Stark v. Boston Scientific Corporation
Filing
99
MEMORANDUM OPINION AND ORDER (Defendant's Motion for Summary Judgment) Boston Scientific Corporation's 51 MOTION for Summary Judgment is GRANTED IN PART with respect to the plaintiff's claims of strict liability for manufacturing defect, strict liability for failure to warn, negligent manufacturing, negligent failure to warn, breach of express warranty, breach of implied warranty of merchantability, and breach of implied warranty of fitness for a particular purpose, and DE NIED IN PART with respect to the plaintiff's claims of strict liability for design defect and negligent design, as more fully set forth herein. Signed by Judge Joseph R. Goodwin on 5/3/2016. (cc: counsel of record; any unrepresented party) (ts)
IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
CHARLESTON DIVISION
CATHERINE STARK,
Plaintiff,
v.
Civil Action No. 2:13-cv-21637
BOSTON SCIENTIFIC CORP.,
Defendant.
MEMORANDUM OPINION AND ORDER
(Defendant’s Motion for Summary Judgment)
Pending before the court is Defendant Boston Scientific Corporation’s Motion for
Summary Judgment and Memorandum in Support Against Plaintiff Catherine Stark (“Motion”)
[Docket 51]. As set forth below, BSC’s Motion is GRANTED IN PART with respect to the
plaintiff’s claims of strict liability for manufacturing defect, strict liability for failure to warn,
negligent manufacturing, negligent failure to warn, breach of express warranty, breach of implied
warranty of merchantability, and breach of implied warranty of fitness for a particular purpose.
BSC’s Motion is DENIED IN PART with respect to the plaintiff’s claims of strict liability for
design defect and negligent design.
I.
Background
This case resides in one of seven MDLs assigned to me by the Judicial Panel on
Multidistrict Litigation concerning the use of transvaginal surgical mesh to treat pelvic organ
prolapse (“POP”) and stress urinary incontinence (“SUI”). In the seven MDLs, there are more than
75,000 cases currently pending, approximately 19,000 of which are in the Boston Scientific Corp.
(“BSC”) MDL, MDL 2326. In an effort to efficiently and effectively manage this massive MDL,
I decided to conduct pretrial discovery and motions practice on an individualized basis so that once
a case is trial-ready (that is, after the court has ruled on all Daubert motions and summary judgment
motions, among other things), it can then be promptly transferred or remanded to the appropriate
district for trial. To this end, I ordered the plaintiffs and defendant to each select 50 cases, which
would then become part of a “wave” of cases to be prepared for trial and, if necessary, remanded.
(See Pretrial Order # 65, In re Boston Scientific Corp. Pelvic Repair Sys. Prods. Liab. Litig., No.
2:12-md-002326, entered Dec. 19, 2013, available at http://www.wvsd.uscourts.gov/MDL/boston/
orders.html). This selection process was completed twice, creating two waves of 100 cases, Wave
1 and Wave 2. Ms. Stark’s case was selected as a Wave 1 case by BSC.
On October 19, 2010, Ms. Stark was surgically implanted with the Obtryx Transobturator
Mid-Urethral Sling System (the “Obtryx”), a product manufactured by BSC to treat SUI. (See
Mot. [Docket 51], at 1–2). Dr. Terri Scott implanted the product at St. Luke’s The Woodlands
Hospital in The Woodlands, Texas. (Short Form Compl. [Docket 1], at 4). Ms. Stark claims that
as a result of implantation of the Obtryx, she has experienced multiple complications. She brings
the following claims against BSC: strict liability for design defect, manufacturing defect, and
failure to warn; negligence; breach of express and implied warranties; and punitive damages. (Id.
at 4–5).
II.
Legal Standards
A.
Summary Judgment
To obtain summary judgment, the moving party must show that there is no genuine dispute
as to any material fact and that the moving party is entitled to judgment as a matter of law. Fed. R.
