Cline v. Boston Scientific Corporation et al

Filing 83

MEMORANDUM OPINION and ORDER granting in part and denying in part 71 Motion for Summary Judgment (See order regarding ruling on counts). Signed by Honorable Timothy L. Brooks on February 11, 2021. (src)

IN THE UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF ARKANSAS
FAYETTEVILLE DIVISION
PLAINTIFF

KORTNEY R. CLINE

V.

CASE NO. 5:14-CV-5090
DEFENDANT

BOSTON SCIENTIFIC CORPORATION
MEMORANDUM OPINION AND ORDER

Before the Court are a Motion for Summary Judgment (Doc. 71) filed by Defendant
Boston Scientific Corporation ("BSC") and a Response in Opposition (Doc. 72) filed by
Plaintiff Kortney R. Cline. This case was recently transferred to this Court from the District
Court for the Southern District of West Virginia, where the Honorable Joseph R. Goodwin
was presiding over seven separate multi-district litigations ("MDL") concerning products
sold by BSC. This case was related to one of the seven MDLs. See Transfer Order, Doc.
30. The Court has now considered the parties' briefing and finds that the Motion for
Summary Judgment should be GRANTED IN PART AND DENIED IN PART.
I. BACKGROUND
Ms. Cline's original complaint was filed in this Court on March 14, 2014 (Doc. 1).
An amended complaint was filed on April 4, 2014 (Doc. 11). BSC answered the amended
complaint on April 18, 2014 (Doc. 14); however, on June 10, 2014, the entire case was
removed to the MDL, and a Master Long Form Complaint (Doc. 32) and Amended Short
Form Complaint (Doc. 81) were subsequently filed in that forum. The Court understands
that the Amended Short Form Complaint and Master Long Form Complaint are the joint
operative pleadings in this case.

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Ms. Cline brings the following causes of action against BSC: Count I, negligence;
Count 11, strict liability-design defect; Count 111, strict liability-manufacturing defect;
Count IV, strict liability-failure to warn; Count V, breach of express warranty; Count VI,
breach of implied warranty; Count VII, discovery rule/tolling/fraudulent concealment;
Count VIII, punitive damages; Count IX, violations of the Arkansas Deceptive Trade
Practices Act ("ADTPA"), and Count X, fraud/deceit. The parties agree that all claims are
brought under Arkansas law, and the Court concurs with that assessment.
BSC's Motio� for Summary Judgment seeks the dismissal of Counts I-VI and does
not mention Counts VII-X.

Nevertheless, the Court has determined, sua sponte, that

Counts VII and VIII merit dismissal. Count VII alleges "that the discovery rule should be
applied to toll the running of the statute of limitations." (Doc. 32, p. 28). This tolling
argument is not a separate tort claim but is instead a preemptive response to a statute­
of-limitations defense-which BSC has failed to pursue on summary judgment. The Court
therefore finds that Count VII is moot and will be dismissed on the Court's own motion.
As for Count Vlll's claim for punitive damages, this is a remedy and not a standalone
cause of action under Arkansas law. See Bergan v. Ocwen Fin. Corp., 2018 WL 9986722,
at *3 (E.D. Ark. Nov. 1, 2018). To be clear, the Court's dismissal of Count VIII will not
preclude Ms. Cline from seeking a jury instruction on punitive damages at trial.
With those housekeeping matters out of the way, the Court now turns to a summary
of Ms. Cline's claims. She contends that she suffered injuries following her implantation
with a medical device made by BSC called a transobturator mid-urethral sling (referred to
by the parties as the "Obtryx" device). Her implantation surgery took place on July 22,
2009, and was performed by Dr. Gregory D. Reiter in a hospital in Johnson, Arkansas.

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The Obtryx is used to treat symptoms of stress urinary incontinence. According to Ms.
Cline, she suffered from stress urinary incontinence prior to surgery, and she trusted her
doctor's recommendation that the Obtryx would eliminate that condition once implanted.
Unfortunately, Ms. Cline complained that after surgery she suffered from "burning" pelvic
pain, cramping, urinary incontinence, an inability to engage in sexual intercourse due to
pain, and various other injuries. She underwent a second surgery to remove the Obtryx
on June 11, 2018, but she maintains that her injuries never fully resolved and that she
lives with permanent pain and damage.
In the discussion below, the Court will first address Counts II-IV, which are strict­
liability claims brought under the Arkansas Products Liability Act ("APLA"). Next, the
Court will consider BSC's request for dismissal of Count I, which is a claim for common­
law negligence. Lastly, the Court will take up Ms. Cline's breach-of-warranty claims,
which appear in Counts V and VI.

