Winebarger et al v. Boston Scientific Corporation

Filing 225

ORDER denying 180 Plaintiff's Motion for Reconsideration. Signed by District Judge Richard Voorhees on 9/30/15. (smj)

IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF NORTH CAROLINA
STATESVILLE DIVISION
LEAD CASE NO. 5:15CV57-RLV; 3:15CV211-RLV

MARTHA CARLSON,
Plaintiff,
v.

BOSTON SCIENTIFIC
CORPORATION,
Defendant.
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ORDER

THIS MATTER is before the Court on Plaintiff Martha Carlson’s Motion to Reconsider
Summary Judgment in favor of Boston Scientific Corporation on her Failure to Warn Claim,
N.C. Gen. Stat. §§ 99B-5, filed August 25, 2015. (Doc. 180). Defendant Boston Scientific
Corporation opposes Plaintiff’s motion. (Doc. 191). Plaintiff filed a Reply on September 21,
2015. (Doc. 207). Trial is scheduled for October 5, 2015.
I. Standard
Plaintiff brings her Motion to Reconsider pursuant to Rule 54 of the Federal Rules of
Civil Procedure. Rule 54(b) of the Federal Rules of Civil Procedure provides that, in the absence
of an express order directing final judgment as to certain claims or parties:
[A]ny order or other decision, however designated, that adjudicates fewer
than all of the claims or the rights and liabilities of fewer than all the parties does
not end the action as to any of the claims or parties and may be revised at any
time before the entry of a judgment adjudicating all the claims and all the parties’
rights and liabilities.
Fed. R. Civ. P. 54(b). Pursuant to this rule, the Court “retains the power to reconsider and modify
its interlocutory judgments, including partial summary judgments, at any time prior to final

judgment when such is warranted.” Am. Canoe Ass’n v. Murphy Farms, Inc., 326 F.3d 505, 514–
15 (4th Cir. 2003). The decision to grant or deny a Rule 54(b) motion is “committed to the
discretion of the district court.” Id. at 515. A prior dispositive order should be followed unless
“(1) a subsequent trial produces substantially different evidence, (2) controlling authority has
since made a contrary decision of law applicable to the issue, or (3) the prior decision was clearly
erroneous and would work manifest injustice.” Id. (internal quotations omitted).
In an attempt to further clarify when the rare motion for reconsideration might be
warranted, this district court previously explained that this avenue of relief is well taken when
“the Court has patently misunderstood a party, or has made a decision outside the adversarial
issues presented to the Court by the parties, or has made an error not of reasoning but of
apprehension . . . .” N. Carolina ex rel. Cooper v. Tennessee Valley Auth., No. 1:06CV20, 2008
WL 2115159, * 2 (W.D.N.C. May 16, 2008) (quoting Wiseman v. First Citizens Bank & Trust
Co., 215 F.R.D. 507, 509 (W.D.N.C. May 27, 2003) (motions for reconsideration only “allowed
in certain, limited circumstances”).
II. Inadequate Warning, N.C. Gen. Stat. § 99B-5
According to Plaintiff Carlson, the MDL Judge’s analysis of her inadequate warning
claim was skewed by a patent misunderstanding of the underlying facts surrounding Dr.
Kennelly’s awareness and purported lack of reliance on the Uphold DFU. Under North Carolina
law:
(a) No manufacturer or seller of a product shall be held liable in any product
liability action for a claim based upon inadequate warning or instruction unless
the claimant proves that the manufacturer or seller acted unreasonably in failing to
provide such warning or instruction, that the failure to provide adequate warning
or instruction was a proximate cause of the harm for which damages are sought,
and also proves one of the following:

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(1) At the time the product left the control of the manufacturer or seller,
the product, without an adequate warning or instruction, created an
unreasonably dangerous condition that the manufacturer or seller knew, or
in the exercise of ordinary care should have known, posed a substantial
risk of harm to a reasonably foreseeable claimant.
(2) After the product left the control of the manufacturer or seller, the
manufacturer or seller became aware of or in the exercise of ordinary care
should have known that the product posed a substantial risk of harm to a
reasonably foreseeable user or consumer and failed to take reasonable
steps to give adequate warning or instruction or to take other reasonable
action under the circumstances.
(c) Notwithstanding subsection (a) of this section, no manufacturer or seller of a
prescription drug shall be liable in a products liability action for failing to provide
a warning or instruction directly to a consumer if an adequate warning or
instruction has been provided to the physician or other legally authorized person
who prescribes or dispenses that prescription drug for the claimant unless the
United States Food and Drug Administration requires such direct consumer
warning or instruction to accompany the product.
N. C. Gen. Stat. §§ 99B-5(a) and (c) (2015).1 Most relevant here is that Plaintiff establish “the
failure to provide adequate warning or instruction was a proximate cause of the harm for which
damages are sought.” § 99B-5(a).
Although the North Carolina Supreme Court has never expressly ruled on this issue,
courts have presumed that the North Carolina Supreme Court would apply the learned
intermediary doctrine in a case involving a medical device such as this. See e.g., Baraukas v.
Danek Medical, Inc., 2000 WL 223508, at * 4 (M.D.N.C. January 13, 2000) (learned
intermediary doctrine applied in context of action challenging surgical bone screw and
observing, “There are indications that North Carolina courts would adhere to the learned
intermediary doctrine.”) (citing Foyle By and Through McMillian v. Lederle Laboratories, 674

1

Subsection (c) of § 99B-5, which applies only to prescription drugs and is not applicable here,
is a codification of the learned intermediary doctrine.