Civ. P. 56(a). In considering a motion for summary judgment, the court will not “weigh the
2
evidence and determine the truth of the matter.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242,
249 (1986). Instead, the court will draw any permissible inference from the underlying facts in the
light most favorable to the nonmoving party. Matsushita Elec. Indus. Co. v. Zenith Radio Corp.,
475 U.S. 574, 587–88 (1986).
Although the court will view all underlying facts and inferences in the light most favorable
to the nonmoving party, the nonmoving party nonetheless must offer some “concrete evidence
from which a reasonable juror could return a verdict” in his or her favor. Anderson, 477 U.S. at
256. Summary judgment is appropriate when the nonmoving party has the burden of proof on an
essential element of his or her case and does not make, after adequate time for discovery, a showing
sufficient to establish that element. Celotex Corp. v. Catrett, 477 U.S. 317, 322–23 (1986). The
nonmoving party must satisfy this burden of proof by offering more than a mere “scintilla of
evidence” in support of his or her position. Anderson, 477 U.S. at 252. Likewise, conclusory
allegations or unsupported speculation, without more, are insufficient to preclude the granting of
a summary judgment motion. See Dash v. Mayweather, 731 F.3d 303, 311 (4th Cir. 2013); Stone
v. Liberty Mut. Ins. Co., 105 F.3d 188, 191 (4th Cir. 1997).
B.
Choice of Law
Under 28 U.S.C. § 1407, this court has authority to rule on pretrial motions in MDL cases.
The choice of law for these pretrial motions depends on whether they concern federal or state law:
When analyzing questions of federal law, the transferee court should apply the law
of the circuit in which it is located. When considering questions of state law,
however, the transferee court must apply the state law that would have applied to
the individual cases had they not been transferred for consolidation.
In re Temporomandibular Joint (TMJ) Implants Prods. Liab. Litig., 97 F.3d 1050, 1055 (8th Cir.
1996) (internal citations omitted). To determine the applicable state law for a dispositive motion,
I generally refer to the choice-of-law rules of the jurisdiction where the plaintiff first filed her
3
claim. See In re Air Disaster at Ramstein Air Base, Ger., 81 F.3d 570, 576 (5th Cir. 1996) (“Where
a transferee court presides over several diversity actions consolidated under the multidistrict rules,
the choice of law rules of each jurisdiction in which the transferred actions were originally filed
must be applied.”); In re Air Crash Disaster Near Chi., Ill., 644 F.2d 594, 610 (7th Cir. 1981); In
re Digitek Prods. Liab. Litig., MDL No. 2:08-md-01968, 2010 WL 2102330, at *7 (S.D. W. Va.
May 25, 2010).
If a plaintiff files her claim directly into the MDL in the Southern District of West Virginia,
however, as Ms. Stark did in this case, I consult the choice-of-law rules of the state in which the
plaintiff was implanted with the product. See Sanchez v. Boston Scientific Corp., 2:12-cv-05762,
2014 WL 202787, at *4 (S.D. W. Va. Jan. 17, 2014) (“For cases that originate elsewhere and are
directly filed into the MDL, I will follow the better-reasoned authority that applies the choice-oflaw rules of the originating jurisdiction, which in our case is the state in which the plaintiff was
implanted with the product.”). Ms. Stark received the Obtryx implantation surgery in Texas. Thus,
the choice-of-law principles of Texas guide this court’s choice-of-law analysis.
The parties agree, as does this court, that these principles compel application of Texas law
to the plaintiff’s claims. In tort actions, Texas adheres to the Restatement (Second) of Conflict of
Laws. (Am. Law Inst. 1971). Gutierrez v. Collins, 583 S.W.2d 312, 318 (Tex. 1979). Under section
145 of the Restatement (Second) of Conflict of Laws, the court must apply the law of the state
with the most “significant relationship to the occurrence and the parties.” Here, Ms. Stark resides
in Texas, and the product was implanted in Texas. Thus, I apply Texas’s substantive law to this
case.
4
III.
