Williams et al v. Smith & Nephew Inc.
Filing
542
MEMORANDUM in all BHR Tracks Signed by Judge Catherine C. Blake on 3/1/2021. Associated Cases: 1:17-md-02775-CCB et al.(cags, Deputy Clerk)
Case 1:14-cv-03138-CCB Document 542 Filed 03/01/21 Page 1 of 34
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MARYLAND
IN RE: SMITH & NEPHEW
BIRMINGHAM HIP RESURFACING
(BHR) HIP IMPLANT PRODUCTS
LIABILITY LITIGATION
MDL No. 2775
Master Docket No. 1:17-md-2775
JUDGE CATHERINE C. BLAKE
THIS DOCUMENT RELATES TO ALL
BHR TRACK CASES
MEMORANDUM
Now pending are several motions filed by defendant Smith & Nephew to exclude the
opinion testimony of the plaintiffs’ expert witnesses. These motions require the court to decide
whether the proffered testimony concerns matters preempted from litigation and whether various
experts are qualified to offer the challenged opinions. The matter has been fully briefed and oral
argument was heard on January 27, 2021. Preliminarily, the court notes the difficulty of drawing
precise lines that anticipate every iteration of an opinion that may be offered in support of a specific
claim that itself is yet to be precisely defined in the context of an individual case. With that caveat,
and for the reasons stated herein, the court will grant in part, reserve in part, and deny in part each
of the motions.
LEGAL STANDARD
Rule 702 of the Federal Rules of Evidence, which “was intended to liberalize the
introduction of relevant expert evidence,” Westberry v. Gislaved Gummi AB, 178 F.3d 257, 261
(4th Cir. 1999), provides that a qualified expert witness “may testify in the form of an opinion or
otherwise if . . . [his or her] scientific, technical, or other specialized knowledge will help the trier
of fact to understand the evidence or to determine a fact in issue.” Fed. R. Evid. 702(a). The
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expert’s testimony must be “based on sufficient facts or data” and must be “the product of reliable
principles and methods.” Fed. R. Evid. 702(b), (c). And the expert must “reliably appl[y] the
principles and methods to the facts of the case.” Fed. R. Evid. 702(d).
It is the district judge’s responsibility to make an initial determination of an expert’s
qualifications, see Fed. R. Evid. 104(a), and to “ensur[e] that an expert’s testimony both rests on a
reliable foundation and is relevant to the task at hand.” Daubert v. Merrell Dow Pharms., 509 U.S.
579, 597 (1993). Relevant evidence is of course that which “helps the trier of fact to understand
the evidence or determine a fact in issue.” McKiver v. Murphy-Brown, LLC, 980 F.3d 937, 959
(4th Cir. 2020) (internal quotation marks omitted). Reliable expert testimony is “based on
scientific, technical, or other specialized knowledge and not on belief or speculation” and derives
any inferences “using scientific or other valid methods.” Id. (internal quotation marks omitted).
The Supreme Court has identified five factors that the court may consider in evaluating the
reliability of an expert’s reasoning or methodology: (1) whether the particular scientific theory has
been or can be tested; (2) whether the theory has been subjected to peer review and publication;
(3) the known or potential rate of error; (4) whether there are standards controlling the method;
and (5) whether the technique has gained general acceptance in the relevant scientific community.
See Daubert, 509 U.S. at 593–94. These factors, which “may or may not be pertinent in assessing
reliability,” are not meant to be “definitive” or to constitute a “checklist.” Kumho Tire Co., Ltd. v.
Carmichael, 526 U.S. 137, 150, 151 (1999) (internal quotation marks omitted).
“As in all questions of admissibility,” the party seeking the admission of expert testimony
“must come forward with evidence from which the court can determine that the proffered
testimony is properly admissible”—i.e., that it is reliable and relevant. Md. Cas. Co. v. Therm-ODisc, Inc., 137 F.3d 780, 783 (4th Cir. 1998). Yet the trial court’s role as a gatekeeper is not
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intended to serve as a “replacement for the adversary system, and consequently, the rejection of
expert testimony is the exception rather than the rule.” In re Lipitor (Atorvastatin Calcium) Mktg.,
Sales Practices and Prods. Liab. Litig., 892 F.3d 624, 631 (4th Cir. 2018) (internal quotation marks
omitted).
ANALYSIS
The plaintiffs have retained as expert witnesses Larry Spears, Mari Truman, Jeffrey
Shapiro, Yadin David, and L. Scott Marshall. Smith & Nephew contends that much of the
testimony offered by these experts is inadmissible for either of two primary reasons: (1) it is
irrelevant insofar as it only relates to claims preempted from this litigation and (2) the experts are
not qualified to offer certain opinions. The court will first clarify which claims are preempted from
litigation and then proceed to evaluate the admissibility of the various opinions challenged by
Smith & Nephew.
I. PREEMPTION
As this court has explained in previous decisions, the states are expressly preempted from
establishing with respect to devices intended for human use any requirements which are different
from or in addition to requirements imposed under the FDA’s statutory framework governing
premarket approval of such devices. See, e.g., In re Smith & Nephew Birmingham Hip Resurfacing
(BHR) Hip Implant Prods. Liab. Litig., 300 F. Supp. 3d 732, 743, 745 (D. Md. 2018) (hereinafter
“In re BHR”); see also 21 U.S.C. § 360k. State law requirements are different from or in addition
to requirements under the statute if (1) the federal government has established requirements
applicable to the challenged medical device and (2) the state law requirements are different from
or in addition to those requirements and relate to safety and effectiveness. See Riegel v. Medtronic,
Inc., 552 U.S. 312, 321–24 (2008). Still, under Riegel states remain free to impose duties that
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parallel, rather than add to, federal requirements. Id. at 330. A state law parallels federal
requirements if it seeks to impose liability for conduct that also violates an FDA regulation. See
Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1326 (11th Cir. 2017).
A state law is impliedly preempted by FDA regulations if the law exists “solely” by virtue
of the federal requirements and is not a “traditional state tort law which [] predate[s] the federal
enactments in question[].” Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 353 (2001); see
21 U.S.C. 337(a) (subject to a few enumerated exceptions, all proceedings to enforce or restrain
violations of the FDA statute must be brought by the federal government). A plaintiff therefore
may not transform a federal regulation into a private right of action, even if a plaintiff may rely on
preexisting and traditional state tort law to assert his or her claims. See In re BHR, 300 F. Supp.
3d at 747.
Preemption is a significant hurdle. To survive a preemption challenge, “a plaintiff has to
sue for conduct that violates a federal requirement (avoiding express preemption), but cannot sue
only because the conduct violated that federal requirement (avoiding implied preemption).” Mink,
860 F.3d at 1327.
This court has previously held that some of the plaintiffs’ claims are preempted, including:
•
•
•
•
•
any strict liability claims;
any claim that Smith & Nephew had a duty to change its labeling;
any claim that Smith & Nephew had a duty to directly warn patients or the medical
community (as opposed to a duty to warn the FDA);
any claim that attempts to impose liability on Smith & Nephew for claiming the
BHR was safe (as opposed to safer than competitor models);
and any claim that attempts to impose liability on Smith & Nephew for any
representation the FDA required Smith & Nephew to make.
In re BHR, 300 F. Supp. 3d at 743, 745, 747–48. But the plaintiffs’ other claims, to the extent they
parallel federal obligations, are not necessarily preempted. See id. at 743–44.
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Smith & Nephew points to this court’s prior rulings to contend that much of the testimony
offered by these experts is irrelevant insofar as it only relates to preempted claims. The plaintiffs’
response, in essence, is that Smith & Nephew’s arguments in support of preemption ignore the
federal duties imposed by the conditions of the PMA approval. That approval, issued in 2006,
authorized Smith & Nephew to begin commercial distribution of the BHR system subject to
conditions requiring, among other things, a surgeon training program and the reporting of adverse
events.
