`FOR THE NORTHERN DISTRICT OF IOWA
`EASTERN DIVISION
`
`
`SUSAN KELLY; and TIMOTHY
`KELLY,
`
`
`Plaintiffs,
`
`vs.
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`ETHICON, INC.; and JOHNSON &
`JOHNSON,
`
`
`Defendants.
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`
`
`No. 20-CV-2036-CJW-MAR
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`
`
`MEMORANDUM OPINION
`AND ORDER
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`
`
`_______________________________
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`TABLE OF CONTENTS
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`I.
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`II.
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`III.
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`
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`
`
`INTRODUCTION ......................................................................... 3
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`RELEVANT BACKGROUND ........................................................... 3
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`PLAINTIFFS’ MOTION FOR LEAVE TO TAKE THE DEPOSITION OF
`RANDALL BREMNER, M.D. .......................................................... 6
`
`A. Applicable Law ...................................................................... 6
`
`B.
`
`Analysis ............................................................................... 7
`
`
`IV. PLAINTIFFS’ MOTION TO RECONSIDER THIS COURT’S ORDER ON
`DEFENDANTS’ MOTION FOR PARTIAL SUMMARY JUDGMENT ........10
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`
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`
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`
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`A. Applicable Law .....................................................................10
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`B.
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`Analysis ..............................................................................12
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`Case 6:20-cv-02036-CJW-MAR Document 92 Filed 10/16/20 Page 1 of 29
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`1.
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`Strict Liability for Design Defect .......................................12
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`2.
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`Negligent Failure to Warn ...............................................14
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`a.
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`Application of the Learned Intermediary Doctrine ..........14
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`b.
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`Exception to the Learned Intermediary Doctrine.............16
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`c.
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`Post-Sale Duty to Warn ..........................................18
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`3.
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`Negligent Misrepresentation .............................................21
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`4.
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`Fraud-Based Claims .......................................................22
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`5.
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`Loss of Consortium ........................................................22
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`V. DEFENDANTS’ MOTION FOR LEAVE TO FILE SUPPLEMENTAL
`MOTION FOR SUMMARY JUDGMENT ON THE STATUTE OF
`LIMITATIONS .............................................................................23
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`
`
`
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`A. Applicable Law .....................................................................23
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`B.
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`Analysis ..............................................................................24
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`VI. CONCLUSION .............................................................................29
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`Case 6:20-cv-02036-CJW-MAR Document 92 Filed 10/16/20 Page 2 of 29
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`2
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`I.
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`INTRODUCTION
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`This matter is before the Court on plaintiffs Susan Kelly (“plaintiff”) and Timothy
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`Kelly’s (“Timothy”) (collectively “plaintiffs”) Motion for Leave to Take the Deposition
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`of Randall Bremner, M.D. (“Dr. Bremner”) (Doc. 83) and plaintiffs’ Motion to
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`Reconsider and Amend this Court’s Memorandum Opinion and Order on Defendants’
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`Motion for Summary Judgment (Doc. 84). As to both motions, defendants Johnson &
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`Johnson and Ethicon, Inc. (“Ethicon”) timely resisted and plaintiffs timely replied.
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`(Docs. 87, 88, 89, & 90). For the following reasons, the Court denies both of plaintiffs’
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`motions.
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`This matter is also before the Court on defendants’ Motion for Leave to File
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`Supplemental Motion for Summary Judgment on the Statute of Limitations. (Doc. 82).
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`Plaintiffs timely resisted and defendants timely replied. (Docs. 85 & 86). For the
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`following reasons, the Court grants defendants’ motion.
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`The Court will address each motion below in the following order: (1) plaintiffs’
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`motion for leave to depose Dr. Bremner (Doc. 83); (2) plaintiffs’ motion for
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`reconsideration (Doc. 84); and (3) defendants’ motion for leave to file a supplemental
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`motion for summary judgment (Doc. 82).
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`II.
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`RELEVANT BACKGROUND
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`Plaintiffs have resided in Iowa since at least 1990. (Doc. 38–1, at 3). Johnson &
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`Johnson and its subsidiary Ethicon are both New Jersey corporations. (Doc. 1-1, at 1).
