author: DIANA GRIBBON MOTZ, Circuit Judge:

text:
    Jo HUSKEY; Allen Huskey, Plaintiffs-Appellees, v. ETHICON, INC.; Johnson & Johnson, Defendants-Appellants.
    No. 15-2118
    United States Court of Appeals, Fourth Circuit.
    Argued: December 8, 2016
    Decided: January 26, 2017

      ARGUED: David B. Thomas, Thomas Combs & Spann, PLLC, Charleston, West Virginia, for Appellants. Edward Anthony Wallace, Wexler Wallace LLP, Chicago, Illinois; Fidelma Louise Fitzpatrick, Motley Rice LLC, Providence, Rhode Island, for Appellees. ON BRIEF: Charles C. Lif-land, Los Angeles, California, Stephen D. Brody,’ David K. Roberts, O’Melveny & Myers LLP, Washington, D.C.; Philip J. Combs, Thomas Combs & Spann, PLLC, Charleston, West Virginia; Christy D. Jones, Butler Snow LLP, Ridgeland, Mississippi, for Appellants. Mark R. Miller, Wexler Wallace LLP, Chicago, Illinois; Jeffrey Kuntz, Adam Davis, Wagstaff &

    Cartmell LLP, Kansas City, Missouri, for Appellees.
    Before MOTZ and DIAZ, Circuit Judges, and DAVIS, Senior Circuit Judge.
   DIANA GRIBBON MOTZ, Circuit Judge:

After Jo Huskey experienced complications from the implantation of a transva-ginal mesh medical device, she and her husband Allen Huskey filed this products liability action against Ethicon, Inc. and Johnson & Johnson (collectively “Ethi-con”). Following a nine-day trial, the jury returned a general verdict for the Hus-keys on their design defect, failure to warn, and loss of consortium claims. Ethi-con now appeals the denial of its post-trial renewed motion for judgment as a matter of law or, in the alternative, for a new trial. The Huskeys offered sufficient evidence to sustain the jury’s verdict and the district court committed no reversible error. Accordingly, we affirm.

I.

A.

In 2008, Mrs. Huskey began suffering symptoms of Stress Urinary Incontinence (“SUI”). In January 2011, after her condition had worsened, she discussed treatment options with her doctor, Dr. Gretchen Byrkit. By this time, Mrs. Huskey was regularly leaking urine while coughing, laughing, and sneezing, and she also experienced pain during intercourse. At Dr. Byrkit’s suggestion, Mrs. Huskey agreed to have Dr. Byrkit surgically implant a medical device called the Tension-Free Vaginal Tape-Obturator (“TVT-O”).

The TVT-0 is a mid-urethral sling that uses a heavy-weight laser-cut mesh. Ethi-con received clearance from the Food and Drug Administration (“FDA”) to market the TVT-0 in December 2008. Ethicon uses polypropylene for the TVT-O’s mesh. The TVT-0 was not the first mid-urethral sling Ethicon had manufactured; rather, it was a second-generation version of an earlier Ethicon device called the Gynecare TVT and is one of multiple slings that Ethicon has manufactured and sold.

On February 23, 2011, Dr. Byrkit performed Mrs. Huskey’s implantation surgery. A few weeks later, Mrs. Huskey visited Dr. Byrkit’s office for a post-operative check-up. At this visit, Dr. Byrkit examined Mrs. Huskey and found that some mesh on her right side had eroded. This eroded mesh caused Mrs. Huskey to experience pelvic pain.

On June 24, 2011, after various alternative treatments that Dr. Byrkit had recommended failed, Mrs. Huskey agreed to have a second surgical operation to cover the exposed mesh. Dr. Byrkit performed this operation on June 29, 2011. Unfortunately, this operation was not successful and did not relieve Mrs. Huskey’s pain. Dr. Byrkit then referred Mrs. Huskey to Dr. Sohail Siddique, a urogynecologist, for further treatment.

On November 18, 2011, Dr. Siddique performed surgery to excise Mrs. Hus-key’s mesh. He found that she had an infection and that the mesh on Mrs. Hus-key’s right side had completely eroded. He could not remove all the mesh because some had retracted behind Mrs. Huskey’s pubic bone.

To this day, the remaining mesh and scar tissue from her operations cause Mrs. Huskey to experience severe pain, particularly when engaging in physical activity and sexual intercourse. Additionally, her SUI symptoms have returned. For the rest of her life, she will require medication for pain management; no surgical intervention can permanently cure her.

B.

On September 6, 2012, the Huskeys filed the operative Short Form Complaint in the Southern District of West Virginia in the instant multidistrict litigation, In Re Ethicon Inc., Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2327. The Huskeys, Illinois residents, brought all of their claims under Illinois law. After the district court granted Ethicon partial summary judgment, five, claims remained for trial: strict liability and negligent design defect; strict liability and negligent failure to warn; and Mr. Huskey’s loss of consortium. Beyond actual damages, Mrs. Huskey sought punitive damages for the substantive claims.

Trial began on August 22, 2014 and lasted nine days. The Huskeys presented their case, which consisted of testimony from thirteen witnesses and the introduction of numerous documents, over the first six trial days. At the conclusion of their case, Ethicon orally moved for judgment as a matter of law under Federal Rule of Civil Procedure 50(a). The court granted the motion as to Mrs. Huskey’s claim for punitive damages but otherwise deferred ruling on the motion. Ethicon renewed its motion at the close of its case, and the court, again deferring a ruling, submitted the case to the jury.

The jury returned a unanimous general verdict for the Huskeys on all five claims. The jury awarded Mrs. Huskey $3.07 million in total damages, allocated between past expenses for medical care, previous pain and suffering, and future pain and suffering. The jury awarded Mr. Huskey an additional $200,000 for his loss of consortium.

After the jury returned its verdict, Ethicon again renewed its motion for judgment as a matter of law. In the alternative, Ethicon sought a new trial pursuant to Rule 59(a)(1)(A). The court issued a thorough written order denying the motion. Huskey v. Ethicon, Inc., No. 2:12-cv-05201, 2015 WL 4944339 (S.D. W. Va. Aug. 19, 2015). Ethicon subsequently noted this timely appeal.

II.

A.

Ethicon initially contends that the district court erred in denying it judgment as a matter of law. We review de novo the denial of Ethicon’s motion. Durham v. Jones, 737 F.3d 291, 298 (4th Cir. 2013). A court “may grant judgment as a matter of law only if, viewing the evidence in a light most favorable to the non-moving party and drawing every legitimate inference in that party’s favor, ... the only conclusion a reasonable jury could have reached is one in favor of the moving party.” Saunders v. Branch Banking & Tr. Co. of Va., 526 F.3d 142, 147 (4th Cir. 2008). If, upon the conclusion of a party’s case, “a reasonable jury would not have a legally sufficient evidentiary basis to find for the party on that issue,” a court may grant a motion from the opposing party for judgment as a matter of law. Fed. R. Civ. P. 50(a). When the court defers ruling on such a motion, Rule 50(b) allows a party to renew it after the jury returns a verdict.

Ethicon moved for judgment as a matter of law on all five of the Huskeys’ claims. As Ethicon’s counsel conceded at oral argument, since the jury returned a general verdict, we can reverse the court’s denial of Ethicon’s motion only if the Huskeys failed, as a matter of law, to prove both their design defect and failure to warn claims. Given our resolution of the Hus-keys’ design defect claims, we need not discuss their failure to warn claims. Moreover, because their negligent design defect claim relies on the same facts and arguments as their strict liability design defect claim, we address those claims together. Similarly, because it is wholly derivative of Mrs. Huskey’s claims, we do not separately consider Mr. Huskey’s loss of consortium claim. See Blagg v. Ill. F.W.D. Truck & Equip. Co., 143 Ill.2d 188, 157 Ill.Dec. 456, 572 N.E.2d 920, 926 (1991).

B.

To prevail on their design defect claims, the Huskeys had to demonstrate: 1) that a certain condition of the TVT-0 resulted from Ethicon’s design, 2) that this condition made the product unreasonably dangerous, 3) that the dangerous condition existed when Mrs. Huskey’s TVT-O left Ethicon’s control, and 4) that the dangerous condition in the TVT-O proximately caused harm to Mrs. Huskey. See Mikolajczyk v. Ford Motor Co., 231 Ill.2d 516, 327 Ill.Dec. 1, 901 N.E.2d 329, 345 (2008). Ethicon makes two arguments in support of its contention that the court erred in denying it judgment as a matter of law: 1) that the Huskeys failed to prove a specific flaw in the TVT-O’s design — as opposed to a general complication flowing from implantation, and 2) that comment k of the Restatement (Second) of Torts § 402A shields it from liability. We address these arguments in turn. '

1.

