The opinion
UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF FLORIDA
TAMPA DIVISION
OVIS ELLERBEE and JAMES
ELLERBEE,
Plaintiffs,
v. Case No. 8:20-cv-1514-TPB-AEP
ETHICON, INC. and JOHNSON &
JOHNSON,
Defendants.
/
ORDER GRANTING IN PART AND DENYING IN PART
“DEFENDANTS’ MOTION TO EXCLUDE GENERAL-CAUSATION
TESTIMONY OF ROBERT BRIAN RAYBON, M.D.”
This matter is before the Court on “Defendants’ Motion to Exclude General-
Causation Testimony of Robert Brian Raybon, M.D. and Brief in Support,” filed on
March 15, 2021. (Doc. 107). Plaintiffs responded in opposition on April 5, 2021.
(Doc. 112). Upon review of the motion, response, court file, and record, the Court
finds as follows:
Background
This case is one of thousands of similar cases filed since 2010.1 Plaintiffs
Ovis Ellerbee and James Ellerbee sued directly in the Southern District of West
1 In the seven MDLs, over 100,000 cases have been filed, approximately 40,000 of which are in the
Ethicon MDL. See MDL 2187 (C.R. Bard) Member List of Cases,
https://www.wvsd.uscourts.gov/caselist/caseviewlist.aspx?mdl=2187; MDL 2325 (American Medical
Systems) Member List of Cases, https://www.wvsd.uscourts.gov/caselist/caseviewlist.aspx?mdl=2325;
MDL 2326 (Boston Scientific) Member List of Cases,
https://www.wvsd.uscourts.gov/caselist/caseviewlist.aspx?mdl=2326; MDL 2327 (Johnson & Johnson,
Ethicon) Member List of Cases, https://www.wvsd.uscourts.gov/caselist/caseviewlist.aspx?mdl=2327;
Virginia as part of the multidistrict litigation (MDL) entitled In re: Ethicon, Inc.,
Pelvic Repair Sys. Prods. Liab. Lit., MDL No. 2327. The case was not resolved by
the MDL transferee court (“MDL Court”), and on July 1, 2020, it was transferred to
this Court.
On November 7, 2006, Ms. Ellerbee was implanted with Ethicon’s TVT-O and
Prolift devices at a hospital in Tampa, Florida. Both devices were designed and
manufactured by Defendants Johnson & Johnson and Ethicon, Inc. In early 2017,
Ms. Ellerbee’s physician surgically removed what Plaintiffs claim to have been
mesh located in the bladder mucosa. On February 23, 2017, Ms. Ellerbee
underwent a revision/removal procedure and an anterior colporrhaphy. Ms.
Ellerbee later had another mesh sling implanted.
On June 24, 2015, Plaintiffs sued directly in the MDL using a short-form
complaint, alleging: Negligence (Count I), Strict Liability – Manufacturing Defect
(Count II), Strict Liability – Failure to Warn (Count III), Strict Liability – Defective
Product (Count IV), Strict Liability – Design Defect (Count V), Common Law Fraud
(Count VI), Fraudulent Concealment (Count VII), Constructive Fraud (Count VIII),
Negligent Misrepresentation (Count IX), Negligent Infliction of Emotional Distress
(Count X), Breach of Express Warranty (Count XI), Breach of Implied Warranty
(Count XII), Violation of Consumer Protection Laws (Count XIII), Gross Negligence
(Count XIV), Unjust Enrichment (Count XV), Loss of Consortium (Count XVI),
MDL 2387 (Coloplast) Member List of Cases,
https://www.wvsd.uscourts.gov/caselist/caseviewlist.aspx?mdl=2387; MDL 2440 (Cook Medical)
Member List of Cases, https://www.wvsd.uscourts.gov/caselist/caseviewlist.aspx?mdl=2440; and
MDL 2511 (Neomedic) Member List of Cases,
https://www.wvsd.uscourts.gov/caselist/caseviewlist.aspx?mdl=2511.
Punitive Damages (Count XVII), and Discovery Rule and Tolling (Count XVIII). On
September 2, 2020, the Court granted in part, and denied in part, Defendants’
motion for summary judgment, finding that Defendants were entitled to summary
judgment on Counts I (in part), II, IV, VII, VIII, X, XI, XII, XIII, XIV (in part), XV,
and XVI. (Doc. 85).
In the motion before this Court, Defendants raise various Daubert challenges
to the proposed testimony of Robert Brian Raybon, M.D. Dr. Raybon has previously
been qualified as an expert witness in pelvic mesh MDL litigation. See, e.g.,
Heatherman v. Ethicon, Inc., No. 1:20-cv-1932-RBJ, 2020 WL 5798533 (D. Colo.
Sept. 29, 2020); Pitlyk v. Ethicon, Inc., No. 20-cv-886-SRB, 2020 WL 8224837 (E.D.
Mo. Aug. 12, 2020); Wise v. C.R. Bard, Inc., No. 2:12-cv-1378, 2015 WL 521202, at
*13 (S.D.W. Va. Feb. 7, 2015); Eghnayem v. Boston Scientific Corp., 57 F. Supp. 3d
658, 699-701 (S.D.W. Va. 2014).