Analysis
BSC argues that it is entitled to summary judgment because Ms. Starks’s legal theories are
without evidentiary or legal support. (Mot. [Docket 51], at 1). Ms. Stark concedes her claims for
(1) breach of express warranty, (2) breach of implied warranty, (3) strict liability for manufacturing
defect, and (4) negligent manufacturing. (See Pl.’s Resp. in Opp’n to Def.’s Mot. for Summ. J.
(“Resp.”) [Docket 67], at 1). Accordingly, BSC’s Motion as to those claims is GRANTED. Below,
I apply the summary judgment standard to each remaining claim.
A.
Statute of Limitations
BSC first argues that each of the plaintiff’s personal injury claims are barred by Texas’s
statute of limitations. (Mot. [Docket 51], at 6–7). Under Texas law, the statute of limitations for
personal injury actions is two years. Tex. Civ. Prac. & Rem. Code Ann. § 16.003(a). Accordingly,
a plaintiff must file her claims within two years of the date the alleged wrongful act caused her
injury. Childs v. Haussecker, 974 S.W.2d 31, 36 (Tex. 1998). This period, however, may be tolled
by application of the discovery rule. The discovery rule tolls accrual “until a plaintiff knows or,
through the exercise of reasonable care and diligence, should have known of the wrongful act and
resulting injury.” Id. (internal quotations and citation omitted); see also Woodruff v. A.H. Robbins
Co., 742 F.2d 228, 230 (5th Cir. 1984) (“[T]he Texas discovery rule . . . provides that certain
‘inherently undiscoverable causes of action’ do not accrue until the plaintiff learns or reasonably
should have learned of the negligent cause . . . .”).
Ms. Stark filed this action on August 8, 2013. (Short Form Compl. [Docket 1]). According
to BSC, the statute of limitations dictated that the action be filed by May 26, 2013, two years after
Ms. Stark expressed concern that her incontinence and pain were related to the implantation of the
5
Obtryx. (Mot. [Docket 51], at 7 (citing Pl. Medical Rs., Ex. E [Docket 51-1], at 1)). The record,
however, is not indisputable, as BSC presents. In fact, the patient’s medical records state:
She noted one episode of incontinence yesterday. She is concerned about her
bladder sling. She also notes that her sexual partner was hospitalized with a bladder
infection for 4 days recently. She states they always use a condom. She is having
left low back pain which radiates to the left lower quadrant. She has been taking
some pain medication she had at home. She is to see Dr[.] Scott next week. She
states she had bladder issues in the past while on ambilify which she is taking now.
Contrary to BSC’s view, I am not persuaded that the reference to the Obtryx shows that “Ms. Stark
voiced concerns that the issues were related to the implantation of the Obtryx device.” A
generalized statement that “she is concerned about her bladder sling” says nothing, as a matter of
law, about Ms. Stark’s belief that the Obtryx was responsible for her incontinence or any other
symptom. BSC has not pointed to any other evidence that Ms. Stark discovered her potential claims
against the defendant more than two years before filing this lawsuit. On this reasoning, and bearing
in mind my duty to draw all legitimate inferences in favor of the nonmovant, I DENY BSC’s
Motion with respect to the statute of limitations.
B.
Strict Liability
Texas has adopted the doctrine of strict liability for defective products set forth in section
402A of the Restatement (Second) of Torts. See McKisson v. Sales Affiliates, Inc., 416 S.W.2d 787,
789 (Tex. 1967). Section 402A provides:
(1)
One who sells any product in a defective condition unreasonably dangerous
to the user or consumer or to his property is subject to liability for physical
harm thereby caused to the ultimate user or consumer, or to his property, if
(a)
(b)
(2)
the seller is engaged in the business of selling such a product, and
it is expected to and does reach the user or consumer without substantial
change in the condition in which it is sold.
The rule stated in Subsection (1) applies although
6
(a)
the seller has exercised all possible care in the preparation and sale of
his product, and
(c)
the user or consumer has not bought the product from or entered into
any contractual relation with the seller.
