Robbins et al v. Boston Scientific Corporation
Filing
115
MEMORANDUM OPINION AND ORDER (Defendant's Motion for Summary Judgment) Boston Scientific Corporation's 59 MOTION for Summary Judgment Against Plaintiffs Mistee Robbins and Shawn Robbins is GRANTED IN PART with respect to Ms. Robbin s's claims for manufacturing defect, under theories of strict liability and negligence; breach of implied warranty; and breach of express warranty and DENIED IN PART with respect to Ms. Robbins's claims for strict liability for failure to warn, strict liability for design defect, and negligence; and Mr. Robbins's claim for loss of consortium. Signed by Judge Joseph R. Goodwin on 10/6/2015. (cc: counsel of record; any unrepresented party) (ts)
IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
CHARLESTON DIVISION
MISTEE ROBBINS and SHAUN ROBBINS,
Plaintiffs,
v.
Civil Action No. 2:12-cv-01413
BOSTON SCIENTIFIC CORP.,
Defendant.
MEMORANDUM OPINION AND ORDER
(Defendant’s Motion for Summary Judgment)
Pending before the court is defendant Boston Scientific Corporation’s (“BSC”) Motion for
Summary Judgment against Plaintiffs Mistee Robbins and Shaun Robbins [Docket 59]. As set
forth below, BSC’s Motion for Summary Judgment is GRANTED IN PART with respect to Ms.
Robbins’s claims for manufacturing defect, under theories of strict liability and negligence; breach
of implied warranty; and breach of express warranty. BSC’s Motion for Summary Judgment is
DENIED IN PART with respect to Ms. Robbins’s claims for strict liability for failure to warn,
strict liability for design defect, and negligence; and Mr. Robbins’s claim for loss of consortium.
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 nearly
70,000 cases currently pending, approximately 19,000 of which are in the 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 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. The
Robbinses’ case was selected as a Wave 1 case by the plaintiffs.
Ms. Robbins was surgically implanted with the Uphold Vaginal Support System (the
“Uphold”) and the Solyx SIS System (the “Solyx”) on April 20, 2010. (BSC’s Mot. for Summ. J.
& Mem. in Supp. (“Mem. in Supp.”) [Docket 59], at 2). She received the surgery at a hospital in
Cedar City, Utah. (Id. at 3). As a result of implantation of the Uphold and the Solyx, she has
allegedly experienced various injuries. She brings the following claims against BSC: strict liability
for design defect, manufacturing defect, and failure to warn; negligence; breaches of express and
implied warranties; and punitive damages. (Am. Short Form Compl. [Docket 14], at 4–5). Mr.
Robbins brings a claim for loss of consortium. (Id. at 5). In the instant motion, BSC moves for
summary judgment on the grounds that the Robbinses’ “legal theories are without evidentiary or
legal support.” (Mem. in Supp. [Docket 59], at 1).
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.
2
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,
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
such as this. The choice of law for these pretrial motions depends on whether they involve 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.
3
Liab. Litig., 97 F.3d 1050, 1055 (8th Cir. 1996) (internal citations omitted). In cases based on
diversity jurisdiction, the choice-of-law rules to be used are those of the states where the actions
were originally filed. 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). The Robbinses’ action was originally filed in the United States
District Court for the District of Massachusetts. (Compl. [Docket 1]). Thus, the choice-of-law
principles of Massachusetts guide this court’s choice-of-law analysis.
The choice-of-law principles of Massachusetts compel application of Utah law. Under
Massachusetts law, “unless another state has a more significant relationship to the underlying
cause of action, tort claims remain governed by the law of the state in which the alleged injury
occurred.” Geshke v. Crocs, Inc., 889 F. Supp. 2d 253, 260 (D. Mass. 2012) (citing Watkins v.
Omni Life Sci., Inc., 692 F. Supp. 2d 170, 174 (D. Mass. 2010)). Here, the alleged injury occurred
in Utah, where Ms. Robbins was implanted with the allegedly defective device. Thus, in the
absence of a state with a more significant relationship to the underlying causes of action, I apply
Utah’s substantive law to the claims in this case.
