Howard Nease v. Ford Motor Company , 848 F.3d 219 ( 2017 )


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  •                                 PUBLISHED
    UNITED STATES COURT OF APPEALS
    FOR THE FOURTH CIRCUIT
    No. 15-1950
    HOWARD E. NEASE; NANCY NEASE,
    Plaintiffs – Appellees,
    v.
    FORD MOTOR COMPANY, a Delaware Corporation,
    Defendant – Appellant.
    Appeal from the United States District Court for the Southern
    District of West Virginia, at Huntington.  Robert C. Chambers,
    Chief District Judge. (3:13-cv-29840)
    Argued:   September 21, 2016                 Decided:   February 1, 2017
    Before MOTZ, TRAXLER, and AGEE, Circuit Judges.
    Reversed and remanded with instructions by published opinion.
    Judge Traxler wrote the opinion, in which Judge Motz and Judge
    Agee joined.
    ARGUED: Jonathan D. Hacker, O’MELVENY & MYERS LLP, Washington,
    D.C., for Appellant.    Larry Lee Javins, II, BAILEY, JAVINS &
    CARTER, L.C., Charleston, West Virginia, for Appellees.      ON
    BRIEF: Andrew B. Cooke, FLAHERTY, SENSABAUGH & BONASSO, PLLC,
    Charleston, West Virginia; Bradley N. Garcia, O’MELVENY & MYERS
    LLP, Washington, D.C., for Appellant.     Tony L. O’Dell, TIANO
    O’DELL, PLLC, Charleston, West Virginia, for Appellees.
    TRAXLER, Circuit Judge:
    Howard    and    Nancy    Nease     commenced     this      product     liability
    action against Ford Motor Company, alleging that Howard suffered
    serious injuries in an accident caused by a design defect in the
    speed control system of his 2001 Ford Ranger pickup truck.                            Over
    Ford’s objection, the Neases offered the expert testimony of
    Samuel Sero that the speed control cable in the 2001 Ranger is
    susceptible to getting stuck or “bound” while the throttle to
    which it is linked is in the open position, thus preventing the
    driver from slowing down the vehicle.                        The Neases claim that
    this is precisely what happened while Howard was driving his
    2001    Ranger.          A    West    Virginia        jury    awarded       the      Neases
    $3,012,828.35 in damages.             Ford made several post-trial motions,
    including a motion for judgment as a matter of law under Rule
    50(b) of the Federal Rules of Civil Procedure.                         In its motion,
    Ford renewed its pre-trial argument that Sero’s testimony was
    inadmissible under Daubert v. Merrell Dow Pharmaceuticals, Inc.,
    
    509 U.S. 579
    (1993), and should have been excluded.                                 In the
    alternative,      Ford       sought   a   new   trial    on    the    basis    that     the
    district    court       erroneously        instructed        the     jury     on    strict
    liability       under    West    Virginia       law   and     erroneously          admitted
    evidence of prior incidents involving Ford vehicles.
    The district court denied Ford’s post-trial motions.                           Ford
    now appeals.           For the reasons that follow, we conclude that
    2
    Sero’s testimony should not have been admitted.                                    And, without
    any    other      expert   testimony       to     establish         that       the       2001    Ford
    Ranger      was    defectively       designed       and    that          there       were       safer
    alternative         designs       available        that        a     reasonably             prudent
    manufacturer would have adopted, the Neases cannot prove their
    case under West Virginia law.                   Accordingly, we must reverse and
    remand for entry of judgment in Ford’s favor.
    I.
    On   November       20,    2012,     Howard      was        driving         his    recently
    purchased, used 2001 Ford Ranger pickup truck on U.S. Route 60
    in    St.   Albans,    West       Virginia.        According            to    Howard,       he    was
    traveling 45-50 mph when he discovered his vehicle would not
    slow down when he released the accelerator pedal.                                    He tried to
    slow the pickup truck by applying the brakes, but to no avail.
    In order to avoid running into pedestrians or other cars, Howard
    turned the Ranger off the road, drove over a curb, and crashed
    into a brick car wash building.                    For about 25-30 seconds after
    the    pickup      truck    hit    the    brick     wall,          the       tires    reportedly
    continued spinning until the engine shut down.                                Howard’s Ranger
    had    approximately        116,000       miles    on     it       at    the       time     of    the
    accident, and there is no indication in the record that the
    vehicle      had    ever    manifested        problems         with          the   accelerator,
    cruise control or throttle.                 The Neases thereafter filed this
    action      against        Ford     Motor       Company,           alleging          that        Ford
    3
    defectively designed the accelerator pedal-to-throttle assembly
    of the 2001 Ranger pickup truck.                The complaint asserted causes
    of   action     for   strict    liability,       negligence,     and    breach     of
    warranty.
    A.
    The general design and function of the throttle control
    system    in    the   2001     Ford    Ranger    is    typical   of    any    modern
    passenger      vehicle.        The     driver    controls    engine     speed      by
    depressing      the   accelerator       pedal,     which    is   linked      to   the
    throttle, which, in turn, regulates the amount of air flowing
    into the engine.        When the accelerator pedal is depressed, the
    throttle opens and engine speed increases; when the accelerator
    pedal is released, the throttle closes, airflow is restricted
    and engine speed decreases.
    In the 2001 Ford Ranger, the accelerator pedal is linked to
    the throttle body by a steel accelerator cable.                  The accelerator
    cable is attached to a lever on the throttle body; the lever
    operates the throttle valve and the throttle valve controls the
    engine’s air intake.           As “the accelerator pedal is depressed,
    the accelerator cable [which is attached to the throttle lever]
    is pulled to open the throttle [valve] and increase the engine
    speed.”        J.A.   83.      In    essence,    the   accelerator     pedal,     the
    accelerator cable and the throttle lever form a pulley system
    that opens the throttle.               As a safety feature, the throttle
    4
    lever is equipped with return springs that exert 7.2 pounds of
    continuous force to pull the throttle closed when the driver
    takes his foot off of the accelerator.