The record belies Ethicon’s assertion that the Huskeys failed to prove that a specific defect of the TVT-O’s design caused harm to Mrs. Huskey. As the district court properly held, the Huskeys offered sufficient evidence for a reasonable jury to find that Ethicon’s use of heavyweight polypropylene mesh in the TVT-0 caused Mrs. Huskey’s injuries.

First, Dr. Scott Guelcher, an associate professor of chemical engineering at Vanderbilt University and one of the Huskeys’ expert witnesses, testified about the body’s reaction to polypropylene and the consequences that ensue. He explained that “the body recognizes [the polypropylene mesh] as a foreign material, and ... will continue to attack it in this way until it’s removed or destroyed or it’s gone.” And Dr. Guelcher testified, based on his research, that “it’s best to minimize the amount of polypropylene that’s present in the mesh,” because “the more polypropylene surface that’s present, the greater those changes would be, [and] the more hazardous they could be.”

Next, Dr. Bruce Rosenzweig, a urogyne-cologist and another of the Huskeys’ expert witnesses, bolstered Dr. Guelcher’s testimony. Dr. Rosenzweig testified that Ethicon used a heavyweight mesh and “[t]he more mesh there is in the pelvis, the more of a foreign body response.” He explained that heavyweight mesh can lead to a foreign body response in an area near the inner thigh called the obturator space, and that these foreign bodies can “irritate the nerve [that passes nearby] and lead to pain.”

Additionally, Dr. Brigitte Hellhammer, a former Ethicon employee, testified that she had no reason to believe that lightweight mesh could not effectively treat SUI. Dr. Hellhammer explained that one risk of implanting mesh devices in patients was that the mesh would shrink, and that the weight of the mesh helps determine the likelihood of shrinkage. Dr. Hellham-mer testified to a generally-recognized understanding that lightweight mesh “would help in reducing a foreign body response, inflammatory response, and would reduce the potentiation for sear plating.”

Finally, Dr. Jerry Blaivas, a urologist and another expert witness for the Hus-keys who had conducted a pelvic examination of Mrs. Huskey, testified that Mrs. Huskey had severe scarring and suffered from “chronic pelvic pain.” Dr. Blaivas believed Mrs. Huskey’s symptoms were “a reaction to the mesh” and that he did not “know of anything else that can cause ... this particular constellation of symptoms.”

Drawing all inferences in the Huskeys’ favor, a reasonable jury could conclude from this expert testimony that Ethicon’s use of a heavyweight quantity of polypropylene mesh in the TVT-0 constituted a design defect that caused Mrs. Huskey’s inflammation and pelvic pain.

2.

Ethicon next argues that an exception to strict liability found in comment k to § 402A of the Restatement (Second) of Torts, on which Illinois courts rely, nevertheless shields it from liability. See Kirk v. Michael Reese Hosp. & Med. Ctr., 117 Ill.2d 507, 111 Ill.Dec. 944, 513 N.E.2d 387, 392 (1987) (citing comment k in a recitation of applicable law).

Comment k, which is captioned “[unavoidably unsafe products,” recognizes that “some products ..., in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use.” Restatement (Second) of Torts § 402A cmt. k (Am. Law Inst. 1965). Comment k recommends that such products, “with the qualification that they are properly prepared and marketed, and proper warning is given,” not trigger strict liability. Id. This is because “the marketing and the use of [unavoidably unsafe products] are fully justified, notwithstanding the unavoidable high degree of risk which they involve.” Id. Such products, it explains, are neither “defective, nor ... unreasonably dangerous.” Id.

Although comment k notes that unavoidably unsafe products “are especially common in the field of drugs,” id., under Illinois law,' courts determine “on a case by case basis” if a particular product falls within comment k, Glassman v. Wyeth Labs., Inc., 238 Ill.App.3d 533, 179 Ill.Dec. 506, 606 N.E.2d 338, 342 (1992). Whether a product is unavoidably unsafe is a question of fact on which the defendant bears the burden of proof. Id., 179 Ill.Dec. 506, 606 N.E.2d at 343. If a reasonable jury could find that the TVT-O did not meet comment Ids parameters, Ethicon’s reliance on comment k fails.

Much of the trial evidence indicating that the use of heavyweight polypropylene mesh constituted a design defect also suggests that comment k provides Ethicon no defense. Specifically, the jury could reasonably infer from Dr. Guelcher’s testimony that the greater quantity of mesh Ethi-con used in the TVT-O, the greater the chance that a patient would experience an adverse foreign body response. The jury could also reasonably infer from Dr. Hell-hammer’s testimony that had Ethicon used lightweight mesh, the TVT-0 would have remained effective and patients would have a reduced risk of an adverse foreign body response. Taken together, the expert testimony allowed the.jury to infer that Ethi-con could have designed the TVT-0 with lightweight mesh without sacrificing any performance. Consequently, the jury could reasonably conclude that the TVT-0 was not unavoidably unsafe. Comment k does not shield Ethicon from liability.

III.

We next address Ethicon’s contention that the district court should have granted it a new trial. Federal Rule of Civil Procedure 59(a)(1)(A) allows a court to grant a party’s motion for a new trial if the verdict is contrary to the clear weight of the evidence, rests upon false evidence, or will cause a miscarriage of justice. Minter v. Wells Fargo Bank, N.A., 762 F.3d 339, 346 (4th Cir. 2014).

We review a denial of a new trial for abuse of discretion. United States ex rel. Drakeford v. Tuomey, 792 F.3d 364, 375 (4th Cir. 2015). A court abuses its discretion if it relies on incorrect legal conclusions or clearly erroneous findings of fact. Belk, Inc. v. Meyer Corp., U.S., 679 F.3d 146, 161 (4th Cir. 2012). Moreover, we can reverse even without such errors “if we have ‘a definite and firm conviction that the court below committed a clear error of judgment in the conclusion it reached upon a weighing of the relevant factors.’ ” Id. (quoting Westberry v. Gislaved Gummi AB, 178 F.3d 257, 261 (4th Cir. 1999)).

Ethicon raises two grounds for a new trial. First, it contends that the district court improperly refused to instruct the jury on comment k. Next, it asserts that the court improperly excluded multiple pieces of evidence involving the FDA.

A.

We turn first to the comment k instruction. Ethicon argued at trial that comment k entitled it to “at a minimum, an appropriate jury instruction.” After considering briefing and oral argument on the question, the district court declined to include the requested comment k instruction. Instead, the court instructed the jury that it could find Ethicon liable on the design defect claim only if it found that the TVT-0 was unreasonably dangerous. The court then defined an “unreasonably dangerous” product as one in which the “risk of danger inherent in the design outweighs the benefits of the design when the product is put to a use that is reasonably foreseeable considering the nature and function of the product.”

We review the district court’s refusal to provide Ethicon’s proposed instruction for abuse of discretion. Rowland v. Am. Gen. Fin., Inc., 340 F.3d 187, 191 (4th Cir. 2003). We evaluate the jury charge as a whole, and an instructional error warrants a new trial only if it fails to inform the jury of the controlling legal principles. Id. Any lack of clarity must prejudice the challenging party. Id.

Again, to show that a product falls within comment k’s protection, the defendant must prove that a product’s “marketing and ... use ... are fully justified, notwithstanding the unavoidable high degree of risk which [it] involve[s].” Restatement (Second) of Torts § 402A cmt. k. We can discern only one difference between comment k and the jury instruction the court gave. .That difference is the burden of proof, which of course shifts to the defendant for comment k. Even assuming that Ethicon had produced sufficient evidence to justify the issuance of a comment k instruction, we cannot hold that it suffered prejudice from the absence of that instruction. As the district court correctly observed, the failure to provide an instruction that shifts the burden to Ethicon would not likely have provided Ethicon with a more favorable outcome. Without any prejudice, the district court did not abuse its discretion in denying Ethicon a new trial on that basis.

B.

We next address Ethicon’s evidentiary contentions. Ethicon posits that the district court’s exclusion of four pieces of FDA evidence warrants a new trial. Those four pieces of evidence are: evidence of the TVT-O’s compliance with the FDA’s Section 510(k) evaluation process; evidence that a 2011 FDA Advisory Committee deemed mesh slings, including the TVT-O, safe and effective; a 2013 published guidance, which reported the Advisory Committee’s conclusions; and the regulatory history of the Prolene suture, an Ethicon product that contains the same polypropylene as the TVT-O’s mesh.

