MEMORANDUM OPINION AND ORDER (Defendant's Motion for Summary Judgment)

JOSEPH R. GOODWIN, District Judge.

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. 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. 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 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

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 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:

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 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 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. 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, 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.