    In addition to the accelerator pedal-to-throttle assembly,
    another means by which the driver of a 2001 Ranger can open the
    throttle is the cruise control system.               This system is operated
    by a “speed control actuator and [a] speed control cable.”                   J.A.
    85.     The cruise control system incorporates an electric motor
    that operates a steel cable—the speed control cable—to open and
    close the throttle.          The speed control cable and the accelerator
    cable are attached to the same throttle lever/pulley system that
    operates the throttle valve.           When the speed control actuator
    receives input from the cruise control switch on the steering
    column, the motor manipulates the speed control cable to pull
    the throttle lever independently of the main accelerator cable.
    The throttle control design takes into account that both
    cables are attached to the same throttle lever/pulley-system.
    In    order   to   prevent    significant   stress    to   the   speed    control
    cable that could potentially occur when the cruise control is
    not engaged and the throttle lever is being controlled by the
    accelerator pedal and cable, Ford incorporated a “‘lost motion’
    configuration” for the speed control cable assembly.                     J.A. 85.
    In this design, the steel speed control cable runs from the
    motor in the speed control actuator through a plastic “guide
    5
    tube,”      and   is    attached        to     the   throttle    lever    by    a    plastic
    “connector.”           
    Id. The connector
    and the guide tube move with
    the throttle lever when it is being operated by the accelerator
    cable.       The speed control cable itself stays stationary while
    the guide tube moves up and down the cable and in and out of a
    stationary plastic casing tube, called a “casing cap,” which is
    attached to the motor.                  
    Id. The gap
    between the moving guide
    tube and the stationary casing cap is approximately 0.04 inches.
    B.
    Following the accident, plaintiffs hired Samuel Sero, an
    electrical        engineer,        to   examine      the   engine   and   the       throttle
    assembly     in    Howard’s        2001       Ford   Ranger.     Sero    approached       his
    examination with the view that in failure-to-decelerate cases,
    the issue is often one of “mechanical binding” and that a post-
    accident investigation should “look at the accelerator cable,
    [to] see if there’s anything on it that bound up and prevented
    it   from    closing         the   throttle      when   the    accelerator      pedal     was
    released, looking for . . . any kind of grime, grit, or anything
    that could bind that one.”                     J.A. 613. 1      Sero indicated that a
    post-accident          investigation           should      therefore     look       for   the
    1Contaminants that typically build up on automobile engine
    parts over time include carbon, substances accumulating from
    “vapors off of gasoline, brake fluid, hydraulic fluids, battery
    acids, steel, copper, aluminum, [and] magnesium,” J.A. 644, as
    well as the dirt and grime that washes up into the engine from
    the surface of the road.
    6
    presence of contaminants and particles that could lodge between
    the speed control guide tube and the casing cap and create a
    “wedging effect.”           J.A. 628.        Sero used a borescope to inspect
    the speed control assembly.
    A borescope is essentially a fiber-optic tube equipped with
    a    light   that    a     mechanic     or   an    engineer      can   insert    into   an
    inaccessible        area    of    the   engine      and   view    a    given    component
    without having to disassemble the engine.                     When he examined the
    speed control cable in the Neases’ pickup, Sero did not find any
    materials wedged between the guide tube and the cap.                            In fact,
    he     noted    that        the    speed      control      cable        moved    freely.
    Nevertheless, Sero concluded that contaminants had entered and
    built up in the casing cap over time, causing the guide tube to
    stick and, therefore, the throttle plate to remain open.                            Sero
    testified that he was able to identify “a lot of contaminant . .
    . deposited” in the casing cap, J.A. 636, and “along the guide
    tube,” J.A. 631.            Sero also noticed “gouges or striations” on
    the guide tube.          J.A. 645.      From this observation, Sero believed
    that there had been “a rough, abrasive material between the . .
    . interior of the [casing] cap tube and the surface of the guide
    tube,” indicative of binding.                     J.A. 645.       Sero surmised that
    sufficient debris had accumulated to create the “wedging effect”
    needed to keep the throttle open after the accelerator pedal was
    released.      However, Sero had no way of knowing precisely how
    7
    much contaminant was present in the casing cap or whether it was
    enough to lodge in the 0.04 inch-gap between the cap and the
    guide tube such that the throttle would be stuck in the open
    position.    The borescope is simply a viewing tool; it does not
    afford a means for determining the amount of the contaminant
    that can be seen with the device.
    To bolster his opinion, Sero pointed to a document Ford had
    prepared    in    1987    identifying        potential    risks    Ford     engineers
    should consider addressing in the design of particular vehicles
    in the future.           This document is called a Failure Mode and
    Effects    Analysis      (“FMEA”).         According     to   Ford’s      “Potential
    Failure Mode and Effects Analysis” Handbook, “[a]n FMEA can be
    described as a systemized group of activities intended to: (a)
    recognize        and     evaluate        the     potential        failure        of    a
    product/process        and    its   effects,     (b)    identify    actions       which
    could eliminate or reduce the chance of the potential failure
    occurring,    and      (c)    document     the   process.”        J.A.    968.        The
    primary    purposes      of   an    FMEA   include     “identify[ing]       potential
    failure modes and rat[ing] the severity of their effects” and
    “help[ing] engineers focus on eliminating product and process
    concerns and help[ing] prevent problems from occurring.”                              
    Id. An FMEA
    “is meant to be a ‘before-the-event’ action, not an
    ‘after-the-fact’ exercise.”            
    Id. 8 Sero
    testified that the 1987 FMEA “directly addresse[d] the
    fact [that] dirt, grease or ice has formed between cable and
    cable sheath” and therefore demonstrated that “Ford [was] well
    aware of the problem of binding in the lost motion device/cruise
    cable.”      J.A. 52.   Sero asserted therefore that the 1987 FMEA
    proved the speed control assembly in the 2001 Ford Ranger was
    susceptible to binding.        Sero was apparently unaware, however,
    that the 1987 FMEA did not even apply to the 2001 Ford Ranger.