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`On March 7, 2004, plaintiff received a tension-free vaginal tape (“TVT”) mesh
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`implant manufactured by Ethicon. See (Doc. 39, at 2). Plaintiff’s implantation procedure
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`took place in Waterloo, Iowa. (Id.). Plaintiff received the implant to stabilize her
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`prolapsed bladder. (Doc. 40-1, at 44). Dr. Bremner performed the procedure. (Doc.
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`39, at 2). Plaintiff testified that she does not remember receiving any brochures,
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`handouts, or other materials about the TVT implant before her surgery, that she did not
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`3
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`know who manufactured the implant, and that she did not rely on any statements by
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`defendants in selecting it. (Id., at 2–3; Doc. 45, at 3–4). Plaintiff, however, states that
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`Dr. Bremner failed to inform her of the potential risks posed by the TVT implant and
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`that she relied on his advice. (Doc. 45, at 3–6). Plaintiff states she was only informed
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`of the risks posed by the implant procedure and not the TVT implant itself. (Id., at 5).
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`Plaintiff alleges that, as a result of her TVT implant corroding, oxidizing, or eroding,
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`she has suffered from, among other things, “depression, pelvic pain, dyspareunia, loss
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`of services of her spouse, continued and worsening incontinence, [urinary tract
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`infections], urinary retention, abdominal pain, urgency, frequency, and dysuria.” (Id.,
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`at 4) (citing plaintiff’s deposition testimony).
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`On February 28, 2014, plaintiffs filed suit in the multidistrict litigation (“MDL”)
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`related to defendants’ TVT implant in the United States District Court for the Southern
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`District of West Virginia. (Doc. 1). Plaintiffs asserted 17 claims consisting of:
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`negligence (Count I); strict liability for a manufacturing defect (Count II); strict liability
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`for failure to warn (Count III); strict liability for a defective product (Count IV); strict
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`liability for a design defect (Count V); common law fraud (Count VI); fraudulent
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`concealment (Count VII); constructive fraud (Count VIII); negligent misrepresentation
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`(Count IX); negligent infliction of emotional distress (Count X); breach of express
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`warranty (Count XI); breach of implied warranty (Count XII); violation of consumer
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`protection laws (Count XIII); gross negligence (Count XIV); unjust enrichment (Count
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`XV); loss of consortium (Count XVI); and punitive damages (Count XVII). (Id.).1 On
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`September 17, 2014, plaintiff had part of her TVT implant removed in Iowa City, Iowa
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`by Dr. Elizabeth Takacs. (Docs. 39, at 2; 45, at 3).
`
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`1 As previously noted, Timothy’s only claim is for loss of consortium. (Doc. 81, at 4 n.1).
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`4
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`
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`On August 9, 2019, defendants moved for partial summary judgment on plaintiff’s
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`claims for negligence (to the extent it asserted claims for negligent failure to warn or
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`negligent manufacturing defect) (Count I), strict liability for manufacturing defect (Count
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`II), strict liability for failure to warn (Count III), strict liability for defective product
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`(Count IV), strict liability for design defect (Count V), common law fraud (Count VI),
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`fraudulent
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`concealment
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`(Count VII),
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`constructive
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`fraud
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`(VIII), negligent
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`misrepresentation (Count IX), negligent infliction of emotional distress (Count X), breach
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`of express warranty (Count XI), breach of implied warranty (Count XII), violation of
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`consumer protection laws (Count XIII), gross negligence (Count XIV), and unjust
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`enrichment (Count XV). (Doc. 38, at 1). On August 28, 2019, plaintiffs timely filed a
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`resistance. (Doc. 45).