III. Analysis
BSC argues that it is entitled to summary judgment in this case because Ms. Robbins’s
claims lack either evidentiary or legal support. Ms. Robbins has agreed not to pursue claims for:
(1) strict liability for manufacturing defect; (2) breach of implied warranties; and (3) breach of
express warranty. (Pls.’ Resp. in Opp’n to BSC’s Mot. for Summ. J. (“Resp.”) [Docket 75], at 7
4
n.33). Accordingly, BSC’s Motion for Summary Judgment on Ms. Robbins’s claims for strict
liability for manufacturing defect, breach of implied warranty, and breach of express warranty is
GRANTED. Below, I apply the summary judgment standard to each remaining claim.
A. Strict Liability for Design Defect
Under Utah law, strict products liability is governed by section 402A of the Restatement
(Second) of Torts. Ernest W. Hahn, Inc. v. Armco Steel Co., 601 P.2d 152, 156 (Utah 1979).
Accordingly, a manufacturer who sells a product “in a defective condition unreasonably dangerous
to the user or consumer” is strictly liable “for physical harm thereby caused to the ultimate user or
consumer.” Restatement (Second) of Torts § 402A (1965). To recover, a plaintiff must establish:
“(1) that the product was unreasonably dangerous due to a defect or defective condition, (2) that
the defect existed at the time the product was sold, and (3) that the defective condition was a cause
of the plaintiff’s injuries.” Lamb v. B & B Amusements Corp., 869 P.2d 926, 929 (Utah 1993).
For a product to be “unreasonably dangerous,” it must be “dangerous to an extent beyond
which would be contemplated by the ordinary and prudent buyer, consumer, or user of that product
in that community considering the product’s characteristics, propensities, risks, dangers, and uses
together with any actual knowledge, training, or experience possessed by that particular buyer,
user, or consumer.” Utah Code Ann. § 78B-6-702. Nonetheless, a product is presumed to be not
defective
where the alleged defect in the plans or designs for the product or the methods and
techniques of manufacturing, inspecting and testing the product were in conformity
with government standards established for that industry which were in existence at
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the time the plans or designs for the product or the methods and techniques of
manufacturing, inspecting and testing the product were adopted.
Id. § 78B-6-703.
Here, BSC argues that Ms. Robbins’s claim for strict liability for design defect fails
because BSC complied with FDA regulations and requirements in bringing the Uphold and the
Solyx to the market. Critical to Ms. Robbins’s case, however, when assessing the application of a
government standards rebuttal, “parties may not present evidence regarding the 510(k) clearance
process or subsequent FDA enforcement actions” because “[t]he 510(k) process is not a safety
statute or administrative regulation.” Lewis v. Johnson & Johnson, 991 F. Supp. 2d 748, 755–56
(S.D. W. Va. 2014); see also Tingey v. Radionics, 193 F. App’x 747 (10th Cir. 2006) (applying
Utah law) (holding that 510(k) clearance did not qualify for the government standards rebuttal).
Accordingly, the rebuttable presumption afforded by section 78B-6-703 is not applicable to Ms.
Robbins’s case.
BSC next argues that Ms. Robbins’s claim for strict liability for design defect fails under
the “unavoidably unsafe” doctrine. Comment k of section 402A of the Restatement describes
certain products as “unavoidably unsafe products.” Under Utah law, “the seller of such products,
when the products are properly prepared and marketed and distributed with appropriate warnings,
should not be held strictly liable for the ‘unfortunate consequences’ attending their use.”
Grundberg v. Upjohn Co., 813 P.2d 89, 92 (Utah 1991). “Thus, under Utah law, comment k shields
manufacturers and sellers of [unavoidably unsafe products] from strict liability based on
allegations of a design defect.” Schaerrer v. Stewart’s Plaza Pharmacy, Inc., 79 P.3d 922, 928
(Utah 2003).
Courts have varied in the application of comment k. Some courts have found that comment
k categorically bars design defect claims for certain medical products. See, e.g., Brown v. Superior
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Court, 751 P.2d 470, 477 (Cal. 1988) (leading case adopting categorical approach). Thus, 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 the case-by-case states, whether comment k bars a design defect claims depends on
the particular product at hand.