The court relied on Federal Rule of Evidence 403 in excluding this evidence. That Rule allows a court to exclude relevant evidence when its “probative value is substantially outweighed by a danger of one or more of the following: unfair prejudice, confusing the issues, misleading the jury, undue delay, wasting time, or needlessly presenting cumulative evidence.” Fed. R. Evid. 403. We review a decision to exclude evidence on this basis for abuse of discretion. United States v. Davis, 690 F.3d 226, 257 (4th Cir. 2012). Improper exclusion of evidence warrants a new trial only if it results in “a high probability that the error ... affect[ed] the judgment.” Drakeford, 792 F.3d at 375.

We will address each exclusion in turn. But before doing so, we consider whether Ethicon has waived any challenge pertaining to the latter three pieces of evidence. The Huskeys argue that Ethicon never sought to introduce these three pieces of evidence, and that Ethicon thus cannot now rely on the exclusion of this evidence to gain a new trial. To the extent this accurately represents the proceedings below — a notion Ethicon strongly contests — the Huskeys have waived this argument.

Ethieon’s memorandum in support of its post-trial motion contended that the exclusion of all of the evidence it invokes on appeal justified a new trial. The Huskeys’ only response to this argument in their briefing was to incorporate by reference their pre-trial filing to exclude the 510(k) evidence. Nowhere did they contend that Ethicon had not sufficiently sought to introduce the other FDA evidence, or had otherwise waived its ability to assert that the exclusion of this evidence compelled a new trial. The Huskeys thus waived this argument by omitting it from their post-trial briefing. Cf. United States v. Carthorne, 726 F.3d 503, 509 n.5 (4th Cir. 2013) (holding that the Government “waived the waiver argument” when it failed to argue that plain error review applied to a particular appellate challenge). Having resolved this issue, we now examine the evidence in question.

1.

We begin with the evidence of the TVT-O’s compliance with the 510(k) process. Under the Federal Food, Drug, and Cosmetic Act, a manufacturer seeking to market a new medical device may attempt to bypass the FDA’s normal premarket approval process by submitting a “§ 510(k) notification.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 478, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). The FDA then evaluates whether the new device is “ ‘substantially equivalent’ to a pre-existing device.” Id. If the FDA finds substantial equivalence, the new device “can be marketed without further regulatory analysis.” Id. The district court refused to permit Ethicon to introduce evidence that it had cleared the 510(k) process and evidence explaining that process.

We recently held in Cisson v. C.R. Bard, Inc. (In re C.R. Bard, Inc.), 810 F.3d 913, 919 (4th Cir. 2016), a bellwether case from a related MDL, that this same district judge did not abuse his discretion when he excluded evidence that the device in question had complied with the 510(k) process. We noted that the 510(k) process focuses mostly on the equivalence between the product in question and an older one, and only “tangentially” examines the safety of the product going through the process. Id. at 922 (emphasis added). We rejected the view that “[b]ald assertions by the FDA” as to 510(k) compliance are highly probative of a product’s safety. Id. at 921. Given its limited probative value and the risk of confusing the jury by, inter alia, causing a battle of the experts over the robustness of the 510(k) process’s safety examinations, we held that exclusion of the 510(k) compliance evidence was not improper. Id. at 921-22.

We see no reason to distinguish Cisson here. The information Ethicon sought to introduce would, at best, have had “tangential ]” relevance to the case. This relative lack of probative value, especially given a possible battle of experts over the 510(k) process, underscores the risks of confusion and wasted time that would follow the introduction of this evidence. Ethi-con’s effort to distinguish Cisson on the ground that the TVT-O’s 510(k) compliance process actually did focus heavily on safety would only amplify the risk, as the trial would then likely face a substantial diversion into just how rigorous those safety considerations were, how forthcoming Ethicon was to the FDA, and how robust the 510(k) process is. The district court did not abuse its discretion in excluding this evidence.

2.

We next address the FDA Advisory Committee evidence. In 2011, an Obstetrics and Gynecology Devices Advisory Committee (the “FDA Advisory Committee”) conducted an examination of the “risks and benefits of surgical mesh ... based on the published literature and adverse event data from” an FDA database, and noted that “[a] substantial number of quality clinical trials, as well as systematic reviews, have been published for the first generation minimally invasive slings that provide evidence of safety and effectiveness of these devices.” FDA Advisory Committee, Surgical Mesh for Treatment of Women with Pelvic Organ Prolapse and Stress Urinary Incontinence: FDA Executive Summary 1, 28 (2011). In 2013, the FDA issued a published guidance reiterating these conclusions.

While the district court did not permit Ethicon to present evidence as to the FDA’s view of the underlying studies, it did permit Ethicon to introduce those studies themselves. The FDA did not use its own analysis of the TVT-0 to reach a conclusion regarding the device’s safety and efficacy. Rather, it simply opined on the work others had done. The underlying studies themselves enabled Ethicon to obtain most of the probative value from the FDA Advisory Committee evidence without risking a usurpation of the jury’s essential role in determining if the Huskeys had adequately proven their claims.

Additionally, the FDA’s use of the 510(k) process to approve the TVT-0 layers on another risk of introducing the FDA Advisory Committee evidence. As discussed above, the 510(k) process focuses on a particular device’s equivalence to an older device. Thus, the FDA’s only original conclusion regarding the TVT-0 did not address its safety. This dynamic creates a potentially confusing disjunction for the jury between what the FDA deems other literature has to say about the TVT-O’s safety and what the FDA itself found about the TVT-O’s equivalence to an earlier device. This goes beyond the mere specter of too much jury deference to the FDA and tacks on the prospect of the jury misunderstanding the FDA Advisory Committee’s actual conclusions. In these circumstances, therefore, the court did not abuse its discretion in excluding the FDA Advisory Committee evidence.

3.

Finally, we consider the evidence of the regulatory history of Prolene used in the Prolene sutures — the same polypropylene used in the TVT-O’s mesh also makes up part of the Prolene suture. Ethi-con wanted to introduce evidence that the FDA had approved the Prolene suture not only in an initial application, but also in over thirty subsequent New Drug Applications. Ethicon also sought to introduce evidence that the “FDA approved language indicating that Prolene [in the suture] is not subject to degradation via tissue enzymes.”

As the district court correctly explained, “evidence regarding the FDA process that the Prolene suture underwent ... says little about the safety and effectiveness of the final product, the TVT-O.” Huskey, 2015 WL 4944339, at *13 (emphasis added). The jury ultimately had to make a determination about the entire device that Mrs. Huskey received, not just a component of it. Introducing the evidence regarding Prolene sutures alone could quite plausibly cause a diversion into how similar and integral the Prolene sutures are to the TVT-0 end product and the role that other components of the TVT-0 might play in triggering foreign body responses or interacting with the Prolene sutures to mitigate safeguards against such responses. And that is to say nothing of the risk, also present with the FDA Advisory Committee evidence, that the jury might draw too strong a conclusion from the fact that the evidence of Prolene’s safety comes from the FDA. These drawbacks underscore that the court acted within its discretion.

Moreover, even without the evidence of the regulatory history of the Prolene sutures, the court permitted Ethicon to introduce evidence of their robust safety record. On cross-examination, Ethicon’s counsel elicited testimony from Dr. Guelcher that Prolene sutures have an identical chemical composition to the Pro-lene Ethicon uses in both its hernia meshes and in its TVT meshes to treat SUI. In that same line of questioning, Dr. Guelcher also acknowledged that his research had uncovered no “problem[s] with polypropylene mesh.” Ethicon was thus able to extract the same information that would have made up the core probative value of the Prolene suture’s regulatory history without bringing in the potential negative effects of introducing that evidence. The court did not abuse its discretion in excluding evidence of that other product’s regulatory history.

IV.

Accordingly, for the reasons set forth above, the judgment of the district court is

AFFIRMED.

      . Ethicon titled the instruction it requested "Inherent Risks,” and the proposed instruc- ' tion read:
      Some useful products are inherently dangerous and cannot be made safe for their intended and ordinary use. An example is a prescription drug. A prescription drug is not defective simply because it ... has unavoidable side effects.
      Products that contain inherent dangers are not defectively designed or unreasonably dangerous so long as they are accompanied by proper directions and warning.
      If you find that the risks that allegedly injured Mrs. Huskey ... were unavoidable, inherent risks of the product, and that the product was accompanied by proper directions and warnings, you should find that the product is not defective.