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`On June 2, 2020, this case was transferred from the Southern District of West
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`Virginia to this Court. (Doc. 62). On August 7, 2020, the Court granted in part and
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`denied in part defendants’ motion for partial summary judgment. (Doc. 81). The Court
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`granted summary judgment on plaintiff’s claims for negligence (as it relates to negligent
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`failure to warn and negligent manufacturing defect) (Count I); strict liability for
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`manufacturing defect (Count II); strict liability for failure to warn (Count III); strict
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`liability for defective product (Count IV); strict liability for design defect (Count V);
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`common law fraud (Count VI); fraudulent concealment (Count VII); constructive fraud
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`(VIII); negligent misrepresentation (Count IX); breach of express warranty (Count XI);
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`breach of implied warranty (Count XII); violation of consumer protection laws (Count
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`XIII); and gross negligence (Count XIV). (Id., at 22). It denied summary judgment on
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`plaintiff’s claims for negligence (as it relates to negligent design) (Count I); negligent
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`infliction of emotional distress (Count X); and unjust enrichment (Count XV). (Id., at
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`23). Defendants did not request, and the Court did not grant, summary judgment on
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`plaintiffs’ claims for loss of consortium (Count XVI) and punitive damages (Count XVII).
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`5
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`
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`III. PLAINTIFFS’ MOTION FOR LEAVE TO TAKE THE DEPOSITION OF
`RANDALL BREMNER, M.D.
`
`A.
`
`Applicable Law
`
`Most courts in the Eighth Circuit have analyzed a motion for leave to take a
`
`deposition after the close of discovery under Federal Rule of Civil Procedure 16(b). See,
`
`e.g., Bell v. Mine Safety Appliances, No. 1:13-cv-01075, 2015 U.S. Dist. LEXIS
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`178459, at *2–3 (W.D. Ark. Nov. 17, 2015); Optimal Interiors, LLC v. Hon Co., No.
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`3:09-cv-00177-JEG-RAW, 2011 WL 13308179, at *1 (S.D. Iowa Mar. 7, 2011). Rule
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`16(b) states that a court must issue a scheduling order which sets deadlines for, among
`
`other things, discovery. FED. R. CIV. P. 16(b)(3). Rule 16(b)(4) states that “[a] schedule
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`may be modified only for good cause and with the judge’s consent.” Thus, courts
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`generally employ a flexible good cause standard when evaluating a motion for leave to
`
`take a late deposition. See, e.g., Bell, 2015 U.S. Dist. LEXIS 178459, at *2–3 (finding
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`the defendants did not show good cause); Hon Co., 2011 WL 13308179, at *1 (“When
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`a dispute arises and a party requests leave to take trial depositions after the discovery
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`deadline, a certain amount of flexibility in application of [Rule] 16(b)(4) good cause
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`standard is often in order to assure basic fairness and presentation of a full record to the
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`fact finder.”).
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`“The primary measure of [the] ‘good cause’ standard is the moving party’s
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`diligence in attempting to meet the [scheduling] order’s requirements.” Bradford v.
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`DANA Corp., 249 F.3d 807, 809 (8th Cir. 2001) (citing Johnson v. Mammoth
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`Recreations, Inc., 975 F.2d 604, 609 (9th Cir.1992)). Nevertheless, even if the movant
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`shows good cause, the court “retains discretion as to whether to grant the motion”
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`because the scheduling order is “a vehicle designed to streamline the flow of litigation
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`through our crowded dockets.” Id. (citing In re Milk Prods. Antitrust Litig., 195 F.3d
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`430, 437 (8th Cir.1999)).
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`6
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`Some courts in the Eighth Circuit have, however, applied Federal Rule of Civil
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`Procedure 60(b) instead of Rule 16(b) in ruling on a motion to take an untimely
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`deposition. See, e.g., Pippin v. Hill-Rom Co., No. 4:08CV263 TIA, 2008 WL 4911800,
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`at *1 (E.D. Mo. Nov. 13, 2008) (finding that Federal Rule of Civil Procedure 60(b) “can
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`allow a party to complete an act [after] the deadline has passed”). Rule 60(b) provides
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`several different equitable grounds for relief, namely:
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`(1) mistake, inadvertence, surprise, or excusable neglect;
`(2) newly discovered evidence that, with reasonable diligence, could not
`have been discovered in time to move for a new trial under Rule 59(b);
`(3) fraud (whether previously called intrinsic or extrinsic),
`misrepresentation, or misconduct by an opposing party;
`(4) the judgment is void;
`(5) the judgment has been satisfied, released, or discharged; it is based on
`an earlier judgment that has been reversed or vacated; or applying it
`prospectively is no longer equitable; or
`(6) any other reason that justifies relief.
