MEMORANDUM OPINION AND ORDER (Motions for Summary Judgment)

JOSEPH R. GOODWIN, District Judge.

Pending before the court are the defendants' Motion for Partial Summary Judgment [Docket 161], Motion for Partial Summary Judgment Based on Preemption of Certain Claims [Docket 178], Motion for Partial Summary Judgment on Punitive Damages [Docket 187], and Plaintiffs Jo and Allen Huskey's Motion for Partial Summary Judgment on Defendant Ethicon Inc.'s Separate Defenses [Docket 163]. For the reasons stated below, the Motion for Partial Summary Judgment [Docket 161] is GRANTED in part and DENIED in part, the Motion for Partial Summary Judgment Based on Preemption of Certain Claims [Docket 178] is DENIED, the Motion for Partial Summary Judgment on Punitive Damages [Docket 187] is DENIED, and Plaintiffs Jo and Allen Huskey's Motion for Partial Summary Judgment on Defendant Ethicon Inc.'s Separate Defenses [Docket 163] is GRANTED.

I. Background

This case is one of more than 60,000 that have been assigned to me by the Judicial Panel on Multidistrict Litigation in seven MDLs involving pelvic mesh products. Approximately 19,000 of these cases reside in the In re Ethicon, Inc. MDL, MDL No. 2327.

The device at issue in this case is the Gynecare TVT Obturator ("TVT-O"), manufactured by the defendants, Ethicon, Inc. and Johnson & Johnson, Inc. (collectively, "Ethicon"). The TVT-O is a medical device that includes a mechanism used to place a mesh tape, or sling, under the urethra to provide support to the urethra to treat stress urinary incontinence. (Mem. in Supp. of Mot. for Partial Summ. J. [Docket 162], at 1).

Before being implanted with the TVT-O, Ms. Huskey suffered from stress urinary incontinence which caused her to leak urine when she laughed, coughed, sneezed, exercised, or experienced abdominal pressure. (See Byrkit Dep. [Docket 161-3], at 187:21-23; 189:3-6). Ms. Huskey initially utilized pelvic floor strengthening exercises to alleviate her symptoms. (See Huskey Dep. [Docket 161-4], at 308:18-309:4; 309:22-310:4). When those exercises failed to fully remedy her stress urinary incontinence, she sought surgical treatment. (See id. at 312:22-313:1).

Ms. Huskey's physician, Dr. Gretchen Byrkit, implanted the TVT-O device on February 23, 2011. (See Statement of Undisputed Facts Regarding Jo Huskey's Medical History and Condition [Docket 215], at 5). After the surgery, Ms. Huskey experienced several complications, including erosion of the mesh and dyspareunia. (See id. at 5-6). Ms. Huskey underwent a revision surgery with Dr. Sohail Siddique on November 18, 2011, which excised a portion of the TVT-O's mesh. (See id. at 6-7). After her revision, Ms. Huskey's stress urinary incontinence symptoms returned, and she experienced constant pelvic and vaginal pain. (See id. at 8).

Ms. Huskey and her husband, Allen Huskey, currently advance several claims against Ethicon, including negligence, strict liability for design defect, strict liability for failure to warn, strict liability for manufacturing defect, fraud, fraudulent concealment, constructive fraud, negligent misrepresentation, negligent infliction of emotional distress, breach of express and implied warranty, gross negligence, unjust enrichment, and violation of the Illinois Consumer Fraud Act, 815 Ill. Comp. Stat. 505/1 et seq. (See Short Form Compl. [Docket 1], at 4-5).

II. Legal Standards

A. Summary Judgment

To obtain summary judgment, the moving party must show that there is no genuine issue 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, 106 S.Ct. 2505, 91 L.Ed.2d 202 (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, 106 S.Ct. 1348, 89 L.Ed.2d 538 (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, 106 S.Ct. 2505. 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, 106 S.Ct. 2548, 91 L.Ed.2d 265 (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, 106 S.Ct. 2505. Likewise, conclusory allegations or unsupported speculation, without more, are insufficient to preclude the granting of a summary judgment motion. See Felty v. Graves-Humphreys Co., 818 F.2d 1126, 1128 (4th Cir.1987); Ross v. Comm'ns Satellite Corp., 759 F.2d 355, 365 (4th Cir.1985), abrogated on other grounds, Price Waterhouse v. Hopkins, 490 U.S. 228, 109 S.Ct. 1775, 104 L.Ed.2d 268 (1989).