      . Ethicon argues that the district court’s actual instruction did not capture “the policy rationale underlying comment k,” namely, that of encouraging medical innovations. This argument fails however, given that defendants must prove comment k’s applicability "on a case by case basis.” Glassman, 179 Ill.Dec. 506, 606 N.E.2d at 342.


source: Caselaw Access Project

author: PAMELA HARRIS, Circuit Judge:

license: Public Domain

text:
    UNITED STATES of America, Plaintiff-Appellee, v. Juan Antonio MORENO-TAPIA, a/k/a Julian Castellanos, Defendant-Appellant.
    No. 15-4610
    United States Court of Appeals, Fourth Circuit.
    Argued: October 28, 2016
    Decided: January 26, 2017

      ARGUED: John Arthur Duberstein, Office of the Federal Public Defender, Greensboro, North Carolina, for Appellant. Anand P. Ramaswamy, Office of the United States Attorney, Greensboro, North Carolina, for Appellee. ON BRIEF: Louis C. Allen, Federal Public Defender, Office of the Federal Public Defender, Greensboro, North Carolina, for Appellant. Ripley Rand, United States Attorney, Office of the United States Attorney, Greensboro, North Carolina, for Appellee.
    Before TRAXLER, DIAZ, and HARRIS, Circuit Judges.
   PAMELA HARRIS, Circuit Judge:

In 2007, appellant Juan Antonio Moreno-Tapia, a native of Mexico, pleaded guilty in North Carolina court to three counts of indecent liberties with a child. According to Moreno-Tapia, neither his counsel nor the court informed him of the potential immigration consequences of his guilty plea. But those consequences turned out to be significant, and in 2009, Moreno-Tapia was removed from the United States on the basis of his state convictions.

After Moreno-Tapia reentered fhe country without permission, he was charged in federal court in 2014 with illegal reentry by a removed alien, see 8 U.S.C. § 1326(a), (b)(2), as well as failure to register as a sex offender under SORNA, the Sex Offender Registration and Notification Act, see 18 U.S.C. § 2250. Moreno-Tapia argued, however, that his underlying convictions were unconstitutional in light of the Supreme Court’s intervening decision in Padilla v. Kentucky, 559 U.S. 356, 374, 130 S.Ct. 1473, 176 L.Ed.2d 284 (2010), holding that the Sixth Amendment requires a defense attorney to advise a non-citizen client of the immigration risks of a guilty plea. And, indeed, in 2015, a North Carolina court vacated Moreno-Tapia’s convictions, relying on Padilla.

The primary question before us now is what effect the alleged constitutional deficiency in Moreno-Tapia’s state convictions has on his subsequent prosecution for illegal reentry. We conclude that the alleged infirmity has no effect. Because Padilla does not apply retroactively to defendants like Moreno-Tapia, convicted before the case was decided, see Chaidez v. United States, — U.S.-, 133 S.Ct. 1103, 1105, 185 L.Ed.2d 149 (2013), Moreno-Tapia’s convictions remain valid today as a matter of federal law, and his attempt to collaterally attack his 2009 removal is unavailing on that ground alone.

Accordingly, we hold that the district court properly denied Moreno-Tapia’s motion to vacate the 2009 removal order and to withdraw his guilty plea to the charge of illegal reentry. And for similar reasons, we find no error in the district court’s reliance on the vacated state convictions in determining Moreno-Tapia’s sentencing range under the Sentencing Guidelines. We therefore affirm the judgment of the district court in all respects.

I.

A.

We begin with a brief overview of the statutory background relevant to the illegal reentry charge against Moreno-Tapia. Under 8 U.S.C. § 1326(a) and b(2), an alien who has been removed from the United States after being convicted of an aggravated felony — as Moreno-Tapia was in 2009, based on his state convictions— commits a felony if he subsequently reenters the United States without permission. To win a conviction under § 1326, the government must prove, as an element of the offense, the defendant’s prior removal or deportation. See United States v. El Shami, 434 F.3d 659, 663 (4th Cir. 2005).

Typically, the government may rely on the removal order itself, issued by the Department of Homeland Security (“DHS”), to meet this burden. But in United States v. Mendoza-Lopez, 481 U.S. 828, 107 S.Ct. 2148, 95 L.Ed.2d 772 (1987), the Supreme Court held that the fact of a removal order may not be treated as conclusive proof of an element of a criminal offense where the immigration proceeding “was not conducted in conformity with due process.” Id. at 834, 838-39,107 S.Ct. 2148. In that case, the Court concluded, the underlying immigration proceeding violated due process, because the immigration judge permitted improper waivers of the right to appeal and failed to advise of eligibility to apply for suspension of deportation. Id. at 840, 107 S.Ct. 2148. And because those procedural defects foreclosed judicial review of the resulting deportation order, the Court held, the defendants were entitled to collaterally attack that order in their subsequent prosecution for illegal reentry. Id. at 837-39, 107 S.Ct. 2148.

Congress responded by codifying the principle of Mendoza-Lopez in 8 U.S.C. § 1326(d). See United States v. Sosa, 387 F.3d 131, 136 (2d Cir. 2004). Under that statute, in order to bring a successful collateral attack against a removal order, the defendant in an illegal reentry prosecution must meet three requirements, demonstrating that:

(1) [he or she] exhausted any administrative remedies that may have been available to seek relief against the order;
(2) the deportation proceedings at which the order was issued improperly deprived the alien of the opportunity for judicial review; and
(3) the entry of the order was fundamentally unfair.

8 U.S.C. § 1326(d); see United States v. Lopez-Collazo, 824 F.3d 453, 458 (4th Cir. 2016). Like Mendoza-Lopez, these three factors — exhaustion of administrative remedies, the denial of judicial review, and fundamental unfairness — are concerned with procedural irregularities in immigration proceedings that may insulate the resulting orders from judicial review, making it fundamentally unfair to rely on those orders in later criminal prosecutions. Sosa, 387 F.3d at 136.

B.

Moreno-Tapia immigrated to the United States from Mexico with his family as a child. His parents became legal permanent residents, as did his five siblings. Moreno-Tapia applied for legal permanent residency, but the process never advanced due to his eventual removal from the United States.

There are two underlying proceedings relevant to this case: a state prosecution for indecent liberties with a child, and a subsequent immigration proceeding that led to Moreno-Tapia’s deportation. First, in 2006, Moreno-Tapia was charged in North Carolina court with three counts of felony indecent liberties with a child, see N.C. Gen. Stat. Ann. § 14-202.1, arising from Moreno-Tapia’s consensual relationship with a fifteen-year old girl when he was twenty-one. Moreno-Tapia pleaded guilty and was sentenced to 15 to 18 months’ imprisonment. At the plea hearing, the court instructed Moreno-Tapia that he would be required to register as a sex offender after his release from prison. But Moreno-Tapia alleges that he was not informed of the immigration consequences of his guilty plea by his attorney or by the court. Although his plea document noted that deportation was a possible consequence, Moreno-Tapia did not sign the plea document and claims he never saw a copy of it.

Second, while Moreno-Tapia was serving his state sentence, DHS initiated removal proceedings, on the ground that his indecent liberties convictions qualified as aggravated felonies subjecting him to deportation. See 8 U.S.C. § 1227(a)(2)(A)(iii). Because Moreno-Tapia was never lawfully admitted to the United States for permanent residence, he was subject to an expedited removal process. See 8 U.S.C. § 1228(b); Etienne v. Lynch, 813 F.3d 135, 138-40 (4th Cir. 2015) (describing expedited removal process). Instead of being afforded a hearing before an immigration judge, Moreno-Tapia was served with a Notice of Intent to Issue a Final Administrative Removal Order (“NOI”), indicating that DHS would enter a final removal order and that Moreno-Tapia had ten days to rebut the charge in writing. See 8 C.F.R. § 238.1(b)(2)(i); Etienne, 813 F.3d at 138-39. Moreno-Tapia did not contest the charge and instead requested that he be removed to Mexico. In March of 2009, soon after service of a final removal order and Moreno-Tapia’s release from state prison, DHS deported Moreno-Tapia.

C.

At some point prior to 2011, Moreno-Tapia reentered the United States without permission and returned to North Carolina. He did not register as a sex offender under SORNA, despite his convictions for a qualifying sex offense. A subsequent arrest revealed him to the authorities and led to the current federal proceeding.

In June 2014, Moreno-Tapia was indicted in the Middle District of North Carolina on two charges: illegal reentry by a removed alien, under 8 U.S.C. § 1326(a) and (b)(2); and failure to register as a sex offender, under 18 U.S.C. § 2250. The parties entered into a written plea agreement, under which Moreno-Tapia pleaded guilty to the illegal reentry charge, and the government agreed to dismissal of the charge for failure to register.

After his guilty plea, Moreno-Tapia in February 2015 returned to North Carolina court and filed a Motion for Appropriate Relief (“MAR”) seeking to vacate his state indecent liberties convictions. Relying on the Supreme Court’s 2010 decision in Padilla v. Kentucky, 559 U.S. 356, 130 S.Ct. 1473 (2010) — issued three years after his convictions — Moreno-Tapia argued that his convictions should be set aside because his lawyer’s failure to inform him of the immigration consequences of his guilty plea meant that his plea was not knowing and voluntary. The North Carolina court agreed, and vacated Moreno-Tapia’s convictions on the ground that they “were the result of a plea that was not sufficiently knowing and voluntary under Padilla[.]” J.A. 237. Neither Moreno-Tapia nor the North Carolina court addressed the Supreme Court’s 2013 decision holding that Padilla does not apply retroactively to defendants like Moreno-Tapia, whose convictions became final before that decision was issued. See Chaidez, 133 S.Ct. at 1113.

