Flores-Banda v. Boston Scientific Corporation
Filing
97
MEMORANDUM OPINION AND ORDER (Defendant's Motion for Summary Judgment) Boston Scientific Corporation's 39 MOTION for Summary Judgment is GRANTED IN PART with respect to the plaintiff's claims of strict liability for manufactu ring defect, strict liability for failure to warn, negligent manufacturing defect, 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 plaintiffs claims of strict liability for design defect and negligent design. 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
ROSE FLORES-BANDA,
Plaintiff,
v.
Civil Action No. 2:13-cv-04434
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 Rose Flores-Banda (“Motion”)
[Docket 39]. 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. Flores-Banda’s case was selected
as a Wave 1 case by the plaintiffs.
On December 12, 2005, Ms. Flores-Banda was surgically implanted with the Obtryx
Transobturator Mid-Urethral Sling System (the “Obtryx”), a product manufactured by BSC to treat
SUI. She received her surgery at a hospital in Texas. Ms. Flores-Banda claims that as a result of
implantation of the Obtryx, she has experienced multiple complications, including pain, urinary
problems, and erosion. 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. (Short Form Compl. [Docket 1], at 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
evidence and determine the truth of the matter.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242,
2
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
claim. See In re Air Disaster at Ramstein Air Base, Ger., 81 F.3d 570, 576 (5th Cir. 1996) (“Where
3
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. Flores-Banda 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., 2:12cv-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-of-law rules of the originating jurisdiction, which in our case is the state in which the
plaintiff was implanted with the product.”). Ms. Flores-Banda 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. Flores-Banda
resides in Texas, and the product at issue was implanted in Texas. Thus, I apply Texas’s
substantive law to this case.
III.
Analysis
BSC argues that it is entitled to summary judgment in this case because Ms. Flores-Banda’s
claims lack evidentiary support. Ms. Flores-Banda has agreed not to pursue claims for (1) breach
4
of express warranty and (2) breach of implied warranty. (See Pl.’s Resp. in Opp’n to Def.’s Mot.
for Summ. J. (“Resp.”) [Docket 53], at 1). Accordingly, BSC’s Motion on Ms. Flores-Banda’s
claims for breach of express warranty, and breach of implied warranty is GRANTED. Below, I
apply the summary judgment standard to each remaining claim.
A.
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)
the seller is engaged in the business of selling such a product, and
(b)
(2)
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
(a)
the seller has exercised all possible care in the preparation and sale of
his product, and
(b)
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
5
devices, both of which bar Ms. Flores-Banda’s claims. (Mot. [Docket 39], at 9–12). 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 has 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
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. 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)
Other courts have 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).
1
6
clearance process is not a mandatory safety standard or regulation, I FIND section 82.008(a)
inapplicable in this case.
Section 82.008(c) of the Texas Civil Practice and Remedies Code 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) (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) clearance process relates to a medical
device’s equivalence to a preexisting device; it does not entail “full consideration of the 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.
Manufacturing Defect
To prevail on a manufacturing defect claim, a plaintiff must show “a manufacturing flaw
which renders the product unreasonably dangerous[,] that the defect existed at the time the product
left the seller, and that the defect was the producing cause of the plaintiff’s injuries.” Gerber v.
Hoffmann-La Roche, Inc., 392 F. Supp. 2d 907, 922 (S.D. Tex. 2005) (citing Dico Tire, Inc. v.
Cisneros, 953 S.W.2d 776, 783 (Tex. App. 1997)). BSC argues that the plaintiff has failed to proffer
any evidence to support the existence of a manufacturing defect. I agree. Therefore, BSC’s motion
for summary judgment is GRANTED on Ms. Flores-Banda’s manufacturing defect claim.
7
3.
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 Sv. 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 plaintiff’s design defect claim. Comment
k exempts certain products from strict liability because they are “unavoidably unsafe.” 2 The
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 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
8
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 claims of design defect 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). 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.”), is applicable here, given that the Obtryx is neither FDA-approved nor
a prescription drug. 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
any material fact. See Fed. R. Civ. P. 56(a); Adickes v. S.H. Kress & Co., 398 U.S. 144, 157 (1970),
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).
9
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.
4.
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 the implanting physician, Dr. Rowe, was adequately warned of the risks
associated with the products before implanting them in Ms. Flores-Banda, and the plaintiff cannot
establish causation. The record does not include any evidence that Dr. Rowe would not have used
or prescribed the products if the warnings were different. Therefore, the plaintiff cannot establish
causation, and her failure to warn claim fails. 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 failure to warn claim is GRANTED.
B.
Negligence
“Before a negligence theory can be utilized in a products liability case, there must be proof
10
of a defect in the product.” Toshiba Int’l Corp. v. Henry, 152 S.W.3d 774, 785 (Tex. App. 2004);
see also Garrett v. Hamilton Standard Controls, Inc., 850 F.2d 253, 257 (5th Cir. 1988) ([A]
manufacturer logically cannot be held liable for failing to exercise ordinary care when producing
a product that is not defective . . . .”). Proving the plaintiff’s negligent manufacturing claim—like
the plaintiff’s strict liability for manufacturing defect claim—requires proof of a defect. The court
granted summary judgment on the plaintiff’s strict liability for manufacturing defect claim because
the plaintiff did not demonstrate a defect; therefore, the court also GRANTS the defendant’s
Motion with respect to the plaintiff’s negligent manufacturing claim.
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 also GRANTS the
defendant’s Motion with respect to the plaintiff’s negligent failure to warn claim.
The defendant has 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, BSC’s Motion [Docket 39] 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 defect, negligent failure to warn, breach of express warranty,
breach of implied warranty of merchantability, and breach of implied warranty of fitness for a
11
particular purpose, and DENIED IN PART with respect to the plaintiff’s claims of strict liability
for design defect and negligent design.
The Court DIRECTS the Clerk to send a copy of this Order to counsel of record and any
unrepresented party.
ENTER:
12
May 3, 2016
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