Condition No. 3 required Smith & Nephew to implement a surgeon training program “as
outlined in the PMA.” (ECF 2427, Ex. 9 at 6). To summarize, under Condition No. 3, the training
was to include quarterly teleconferences or meetings for the first two years in order to provide
clinical updates, discuss adverse events, and identify recommendations for improvements to the
training program and to labeling. (Id.). As the plaintiffs explain in their opposition, the FDA did
not initially provide any other specific requirements for the content of the surgeon training
program, though Smith & Nephew created a program that was merged with the post-approval
study requirements into a single document. (See ECF 2427, Ex. 119). The surgical training plan
stated that it is important for surgeons to be “familiar with the indications, contraindications,
warnings, and precautions.” (Id. at ¶ 2.1). The program required Smith & Nephew to provide
“thorough training” to a “Core Surgeon” group which would then acquire “actual device
implantation experience.” (Id.). The Core Surgeons would in turn “transfer their experience and
knowledge to other interested surgeons in the US.” (Id.). Both the introductory training for Core
Surgeons and the later training for interested U.S. surgeons was to include lectures covering
several topics, including “[a]nticipated PMA approved indications, contraindications, warnings,
and precautions (as known at the time and reinforced after approval).” (Id. at ¶¶ 2.2, 2.4). And the
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training was to be “linked to the Post-Approval Study conducted in the U.S.” as the Core Surgeons
and others trained under the program would “participate in a Post-Approval Study.” (Id. at ¶ 2.6).
Condition No. 4 required Smith & Nephew to provide data—at first on a biannual basis
and then on an annual basis—analyzing “adverse events and complaints (including MDRs)
received regarding the BHR system.” (ECF 2427, Ex. 9 at 6). Additionally, it required Smith &
Nephew to “use this analysis to provide a justification for modifications to the training program,
post-approval study, labeling, and/or device design.” (Id.). And it provided that “[a]ny
modification to the post-approval study, labeling, and/or device design will be submitted for FDA
review and approval prior to implementation.” (Id.). The PMA provided that “continued approval
. . . is contingent upon the submission of postapproval reports required under 21 CFR 814.84 at
intervals of 1 year from the date of the original PMA.” (Id. at 9). The PMA notes that the
postapproval reports “shall include” an “[i]dentification of changes described in 21 CFR 814.39(a)
and changes required to be reported to FDA under 21 CFR 814.39(b),” as well as a bibliography
and summary “of unpublished reports of data from any clinical investigations or nonclinical
laboratory studies involving the device or related devices” and “reports in the scientific literature
concerning the device.” (Id.). See also 21 C.F.R. § 814.84(b)(2)(i)–(ii) (requiring periodic reports
to contain a summary and bibliography of unpublished and published reports of data from any
clinical investigations or nonclinical laboratory studies involving the device).
Additionally, the PMA and 21 C.F.R. § 814.82(a)(9) requires Smith & Nephew to submit
copies of written adverse reaction and device defect reports to the FDA after it receives or has
knowledge about, among other things, “[a]ny adverse reaction, side effect, injury, toxicity, or
sensitivity reaction that is attributable to the device” and either “has not been addressed by the
device’s labeling” or “has been addressed by the device’s labeling but is occurring with unexpected
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severity or frequency.” (ECF 2427, Ex. 9 at 9). And finally, the PMA and the Medical Device
Reporting (“MDR”) Regulation require Smith & Nephew to report to the FDA whenever they
become aware of information that reasonably suggests a device marketed by the manufacturer may
have caused serious injury or death or has malfunctioned and would be likely to cause or contribute
to a death or serious injury if the malfunction were to recur. (Id. at 10). See also 21 C.F.R. §
803.10(c).
The PMA Approval Letter also advised Smith & Nephew that “the results of the postapproval studies, training program assessment, and adverse event analysis outlined in [Conditions]
1–4 . . . must be reflected in the labeling (via a supplement) when the post-approval study is
completed, and/or at earlier timepoints, as needed.” (ECF 2427, Ex. 9 at 6). Failure to comply with
“any postapproval requirement constitutes a ground for withdrawal of approval of a PMA” and
“[c]ommercial distribution of a device that is not in compliance with these conditions is a violation
of the act.” (Id. at 7). And regarding warranties, the PMA letter stated any warranty statements
“must be truthful, accurate, and not misleading, and must be consistent with applicable Federal
and State laws.” (Id. at 3).
With this background in mind, the court will address Smith & Nephew’s objections in turn.
A. Premarket Approval and Fraud-on-the-FDA
Smith & Nephew believes that several opinions offered by the plaintiffs’ experts
impermissibly seek to challenge the FDA’s decision to grant a PMA or otherwise raise a fraud-onthe-FDA claim. These opinions include, among others, the following assertions:
1. “There were numerous pieces of information that Smith & Nephew did not provide to FDA
during the PMA process.” (ECF 2384-3, Ex. C, Spears Report at 6).
2. “FDA would have more likely than not delayed the approval decision” if Smith & Nephew
had disclosed additional information. (Id. at 7).
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3. “Smith & Nephew failed to provide FDA and surgeons implanting the BHR a reasonable
assurance of the safety and efficacy of the BHR.” (Id. at 4).
4. Smith & Nephew’s “[a]nnual reports . . . contained misleading statements about what
Smith & Nephew knew about [the BHR’s] performance” (Id. at 21).
5. Smith & Nephew failed to disclose “data to the FDA during the PMA approval process.”
(ECF 2385-4, Ex. B, Truman Report at 5).
6. Smith & Nephew “failed to act as a reasonably prudent manufacturer in that it did not
provide a reasonable assurance of safety and efficacy to the FDA when it used and
submitted only five years of McMinn’s data to seek and obtain approval.” (ECF 2388-3,
Ex. A, David Report at 10).
7. Smith & Nephew “failed to . . . provide the FDA with information regarding the learning
curve for surgeons implanting the device.” (Id.).
The plaintiffs believe that these opinions are admissible insofar as they point to violations
of federal requirements which also could establish a state law negligence claim. Specifically, the
plaintiffs argue that Smith & Nephew violated its traditional state law duty to warn surgeons when
it first introduced the BHR to market and that it acted negligently in seeking BHR approval based
on the problematic data provided by the inventor of the BHR. (See ECF 2427, Opposition at 53).
The plaintiffs believe violations of these state law duties can be shown through Smith & Nephew’s
purported violation of 21 U.S.C. § 360e, which provides that any person “seeking premarket
approval for a class III device” may file with the FDA a report which “shall” contain “[a] statement
that the applicant believes to the best of the applicant’s knowledge that all data and information
submitted” to the FDA “are truthful and accurate and that no material fact has been omitted in the
report.” 21 U.S.C. § 360e(c)(2)(A)(x).
In Buckman Co. v. Plaintiffs’ Legal Committee, the Supreme Court described the FDA’s
various mechanisms to detect and punish false statements and fraud in the context of the 510(k)
process—and, by reference, in the PMA approval process. 531 U.S. at 348–49. Because “the
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federal statutory scheme amply empowers the FDA to punish and deter fraud” perpetrated against
the agency, the Supreme Court held that a plaintiff’s state-law “fraud-on-the-FDA claims conflict
with, and are therefore impliedly preempted by, federal law.” Id. at 348. The Court reasoned that
fraud-on-the-FDA claims would “cause applicants to fear that their disclosures to the FDA,
although deemed appropriate by [the FDA], will later be judged insufficient in state court.” Id. at
351.
That is why, as this court has previously stated, “PMA approval is a decision left to the
FDA[.]” In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Prods. Liab.
Litig., No. 17-md-1775, 2018 WL 3079699, at *2 n.4 (D. Md. June 20, 2018). If the plaintiffs were
allowed to challenge the premarket approval process, courts would, contrary to Congress’s desire,
“have the power to declare medical devices unreasonably dangerous after the FDA had already
granted device approval.” In re BHR, 300 F. Supp. 3d at 743. It is of no avail that the plaintiffs
here wish to assert not that Smith & Nephew committed fraud on the FDA, but rather that it was
negligent in omitting material facts when submitting its PMA. The FDA has the power to require
the submission of any additional information it deems necessary during the approval process, so a
state law negligence claim which would impose further disclosure requirements than already
provided for in the statute is preempted. See 21 U.S.C. § 360e(c)(2)(A)(xi); cf. Buckman, 531 U.S.
at 348 (citing the parallel provision for the Section 510(k) process).