B. Preemption

Federal preemption originates from the Constitution's Supremacy Clause. See U.S. Const. art. VI, cl. 2.1 In addressing a preemption issue, the court's first task is to determine whether Congress intended to preempt. See Cal. Fed. Savings & Loan Ass'n v. Guerra, 479 U.S. 272, 280-81, 107 S.Ct. 683, 93 L.Ed.2d 613 (1987). Intent to preempt can manifest itself in three forms: field preemption, express preemption, and conflict preemption. See H & R Block E. Enters. v. Raskin, 591 F.3d 718, 722 (4th Cir.2010). Field preemption occurs when the "federal scheme of regulation of a defined field is so pervasive that Congress must have intended to leave no room for the states to supplement it[.]" City of Charleston, S.C. v. A Fisherman's Best, Inc., 310 F.3d 155, 169 (4th Cir.2002). Express preemption arises when "Congress expressly declares its intent to preempt state law." Pinney v. Nokia, Inc., 402 F.3d 430, 453 (4th Cir. 2005). Finally, conflict preemption occurs when "state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress." Hillsborough Cnty., Fla. v. Automated Med. Labs., Inc., 471 U.S. 707, 713, 105 S.Ct. 2371, 85 L.Ed.2d 714 (1985) (internal quotation omitted). Conflict preemption can also arise when "compliance with both federal and state regulations is a physical impossibility[.]" Id. (internal quotation omitted).

Once Congress's intent to preempt is determined, the focus turns to the scope of that preemption. See Duvall v. Bristol-Myers-Squibb Co., 103 F.3d 324, 328 (4th Cir.1996). Two presumptions guide this inquiry. See id. First, "`the purpose of Congress is the ultimate touchstone' in every pre-emption case." Medtronic, Inc. v. Lohr, 518 U.S. 470, 485, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) (quoting Retail Clerks v. Schermerhorn, 375 U.S. 96, 103, 84 S.Ct. 219, 11 L.Ed.2d 179 (1963)). Second, a court starts "with the basic assumption that Congress did not intend to displace state law." Maryland v. Louisiana, 451 U.S. 725, 746, 101 S.Ct. 2114, 68 L.Ed.2d 576 (1981). "This presumption is strongest when Congress legislates `in a field which the States have traditionally occupied.'" S. Blasting Servs., Inc. v. Wilkes Cnty., N.C., 288 F.3d 584, 590 (4th Cir.2002) (quoting Lohr, 518 U.S. at 485, 116 S.Ct. 2240).

C. Choice of Law

The parties agree that Illinois's choice-of-law rules apply in this case. Illinois has adopted the most-significant-relationship test as enumerated in Restatement (Second) of Conflict of Laws. See Townsend v. Sears, Roebuck & Co., 227 Ill.2d 147, 316 Ill.Dec. 505, 879 N.E.2d 893, 901 (2007); Gregory v. Beazer E., 384 Ill.App.3d 178, 322 Ill.Dec. 926, 892 N.E.2d 563, 578 (2008). Under that test, courts should consider the following factors: (1) the place where the injury occurred, (2) the place where the conduct causing the injury occurred, (3) the domicile, residence, nationality, place of incorporation and business of the parties, and (4) the place where the relationship, if any, between the parties is centered. See Townsend, 316 Ill.Dec. 505, 879 N.E.2d at 901 (citing Restatement (Second) of Conflict of Laws § 145(2), at 414 (1971)). This choice of law analysis applies to each individual issue in a case. See Townsend, 316 Ill.Dec. 505, 879 N.E.2d at 901; Gregory, 322 Ill.Dec. 926, 892 N.E.2d at 578. Here, the surgery to implant the device and any alleged injuries to the plaintiffs occurred in Illinois. Therefore, for the plaintiffs' substantive claims, I apply the law of Illinois.

The analysis is different for punitive damages. Illinois courts permit dépeçage, or a separate choice-of-law analysis for each individual issue. See Townsend, 316 Ill.Dec. 505, 879 N.E.2d at 901-02 (explaining that Illinois follows the Restatement, which uses dépeçage). Ethicon urges the court to apply New Jersey law to the punitive damages claim because the alleged conduct that gives rise to the punitive damages claim occurred there. Ethicon's argument is in line with the Restatement, which states that "when the primary purpose of the tort rule involved is to deter or punish misconduct, the place where the conduct occurred has peculiar significance." Restatement (Second) of Conflict of Laws § 145 cmt. e. The plaintiffs, appearing to agree with Ethicon, likewise brief punitive damages in relation to New Jersey law. The focus of the punitive damages inquiry is Ethicon's corporate conduct, and that conduct allegedly occurred in New Jersey. Therefore, New Jersey law applies to the plaintiffs' punitive damages claim.