Legal Standard
An expert witness may testify in the form of an opinion if “(a) the expert’s
scientific, technical, or other specialized knowledge will help the trier of fact to
understand the evidence or to determine a fact in issue; (b) the testimony is based
on sufficient facts or data; (c) the testimony is the product of reliable principles and
methods; and (d) the expert has reliably applied the principles and methods to the
facts of the case.” Fed. R. Evid. 702; see also Daubert v. Merrell Dow
Pharmaceuticals, Inc., 509 U.S. 579, 597 (1993). “The party offering the expert
testimony bears the burden of establishing, by a preponderance of the evidence, the
expert's qualification, reliability, and helpfulness.” Payne v. C.R. Bard, Inc., 606 F.
App’x 940, 942 (11th Cir. 2015) (citing United States v. Frazier, 387 F.3d 1244, 1260
(11th Cir. 2004) (en banc)).
Functioning as a gatekeeper, the district court plays an important role by
ensuring that all scientific testimony is relevant and reliable. See In re C.R. Bard,
Inc., 948 F. Supp. 2d 589, 601 (S.D.W. Va. 2013). Although Daubert references
specific factors for the district court to consider when evaluating relevancy and
reliability, “[t]he inquiry to be undertaken by the district court is a flexible one
focusing on the principles and methodology employed by the expert, not on the
conclusions reached.” Id. at 601-02 (internal quotations and citations omitted); see
Hanna v. Ward Mfg., Inc., 723 F. App’x 647, 649 (11th Cir. 2018) (outlining the
criteria for the admissibility of expert witness testimony). Essentially, the Court is
simply asked to determine if the evidence “rests on a reliable foundation and is
relevant.” Huskey v. Ethicon, Inc., 29 F. Supp. 3d 691, 701 (S.D.W. Va. 2014)
(quoting Daubert, 509 U.S. at 597).
Analysis
Plaintiffs designated Dr. Raybon – a board certified pelvic surgeon and
urogynecologist – to offer general causation opinions involving Ethicon’s Prolift
device, which is used to treat pelvic organ prolapse. Here, Defendants make no
argument that Dr. Raybon is unqualified to serve as an expert. However, they seek
to exclude his testimony, arguing that (1) Dr. Raybon did not submit a report
reflecting opinions about the TVT-O device used to treat Ms. Ellerbee’s stress
urinary incontinence; (2) Dr. Raybon’s opinions regarding the competency of other
physicians are irrelevant and will not assist the jury; and (3) Dr. Raybon’s opinions
regarding safter alternative designs are not sufficiently reliable.
TVT-O Device
Ms. Ellerbee was implanted with two Ethicon devices – the Prolift to treat
her pelvic organ prolapse, and the TVT-O to treat her stress urinary incontinence.
Defendants seek to preclude Dr. Raybon from offering opinions about the TVT-O
device. Plaintiffs agree that Dr. Raybon will offer testimony only about the Prolift
device, and not as to the TVT-O device. As such, the motion is granted as to this
request.
Opinions on the Competency of Other Physicians
Defendants also seek to exclude Dr. Raybon’s opinions regarding the
competency of other physicians. The MDL Court previously excluded Dr. Raybon’s
proposed opinions regarding physician training and competency, concluding that
these opinions were irrelevant. See Wise, 2015 WL 521202, at *13 (citing Sanchez v.
Boston Scientific Corp., No. 2:12-cv-5762, 2014 WL 4851989, at *32 (S.D.W. Va.
Sept. 29, 2014)). The Court sees no reason to depart from this reasoning.2 The
motion is granted as to this request.
Opinions on Safer Alternatives to Defendants’ Products
Defendants finally contend that Dr. Raybon’s opinions regarding safer
alternatives are not admissible because they are not supported by sufficient facts or
2 The Court notes that the MDL Court specifically considered and rejected an argument
raised by plaintiffs in another MDL case that Dr. Raybon’s opinion on physician training is
relevant to counter Bard’s “blame the doctor” defense. See Wise, 2015 WL 521202, at *13
n.8.
data. However, Dr. Raybon cites extensive data from Ethicon’s own internal
documents to support his opinions on safter alternatives. See Wise, 2015 WL
521202, at *15. As such, the Court concludes that Dr. Raybon’s opinions are
sufficiently supported. To the extent that Defendants argue that Dr. Raybon’s
opinions conflict with Plaintiffs’ case-specific expert, Dr. Hoyte, such argument is
more appropriate for cross-examination. Consequently, Defendant’s request to
exclude Dr. Raybon’s opinions as to safer alternatives is denied.
Accordingly, it is
ORDERED, ADJUDGED, and DECREED:
(1) “Defendants’ Motion to Exclude General-Causation Testimony of Robert
Brian Raybon, M.D. and Briefin Support” (Doc. 107) is GRANTED IN
PART and DENIED IN PART.
(2) The motionis GRANTED to the extent that Dr. Raybon’s opinions on the
TVT-O device and physician training and competence are excluded.
(3) The motion is otherwise DENIED.
DONE and ORDERED in Chambers, in Tampa, Florida, this 28th day of
April, 2021.
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“TOMBARBER i aws—‘“‘C:stsS
UNITED STATES DISTRICT JUDGE
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