II. LEGAL STANDARD
The standard for summary judgment is well established. Under Federal Rule of
Civil Procedure 56(a), "[t]he court shall grant summary judgment if the movant shows that
there is no genuine dispute as to any material fact and the movant is entitled to judgment
as a matter of law." The Court must review the facts in the light most favorable to the
opposing party and give that party the benefit of any inferences that can be drawn from
those facts. Canada v. Union Elec. Co., 135 F.3d 1211, 1212-13 (8th Cir. 1997). The
moving party bears the burden of proving the absence of a genuine dispute of material
fact and that it is entitled to judgment as a matter of law. See Fed. R. Civ. P.

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56(c); Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586-87
(1986); Nan. Bank of Com. of El Dorado v. Dow Chem. Co., 165 F.3d 602 (8th Cir. 1999).
Once the moving party has met its burden, the non-moving party must "come
forward with 'specific facts showing that there is a genuine issue for trial."' Matsushita,
475 U.S. at 587 (quoting Fed. R. Civ. P. 56(c)). However, "the mere existence of a
scintilla of evidence in support of the plaintiff's position will be insufficient" to survive
summary judgment. Anderson v. Durham D&M, L.L.C., 606 F.3d 513, 518 (8th Cir.
2010) (quoting Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 252 (1986)). Rather, in
order for there to be a genuine issue of material fact that would preclude summary
judgment, the non-moving party must produce evidence "such that a reasonable jury
could return a verdict for the nonmoving party." Allison v. Flexway Trucking, Inc., 28 F.3d
64, 66 (8th Cir. 1994) (quoting Anderson, 477 U.S. at 248).

Ill. DISCUSSION
A. APLA Claims
Counts II, Ill, and IV are brought pursuant the APLA. According to that statute, a
"'[p]roduct liability action' includes all actions brought for or on account of personal injury,
death, or property damage caused by or resulting from the manufacture, construction,
design, formula, preparations, assembly, testing, service, warning, instruction, marketing,
packaging or labeling of any product." Ark. Code Ann.§ 16-116-202(5).

1. Count II: Design Defect
BSC argues that Ms. Cline's design-defect claim should be dismissed "for lack of
evidence." (Doc. 71, p. 9). Specifically, BSC maintains that Ms. Cline cannot establish
that the Obtryx was supplied to her in a defective condition that rendered it unreasonably

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dangerous or that this defective condition was the proximate cause of her damages. BSC
points out that "[e]ven Plaintiff's expert concedes that the Obtryx was the standard of care
to treat [stress urinary incontinence] when [she] had her Obtryx implant." Id. Further,
BSC contends that there is no surgical alternative treatment for stress urinary
incontinence that is without risk, and pursuant to the "comment k defense" located in
Section 402A of the Restatement (Second) of Torts-which Arkansas has adopted-a
manufacturer will not be liable for selling so-called "unavoidably unsafe products" that
carry "a medically recognizable risk" if the products are marketed and sold with proper
warnings of the risk.
The Court finds that there are genuine, material disputes of fact as to Count 11,
such that summary judgment must be denied. First, Ms. Cline points out that the Obtryx
is made of a material called Marlex polypropylene, which she believes should not be used
for permanent human implantation. It appears that Ms. Cline's experts and BSC's experts
disagree as to the safety and efficacy of this material. Second, with respect to the
comment k defense, Ms. Cline offers proof that BSC knew the Obtryx contained an unsafe
material-Marlex polypropylene-and did not provide proper product warnings about that
material. Third, Ms. Cline presents evidence that the Obtryx was not the only treatment
option available for stress urinary incontinence. The Court is therefore persuaded that
summary judgment should be denied on Count II.
2. Count Ill: Manufacturing Defect

Ms. Cline states in her Brief in Response to Summary Judgment that she "hereby
dismisses her strict liability-manufacturing defect cause of action." (Doc. 72, p. 2 n.1).

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The Court interprets this to mean that Ms. Cline does not oppose the entry of summary
judgment on Count 111, and the Court will not consider the merits of the claim further.
3. Count IV: Failure-to-Warn
Under Arkansas law, "the manufacturer of a product has a duty to warn the user
of dangers inherent in that product under the theories of strict liability, negligence and
breach of warranty, and the comment k defense." Hill v. Searle Labs., 884 F.2d 1064,
1070 (8th Cir. 1989).