The Supreme Court of Utah has categorically barred claims for strict liability for design
defect arising out of the use of prescription drugs. See Grundberg, 813 P.2d at 95. The court,
however, has not extended the application of comment k’s preclusive effect to bar claims arising
out of the use of medical devices. Importantly, in deciding to categorically label prescription drugs
as “unavoidably unsafe,” the Grundberg court relied heavily on society’s need for a complex
scheme to regulate the manufacture of prescription drugs, including a risk/benefit analysis
employed by the FDA. 813 P.2d at 96–99. The Supreme Court of Utah explained:
To determine whether a drug’s benefit outweighs its risk is inherently complex
because of the manufacturer’s conscious design choices regarding the numerous
chemical properties of the product and their relationship to the vast physiologic
idiosyncracies of each consumer for whom the drug is designed. Society has
recognized this complexity and in response has reposed regulatory authority in the
FDA. Relying on the FDA’s screening and surveillance standards enables courts to
find liability under circumstances of inadequate warning, mismanufacture,
improper marketing, or misinforming the FDA—avenues for which courts are
better suited. Although this approach denies plaintiffs one potential theory on which
to rely in a drug products liability action, the benefits to society in promoting the
development, availability, and reasonable price of drugs justifies this conclusion.
Id. at 99. Differing from a defective prescription drug, the defective design of a medical device
approved via the 510(k) clearance process is not smoked out under the screening and surveillance
standards of the FDA. See Lewis, 991 F. Supp. 2d at 761–62 (“[T]he 510(k) process relates to a
medical device’s equivalence to a pre-existing device; it does not require ‘full consideration of the
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product’s risks and benefits[.]’”). In light of this reasoning, I predict that the Supreme Court of
Utah would not apply comment k as a categorical bar to claims for strict liability for design defect
arising out of the use of medical devices such as the Uphold and the Solyx.
Accordingly, the application of comment k to this case is a mixed question of law and fact,
Kearl v. Lederle Labs., 218 Cal. Rptr. 453, 463 (Ct. App. 1985), disapproved of on other grounds
by Brown v. Superior Court, 751 P.2d 470 (Cal. 1988), and “require[s] a full evidentiary hearing.”
Toner, 732 P.2d at 308. In turn, I find that the issue of whether the Uphold and the Solyx are
unavoidably unsafe cannot be resolved at the summary judgment stage. To the extent that BSC
otherwise contends that summary judgment is warranted, I find that genuine disputes of material
fact exist with regard to whether the Uphold and the Solyx are unreasonably dangerous.
Furthermore, the plaintiff has offered concrete evidence from which a reasonable juror could return
a verdict in her favor. Therefore, BSC’s Motion for Summary Judgment on Ms. Robbins’s strict
liability for design defect claim is DENIED.
B. Strict Liability for Failure to Warn
Under Utah law, “in order for a warning to be adequate, it must completely disclose all the
risks involved, as well as the extent of those risks.” House v. Armour of Am., Inc., 886 P.2d 542,
551 (Utah Ct. App. 1994) aff’d, 929 P.2d 340 (Utah 1996). Specifically, “[a] warning must (1) be
designed so it can reasonably be expected to catch the attention of the consumer; (2) be
comprehensible and give a fair indication of the specific risks involved with the product; and (3)
be of an intensity justified by the magnitude of the risk.” Id. (quoting Pavlides v. Galveston Yacht
Basin, Inc., 727 F.2d 330, 338 (5th Cir. 1984)). Importantly, “[i]n any failure to warn claim, a
plaintiff must show that the failure to give an adequate warning in fact caused the injury; i.e., that
had warnings been provided, the injured party would have altered his use of the product or taken
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added precautions to avoid the injury.” House v. Armour of Am., Inc., 929 P.2d 340, 346 (Utah
1996).
Relevant to my analysis here, Utah courts adhere to the learned intermediary doctrine. As
stated by the Supreme Court of Utah, under the learned intermediary doctrine, “manufacturers of
prescription drugs have a duty to warn only the physician prescribing the drug, not the end user or
patient.” Schaerrer, 79 P.3d at 928. The United States Court of Appeals for the Tenth Circuit,
applying Utah law, has predicted that Utah courts would likewise apply the learned intermediary
doctrine to failure to warn claims arising out of the use of medical devices. Tingey v. Radionics,
193 F. App’x 747, 757 (10th Cir. 2006) (“Courts have applied this doctrine to claims involving
medical devices, . . . and we assume Utah would do so as well.”). Accordingly, I do the same.