    The   1987    FMEA   “dealt   with   a       vacuum-actuated    speed   control
    system” that was not present in the 2001 Ranger.               J.A. 1260.
    Based on his borescope exam and the 1987 FMEA, Sero opined
    that the 2001 Ford Ranger’s design was not reasonably safe and
    that there were several alternative designs that Ford could have
    utilized in the design of the speed control assembly:
    It is my opinion, . . . within a                    reasonable
    degree of engineering certainty that . . .
    1. Mr. Nease’s 2001 Ranger experienced a failure
    to decelerate by reason of the binding of the lost
    motion portion of the cruise . . . cable while the
    throttle was substantially open;
    2.   The cable design employed by Ford in the
    subject 2001 Ranger permits dirt, grease and grime to
    enter the conduit through which the cable passes and
    is known to cause sticking or binding of the cable;
    3.   The subject cable is defectively designed;
    4. The binding of the cable . . . was caused by
    particles of dirt and/or debris typically found under
    the hood of motor vehicles;
    9
    5.   The open-throttle condition . . . almost
    immediately deplete[d] the vacuum assist to the
    brakes;
    6.    The open-throttle condition, accompanied by
    loss of vacuum assist, required the application of
    brake pedal forces beyond the physical capabilities of
    Mr. Nease;
    7. The binding of the defectively-designed cable
    was the proximate cause of the crash of the Nease
    vehicle;
    8.    Safer, feasible alternative designs were
    available and known to Ford Motor Company at the time
    the 2001 Ranger was manufactured.
    J.A. 53-54.
    Prior to trial, Ford moved to exclude Sero’s opinions under
    Daubert on the grounds that Sero’s opinions were not based on
    any   reliable   methodology      and   that      Sero   had   not   established
    through testing or other means, such as scientific literature,
    that the binding of the speed control assembly could actually
    occur.    See    
    Daubert, 509 U.S. at 597
       (explaining   that   the
    district court must “ensur[e] that an expert’s testimony . . .
    rests on a reliable foundation” (emphasis added)).                     Ford also
    argued that Sero, as an electrical engineer, was unqualified to
    render an expert opinion on matters of automotive design.                     The
    district court denied Ford’s motion to exclude Sero’s testimony,
    concluding that Sero was sufficiently qualified by means of his
    experience “design[ing] and operat[ing] . . . mechanical systems
    in a variety of settings.”        J.A. 525.        The court also determined
    10
    that    in    arriving    at     his       opinion,       Sero     employed      “standard
    engineering methodology to conduct his physical inspection and
    reach his opinions.”           
    Id. This methodology
    included “physically
    inspecting      the    vehicle’s       parts,          understanding      how    they      are
    designed to operate, observing evidence of whether some material
    interfered with the operation of the cable, and opining how that
    could and did occur here.”             
    Id. at 526.
    The case proceeded to trial and Sero offered his opinions.
    Ford attacked Sero’s opinions on cross examination and offered
    its    own    expert    testimony.          Sero        acknowledged      that      when    he
    performed      his    inspection      of    the        speed   control    cable      in    the
    Neases’ Ranger, he did not find any materials actually wedged
    between the guide tube and cap, and he noted that the speed
    control cable moved freely.                Sero further admitted that he had
    never actually found a bound speed cable assembly in any vehicle
    that he had inspected.
    In contrast to Sero’s professed inability to determine how
    much debris was present in the casing cap (because the borescope
    does    not    provide     a    way        to        determine     the   scale      of     the
    contaminants),        Ford’s   experts          performed        tests   on   the   Neases’
    vehicle and were able to quantify the size of the contaminants
    found on the Ranger’s guide tube.                     Dr. Steven MacLean, an expert
    in the field of mechanical engineering, used a scanning electron
    microscope to determine that “the thickest region . . . [found]
    11
    on Mr. Nease’s guide tube . . . was approximately 50 microns in
    thickness,” J.A. 2438.         For perspective, Dr. MacLean explained
    that a piece of paper is about 60 microns thick, making it 10
    microns thicker than the contaminants found on the guide tube in
    the speed control assembly.          Either one is far smaller than the
    .04 inch gap between the casing cap and guide tube.                      And, with
    respect to the gouge marks Sero noticed during the borescope
    exam that he believed were indicative of binding, Dr. MacLean
    testified that his analysis indicated that these marks “are from
    the manufacturing process, the molding process of these parts,”
    not “a binding event.”        J.A. 2419.
    Sero   agreed    that   he   had   never      conducted     any   testing    to
    determine whether enough debris could accumulate in the casing
    cap during normal operation to resist the 7.2 pounds of force
    exerted by the return spring and to cause the throttle to stick
    open.    Sero    simply    relied    upon     his    observations       during    the
    borescope exam, which was videotaped.                 At trial, however, Sero
    was   unable    to    distinguish    between        the   video    of   the   Nease
    borescope and a borescope exam for a previous case in which Sero
    had testified that the speed control cable did not bind.                           He
    could not tell the borescope of the cable that he said did bind
    from the borescope of the cable that he said did not bind.                         In
    other words, he could not tell one from the other.
    12
    With regard to the FMEA process that was so central to
    Sero’s opinion, Ford presented evidence that potential failure
    modes    identified        in    the     FMEA   had      not   occurred    during      actual
    vehicle operation.              For example, Dr. MacLean explained that a
    FMEA    is   a    common       “engineering       tool,”       J.A.   2475,     used   before
    marketing a new product to the public to “proactively try to
    determine what are all of the possible failure modes for that
    particular new design.”                
    Id. According to
    MacLean, an FMEA is
    not a record of existing problems but rather “a forward-looking
    tool for . . . a new product.”                        J.A. 2481.        When an FMEA is
    performed,        the     manufacturer          “bring[s]       in     design    engineers,
    analysis     engineers,          manufacturing           engineers,     people    from    all
    different disciplines, and . . . [the group tries] to come up
    with a very comprehensive and exhaustive list of failure modes.
