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 CERTAIN OPINIONS OF DANIEL ELLIOTT, M.D.
This matter is before the Court on “Defendants’ Motion to Exclude Certain
Opinions of Daniel Elliott, M.D. and Brief in Support,” filed on March 15, 2021.
(Doc. 105). Plaintiffs responded in opposition on April 5, 2021. (Doc. 114). 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
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; 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,
Ovis Ellerbee and James Ellerbee sued directly in the Southern District of West
Virginia as part of the multidistrict litigation (MDL). Their case, In re: Ethicon,
Inc., Pelvic Repair Sys. Prods. Liab. Lit., MDL No. 2327, 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
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.
(Count XIV), Unjust Enrichment (Count XV), Loss of Consortium (Count XVI),
Punitive Damages (Count XVII), and Discovery Rule and Tolling (Count XVIII). On
September 2, 2020, this 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).
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
Defendants raise various Daubert challenges to the proposed testimony of
Daniel Elliott, M.D. Plaintiffs designated Dr. Elliott – a pelvic surgeon and
urogynecologist – to offer general opinions involving Ethicon’s TVT-O device, which
is used to treat stress urinary incontinence (“SUI”), and a Prolift device, which is
used to treat pelvic organ prolapse. Here, Defendants make no argument that Dr.
Elliott is generally unqualified to serve as an expert. However, they seek to exclude
certain testimony and opinions, arguing that (1) Dr. Elliott’s opinion that TVT-O is
unsafe for the surgical treatment of SUI is directly contradicted by his published
literature; (2) Dr. Elliott is not qualified to provide opinions about the duties of a
medical device manufacturer, and those opinions are unreliable; (3) Dr. Elliott’s
opinion that non-synthetic mesh procedures are a safer alternative to TVT-O and
Prolift is irrelevant and unreliable; and (4) Dr. Elliott’s opinion that a device with a
different type of mesh would serve as a safer alternative to TVT-O or Prolift is
unreliable.
Opinions on TVT-O that Contradict Dr. Elliott’s Published Literature
Defendants argue that Dr. Elliott’s opinion that TVT-O is unsafe for the
surgical treatment of SUI is directly contracted by his published literature and
should therefore be excluded. Dr. Elliott was a contributing author to the
referenced article. Any alleged inconsistencies between his current opinions and
the opinions of the article are better addressed through cross-examination than
exclusion.2 The motion is denied as to this ground.
Opinions on Duties Owed by a Manufacturer
Defendants next contend that Dr. Elliott is not qualified to provide opinions
about the duties of a medical device manufacturer, and those opinions are
unreliable.
Adverse Event Reporting
Defendants seek to exclude Dr. Elliott’s opinions about Ethicon’s adverse
event reporting. Plaintiffs agree that Dr. Rosenzweig will not offer the opinions on
the legal adequacy of the testing conducted by Ethicon. As such, the Court will
grant the motion to this extent. Dr. Elliott cannot opine on whether Ethicon
responded appropriately to alleged safety issues with additional research and
2 The case cited by Defendants is clearly distinguishable on its facts – Dr. Blaivas’s opinions
were excluded because when forming his trial opinions, he applied standards different than
those applied in his medical practice. See Wilkerson v. Boston Scientific Corp., 2015 WL
2087048, at *15 (S.D.W. Va. May 5, 2015). Defendants have not made the same argument
here as to Dr. Elliott’s intellectual rigor when forming his trial opinions.
testing. See Wiltgen v. Ethicon, Inc., No. 12-cv-2400, 2017 WL 4467455, at *6 (N.D.
Ill. Oct. 6, 2017). Dr. Elliott may testify concerning the impact that the studies and
tests had on his opinions in this case. See id.
IFU
Defendants argue that Dr. Elliott should be precluded from testifying about
the IFU related to adverse events. The Court will limit Dr. Elliott’s testimony to an
evaluation of the IFU that is based on his knowledge and clinical experience rather
than FDA requirements or regulations. See id. He may not testify about the IFU
from a regulatory viewpoint, but he may testify from a physician’s viewpoint. See
id.
Physician Training
Defendants also seek to exclude Dr. Elliott’s opinions regarding the
competency of other physicians. The MDL Court previously excluded proposed
opinions regarding physician training and competency, concluding that these
opinions were irrelevant. See Wise v. C.R. Bard Inc., No. 2:12-cv-1378, 2015 WL
521202, at *13 (S.D.W. Va. Feb. 7, 2015) (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. The motion is granted as to this
request.
Opinions on Non-Synthetic Mesh Procedures as Safer Alternatives to
Defendants’ Products
Defendants contend that Dr. Elliott’s opinions regarding safer alternatives to
the TVT-O are irrelevant because he opines on safer alternative procedures rather
than safer alternative designs. However, Dr. Elliott’s opinions that alternate
medical procedures were safe and effective are relevant to demonstrating the
products’ inherent risks and assist the jury in appreciating the risk-utility analysis.
See, e.g., Messina v. Ethicon, Inc., No. 6:20-cv-1170-Orl-40LRH, 2020 WL 7419586,
at *4 (M.D. Fla. Dec. 17, 2020); Wiltgen, 2017 WL 4467455, at *3-5. The motion is
denied as to this ground.
Opinions on Devices with Different Type of Mesh as Safer Alternatives to
Defendants’ Products
Defendants finally contend that Dr. Elliott’s opinions that a device with a
different type of mesh would serve as a safer alternative to TVT-O or Prolift are
unreliable. The MDL Court determined that Dr. Elliott could “testify about the
alleged benefits of mesh that is lighter-weight and has larger pores, and in general
found him qualified to testify about whether one mesh is safter than another.”
Wiltgen, 2017 WL 4467455, at *5 (internal quotations omitted). Defendants’ attacks
on Dr. Elliott’s opinions here go toward the weight of the evidence rather than
admissibility. See id.; Herrera-Nevarez by Springer v. Ethicon, Inc., No. 17 C 3930,
2017 WL 3381718, at *7 (N.D. Ill. Aug. 6, 2017). The motion is denied as to this
ground.
Accordingly, it is
ORDERED, ADJUDGED, and DECREED:
(1) “Defendants’ Motion to Exclude Certain Opinions of Daniel Elliott, M.D.
and Brief in Support” (Doc. 105) is GRANTED IN PART and DENIED
IN PART, as set forth herein.
DONE and ORDERED in Chambers, in Tampa, Florida, this 20th day of
May, 2021.
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TOM BARBER
UNITED STATES DISTRICT JUDGE
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