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`These bases of relief under 60(b), given their equitable nature, are consistent with the
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`flexible good cause analysis and discretion described by other courts in the Eighth Circuit
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`discussing Rule 16(b). Thus, the Court’s analysis would be the same under either rule;
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`the Court must identify some good cause or quality of equity that, in its discretion,
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`warrants extension of the deposition deadline set in the scheduling order.
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`B.
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`Analysis
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`Plaintiffs filed their complaint in the MDL on February 28, 2014. (Doc. 1). On
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`February 4, 2019, the MDL court entered an order setting August 1, 2019, as the
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`“[d]eposition deadline and close of discovery.” (Doc. 15, at 3). This order also limited
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`depositions of treating physicians to four, three-hour depositions for each case. (Id., at
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`4). Despite this opportunity, plaintiffs never deposed Dr. Bremner or any other treating
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`physician. (Doc. 83-1, at 2 n.1). It is not clear to the Court when plaintiffs were
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`prompted to begin case-specific discovery. At worst, they had five and a half years from
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`7
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`the date they filed their complaint to depose Dr. Bremner. Even assuming, however,
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`that plaintiffs could not depose Dr. Bremner until the MDL court’s February 4, 2019
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`Order, plaintiffs still had half a year to get it done.
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`On August 9, 2019, after the close of discovery, defendants moved for partial
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`summary judgment. (Doc. 38). Following transfer, the Court granted in part defendants’
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`motion for partial summary judgment on August 7, 2020, nearly a year later. (Doc. 81).
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`Defendants motion for partial summary judgment explicitly pointed out that plaintiffs had
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`not deposed Dr. Bremner. See, e.g., (Doc. 39, at 7–8). Although it would have been
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`untimely, plaintiffs did not move to depose Dr. Bremner to supplement the record at any
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`time before this Court’s summary judgment Order. Now, a month and a half after the
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`Court’s summary judgment Order, plaintiffs request leave to depose Dr. Bremner. (Doc.
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`83). On its face, plaintiffs are excessively tardy in requesting Dr. Bremner’s deposition
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`more than a year after the close of discovery and even after the Court’s summary
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`judgment Order issued.
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`Despite this substantial delay, plaintiffs offer little explanation of good cause or
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`any other viable excuse. First, plaintiffs’ counsel appears to place part of the blame on
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`his caseload related to the MDL, stating “counsel had a total of twenty-six (26) cases
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`selected for work-up and litigation within Wave 11 [of the MDL], the majority of which
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`underwent discovery as best as feasibly possible.” (Doc. 83-1, at 1–2). Counsel’s
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`personal workload is no excuse. Plaintiffs had an ample opportunity to obtain Dr.
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`Bremner’s testimony in some form over the course of, at best, six months. In sum,
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`having other cases to juggle is not good cause for failing to conduct fundamental
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`discovery and does not warrant backtracking this case.
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`Second, plaintiffs argue that despite their efforts, they could not locate Dr.
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`Bremner during the discovery period. (Id., at 2); see also (Doc. 89, at 2–3). On August
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`10, 2020 (three days after this Court granted partial summary judgment), however,
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`8
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`plaintiffs obtained an address for Dr. Bremner by performing a “skip trace.” (Doc. 83-
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`1, at 2). On August 14, 2020, plaintiffs sent Dr. Bremner a letter. (Id.). On August
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`26, 2020, Dr. Bremner responded to plaintiffs and agreed to a potential deposition in
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`October. (Id.). The Court is highly skeptical that Dr. Bremner could not have been
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`timely reached during the discovery period with diligent effort. Dr. Bremner was only
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`partially retired and, thus, must have been publicly accessible to some extent. See (id.).
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`Even if Dr. Bremner was not easily publicly accessible, plaintiffs fail to explain why a
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`skip trace could not have been performed earlier or why social media, public records, or
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`other documents failed to yield any means of contacting him. That plaintiffs were able
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`to find Dr. Bremner’s address three days after this Court’s Order itself indicates Dr.
