting Restatement (Second) of Torts § 388 (Am. Law Inst. 1965)). The Supreme Court of Virginia has spoken at length about this standard, emphasizing that “[t]here is a significant legal difference between the phrases reason to know and should know”:
The words “reason to know” . . . denote the fact that the actor has information from which a person of reasonable intelligence or of the superior intelligence of the actor would infer that the fact in question exists, or that such person would govern his conduct upon the assumption that such fact exists.
The words “should know” . . . denote the fact that a person of reasonable prudence and intelligence or of the superior intelligence of the actor would ascertain the fact in question in the performance of his duty to another, or would govern his conduct upon the assumption that such fact exists.
Owens-Corning Fiberglass Corp. v. Watson , 413 S.E.2d 630, 634–35 (Va. 1992) (enumeration omitted) (quoting Restatement (Second) of Torts § 12). In other words, “‘reason to know’ implies no duty of knowledge,” but “‘should know’ implies that the actor owes another the duty of ascertaining the fact in question[] . . . and that he would ascertain the existence thereof in the proper performance of that duty.” Id. at 635 (quoting Restatement (Second) of Torts § 12 cmt. a).
Dr. Wogalter’s testimony is incompatible with the governing Virginia “reason to know” standard. As Watson shows, Dr. Wogalter’s testimony needed to focus on whether the field testing ODC performed, and the other institutional knowledge within ODC’s purview, like the feedback from its customers about containers, had caused ODC to learn— or otherwise gave them reason to know—that the wooden handholds would fail when pulled with a certain level of force. Id. at 634–35 (holding that the trial court’s instructions that a defendant had “a duty to ascertain and ‘keep informed’ of scientific facts” “imposed an inappropriate standard” under Virginia law, but nonetheless upholding the verdict because the defendant failed to object to the instructions, so they became the law of the case); see also Torkie-Tork v. Wyeth , 757 F. Supp. 2d 567, 572–73 (E.D. Va. 2010) (excluding expert testimony that a company should have tested its pharmaceutical drug more, because the duty to warn in Virginia is only based on “those dangers which [the defendant] knew or had reason to know existed based on the science available at the time the product left [its] hands”).
But that is not the testimony that Dr. Wogalter provided. He did not explain how or
why, based on the facts reasonably available to ODC, its “superior knowledge” would have
caused it to infer that the Container’s handhold had any inherent danger.
See Watson
, 413
S.E.2d at 634. Instead, he merely speculated as to
how
ODC should have gone about
discovering if such a condition was present. Specifically, his testimony regarding the need
to conduct a hazard analysis was premised on ODC’s alleged need to
ascertain
whether
the Container’s handholds would break when pulled on in the field.
See, e.g.
, J.A. 561
(“Hazard analysis, at least the goal of it, is to determine what hazards are potential with the
product.”). And his ultimate opinion was that if ODC had performed a hazard analysis
(which Dr. Wogalter failed to describe), “[it] would have
found
problems that the
[handhold] slat could come off from pulling on it.” J.A. 569 (emphasis added). Stated
differently, Dr. Wogalter testified about what ODC
should
have known. That genre of
testimony is incompatible with Virginia law,
see Watson
,
c.
Assuming arguendo that Dr. Wogalter’s hazard analysis testimony was relevant, we would nonetheless conclude that the district court abused its discretion in finding his ultimate conclusions reliable.
None of the
Daubert
hallmarks of reliability––testing, peer review, literature, rate
of error, or general acceptance––are present in Dr. Wogalter’s testimony that an undefined
hazard analysis would have uncovered the alleged dangers in the Container’s design. First,
as to testing, Dr. Wogalter admitted that he did not develop a hazard analysis protocol that
would be proper for the Container in this case. He admitted that he did not perform a hazard
analysis of an exemplar Container or any computer modeled facsimile. He could not recite
a hazard analysis he or anyone else performed in an analogous context that would apply to
the Container. And he admitted that he “[was] not familiar with all the ways that [the
Container] is even handled,” because, in his words, “I don’t have access to stuff that you
[ODC’s counsel] are saying I should have.” J.A. 595. Just as in
Nease
, Dr. Wogalter
“presented a hypothesis only,” but “failed to validate it with testing” or any other objective
comparison, which “renders his opinions . . . unreliable.”