    . . . [and seek to determine] how likely it is to occur, and
    what does my system do to possibly detect it and prevent it from
    happening.”             J.A.     2475.         Similarly,       Karl     Stopschinski,      a
    registered professional engineer and member of the Society of
    Automotive Engineers, testified that the FMEA process is akin to
    a   “brainstorming         session”       to    “identify       any    potential       failure
    modes.”          J.A.    2157     (emphasis       added).          Additionally,       Ford’s
    engineering experts indicated that the 1987 FMEA on which Sero
    relied did not even apply to the Neases’ 2001 Ranger pickup
    truck.       Rather,           James     Engle,      a    design      analysis    engineer,
    13
    indicated that it is the 2004 FMEA that applies to the 2001
    Ranger because it was “originated in February of ’97 and carried
    forward.”      J.A. 1265.
    Finally,     Sero     testified        that    several      alternative      speed
    control cable designs were available at the time and that Ford
    could have made the 2001 Ranger safer by incorporating one of
    these designs.        He admitted, however, that he had not tested any
    of these alternative designs to determine whether any of them
    would   have    prevented      the     accident       in    question.        In    Sero’s
    opinion, testing of the alternative designs he identified was
    unnecessary       because    the     designs        had    been   in   use    in   other
    vehicles for years and were therefore “proven commodit[ies].”
    J.A. 717.
    The district court instructed the jury that on plaintiffs’
    strict liability claim, plaintiffs had to prove that the design
    of   the   2001    Ford     Ranger     was    not     “reasonably      safe    for   its
    intended use.”        J.A. 1922.        Although the court explained that
    the “plaintiffs are only entitled to a reasonably safe product,
    not to an absolutely safe product,” the court then instructed,
    over Ford’s objection, that “[i]f a product can be made safer
    and the danger may be reduced by an alternative design at not
    substantial increase in price, then the manufacturer has a duty
    to   adopt     such   a     design.”         
    Id. During closing
        argument,
    14
    plaintiffs’    counsel   highlighted      the    safer   alternative      design
    instruction:
    . . .   If a product can be made safer and the
    danger reduced by an alternative design or device at
    no substantial increase in cost, then the manufacturer
    has a duty to adopt such design. All that means is if
    you find that one of the other designs was safer and
    it wasn’t going to cost very much . . . [t]hen you can
    find that Ford breached its duty.
    J.A. 1960.
    The jury returned a verdict for the Neases on the strict
    liability count and awarded damages of $3,012,828.35.                The jury
    returned   defense   verdicts   on     the      negligence    and   breach    of
    warranty counts.
    After trial Ford filed a Renewed Motion for Judgment as a
    Matter of Law pursuant to Rule 50(b).              First, Ford argued that
    “there was insufficient evidence to support the jury’s verdict
    for strict liability because the claim was dependent upon the
    testimony of Plaintiffs’ expert . . . Sero.”                 J.A. 3477.      And,
    Ford argued, as it had prior to trial, that Sero’s testimony
    should not have been admitted because Sero was unqualified to
    testify as an expert and that Sero’s opinions should have been
    excluded under Daubert.       Specifically, Ford argued that “Sero
    never demonstrated unidirectional binding of Mr. Nease’s speed
    control cable, he did not attempt to simulate his theory, he did
    not conduct any tests that a foreign substance could withstand
    the seven-pound spring pressure, [and] he did not demonstrate
    15
    alternative designs were equally or more safe.”                           J.A. 3478.      The
    district court denied the Rule 50 motion, concluding that Sero’s
    methodology was reliable because he used the FMEA methodology
    used by Ford and that the borescope examination was “consistent
    and trustworthy and what historically [was] used in failure to
    decelerate cases.”         J.A. 3479.
    Alternatively, Ford moved for a new trial pursuant to Rule
    59(a)(1)(A),        arguing    that   the         verdict    should        be    set    aside
    because the district court issued an improper “duty to adopt”
    jury instruction as to safer alternative designs.                                Ford also
    contended that the district court erroneously admitted evidence
    of other incidents involving Ford vehicles with an allegedly
    defective     speed      control    assembly        unit.      The        district      court
    denied the motion for a new trial on both grounds.                               The court
    did   not    expressly     reject     Ford’s       position        that    the    “duty    to
    adopt”      instruction       was   incorrect        under     West        Virginia      law.
    Instead,     the    district    court    concluded          that    even    if    the    jury
    instruction        was   erroneous,     it    was    harmless       because       the    jury
    found that the product was defective and not reasonably safe,
    and thus the jury did not need to reach the question of the duty
    to adopt a safer alternative design.                  Additionally, the district
    court noted that the jury instructions were otherwise correct
    and informed the jury that the Neases were not entitled to an
    absolutely safe product.            Finally, the district court ruled that
    16
    even if the admission of evidence regarding other incidents was
    erroneous,      it    was     harmless       in    view     of    court’s    limiting
    instruction to the jury that it “only consider the alleged other
    incidents for the limited purpose of determining whether Ford
    had notice of the defect” and not “as evidence that the 2001
    Ford Ranger was defective.”            J.A. 3486.
    Ford appeals, arguing that the district court incorrectly
    admitted     Sero’s    expert        testimony       in    contravention     of   the
    requirement that such testimony be reliable under Daubert and
    its progeny; that the district court’s erroneous “duty to adopt”
    jury instruction was not harmless in view of the fact that it
    was the only instruction that counsel for Nease highlighted in
    his   closing    argument       to    the    jury;    and    that    the    erroneous
    admission of other incident evidence was not rendered harmless
    by    the   district        court’s    limiting       instruction      because    the
    limiting instruction did not apply to the other incidents at
    issue.      To resolve this appeal, we need only address Ford’s
    Daubert argument.
    II.
    Ford contends that the district court erroneously denied
    its motion to exclude Sero’s opinion that Ford’s design of the
    speed control assembly in the 2001 Ford Ranger was defective and
    that Ford could have used a different design that would have
    prevented    Nease’s    accident.           We    review    the   district    court's
    17
    application of Daubert for abuse of discretion.                    See Anderson v.