However, Arkansas law also acknowledges that one of the

exceptions to a manufacturer's duty to warn is "the learned intermediary rule, which
assumes that it is reasonable for a manufacturer to rely on the prescribing physician to
forward to the patient, who is the ultimate user of the ... products, any warnings regarding
their possible side effects." Id. This rule recognizes that "medical ethics and practice
dictate that the doctor must be an intervening and independent party between patient and
[device] manufacturer," that "the information regarding risks is often too technical for a
patient to make a reasonable choice," and that "it is virtually impossible in many cases for
a manufacturer to directly warn each patient." Id. "Thus, a warning to the [physician] is
deemed a warning to the patient; the manufacturer need not communicate directly with
all ultimate users of [medical devices]." Kirsch v. Picker Int'/, Inc., 753 F.2d 670, 671 (8th
Cir. 1985). "Courts are generally in agreement that a warning is adequate where it is
reasonable under the circumstances." Eh/is v. Shire Richwood, Inc., 233 F. Supp. 2d
1189, 1196 (D.N.D. 2002).
Here, BSC argues that it satisfied its duty to warn by providing clear warnings of
the risks associated with the Obtryx in the product brochure, which was provided to Ms.
Cline's implanting physician, Dr. Reiter. The brochure and associated written materials

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warned Dr. Reiter of the post-implantation risk of pain, dyspareunia (painful intercourse),
bleeding, incontinence, infection, erosion, and the possible migration of the device from
the desired location, and Ms. Cline agrees that Dr. Reiter advised her of certain risks,
complications, and benefits of the surgery.

In spite of all that, however, Ms. Cline

maintains that she suffered some injuries that were not contemplated in the product
brochure and written materials. She claims that BSC failed to provide Dr. Reiter with
information about all the possible risks associated with the Obtryx, such that he was
unable to make a knowledgeable risk assessment and could not adequately advise her.
Ms. Cline posits that when a doctor does not receive full and appropriate warnings about
a product from the manufacturer and would have changed his advice to a patient had he
received adequate warnings, the learned intermediary exception should not shield the
manufacturer from liability for failure to warn.
After reviewing the evidence in the light most favorable to Ms. Cline, the Court
finds there is proof that Dr. Reiter was not provided clear and complete warnings of the
risks associated with the Obtryx. If Ms. Cline is correct about those risks, the learned­
intermediary exception would not be available to BSC to protect it from liability on the
failure-to-warn claim.

"Once a plaintiff proves the lack of an adequate warning or

instruction, a presumption arises that the user"-or in this case, the implanting
physician-"would have read and heeded adequate warnings or instructions." Bushon v.
Garman Co., 843 S.W.2d 807, 811 (Ark. 1992). In the case at bar, Dr. Reiter testified
that he was unaware that the Obtryx contained Marlex polypropylene. (Doc. 72-2, pp. 1516). He admits he did not receive warnings about certain studies that had concluded
Marlex polypropylene was not recommended for permanent use in humans. Id. at p. 12.

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He also testified that if he had been warned by BSC about possible dangers associated
with Marlex polypropylene,

this knowledge might have affected his product

recommendation to Ms. Cline. Id. at p. 44-45 ("I think I would like to see more material
or more information on any of the meshes now. If there's things like this being said, I'd
like to see more information period.").
Ms. Cline has raised a triable question of fact as to whether BSC failed to warn Dr.
Reiter of a risk associated with the Obtryx that was not otherwise known to him. She has
also raised a genuine, material dispute of fact as to whether a failure to warn Dr. Reiter
of certain risks associated with the Obtryx was a cause in fact and the proximate cause
of her injuries.

Finally, she has identified a material dispute about whether certain

warnings about the Obtryx-if true-would have changed Dr. Reiter's decision to
recommend the product for implantation. Summary judgment as to Count IV is denied.

B. Count I: Negligence
BSC contends that Ms. Cline's negligence claim should be dismissed for the same
reasons that her APLA claims should be dismissed. As explained above, two of Ms.
Cline's APLA claims will be preserved for trial. Moreover, Arkansas law permits Ms. Cline
to simultaneously maintain both her negligence claim under Count I and her strict liability
claims under Counts II and IV. According to the Arkansas Supreme Court, "[n]egligence
and strict liability are not mutually exclusive claims. More than one theory of liability is
permissible in a products liability claim." Nationwide Rentals Co. v. Carter, 765 S.W.2d

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931, 933 (Ark. 1989) (citing WM. Bash/in Co. v. Smith, 643 S.W.2d 526, 529 (Ark.
1982)). 1 Summary judgment is therefore denied as to Count I.