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`Bremner could have been contacted with reasonable effort and, it appears, would have
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`agreed to being deposed. Thus, this excuse also does not constitute good cause.
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`Last, plaintiffs reiterate that Dr. Bremner’s testimony is pivotal to some of their
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`claims. (Doc. 83-1, at 2–3, 4). This is undoubtedly true. The Court granted summary
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`judgment on several claims in part because the record did not contain any evidence of
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`Dr. Bremner’s decisions and conduct regarding the TVT implant. The Court’s concern
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`here is not, however, whether Dr. Bremner’s deposition would be duplicative,
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`burdensome, or costly as plaintiffs discuss. (Id., at 4–6). Rather, the Court’s concern
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`is plaintiffs’ failure to take Dr. Bremner’s deposition in a timely fashion. Plaintiffs note
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`that “the issues in this case have been litigated for more than six (6) years” and thus, they
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`should “have the opportunity to obtain complete evidence.” (Id., at 6). As discussed,
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`plaintiffs have failed to show good cause as to why this deposition could not have taken
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`place at any time during discovery. In other words, plaintiffs had their opportunity to
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`complete the evidence, but failed to seize it.
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`Indeed, it would be highly prejudicial to defendants to backtrack a year’s worth of
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`litigation by undoing the Court’s grant of partial summary judgment, reinstating some of
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`9
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`
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`plaintiffs’ claims, and requiring defendants to participate in a deposition that could have
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`taken place a year and a half ago or more.
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`The additional discovery plaintiffs seek from Dr. Bremner also does not warrant
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`his untimely deposition. See (id., at 4–5). In its summary judgment Order, the Court
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`noted that plaintiffs’ failure to depose Dr. Bremner, although serious, was not inherently
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`fatal because other evidence could exist—such as a note or publication authored by Dr.
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`Bremner about TVT implants—which could indicate that Dr. Bremner would have
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`changed his decision if given different warnings. (Doc. 81, at 10–11). The Court
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`concluded, however, that no such evidence existed in the record. (Id., at 11). Now,
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`plaintiff argues she should be able to depose Dr. Bremner to discover whether such notes
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`or publications exist. (Doc. 84-1, at 6–7). The Court declines to stretch its hypothetical
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`discussion into a basis for purely speculative discovery. See (Doc. 83-1, at 4–5) (stating
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`that plaintiff has no reason to believe these documents even exist—in fact, the opposite);
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`(Doc. 89, at 3) (“It is highly unlikely that this information even exists.”). As discussed
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`above, the Court finds that plaintiffs’ failure to depose Dr. Bremner before the close of
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`discovery does not warrant re-opening these already resolved issues.
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`In sum, the Court finds that plaintiffs have not shown good cause or any other
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`equitable reason why the Court should substantially alter the course of this case to allow
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`plaintiffs to conduct a deposition that they already had an ample opportunity to conduct.
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`Thus, the Court denies plaintiffs’ motion for leave to depose Dr. Bremner. (Doc. 83).
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`IV. PLAINTIFFS’ MOTION TO RECONSIDER THIS COURT’S ORDER ON
`DEFENDANTS’ MOTION FOR PARTIAL SUMMARY JUDGMENT
`
`A.
`
`Applicable Law
`
`Generally, Federal Rules of Civil Procedure 59(e) and 60(b) apply to a motion to
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`reconsider a court’s grant of summary judgment. Rule 59(e) enables parties to submit a
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`motion to alter or amend a judgment within 28 days of the judgment’s entry. “A district
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`10
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`court has broad discretion in determining whether to grant or deny a motion to alter or
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`amend judgment pursuant to Rule 59(e)[.]” United States v. Metropolitan St. Louis Sewer
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`Dist., 440 F.3d 930, 933 (8th Cir. 2006). “Rule 59(e) motions serve the limited function
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`of correcting manifest errors of law or fact[.]” Id. (citation and internal quotation marks
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`omitted). Rule 59(e) motions should “also be granted where the court overlooked a
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`factual or legal argument presented by a party, but not where a party failed to present a
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`relevant factual or legal argument to the court in the first instance.” Stults v. Bush Boake
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`Allen, Inc., No. C11-4077-MWB, 2014 WL 775525, at *2 (N.D. Iowa Feb. 25, 2014)
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`(citations and emphasis omitted). Rule 60(b), as discussed above, enables a court to
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`provide relief from a final judgment in a limited set of circumstances.