    Westinghouse Savannah River Co., 
    406 F.3d 248
    , 260 (4th Cir.
    2005).      “If the district court makes an error of law in deciding
    an evidentiary question, that error is by definition an abuse of
    discretion.”          
    Id. (internal quotation
       marks    omitted).        A
    district      court   likewise       abuses     its   discretion    in    deciding   a
    Daubert      challenge      if     its   conclusion     “rests     upon   a   clearly
    erroneous factual finding.”                Bryte ex rel. Bryte v. American
    Household, Inc., 
    429 F.3d 469
    , 475 (4th Cir. 2005).
    A.   Daubert’s Applicability
    We first must visit the question of whether Daubert even
    applies under these circumstances.                    The Neases insist that it
    does not.      We disagree; Daubert clearly applies here.
    In    Daubert,    the     Supreme      Court   addressed     an    evidentiary
    issue       that   had      long     divided     federal    courts—whether        the
    admissibility of expert scientific testimony was governed by the
    “general acceptance” test established in Frye v. United States,
    
    293 F. 1013
    (D.C. Cir. 1923), 2 or the later-adopted standards set
    forth in Federal Rule of Evidence 702, 
    see 509 U.S. at 586
    –87 &
    n.5.       Daubert held that the Federal Rules of Evidence superseded
    Frye and that the admissibility of scientific evidence no longer
    2
    Under Frye, expert scientific testimony was admitted only
    if the expert opinion was based on principles that were
    “generally accept[ed]” in “the particular field in which it
    
    belongs.” 293 F. at 1014
    .
    18
    was limited to knowledge or evidence “generally accepted” as
    reliable in the relevant scientific community.                 
    See 509 U.S. at 588
    –89.
    Thus, Daubert made clear that the governing standard for
    evaluating proposed expert testimony was set forth in Rule 702,
    which at the time provided:           “If scientific, technical, or other
    specialized    knowledge       will    assist    the     trier        of   fact     to
    understand    the   evidence    or    to   determine     a   fact     in   issue,    a
    witness qualified as an expert by knowledge, skill, experience,
    training, or education, may testify thereto in the form of an
    opinion or otherwise.”         
    Daubert, 509 U.S. at 588
    .               Implicit in
    the text of Rule 702, the Daubert Court concluded, is a district
    court’s gatekeeping responsibility to “ensur[e] that an expert’s
    testimony both rests on a reliable foundation and is relevant to
    the task at hand.”       
    Id. at 597
    (emphasis added).
    Relevant evidence, of course, is evidence that helps “the
    trier of fact to understand the evidence or to determine a fact
    in issue.”    
    Id. at 591
    (internal question marks omitted).                   To be
    relevant under Daubert, the proposed expert testimony must have
    “a valid scientific connection to the pertinent inquiry as a
    precondition to admissibility.”            
    Id. at 592.
    With respect to reliability, the district court must ensure
    that   the   proffered    expert      opinion   is   “based      on    scientific,
    technical, or other specialized knowledge and not on belief or
    19
    speculation, and inferences must be derived using scientific or
    other valid methods.”              Oglesby v. Gen. Motors Corp., 
    190 F.3d 244
    ,    250     (4th    Cir.   1999).               Daubert       offered    a    number     of
    guideposts       to     help   a    district          court       determine       if     expert
    testimony is sufficiently reliable to be admissible.                                First, “a
    key question to be answered in determining whether a theory or
    technique is scientific knowledge that will assist the trier of
    fact will be whether it can be (and has been) 
    tested.” 509 U.S. at 593
    .       A second question to be considered by a district court
    is “whether the theory or technique has been subjected to peer
    review and publication.”                
    Id. Publication regarding
    the theory
    bears    upon    peer    review;        “[t]he      fact     of   publication       (or    lack
    thereof) in a peer reviewed journal will be a relevant, though
    not     dispositive,      consideration             in      assessing       the   scientific
    validity of a particular technique or methodology on which an
    opinion is premised.”              
    Id. at 594.
                 Third, “in the case of a
    particular      scientific     technique,             the    court    ordinarily         should
    consider the known or potential rate of error.”                               
    Id. Fourth, despite
       the    displacement           of    Frye,      “‘general     acceptance’”         is
    nonetheless       relevant         to     the        reliability        inquiry.            
    Id. “Widespread acceptance
           can    be     an      important    factor      in     ruling
    particular evidence admissible, and a known technique which has
    been able to attract only minimal support with the community may
    properly be viewed with skepticism.”                        
    Id. (citation and
    internal
    20
    quotation     marks        omitted).           Daubert’s            list        of     relevant
    considerations       is     not    exhaustive;           indeed,       the           Court    has
    cautioned     that        this    “list      of        specific       factors              neither
    necessarily nor exclusively applies to all experts or in every
    case,” Kumho Tire Co. v. Carmichael, 
    526 U.S. 137
    , 141 (1999),
    and that a trial court has “broad latitude” to determine whether
    these   factors      are    “reasonable      measures          of    reliability             in   a
    particular case,” 
    id. at 153.
    The Neases contend that we can affirm because the district
    court   was    not    obliged      to     perform        its    Daubert          gatekeeping
    function in the first place:                   “Because the Daubert test for
    assessing the validity of scientific evidence applies only to
    novel   scientific     testimony,       it     does     not    apply       in        the   expert
    field   of    engineering.”         Brief         of    Appellees          at    29.         This
    bifurcated argument is dead wrong on both counts.
    First, Daubert itself makes clear that its application is
    not limited to newfangled scientific theory, explaining that “we
    do not read the requirements of Rule 702 to apply specially or
    exclusively to unconventional evidence.”                       
    Daubert, 509 U.S. at 592
    n.11.      The Court recognized the common-sense premise that
    “well-established propositions are less likely to be challenged
    than those that are novel,” 
    id., but clearly
    never suggested
    that longstanding theories are immune to a Daubert analysis.