III. Failure to Warn

Ethicon first challenges the plaintiffs' failure-to-warn claim. To recover on a failure-to-warn claim, a plaintiff must establish that inadequate warnings rendered a product unreasonably dangerous and caused the plaintiff's injuries. Mikolajczyk v. Ford Motor Co., 231 Ill.2d 516, 327 Ill.Dec. 1, 901 N.E.2d 329, 345 (2008). In the case of medical devices, the duty to warn is to the prescribing physician, not the patient. Giles v. Wyeth, Inc., 500 F.Supp.2d 1063, 1065 (S.D.Ill.2007); Hansen v. Baxter Healthcare Corp., 198 Ill.2d 420, 261 Ill.Dec. 744, 764 N.E.2d 35, 42 (2002). Ethicon advances two arguments against the plaintiffs' failure-to-warn claim: (1) that the TVT-O's warnings were adequate because Dr. Byrkit was aware of the TVT-O risks, and (2) that the plaintiffs failed to present evidence that the allegedly inadequate warnings caused the plaintiffs' injuries. Ethicon's arguments fail on both counts.

A. Adequacy of Warnings

Ethicon contends that the TVT-O's warnings were adequate because the implanting physician, Dr. Byrkit, was independently aware of the TVT-O's potential complications and risks. In Illinois, "there is no duty to warn of a risk that is already known by those to be warned." Proctor v. Davis, 291 Ill.App.3d 265, 225 Ill.Dec. 126, 682 N.E.2d 1203, 1211 (1997); see also Hansen, 261 Ill.Dec. 744, 764 N.E.2d at 42 ("[A] prescription medical device manufacturer need not provide a warning of risks already known to the medical community."). A duty to warn arises only when there is "unequal knowledge and the defendant, possessed of such knowledge, knows or should know that harm might occur if no warning is given." Proctor, 225 Ill.Dec. 126, 682 N.E.2d at 1211 (quotation marks omitted).

The plaintiffs argue that there is a dispute of fact as to whether the TVT-O's warnings were adequate because Dr. Byrkit was not warned about the TVT-O's alleged potential to rope and curl after implantation, polypropylene mesh's propensity to degrade in vivo, or the risks associated with small pore, heavy-weight mesh. Ethicon attempts to construe these risks as "mechanisms and design defects" about which there is no duty to warn. (See Reply in Supp. of Mot. for Partial Summ. J. [Docket 228], at 10). Ethicon cites no support for this proposition, and Illinois law appears to make no such formalistic distinction. Illinois law requires that manufacturers warn of "dangerous condition[s]," not merely the potential injuries that might result from use of the product. Happel v. Wal-Mart Stores, Inc., 199 Ill.2d 179, 262 Ill.Dec. 815, 766 N.E.2d 1118, 1123 (2002); Kennedy v. Medtronic, Inc., 366 Ill.App.3d 298, 303 Ill.Dec. 591, 851 N.E.2d 778, 783 (2006); see also Hansen, 261 Ill.Dec. 744, 764 N.E.2d at 42 ("dangerous propensities"). For instance, in Hansen, the Illinois Supreme Court found a dispute of fact over the adequacy of warnings where a medical device manufacturer allegedly failed to warn about the proper use of the device's mechanisms. The defendant manufactured IV tubes and failed to warn about the need to use particular tubes — those with threaded connections — with IVs inserted into patients' jugular veins. See Hansen, 261 Ill.Dec. 744, 764 N.E.2d at 43.

Here, the TVT-O's potential to rope and fray, polypropylene's propensity to degrade, and complications associated with small pore mesh are all potential dangerous conditions about the TVT-O of which Dr. Byrkit allegedly was not warned. Therefore, there is a dispute of fact about whether the TVT-O's warnings were adequate.

B. Causation

Ethicon also argues that the plaintiffs have failed to present evidence that the allegedly inadequate warnings caused the plaintiffs' harm. Ethicon argues that Dr. Byrkit did not rely on the product's IFU and that Dr. Byrkit would not have changed her decision to prescribe the device if she had received a better warning.

