Full opinion text
MEMORANDUM OPINION NORA BARRY FISCHER, District Judge. I. INTRODUCTION In this action, Plaintiff Donald Gross (“Plaintiff’) brings multiple medical device liability claims against Defendants Stryker Corporation t/a/d/b/a Stryker Howmedica Osteonics (“Stryker”); Stryker Orthoppedics [sic], a division of Howmedica Osteonics Corporation; and Stryker Orthopedics, a division of Howmedica Osteonics Corporation, whereby he seeks to recover damages, including punitive damages, arising from the surgical implantation of an artificial hip prosthesis known as the Trident System. (See Docket No. 1-3). Plaintiff alleges that due to a defect present in a component of the Trident System prosthesis he received, he suffered an infection at the operation site, experienced severe left hip pain, and required a revision procedure to replace the defective device. (See id. at ¶¶4-8, ¶23). He brings claims sounding in strict liability based on manufacturing defect and marketing defect theories (Count I), negligence and res ipsa loquitur (Count II), as well as breach of express and implied warranties (Count III). (See id. at 13-18). Stryker moves to dismiss the Complaint under Rule 12(b)(6) on the grounds that it is not a proper party to this litigation and Plaintiffs claims are all expressly preempted by the Medical Device Amendments of 1976 (“MDA”), 21 U.S.C. § 360k, to the Federal Food, Drug and Cosmetics Act (“FDCA”). (See Docket No. 8). Alternatively, Stryker argues that Plaintiff failed to adequately plead cognizable parallel claims and that Plaintiffs purported strict liability and breach of express warranty claims fail to state claims upon which relief can be granted. (See id.). Upon consideration of all the parties’ submissions and for the reasons outlined herein, Stryker’s Motion to Dismiss under Rule 12(b)(6) is granted and all of Plaintiffs claims against Stryker are dismissed, with prejudice. II. BACKGROUND A. Factual Background On October 20, 2007, Plaintiff underwent a left hip arthroplasty performed by Dr. Ari Pressman, M.D., at Mercy Hospital in Pittsburgh, PA. (Docket No. 1-3 at ¶ 3). Plaintiffs left hip was replaced with an artificial hip prosthesis called the Trident System, which Stryker allegedly designed, manufactured, and marketed. (Id.). The Trident System is comprised of a ceramieon-ceramic acetabular bearing couple. (Id. at ¶ 11). This ceramic-on-ceramic ace-tabular bearing couple is itself made up of (1) an alumina ceramic insert (alternatively, “socket liner”) and (2) an alumina ceramic femoral head (alternatively, “ball”). (Id.). The Trident System is used with a metal acetabular shell (alternatively, “metal acetabular cup” or “socket”) and a metal femoral stem (alternatively, “hip stem”). (Id.). Plaintiffs suit focuses on the allegedly defective metal acetabular cup component of the Trident System. (Id. at ¶¶ 6-7, ¶ 23). After his hip replacement surgery, Plaintiff claims that he experienced an infection at the operation site and needed antibiotic intervention. (Id. at ¶ 4). Plaintiff suffered left hip pain for approximately one year after surgery, which he contends “incrementally increas[ed]” until about October 2008, when an X-ray revealed a dislocation of Plaintiffs left hip and a failure of the hip prosthesis. (Id. at ¶¶ 5-6). Dr. Pressman informed Plaintiff that his severe left hip pain had been caused by the failure of at least the Trident acetabular insert and shell. (Id. at ¶ 6). Consequently, Plaintiff underwent revision hip replacement surgery in October 2008. (Id. at ¶ 7). During the surgery, it was found that the Trident acetabular insert had fractured and required removal and replacement. (Id.). Plaintiff claims that Stryker obtained approval from the United States Food and Drug Administration (“FDA”) to market the Trident System consisting of the ceramic-on-ceramic acetabular bearing couple under the premarket approval (“PMA”) process on approximately February 3, 2003. (Id. at ¶ 12). Prior to receiving approval through the PMA process for the entire prosthesis, individual components of the Trident System were approved by the FDA pursuant to either the PMA or the § 510(k) processes. (Id. at ¶¶ 12-15). Notably, earlier generations of the Trident acetabular shell received FDA approval pursuant to the § 510(k) process on December 11, 1998, August 4, 2000, and December 5, 2001. (Id. at ¶ 13). On November 28, 2007, the FDA issued a warning letter to Stryker after inspecting its Mahwah, New Jersey facilities in June and July of 2007. (Id. at ¶¶ 19, 25-30). According to the warning letter that Plaintiff attached to his Complaint, the FDA investigation revealed that the Trident System devices were “adulterated,” meaning “that the methods used in, or the facilities or controls used for their manufacture, packing, storage, or installation [were] not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of General Regulations (C.F.R.), Part 820.” (Id. at 25). Prior to receiving this warning letter, Stryker received a Form FDA 483, List of Inspectional Observations, identifying problems related to the production of the Trident System. (Id. at ¶ 19). On June 12, 2008, Stryker allegedly recalled certain Trident metal acetabular shells that were manufactured at its Mahwah, New Jersey facilities between January 2000 and December 2007. (Id. at ¶ 20). Plaintiff claims that his hip prosthesis bearing the serial numbers of 508-11-64G and 690-10-28H was included in this recall. (Id. at ¶ 23). The recall occurred after an investigation revealed the presence of excessive bioburden and viable microorganisms in the devices’ final rinse tank, thereby contaminating the devices and leaving behind impermissible, excessive manufacturing residuals. (Id. at ¶ 20). In describing these residues, Plaintiff states that they are not an acceptable part of the manufacturing process for any hip device and are ostensibly direct evidence of an adulterated device. (Id.). Plaintiff notes in his Complaint that he has not yet determined whether the residues on the hip prosthesis were foreign bodies or native material from the manufacturing process. (Id.). Despite this uncertainty, Plaintiff alleges that orthopedic surgeons have expressed the opinion that when such residues remain on the back of the acetabular cup, “boney ingrowth” is inhibited and the cup is not held securely into the socket. (Id. at ¶23). Plaintiff further avers that when his own hip prosthesis was removed, the back of his Trident metal acetabular cup had fractured, which caused the cup to loosen thereby necessitating the revision surgery. (Id.). Plaintiff also claims that by recalling the Trident acetabular devices, Stryker admitted the cup was manufactured in a way that violated certain federal regulations and requirements. (M). B. Procedural History Plaintiff, a resident of Allegheny County, Pennsylvania, initially filed a Praecipe for Writ of Summons on September 28, 2010 in the Court of Common Pleas of Allegheny County, Pennsylvania against Defendants, Stryker Corporation Va/d/b/a Stryker Howmedica Osteonics, Stryker Orthoppedics [sic], and Stryker Orthopedies. (See Docket No. 1 at ¶ 1). Stryker