    21
    Second, the Supreme Court made clear more than 17 years ago
    in Kumho Tire that Daubert was not limited to the testimony of
    scientists but also applied “to testimony based on ‘technical’
    and ‘other specialized’ 
    knowledge.” 526 U.S. at 141
    .           Despite
    having         cited        Kumho    Tire        in     their     brief,    the       Neases    are
    apparently        unaware           that    the       very    issue   there          involved   the
    application            of     Daubert       to        the    testimony     of     a     mechanical
    engineer.         See 
    id. at 141
    (“This case requires us to decide how
    Daubert applies to the testimony of engineers and other experts
    who are not scientists.” (emphasis added)).                                 The Kumho Court
    concluded that Rule 702 “applies to all expert testimony” as its
    “language        makes        no    relevant          distinction     between         ‘scientific’
    knowledge and ‘technical’ or ‘other specialized’ knowledge.                                      It
    makes clear that any such knowledge might become the subject of
    expert testimony.”                  
    Id. at 147.
                The Kumho Court affirmed the
    district court’s application of Daubert and decision to exclude
    the engineering expert’s testimony as unreliable.                                      See 
    id. at 158.
    3        And, finally, if Kumho were not enough, this court has
    also         sanctioned       the     application            of   Daubert       to    assess    the
    reliability of expert engineering testimony.                                See Oglesby, 190
    3
    In so holding, the Supreme Court rejected the Eleventh
    Circuit’s view that engineering testimony “[fell] outside the
    scope of Daubert, [and] that the district court erred as a
    matter of law by applying Daubert in this case,” Kumho 
    Tire, 526 U.S. at 146
    , which is precisely the same argument the Neases
    make 
    here. 22 F.3d at 250-51
           (affirming      district       court’s       application        of
    Daubert principles to testimony of a mechanical engineer and
    concluding that the district court did not abuse its discretion
    in excluding the engineer’s opinion as unreliable).
    Accordingly,         we    conclude         that    Daubert       most       certainly
    applies to Sero’s testimony.                  We now turn to consider whether,
    under    Daubert,      the       district     court       properly       admitted     Sero’s
    testimony.
    B.    The     District        Court’s    Application         of    Daubert      to    Sero’s
    Opinions
    As    we   already        explained,        Rule    702     imposes      a    special
    gatekeeping       obligation       on   the    trial      judge    to    ensure      that   an
    opinion offered by an expert is reliable.                         And although a trial
    judge has broad discretion “to determine reliability in light of
    the particular facts and circumstances of the particular case,”
    
    Kumho, 526 U.S. at 158
    , such discretion does not include the
    decision “to abandon the gatekeeping function,” 
    id. at 158–59
    (Scalia, J., concurring).
    In    ruling    on    Ford’s     motion      in    limine    to    exclude     Sero’s
    testimony as unreliable under Daubert, the district court simply
    dismissed “[e]very argument raised by [Ford]” as “go[ing] to the
    weight, not admissibility, of [Sero’s] testimony.”                              J.A. 526.
    The court did not use Daubert’s guideposts or any other factors
    to assess the reliability of Sero’s testimony, and the court did
    23
    not make any reliability findings.                  Indeed, the district court
    referred neither to Rule 702 nor to Daubert.                   We are forced to
    conclude that the court abandoned its gatekeeping function with
    respect to Ford’s motion in limine.
    In denying Ford’s post-trial Rule 50(b) motion for judgment
    as a matter of law (which renewed Ford’s argument that Sero’s
    opinion should have been excluded under Daubert), the district
    court again “[found] that Ford’s arguments go to the weight the
    jury should afford Mr. Sero’s testimony, not its admissibility.”
    J.A. 3481.      Although the district court this time cited Daubert
    and stated that, according to Sero, “the methodology he employed
    is consistent and trustworthy and what historically is used in
    failure to decelerate cases,” J.A. 3479, the court repeatedly
    emphasized that Ford effectively raised its objections to Sero’s
    opinion through cross-examination.                  For the district court to
    conclude that Ford’s reliability arguments simply “go to the
    weight    the    jury   should    afford     Mr.     Sero’s   testimony”       is   to
    delegate   the    court’s    gatekeeping          responsibility    to   the   jury.
    “The main purpose of Daubert exclusion is to protect juries from
    being swayed by dubious scientific testimony.”                     In re Zurn Pex
    Plumbing Prods. Liab. Litig., 
    644 F.3d 604
    , 613 (8th Cir. 2011).
    The   district     court’s       “gatekeeping        function”     under   Daubert
    ensures    that    expert    evidence        is    sufficiently     relevant        and
    reliable when it is submitted to the jury.                    Rather than ensure
    24
    the reliability of the evidence on the front end, the district
    court effectively let the jury make this determination after
    listening to Ford’s cross examination of Sero.
    In sum, the district court did not perform its gatekeeping
    duties   with   respect     to   Sero’s     testimony.      The   fact    that    an
    expert   witness      was    “subject       to    a   thorough    and    extensive
    examination” does not ensure the reliability of the expert’s
    testimony; such testimony must still be assessed before it is
    presented to the jury.           McClain v. Metabolife Int’l, Inc., 
    401 F.3d 1233
    , 1238 (11th Cir. 2005).                 Thus, we are of the opinion
    that the district court abused its discretion here “by failing
    to act as a gatekeeper.”              Id.; see 
    Kumho, 526 U.S. at 158
    –59
    (Scalia, J. concurring) (“[T]rial-court discretion in choosing
    the manner of testing expert reliability . . . is not discretion
    to abandon the gatekeeping function . . . [or] to perform the
    function inadequately.”).
    C.   Sero’s testimony should have been excluded under Daubert
    1. Sero’s testimony that the speed control assembly                       was    not
    reasonably safe because it was susceptible to binding
    “[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, 190 F.3d at 249
    (internal quotation marks omitted).                     “A
    reliable expert opinion must [not] be based . . . on belief or
    25
    speculation.”           
    Id. at 250.