Again, the other Daubert reliability guideposts confirm this point. Dr. Wogalter utilized no specified methodology, so his theories could not have been subject to peer review. In fact, he conceded that there is no existing literature on how to test human factors “that [he] know[s] of.” J.A. 574. He also confirmed that it is not general knowledge that part of a hazard analysis for garage door hood containers is “a pulling test” to determine pull-strength resistance. J.A. 571–72. Nor could Dr. Wogalter describe any other prior case in which he, or any other expert, conducted a hazard analysis on a similar container that also involved an allegedly defective handhold. Nowhere in his testimony did he offer any facts, test data, or peer-reviewed literature for reaching his conclusion. [7] Thus, it was impossible for the district court, and impossible for us on appeal, to ascertain the potential rate of error in Dr. Wogalter’s hazard analysis approach and whether hazard analyses are widely accepted in the field of “human factors.”
The district court recognized as much when it engaged in its own extensive questioning of Dr. Wogalter. It attempted to pinpoint a basis for Dr. Wogalter’s proposed hazard analysis because, in the court’s own words,
you [Dr. Wogalter] haven’t even given us an example of this happening in the real world other than your thought that this is something that they ought to have done. What you have given us is kind of vague . . . . So I sort of would like to know how this process works in a little more detail so that we can figure out whether there is a likelihood of good results. I haven’t heard that. Maybe I am just missing something.
J.A. 573 (emphasis added). The district court, in fact, was not missing anything. Dr.
Wogalter simply offered only his
ipse dixit
in support of his opinions. This is the hallmark
of an unreliable opinion.
See, e.g.
,
Oglesby
,
The same deficits are present in his conclusions regarding the need for warnings.
He testified that to abate the hazards inherent in the Container’s handholds, ODC had to
give “appropriate warnings . . . whatever they might be. And there is a whole literature on
how to make proper warnings[.]” J.A. 577. But, he admitted, he did not “determine[] the
exact language” that should have been included in the warnings. J.A. 583. He nonetheless
opined that the lack of an unspecified warning proximately caused Mr. Sardis’ death. He
pointed to no peer-reviewed literature, test data, or any other facts to support his claim that
an unspecified warning placed on the Container would have been heeded by Mr. Sardis.
Again, all that supported Dr. Wogalter’s opinions was his own
ipse dixit
. Thus, just as with
Dr. Singh, it was an abuse of discretion to admit this testimony into evidence.
See Nease
,
* * * *
Because Drs. Singh and Wogalter provided irrelevant and unreliable testimony as a matter of law, we hold that the district court necessarily committed harmful error when it abdicated its critical gatekeeping function both at the motion in limine and Rule 50(b) stages. With that inadmissible expert testimony excised from our own consideration, we turn our attention to whether the remaining admissible evidence could support the jury’s verdict.
IV.
Even without Drs. Singh’s and Wogalter’s testimony, the Estate contends that ODC is not entitled to judgment as a matter of law. It asserts that the lay witness testimony offered at trial, largely from ODC’s corporate designee, was sufficient to establish both that the Container was defectively designed, and that ODC breached its duty to warn consumers of the dangers inherent in the Container’s handholds. Both contentions fail.
A.
The Estate first argues that it sufficiently demonstrated that the Container was defectively designed through the consumer expectations test. It points to the testimony of ODC’s corporate designee, Mr. Knable, who “agree[d]” that users “can reasonably expect that if they pull on [the Container’s handhold] that it will hold up[.]” J.A. 1372. Taking this statement in the light most favorable to the Estate still does not establish a design defect.
Under Virginia law, a design defect can be shown if a product fails to conform with
“reasonable consumer expectations”––“those expectations [that] reveal how society
‘balances known risks and dangers [inherent in a product design] against the feasibility and
practicability of applying any given technology’ to enhance product safety.”
Redman v.
John D. Brush & Co.
,
Our Redman decision is instructive. There, the plaintiff sought to establish that a safe marketed as “burglar-deterrent” was defectively designed, because a reasonable consumer “would have expected the particular safe [the plaintiff] purchased to provide more burglary protection than it did.” 111 F.3d at 1181. We held that the plaintiff’s evidence––which consisted only of his own self-serving statements that the safe was “marketed as ‘burglar-deterrent’” and “would provide ‘a degree of protection against burglary’”––was insufficient to establish what a reasonable consumer expected of the safe. Id. Besides the subjective nature of this evidence, we faulted the plaintiff for failing to “establish how much burglary protection reasonable consumers would expect from a burglar-deterrent safe.” Id. (emphasis added).