With the state MAR ruling vacating his convictions in hand, Moreno-Tapia returned to federal district court. According to Moreno-Tapia, his removal order — a predicate for the charge of illegal reentry — was subject to collateral attack under 8 U.S.C. § 1326(d) on the ground that it rested on unconstitutional and since-vacated convictions. Moreno-Tapia thus.moved to vacate the 2009 removal order and, if successful, to withdraw his guilty plea to the charge of illegal reentry. That would leave in place the charge for failure to register as a sex offender — but that charge, too, Moreno-Tapia argued, could not go forward in light of the vacatur of his underlying convictions. Accordingly, Moreno-Tapia also moved the district court to dismiss both counts of the indictment against him.

At a hearing in July 2015, the district court denied all of Moreno-Tapia’s motions. As to the illegal reentry charge, the district court explained, the vacatur of Moreno-Tapia’s state convictions was not dispositive; to make a case of illegal reentry under § 1326, the government need not prove the underlying convictions from 2007, but only that Moreno-Tapia in fact had been removed in 2009. See J.A. 171 (“[T]he new prosecution for illegal reentry is not based on the old vacated conviction, it is based on the deportation; and the deportation was based on a facially valid conviction at the time of the deportation[.]”).

Nor, the district court held, could Moreno-Tapia mount a collateral attack on the 2009 removal order based on the purported constitutional deficiency of his 2007 convictions. The district court reviewed the three-part standard of § 1326 — exhaustion of administrative remedies, preclusion of judicial review, and fundamental unfairness — and held that Moreno-Tapia, who had consented to his deportation and never sought “any sort of review of any part of the deportation proceedings,” could not meet the first two requirements. J.A. 167. The court rejected Moreno-Tapia’s argument that his failure to seek administrative or judicial review should be excused because he was then unaware of a potential constitutional infirmity in his state convictions. Though there are cases excusing a failure to exhaust when it is caused by a procedural irregularity in a deportation proceeding itself, the court explained, those cases “concern rights one has with the immigration proceeding,” not with respect to an underlying conviction. J.A. 170. And here, Moreno-Tapia had identified no procedural problems with his immigration proceeding at all:

Mr. Moreno-Tapia does not contend he was affirmatively misadvised by anyone involved in the deportation proceedings concerning his right to contest the deportation or to appeal the decision.... He has not identified anything that immigration authorities Should have done during the course of the deportation proceedings that they did not do, and the Court thus finds that he’s not met the first two requirements of the statute as those requirements would ordinarily be interpreted.

J.A. 167.

Relying on Moreno-Tapia’s failure to satisfy the first two requirements of § 1326, the district court had no need to make a final determination as to the third factor, fundamental unfairness. But the court did note that Moreno-Tapia was not asserting actual innocence of the indecent liberties charges, and that Padilla, on which the state MAR court relied, does not apply retroactively. Ultimately, the court concluded that § 1326 and Mendoza-Lopez could provide no relief because Moreno-Tapia’s complaint was not with his immigration proceedings but rather with his underlying state convictions, independently subject to judicial review through the state-court MAR process. The court therefore denied Moreno-Tapia’s motions to vacate the 2009 removal order and to withdraw his guilty plea to the illegal reentry charge.

The district court recognized that Moreno-Tapia’s motion to dismiss the indictment against him was “dependent” on the success of his motions to vacate his removal order and withdraw his plea. J.A. 156. If the removal order and plea agreement remained in effect, that is, then Moreno-Tapia would stand convicted of illegal reentry, and the charge of failure to register as a sex offender would be dismissed pursuant to the plea agreement. Id. (“If I deny the motion to vacate the deportation order ... the motion to withdraw the guilty plea ... doesn’t need to be heard ... and it sort of does away with the motion to dismiss the indictment as well[.]”). Nevertheless, the court went on to deny the motion to dismiss both counts of the indictment “[t]o the extent [it] is still before the [c]ourt.” J.A. 176.

In September 2015, the district court held a sentencing hearing on the illegal reentry charge. Consistent with the Pre-sentence Report (“PSR”), and over Moreno-Tapia’s objection, the district court used the vacated indecent liberties convictions as the basis for a twelve-level enhancement to Moreno-Tapia’s offense level under § 2L1.2 of the Sentencing Guidelines, on the ground that Moreno-Tapia “previously was deported” after a conviction for a “crime of violence.” U.S. Sentencing Guidelines Manual § 2L1.2(b)(1) (U.S. Sentencing Comm’n 2014) (amended 2016). After a minor downward departure, the district court was left with a Guidelines range of 24 to 30 months, and sentenced Moreno-Tapia to 27 months’ imprisonment.

This timely appeal followed.

II.

A.

We begin with the core issue in this case: Moreno-Tapia’s motion to vacate his removal order, without which, he argues, he may not be convicted of illegal reentry. This court reviews de novo a collateral attack on a removal order under 8 U.S.C. § 1326(d). El Shami, 434 F.3d at 663.

As described above, § 1326(d), like the Mendoza-Lopez decision it codifies, is concerned with failures of due process in an immigration proceeding that would make it fundamentally unfair to rely on a removal order coming out of that proceeding. In particular, where a procedural defect in an immigration proceeding insulates the resulting order from judicial review, due process requires that the order be subject to collateral attack if it is relied on in a subsequent criminal prosecution. See Mendoza-Lopez, 481 U.S. at 840, 107 S.Ct. 2148 (holding that immigration proceeding violated due process because immigration judge permitted waivers of right to appeal that were not knowing); § 1326(d)(1), (2) (requiring, as condition of collateral attack, that defendant have exhausted administrative remedies and been deprived of judicial review). That principle is broad enough, courts have held, that a failure to exhaust administrative remedies or seek judicial review as required by § 1326(d) will be excused, and a collateral attack permitted, where that failure is itself the product of a procedural flaw in the immigration proceeding. See, e.g., Sosa, 387 F.3d at 137 (excusing administrative exhaustion requirement of § 1326(d)(1) where immigration judge fails to inform of right to apply for administrative relief); United States v. Muro-Inclan, 249 F.3d 1180, 1183 (9th Cir. 2001) (finding waiver of right to appeal removal order does not preclude collateral attack under § 1326(d) where immigration judge failed to advise of right to seek relief from deportation); see also Lopez-Collazo, 824 F.3d at 459 (accepting government concession that § 1326(d) exhaustion requirements are excused by failure to provide translator where language barrier prevents informed decision to waive appeal rights).

But this case, as the district court recognized, is quite different. The thrust of Moreno-Tapia’s argument is not that his immigration proceedings were procedurally defective; it is that his underlying state criminal proceedings were rendered constitutionally infirm by his counsel’s failure to inform him of the potential immigration consequences of his guilty plea. At bottom, Moreno-Tapia asks us to find that his immigration proceedings were fundamentally unfair and violated due process not because of any intrinsic procedural irregularity, but because they were predicated on unconstitutional state convictions.

As the district court observed, there is an obvious mismatch between the kind of claim Moreno-Tapia seeks to advance and the concerns of Mendoza-Lopez and requirements of § 1326(d). Perhaps most important, whereas Mendozar-Lopez and § 1326(d)(2) focus on the preclusion of judicial review of an immigration order as justification for subsequent collateral attack, here Moreno-Tapia had access to a well-established route to judicial review of his underlying state conviction, by way of the state MAR statute. See J.A. 173 (“Mendoza-Lopez doesn’t help ... because in that case there were no avenues for judicial review of the decision at issue. Here, the state court MAR statute provides a well-established mechanism for judicial review of an allegedly unconstitutional [conviction.]”). And while immigration officials must satisfy certain due process obligations with respect to their own proceedings, see, e.g., Mendoza-Lopez, 481 U.S. at 840, 107 S.Ct. 2148; Lopez-Collazo, 824 F.3d at 461, there is no authority imposing on them the duty to advise aliens of potential legal infirmities in prior criminal proceedings. See J.A. 170 (due process does not require “that immigration officials evaluate and advise someone facing deportation based on a deport-able criminal conviction of all the possible reasons the conviction might be invalid”).