But not every allegation that a manufacturer has made misrepresentations to the FDA will
constitute a preempted fraud-on-the-FDA claim. In Hughes v. Boston Scientific Corp., the Fifth
Circuit Court of Appeals addressed the question of whether a plaintiff’s state law failure to warn
claim would be preempted under Buckman. 631 F.3d 762, 775 (5th Cir. 2011). Hughes brought a
failure to warn claim against the defendant manufacturer and attempted to base the claim on the
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corporation’s violation of the FDA’s MDR regulations. Id. In Buckman, by contrast, the plaintiffs
attempted to assert a freestanding federal cause of action based solely on a violation of the FDA’s
regulations without reference to any parallel state law cause of action. 531 U.S. at 352–53 (“In the
present case . . . the fraud claims exist solely by virtue of the [federal] disclosure requirements.”).
The Fifth Circuit held that Hughes’ failure to warn claim, which was based on Mississippi tort law,
was “not analogous to the ‘fraud-on-the-FDA’ theory in Buckman,” which was based only on a
violation of federal regulations. 631 F.3d at 775. Consequently, Hughes’ failure to warn claims
were not preempted. Id. at 776.
Thus, in accord with Buckman, the court will exclude the challenged testimony that relates
to the PMA approval process. 1 The claims to which such testimony might be relevant are expressly
or impliedly preempted by federal law and such testimony would invite a jury to question the
FDA’s decision to grant premarket approval. On the other hand, in accord with Hughes, the court
will not exclude any opinions that Smith & Nephew failed to make adequate disclosures in its
required annual reports after receiving premarket approval, as those opinions may be relevant to a
failure to warn claim that is not preempted. Smith & Nephew cannot defeat such failure-to-warn
claims, which are based on a failure to comply with the conditions of premarket approval, simply
by recharacterizing such claims as fraud-on-the-FDA claims. See Hughes, 631 F.3d at 775.
B. Labeling
1
It is a separate issue whether any experts may properly offer opinions speculating as to hypothetical actions the
FDA may or may not have taken, as Spears’ second challenged opinion does—and as several other challenged
opinions subsequently discussed within this memorandum do. The Fifth Circuit Court of Appeals has suggested, at
least on the basis of Mississippi law, that an “entirely speculative” claim about regulatory actions the FDA may have
taken is an untenable theory of causation. Hughes v. Boston Sci. Corp., 631 F.3d 762, 776 n.12 (5th Cir. 2011). Yet
the court does not dwell on this issue because counsel for the plaintiffs represented at oral argument that the
plaintiffs would not seek to admit into evidence any such speculative testimony at trial.
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Smith & Nephew believes that several opinions offered by the plaintiffs’ experts
impermissibly seek to challenge the adequacy of the BHR system’s FDA-approved labeling. These
opinions include, among others, the following assertions:
1. “Smith & Nephew was aware that females and smaller heads were not doing as well as the
larger head sizes and thus it was necessary to make a label change in the [IFU].” (ECF
2384-3, Ex. C, Spears Report 12).
2. “A prudent medical device company is under a duty to . . . make product or labeling
modifications when it has evidence of higher than expected failure rates.” (Id. at 19).
3. The BHR’s “labeling and IFUs inadequately addressed the incidence and severity of
implant failure.” (ECF 2386-3, Ex. A, Shapiro Report at 3).
4. The BHR’s labeling and IFUs “failed to adequately provide physicians with information
they needed to assess the propriety of using the BHR implant, or to enable them to have
complete and accurate discussions with their patients about the risks, benefits and
alternatives to the BHR medical device.” (Id.).
5. Smith & Nephew failed to “use the analysis of adverse events and complaints . . . to inform
surgeons of the known risks associated with the BHR through label changes.” (ECF 23883, Ex. A, David Report at 17).
6. Smith & Nephew “was under a duty to contact the FDA to request [the] addition of updated
risk information as well as updated warnings [and] precautions[.]” (ECF 2385-4, Ex. B,
Truman Report at 9).
7. With additional revision rate information, the “FDA would have more likely than not
caused Smith & Nephew to seek product or labeling changes at that time.” (ECF 2384-3,
Ex. C, Spears Report at 22)
8. “The warnings and instructions provided with BHR were deficient at all times.” (ECF
2385-4, Ex. B, Truman Report at 9).
The plaintiffs believe these opinions are admissible because Smith & Nephew had a duty
under PMA Condition No. 4 to analyze adverse events and provide a justification for labeling
changes. But Condition No. 4 does not require Smith & Nephew to change its labeling; rather, it
requires Smith & Nephew to provide the FDA with an “analysis of adverse events and complaints”
which Smith & Nephew “agree[d]” to use to “provide a justification for modifications” to labeling.
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(ECF 2427, Ex. 9 at 6). Significantly, though, “[a]ny modification” to labeling “will be submitted
for FDA review and approval prior to implementation.” (Id.). Thus, as this court previously held,
“[a]ny claim . . . that Smith & Nephew had a duty to change its labeling . . . should be preempted
as an attempt to impose requirements that add to or differ from federal regulations.” In re BHR,
300 F. Supp. 3d at 745; see also Hughes, 631 F.3d at 769 (holding that the plaintiff’s products
liability claim challenging the adequacy of FDA-approved labeling was preempted). The court will
therefore exclude the challenged testimony.
However, this ruling is not to be construed as applying wholesale to each theory underlying
the plaintiffs’ failure to warn claims. A claim which challenges a representation the FDA blessed
in the approval process is preempted, while a claim challenging a warranty above and beyond any
guarantee that was explicitly or implicitly approved by the FDA is not preempted. See Wildman v.
Medtronic, Inc., 874 F.3d 862, 868 (5th Cir. 2017). The plaintiffs may pursue their failure to warn
claims, but they may not do so by challenging the sufficiency of the FDA-approved labeling.
C. Warnings
Smith & Nephew believes that several opinions offered by the plaintiffs’ experts which
suggest Smith & Nephew had a duty to warn doctors are impermissible in light of this court’s prior
ruling that any claims Smith & Nephew had a duty to send Dear Doctor letters or other
communications to surgeons are expressly preempted. See In re BHR, 300 F. Supp. 3d at 745.
Additionally, Smith & Nephew challenges any opinion that it had a duty to make changes to its
medical training program. These opinions include, among others, 2 the following assertions:
1. “[The] FDA would not have prevented Smith & Nephew from providing [additional
revision] data to surgeons through . . . Dear Doctor letters.” (ECF 2384-3, Ex. C, Spears
Report at 11).
2
Smith & Nephew also appears to challenge several opinions offered by Truman which go the issue of the adequacy
of warnings, though it is not always clear whether those challenges are based on preemption or on Truman’s
qualifications. The plaintiffs rely heavily on In re Biomet M2a Magnum Hip Implant Products Liability Litigation to
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2. Smith & Nephew should have provided revision data “to implanting surgeons . . . by way
of . . . a Dear Doctor letter or other communication.” (Id. at 20).
3. Smith & Nephew was under a duty to “communicate in unequivocal terms to the FDA and
the professional and lay communities” any newly discovered information that a product
did not provide a “safe patient experience.” (ECF 2388-3, Ex. A, David Report at 6–7).
4. Smith & Nephew “did not notify surgeons already using its implants about failure issues
when S&N made changes to the IFUs.” (ECF 2386-3, Ex. A, Shapiro Report at 3).
5. “Smith & Nephew failed to . . . make changes to the . . . medical education program.” (ECF
2384-3, Ex. C, Spears Report at 19).