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`Admittedly, “the Federal Rules of Civil Procedure do not seem to provide any
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`basis for a motion to reconsider [a] court’s granting of a partial summary judgment[.]”
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`Helm Fin. Corp. v. Iowa N. Ry. Co., 214 F. Supp. 2d 934, 999 (N.D. Iowa 2002)
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`(emphasis altered). Courts have found, however, that the absence of this relief in the
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`Federal Rules “means that [the] court actually has more, rather than less, discretion to
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`alter or amend such an interlocutory order than is provided in either Rule 59(e) or
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`60(b)[.]” Id. Like the denial of a summary judgment motion, the court retains the power
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`to reconsider or amend its ruling “up until the time a final judgment is entered.” Id.
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`Thus, a court has discretion to reconsider challenged portions of an order granting partial
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`summary judgment. Id. In doing so, a court is not bound by the specifications and
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`standards of Rules 59(e) and 60(b). EEOC v. Am. Home Prods. Corp., 165 F. Supp. 2d
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`886, 891–92 (N.D. Iowa 2001) (citations omitted).
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`11
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`
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`B.
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`Analysis
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`Plaintiffs request the Court reconsider or amend its Order on defendants’ Motion
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`for Partial Summary Judgment in five respects. (Doc. 84-1, at 4–14).2 First, plaintiff
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`argues that under Iowa law her claim for strict liability for design defect may not be
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`subsumed by her claim for negligent design defect and thus, she withdraws her
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`abandonment of this claim. (Id., at 4–6). Second, plaintiff argues the learned
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`intermediary doctrine does not apply to her negligent failure to warn claim, or
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`alternatively, that exceptions to the doctrine apply, or that defendants violated a post-sale
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`duty to warn. (Id., at 6–10). Third, plaintiff argues her negligent misrepresentation
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`claim should be allowed to proceed due to defendants’ alleged misrepresentations or
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`fraudulent behavior. (Id., at 10–12). Fourth, plaintiff argues she sufficiently stated her
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`fraud claims. (Id., at 12–13). Last, Timothy appears to request some type of relief
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`related to his claim for loss of consortium, even though the Court’s Order did not affect
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`his claim. (Id., at 13–14).
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`1.
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`Strict Liability for Design Defect
`
`In response to defendants’ motion for partial summary judgment, plaintiff did not
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`oppose granting summary judgment on her claim of strict liability for design defect, or
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`her other two strict liability claims. (Doc. 45, at 7–8). Thus, the Court granted summary
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`judgment on plaintiff’s claim for strict liability for design defect. (Doc. 81, at 7).
`
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`2 Although Rule 59(e) does not apply here, as plaintiffs agree (Doc. 84-1, at 3–4), the timeliness
`of plaintiffs’ motion is still a “valid consideration” that the Court can take into account, see Am.
`Home Prods. Corp., 165 F. Supp. 2d at 892 (quoting Deimer v. Cincinnati Sub-Zero Prods.,
`Inc., 990 F.2d 342, 346 (7th Cir. 1993) (noting that the movant’s tardiness was still a valid
`consideration). Here, plaintiffs filed their motion to reconsider 40 days after the Court granted
`in part defendants’ partial motion for summary judgment (Docs. 81 & 84), far outside the usual
`28-day window of Rule 59(e). Although the Court declines to incorporate this fact into its
`analysis, plaintiffs’ delay in reasserting issues that have already been addressed is detrimental to
`a speedy resolution of the remaining claims.