Restatement (Second) of Torts § 402A (Am. Law Inst. 1965). “The concept of defect is central to
a products liability action brought on a strict tort liability theory, whether the defect be in conscious
design, or in the manufacture of the product, or in the marketing of the product.” Turner v. Gen.
Motors Corp., 584 S.W.2d 844, 847 (Tex. 1979).
1.
Statutory Defense
BSC argues that Chapter 82 of the Texas Civil Practice and Remedies Code provides two
separate statutory presumptions of non-liability that apply to FDA-regulated prescription medical
devices, both of which bar Ms. Stark’s claims. (Mot. [Docket 51], at 9–13). The first, section
82.008(a) of the Texas Civil Practice and Remedies Code states that:
In a products liability action brought against a product manufacturer or seller, there
is a rebuttable presumption that the product manufacturer or seller is not liable for
any injury to a claimant caused by some aspect of the formulation, labeling, or
design of a product if the product manufacturer or seller establishes that the
product’s formula, labeling, or design complied with mandatory safety standards or
regulations adopted and promulgated by the federal government, or an agency of
the federal government, that were applicable to the product at the time of
manufacture and that governed the product risk that allegedly caused harm.
Tex. Civ. Prac. & Rem. Code § 82.008(a) (emphasis added).
As I have previously held, the 510(k) process is not a safety statute or administrative
regulation. See generally Lewis, et al. v. Johnson & Johnson, et al., 991 F. Supp. 2d 748 (S.D. W.
Va. 2014). The Supreme Court determined that “the 510(k) process is focused on equivalence, not
safety.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 493, 116 S. Ct. 2240 (1996) (internal quotation
omitted); see also Riegel v. Medtronic, Inc., 552 U.S. 312, 323, 128 S. Ct. 999 (2008) (“While §
510(k) is focused on equivalence, not safety, premarket approval is focused on safety, not
7
equivalence.”) (internal quotation omitted).1 FDA regulations also state that 510(k) clearance
“does not in any way denote official approval of the device.” 21 C.F.R. § 807.97 (2012). The FDA
thus prohibits manufacturers of devices cleared through the 510(k) process from making any
representations that their devices have been approved by the FDA. See id. (“Any representation
that creates an impression of official approval of a device because of complying with the premarket
notification regulations is misleading and constitutes misbranding.”). Because the FDA’s 510(k)
clearance process is not a mandatory safety standard or regulation, I FIND section 82.008(a)
inapplicable here.
Next, BSC relies on Section 82.008(c) of the Texas Civil Practice and Remedies Code,
which provides as follows:
In a products liability action brought against a product manufacturer or seller, there
is a rebuttable presumption that the product manufacturer or seller is not liable for
any injury to a claimant allegedly caused by some aspect of the formulation,
labeling, or design of a product if the product manufacturer or seller establishes that
the product was subject to pre-market licensing or approval by the federal
government, or an agency of the federal government, that the manufacturer
complied with all of the government's or agency’s procedures and requirements
with respect to pre-market licensing or approval, and that after full consideration
of the product’s risks and benefits the product was approved or licensed for sale by
the government or agency.
Tex. Civ. Prac. & Rem. Code § 82.008(c) (2013) (emphasis added). The FDA conducts a full
analysis of the product’s risks and benefits when a product goes through the premarket approval
process, not the 510(k) clearance process. As discussed above, the 510(k) process relates to a
medical device’s equivalence to a preexisting device; it does not require “full consideration of the
1
Other courts interpreted Lohr as I do, holding that the 510(k) process does not go to whether a product is safe and
effective or impose any requirements on its own. See, e.g., Martin v. Am. Med. Sys., Inc., 116 F.3d 102, 104 (4th Cir.
1997); Bass v. Stryker Corp., 669 F.3d 501, 507 (5th Cir. 2012); Brooks v. Howmedica, Inc., 273 F.3d 785, 794 (8th
Cir. 2001); Mack v. Stryker Corp., 893 F. Supp. 2d 976, 985 (D. Minn. 2012); Soufflas v. Zimmer, Inc., 474 F. Supp.