6. Smith & Nephew’s “surgeon training and medical education program failed to warn
surgeons” in its core training group about the “1,000 surgery learning curve” and “about
appropriate patient selection.” (ECF 2386-3, Ex. A, Shapiro Report at 35).
The plaintiffs cite to Williams v. Smith & Nephew for the proposition that a duty to warn
under Maryland law “extends beyond the time of sale, and requires the manufacturer to make
‘reasonable efforts’ to convey an effective warning” and for the idea that “reasonable efforts”
include warning a third party “such as the FDA.” 123 F. Supp. 3d 733, 742–43 (D. Md. 2015)
(citation omitted). At first glance, the quoted language appears to leave open the possibility that a
failure to warn claim could encompass a theory that a manufacturer had a duty to directly warn
surgeons or the general public. But a closer reading of the case forecloses that possibility. In
analyzing the plaintiffs’ failure to warn claim in that case, the court noted that the claim was
premised on specific duties imposed on the manufacturer by the PMA, including the duty to
provide the FDA adverse reaction and device defect reports, as well as the duty to report to the
support their argument that Truman is qualified to offer opinions about the adequacy of Smith & Nephew’s
warnings. No. 3:12-MD-2391, 2017 WL 10845178, at *12–13 (N.D. Ind. Dec. 21, 2017). But In re Biomet dealt
only with Truman’s qualifications, i.e., whether her opinions were reliable; it did not deal with preemption, i.e.,
whether her testimony would be relevant to claims in the litigation. Therefore, this court’s preemption ruling with
respect to warnings generally will apply with equal force to any opinions about the adequacy of Smith & Nephew’s
warnings offered by Truman specifically.
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FDA whenever the manufacturer becomes aware that their device may have caused a death or
serious injury. Id. Thus, the plaintiffs’ failure to warn claims in Williams were, like those in
Hughes, “based only on [the manufacturer’s] failure to comply with FDA regulations” and were
therefore “not expressly preempted.” Hughes, 631 F.3d at 769.
That is why, in In re BHR, this court stated that any claim that Smith & Nephew had a duty
to “communicate information to patients or the medical community . . . should be preempted as an
attempt to impose requirements that add to or differ from federal regulations.” 300 F. Supp. 3d at
745; see also Bass v. Stryker Corp., 669 F.3d 501, 515 (5th Cir. 2012) (noting that where the
plaintiff did not plead that the defendant failed to include FDA-approved warnings, any claim that
the defendant had a duty to warn consumers was preempted under Section 360(k)). Accordingly,
the court will exclude the challenged testimony relating to Dear Doctor letters and other
communications to the medical community or patients, but the court also notes that testimony
opining that Smith & Nephew had a duty under the PMA or another federal requirement to disclose
certain information to the FDA directly could still be relevant to a parallel state law failure to warn
claim (as a portion of David’s opinion, cited above, does), so long as that claim can be proved
based on a violation of a condition imposed by the FDA. 3
As to the claims about Smith & Nephew’s duty to make changes to the medical education
program, the plaintiffs have not identified any specific federal requirement which would require
such changes. As this court previously noted, PMA Condition No. 3 required that Smith & Nephew
3
De La Paz v. Bayer Healthcare LLC is instructive on this point. In that case, the U.S. District Court for the
Northern District of California explained that “a claim based on the failure to warn the FDA of adverse events is not
preempted to the extent start tort law recognizes a parallel duty,” with the caveat that “a claim based on a failure to
warn physicians or patients of adverse events would be preempted.” 159 F. Supp. 3d 1085, 1096–97 (N.D. Cal.
2016). To state a failure to warn claim under California law, the plaintiff would have to prove that if the defendant
had properly reported the adverse events to the FDA as required under federal law, that information would have
reached her doctors in time to prevent her injuries. Id. at 1097. Ultimately, the court held that the plaintiff had pled
no facts to plausibly indicate that she or her doctor would have become aware of the adverse events that were
purportedly withheld even if the defendant had timely reported them. Id.
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implement a surgeon training program, see In re BHR, 300 F. Supp. 3d at 744, but no requirement
to make updates to that program has been identified. (ECF 2427, Ex. 9 at 6). And PMA Condition
No. 4, contrary to the plaintiffs’ assertion, did not require Smith & Nephew to make changes to its
medical education program; rather, it required it to analyze adverse events and provide a
justification for any proposed changes to its medical education program. (Id.). Absent a federal
violation, the court must exclude any testimony suggesting Smith & Nephew had a duty to modify
its training program; such a claim would add to, or differ from, the federal requirement that Smith
& Nephew merely implement a training program. See Riegel, 552 U.S. at 330.
D. Withdrawal
Smith & Nephew argues that several opinions offered by the plaintiffs’ experts which
suggest Smith & Nephew had a duty to withdraw its BHR system from the market earlier are
impermissible in light of this court’s prior ruling that only the FDA has the authority to withdraw
approval from a device. See In re BHR, 300 F. Supp. 3d at 737 n.5. The challenged opinions
include, among others, the following statements:
1. Smith & Nephew’s voluntary withdrawal of smaller BHR component sizes “should have
been taken much earlier.” (ECF 2384-3, Ex. C, Spears Report at 19)
2. “[The] FDA would have likely opened an additional line of questioning regarding risk, and
would have clearly sought . . . withdrawal from the market of the BHR in head sizes 46
mm and below.” (Id. at 27).
3. “Smith & Nephew was obligated to contraindicate use of head sizes < 48 mm and to
contraindicate use of BHR in females in 2009 and again in 2012 when it withdrew the R3.”
(ECF 2385-4, Ex. B, Truman Report at 8).
4. “[C]atastrophic failure[s]” associated with “metal-on-metal articulation devices” should
have been “a clear red flag to discontinue use of the BHR product.” (ECF 2386-3, Ex. A,
Shapiro Report at 10).
5. Smith & Nephew “had a duty to stop selling BHR to [certain patients].” (ECF 2388-3, Ex.
A, David Report at 35).
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The plaintiffs argue that Smith & Nephew voluntarily withdrew its products based on the
results of post-market surveillance required by the FDA, and that therefore this decision was
required under the PMA. This is only partially correct. Smith & Nephew undoubtedly had a duty,
under PMA Condition No. 4 and the federal regulations, to report adverse events to the FDA. But
any claim that Smith & Nephew had a duty to withdraw its products adds to or differs from the
federal requirements, which vests in the FDA the sole authority to withdraw approval. 21 U.S.C.
§ 360e(e)(1)(A)–(B); see also In re BHR, 300 F. Supp. 3d at 737 n.5 (“Only the FDA has authority
to withdraw approval from a device, and it did not do so here.”). Accordingly, the court will
exclude the challenged statements.
E. Duties of a Reasonable Manufacturer
Smith & Nephew also challenges any opinions offered by the plaintiffs’ experts regarding
the duties of a reasonable manufacturer that are not also pinned to federal requirements. The
challenged opinions include, among others, the following statements:
1. “Smith & Nephew could have and should have raised more questions [about registry data
in the period between 2007 and 2009] and followed up appropriately. Smith & Nephew did
not provide this analysis to the FDA as required by PMA Condition No. 4.” (ECF 2384-3,
Ex. C, Spears Report at 9–10).
2. Smith & Nephew failed to “act as a reasonably prudent manufacturer” in that it “elected to
rely on [a] single study source that was never replicated or validated by others” and that
was “limited to five years of clinical data.” (ECF 2388-3, Ex. A, David Report at 8).