Here, the plaintiff has offered concrete evidence from which a reasonable juror could return
a verdict in her favor, and genuine disputes of material fact exist with regard to (1) whether BSC’s
warning was adequate, and (2) whether the alleged inadequate warning proximately caused the
alleged harm to Ms. Robbins. Therefore, BSC’s Motion for Summary Judgment on Ms. Robbins’s
strict liability for failure to warn claim is DENIED.
C. Negligence
Under Utah law, “[i]n a products liability case, the plaintiff must . . . prove that there was
a duty owed by the defendant to the plaintiff, that the duty was breached and that the conduct
complained of was the cause in fact of the injury.” Barson ex rel. Barson v. E.R. Squibb & Sons,
Inc., 682 P.2d 832, 835 (Utah 1984). To determine “whether a duty of reasonable care exists, a
court should consider the following factors: ‘(1) the extent that the manufacturer could foresee that
its actions would cause harm; (2) the likelihood of injury; (3) the magnitude of the burden of
guarding against it; and (4) the consequences of placing the burden on the defendant.’” Niemela v.
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Imperial Mfg., Inc., 263 P.3d 1191, 1198 (Utah Ct. App. 2011) (quoting Slisze v. Stanley-Bostitch,
979 P.2d 317, 320 (Utah 1999)).
Here, Ms. Robbins’s negligence claims fall into the same three categories as her strict
liability claims: (1) negligent manufacturing, (2) negligent failure to warn, and (3) negligent
design. (See Master Long Form Compl. & Jury Demand, MDL No. 2326, ¶¶ 55–59; Am. Short
Form Compl. [Docket 14] ¶ 13). BSC has moved for summary judgment on each category.
1.
Manufacturing Defect
Ms. Robbins has presented no evidence that the Uphold and the Solyx were negligently
manufactured. Thus, she has not met her burden of producing “specific facts showing that there is
a genuine [dispute] for trial.” See Celotex, 477 U.S. at 322–23. Therefore, BSC’s Motion for
Summary Judgment on Ms. Robbins’s negligent manufacturing claim is GRANTED.
2.
Design Defect
As discussed above, see supra Section III.A, genuine disputes of material fact exist with
regard to whether the Uphold and the Solyx are unreasonably dangerous. Therefore, BSC’s Motion
for Summary Judgment on Ms. Robbins’s negligent design claim is DENIED.
3.
Failure to Warn
As discussed above, see supra Section III.B, genuine disputes of material fact exist with
regard to (1) whether BSC’s warning was adequate, and (2) whether the alleged inadequate
warning proximately caused the alleged harm to Ms. Robbins. Therefore, BSC’s Motion for
Summary Judgment on Ms. Robbins’s negligent failure to warn claim is DENIED.
D. Loss of Consortium
BSC contends that it is entitled to summary judgment on Mr. Robbins’s loss of consortium
claim because loss of consortium is a derivative claim that cannot survive without Ms. Robbins’s
claims. While an accurate statement of the law, because Ms. Robbins’s claims for failure to warn,
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design defect, and negligence survive summary judgment, so does Mr. Robbins’s loss of
consortium claim. BSC’s Motion for Summary Judgment on this claim is DENIED.
IV. Conclusion
For the reasons discussed above, it is ORDERED that BSC’s Motion for Summary
Judgment [Docket 59] is GRANTED IN PART with respect to Ms. Robbins’s claims for
manufacturing defect, under theories of strict liability and negligence; breach of implied warranty;
and breach of express warranty. BSC’s Motion for Summary Judgment is DENIED IN PART
with respect to Ms. Robbins’s claims for strict liability for failure to warn, strict liability for design
defect, and negligence; and Mr. Robbins’s claim for loss of consortium.
The Court DIRECTS the Clerk to send a copy of this Order to counsel of record and any
unrepresented party.
ENTER: October 6, 2015
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