Corporation appeared. (See id.). Stryker Corporation is a Michigan corporation with a principal place of business in Kalamazoo, Michigan. (Docket No. 1-3 at ¶ 2; Docket No. 8-1 at ¶ 1). As the Court has noted, Plaintiff undertook no discovery in aid of filing the Complaint. Instead, on July 26, 2011, Stryker served a Praecipe of Rule to File Complaint on Plaintiff, and on August 27, 2011, Stryker was served with the Complaint. (See Docket No. 1-2.). Stryker has admitted that Howmedica Osteonics Corporation is a wholly-owned subsidiary of Stryker Corporation. (Docket No. 1 at ¶ 4 n. 2). Yet, Stryker maintains Howmedica Osteonics Corporation was never served with a copy of the Complaint. (Docket No. 1 at ¶ 4 n. 2; Docket No. 8 at 15 n. 3). Plaintiff asserts claims sounding in strict liability for manufacturing and marketing defects (Count I), negligence and res ipsa loquitur (Count II), as well as breach of express and implied warranties (Count III). (Docket No. 1-3 at 13-18). Plaintiff also seeks punitive damages due to Stryker’s alleged gross negligence or, alternatively, Stryker’s “fraud, oppression, and malice.” (Id. at 19-22). On September 26, 2011, Stryker filed a petition for removal from state court, premised on diversity jurisdiction. (See Docket No. 1 at 1, ¶¶ 4-7). A week later, Stryker filed a Motion to Dismiss for failure to state a claim under Rule 12(b)(6) and an accompanying brief in support. (See Docket Nos. 7-8). At Exhibit A to Stryker’s brief in support, Stryker filed a Certification by Erica Visokey, in which she states, “Stryker Corporation does not design, manufacture, assemble, equip, test, inspect, service, maintain, repair,, advertise, market or sell the TridentO Ceramic on Ceramic Acetabular System or any of its components.” (See Docket No. 8-1 at ¶ 3). Plaintiff filed a Response (Docket No. 10), and Stryker replied to said Response (Docket No. 11). Plaintiff did not file a surreply nor seek to do so by way of a motion for leave, despite Stryker’s preliminary statement that Plaintiff did not address all of Stryker’s arguments. (See Docket No. 11 at 5). Nor has either party requested argument on this Motion. On February 27, 2012, the Court requested additional briefing from Plaintiff and Stryker in light of the recent decision in Bass v. Stryker Corp., 669 F.3d 501 (5th Cir.2012). (Docket No. 15). Both Plaintiff and Stryker filed said supplemental briefs on March 9, 2012. (Docket Nos. 16, 17). Thus, Stryker’s Motion is now fully briefed and ripe for disposition. III. STANDARD OF REVIEW A motion to dismiss pursuant to Fed. R. Civ. P. 12(b)(6) challenges the legal sufficiency of a complaint. The United States Supreme Court has held that “[a] plaintiffs obligation to provide the ‘grounds’ of his ‘entitle[ment] to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167.L.Ed.2d 929 (2007) (citing Papasan v. Allain, 478 U.S. 265, 286, 106 S.Ct. 2932, 92 L.Ed.2d 209 (1986)) (alterations in original). The Court must accept as true all well-pleaded facts and allegations and must draw all reasonable inferences therefrom in favor of the plaintiff. As the Supreme Court made clear in Twombly, however, the “factual allegations must be enough to raise a right to relief above the speculative level.” Twombly, 550 U.S. at 555, 127 S.Ct. 1955. The Supreme Court has subsequently broadened the scope of this requirement, stating that “only a complaint that states a plausible claim for relief survives a motion to dismiss.” Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 1950, 173 L.Ed.2d 868 (2009) (emphasis added). Thus, after Iqbal, a district court must conduct a two-part analysis when presented with a motion to dismiss for failure to state a claim. Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir.2009). First, the Court must separate the factual and legal elements of the claim. Id. Although the Court “must accept all of the complaint’s well-pleaded facts as true, [it] may disregard any legal conclusions.” Id. at 210-211. Second, the Court “must then determine whether the facts alleged in the complaint are sufficient to show that the plaintiff has a ‘plausible claim for relief.’ In other words, a complaint must do more than allege the plaintiffs entitlement to relief. A complaint has to ‘show* such an entitlement with its facts.” Id. at 211 (citing Iqbal, 129 S.Ct. at 1949). The determination for “plausibility” will be “ ‘a context-specific task that requires the reviewing court to draw on its judicial experience and common sense.’” Fowler, 578 F.3d at 211 (quoting Iqbal, 129 S.Ct. at 1950). As a result, “pleading standards have seemingly shifted from simple notice pleading to a more heightened form of pleading, requiring a plaintiff to plead more than the possibility of relief to survive a motion to dismiss.” Fowler, 578 F.3d at 211. That is, “all civil complaints must now set out ‘sufficient factual matter’ to show that the claim is facially plausible. This then ‘allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.’ ” Id. at 210 (quoting Iqbal, 129 S.Ct. at 1948). However, nothing in Twombly or Iqbal changed the other pleading standards for a motion to dismiss pursuant to Fed. R. Civ. P. 12(b)(6), and the requirements of Fed. R. Civ. P. 8 must still be met. See Phillips v. Co. of Allegheny, 515 F.3d 224, 231 (3d Cir.2008) (internal citations omitted). Fed. R. Civ. P. 8 requires a showing, rather than a blanket assertion, of entitlement to relief, and “contemplates the statement of circumstances, occurrences, and events in support of the claim presented and does not authorize a pleader’s bare averment that he wants relief and is entitled to it.” Twombly, 550 U.S. at 555 n. 3, 127 S.Ct. 1955 (internal citations and quotations omitted). Additionally, the Supreme Court did not abolish the Fed. R. Civ. P. 12(b)(6) requirement that “the facts must be taken as true and a complaint may not be dismissed merely because it appears unlikely that the plaintiff can prove those facts or will ultimately prevail on those merits.” Phillips, 515 F.3d at 231 (citing Twombly, 550 U.S. at 553, 127 S.Ct. 1955). The parties’ attorneys must also be cognizant of Rule 11 of the Federal Rules of Civil Procedure, which establishes the standards that counsel and unrepresented parties must follow when making written representations to the court. See Fed. R. Civ. P. 11. Rule 11(b) provides, in pertinent part: By presenting to the court a pleading, written motion, or other paper — whether by signing, filing, submitting, or later advocating it — an attorney or unrepresented party certifies that to the best of the person’s knowledge, information, and belief, formed after an inquiry reasonable under the circumstances: (3) the factual contentions have evidentiary support or, if specifically so identified, will likely have evidentiary support after a reasonable opportunity for further investigation or discovery];.] Fed. R. Civ. P. 11(b)(3). Generally, Rule II “‘imposes on counsel a duty to look before leaping and may be seen as a litigation version of the familiar railroad crossing admonition to ‘stop, look, and listen.’ ’ ” Oswell v. Morgan Stanley Dean Witter & Co., 507 F.Supp.2d 484, 488 (D.N.J.2007) (quoting Lieb v. Topstone Indus., 788 F.2d 151, 157 (3d Cir.1986)). Furthermore, in deciding a Rule 12(b)(6) motion to dismiss, the Court may consider “only the allegations in the complaint, exhibits attached to the complaint, matters of public record, and documents that form the basis of a claim.” Lum v. Bank of Am,., 361 F.3d 217, 222 n. 3 (3d Cir.2004). A document forms the basis of a claim if it is “integral to or explicitly relied upon in the complaint.” In re Rockefeller Ctr. Props., Inc. Sec. Litig., 184 F.3d 280, 287 (3d Cir.1999) (emphasis in original; internal citations and quotations omitted). IV. DISCUSSION Stryker advances several arguments in support of its Motion to Dismiss Plaintiffs claims. (See Docket No. 8). Specifically, Stryker maintains that: (1) it is not a proper party to this litigation; (2) all claims against the Trident System, a Class III PMA medical device, are expressly preempted pursuant to the Supreme Court’s decision in Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008); (3) Plaintiff has not alleged parallel claims to avoid express preemption; (4) Plaintiff fails to state claims for strict liability and breach of express warranty; and (5) Plaintiffs claim for punitive damages must be dismissed. (See Docket No. 8). Due to the overlapping nature of these arguments, the Court will first address whether Stryker is a proper party and then will address Stryker’s challenges to each of Plaintiffs claims in the order that the claims are presented in the Complaint. (See Docket No. 1-3). Therefore, this Court will discuss the strict liability claims at Count I, followed by the claims for negligence, res ipsa loquitur, breach of implied warranty at Counts II and III, and then the claim for breach of express warranty at Count III. Next, this Court will address Plaintiffs request for punitive damages. Finally, the Court will determine whether this Court should convert the pending motion to one for summary judgment and with said conversion permit discovery. A. “Proper Party” Argument The Court first turns to Stryker’s argument that it is an improper party to this litigation. (See Docket No. 8 at 14-15). Plaintiff alleges in his Complaint that “Defendants were in the business of designing, manufacturing, marketing and selling hip prostheses including the Trident System shell and liners implanted in Plaintiff on October, 2007.” (Docket No. 1-3 at ¶ 9). Stryker claims that this allegation is erroneous as Howmedica Osteonics Corporation, another named defendant and a wholly-owned subsidiary of Stryker Corporation, is the entity which should be the defendant in the instant suit. (Docket No. 1 at ¶ 4 n. 1; Docket No. 8 at 15 n. 3). Defendant Howmedica Osteonics Corporation was never served with a copy of the Complaint and has been dismissed from the lawsuit. (See Docket Nos. 13-14; see also Docket No. 1 at ¶ 4 n. 2; Docket No. 8 at 15 n. 3). Plaintiff did not respond to Stryker’s argument that it is an improper party. (See Docket No. 10). To illustrate that it is an improper party to this litigation, Stryker explains that it “does not design, manufacture, assemble, equip, test, inspect, service, maintain, repair, advertise, market, or sell the Trident System, any of its component parts, or medical devices of this type.” (Id. at 14). In making this statement, Stryker quotes the sworn affidavit of Erica Visokey, Counsel for Stryker Legal, that it attached as Exhibit A to its brief in support of the Motion to Dismiss. (See Docket No. 8-1). For the Court to consider the affidavit of Erica Visokey at this stage in the litigation, the Court would first have to convert Stryker’s Motion to Dismiss to a motion for summary judgment. See Fed. R. Crv. P. 12(d). In adjudicating Rule 12(b)(6) motions, the court may consider “only the allegations in the complaint, exhibits attached to the complaint, matters of public record, and documents that form the basis of a claim.” Lum, 361 F.3d at 222 n. 3. There is an exception to this general rule in which a court may also “consider an undisputedly authentic document that a defendant attaches as an exhibit to a motion to dismiss if the plaintiffs claims are based on the document.” Pension Ben. Guar. Corp. v. White Consol. Indus., Inc., 998 F.2d 1192, 1196 (3d Cir.1993). Otherwise, a plaintiff with a legally insufficient claim could survive a motion to dismiss “simply by failing to attach a dis-positive document on which it relied.” Id. Only “narrowly defined types of material” fit this exception, such as a “document integral to or explicitly relied upon in the complaint.” In re Rockefeller Ctr. Props., Inc. Sec. Litig., 184 F.3d at 287 (emphasis in original; internal citations and quotations omitted). The Court declines to convert Stryker’s Motion to Dismiss to a motion for summary judgment so that this affidavit may be considered. Although the affidavit is sworn (see Docket No. 8-1), it is not a document that is integral to or explicitly relied upon in Plaintiffs Complaint (see Docket No. 1-3). Moreover, even though Plaintiff has not directly questioned the authenticity of this document in his reply to Stryker’s Motion to Dismiss (see Docket No. 10), the affidavit does not fall within the definition of an “undisputedly authentic document” that may be considered by the Court at the motion to dismiss stage. See Pension Ben. Guar. Corp., 998 F.2d at 1196. Plaintiff avers in his Complaint and in his reply to Stryker’s Motion to Dismiss that “Defendant Stryker designed, manufactured and marketed an artificial hip replacement system that was implanted in Plaintiff,” which contradicts the content of the affidavit by Erica Visokey. (Docket No. 10 at 2; see also Docket No. 1-3 at ¶ 11). Consequently, the Court will regard this affidavit as a document that is outside of the pleadings and will exclude it from consideration. See Fed. R. Civ. P. 12(d). The Court will take all of Plaintiffs allegations contained in its Complaint, including that Stryker designed, manufactured, and marketed the Trident System, to be true in accordance with the proper procedure for adjudicating Rule 12(b)(6) motions. (See Docket No. 1-3 at ¶ 3). See Fowler, 578 F.3d at 210-11. In addition, the Court believes that the substitution of Howmediea Osteonics Corporation as the proper party would not modify the Court’s rulings that all of Plaintiffs claims must be dismissed, with prejudice. See e.g. Loh v. Richardson-Browne, No. 10-0054, 2010 WL 5055787, at *1 n. 1, 2010 U.S. Dist. LEXIS 128016, at *1 n. 1 (D.N.J. Dec. 2, 2010) (finding that even though defendants were improper parties to the suit, the court would proceed with its analysis because it would not alter the court’s decision as to the underlying claims). Thus, the Court finds it appropriate to continue its analysis of the parties’ remaining arguments. B. Strict Liability (Count I) Stryker next argues that Plaintiffs strict liability claim should be dismissed for its failure to state a claim under Pennsylvania law. (Docket No. 8 at 31, 33). Stryker contends that, pursuant to comment k of Section 402A of the Restatement (Second) of Torts, the strict liability theory of recovery does not apply to “unreasonably dangerous” products, which include prescription medical devices like the Trident System. (Id. at 31). Plaintiff does not address this argument in his brief in response. (See Docket No. 10). Pennsylvania has adopted Restatement (Second) of Torts § 402A, which provides that a manufacturer is strictly liable for physical harm to the “ultimate user or consumer, or to his property” that may result from the sale of “any product in a defective condition unreasonably dangerous.” See Webb v. Zern, 422 Pa. 424, 220 A.2d 853, 854 (1966). Pennsylvania courts have also adopted comment k to Restatement (Second) of Torts § 402A, which creates an exception to this rule and exempts “unavoidably unsafe products” from strict liability: k. Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk. Rest. (Second) of Torts § 402A cmt. k. Although comment k mentions prescription medical drugs, it does not refer directly to medical devices. See id. In Riley v. Medtronic, Inc., a decision addressing the viability of a strict liability claim under Pennsylvania law against the manufacturer of a cardiac pacer machine, this Court summarized the applicable law as follows: In Hahn v. Richter, the Pennsylvania Supreme Court adopted comment k, concluding that strict liability could not be applied to prescription drugs where adequate warnings of the drug’s potential risks had been provided. Hahn v. Richter, 543 Pa. 558, 673 A.2d 888, 890-91 (Pa.1996). The Pennsylvania Superi- or Court concluded that comment k applied to medical devices, finding “no reason why the same rationale applicable to prescription drugs may not be applied to medical devices.” Creazzo v. Medtronic, Inc., 2006 PA Super 152, 903 A.2d 24, 31 (Pa.Super.2006). In addition, several federal district courts have extended comment k to prescription medical devices. The United States District Court for the Eastern District of Pennsylvania noted “that the reasoning behind comment k, and the Pennsylvania Supreme Court’s reasoning in Hahn, supports [comment k’s] application to prescription medical devices.” Soufflas v. Zimmer, 474 F.Supp.2d 737, 750 (E.D.Pa.2007) (citing Taylor v. Danek Medical, Inc., No. 95-7232, 1998 U.S. Dist. LEXIS 20265, 1998 WL 962062, *7 (E.D.Pa.1998)). Applying the same reasoning as Taylor, several federal courts have determined that prescription medical devices are not covered by Section 402A and have denied plaintiffs’ strict liability claims based on prescription medical devices. See Burton v. Danek Medical, Inc., et al., No. 95-5565, 1999 U.S. Dist. LEXIS 2619, 1999 WL 118020 (E.D.Pa.1999); Murray v. Synthes, No. 95-7796, 1999 U.S. Dist. LEXIS 13436, 1999 WL 672937 (E.D.Pa.1999); Davenport v. Medtronic, Inc., 302 F.Supp.2d 419 (E.D.Pa.2004); Parkinson v. Guidant Corp., 315 F.Supp.2d 741 (W.D.Pa.2004); Kester v. Zimmer Holdings, Inc., 2010 U.S. Dist. LEXIS 59869, 2010 WL 2696467 (W.D.Pa.2010). Riley v. Medtronic, Inc., 2011 WL 3444190, at *10, 2011 U.S. Dist. LEXIS 87368, at *29-30 (W.D.Pa. Aug. 8, 2011). Subsequent to this Court’s decision in Riley, no change in the law has occurred, and district courts have continued to apply comment k to medical devices. See Horsmon v. Zimmer Holdings, Inc., No. 11-1050, 2011 WL 5509420, at *1-2, 2011 U.S. Dist. LEXIS 130415, at *3-6 (W.D.Pa. Nov. 10, 2011); Esposito v. I-Flow Corp., No. 10-cv-3883, 2011 WL 5041374, at *4-5, 2011 U.S. Dist. LEXIS 122570, at *13-14 (E.D.Pa. Oct. 24, 2011). Although the aforementioned legal principles described in Riley apply to the instant case, the outcome in Riley does not dictate the same result here as the facts are distinguishable. The defendant in Riley filed a motion to dismiss the plaintiffs’ strict liability claim, alleging that it failed to state a claim under Pennsylvania law. Riley, 2011 WL 3444190, at *1, 2011 U.S. Dist. LEXIS 87368, at *1. Despite the fact that the plaintiffs’ complaint did not specifically identify the cardiac pacer machine as a prescription medical device, the defendant argued that such an inference could readily be made by the Court. Id. at *11, 2011 U.S. Dist. LEXIS 87368 at *31. The parties’ briefs illustrated the existence of a question of fact concerning whether the pacer box was a prescription medical device. Id. By construing the plaintiffs’ allegations in their favor, the Court held that the plaintiffs’ allegations were sufficient for the case to continue through the discovery stage during which the precise nature of the cardiac pacer machine could be determined. Id. at *11, 2011 U.S. Dist. LEXIS 87368 at *31-32. Accordingly, the defendant’s motion to dismiss the strict liability claim was denied. Id. at *11, 2011 U.S. Dist. LEXIS 87368 at *32. Even though the motion to dismiss was denied in Riley, the facts in the instant matter do not support a similar conclusion here. Unlike the pacer box at issue in Riley, the Trident System is a Class III medical device which received FDA approval pursuant to the PMA process. See FDA, Summary of Safety and Effectiveness Data, available at http:// www.accessdata.fda.gov/cdrh_docs/pdRP 000013b.pdf (last visited Feb. 26, 2012). Further, it is a matter of public record that the Trident System is a hip prosthesis “indicated for patients requiring primary total hip arthroplasty due to painful disabling joint disease resulting from non-inflammatory degenerative arthritis.” Id. Moreover, the inherently rigorous nature of the premarket approval process and the contraindications, warnings, and precautions described in the Trident System’s Summary of Safety and Security Data all suggest that the Trident System is an “unavoidably unsafe” product to which strict liability does not apply. Id. Most importantly, courts within the Third Circuit have barred strict liability claims against Stryker and other analogous medical device manufacturers by applying comment k to § 402A. See e.g. Horsmon, 2011 WL 5509420, at *2, 2011 U.S. Dist. LEXIS 130415, at *6 (W.D.Pa. Nov. 10, 2011) (holding that a strict liability claim against medical device manufacturer was barred by Pennsylvania law); Esposito, 2011 WL 5041374, at *4-5, 2011 U.S. Dist. LEXIS 122570, at *14 (same); Geesey v. Stryker Corp., No. 09-2988, 2010 WL 3069630, at *4-5, 2010 U.S. Dist. LEXIS 78677, at *13-14 (E.D.Pa. Aug. 4, 2010) (same); Delaney v. Stryker Orthopaedics, No. 08-03210, 2009 WL 564243, at *6-7, 2009 U.S. Dist. LEXIS 16865, at *18-19 (D.N.J. Mar. 5, 2009) (same). As a result, the Trident System can be considered a prescription medical device that falls within the scope of comment k to § 402A. See Riley, 2011 WL 3444190, at *10-11, 2011 U.S. Dist. LEXIS 87368, at *29-30. Plaintiff does not provide the Court with any reason that would prevent application of comment k to § 402A to his claim for product liability under a manufacturing defect theory. (See Docket No. 10). In fact, Plaintiff fails to address this argument entirely. (See id.). Therefore, this Court holds that Plaintiffs strict liability claims (Count I) are not viable under Pennsylvania law. Accordingly, Stryker’s Motion to Dismiss as to Count I for failure to state a claim is granted, and