Similarly, here, Mr. Knable’s statement fails to establish a reasonable consumer’s expectations as to how much pull-strength resistance would apply to the Container’s handhold. Any consumer (i.e., an ODC distributor’s employee handling a Container) would expect the handhold to “hold up” when pulled. But just as in Redman , the Estate was required, but failed, to “establish how much [pull-strength resistance] reasonable consumers would expect.” Id. (emphasis added). Moreover, the Estate provided no admissible evidence on the issue of proximate causation. It failed to demonstrate (1) that the force that Mr. Sardis used in pulling on the Container’s handhold fell within a consumer’s expected metric, or (2) that with the proposed modification (end cleats), the Container’s handhold here would not have failed based on the force used. The fact that a handhold may have failed on one occasion does not establish reasonable consumer expectations. In short, apart from the metaphysical speculation of a handhold that sustains an unidentified quantum force, the Estate offered no evidence to quantify any expectation of force resistance.
Accordingly, without Dr. Singh’s inadmissible expert testimony, the Estate failed to meet its burden of proof on its design defect claim.
B.
Next, the Estate asserts that its failure to warn claim survives without Dr. Wogalter’s expert testimony. In support, it points to four alleged admissions that ODC made during trial: (1) that ODC has an “obligation to [e]nsure that its products that it designs and manufactures comply with industry standards,” J.A. 794–95; (2) that industry standards exist “[t]o protect people,” J.A. 1298; (3) that “ODC shouldn’t sell or distribute a product that does not comply with applicable industry standards,” J.A. 1298–99; and (4) that “one of the ways people can be injured or killed is if [ODC] sells or distributes a product that does not comply with applicable industry standards,” J.A. 1299. This testimony, the Estate posits, “provided ample grounds for the jury to conclude that the company had reason to know of the [Container’s] potential dangers.” Response Br. 23. Even when reading these statements in the light most favorable to the Estate, we disagree.
In order for these statements to support the jury’s finding that ODC had a duty to
warn of the dangers allegedly posed by the Container’s handholds, we must discern some
evidence that ODC knew or had reason to know of those dangers.
See Watson
, 413 S.E.2d
at 634;
Featherall
,
The district court found that ODC breached its duty to warn by “bury[ing] its head in the sand” to the handhold’s potential dangers, J.A. 1185 (citation omitted), based on Mr. Knable’s testimony that ODC “[n]ever consider[ed] the potential dangers that its packaging or crates can pose to others,” J.A. 1297. Assuming that this theory of breach is compatible with Virginia law––and that the Estate sufficiently proved it––the Estate nonetheless failed to prove causation as a matter of law.
The burden of establishing that ODC’s breach of a duty to warn proximately caused
Mr. Sardis’ injuries lies with the Estate.
See, e.g.
,
Robey v. Richmond Coca-Cola Bottling
Works
,
In sum, without Drs. Singh and Wogalter, the Estate did not prove that ODC had a duty to warn, that it breached that duty to warn, or that such a breach proximately caused Mr. Sardis’ injuries. Its failure to warn claim therefore fails as a matter of law.
C.
Given our holdings above regarding the Estate’s evidentiary failures on its design
defect and failure to warn claims, ODC’s arguments pertaining to the general negligence
and breach of the implied warranty of merchantability claims may be addressed in
relatively short order. As noted at the outset, Virginia law imposes identical requirements
for products liability claims brought under both negligence and breach of the implied
warranty of merchantability theories.
Evans
,
D.
The final matter for our consideration is whether we should remand this case for a
new trial, remand for the district court to assess whether a new trial is proper, or direct that
judgment be entered for ODC as a matter of law.
See
Fed. R. Civ. P. 50(e). One of the
“key[s] to [our] exercise of . . . discretion” in this analysis is “fairness to the parties.”