With respect to Spears’s opinion, Smith & Nephew points to his deposition testimony to
conclude that he has conceded that the duty of a reasonable manufacturer is not pinned to any
federal requirement at all. (See ECF 2384-2, Ex. B, Spears Dep. at 142:19–143:2 (Question:
“[H]ave you identified anything else outside of this document from the 2007 to 2008 time period
that the company failed to provide to FDA in violation of an FDA requirement?” Answer: “The
answer to that is no.”)). And yet Smith & Nephew’s expert, Dr. Tillman, testified that companies
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have a duty under the federal regulations to report to the FDA in their annual reports any published
or unpublished data, including from registries, that are known or reasonably should be known to
the applicant. (See ECF 2427, Ex. 24, Tillman Dep. at 112:10–115:15). See also 21 C.F.R. §
814.84(b)(2)(i)–(ii) (requiring periodic reports to contain a summary and bibliography of
unpublished and published reports of data from any clinical investigations or nonclinical
laboratory studies involving the device which should reasonably be known to the manufacturer).
To the extent that any expert testimony seeks to rely exclusively on state law duties that
are not pinned to federal requirements, they are irrelevant to the remaining claims in this case. But
Spears’ challenged opinion, to the extent it is based on a violation of a federal regulation or a
condition of approval, is not preempted and the court will not exclude it. David’s opinion, on the
other hand, will be excluded as it does not appear to be based on any federal requirement. See
Riegel, 552 U.S. at 330. If anything, the opinion would be relevant only to a fraud-on-the-FDA
claim, which as previously explained, is preempted. See supra, Section I.A.
F. Unreasonably Dangerous
Finally, Smith & Nephew challenges certain opinion testimony which seeks to establish
that the BHR system was unreasonably dangerous, arguing that such testimony runs afoul of this
court’s prior holding that once a device obtains premarket approval a state law cannot declare it
unreasonably dangerous. See In re BHR, 300 F. Supp. 3d at 743. The challenged opinions include:
1. “[A metal on metal system] is inherently and unreasonably dangerous and defective.” (ECF
2385-4, Ex. B, Truman Report at 15).
2. “[M]etal-on-metal articulations have been shown, in general, and including the BHR
device, to be at a higher risk for failure, when compared to the standard metal-on-plastic
designs.” (ECF 2386-3, Ex. A, Shapiro Report at 2).
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3. Smith & Nephew “had a duty to . . . change the design to reduce risks to women and men
[posed by implanting certain head sizes].” 4 (ECF 2388-3, Ex. A, David Report at 35).
The plaintiffs argue that this testimony supports a failure to warn theory in that Smith &
Nephew was “required to provide surgeons a reasonable assurance of safety and efficacy of the
BHR.” (ECF 2427 at 53). Yet as this court has previously stated, Congress has left questions about
the safety and efficacy of a device to the FDA. See In re BHR, 300 F. Supp. 3d at 743. Because
premarket approval “is FDA recognition of a particular medical device’s fitness for the market,”
once that approval is received, “the BHR system cannot be labeled unreasonably dangerous by
state law[.]” Id. Accordingly, the court will exclude any testimony that seeks to label the BHR
system inherently and unreasonably dangerous in a manner that would add to or differ from federal
requirements.
II.
OTHER CHALLENGES
Smith & Nephew next raises several other challenges to the plaintiffs’ expert testimony.
These challenges can be grouped into the following general categories with respect to Spears,
Truman, Shapiro, and David: (1) expert qualifications, (2) speculative testimony, (3) factual
narratives and summaries, and (4) legal conclusions. The challenges to Marshall’s testimony are
made largely on grounds of relevance and reliability. The court will address each category in turn
before proceeding to analyze Marshall’s opinions.
A. Qualifications
Smith & Nephew argues that Spears, who worked in the FDA’s Office of Compliance, is
not qualified to testify as to matters that were within the purview of the Office of Device
Evaluation; that Truman, a biomedical engineer, is not qualified to testify about medical or
4
Smith & Nephew also contends that David lacks adequate data to make this conclusion. Because the court holds
that this testimony is preempted, it need not reach the issue.
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regulatory matters; and that Shapiro, an orthopedic surgeon, is not qualified to testify about
regulatory matters. A person qualified as an expert in one field may not necessarily be qualified in
another. See Giddings v. Bristol-Myers Squibb Co., 192 F. Supp. 2d 421, 425 (D. Md. 2002). But
the question is one of degree and abstraction, and a court must consider a proposed expert’s “full
range of experience and training”—not just “his professional qualifications”—in deciding whether
the expert has “sufficient specialized knowledge” to assist the jurors in deciding issues in the case.
Belk, Inc. v. Meyer Corp., U.S., 679 F.3d 146, 162 (4th Cir. 2012) (citations and quotations
omitted); see also Thomas J. Kline, Inc. v. Lorillard, Inc., 878 F.2d 791, 799 (4th Cir. 1989) (citing
Martin v. Fleissner GMBH, 741 F.2d 61, 64 (4th Cir. 1984) (“One knowledgeable about a
particular subject need not be precisely informed about all details of the issues raised in order to
offer an opinion.”)).
i. Spears
Spears, who spent decades at the FDA and in private practice working on compliance
issues—including PMAs—is qualified as a regulatory expert to offer opinions on the regulatory
process. (See ECF 2384-3, Ex. C, Spears Report at 2, 42–44). The plaintiffs have not, by way of
comparison, summoned a podiatrist to opine on psychiatric matters. Spears’s proffered opinions
were formed using the same standards as those “utilized by medical device companies to meet the
pre-approval and post-approval FDA requirements for medical devices[.]” (Id. at 2). Spears may
not have the same level of experience as someone who worked directly in the device evaluation
office, but the court is convinced that his experience is sufficient to assist the trier of fact. See Belk,
679 F.3d at 162. The particulars of his experience and training go to the weight of his testimony
and may be tested by cross-examination. 5
5
Spears may offer his opinion within a reasonable degree of professional certainty, but not within a reasonable
degree of medical certainty, as his report at times purports to do.
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ii. Truman
Truman, who holds numerous patents for orthopedic devices, has extensive experience
with the orthopedic industry, and has experience consulting with industry on labeling
requirements, offers opinions about the toxicity of particles shed by the BHR system. (ECF 23854, Ex. C, Truman Report at 6 (“[T]here were millions more bioreactive particles that could become
toxic to tissues.”). Other courts have considered similar challenges to the proper scope of Truman’s
expert testimony. See Bayes v. Biomet, Inc., No. 4:13-cv-00800-SRC, 2020 WL 5594059, at *6
(E.D. Mo. Sept. 18, 2020) (excluding Truman’s medical causation opinions but permitting
testimony that relied on medical records and a medical doctor’s opinion); Hardison ex rel.
Hardison v. Biomet, Inc., No. 5:19-CV-00069-TES, 2020 WL 4334108, at *12 (M.D. Ga. July 27,
2020) (same); Saacsk v. Privilege Underwriters Reciprocal Exch., No. 16-1149, 2017 WL
3867761, at *2 (E.D. La. Feb. 2, 2017) (permitting testimony about the forces present in an
accident, but not about the causes of the resulting injuries); In re Biomet M2a Magnum Hip Implant
Prods. Liab. Litig. (hereinafter “In re Biomet”), No. 3:12-MD-2391, 2017 WL 10845178, at *15
(N.D. Ind. Dec. 21, 2017). 6 In Hardison v. Biomet, a case concerning the M2a Magnum Hip
System, Truman offered opinions on medical causation, including that “the design defect
contributed to [the plaintiff’s] death, injuries, and need for revision surgery.” 2020 WL 4334108
at *12. In that case, the court held that Truman lacked “the requisite medical background” and
excluded all of her medical causation opinions, but noted that if medical experts were to establish
such opinions, Truman could then rely on those opinions for her analysis. Id. And in In re Biomet,
Truman offered the opinion that Biomet’s metal-on-metal devices can cause “elevated metal ions
with immune response complications” and “tissue necrosis.” 2017 WL 10845178 at *14. There,
6
Unpublished opinions are cited for the soundness of their reasoning and not for their precedential value.