In Illinois, causation under a products liability theory is the same as under a negligence theory. See Smith v. Eli Lilly & Co., 137 Ill.2d 222, 148 Ill.Dec. 22, 560 N.E.2d 324, 328 (1990). Therefore, a plaintiff must prove that the defendant's conduct was both the cause-in-fact and the legal cause of her injuries. See Rodriguez v. Glock, Inc., 28 F.Supp.2d 1064, 1070 (N.D.Ill.1998). Illinois courts have utilized two tests to determine whether a defendant's conduct was a cause-in-fact: the "substantial factor" test and the "but-for" test. Rodriguez, 28 F.Supp.2d at 1070; Kerns v. Engelke, 54 Ill.App.3d 323, 12 Ill.Dec. 270, 369 N.E.2d 1284, 1292 (1977), aff'd in part, 76 Ill.2d 154, 28 Ill.Dec. 500, 390 N.E.2d 859 (1979). The "substantial factor" test asks whether the defendant's conduct is a "material element" and a "substantial factor" in bringing about the plaintiff's injury. Wehmeier v. UNR Indus., Inc., 213 Ill.App.3d 6, 157 Ill.Dec. 251, 572 N.E.2d 320, 335 (1991). Under the "but-for" test, "the defendant's conduct is not a cause of an event if the event would have occurred without it." Kerns, 12 Ill.Dec. 270, 369 N.E.2d at 1292.

First, Ethicon argues that the allegedly inadequate warnings did not cause the plaintiffs' injuries because Dr. Byrkit did not rely on the TVT-O's Instructions for Use ("IFU") in making her decision. But there is no such testimony in the record. Dr. Byrkit read the IFU before implanting the TVT-O, although she could not "recall the last time" she reviewed it. (See Byrkit Dep. [Docket 213-1], at 31:15-18; 67:7-11; 206:2-9). Dr. Byrkit also stated that she uses "the same" implantation procedure described in the IFU on every patient. (See id. at 90:3-15; 102:1-9). There is, therefore, sufficient evidence that Dr. Byrkit relied on the IFU in prescribing the TVT-O.2

Second, Ethicon argues that Dr. Byrkit would not have changed her decision to prescribe the TVT-O if she had received a better warning.3 Dr. Byrkit's testimony is inconsistent. On the one hand, she testified that she would have changed her decision had she received a better warning:

(Byrkit Dep. [Docket 161-3], at 96:2-7). However, when asked whether she would again prescribe the TVT-O to a patient "with the same signs and symptoms" as the plaintiff, Dr. Byrkit responded that she "would use the TVT-O again." (Id. at 279:1-10). She also testified that she continues to use the TVT-O in her practice today. (Id. at 58:10-20). This conflicting testimony demonstrates the existence of a genuine dispute of fact over whether Dr. Byrkit would have prescribed the TVT-O to Ms. Huskey had she received a better warning. Therefore, under either the "substantial factor" or the "but-for" test, the plaintiffs have set forth evidence creating a genuine dispute of fact on the issue of causation.

Accordingly, Ethicon's motion for summary judgment on the failure-to-warn claim is DENIED.

IV. Fraud-Based Claims and Warranty Claims

The plaintiffs bring several claims based on fraud: common law fraud, fraudulent concealment, constructive fraud, and negligent misrepresentation. I refer to these claims as the plaintiffs' "fraud-based claims." The plaintiffs also bring claims for breach of express and implied warranties. Ethicon argues that all of these claims are simply repackaged failure-to-warn claims, to which the learned intermediary doctrine applies and prevents recovery. I agree with Ethicon.

Under the learned intermediary doctrine, manufacturers of drugs and medical devices have a duty to warn prescribing physicians, not end-users, about the product's dangerous propensities. Hansen, 261 Ill.Dec. 744, 764 N.E.2d at 42; Kirk v. Michael Reese Hosp. & Med. Ctr., 117 Ill.2d 507, 111 Ill.Dec. 944, 513 N.E.2d 387, 393 (1987). The prescribing physician functions as a learned intermediary between the manufacturer and the patient by deciding which product "best fits the patient's needs and choos[ing] which facts from the various warnings should be conveyed to the patient[.]" Kirk, 111 Ill.Dec. 944, 513 N.E.2d at 393. Ethicon argues that because Illinois's learned intermediary doctrine does not require medical device manufacturers to warn end-users, the doctrine should bar the fraud-based claims premised on representations made to Ms. Huskey. Otherwise, Ethicon contends, plaintiffs could simply plead around the learned intermediary doctrine by characterizing failure-to-warn claims as fraud claims.