Weisgram
,
Writing for the unanimous Weisgram Court, Justice Ginsburg observed that “[s]ince Daubert , . . . parties relying on expert evidence have had notice of the exacting standards of reliability such evidence must meet.” Id. at 455. So it is fair to enter judgment as a matter of law for the losing party below when the appellate court finds the prevailing party’s expert testimony inadmissible on appeal, because “[i]t is implausible to suggest, post- , that parties will initially present less than their best expert evidence in the expectation of a second chance should their first try fail.” Id. at 455–56. That fairness is only amplified in a case like this, where “[the Estate] was on notice every step of the way that [ODC] was challenging [its] experts, [and it] made no attempt to add or substitute other evidence.” Id. at 456. As in Weisgram , the Estate has “offered no specific grounds for a new trial”; it only asserts that the evidence it presented below was sufficient to support the verdict entered in its favor. Id. Given the near identical overlap between the circumstances of this case and that in Weisgram , we elect to follow the path already cleared by the Supreme Court, and direct that judgment as a matter of law be entered in ODC’s favor as to all of the Estate’s claims for relief.
V.
For the foregoing reasons, we reverse the judgment of the district court and remand this case with instructions for the district court to enter final judgment in ODC’s favor.
REVERSED AND REMANDED WITH INSTRUCTIONS
Notes
[1] During discovery, the Estate requested that ODC produce at least three containers identical to the one involved in Mr. Sardis’ accident. ODC responded that it did not have any such container in its possession because it only manufactures them on-demand, but offered to construct three replicas of the Container. The Estate rejected this offer, claiming it “would have no way of knowing whether ODC made subtle changes to its design intended to strengthen the crates and/or the handholds, rendering any such testing wholly unreliable.” Pl.’s Opp. to Def.’s Mot. to Exclude Dr. Singh at 24, Sardis v. Overhead Door Corp. , No. 3:17-cv-00818-JAG (E.D. Va. filed Nov. 15, 2018), ECF No. 75.
[2] The district court properly had diversity jurisdiction over this case. Mr. Sardis was domiciled in Virginia, and so is his Estate; ODC maintains its principal place of business in Texas; and the Estate’s Complaint sought damages well in excess of $75,000. See 28 U.S.C. § 1332(a)(1).
[3] The Estate’s Complaint asserted a fifth cause of action based on an alleged manufacturing defect, but it abandoned this claim before trial.
[4] The Estate also points to Dr. Singh’s reliance on Chapter Four of the Handbook of Paper and Wood Packaging Technology as a relevant industry standard. That treatise provides that placing cleats on the inside of a wooden crate (which the Container here did) “reduces the carrying capacity to less than 200 pounds.” J.A. 475. Dr. Singh never explained, however, how a reduction in carrying capacity would reduce the strength of handholds on the outside of a container. So even assuming that this is an industry standard, it is irrelevant to the handhold discussion.
[5] During oral argument, the Estate asserted that ODC waived any challenge to Dr.
Singh’s proximate causation opinion by failing to object to it when Dr. Singh offered it at
trial.
See also
Response Br. 17. We disagree. ODC properly preserved this issue for appeal
by filing a motion in limine specifically requesting,
inter alia
, that the district court exclude
Dr. Singh’s proximate causation opinion at trial under , which the district court
denied.
See United States v. Williams
,
[6] Had Dr. Wogalter grounded his testimony in an industry standard (which, assuming it exists, he never identified) governing the testing of container handholds, then his theory may have relevance because that could show inadequacies in ODC’s field testing of the Container design and how it failed to maintain superior knowledge of its product. But Dr. Wogalter never once pointed to an industry standard governing the testing of handholds. In fact, he admitted that there is no existing literature on how to test human factors generally. Without that foundation, his testimony is nothing more than his mere ipse dixit , his speculative guess, about what ODC should have done in hindsight. Thus, we need not consider whether Virginia law would contemplate a manufacturer being held liable for a failure to warn under a “bury its head in the sand” line of reasoning.
[7] Dr. Wogalter also cited Dr. Singh’s testimony, explaining that ODC’s hazard analysis was insufficient because it failed to conduct “a pulling test.” J.A. 571–72. But as noted above, Dr. Singh’s testimony failed to reliably demonstrate how this would have shown that the Container was defectively designed. Dr. Wogalter’s inability to explain this point only confirms the unreliability of this portion of his testimony.
[8] Given these holdings, we need not address ODC’s remaining contentions that the district court erred in formulating the verdict form and a number of the jury instructions.