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Truman’s opinion was offered in support of one of her report’s central conclusions, namely “that
Biomet’s metal-on-metal devices are unreasonably dangerous.” Id. The court noted that Truman
admitted she was not a surgeon or a toxicologist, but asserted in her deposition testimony that “she
reviewed the peer-reviewed literature to familiarize herself with the topic because experts
considering the devices’ design and risks should be familiar with that literature.” Id. Nevertheless,
the court held that Truman could not testify as an expert “on the clinical effects of metal ions, but
she [could] permissibly rely on other experts’ opinions that metal ions cause clinical effects to
support her opinion that metal-on-metal devices are unreasonably dangerous.” Id. at *15.
In this case, Truman’s opinion that despite being advertised as resistant to wear, the BHR
contained “millions more bioreactive particles that could become toxic to tissues” is offered in
support of her conclusion that Smith & Nephew failed to act as a reasonable medical device
manufacturer insofar as it failed to warn physicians of serious risks and insofar as it misbranded
the device in its medical education. (See ECF 2385-4, Ex. B, Truman Report at 6, 82). This opinion
is not, as in Bayes and Hardison, offered to establish medical causation and it will not be excluded
on those grounds. Rather, the opinion goes to the plaintiffs’ potentially viable failure to warn claim.
In that respect, the court will follow In re Biomet: to the extent that Truman’s opinion that the BHR
system contained bioreactive particles that could become toxic to tissues is based upon the
testimony of experts qualified to express that opinion, her opinion will not be excluded.
iii. Shapiro
Shapiro is an orthopedic surgeon with extensive training in hip and knee implants and has
reviewed available scientific literature on metal-on-metal hip implants. Smith & Nephew contends
his testimony that its training program was inadequate to “certify” surgeons to use the BHR in
patients is unreliable because the adequacy of its training program is a regulatory question, because
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he has no experience training surgeons to implant medical devices, and because he is not familiar
with what the FDA required of Smith & Nephew with respect to surgeon training. 7 The plaintiffs
counter that Shapiro is qualified to offer his testimony from the perspective of a surgeon and that
it would be helpful to a jury in assessing the impact of Smith & Nephew’s warnings and disclosures
on orthopedic surgeons. Shapiro’s placement of quotation marks around the word “certify” in his
report leaves the court uncertain if his proffered testimony is meant to opine on whether Smith &
Nephew’s program met the FDA’s regulatory requirements or whether it is a more colloquial way
to state that the program would not be adequate to inform a surgeon under a common law standard.
The section of Shapiro’s report detailing his findings on Smith & Nephew’s training program
makes an oblique reference to “very specific” training requirements imposed by the FDA, without
naming a single specific requirement. (ECF 2386-3, Ex. A, Shapiro Report at 34). But the thrust
of the opinion is that the failure to provide surgeons with data on the learning curve and patient
selection resulted in an inadequate and inconsistent training program. (Id. at 34–35). Given the
somewhat uncertain basis of this opinion, the court concludes in general terms that Shapiro is not
qualified to offer testimony opining on Smith & Nephew’s compliance with the various FDA
regulations and requirements, but he is qualified to opine on the adequacy of the training program
from the perspective of an implanting surgeon to the extent, if any, that such testimony may be
relevant to any of the plaintiffs’ non-preempted claims.
Smith & Nephew also challenges Shapiro’s testimony that his experience performing
implants led him to abandon metal-on-metal technology, concluding that it is inferior to metal-onplastic and poses an unnecessary risk. Shapiro has never implanted a BHR device and his
7
The proffered opinion reads: “Having full knowledge of the increased complexity and importance of proper
surgical technique, and being fully aware of higher failure rates for surgeons new to the implanting techniques as
well as the longer learning curve for proper implantation, the training that Smith & Nephew provided was
inadequate to ‘certify’ them to use the BHR in patients.” (ECF 2386-3, Ex. A, Shapiro Report at 3).
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experience is limited to performing total hip arthroplasty. But Dr. Shapiro, in his capacity as an
orthopedic surgeon, has reviewed performance data for a wide variety of hip systems. There is no
requirement that a doctor have specific clinical experience implanting a particular device in order
to testify about it, so long as the testimony—as here—is based upon sufficient specialized
knowledge stemming from, for example, review of clinical studies and other literature. See
Eghnayem v. Boston Sci. Corp., 57 F. Supp. 3d 658, 672–73 (S.D. W. Va. Oct. 27, 2014)
(knowledge in the field of pathology sufficient to qualify an expert to testify about the clinical
effect of a product despite the expert never having implanted the product and never having treated
patients for complications resulting therefrom). Though it is not apparent to which claim this
testimony would be relevant, Dr. Shapiro is qualified to offer this testimony on any point for which
it is in fact relevant.
B. Speculative Testimony
Smith & Nephew also argues that the plaintiffs’ experts may not offer testimony that
speculates as to actions the FDA may or may not have taken or that speculates as to the company’s
state of mind. As already noted, the plaintiffs, appropriately, do not plan to offer speculative
testimony about what the FDA might or might not have done if presented with different or
additional information. As to the company’s state of mind, while an expert may testify “about his
or her review of internal corporate documents solely for the purpose of explaining the basis for his
or her opinions,” a party’s “knowledge, state of mind, or other matters related to corporate conduct
and ethics are not appropriate subjects of expert testimony because opinions on these matters will
not assist the jury.” Eghnayem, 57 F. Supp. 3d at 670; see also Huskey v. Ethicon, Inc., 29 F. Supp.
3d 691, 728 (S.D. W. Va. 2014) (excluding expert testimony that did nothing more than provide
subjective belief or unsupported speculation); In re Fosamax Prods. Liab. Litig., 645 F. Supp. 2d
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164, 192 (S.D.N.Y. 2009) (conjecture as to the “knowledge, motivations, intent, state of mind, or
purposes” of a defendant are “not a proper subject for expert or even lay testimony”). Accordingly,
any opinions which are based on any of the experts’ subjective beliefs—as opposed to his or her
specialized knowledge, skill, experience, training, or education—are unreliable and should be
excluded.
C. Historical and Factual Narratives
Smith & Nephew objects that experts may not simply provide narratives or factual
summaries of evidence, such as the summary titled “BHR Early Development Background” in
Appendix C of Truman’s report, because such narratives are not based on specialized knowledge.
(ECF 2385-4, Ex. C, Truman at 197). An expert cannot “be presented to the jury solely for the
purpose of constructing a factual narrative based upon record evidence.” In re Fosamax, 645 F.
Supp. 2d at 192 (citation and quotation omitted). But a factual narrative may be admissible when
in relaying it the witness relies on her expertise to explain the context in which various documents
were created, to define specialized terminology appearing in the documents, or otherwise to draw
inferences requiring specialized expertise. Id.; see also In re DePuy Orthopaedics, Inc. Pinnacle
Hip Implant Prods. Liab. Litig., 2014 WL 3557345, at *7 (N.D. Tex. July 18, 2014) (“Expert
narrative testimony is entirely permissible where the documents and other information the expert
is reviewing are complicated, voluminous, or involve scientific or technical data and such narrative
summary would assist the trier of fact in understanding the documents.”).
Truman’s summary appears in the appendix to her report in a manner not obviously related
to any of her conclusions or findings. It is therefore not clear how much of Truman’s summary of
BHR development the plaintiffs will seek to elicit at trial, nor for what purpose. Because it is
difficult to determine whether such a summary will be offered solely for the purpose of
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constructing a factual narrative or for some purpose that calls for an expert’s specialized
knowledge, the court will reserve ruling on this issue. See DePuy Orthopaedics, 2014 WL
3557345, at *8 (admission of speculation and narrative testimony implicates a court’s discretion
over the presentation of evidence at trial and should be taken up at trial).
Shapiro’s historical narrative, which concludes with the assertion that modern metal-onmetal devices have failed at catastrophic rates, appears to be tied to his opinion that the BHR
system was too dangerous and should have been voluntarily withdrawn. (See ECF 2386-3, Ex. A,
Shapiro Report at 10 (“[T]hese issues should have been a clear red flag to discontinue use of the
BHR.”)). As discussed previously, see supra Sections I.D and I.F, such opinions are not admissible
because they are relevant only to preempted claims. Still, to the extent that any other portion of
Shapiro’s historical narrative may be offered to provide helpful context for an opinion that is
relevant to one of the plaintiffs’ surviving claims, the testimony may be admissible. The court
reserves ruling on that issue, which is more properly addressed in the context of trial. See DePuy
Orthopaedics, 2014 WL 3557345, at *8.