Illinois courts have not directly addressed this issue. However, courts around the country have extended the learned intermediary doctrine to all claims based on a manufacturer's failure to warn, including claims for fraud, misrepresentation, and breach of warranty. See, e.g., Talley v. Danek Med., Inc., 179 F.3d 154, 163-64 (4th Cir.1999) (barring breach of warranty and fraud claims); Lee v. Mylan, Inc., 806 F.Supp.2d 1320, 1325 (M.D.Ga. 2011) (negligent misrepresentation and breach of warranty claims); Beale v. Biomet, Inc., 492 F.Supp.2d 1360, 1372 (S.D.Fla.2007) (negligent misrepresentation); Southern v. Pfizer, Inc., 471 F.Supp.2d 1207, 1218 (N.D.Ala.2006) (fraudulent misrepresentation); In re Norplant Contraceptive Prods. Liab. Litig., 955 F.Supp. 700, 709 (E.D.Tex.1997) (misrepresentation and implied warranty); Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 169 (Tex.2012) (fraud by omission).

Here, the plaintiffs' fraud-based claims and warranty claims are simply repackaged failure-to-warn claims. The plaintiffs appear to concede that their fraud-based claims are based solely on representations made by Ethicon to Ms. Huskey. They state that these claims "in no way rely on anything that Ethicon communicated to Dr. Byrkit, or anything that Dr. Byrkit told to Mrs. Huskey," (Pls.' Mem. in Opp. to Ethicon's Mot. for Summ. J. [Docket 213], at 15). But Ms. Huskey was unable to identify any particular statements by Ethicon upon which she relied:

(Huskey Dep. [Docket 161-4], at 474:20-476:3). This inability to identify any particular fraudulent statements upon which Ms. Huskey relied indicates that the gravamen of these claims is Ethicon's failure to warn Ms. Huskey about particular risks or dangers associated with the TVT-O. If the learned intermediary doctrine "could be avoided by casting what is essentially a failure to warn claim under a different cause of action ... then the doctrine would be rendered meaningless." In re Norplant Contraceptive Products Liab. Litig., 955 F.Supp. 700, 709 (E.D.Tex.1997). Accordingly, I predict with confidence that, if confronted with this issue, the Illinois Supreme Court would hold that the learned intermediary doctrine applies to all claims based on a medical device manufacturer's failure to warn, including fraud, fraudulent concealment, constructive fraud, negligent misrepresentation, and breach of warranty.4 Therefore, Ethicon's motion for summary judgment on fraud-based claims and warranty claims is GRANTED.

V. Unjust Enrichment, Manufacturing Defect Claims, Illinois Consumer Fraud Act

Ethicon moves for summary judgment on the plaintiffs' claims for unjust enrichment, manufacturing defect, and violation of the Illinois Consumer Fraud Act, 815 Ill. Comp. Stat. 505/1 et seq. The plaintiffs do not oppose summary judgment and withdraw these claims. (See Pls.' Mem. in Opp. to Def. Ethicon's Mot. for Partial Summ. J. [Docket 213], at 15, 20). Therefore, Ethicon's motion for summary judgment on claims for unjust enrichment, manufacturing defect, and violation of the Illinois Consumer Fraud Act, 815 Ill. Comp. Stat. 505/1 et seq., is GRANTED as unopposed.

VI. Punitive Damages

Ethicon moves for summary judgment on the issue of punitive damages [Docket 187]. As previously stated, the law of New Jersey applies to the plaintiffs' claim for punitive damages. Ethicon argues that the New Jersey Product Liability Act ("NJPLA"), N.J. Stat. Ann. § 2A:58C-1 et seq., precludes an award of punitive damages in this case. The NJPLA provides that manufacturers of medical devices are immune from punitive damages awards where their products have been approved, licensed, or generally recognized as safe and effective by the FDA. The relevant statute reads, in pertinent part,

N.J. Stat. Ann. § 2A:58C-5 (emphasis added).5 Ethicon contends that the FDA has endorsed and recognized the safety and effectiveness of the TVT-O in its 510(k) clearance. I decided this exact issue in relation to Lewis v. Johnson & Johnson. See In re Ethicon, Inc., Pelvic Repair Sys. Prods. Liab. Litig., No. 2:12-cv-4301, 2014 WL 186869, at *10 (S.D.W.Va. Jan. 15, 2014). As I explained there, and in a separate opinion in that case, Lewis v. Johnson & Johnson, 991 F.Supp.2d 748, 753-56, 2014 WL 152374, at *4-6 (S.D.W.Va.2014), the FDA has not "approved or licensed" or "generally recognized" the TVT-O as "safe and effective." N.J. Stat. Ann. § 2A:58C-5.

