NORA BARRY FISCHER, District Judge.
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,
On October 20, 2007, Plaintiff underwent a left hip arthroplasty
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 Plaintiff's 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 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."
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
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
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 t/a/d/b/a Stryker Howmedica Osteonics, Stryker Orthoppedics [sic], and Stryker Orthopedics.
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,
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).
Thus, Stryker's Motion is now fully briefed and ripe for disposition.
A motion to dismiss pursuant to FED. R. CIV. P. 12(b)(6) challenges the legal sufficiency of a complaint.
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 plaintiff's 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:
FED. R. CIV. P. 11(b)(3). Generally, Rule 11 "`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).
Stryker advances several arguments in support of its Motion to Dismiss Plaintiff's 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) Plaintiff's 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 Plaintiff's 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.
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
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.
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 Plaintiff's Complaint (see Docket No. 1-3). Moreover, even though
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 Plaintiff's 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 Howmedica Osteonics Corporation as the proper party would not modify the Court's rulings that all of Plaintiff's 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.
Stryker next argues that Plaintiff's strict liability claim should be dismissed for its failure to state a claim under Pennsylvania law.
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."
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:
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.
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 Plaintiff's 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.
Stryker also contends that Plaintiff's 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.
Although many courts have held that negligence claims are expressly preempted as well, further analysis of Plaintiff's
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. Riegel,
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:
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 plaintiff's 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 "[g]eneralized common law theories of liability," are preempted by the MDA).
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
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 devic[e]." (Docket No. 10 at 8). In response, Stryker argues that the entire Trident System, including the metal acetabular cup, received premarket approval, and thus Plaintiff's 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.
(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 ceramic-on-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.
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.
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, "Plaintiff's 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:
(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 acetabular 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
This Court must next determine whether Plaintiff's 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 plaintiff's 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;
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 S.C. 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).
As was previously explained, Plaintiff asserts that express preemption pursuant to § 360k is entirely inapplicable to the metal acetabular cup due to its approval
The Court agrees with Stryker's argument, however, that Plaintiff's 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.
Although not labeled as such, Plaintiff's 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 Plaintiff's
This Court also recognizes that a sizable number of courts have held that negligence claims against the manufacturer of the Trident System are expressly preempted by the MDA. See e.g., inter alia, Rhynes, 2011 WL 5117168, 2011 U.S. Dist. LEXIS 58286; Lewkut, 724 F.Supp.2d 648; Anthony, 2010 WL 1387790, 2010 U.S. Dist. LEXIS 31031. In Riegel, 552 U.S. at 324-25, 327-28, 128 S.Ct. 999, the Supreme Court held that a common law claim for negligence against the manufacturer of a defective medical device was subject to express preemption. To the extent that Plaintiff's claims rely on general, common law negligence standards, said claims are expressly preempted.
Plaintiff's negligence and res ipsa loquitur claims can only survive if he pleads specific violations of federal law that establish a parallel state duty, rather than a duty that is different, or in addition to, those imposed by federal regulations. One subparagraph of Plaintiff's negligence claim in Count II alleges a "violation of the FDA requirements and standards as set forth and describe[d] above in the Statement of Facts and Count One." (Docket No. 1-3 at 16). A generous reading of the Complaint reveals that the "requirements and standards" to which Plaintiff refers are violations of federal regulations related
To that end, the Court will evaluate Plaintiff's claim for negligence and res ipsa loquitur (Count II) as purported parallel claims. The Court acknowledges that unlike the breach of implied warranty claim that is based on Pennsylvania state law, the negligence and res ipsa loquitur claims include a reference to Stryker's alleged violations of federal regulations. (See Docket No. 1-3 at 15-16). Plaintiff has conceded, however, that his res ipsa loquitur claim fails as a purported parallel claim. (Docket No. 16 at 6)
In Riegel, the Supreme Court found that "[21 U.S.C.] § 360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations" because the state duties would "`parallel,' rather than add to, federal requirements." Riegel, 552 U.S. at 330, 128 S.Ct. 999 (citing Lohr, 518 U.S. at 495, 513, 116 S.Ct. 2240). "To properly allege parallel claims, the complaint must set forth facts showing `action or inaction in [defendants'] efforts to take part in the PMA process or implement its results.'" Parker, 584 F.Supp.2d at 1301 (quoting Heisner ex rel. Heisner v. Genzyme Corp., No. 08-C-593, 2008 WL 2940811, at *4-5, 2008 U.S. Dist. LEXIS 60569, at *12-13 (N.D.Ill. July 25, 2008)); accord Williams v. Cyberonics, Inc., 654 F.Supp.2d 301, 306 (E.D.Pa.2009), aff'd, 388 Fed.Appx. 169 (3d Cir.2010) (finding, "To avoid federal preemption, a plaintiff must make a showing that the medical device was not manufactured in accordance with FDA standards").