           One especially important factor for
    guiding a court in its reliability determination is whether a
    given theory has been tested.                     According to Daubert, “a key
    question    to      be    answered    in     determining      whether    a   theory         or
    technique is scientific knowledge that will assist the trier of
    fact will be whether it can be (and has been) 
    tested.” 509 U.S. at 593
    .
    Sero’s opinion had three critical components:                            that the
    speed control assembly in the 2001 Ford Ranger was vulnerable to
    binding    because        the   design      allowed     for   contaminant       to    lodge
    between the speed control guide tube and the casing cap; that
    such binding in fact occurred while Howard was driving his 2001
    Ranger, resulting in the accident; and that there were safer
    alternative speed control assembly designs available to Ford for
    use in the 2001 Ranger.
    Testing was of critical importance in this case as Sero
    conceded that the speed control cable in the Neases’ Ranger was
    not    bound       or    wedged;     the    cable     “moved       freely”   when         Sero
    performed      a    post-accident          inspection    of    the    Neases’    Ranger.
    J.A. 676.      In fact, Sero admitted he has never seen any vehicle
    with “post-crash binding.”                 J.A. 679.     Sero, however, conducted
    no testing whatsoever to arrive at his opinion.                          Specifically,
    he has never tested a 2001 Ford Ranger to determine whether it
    is    actually      possible    for    enough     debris      to   accumulate        in    the
    26
    casing cap during normal operation to resist the 7.2 pounds of
    force exerted by the return springs to pull the throttle closed.
    Sero conceded that he never ran any tests to confirm his theory:
    Q.   Now, as I understand it, . . . you have not
    demonstrated your unidirectional binding theory on Mr.
    Nease’s speed control cable, have you?
    A.    No, I have not.
    Q. You have not even attempted to simulate your speed
    control binding theory on Mr. Nease’s speed control
    cable, have you?
    A.    No.
    Q. You have not demonstrated your unidirectional
    binding theory [using] another 2001 Ford Ranger, have
    you?
    A.    No.
    Q. You have not even attempted to simulate your speed
    control malfunction theory with an exemplar 2001 Ford
    Ranger, have you?
    A.    No, I have not.
    J.A. 678.
    Sero’s failure to test his hypothesis renders his opinions
    on the cause of Howard’s accident unreliable.                   Although Sero’s
    theory is plausible and “may even be right[,] . . . it is no
    more than a hypothesis, and it thus is not knowledge, nor is it
    based upon sufficient facts or data or the product of reliable
    principles       and     methods   applied    reliably   to   the   facts   of   the
    case.”       Tamraz v. Lincoln Elec. Co., 
    620 F.3d 665
    , 670 (6th Cir.
    2010)        (internal     quotation    marks    and     alterations    omitted).
    27
    Generally,          scientific             methodology            involves         “generating
    hypotheses and testing them to see if they can be falsified.”
    
    Daubert, 509 U.S. at 593
    .                   Sero presented a hypothesis only—he
    failed to validate it with testing.
    Daubert      is    a    flexible         test     and    no   single      factor,     even
    testing,       is   dispositive.                But      Daubert’s       other     reliability
    markers likewise suggest that Sero’s testimony should not have
    been    admitted         under      Rule    702.         Sero     has    not     published     or
    otherwise subjected his theory to peer review.                                   Actually, it
    would    hardly     be     possible        to     solicit       peer    review     since     Sero
    conducted no tests and used no “methodology” for reaching his
    opinions other than merely observing dirt on the speed control
    assembly    components.              And,       for     this    same    reason,        we   cannot
    assess the potential rate of error of Sero’s methodology—he did
    not employ a particular methodology to reach his conclusions.
    Daubert also suggests that district courts, in performing
    their gatekeeping functions, consider whether and to what extent
    an     expert’s     theory          has    been        accepted      within      the    relevant
    scientific or engineering community.                           See 
    Daubert, 509 U.S. at 593
    -94.     Despite their contention that Daubert does not apply,
    the Neases nonetheless suggest that the internal FMEA performed
    by Ford in 1987, which Sero relied upon to support his opinion,
    is widely accepted by engineers—Ford’s own engineers in this
    case—as    a    method        for    identifying          design       defects.        The   FMEA
    28
    relied upon by Sero, however, does not establish that Sero’s
    theory is widely accepted in the relevant engineering community.
    To begin with, the 1987 FMEA does not even apply to the
    2001 Ranger; rather, the 2004 FMEA, which originated in 1997,
    applied to the 2001 Ranger at issue here.                   In other words, Sero
    rests his theory on an FMEA produced for different designs.                            The
    1987 FMEA, therefore, lacks a “valid scientific connection to
    the pertinent inquiry,” 
    Daubert, 509 U.S. at 592
    , and is not
    “relevant to the task at hand,” 
    id. at 597.
    Moreover, to the extent Nease claims the FMEA performed by
    Ford    in   1987   proves   that      the    speed   cable   is   susceptible          to
    binding, he misconstrues the nature of the FMEA process.                           FMEA
    is part of the design process itself; design engineers follow
    this    method   well    before    the   design       is   complete    to    “identify
    potential failure modes and rate the severity of their effects”
    and “help engineers focus on eliminating product and process
    concerns and help prevent problems from occurring.”                         J.A. 968.
    As Ford engineer James Engle explained, “[t]he purpose [of] the
    FMEA is to analyze the [current] design . . . [and] give[] the
    engineer information beforehand . . . to let the engineer know
    areas    where      he   needs    to   focus.”         J.A.    1279.         It   is     a
    “brainstorming session” performed on the front end of the design
    process to “identify any potential failure modes.”                          J.A. 2157.