As for Shapiro’s testimony summarizing Smith & Nephew’s internal documents, the
plaintiffs contend this is admissible insofar as they are documents that an expert may rely upon in
forming his opinion. Shapiro’s testimony summarizing these documents appears calculated to
reach the conclusion that Smith & Nephew “used post-market surveillance to analyze adverse
events and complaints” such that it “knew it had a problem with the performance of the BHR”—
information which, Shapiro contends, physicians using hip implants “needed to know . . . to be
able to use their medical judgment in determining whether a particular implant is viable for a
particular patient.” (ECF 2386-3, Ex. A, Shapiro Report at 25). Shapiro is qualified to offer
opinions, if relevant, about what a physician would need to know in order to make an informed
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medical judgment; however, Shapiro may not offer extensive factual summaries of Smith &
Nephew’s internal documents—including emails, memoranda, and other communications—unless
that testimony is connected to an otherwise admissible opinion. See In re Fosamax, 645 F. Supp.
2d at 192.
D. Legal Conclusions
Smith & Nephew further objects to testimony proffered by Truman and David that appear
to state legal conclusions. Rule 704(a) allows the admission of expert testimony that embraces an
ultimate issue to be decided by the trier of fact, explaining that “[a]n opinion is not objectionable
just because it embraces an ultimate issue.” Fed. R. Evid. 704(a). This is because “questions of
fact that are committed to resolution by the jury are the proper subject of opinion testimony.”
United States v. McIver, 470 F.3d 550, 561 (4th Cir. 2006). But “opinion testimony that states a
legal standard or draws a legal conclusion by applying law to the facts is generally inadmissible,”
except in a case involving a specialized industry where such a conclusion may be helpful to the
trier of fact. Id. at 562 & n.13.
i. Truman
Truman’s conclusion that Smith & Nephew’s conduct amounts to a violation of specific
statutory requirements is inadmissible as stating an improper legal conclusion for which she has
no expertise. See id. at 562; see also Moore v. Wright Med. Tech., Inc., No. 1:14-cv-62, 2016 WL
1316716, at *9–10 (S.D. Ga. Mar. 31, 2016) (excluding as unhelpful to the trier of fact testimony
offered by Truman that the defendant unreasonably exposed the plaintiff to hazards and that the
defendant’s implant system had design and warning defects which caused the premature failure of
the plaintiff’s implant). Even if such a conclusion were helpful to a trier of fact because, for
example, the medical device industry is so specialized, Truman is not qualified to offer such legal
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conclusions. Truman’s opinions that Smith & Nephew “failed to comply with BHR PMA
Approval Letter Requirements” and violated the “Safe Medical Devices Act in the commercial
distribution of the BHR,” if offered without the more specific context provided in the report, would
not merely embrace the ultimate issue—they would consume it. (ECF 2385-4, Ex. B, Truman
Report at 5). And even if offered with the more helpful explanation of how Smith & Nephew
purportedly violated these requirements, her testimony on this issue lies outside her area of
expertise. Truman’s credentials ably qualify her—and she is properly offered—as a biomedical
engineering expert. But she lacks the regulatory and legal expertise necessary to reliably and
helpfully opine so broadly on whether Smith & Nephew conformed its conduct to the requirements
of the PMA approval letter and the relevant federal statutes.
ii. David
Finally, Smith & Nephew contends that David is not a regulatory expert and is not qualified
to offer opinions on Smith & Nephew’s compliance with FDA regulations or on the standard of
care. Indeed, as Smith & Nephew points out, David is a biomedical engineer with a doctorate in
educational psychology and he has never worked for the FDA. David is undoubtedly qualified to
offer opinions on topics within the field of biomedical engineering. But this, by itself, does not
mean he is unqualified to offer opinions on regulatory matters—so long as he has the scientific,
technical, or other specialized knowledge necessary to do so reliably. See Fed. R. Evid. 702.
This is not the first case in which David’s expert testimony on this issue has been
challenged. In Stevens v. Stryker Corp., which Smith & Nephew relies on, the court considered a
similar challenge to David’s testimony, namely that he is not qualified to offer opinions about FDA
regulations. No. 12-cv-63-bbc, 2013 WL 4758948, at *4 (W.D. Wis. Sept. 4, 2013). In that case,
David’s report consisted of “nothing but a list of regulations and conclusions that defendants
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violated them, along with a narrative of historical facts that does not require an expert to interpret.”
Id. Because “nothing in David’s report suggests that he is a regulatory expert,” the court excluded
David’s testimony. Id. Yet the court reached a different result in Woodard v. Stryker Corp., No.
11-CV-36-F, 2012 WL 3475079 (D. Wyo. July 16, 2012). In that case, relating to the 510(k)
process, David likewise attempted to testify about “Stryker’s alleged breach of numerous federal
regulations to demonstrate that Stryker failed to act like a reasonably prudent manufacturer.” Id.
at * 7. The court noted that David had experience doing risk-assessment for the particular kind of
product at issue in the litigation, that David had advised the FDA about the 510(k) review process,
and that David had even participated in the 510(k) process himself. Id. at *8–9. Consequently, the
court held that David was qualified by way of his experience and did not exclude David’s
testimony. Id. at *9.
In this case, although David is a biomedical engineer, he has in that capacity “developed
and implemented a medical technology assessment process” used by the Texas Medical Center
and other hospital systems. (ECF 2388-3, Ex. A, David Report at 3). This process included, among
other things, evaluations of “product compliance with regulatory and technical standards.” (Id.).
The court therefore cannot conclude that “nothing in David’s report suggests that he is a regulatory
expert,” Stevens, 2013 WL 4758948, at *4 (emphasis added), for David does have some experience
with regulatory compliance, even if his formal education is not in that field. Additionally, his report
is not, as in Stevens, exclusively a list of regulations and a conclusion that Smith & Nephew
violated them, even though much of his thirty-seven-page report consists of the text of a regulation
followed by extensive citations to deposition testimony showing that Smith & Nephew violated
the regulation. (See ECF 2388-3, Ex. A, David Report at 12–30). Considering “the full range of
[David’s] experience and training,” the court is persuaded that David possesses “sufficient
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specialized knowledge” to reliably opine on any aspect of the regulatory process that is informed
by his experience working on regulatory issues at the Texas Medical Center. Belk, 679 F.3d at 162.
His testimony will therefore not be excluded as unreliable.
But the court notes that relevance is a separate hurdle. As explained previously, some of
David’s testimony pertains only to preempted claims concerning, for example, challenges to the
PMA approval process. See supra Section I.A. The plaintiffs have not, as of yet, clearly identified
a claim to which David’s testimony would be relevant, but the court cannot at this time rule out
the possibility that they may be able to do so.