Ethicon states, without explanation, that this case is distinguishable from my holding in Lewis. (Mem. in Supp. of Mot. for Partial Summ. J. on Punitive Damages [Docket 188], at 11). Ethicon simply rehashes old arguments and, yet again, essentially asks that I reconsider an earlier decision. As Ethicon is well aware, it is improper to ask the court "to rethink what the Court ha[s] already thought through — rightly or wrongly." In re C.R. Bard, Inc., 948 F.Supp.2d 589, 649 (S.D.W.Va. 2013) (quotations omitted). Therefore, Ethicon's motion for summary judgment on the issue of punitive damages [Docket 187] is DENIED.

VII. Preemption

Ethicon moves for partial summary judgment based on preemption [Docket 178]. Ethicon argues that the plaintiffs' claims should be preempted to the extent that any claim contends "that PROLENE* in mesh degrades and that degradation leads to other consequences, such as infection." (Mot. for Partial Summ. J. Based on Preemption of Certain Claims ("Preemption Mot.") [Docket 178], at 2). Ethicon bases this argument on the fact that the Prolene suture, which they argue is a component part of the TVT-O, went through the FDA's rigorous premarket approval process, rather than the less stringent 510(k) clearance process. The Prolene suture is a different medical device and, like the mesh contained in the TVT-O, is made of polypropylene. This court examined that exact issue in Lewis v. Johnson & Johnson and found that the plaintiffs' claims were not preempted. See 991 F.Supp.2d 748, 760-62, 2014 WL 152374, at *10-11 (S.D.W.Va.2014); see also id. at 750-52 2014 WL 152374 at *1-2 for a discussion of the differences between 510(k) clearance and premarket approval. As noted in Lewis, the Supreme Court has determined that claims related to devices approved through the FDA's premarket approval process are preempted while claims related to medical devices cleared through the FDA's 510(k) clearance process are not. See id. at 755-56, 2014 WL 152374 at *6; Riegel v. Medtronic, Inc., 552 U.S. 312, 322-23, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008); Medtronic, Inc. v. Lohr, 518 U.S. 470, 501-02, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996).

Ethicon attempts to distinguish the instant case from Lewis and argues that the court has not yet addressed the following issues:

(Preemption Mot. [Docket 178], at 1-2). Ethicon's arguments are without merit. As I explained in Lewis,

991 F.Supp.2d at 757-59, 2014 WL 152374 at *7-9 (internal citations omitted).

Additionally,

Id. at 759-61, 2014 WL 152374 at *9-10. None of Ethicon's arguments demonstrate that I should deviate from this reasoning. Although Ethicon may have rephrased some of its arguments and has submitted an additional declaration from an Ethicon employee, the legal reasoning here is the same as in Lewis.

Ethicon also argues that I should reconsider my ruling in Lewis based on the reasoning in two other cases: Bertini v. Smith & Nephew, Inc., 8 F.Supp.3d 246, No. 13 Civ. 79, 2014 WL 1028950, 2014 U.S. Dist. LEXIS 35837 (E.D.N.Y. Mar. 17, 2014) and Simon v. Smith & Nephew, Inc., 990 F.Supp.2d 395 (S.D.N.Y.2013). These cases concern the same allegedly defective hip replacement system, the R3 Acetabular System, developed by Smith & Nephew. See Bertini, 8 F.Supp.3d at 249, 2014 WL 1028950, at *1, 2014 U.S. Dist. LEXIS 35837, at *2; Simon, 990 F.Supp.2d at 402, 2013 WL 6244525, at *4. The R3 System "is a hip implant system used in total hip replacement procedures." Bertini, 8 F.Supp.3d at 249, 2014 WL 1028950, at *1, 2014 U.S. Dist. LEXIS 35837, at *2. "The R3 System is made up of the Acetabular Cup (shell) ... and one of several possible liners." Id. The purpose of the liner is "to prevent the loosening of the hip components, which is a defect in total hip replacement systems that often results in pain and a decrease in the hip implant's stability." Id. The R3 System received 510(k) clearance from the FDA. Id. at 249, 2014 WL 1028950, at *1, 2014 U.S. Dist. LEXIS 35837, at *2-3. Later, Smith & Nephew developed a new hip replacement system, the Birmingham Hip Resurfacing ("BHR") System. Id. at 249, 2014 WL 1028950, at *1, 2014 U.S. Dist. LEXIS 35837, at *3. The BHR System was approved through the premarket approval process. Id. Thereafter, the FDA granted supplemental premarket approval to the BHR System using the R3 acetabular metal hip liner. Id. at 249-51, 2014 WL 1028950, at *1-2, 2014 U.S. Dist. LEXIS 35837, at *3-4. Essentially, the premarket approval of the BHR System was amended to include one of the same components as the R3 System — the R3 acetabular metal hip liner. See id. Importantly, in both Bertini and Simon, the plaintiff was implanted with an R3 System (which received 510(k) clearance rather than premarket approval), not the BHR System. See Bertini, 8 F.Supp.3d at 253-54, 2014 WL 1028950, at *4-5, 2014 U.S. Dist. LEXIS 35837, at *12; Simon, 990 F.Supp.2d at 402, 2013 WL 6244525, at *4.