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`
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`12
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`Now, plaintiff argues that her strict liability for design defect claim may not be
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`subsumed by her negligent design defect claim as previously thought. (Doc. 84-1, at 4–
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`6). Plaintiff further states, without citation, that “[i]t appears that your Honor is of the
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`position that [plaintiff]’s Strict Liability – Design Defect claim did not merge with her
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`Negligent Design claim.” (Id., at 6). Thus, plaintiff “withdraws her abandonment as to
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`this claim” and asserts it is factually supported by expert testimony. (Id.).
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`Plaintiff’s argument relies on outdated authority. “The Iowa Supreme Court has
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`. . . held that design defect claims are not strict liability claims.” Wurster v. Plastics
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`Grp., Inc., 917 F.3d 608, 615 (8th Cir. 2019) (citing Scott v. Dutton-Lainson Co., 774
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`N.W.2d 501, 505 (Iowa 2009)). Indeed, in Wright v. Brooke Group, Ltd., the Iowa
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`Supreme Court stated that “negligence principles are more suitable for” all defective
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`design cases aside from manufacturing defects, which require a strict liability analysis.
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`652 N.W.2d 159, 169 (Iowa 2002); see also Scott, 774 N.W.2d at 504 (discussing
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`Wright). Despite this, the Iowa Supreme Court expressed its reluctance to affix any
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`doctrinal label to design defect claims. Wright, 652 N.W.2d at 169. Instead, the court
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`found that negligent design defect and strict liability for design defect were not
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`meaningfully distinct and should not be presented in tandem to a jury. Id. Thus, when
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`both design defect theories are asserted, this Court has merged them into a single design
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`defect claim. See, e.g., Nicholson v. Biomet, Inc., No. 18-CV-3057-CJW-KEM, 2020
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`WL 3399899, at *19 (N.D. Iowa Mar. 6, 2020).
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`Plaintiff’s request is moot. The Court did not grant summary judgment on
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`plaintiff’s claim for negligent design defect. (Doc. 81, at 12). Thus, even if the Court
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`accepted plaintiff’s withdrawal of her abandonment of her strict liability for design defect
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`claim, reversed summary judgment, and reinstated the claim, it would merely merge into
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`her already viable claim for negligent design defect. Whether this surviving claim is
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`Case 6:20-cv-02036-CJW-MAR Document 92 Filed 10/16/20 Page 13 of 29
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`labelled as negligent design defect or simply design defect is immaterial; both terms are
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`consistent with Iowa law. See Wright, 652 N.W.2d at 169.
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`Thus, the Court denies as moot plaintiff’s motion on this issue.
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`2.
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`Negligent Failure to Warn
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`In its Order on defendants’ motion for partial summary judgment, the Court
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`granted summary judgment on plaintiff’s negligent failure to warn claim because there
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`was no evidence of proximate causation. (Doc. 81, at 9–12). Specifically, under the
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`learned intermediary doctrine, the Court found that plaintiff had not shown that different
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`warnings by defendants would have changed Dr. Bremner’s decision to use the TVT
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`implant or how he explained the risks to plaintiff. (Id., at 10–12).
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`Now, plaintiff argues (1) that the learned intermediary doctrine does not apply or,
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`alternatively, (2) that exceptions to the doctrine apply, or (3) defendants had a continuing
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`duty to warn even after the sale of the TVT implant. (Doc. 84-1, at 6–10). The Court
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`will address each argument in turn.
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`a.
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`Application of the Learned Intermediary Doctrine
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`Plaintiff argues the learned intermediary doctrine does not apply here. (Doc. 84-
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`1, at 6–7) (citing Mercer v. Pittway Corp., 616 N.W.2d 602, 624 (Iowa 2000) (involving
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`litigation over a smoke detector); Lovick v. Wil-Rich, 588 N.W.2d 688, 700 (Iowa 1999)
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`(involving litigation over a farm cultivator)). Because plaintiff asserts she would not have
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`consented to the TVT implant if different warnings were given, plaintiff argues the Court
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`should reinstate her negligent failure to warn claim. (Id.).