C. Counts V and VI: Breach of Express and Implied Warranties
BSC's final arguments concern Ms. Cline's warranty of merchantability claims. As
to the express warranty claim, BSC contends that Ms. Cline has failed to identify an
express warranty that she relied on in making her decision to be implanted with the Obtryx
device. According to BSC, Ms. Cline admitted in her deposition that she never relied on
any written materials authored by BSC, nor did any written materials influence her to
proceed with the implantation surgery. At the same time, BSC acknowledges that the
learned intermediary doctrine applies in this case, and it is undisputed that Ms. Cline
relied on the representations and recommendations of her doctor regarding the safety
and efficacy of the Obtryx product when she made the decision to go forward with her
surgery. As the Court previously explained, a warning-express or implied-issued to a
physician "is deemed a warning to the patient" and "the manufacturer need not
communicate directly with all ultimate users of [medical devices]." Kirsch, 753 F.2d at
671. The learned intermediary doctrine applies to all theories of products liability including
breach of warranty. Hill, 884 F.2d at 1070.
Dr. Reiter relied on BSC's written materials about the Obtryx, including the written
product brochures, and shared that information with Ms. Cline. There is a genuine,

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Arkansas Model Civil Jury Instruction 1013, titled "Products Liability-Issues-Claims
Involving Two or More Theories of Liability," explains in the "Note on Use" that it "can be
used to submit to the jury any combination of five separate causes of action in the field of
products liability: strict liability (AMI 1008); negligence (AMI 203); breach of implied
warranty of merchantability (AMI 101O); breach of implied warranty of fitness for a
particular purpose (AMI 1011); and breach of an express warranty (AMI 1012)."
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material dispute of fact as to whether the product brochures or other writings provided to
Dr. Reiter contained complete, truthful information about the fitness and merchantability
of the device for permanent implantation in human patients.

For these reasons, the

breach-of-express-warranty claim will go to trial.
As for the breach-of-implied-warranty claim, to survive summary judgment Ms.
Cline must provide evidence that the Obtryx was unsuited for its ordinary purpose, Ark.
Code Ann.§ 4-2-314, or unfit for the purpose for which it was required, Ark. Code Ann.
§ 4-2-315. To do this, she identifies expert witnesses who will testify that the Obtryx is
not fit for its ordinary purpose or for a particular purpose due to the presence of Marlex
polypropylene in the product.

BSC responds that the Obtryx was considered the

"standard of care" at the time of Ms. Cline's surgery, and her implanting doctor believed
it would provide the correct treatment for Ms. Cline's symptoms. BSC also notes that
wide usage of the Obtryx to treat stress urinary incontinence was not "objected to within
the trade." (Doc. 71, p. 13).
After considering the parties' arguments and reviewing the proposed evidence, the
Court concludes that despite the fact that the Obtryx was recommended for use by
doctors-including Ms. Cline's own doctor-at the time of her surgery, this does not
necessarily mean that the product was suited for its ordinary purpose or for the purpose
for which it was required. There are genuine, material disputes of fact regarding whether
the Obtryx was a product suitable for permanent implantation in women and whether,
given its materials and design, it was fit for use as a medical device to treat stress urinary
incontinence. Accordingly, the implied breach-of-warranty claim will be preserved for trial.

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IV. CONCLUSION
For the reasons described herein, IT IS ORDERED that Defendant Boston
Scientific Corporation's Motion for Summary Judgment (Doc. 71) is GRANTED IN PART
AND DENIED IN PART. The Motion is GRANTED as to Count Ill and DENIED as to
Counts I, II, IV, V, and VI.
IT IS FURTHER ORDERED that Counts VII and VIII are DISMISSED on the
Court's own motion.
To recap, the following claims remain for trial: Count I, negligence; Count II, strict
liability-design defect; Count IV, strict liability-failure to warn; Count V, breach of
express warranty; Count VI, breach of implied warranty; Count IX, violations of the

tc\
IT IS SO ORDERED on this Jt_ day of Febru

ADTPA, and Count X, fraud/deceit.

OKS
DISTRICT JUDGE

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