In Simon, the plaintiff argued that the R3 System was defectively designed. See 990 F.Supp.2d at 402, 2013 WL 6244525, at *4. The plaintiff argued that the design defect claims were not preempted because the R3 system was not approved through the premarket approval process. See id. at 402, 2013 WL 6244525, at *4. The defendant argued that each of the plaintiff's claims "challenge[d] the safety and effectiveness of the optional metal liner; and the R3 metal liner was indeed [premarket]-approved." (Id.). The court's actual holding in Simon was that the plaintiff's Amended Complaint failed to state a claim for strict liability, negligence, and breach of implied warranty. See id. at 404, 405, 406, 2013 WL 6244525 at *6, *7, *8. However, the court also found that even if the complaint had stated claims, those claims would have been preempted. See id. In relevant part, the court stated:

Id. at 405, 2013 WL 6244525 at *7. To support this proposition, the court cited to Lewkut v. Stryker Corp., 724 F.Supp.2d 648, 656 (S.D.Tex.2010), which stated: "To require that a distinction be drawn between the approval process of the individual components of a system and the system itself, would, it seems, add a level of complication to the medical device approval process not anticipated by Congress, the FDA, or medical device manufacturers." Id. It also cited to Riley v. Cordis Corp., 625 F.Supp.2d 769, 780 (D.Minn.2009), for the proposition that "separating components of [premarket]-approved device to apply different preemption analysis `makes no sense.'" Id.

I respectfully disagree with the Simon court's analysis. First, neither Lewkut nor Riley held that premarket approval of a component part of a device meant that all claims against a 510(k) cleared device were preempted. Notably, Lewkut dealt with a device that was, as a whole, approved through the premarket approval process. See 724 F.Supp.2d at 652. That device contained a component that, prior to the device's premarket approval, was cleared through the 510(k) process. See id. The court in Lewkut found the fact that the component part "was previously approved through only the § 510(k) process, and was commercially available when" the medical device received premarket approval did "not change the fact that it was later subject to the more rigorous scrutiny of the [premarket approval] process as a component of" the full medical device. Id. at 657. The court ultimately held that because the entire device had gone through the premarket approval process, the plaintiff's claims were preempted. See id. at 658. The Simon court's reliance on Lewkut is misplaced; in Lewkut, the entire device had received premarket approval.

The other case relied upon by the Simon court, Riley, also dealt with a device that had received premarket approval. See 625 F.Supp.2d at 774-75. The plaintiff there argued that because the approved device was coated with a drug, the preemption analysis of Riegel v. Medtronic, Inc., 552 U.S. 312, 322-23, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008), should not apply. See id. at 779. The Riley court noted that the device at issue was "not merely a drug or merely a drug-delivery system; it [was] instead a compound of mechanical and chemical parts that work together as a single medical device. In approving the [device], the FDA exercised its authority to regulate medical devices, not its authority to regulate drugs." Id. It also noted that the plaintiff's claims were "manifestly claims against the device as a whole." Id. at 780. The court found that because the FDA had approved and regulated the completed product as a medical device, the court should apply the express preemption analysis set forth in Riegel. See id.

As the above discussion reveals, the Simon court's reliance on Lewkut and Riley as support for applying total preemption to a medical device that only received 510(k) clearance was misguided. Both Lewkut and Riley dealt with whether product liability claims regarding a device that received premarket approval were preempted; the Supreme Court has been clear that they are. See Riegel, 552 U.S. at 330, 128 S.Ct. 999 ("State requirements are pre-empted under the [Medical Device Amendments]... to the extent that they are `different from, or in addition to' the requirements imposed by federal law."). The Supreme Court has been equally clear that product liability claims regarding a device that received 510(k) clearance are not preempted. See Medtronic v. Lohr, 518 U.S. 470, 494, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). The courts in Lewkut and Riley followed the Supreme Court precedent that claims against a device that receives premarket approval are generally preempted.6 The court in Simon, on the other hand, deviated from Supreme Court precedent which found that claims against a device receiving 510(k) approval are not preempted. Read in their entirety, the cases cited in Simon do not suggest that premarket approval of a component part of a device means that claims against the entire device should be preempted.