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`“[I]n the context of prescription medical devices and drugs, Iowa follows the
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`learned intermediary doctrine.” Willet v. Johnson & Johnson, No. 112-CV-00034-JAJ-
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`RAW, 2019 WL 7500524, at *2 (applying the learned intermediary doctrine under Iowa
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`law in a case arising from the same MDL). Although Iowa has not explicitly adopted the
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`learned intermediary doctrine, its use is firmly established:
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`
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`Iowa courts have not explicitly adopted the learned intermediary doctrine.
`The Iowa Supreme Court has, however, acknowledged the learned
`intermediary doctrine and did not prohibit its use. McCormick v. Nikkel &
`Assocs., Inc., 819 N.W.2d 368, 375 (Iowa 2012). Federal courts have also
`applied the learned intermediary doctrine to Iowa cases and predicted that
`Iowa will adopt the doctrine. Petty v. United States, 740 F.2d 1428, 1440
`(8th Cir. 1984); Daughetee v. Chr. Hansen, Inc., 960 F. Supp. 2d 849,
`870 (Iowa 2013) (“[T]he ‘intermediary’ defense is still viable under Iowa
`law.”) (quoting Nationwide Agribusiness Ins. Co. v. SMA Elevator Constr.,
`Inc., 816 F. Supp. 2d 631, 653 (N.D. Iowa 2011)). Additionally, the vast
`majority of other jurisdictions apply the learned intermediary doctrine.
`Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 158 n.17 (Tex. 2012) (stating
`the highest courts of at least thirty-five states have adopted a form of the
`learned intermediary doctrine and the intermediary courts and federal courts
`of additional states apply the doctrine as well). Because the Iowa Supreme
`Court has not rejected the learned intermediary doctrine and because other
`federal courts within the Eighth Circuit have applied the learned
`intermediary doctrine to Iowa cases, the Court finds it is likely Iowa law
`supports using the learned intermediary doctrine and will apply it here [to
`a failure to warn claim involving a medical device].
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`Nicholson, 2020 WL 3399899, at *15; see also Madsen v. Am. Home Prods. Corp., 477
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`F. Supp. 2d 1025, 1033–34 (E.D. Mo. 2007) (citing In re Norplant Contraceptive Prods.
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`Liab. Litig., 215 F. Supp. 2d 795, 821 (E.D. Tex. 2002)) (“Iowa’s adoption of the
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`Restatement (Third) of Torts . . . and the overwhelming precedent adopting the learned
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`intermediary doctrine convinces the Court that the Iowa Supreme Court would recognize
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`that the [learned intermediary] doctrine governs Plaintiff’s [prescription drug-related]
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`failure-to-warn claims at issue.”).
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`Neither of plaintiff’s cited cases are products liability suits involving prescription
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`drugs or medical devices. Neither of them discusses the learned intermediary doctrine.
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`Federal courts presiding over products liability claims involving prescription drugs and
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`medical devices routinely apply the learned intermediary doctrine under Iowa law.
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`
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`Thus, the Court can do little more than to direct plaintiff back to the law the Court
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`cited in its prior Order:
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`Under the learned intermediary doctrine, a manufacturer of
`prescription drug or medical device need not provide warnings directly to
`patients using its products so long as adequate warnings were given to the
`health care provider supplying the products to patients. RESTATEMENT
`(THIRD) OF TORTS § 6 cmt. e; see also Daughetee, 960 F. Supp. 2d at 869–
`70. When a manufacturer supplied warnings to the health care provider,
`the plaintiff must show different or additional warnings were necessary and
`would have altered the health care provider’s decision to supply the product
`at issue. Willet v. Johnson & Johnson, No. 1:12-CV-00034-JAJ-RAW,
`2019 WL 7500524, at *2–3 (S.D. Iowa Sept. 30, 2019). Indeed, to
`establish proximate causation, “the plaintiff must show that a proper
`warning would have changed the decision of the treating physician, i.e.,
`that but for the inadequate warning, the treating physician would not have
`used or prescribed the product.” Wessels v. Biomet Orthopedics, LLC, No.
`18-CV-97-KEM, 2020 WL 3421478, at *14 (N.D. Iowa June 22, 2020)
`(citations and quotation marks omitted).
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`(Doc. 81, at 9–10). This case involves a medical device and Dr. Bre