said claim is dismissed, with prejudice. C. Negligence and Res Ipsa Loquitur (Count II) and Breach of Implied Warranty (Count III) Stryker also contends that Plaintiffs claims in Counts I, II, and III of the Complaint are subject to the express preemption provision of the MA, 21 U.S.C. § 360k. (See Docket No. 8 at 9). For a claim against the manufacturer of a medical device to be expressly preempted under this provision, the medical device must have been subject to specific federal requirements related to its safety and effectiveness and the claim must be premised on state law that imposes requirements that are different or additional to the specific federal requirements. See Riegel, 552 U.S. at 321-23, 128 S.Ct. 999. State common law claims challenging the safety and effectiveness of a Class III medical device receiving approval under the FDA’s PMA process are precisely the type of claims that are subject to express preemption. See id. at 324-25, 128 S.Ct. 999. Because the Trident System is subject to specific federal requirements and Plaintiffs claim for breach of implied warranty (Count III) is premised on state common law that imposes different or additional requirements on Stryker, this claim is expressly preempted by 21 U.S.C. § 360k. See Riegel, 552 U.S. at 321-25, 128 S.Ct. 999. Although many courts have held that negligence claims are expressly preempted as well, further analysis of Plaintiffs claims of res ipsa loquitur and negligence (Count II) as purported parallel claims is necessary because Plaintiff attempts to premise these claims on alleged violations of federal regulations. See id. at 330, 128 S.Ct. 999. The Court finds that the references to federal regulations in his negligence and res ipsa loquitur claims are too vague and general to establish what standard of care Stryker allegedly breached. See, inter alia, In re Medtronic Inc. Sprint Fidelis Leads Prod. Liab. Litig., 592 F.Supp.2d 1147, 1158 (D.Minn.2009), aff'd, 623 F.3d 1200 (8th Cir.2010) (“In re Medtronic”); Wolicki-Gables. v. Arrow Int’l, Inc., 634 F.3d 1296, 1301 (11th Cir.2011). Moreover, in Plaintiffs supplemental brief submitted to this Court, he concedes that the res ipsa loquitur claim lacks merit. (Docket No. 16 at 6). As Plaintiff fails to allege sufficient parallel claims sounding in negligence and based on res ipsa loquitur, they are preempted. Plaintiffs claims for negligence and res ipsa loquitur (Count II), as well as Plaintiffs claim for breach of implied warranty (Count III) are thus dismissed, with prejudice. The Court’s analysis follows. 1. Federal Regulation of Medical Devices The MDA, 21 U.S.C. § 360c et seq., established a federal regulatory regime for medical devices. More specifically, the MDA created three classes of medical devices, which categorize the devices “depending on the risks they present.” Riegel, 552 U.S. at 316, 128 S.Ct. 999; see also 21 U.S.C. § 360c (enumerating the three classes of medical devices and describing their characteristics). Of the three classes, Class III devices have the most stringent level of federal oversight. Riegel, 552 U.S. at 317, 128 S.Ct. 999; see also Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 344, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) (identifying Class III devices as “incur[ring] the FDA’s strictest regulation”). Class III devices are intended “for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or ... presents a potential unreasonable risk of illness or injury.” 21 U.S.C. § 360c(a)(1)(C)(ii)(I)-(II). Before a Class III medical device enters the market, the device’s manufacturer must, obtain FDA approval. Medtronic, Inc. v. Lohr, 518 U.S. 470, 477, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). The FDA’s premarket approval process entails a “rigorous” evaluation in which manufacturers submit detailed, voluminous applications to the FDA. Id. Then, the FDA reviews these applications, spending “an average of 1,200 hours on each submission.” Id. The FDA grants PMA if it receives “‘reasonable assurance’ of the device’s ‘safety and effectiveness.’ ” Riegel, 552 U.S. at 318, 128 S.Ct. 999 (quoting 21 U.S.C. § 360e(d)). After obtaining premarket approval, the manufacturer may not “make, without FDA permission, changes ... that would affect safety or effectiveness.” Riegel, 552 U.S. at 319, 128 S.Ct. 999 (citing 21 U.S.C. § 360e(d)(6)(A)(i)). Prior to making any modifications to a medical device that has already received premarket approval, manufacturers must submit an application for supplemental -•premarket approval. Riegel, 552 U.S. at 319, 128 S.Ct. 999 (citing 21 U.S.C. § 360e(d)(6); 21 C.F.R. § 814.39(c)). Additionally, manufacturers must adhere to post-PMA reporting requirements in which newly-reported information could potentially result in the FDA’s withdrawal of its premarket approval. Riegel, 552 U.S. at 319-20, 128 S.Ct. 999 (citing 21 U.S.C. § 360i; 21 U.S.C. § 360e(e)(1); 21 U.S.C. § 360h(e)). The majority of Class III devices do not undergo this intensive PMA review. Rie gel, 552 U.S. at 315, 128 S.Ct. 999. Medical devices that are “substantially equivalent” to existing devices submit to a more limited form of evaluation called § 510(k) premarket notification, which refers to the original section of the MDA describing this review process. Lohr, 518 U.S. at 478, 116 S.Ct. 2240. If the FDA determines that the device in question is “substantially equivalent” to one that is already in existence, then the device satisfies the § 510(k) approval requirements and may be marketed without additional assessment. Id. The FDA completes § 510(k) review “in an average of only 20 hours.” Id. at 479, 116 S.Ct. 2240. 2. Express Preemption of State Law Claims In addition to separating medical devices into three categories, the MDA contains an express preemption provision with two elements that must be satisfied in order for preemption to apply. The provision states: Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement— (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter. 21 U.S.C. § 360k(a). In Riegel, 552 U.S. at 321-23, 128 S.Ct. 999, the Supreme Court held that state laws are preempted by the MDA if: (1) the Federal Government has established “specific requirements applicable to a particular device”; and (2) the plaintiffs claims are based on “state requirements” related to safety and effectiveness that are “different from, or in addition to” the federal requirements. See also Williams v. Cyberonics, Inc., 388 Fed.Appx. 169, 171 (3d Cir.2010) (applying the two-part test for federal preemption pursuant to Riegel). The Supreme Court reasoned that a state law demanding a manufacturer’s devices “to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme.” Riegel, 552 U.S. at 325, 128 S.Ct. 999. Included in the meaning of “state requirements” subject to federal preemption are common law causes of action, such as negligence, strict liability, and breach of implied warranty. Id. at 324-25, 327-28, 128 S.Ct. 999; see also Williams, 388 Fed.Appx. at 171 (holding that appellants’ allegations of strict products liability based on manufacturing defect and breach of warranty, which are “[generalized common law theories of liability,” are preempted by the MDA). a. Element 1: Whether Specific Federal Requirements Apply The § 510(k) approval process does not impose specific federal requirements within the meaning of 21 U.S.C. § 360k(a) that would allow state common law claims to be preempted. See Riegel, 552 U.S. at 322-23, 128 S.Ct. 999. Rather, medical devices entering the market through this procedure are subject to a review that compares them to products already in the marketplace, thus reflecting “entirely generic concerns about device regulation generally.” Id. at 322, 128 S.Ct. 999 (quoting Lohr, 518 U.S. at 501, 116 S.Ct. 2240). The § 510(k) review procedure “ ‘focus[es] on equivalence, not safety,’ ” and devices approved through this process have “ ‘never been formally reviewed under the MDA for safety or efficacy.’ ” Riegel, 552 U.S. at 323, 128 S.Ct. 999 (quoting Lohr, 518 U.S. at 493, 116 S.Ct. 2240) (emphasis in original). Despite the device-specific nature of § 510(k) review, state law claims brought against manufacturers of medical. devices that have been approved through this procedure are not subject to the MDA express preemption provision. Riegel, 552 U.S. at 322, 128 S.Ct. 999. State common law claims against manufacturers of medical devices that are approved through PMA, 'on the other hand, are subject to federal preemption. See id. at 322-25, 128 S.Ct. 999. As was previously explained, the Supreme Court determined in Riegel that the MDA’s express preemption clause “bars common-law claims challenging the safety and effectiveness of a medical device given premarket approval by the [FDA].” Riegel, 552 U.S. at 315, 128 S.Ct. 999. Unlike devices that receive § 510(k) approval, PMA devices are subject to “requirements” that are “specific to individual devices.” Id. at 322-23, 128 S.Ct. 999. Furthermore, PMA inherently “is [a] federal safety review” in which “ ‘the FDA may grant premarket approval only after it determines that a device offers a reasonable assurance of safety and effectiveness.’ ” Id. at 323, 128 S.Ct. 999 (quoting 21 U.S.C. § 360e(d) (emphasis in original)). Consequently, state law claims premised on tort duties regarding safety or effectiveness are in fact “requirements” that are preempted by the PMA process. Riegel, 552 U.S. at 325, 128 S.Ct. 999. It is undisputed that the Trident System hip prosthesis is a Class III medical device. (See Docket No. 1-3 at ¶ 12; Docket No. 8 at 17, 20; Docket No. 10 at 3, 8). The parties disagree, however, on whether the metal acetabular cup, which is the allegedly defective component at issue in the present case, can be regarded as a medical device that is separate from the other portions of the Trident System. Although the entire Trident System hip replacement prosthesis received premarket approval by the FDA, the metal acetabular cup received prior § 510(k) approval in its own right. (See-Docket No. 1-3 at ¶¶ 12-13; Docket No. 10 at 8, 11). Plaintiff contends that this Court should regard the metal acetabular cup as a separate medical device that is not subject to express preemption by the MDA as interpreted by the Supreme Court in Riegel “merely by virtue of [its] coupling with [a] PMA device].” (Docket No. 10 at 8). In response, Stryker argues that the entire Trident System, including the metal acetabular cup, received premarket approval, and thus Plaintiffs claims are preempted and should be dismissed. (See Docket No. 8 at 17-21; Docket No. 11 at 6-11). Resolving the issue of whether the Trident System hip prosthesis should be regarded as a PMA device or, alternatively, a § 510(k) device that has been approved for use with a PMA device, is essential in determining whether express preemption pursuant to Riegel applies. In support of his position that the metal acetabular cup is not a PMA medical device, Plaintiff directs the Court’s attention to the Summary of Safety and Effectiveness Data that the FDA released when it granted premarket approval of the Trident System. (See Docket No. 1-3 at ¶¶ 15-16; Docket No. 10 at 4). The Summary describes the Trident System as a medical device that is “indicated for patients requiring total hip arthroplasty.” Id. In addition, it provides that the Trident System features a “ceramic-on-ceramic acetabular bearing couple” with a ceramic acetabular insert that “features a pre-assembled titanium alloy sleeve on the back of the insert which mates with the metal acetabular shell component.” Id. (emphasis added). The Summary also states that the insert is to be “used in conjunction with the commercially available” Trident acetabular shell. Id. Plaintiff interprets this Summary to mean that only the ceramic-on-ceramic bearing couple, made up of the ceramic liner and ceramic femoral head, received premarket approval. (Docket No. 10 at 4). Although Plaintiff is correct that the Summary does address adverse events relating to the liner and femoral head, the Summary also includes warnings, precautions, testing, and conclusions related to the ace-tabular shell as a component of the Trident System. See FDA, Summary of Safety and Effectiveness Data; see also White v. Stryker Corp., 818 F.Supp.2d 1032, 1035-36 (W.D.Ky.2011) (describing the Summary’s content when discussing the Trident System’s PMA process); Lewkut v. Stryker Corp., 724 F.Supp.2d 648, 655 (S.D.Tex.2010) (same). Plaintiff even quotes one of these specific warnings in his Complaint: Replace both the ceramic insert and the metal acetabular shell if the insert is chipped, cracked, or otherwise damaged during the implant procedure or postoperative time frame. This is because the acetabular shell taper, once it has been deformed through assembly to its mating ceramic insert, cannot be reassembled to another ceramic insert. (Docket No. 1-3 at ¶ 16 (emphasis added)). This warning focuses on the insert, which is part of the ceramic-on-ceramic bearing couple, and the metal acetabular shell in a way that implies that they are both component parts of the entire Trident System hip prosthesis. (See id.). Also, as previously noted, the Summary plainly refers to the shell as a “component.” (See id.). As such, the Summary illustrates that the Trident System, made up of such parts as the metal acetabular shell, underwent thorough FDA evaluation in its entirety and subsequently received premarket approval. (See id.); see also Lewkut, 724 F.Supp.2d at 655 (stating, “[t]hat the acetabular cup is described as a ‘component’ of the approved system is, to this Court, of considerable significance”). Plaintiff further maintains that testimony by Stryker’s agents before an FDA panel supports a finding that the metal acetabular cup is a medical device independent of the ceramicon-ceramic bearing couple. (See Docket No. 10 at 12). Plaintiff, however, does not raise these allegations in his Complaint; instead, he discusses them for the first time in his responding brief. (See id.). Additionally, Plaintiff does not provide a citation to the source of this alleged testimony before an FDA panel at an unidentified date and time. (See id.). Plaintiff also offers no context for this testimony and does not provide