E. Marshall’s Testimony
The plaintiffs have also retained L. Scott Marshall, a materials engineer, to conduct a
materials failure analysis of explanted BHR hip components from five plaintiffs. Smith & Nephew
challenges Marshall’s opinions 11 through 15, and 17, in which he proffers testimony about the
BHR system’s resistance to wear and corrosion, about the effect of metal particles and ions on the
human body, about Smith & Nephew’s marketing practices, and about his personal experience
seeking a hip implant. Smith & Nephew argues this evidence is irrelevant and unreliable. Marshall
also seeks to introduce photographs of BHR devices explanted from five plaintiffs and embedded
with human tissue, which Smith & Nephew argues is unduly prejudicial.
i. Opinions 12–14 (Comparing As-Cast to Heat-Treated Chromium Alloy)
Smith & Nephew challenges Marshall’s testimony opining that the wear and corrosion
resistance of as-cast chromium cobalt materials used in Smith & Nephew’s BHR system is not as
effective as other heat-treated cobalt chromium alloys. Though such testimony may not be
relevant, for example, to certain products liability claims already dismissed from this action, it is
plainly relevant to the plaintiffs’ claim that Smith & Nephew misrepresented the safety of the BHR
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system by claiming it was more effective than other available metal hip replacements on the
market. (See ECF 124, Master Am. Compl. ¶ 467(d)). Smith & Nephew argues that this testimony
suggests the BHR is “unreasonably dangerous” and therefore is relevant only to an impermissible
design defect claim. But the opinion also appears relevant to whether Smith & Nephew’s
representations were misleading and for that purpose it may be relevant to this action. 8
And the opinion, based upon a review of scientific literature and upon examination of the
explanted devices, is the product of reliable methods. Though, as Smith & Nephew points out,
Marshall concedes that there is some conflict in the literature, this goes to the weight of Marshall’s
testimony rather than its admissibility. Cooper v. Smith & Nephew, Inc., 259 F.3d 194 (4th Cir.
2001) does not mandate a different result. In that case, the relevant portion of which concerned a
medical doctor’s differential diagnosis, the Fourth Circuit Court of Appeals noted that a
differential diagnosis which “utterly fails” to take serious account of other potential causes of
illness may be “so lacking” that a district court would be justified in excluding it. Id. at 202. In this
case, though, Marshall based his opinion on a review of scientific literature and is not tasked with
offering a differential diagnosis describing the relative probabilities of various causes or outcomes.
And in In re Rezulin Prods. Liab. Litig., 369 F. Supp. 2d 398 (S.D.N.Y. 2005), relied upon by
Smith & Nephew, the court analyzed several factors in its Daubert analysis, finding that an expert’s
challenged testimony satisfied none of the standard Daubert factors. Id. at 423. Additionally, it
analyzed as an additional factor the consideration given to contrary evidence and concluded that
the expert had ignored substantial quantities of contrary evidence. Id. at 425. In this case,
8
The court does not find persuasive Smith & Nephew’s objection that the Master Amended Consolidated Complaint
doesn’t explicitly reference misrepresentations relating to as-cast and heat-treated chromium alloys. Evidence is
relevant to the extent it has any tendency to make a material fact more or less likely. See Fed. R. Evid. 401. The
complaint alleges that Smith & Nephew “misrepresented to the medical community, patients, and the FDA the
safety of the BHR” in its “communications and advertising[.]” (ECF 124 ¶¶ 24, 26). Thus, evidence which would
tend to make any non-preempted portion of that claim more or less likely—as Marshall’s testimony does—is
relevant, regardless whether the plaintiffs explicitly identified this specific misrepresentation in their complaint.
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Marshall’s testimony satisfies at least some of the Daubert factors, as he relies on an analysis of
peer-reviewed and published scientific literature. Accordingly, the court will not exclude his expert
testimony on this point.
ii. Opinions 11 & 15 (Wear of Chromium Alloy)
Smith & Nephew also challenges Marshall’s testimony opining that as-cast cobalt
chromium alloy deteriorates and that Smith & Nephew’s BHR system exhibited signs of wear and
corrosion. The testimony is relevant to establishing the degree to which metallic ions could be
expected to accumulate in a patient following implant. Marshall is not qualified as a medical expert
to testify as to the effect that various quantities of metallic ions could have on a patient, but another
qualified expert could testify to that effect.
But it is a closer question whether the testimony is reliable. Smith & Nephew argues that
Marshall’s testimony on this point is unreliable because the analysis is subject to a high rate of
error, because it departed from the relevant standard, and because his computed tomography
(“CT”) analysis is not a recognized method for quantifying wear. Even if the error rate is as
significant as Smith & Nephew contends, Daubert does not establish a bright line rule with respect
to error rates. More problematic is Smith & Nephew’s argument that his testing deviated from the
international standard ASTM F2979–14. The crux of this argument is that Marshall was unable,
during his deposition, to assure counsel that he complied with each of the governing standard’s
requirements. (See, e.g., ECF 2387-6, Ex. D, Marshall Dep. at 235:14–236:15). But this appears
not to have been the result of any ignorance of or disregard for the standard, but rather because
Marshall’s staff conducted some of the testing for him. (See id.). Marshall was aware of the
standard and applied it, (see ECF 2387-5, Ex. C, Marshall Dep. at 73:8–20), and his lack of
personal knowledge regarding whether his staff ensured that, for example, the testing room was
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maintained at 20 degrees Celsius for 24 hours exactly, is a proper subject for cross examination
but is not a basis to conclude that the testing as a whole is the product of unreliable methods. As
for the use of the CT machine, which is not specified in the governing standard, Marshall stated
that he used this primarily to confirm the results of the Coordinate Measuring Machine (“CMM”),
which is specified in the governing standard. (ECF 2387-6, Ex. D, Marshall Dep. at 200:5–10).
Though Marshall admits that the CT is less accurate than the CMM, he states that others in his
field use both machines. (Id. at 200:11–23). Accordingly, the court will not exclude the CT results.
Finally, Smith & Nephew objects that Marshall, who is not offered as a case-specific
expert, may not extrapolate insights gleaned from his analysis of the five explanted devices to
reach conclusions applicable to all cases. This argument is not well-developed in Smith &
Nephew’s briefing, nor is it addressed by the plaintiffs in their opposition. The court will
accordingly reserve ruling on this issue.
iii. Opinion 17 (Effect of Metallic Particles on Human Health) & Background
Information on Marketing
Marshall, an expert in materials engineering, is not qualified to offer expert testimony on
medicine or marketing. See Giddings, 192 F. Supp. 2d at 425. However, as with Truman, the court
will follow In re Biomet, 2017 WL 10845178, with respect to Marshall. To the extent that
Marshall’s testimony that the BHR system contained bioreactive particles that could have adverse
consequences for human health is based upon the testimony of experts qualified to express that
opinion, and is offered in connection with another opinion which he is qualified to provide, his
testimony will not be excluded. As for the background statement that Smith & Nephew
aggressively marketed the BHR system, the court is not persuaded that this is the product of any
specialized knowledge or training; it is therefore not an appropriate subject of expert testimony,
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especially testimony offered by a materials engineer with no stated expertise in advertising or
marketing. It will be excluded. See Fed. R. Evid. 702(a).
iv. Photographs of Explanted Devices
The court may exclude relevant evidence if its probative value is substantially outweighed
by, among other litigation evils, unfair prejudice. See Fed. R. Evid. 403. The photographs of the
explanted BHR systems, taken only from five plaintiffs, may be relevant to general causation to
the extent that Marshall, using reliable methods, is able to extrapolate information from them to
draw general conclusions about wear and corrosion on the BHR system. The photographs in
question show what Smith & Nephew plausibly claims is human tissue and bone attached to the
explanted devices. From the court’s perspective, the risk of undue prejudice posed by these images
is slight, if any exists at all. Some of the photographs appear to show very little of the explanted
device, however, and instead focus on the human tissue attached thereto. (See, e.g., ECF 2387-3,
Ex. A, Marshall Report, Enclosure 18). Such images may have very little probative value. At this
point in time it is unclear which photographs, if any, the plaintiffs may seek to enter into evidence.
The court therefore reserves ruling on this issue.
v. Marshall’s Personal Experience with Hip Implants
An expert may be qualified on the basis not just of knowledge, but also of experience. See
Fed. R. Evid. 702. Though far-ranging testimony about Marshall’s personal experience seeking a
hip implant is likely to be irrelevant or unhelpful, the court reserves ruling on the admissibility of
any testimony implicating Marshall’s personal experience. In the context of examination at trial,
the court will be better able to assess the relevance and admissibility of this testimony.
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CONCLUSION
For the reasons described above, the motions to exclude will be granted in part, reserved
in part, and denied in part. A separate Order follows.
3/1/2021
_____________
Date
/s/
Catherine C. Blake
United States District Judge
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