The Bertini court's analysis likewise seems to confuse the preemption analysis. The court repeatedly notes that preemption applies to a device as a whole rather than component parts but then finds that the plaintiffs' claims are preempted because of the premarket approval of a component part, ignoring the status of the device as a whole:

8 F.Supp.3d at 253-54, 2014 WL 1028950, at *5, 2014 U.S. Dist. LEXIS 35837, at *12-14. I disagree with this reasoning. In approving the BHR system with the liner from the R3 System, the FDA did not examine the R3 liner's safety and efficacy with regard to other hip replacement systems — the FDA was instead looking at whether the BHR System, as a whole, was safe and effective. It is difficult to understand why the Bertini court found that premarket approval of one medical device meant that claims against an entirely different medical device were preempted. While these cases from other district courts outside of the Fourth Circuit may be cited to as persuasive authority, I do not find either of them persuasive in light of existing Supreme Court precedent and federal regulations.

Preemption is based on FDA premarket approval of a medical device, not its component parts. Supreme Court precedent speaks to whether a specific device underwent premarket approval or 510(k) clearance. See generally Riegel, 552 U.S. 312, 128 S.Ct. 999; Lohr, 518 U.S. 470, 116 S.Ct. 2240. The relevant federal statute speaks to the approval or clearance of devices. See generally 21 U.S.C. § 360 et seq. The regulations interpreting the preemption provision of that federal statute discuss devices. See 21 C.F.R. 808.1. As I stated in Lewis, "[j]ust as a device receiving premarket approval cannot be separated into its component parts to avoid application of express preemption, a device receiving 510(k) approval cannot be separated into its component parts to create express preemption." 991 F.Supp.2d at 760, 2014 WL 152374 at *10 (internal quotation omitted). The Supreme Court and federal regulations instruct that state requirements are preempted "only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device." Riegel, 552 U.S. at 322, 128 S.Ct. 999 (quoting 21 C.F.R. § 808.1(d) (emphasis added)). The fact that the Prolene suture underwent premarket approval is irrelevant to whether the 510(k) process sets forth specific requirements applicable to the TVT-O. The law is clear that it does not.

For the reasons set forth above, Ethicon's motion for partial summary judgment based on preemption [Docket 178] is DENIED.

VIII. Separate Defenses

The plaintiffs move for summary judgment on several of Ethicon's separate defenses [Docket 163]. Ethicon listed its separate defenses in its Master Answer and Jury Demand of Defendant Ethicon, Inc. to First Amended Master Complaint [Docket 2-2]. In response to the plaintiffs' motion, Ethicon now withdraws most of these defenses. Accordingly, for the following defenses, the plaintiffs' motion for summary judgment is GRANTED as unopposed: 1, 3, 4, 5, 6, 7, 8, 9, 11, 13, 14, 25, 30, 32, 33, 35, 42, 45, 49, 50, 51, 52, 55, 57, 58, 60, 62, 67, 68, 76, 77, 78, and 79.

Ethicon opposes summary judgment on the remaining separate defenses, which relate to punitive damages, preemption, and federal regulations. Ethicon refers the court to the arguments contained in its Motion for Partial Summary Judgment on Punitive Damages [Docket 187] and Motion for Partial Summary Judgment Based on Preemption of Certain Claims [Docket 178]. I have already addressed and rejected Ethicon's arguments contained in those motions and supporting memoranda. Therefore, for the following defenses, which relate to punitive damages, preemption, and federal regulations, the plaintiffs' motion for summary judgment is GRANTED: 10, 15, 16, 17, 18, 19, 20, 22, 23, 24, 39, 59, 74, and 75.

IX. Conclusion

For the reasons stated above, Ethicon's Motion for Partial Summary Judgment [Docket 161] is GRANTED in part and DENIED in part, Ethicon's Motion for Partial Summary Judgment Based on Preemption of Certain Claims [Docket 178] is DENIED, Ethicon's Motion for Partial Summary Judgment on Punitive Damages [Docket 187] is DENIED, and Plaintiffs Jo and Allen Huskey's Motion for Partial Summary Judgment on Defendant Ethicon Inc.'s Separate Defenses [Docket 163] is GRANTED.

The court DIRECTS the Clerk to send a copy of this Order to counsel of record and any unrepresented party.