We need not decide today, however, whether these hurdles might be overcome, or whether due process might in some circumstances demand that an immigration order based on an unconstitutional conviction be subject to collateral attack. That is because in this case, Moreno-Tapia’s argument is flawed in its premise— that his state convictions in fact were constitutionally infirm. Moreno-Tapia pleaded guilty in 2007, three years before the Supreme Court’s decision in Padilla. Because the Supreme Court subsequently decided that Padilla does not apply retroactively, see Chaidez, 133 S.Ct. at 1113, any failure by Moreno-Tapia’s lawyer to warn him of the possible immigration consequences of his guilty plea would not render Moreno-Tapia’s convictions constitutionally unsound. In other words, Moreno-Tapia’s underlying convictions were not obtained unconstitutionally, and as a result, he cannot prevail even if we were to assume that an immigration order resting on an unconstitutional conviction would be open to collateral attack on that ground alone.

That the state MAR court vacated Moreno-Tapia’s convictions under Padilla does not change our analysis. The government suggests that the MAR court’s holding actually may rest on a state-law rule requiring defendants such as Moreno-Tapia to be made aware of deportation consequences arising from guilty pleas. But whatever the explanation, the state court applied Padilla retroactively to convictions that were final before Padilla was decided. And despite Moreno-Tapia’s efforts to re-characterize the state court decision as turning on something other than Padilla, it is clear that the MAR court’s brief order, citing Padilla and no other case, is in fact an application of Padilla, see J.A. 237 (defendant’s plea was “not sufficiently knowing and voluntary under Padilla v. Kentucky”) — which is not surprising, given that Moreno-Tapia’s argument to that court also rested entirely on Padilla. It is true, as Moreno-Tapia argues, that the state court order is not before us for review. But Moreno-Tapia has put before us, and squarely so, the question of whether his underlying state convictions were the result of a constitutional violation. And whatever the merits of the MAR court decision under state law, under Chaidez, there was no federal constitutional violation on which Moreno-Tapia can base a collateral attack here.

Under § 1326(d), this crucial shortcoming in Moreno-Tapia’s case shows up most plainly in application of the third requirement for a collateral challenge — that entry of the removal order in question be “fundamentally unfair.” To demonstrate “fundamental unfairness” under § 1326(d), a defendant must show both that his “due process rights were violated by defects in his underlying deportation proceeding” and also that he “suffered prejudice” as a result. Lopez-Collazo, 824 F.3d at 460 (quoting El Shami, 434 F.3d at 664). We have explained already the gap between Moreno-Tapia’s challenge to his state criminal proceedings and the requirement that he identify a procedural “defect[ ] in his underlying deportation proceeding,” id. (emphasis added). But even assuming Moreno-Tapia could satisfy the first prong of the “fundamental unfairness” standard, the failure of his Padilla claim means that he cannot satisfy the prejudice prong.

In Lopez-Collazo, we held that to meet § 1326(d)’s “actual prejudice” requirement, a defendant must show that but for the procedural errors at issue, there was a “reasonable probability that he would not have been deported.” Id. at 462 (quoting El Shami, 434 F.3d at 665). And, critically, in evaluating whether a defendant likely would have been deported notwithstanding any procedural defect, we consider the law as it stood at the time of the immigration proceedings. Id. at 462-63, 466 (because law at time of removal classified offense as aggravated felony, entry of removal order does not prejudice defendant and subsequent change in classification of offense does not permit collateral attack); see also United States v. Gomez, 757 F.3d 885, 898-99 (9th Cir. 2014) (courts “look to the law at the time of the deportation proceedings” in assessing prejudice under § 1326(d)).

Here, Moreno-Tapia was removed from the United States in 2009, a year before Padilla was decided. The law at the time of his removal, in other words, gave Moreno-Tapia no right to be informed by his counsel of the potential immigration consequences of his guilty plea. Under the reasoning of Lopez-Collazo, it likely follows that any failure of due process connected to Moreno-Tapia’s immigration proceedings could not have caused him “actual prejudice,” as he would have remained subject to removal based on his then-valid prior convictions. See 824 F.3d at 466. But this case is more straightforward still, because as a result of Chaidez’s holding that Padilla does not apply retroactively, Moreno-Tapia’s state convictions not only were constitutional when Moreno-Tapia was removed, but remain constitutional today. There is no process, in other words, that could have led to a finding that Moreno-Tapia’s underlying state convictions were anything but constitutionally valid, and as a result, Moreno-Tapia’s “case for ‘fundamental unfairness’ eollapses[.]” See id. at 465.

Accordingly, we need not consider whether Moreno-Tapia could satisfy the first two requirements of § 1326(d) — administrative exhaustion and deprivation of judicial review — or whether his failure to do so could be excused on some ground. Because the state convictions on which his removal order is based were at the time of removal and are today constitutionally valid, Moreno-Tapia cannot show the requisite “fundamental unfairness” under § 1326(d), and his collateral challenge fails for that reason alone. And by the same token, due process is not offended when, as the district court put it, “someone who has been lawfully deported based on a [constitutionally valid] felony conviction and who has been advised that it would be illegal to come back into the country is prosecuted for exactly that action.” J.A. 176. We therefore affirm the district court’s denial of Moreno-Tapia’s motions to vacate the order of removal and withdraw his guilty plea to illegal reentry.

B.

Moreno-Tapia also challenges his sentence for illegal reentry, arguing that the district court improperly took account of his vacated state convictions in calculating his Sentencing Guidelines range. We review the district court’s legal interpretation of a Guidelines provision de novo, see United States v. Allen, 446 F.3d 522, 527 (4th Cir. 2006), and finding no error, we affirm.

Violations of § 1326’s illegal-reentry provision are governed by § 2L1.2 of the Sentencing Guidelines, which provides for enhancements based on specific offense characteristics. As relevant here, § 2L1.2 imposes a 12-level enhancement to the offense level of a defendant who “previously was deported ... after[ ] a conviction” for a “crime of violence.” U.S.S.G. § 2L1.2(b)(1) (2014). Moreno-Tapia does not dispute that the offense of which he was convicted — indecent liberties with a child — qualifies as a “crime of violence” under § 2L1.2. Instead, he argues that because his convictions were vacated after his removal and illegal reentry, they should not have been taken into account at sentencing under § 2L1.2. We disagree.

Although we have addressed the question only in an unpublished decision, see United States v. Moran-Rosario, 466 Fed. Appx. 257 (4th Cir. 2012), other circuits have reached the same conclusion, holding that the relevant time for determining whether a prior conviction qualifies for enhancement under § 2L1.2 is the date of the defendant’s deportation and not the date of a subsequent illegal reentry charge or sentencing. See id. at 258 (citing cases). In other words, if a qualifying conviction was on the books when the defendant was deported, then it serves to enhance a sentence for illegal reentry under § 2L1.2 even if it is subsequently vacated, see, e.g., United States v. Orduno-Mireles, 405 F.3d 960, 961 n.1 (11th Cir. 2005); United States v. Garcia-Lopez, 375 F.3d 586, 588 (7th Cir. 2004); United States v. Luna-Diaz, 222 F.3d 1, 4 (1st Cir. 2000), or otherwise set aside, see, e.g., United States v. Campbell, 167 F.3d 94, 98 (2d Cir. 1999) (conviction set aside when probation term completed).

This follows, the courts have reasoned, from two features of § 2L1.2. First, the provision is written in the past tense, focusing on the time of deportation: The enhancement applies if a defendant who illegally reenters “previously was deported after[ ] a conviction,” U.S.S.G. § 2L1.2(b)(1), demonstrating that “the present status of the [ ] conviction is irrelevant. It is impossible to alter the historical fact that the defendant was convicted, and then deported.” Luna-Diaz, 222 F.3d at 4. And second, when sentencing provisions are intended to exclude subsequently vacated convictions from their scope, they generally say so expressly — like other Guidelines provisions, see, e.g., U.S.S.G. § 4A1.2, cmt. n.6 (in calculating criminal history, “[s]entenees resulting from convictions that ... have been ruled constitutionally invalid ... are not to be counted”), and the Armed Career Criminal Act, see 18 U.S.C. § 921(a)(20) (barring generally the use of “[a]ny conviction which has been expunged, or set aside”). That § 2L1.2 has no similar express exception for vacated convictions “compels” a different result. Luna-Diaz, 222 F.3d at 5; see Garcia-Lopez, 375 F.3d at 588-89.

We agree with this persuasive line of authority. And indeed, Moreno-Tapia himself does not really.take issue with this straightforward reading of § 2L1.2. Instead, he argues that there should be an exception to the general rule that § 2L1.2 reaches convictions valid at the time of deportation for convictions that subsequently are vacated on constitutional grounds. For support, he points to Luna-Diaz, which leaves open the possibility of such an exception, noting that “allowing § 2L1.2(b)’s enhancement to rest on a prior conviction vacated as a result of a constitutional infirmity, egregious error of law, or determination of innocence, might in some limited circumstances raise constitutional due process concerns.” 222 F.3d at 6 n.5. We similarly left the question open in our unpublished decision in Moran-Rosario, recognizing the potential exception flagged in Luna-Diaz but finding that any such exception was not implicated on the facts of that case. 466 Fed.Appx. at 258-59.