the Court with a record or transcript of this hearing, merely noting that it occurred “before the PMA panel conducting the hearing for the Trident System.” (Id.). By providing the Court with isolated statements allegedly made by Stryker’s agents during this FDA panel hearing without also providing the context in which these statements were made, it is difficult to comprehend their true meaning. (See id.). To that end, the Court is unable to construe these quoted statements as providing support to Plaintiffs argument here. Moreover, this information, even if supported, constitutes matters outside of the pleadings which this Court may not consider on a motion to dismiss. See Lum, 361 F.3d at 222 n. 3. Plaintiff also argues that “[i]t is extremely telling that Defendants’ [sic] have not attached the original PMA application for the Trident System that was submitted to the FDA.” (Docket No. 10 at 12). Plaintiff states that this PMA application, which it has not had the opportunity to review, would have identified the components of the Trident System that actually received premarket approval. (Id.). Again, this argument is misguided. The application submitted to the FDA does not facilitate this Court’s determination of what the FDA actually approved during the PMA process. See Lewkut, 724 F.Supp.2d at 655 (noting, “In determining the legal scope of the FDA approval of the Trident System, this Court is tasked only with determining what was ultimately approved via the PMA process. What was submitted in the FDA application has little bearing on this court’s assessment of what was ultimately approved”). Instead, the focus remains on the approved device and whether Plaintiffs claims challenge the effectiveness of the approved device. See id. Furthermore, Plaintiff argues that “no case has ever specifically held that medical devices approved through the § 510(k) process are cloaked with preemption when coupled with a PMA device.” (Docket No. 10 at 8). Stryker, however, identifies several courts that have rejected the argument that a specific defective component receiving prior § 501(k) approval can be separated from the PMA-device as a whole. (See Docket No. 8 at 18-20; Docket No. 11 at 7). For instance, the court in Bentzley v. Medtronic, Inc., 827 F.Supp.2d 443, 451-52 (E.D.Pa.2011) stated, “Plaintiffs contention that, in considering a preemption issue, the Court must break a medical device into its component parts, is without legal support.” In Riley v. Cordis Corp., 625 F.Supp.2d 769, 780 (D.Minn.2009), the court summarized the illogical nature of this argument, explaining, “[i]t makes no sense — indeed, it would probably be impossible — to pick apart the components of a medical device and apply different preemption analyses to different components.” The Court agrees with Stryker, as well as the courts in Bentzley and Riley, that a device receiving premarket approval cannot be separated into its component parts to avoid application of express preemption. Significantly, several district courts in other circuits have held that the acetabular cup, or shell, of the Trident System, the precise component at issue in the instant matter, should be considered as approved pursuant to PMA as a part of the entire Trident System medical device. The Lewkut court explained: [T]his Court cannot see the logic in holding that the ceramic components of the Trident System were PMA-approved for use with the acetabular shell, but . that that acetabular shell itself was not PMA approved. An acetabular shell being used in conjunction with the identified ceramic components is precisely the device that was approved via PMA. To require that a distinction be drawn between the approval process of the individual components of the 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. 724 F.Supp.2d at 656 (emphasis added). Similarly, in Cornwell v. Stryker Corp., No. 1:10-cv00066-EJL, 2010 WL 4641112, at *3-4, 2010 U.S. Dist. LEXIS 116824, at *8-9 (D.Idaho Nov. 1, 2010): The Court finds the record in this case supports that the Trident System, including its component parts, received PMA approval under the PMA process. Plaintiff argues the Trident acetabular cup was initially approved via the § 510(k) process and even though it was later approved for use with the ceramic-on-ceramic Trident System which received PMA approval, claims regarding the acetabular cup are exempt based on its original approval under § 510(k). This argument has been rejected by every other court determining whether the acetabular cup received approval via the PMA process.... Having found the medical device at issue in this case was approved via the PMA process, the Court finds Plaintiffs product liability claims are preempted by the MDA and must be dismissed. (emphasis added). See also Bass v. Stryker Corp., No. 4:09-cv-632-Y, 2010 WL 3431637, at *3-4, 2010 U.S. Dist. LEXIS 90226, at *8-12 (N.D.Tex. Aug. 31, 2010), rev’d on other grounds, 669 F.3d 501 (5th Cir.2012) (determining that the metal ace-tabular cup is a part of the Trident System, which received premarket approval in its entirety). This Court is persuaded by this authority and finds that the Trident System, in its entirety, received premarket approval. See, inter alia, Cornwell, 2010 WL 4641112, at *3-4, 2010 U.S. Dist. LEXIS 116824, at *8-9; Bass, 2010 WL 3431637, at *3-4, 2010 U.S. Dist. LEXIS 90226, at *8-12; Lewkut, 724 F.Supp.2d at 656. Despite the prior § 501(k) approval of the metal acetabular cup and its commercial availability at the time of the Trident System’s premarket approval, the metal acetabular cup still underwent the PMA process as a component of the Trident System. See, inter alia, Cornwell, 2010 WL 4641112, at *3-4, 2010 U.S. Dist. LEXIS 116824, at *8-9; Bass, 2010 WL 3431637, at *3-4, 2010 U.S. Dist. LEXIS 90226, at *8-12; Lewkut, 724 F.Supp.2d at 656. Therefore, the federal government has imposed device-specific “requirements” on the entire Trident System hip prosthesis, and the first prong of the two-part test of express preemption under 21 U.S.C. § 360(k) has been fulfilled. See Riegel, 552 U.S. at 322-23, 128 S.Ct. 999 b. Element 2: Whether State Requirements are Different From, or in Addition, to the Federal Requirements This Court must next determine whether Plaintiffs claims based on negligence and res ipsa loquitur (Count II) and his breach of implied warranty claim (Count III) are expressly preempted by the MDA. (See Docket No. 15-18). As was previously discussed, the second prong of express preemption under 21 U.S.C. § 360(k) requires the court to evaluate whether the state requirements underlying the plaintiffs claims relate to the device’s safety and effectiveness and are “different from or in addition to” the federal requirements. See Riegel, 552 U.S. at 321-22, 128 S.Ct. 999. In Riegel, the Supreme Court equated state common law duties with state requirements. Id. at 323-24, 327-28, 128 S.Ct. 999. The Supreme Court determined that claims for breach of implied warranty and negligence regarding Class III PMA medical devices suggest that “a device was designed, labeled or manufactured in an unsafe or ineffective manner.” Id. at 