2d 737, 747 n.6 (E.D. Pa. 2007); Nicoll v. I-Flow, LLC, No. 12-1593, 2013 WL 2477032, at *3 (E.D. La. June 7,
2013).
8
product’s risks and benefits.” Also, as stated above, 510(k) clearance does not constitute FDA
“approval” of the device. Therefore, I FIND that section 82.008(c) does not apply to BSC in this
case.
2.
Design Defect
In Texas, a plaintiff bringing a design defect claim under strict liability must prove by a
preponderance of the evidence that (1) the product was unreasonably dangerous due to a defect,
(2) “there was a safer alternative design,” and (3) “the defect was a producing cause” of the
damages. Tex. Civ. Prac. & Rem. Code Ann. § 82.005; see also Timpte Indus., Inc. v. Gish, 286
S.W.3d 306, 311 (Tex. 2009). To determine whether a product is unreasonably dangerous, Texas
courts apply a risk-utility test that considers the following factors:
(1) the utility of the product to the user and to the public as a whole weighed against
the gravity and likelihood of injury from its use; (2) the availability of a substitute
product which would meet the same need and not be unsafe or unreasonably
expensive; (3) the manufacturer’s ability to eliminate the unsafe character of the
product without seriously impairing its usefulness or significantly increasing its
costs; (4) the user’s anticipated awareness of the dangers inherent in the product
and their avoidability because of general public knowledge of the obvious condition
of the product, or of the existence of suitable warnings or instructions; and (5) the
expectations of the ordinary consumer.
Am. Tobacco Co. v. Grinnell, 951 S.W.2d 420, 432 (Tex. 1997); see also Hernandez v. Tokai Corp.,
2 S.W.3d 251, 256 (Tex. 1999). Whether the product is unreasonably dangerous is generally an
issue for the jury. Timpte Indus., 286 S.W.3d at 312; Am. Tobacco, 951 S.W.2d at 432.
BSC argues that comment k to section 402A bars the plaintiff’s design defect claim.
Comment k exempts certain products from strict liability because they are “unavoidably unsafe.”2
2
Comment k provides as follows:
Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite
incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs.
An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very
serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death,
both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk
which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not
9
The interpretation and treatment of this exemption varies. Some courts have found that comment
k categorically bars design defect claims for certain medical products. See, e.g., Brown v. Superior
Court, 751 P.2d 470, 477 (Cal. 1988) (leading case adopting categorical approach). In these states,
comment k is an absolute bar to design defect claims for particular classes of products. Other courts
have adopted a case-by-case approach. See, e.g., Toner v. Lederle Labs., a Div. of Am. Cyanamid
Co., 732 P.2d 297, 308 (Idaho 1987) (leading extant case adopting case-by-case approach). Thus,
in these states, whether comment k bars a claim for design defect depends on the particular product
at hand.
As an initial matter, I reject BSC’s contention that Texas’s absolute bar for FDA-approved
prescription drugs, see Carter v. Tap Pharm., Inc., No. SA-03-CA-0182, 2004 WL 2550593, at *2
(W.D. Tex. Nov. 2, 2004) (“Under Texas law, all FDA-approved prescription drugs are unavoidably
unsafe as a matter of law.”), applies here, given that the products are neither FDA-approved nor
prescription drugs. See Lofton v. McNeil Consumer & Speciality Pharm., 682 F. Supp. 2d 662, 679
(N.D. Tex. 2010) (refusing to “take a leap not taken by Texas courts” in applying comment k
categorically outside the prescription drug context).
BSC has presented no other argument on design defect. Thus, BSC has failed to meet its
burden under the summary judgment standard of showing the absence of a genuine dispute as to
defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of
which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is
also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for
sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such
experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The
seller of such products, again with the qualification that they are properly prepared and marketed, and proper
warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences
attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable
product, attended with a known but apparently reasonable risk.