We again have no occasion to decide the issue. As explained above, because Padilla does not apply retroactively, Moreno-Ta-pia’s state convictions were not unconstitutionally obtained. Nor, as the district court emphasized, has Moreno-Tapia contended that he is actually innocent of the state indecent liberties charges. Accordingly, application of § 2L1.2’s 12-level enhancement does not implicate the potential due process concerns articulated in Luna-Diaz and Moran-Rosario. Cf. Garcia-Lopez, 375 F.3d at 589 (applying § 2L1.2 enhancement where conviction vacated on state-law grounds). Under these circumstances, the district court correctly applied § 2L1.2’s 12-level increase to Moreno-Tapia’s offense level, and we affirm its sentencing determination.

III.

For the foregoing reasons, we affirm the judgment of the district court.

AFFIRMED

      . The terms "deportation” and "removal” are interchangeable for purposes of § 1326. United States v. Gomez, 757 F.3d 885, 891 n.1 (9th Cir. 2014). While § 1326(a) refers, inter alia, to an alien who has been "deported” or "excluded,” the subsequently enacted Illegal Immigration Reform and Immigrant Responsibility Act of 1996 combined those once distinct proceedings into a single category of “removal proceedings.” Jama v. Immigration & Customs Enforcement, 543 U.S. 335, 349-50, 125 S.Ct. 694, 160 L.Ed.2d 708 (2005); Gomez, 757 F.3d at 891 n.1. Cases post-dating this amendment generally use the term "removal proceedings,” although § 1326 continues to refer to "deportation proceedings.” See 8 U.S.C. § 1326(d)(2).

      . For the first time on appeal, Moreno-Tapia does raise certain alleged procedural deficiencies in his expedited immigration proceedings, arguing that he was removed after eight days rather than the fourteen days specified in 8 U.S.C. § 1228(b)(3), and that the notice DHS provided him did not include a citation for the statutory definition of an aggravated felony. Ordinarily, of course, we do not reach issues that were not presented first to the district court. Robinson v. Equifax Info. Servs., LLC, 560 F.3d 235, 242 (4th Cir. 2009). And in any event, for the reasons discussed below, Moreno-Tapia cannot demonstrate that he was prejudiced by any purported defect he now identifies.

      . We therefore need not consider whether the principle articulated in Lopez-Collazo — that courts refer to the law as it stood at the time of removal in assessing prejudice under § 1326(d) — would extend to new substantive rules applied retroactively by the Supreme Court. See Welch v. United States, — U.S. -, 136 S.Ct. 1257, 1264-65, 194 L.Ed.2d 387 (2016).

      . We also find that to the extent Moreno-Tapia's motion to dismiss the indictment was still before the district court, see supra at 220-21, it was properly denied. As discussed above, the government was entitled to charge Moreno-Tapia with illegal reentry notwithstanding the vacatur of his state court convictions. And once the district court held that Moreno-Tapia's plea agreement remained enforceable, there no longer was any ground for a challenge to the charge of failure to register as a sex offender under SORNA: Pursuant to the plea agreement, that count of the indictment was dismissed at sentencing on the government’s motion. We thus have no occasion to consider the merits of Moreno-Tapia’s conditional challenge to his indictment for failure to register.

      . The offense-level increase rises to 16 if a prior conviction for a crime of violence receives criminal history points under a different Guidelines provision. See U.S.S.G. § 2L1.2(b)(1)(A). The parties agree that Moreno-Tapia’s now-vacated state convictions do not receive criminal history points, and the district court did not apply the alternative 16-level enhancement.


text:
    Billy E. PRINCE, individually and as personal representative for the late Judith A. Prince, Plaintiff-Appellant, v. SEARS HOLDINGS CORPORATION, a Delaware corporation, Defendant-Appellee.
    No. 16-1075
    United States Court of Appeals, Fourth Circuit.
    Argued: December 6, 2016
    Decided: January 27, 2017

      ARGUED: Chad Lewis Taylor, SIM-MERMAN LAW OFFICE, PLLC, Clarksburg, West Virginia, for Appellant. Jill E. Hall, BOWLES RICE LLP, Charleston, West Virginia, for Appellee. ON BRIEF: Frank E. Simmerman, Jr., SIMMERMAN LAW OFFICE, PLLC, Clarksburg, West Virginia, for Appellant. Gerard R. Stowers, BOWLES RICE LLP, Charleston, West Virginia, for Appellee.
    Before MOTZ, KEENAN, and THACKER, Circuit Judges.
   DIANA GRIBBON MOTZ, Circuit Judge:

Alleging that his employer improperly administered life insurance benefits, an employee brought suit for misrepresentation, constructive fraud, and infliction of emotional distress. Because the Employee Retirement Income Security Act (“ERISA”) completely preempts these state law claims, we affirm the judgment of the district court dismissing the complaint.

I.

In November 2010, Billy E. Prince submitted an application to his employer for $150,000 in life insurance coverage for his wife, Judith Prince. The employer, Sears, sponsored and administered the life insurance program through The Prudential Insurance Company of America. In May 2011, Sears sent an acknowledgment letter to Prince and began withholding premiums from his pay shortly thereafter.

Later in 2011, Mrs. Prince learned she had Stage IV liver cancer. Almost a year after Mrs. Prince’s initial diagnosis, Prince checked his online benefits summary, which confirmed his election to purchase life insurance coverage for his wife in the amount of $150,000. Another year passed, and Sears sent Prince a letter advising him that Mrs. Prince’s coverage had never become effective because no “evidence of in-surability questionnaire” had been submitted. Sears explained that Prudential had sent a notice to Prince in January 2011 advising that unless a completed insurability questionnaire was submitted, Prudential would terminate his application for the life insurance coverage. Prince claims that he has no record of receipt of that notice but does not dispute that Prudential sent it to him.

On May 26, 2014, Mrs. Prince died. Because Prince did not receive the $150,000 in life insurance, he filed a complaint against Sears in the Circuit Court of Marion County, West Virginia. The complaint asserted one count of “constructive fraud/negligent misrepresentation” and one count of “intentional/reckless infliction of emotional distress,” based on Sears’s alleged misrepresentations regarding the life insurance policy and the harm thereby inflicted on Mr. and Mrs. Prince.

Sears removed the suit to the United States District Court for the Northern District of West Virginia and asked the court to dismiss the complaint, arguing that ERISA completely preempted Prince’s state law claims. Prince opposed the motion and moved to remand the case back to state court. The district court held that ERISA completely preempted Prince’s claims. Accordingly, the court denied Prince’s motion to remand and dismissed the complaint without prejudice. Prince timely filed this appeal.

II.

“We review de novo questions of subject matter jurisdiction, ‘including those relating to the propriety of removal.’ ” Sonoco Prods. Co. v. Physicians Health Plan, Inc., 338 F.3d 366, 370 (4th Cir. 2003) (quoting Mayes v. Rapoport, 198 F.3d 457, 460 (4th Cir. 1999)). The party seeking removal bears the burden of showing removal is proper. Mulcahey v. Columbia Organic Chems. Co., 29 F.3d 148, 151 (4th Cir. 1994). When reviewing the grant of a motion to dismiss, we assume all facts in the complaint as true and resolve all doubts in favor of the non-moving party. Edwards v. City of Goldsboro, 178 F.3d 231, 243-44 (4th Cir. 1999).

“Under the removal statute, ‘any civil action brought in a State court of which the district courts of the United States have original jurisdiction, may be removed by the defendant’ to federal court.” Aetna Health Inc. v. Davila, 542 U.S. 200, 207, 124 S.Ct. 2488, 159 L.Ed.2d 312 (2004) (quoting 28 U.S.C. § 1441(a) (2012)). District courts have original jurisdiction over claims “arising under the Constitution, laws, or treaties of the United States.” 28 U.S.C. § 1331. To determine whether a plaintiffs claims “arise under” the laws of the United States, courts typically use the “well-pleaded complaint rule,” which focuses on the allegations of the complaint. Aetna, 542 U.S. at 207, 124 S.Ct. 2488.