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F.Supp. 530, 535−36 (E.D.N.C.1987), citing, Holley v. Burroughs Welcome Co., 330 S.E.2d 228
(N.C.App. 1985), aff’d, 348 S.E.2d 772 (N.C. 1986). “According to the learned intermediary
doctrine, where a defendant manufactures a product which is dispensed to patients by doctors,
rather than directly, the defendant has a duty to warn only the doctor, rather than the patients of
any risks associated with the product’s use. It is assumed that the doctors will pass along
appropriate information to their patients.” Baraukas, 2000 WL 223508, at * 4 (internal citations
omitted).
Ms. Carlson cannot establish that an alleged inadequate warning for the Uphold was the
proximate cause of her injuries without demonstrating Dr. Kennelly’s reliance on the Uphold
DFU (Directions For Use). The MDL Judge decided this issue on April 29, 2015, approximately
four months prior to the filing of Plaintiff Carlson’s Motion to Reconsider. (Doc. 101, 6−7).
Applying the learned intermediary doctrine, the MDL Judge found that Dr. Kennelly, the
implanting physician, did not rely on the Uphold DFU in prescribing the device. As a factual
matter, the MDL Judge stated:
“Here, the record is devoid of any evidence that would permit a reasonable juror
to infer that Dr. Kennelly read or relied on the Uphold DFU in prescribing the
device to Ms. Carlson.”
(Doc. 101, 7). As a result, the MDL Judge held that “a reasonable juror could not infer that
BSC’s allegedly defective warnings proximately caused Ms. Carlson’s injuries.” Id. (citing
Lewis v. Ethicon, No. 2:12CV4301, 2014 WL 186869, * 4 (S.D.W.Va. January 15, 2014; and
Jones v. C.R. Bard, Inc., No. 2:11CV114, 2013 WL 5591948, * 6 (S.D.W.Va. June 4, 2013)).
In this case, the essence of Ms. Carlson’s motion for reconsideration is that the MDL
Judge analyzed this issue after “misapprehension of a key fact . . . .” 2 (Doc. 207, 4). In support

2

Plaintiff Carlson apparently abandoned one aspect of her initial argument that would seem to
undermine the MDL Judge’s application of the learned intermediary doctrine. Plaintiff Carlson originally

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of reconsideration, Plaintiff points to deposition testimony of Dr. Kennelly wherein Dr. Kennelly
acknowledges that he, in fact, reviewed the Uphold DFU prior to Ms. Carlson’s surgery and was
familiar with its contents. (Kennelly Dep., 58:21−24; 67:13−16). Dr. Kennelly also testified that
he considered the instructions for use in his decision making, and specifically when weighing the
risks and benefits associated with the Uphold device, for Ms. Carlson’s treatment. (Id. at
83:13−17).
In response, Defendant BSC contends that Ms. Carlson is unable to point to testimony
that adequately counters Dr. Kennelly’s testimony that notwithstanding what he knew about the
potential risks, implantation of the Uphold device was the appropriate treatment for Ms.
Carlson.3 (Doc. 191, 2−3). In other words, BSC argues that Dr. Kennelly’s firm opinion that the
Uphold was the correct treatment plan forecloses Plaintiff’s failure to warn claim. The Court’s
reading of the relevant portion of Dr. Kennelly’s deposition testimony in context confirms this
fact. After agreeing that he had adequate information to properly evaluate the risks and the

argued that had BSC published an adequate warning, her own reliance on the DFU as communicated to
her by her physician would be sufficient to present this claim to a jury. Plaintiff does not mention this
argument in her reply brief.
3

Defendant BSC cites the Frankum case, which was also remanded from MDL 2326 to the
Western District of North Carolina for trial. See Frankum v. Boston Scientific Corporation, No.:
1:15CV91-MOC. In Frankum, a similar motion for reconsideration was recently denied despite
Frankum’s assertion that the MDL Judge “improperly assessed the evidence” relevant to the failure to
warn claim. (No.: 1:15CV91, Doc. 123). In Frankum, the MDL Judge found that the general statements
of the treating physician about typically reviewing instructions for medical devices prior to use did not
overcome the physician’s testimony that he did not read the DFU for the device at issue. The pertinent
deposition testimony in Frankum indicated unequivocally that the implanting surgeon did not read the
DFU for the device at issue – a fact that distinguishes Frankum from the instant case, where Dr. Kennelly
testified that he actually read the DFU for the Uphold. (Doc. 123, 4). The MDL Judge held in Frankum
that no genuine issue of material fact existed as to causation. Consequently, the failure to warn claim was
dismissed and summary judgment granted in favor of BSC on that issue. Judge Cogburn, who recognized
that the MDL Judge reviewed all of the deposition testimony, declined to “re-think” the merits of the
MDL Court’s decision. (Doc. 123, 5).

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benefits of the Uphold for Ms. Carlson, and aware of all of the risks (e.g., erosion, recurrence,
urgency symptoms, urinary incontinence, pain), Dr. Kennelly opined that Ms. Carlson was an
appropriate candidate for the Uphold implant. (Kennelly Dep., 155−56). Dr. Kennelly
specifically testified, “I believe that for what [Carlson] had that the Uphold device was the
optimum therapy for her, given her clinical condition, her concerns, her desire for sparing the
uterus.” (Kennelly Dep., 189). Dr. Kennelly’s professional opinion remains that the Uphold is
“a safe and effective option for the treatment of pelvic organ prolapse” in certain cases.
(Kennelly Dep., 55). In conclusion, while Dr. Kennelly’s deposition testimony shows that Dr.
Kennelly read the Uphold DFU, his testimony does not indicate that he relied on the DFU or that
a different DFU content would have altered his treatment recommendation.
Plaintiff’s Motion Reconsideration will be denied.
IT IS THEREFORE ORDERED that Plaintiff Martha Carlson’s Motion For
Reconsideration (Doc. 180) is hereby DENIED.

Signed: September 30, 2015

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