    And, in this case, because it is “conceivable” that “grime or
    29
    some sort of debris [could] enter[] into the cable and caus[e]
    sticking,” Ford naturally listed the potential binding of the
    speed control cable “in a brainstorming session of [potential]
    failure      modes.”        J.A.     2157.        But     Ford   included    numerous
    “mitigating” features in its final design, such as an engine
    cover, aimed at eliminating potential problems identified in the
    FMEA.     J.A. 2157.       Ford also placed the throttle “high up on the
    engine”      to    mitigate    the     intake        of   “[b]igger    and     heavier
    particles [which] take more force to be . . . moved up . . . to
    the    top   of    the    engine.”      J.A.      2157-58.       Additionally,    the
    components of the speed control assembly were made of nylon that
    had a slippery quality and “a very low coefficient of friction.”
    J.A. 2433.
    In sum, the FMEA relied upon by Sero cannot be viewed as
    having established that the binding of the speed control cable
    was a recurring design problem in the 2001 Ranger.                             And it
    cannot be used as a proxy for the testing that Sero failed to
    do.     Ford’s FMEA process merely identifies conceivable design
    failures; it does not produce them via testing.
    2. Sero’s testimony that there were safer alternative designs
    that Ford could have used in the 2001 Ranger
    To establish strict liability under West Virginia law, the
    plaintiff must show that the “product is defective in the sense
    that    it    is    not     reasonably        safe      for   its   intended     use.”
    30
    Morningstar v. Black & Decker Mfg. Co., 
    253 S.E.2d 666
    , 683 (W.
    Va. 1979).         “The standard of reasonable safeness is determined .
    . . by what a reasonably prudent manufacturer’s standards should
    have     been      at    the     time     the      product          was      made.”      
    Id. Significantly, the
    West Virginia Supreme Court explained that
    the determination of what a “reasonably prudent manufacturer’s
    standards should have been at the time” requires a consideration
    of “the general state of the art of the manufacturing process,
    including design.”            
    Id. (emphasis added).
    Ford argues that West Virginia law, as articulated by the
    Morningstar        court,      therefore      requires          a    products       liability
    plaintiff to prove that a reasonably prudent manufacturer would
    have adopted a safer design during the relevant time period.
    The    Neases      disagree,     relying      on   a   couple         of   district    court
    opinions that suggest the West Virginia Supreme Court “has not
    stated       one   way   or    the    other     whether     a       design    defect   claim
    requires proof of a safer alternative design of the allegedly
    defective product.”            Mullins v. Ethicon, Inc., 
    117 F. Supp. 3d 810
    , 821 (S.D.W. Va. 2015) (internal quotation marks omitted);
    Keffer v. Wyeth, 
    791 F. Supp. 2d 539
    , 547 (S.D.W. Va. 2011).
    While it is true that West Virginia law on the matter is
    not crystal clear, we agree with Ford that Morningstar “can only
    be    read    to   require     the    production       of   evidence         on   reasonable
    alternative         design,      to     gauge      what     ‘should          have     been.’”
    31
    Restatement (Third) of Torts: Products Liability § 2, Reporter’s
    Note   (1998).         Although      Morningstar         does    not     use    the    phrase
    “alternative         design,”    a   plaintiff      in    a     design    case,       for    all
    practical purposes, must identify an alternative design in order
    to establish the “state of the art.”                     See Church v. V.R. Wesson,
    
    385 S.E.2d 393
    ,   396    (W.    Va.    1989)     (holding        plaintiff      in    a
    defective design case failed to establish a prima facie case
    because plaintiff’s expert identified an alternative design that
    was not feasible at the time of manufacture and thus failed to
    prove that defendant’s design was not “state of the art”).
    Sero     testified       that    safer,      proven       design        alternatives
    existed       during      the    relevant      time      period     that       would        have
    prevented       Howard’s        accident.          One    preferable           alternative,
    according       to    Sero,     incorporates        a    “nipple       wipe”      to    clean
    contaminants off the cable as it moves.                           Another alternative
    identified by Sero utilizes a “boot” which blocks debris and
    grime from accumulating on the cable.                     And, a third alternative
    design that Sero believed would have prevented Howard’s accident
    simply had a larger gap between the guide tube and the casing
    cap.     Sero pointed out that Ford had been using all of these
    alternative design features for many years by the time the 2001
    Ranger was produced.
    Sero, however, performed no tests or studies to determine
    whether,      in     fact,      these   older,      long-standing          designs          were
    32
    involved in fewer binding incidents.                        According to Sero, such
    tests were unnecessary because designs such as the nipple wipe
    had   been    in    use      for     50     years    and     therefore       were   “proven
    elements.”      J.A. 669.            Similarly, he offered no data from any
    other     studies    or      accident       records    to     prove    that     the      older
    designs were less likely to bind than the one incorporated in
    the Neases’ 2001 Ranger.               Sero instead simply proclaimed without
    any   support      that      the    alternative       designs    he    identified         were
    safer than the design of the speed control cable assembly in the
    2001 Ranger.
    This    testimony            should     have    been     excluded       as    it    was
    “unsupported       by     any      evidence    such    as    test     data    or    relevant
    literature in the field.”                   
    Oglesby, 190 F.3d at 249
    (internal
    question marks omitted).                   The fact that the alternatives have
    generally    been       in   use     for    decades    is    wholly    insufficient        to
    prove that such designs were safer with respect to the alleged
    binding incident and that reasonably prudent manufacturers would
    have adopted them. 4
    4To the extent that the Neases argue that testing or other
    comparative   analysis   of  Sero’s   alternative  designs   was
    unnecessary because they were not novel designs, their argument
    relies upon the same flawed understanding of Daubert that we
    have already rejected.
    33
    III.
    Without Sero’s testimony, the Neases cannot prove that the
    design of the speed control assembly in the 2001 Ford Ranger
    renders the vehicle “not reasonably safe for its intended use.”
    
    Morningstar, 253 S.E.2d at 683
    .      Accordingly, we reverse the
    district court’s denial of Ford’s post-trial motion for judgment
    as a matter of law and remand the case to the district court for
    entry of judgment in Ford’s favor.   And, because the granting of
    judgment as a matter of law effectively ends this litigation, we
    need not reach Ford’s challenges to the jury instruction and the
    admission of prior incidents evidence.
    REVERSED AND REMANDED WITH INSTRUCTIONS
    34