328, 128 S.Ct. 999. Allowing these claims to go forward would result in the imposition of different or additional requirements related to the safety or effectiveness of a device. Id. at 327-28, 128 S.Ct. 999; see also Walker v. Medtronic, Inc., 670 F.3d 569, 578-79 (4th Cir.2012) (2-1 decision) (stating that Riegel “provides a rigorous, comprehensive, and exclusive framework that precludes state law tort claims that seek to impose different or higher standards upon federally approved devices”). “Generalized common law theories of liability ... are precisely the types of claims the MDA sought to preempt.” Williams, 388 Fed.Appx. at 171 (citing Riegel, 552 U.S. at 325, 128 S.Ct. 999; Horn v. Thoratec Corp., 376 F.3d 163, 173 (3d Cir.2004)). Many courts have evaluated state common law claims regarding the very product at issue in this litigation, the Trident System and its component parts, and have deemed them expressly preempted. See e.g. Rhynes v. Stryker Corp., No. 10-5619 SC, 2011 WL 5117168, 2011 U.S. Dist. LEXIS 58286 (N.D.Cal. Oct. 27, 2011) (dismissing negligence and strict liability claims as expressly preempted under the MDA per the Supreme Court’s reasoning in Riegel)-, Cornwell, 2010 WL 4641112, 2010 U.S. Dist. LEXIS 116824 (dismissing product liability claims); Lewkut, 724 F.Supp.2d 648 (dismissing claims for, inter alia, strict liability and negligence premised on alleged manufacturing, marketing, and design defects); Anthony v. Stryker Corp., No. 1:09-cv-2343, 2010 WL 1387790, 2010 U.S. Dist. LEXIS 31031 (N.D.Ohio Mar. 31, 2010) (dismissing claims for strict liability, negligence, breach of implied warranty, breach of express warranty, and misrepresentation); Yost v. Stryker Corp., No. 2:09-cv-28-FtM-29DNF, 2010 WL 1141586, 2010 U.S. Dist. LEXIS 27079 (M.D.Fla. Mar. 23, 2010) (dismissing claims for strict product liability, negligence/wantonness, breach of express warranty, and breach of implied warranties of merchantability and fitness for a particular purpose); Lemelle v. Stryker Orthopaedics, 698 F.Supp.2d 668 (W.D.La.2010) (dismissing product liability claims); Funk v. Stryker Corp., 673 F.Supp.2d 522 (S.D.Tex.2009) (dismissing claims for, inter alia, strict liability and negligence), aff'd, 631 F.3d 777 (5th Cir.2011); Covert v. Stryker Corp., No. 1:08CV447, 2009 WL 2424559, 2009 U.S. Dist. LEXIS 68962. (M.D.N.C. Aug. 5, 2009) (dismissing claims for failure to warn, defective manufacturing, defective design, negligence and recklessness, and breach implied warranties); Delaney, 2009 WL 564243, 2009 U.S. Dist. LEXIS 16865 (dismissing claims for failure to warn, strict liability, negligence and recklessness, and breach of implied warranties as preempted by MDA); Horowitz v. Stryker Corp., 613 F.Supp.2d 271 (E.D.N.Y.2009) (dismissing claims for strict liability, negligence and recklessness, and breach of express and implied warranties); Parker v. Stryker Corp., 584 F.Supp.2d 1298 (D.Colo.2008) (dismissing claims for failure to warn, manufacturing defect, design defect, breach of express and implied warranties, breach of implied warranty of fitness, breach of implied warranty of merchantability, and negligence and recklessness). Upon consideration, the Court finds these decisions to be very persuasive. As was previously explained, Plaintiff asserts that express preemption pursuant to § 360k is entirely inapplicable to the metal acetabular cup due to its approval via the § 510(k) process. (See Docket No. 10 at 11-13). This Court has already rejected this argument in section IV(C)(2)(a) after determining that the Trident System, including the metal acetabular cup component, received approval through the PMA process. In his responsive brief and latest brief, Plaintiff does not address this second prong of the Riegel two-part test directly and instead argues that all of his claims assert violations of federal law which “ ‘parallel’ rather than add to, federal regulations.” (Id. at 13 (quoting Riegel, 552 U.S. at 330, 128 S.Ct. 999); Docket No. 16 at 7 (quoting same)). As such, Plaintiff maintains that his claims are all parallel claims that are premised on violations of specific federal requirements, not different or additional state requirements. (See Docket No. 10 at 13-14; Docket No. 16 at 7-8). The Court agrees with Stryker’s argument, however, that Plaintiffs breach of implied warranty claim is a state law claim that imposes requirements that are different, or in addition to, specific federal requirements imposed by the FDA. (See Docket No. 8 at 20-21). This Court finds no indication in the Complaint that Plaintiffs claim of breach of implied warranty (Count III) alleges violations of federal regulations. (See Docket No. 1-3 at 13-18). Rather, Plaintiff sets forth a general common law claim. (See id.). See also Williams, 388 Fed.Appx. at 171. To find that, despite complying with all FDA regulations, the Trident System violated state requirements, this Court would be imposing different or additional requirements on the Trident System relating to its safety and effectiveness. See Riegel, 552 U.S. at 321-23, 128 S.Ct. 999. Although not labeled as such, Plaintiffs breach of implied warranty claim sets forth allegations of a breach of the implied warranty of merchantability. (See Docket No. 1-3 at 17-18). Pennsylvania has adopted the Uniform Commercial Code formulations of the implied warranty of merchantability. 13 Pa. Cons.Stat. § 2314; see also Gavula v. ARA Servs., Inc., 756 A.2d 17, 21 (Pa.Super.Ct.2000). Under Pennsylvania law, the implied warranty of merchantability “serve[s] to protect buyers from loss where goods purchased are below commercial standards.” Turney Media Fuel, Inc. v. Toll Bros., 725 A.2d 836, 840 (Pa.Super.Ct.1999) (citing Borden, Inc. v. Advent Ink Co., 701 A.2d 255, 258 (Pa.Super.Ct.1997)). Therefore, it is evident that Pennsylvania state law imposes its own standards on the merchantability of goods. See Turney Media Fuel, Inc., 725 A.2d at 840. By virtue of its premarket approval, the Trident System is subject to federal regulations regarding its merchantability. See Riegel, 552 U.S. at 322-25, 128 S.Ct. 999. These federal regulations are in conflict with the Pennsylvania standards for merchantability. See Bentzley, 2011 U.S. Dist. LEXIS 5942128, at *25-26; Davenport v. Medtronic, 302 F.Supp.2d 419, 434 (E.D.Pa.2004) (stating, “[A] judgment for breach of implied warranty would rest on allegations relating to standards ‘different from or in addition to’ federal requirements set forth in the PMA. Specifically, the accepted standards of design and manufacture for products in the state of Pennsylvania would be ‘different from or in addition to’ the requirements set through the PMA process”). Because Plaintiffs implied warranty claim is premised on requirements that are different from, or in addition to, the federal requirements imposed by the FDA, Plaintiffs implied warranty claim is preempted by the MDA. See Williams, 388 Fed.Appx. at 171 (holding that breach of warranty claims are expressly preempted); Bentzley, 2011 U.S. Dist. LEXIS 5942128, at *26 (same); Anthony, 2010 WL 1387790, at *5, 2010 U.S. Dist. LEXIS 31031,