Restatement (Second) of Torts § 402A cmt. k (Am. Law Inst. 1965).
10
any material fact. See Fed. R. Civ. P. 56(a); Adickes v. S.H. Kress & Co., 398 U.S. 144, 157 (1970),
superseded on other grounds by Celotex Corp. v. Catrett, 477 U.S. 317 (1986). Therefore, BSC’s
Motion on the plaintiff’s claim of strict liability for design defect is DENIED.
3.
Failure to Warn
Texas, like many jurisdictions, has adopted the learned intermediary doctrine. Under this
doctrine, a plaintiff must establish two elements: “(1) the warning was defective; and (2) the failure
to warn was a producing cause of the plaintiff’s condition or injury.” Porterfield v. Ethicon, Inc.,
183 F.3d 464, 468 (5th Cir. 1999) (applying Texas law).
Under Texas law, causation—the second element—must be proven by showing “a proper
warning would have changed the decision of the treating physician.” Ackermann v. Wyeth Pharm.,
526 F.3d 203, 208 (5th Cir. 2008) (quoting Dyer v. Danek Med., Inc., 115 F. Supp. 2d 732, 741
(N.D. Tex. 2000)). In other words, the plaintiff must show “that but for the inadequate warning,
the treating physician would have not used or prescribed the product.” Id. (quoting Dyer, 115 F.
Supp. 2d at 741). If a physician, as the learned intermediary, does not testify that he or she would
not have used or prescribed the product, the causal chain is broken, the plaintiff cannot show
causation, and the failure to warn claim fails.
BSC argues that the implanting physician, Dr. Scott, was adequately warned of the risks
associated with the Obtryx before implanting it in Ms. Stark, and that the plaintiff cannot establish
causation. The record does not include any evidence that but for the inadequate warning, Dr. Scott
would not have used the product. Contrary to the plaintiff’s assertion, “Dr. Scott’s commitment to
discussing issues with her patients, her lack of knowledge about certain dangers prior to her
deposition, and her admission that had she been informed about such issues, she would have
[addressed] those issues with her patients,” (Resp. [Docket 67], at 11), is insufficient to sustain the
11
plaintiff’s burden of proffering evidence on causation. Because the failure to warn claim fails for
lack of causation, I need not address the adequacy of the warnings. See Celotex, 477 U.S. at 322–
23. Accordingly, BSC’s motion for summary judgment on the strict liability failure to warn claim
is GRANTED.
C.
Negligence
The learned intermediary doctrine applies with equal force to the plaintiff’s negligent
failure to warn case. See Centocor, 372 S.W.3d at 173 (finding the learned intermediary doctrine
applies to all claims premised on the manufacturer’s alleged failure to warn). Consequently, the
negligent failure to warn claim fails for the same reason the strict liability failure to warn claim
failed: the plaintiff did not meet her burden of demonstrating that the alleged inadequate warning
was the producing cause of the plaintiff’s injuries. Accordingly, the court GRANTS the
defendant’s Motion with respect to the plaintiff’s negligent failure to warn claim.
The defendant has also not presented arguments with respect to the negligent design
defect claim beyond those I have already rejected. Accordingly, BSC’s Motion as to the
negligent design defect claim is DENIED.
IV.
Conclusion
For the reasons discussed above, it is ORDERED that BSC’s Motion [Docket 51] is
GRANTED IN PART with respect to the plaintiff’s claims of strict liability for manufacturing
defect, strict liability for failure to warn, negligent manufacturing, negligent failure to warn, breach
of express warranty, breach of implied warranty of merchantability, and breach of implied warranty
of fitness for a particular purpose, and DENIED IN PART with respect to the plaintiff’s claims of
strict liability for design defect and negligent design.
12
The Court DIRECTS the Clerk to send a copy of this Order to counsel of record and any
unrepresented party.
ENTER: May 3, 2016
13
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?