An exception to the well-pleaded complaint rule occurs when a federal statute completely preempts state law causes of action. Id. at 207-08, 124 S.Ct. 2488. “[C]omplete preemption ‘converts an ordinary state common law complaint into one stating a federal claim.’” Darcangelo v. Verizon Commc’ns, Inc., 292 F.3d 181, 187 (4th Cir. 2002) (quoting Metro. Life Ins. Co. v. Taylor, 481 U.S. 58, 65, 107 S.Ct. 1542, 95 L.Ed.2d 55 (1987)). “[W]hen complete preemption exists, ‘the plaintiff simply has brought a mislabeled federal claim, which may be asserted under some federal statute.’ ” Sonoco, 338 F.3d at 371 (quoting King v. Marriott Int’l, Inc., 337 F.3d 421, 425 (4th Cir. 2003)). Defendants may remove preempted state law claims to federal court, regardless of the “label” that the plaintiff has used. See id.; Griggs v. E.I. DuPont de Nemours & Co., 237 F.3d 371, 379 (4th Cir. 2001).

ERISA’s broad civil enforcement provision, § 502(a), codified at 29 U.S.C. § 1132(a), has the potential to preempt state law causes of action. That provision allows a participant or beneficiary of an ERISA plan to bring a civil action “to recover benefits due to him under the terms of his plan, to enforce his rights under the terms of the plan, or to clarify his rights to future benefits under the terms of the plant,] ... to enjoin any act or practice which violates any provision of this subchapter or the terms of the plan, or ... to obtain ... equitable relief.” Id. “This integrated enforcement mechanism ... is a distinctive feature of ERISA, and essential to accomplish Congress’ purpose of creating a comprehensive statute for the regulation of employee benefit plans.” Aet-na, 542 U.S. at 208,124 S.Ct. 2488.

ERISA § 502(a) completely preempts a state law claim when the following three-prong test is met:

(1) the plaintiff must have standing under § 502(a) to pursue its claim; (2) its claim must “fall[ ] within the scope of an ERISA provision that [it] can enforce via § 502(a)”; and (3) the claim must not be capable of resolution “without an interpretation of the contract governed by federal law,” i.e., an ERISA-governed employee benefit plan.

Sonoco, 338 F.3d at 372 (alterations in original) (quoting Jass v. Prudential Health Care Plan, Inc., 88 F.3d 1482, 1487 (7th Cir. 1996)). Prince concedes that he has standing under ERISA § 502(a) to bring a claim and therefore meets the first prong of the Sonoco test. Accordingly, we need only consider the second and third prongs.

A.

The second prong requires us to determine whether Prince can enforce his claims under § 502(a). This analysis depends on the scope of Prince’s claims. Prince asserts that his claims rely on the actions of Sears prior to the denial of benefits, when the company deducted premiums from his pay and reported that he had coverage. Prince does not dispute that he never submitted the required evidence of insurability and that Sears’s decision to deny benefits was proper given the terms of the plan. Prince apparently believes that focusing on Sears’s actions prior to the denial will allow his claims to escape preemption.

Prince is mistaken. Regardless of whether his claims attack Sears’s actions prior to the denial or in issuing the denial, these claims are enforceable under § 502(a). This is so because they challenge the administration of the ERISA plan — a core § 502(a) claim. Prince is entitled to life insurance benefits only if the ERISA plan provided them. Sears withdrew premiums from Prince’s pay only because the ERISA plan required Sears to do so. “It follows that if an individual brings suit complaining of a denial of coverage ..., where the individual is entitled to such coverage only because of the terms of an ERISA-regulated employee benefit plan, and where no legal duty (state or federal) independent of ERISA or the plan terms is violated, then the suit falls ‘within the scope of ERISA.’ ” Aetna, 542 U.S. at 210, 124 S.Ct. 2488.

Contrary to Prince’s assertions, his claims implicate no independent legal duty that Sears owed him. Of course, Sears employs Prince, but the company also administers an ERISA plan. Distinct from its duties as an employer, Sears has duties as the plan administrator and those duties clearly fall within the scope of ERISA. Prince’s claims concern only the way in which Sears assertedly breached these duties while administering his benefits. His claims are thus entirely within the scope of ERISA § 502(a)(1)(B). See Aetna, 542 U.S. at 211-13, 124 S.Ct. 2488; see also Pizlo v. Bethlehem, Steel Corp., 884 F.2d 116, 120 (4th Cir. 1989) (explaining that while ERISA does not preempt claims based on a contract of employment, it does completely preempt claims related to modification of pension plans).

In arguing to the contrary, Prince relies heavily on an out-of-circuit district court case, Tovey v. Prudential Ins. Co. of Am., 42 F.Supp.2d 919 (W.D. Mo. 1999). There, the court held that ERISA did not preempt a state law claim for negligent misrepresentation. But this was because “[f]irst and foremost” Tovey was not an ERISA plan participant and for this reason was not attempting in enforce her rights under an ERISA plan. Id. at 925-26, 926 n.3. In contrast, Prince concedes that he is an ERISA plan participant.

Prince also asserts that his state law claims lie outside the scope of ERISA preemption because he asks for “damages” rather than benefits. ERISA does not permit recovery of money damages, but its “preemptive scope is not diminished simply because a finding of preemption will leave a gap in the relief available to a plaintiff.” Wilmington Shipping Co. v. New England Life Ins. Co., 496 F.3d 326, 341 (4th Cir. 2007). Indeed, the Supreme Court long ago held that “[t]he policy choices reflected in the inclusion of certain remedies and the exclusion of others under the federal scheme would be completely undermined if ERISA-plan participants and beneficiaries were free to obtain remedies under state law that Congress rejected in ERISA.” Pilot Life Ins. Co. v. De- deaux, 481 U.S. 41, 54, 107 S.Ct. 1549, 95 L.Ed.2d 89 (1987).

Prince can enforce his claims under ERISA; that he cannot recover damages does not require a different conclusion or avoid complete preemption.

B.

Resolution of Prince’s claims would also require interpretation of the ERISA plan, the third and final Sonoco prong. Prince disagrees. He insists that he only challenges the actions Sears took prior to the denial of benefits. This is a distinction without a difference.

Prince’s claims of misrepresentation and constructive fraud require assessment of Sears’s “duty” as the plan administrator. See Folio v. City of Clarksburg, 221 W.Va. 397, 655 S.E.2d 143, 151 (2007) (explaining that under West Virginia law negligent misrepresentation requires “a duty to give information to another”) (emphasis added); Stanley v. Sewell Coal Co., 169 W.Va. 72, 285 S.E.2d 679, 683 (1981) (explaining that under West Virginia law constructive fraud requires “breach of a legal or equitable duty”) (emphasis added). The only duty Sears had to Prince regarding his benefits (both prior to and after the denial of benefits) stemmed from the ERISA plan. See JA 42, 43, 45, 46, 48, 49, 96 (language in the plan explaining information the administrator will provide and what actions it will take). Determining whether Sears met its duty would require examining what the plan obligated Sears to do.

Prince’s infliction of emotional distress claim similarly requires assessment of Sears’s conduct in administering the ERISA plan; only if that administration was so inept that it was “outrageous” could Prince recover. See Travis v. Alcon Labs., Inc., 202 W.Va. 369, 504 S.E.2d 419, 425 (1998) (holding that intentional or reckless infliction of emotional distress requires “that the defendant’s conduct was atrocious, intolerable, and so extreme and outrageous as to exceed the bounds of decency”). Prince claims that Sears misled him when it erroneously withheld the premiums and reported that he had coverage. He claims that these actions, and those Sears took once it discovered the mistake, caused him and his wife distress. Determining whether Sears acted in an “outrageous” way would require examining and interpreting Sears’s duties and responsibilities under the ERISA plan.

In sum, Prince’s claims meet all three prongs of the Sonoco test, and ERISA completely preempts them.

III.

Accordingly, the judgment of the district court is

AFFIRMED.

      . Sears moved to dismiss the appeal, arguing that the district court’s order was not final. We denied the motion, explaining that “no amendment to the complaint would enable Prince’s [state law] claims to survive the district court’s holding that they were preempted by ERISA.” Order, Prince v. Sears Holdings Corp., No. 16-1075, at *2 (4th Cir. May 13, 2016).

      . To the extent that he cites any law for this proposition, Prince appears to rely on Tovey, but his reliance is misplaced. Tovey did not hold that a plaintiff could avoid preemption by asking for damages instead of benefits. Rather, the Tovey court referred to Tovey's request for damages to further illustrate that she was not a plan participant. 42 F.Supp.2d at 926.

      . The district court dismissed Prince’s complaint without prejudice to permit him to refile it as an ERISA action after he had exhausted his administrative remedies. At oral argument, Prince's counsel expressed skepticism that administrative remedies or mediation would be fruitful, but counsel for Sears indicated that they might indeed be fruitful.
      We note that the record reflects that Sears initially offered to reopen enrollment for Mrs. Prince, with Prudential evaluating her coverage based on her 2011 medical information. Given that Prince has not explored his administrative remedies, it remains unclear whether they would be productive.