Even if a plaintiff does properly plead facts demonstrating the defendant's failure to satisfy federal regulations, there is no private cause of action against a device manufacturer under the FDCA. See Buckman Co., 531 U.S. at 349 n. 4, 121 S.Ct. 1012. Only the federal government may file suits against manufacturers that do not comply with federal regulations. See 21 U.S.C. § 337(a) ("[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States"). Although the Supreme Court acknowledged in Riegel that parallel claims based on violations of federal regulations would escape express preemption under § 360k, § 337(a) has been held to impliedly preempt private claims against device manufacturers for failure to comply with federal regulations. See In re Medtronic, 592 F.Supp.2d at 1160-61 & n. 17. As a result, "Riegel and Buckman create a narrow
The United States District Court for the District of Minnesota articulated two exceptions to implied preemption in which a plaintiff could assert a viable parallel claim. See In re Medtronic, 592 F.Supp.2d at 1161 n. 17. First, "an adequately pleaded claim that a specific device was not manufactured in accordance with its PMA specifications can survive preemption." Id. (citing Rollins v. St. Jude Medical, Daig Division, Inc., 583 F.Supp.2d 790 (W.D.La.2008)). To be an adequately pleaded parallel claim, "Plaintiffs cannot simply incant the magic words `[Defendant] violated FDA regulations' in order to avoid preemption." In re Medtronic, 592 F.Supp.2d at 1158; accord Wolicki-Gables, 634 F.3d at 1301 (stating, "Parallel claims must be specifically stated in the initial pleadings"). The second exception to implied preemption recognized in In re Medtronic is for claims brought under a state statute "providing a remedy for a violation of the FDCA." In re Medtronic, 592 F.Supp.2d at 1161 n. 17 (citing Bausch v. Stryker Corp., 2008 WL 5157940, at *4, 2008 U.S. Dist. LEXIS 99118, at *12-13 (N.D.Ill. Dec. 9, 2008), rev'd, 630 F.3d 546 (7th Cir.2010)). Neither of these exceptions is applicable in the instant matter because: (1) Plaintiff fails to adequately plead a sufficient, specific basis for his purported parallel claims, and (2) Plaintiff's claims arise from generalized common theories of liability and not state statutes that provide a private cause of action for FDCA violations.
In support of his purported parallel claims of negligence and res ipsa loquitur, Plaintiff alleges violations of certain CGMPs and asserts the existence of an FDA warning letter and a voluntary recall notice. (See Docket No. 1-3 at ¶¶ 18-23, 13, 16). Plaintiff identifies these CGMPs as follows:
(Id. at 13-14). Plaintiff relies upon these CGMPs, as well as the November 28, 2007 FDA warning letter issued to Stryker and the June 18, 2008 voluntary recall of certain Trident System shells, as establishing Stryker's duty to Plaintiff in his cause of action for negligence. (See id. at ¶¶ 18-23, 13-16). Plaintiff also avers that Stryker must "comply with the FDA standards and requirements established and approved through the PMA process for ... the Trident System." (Id. at ¶ 17).
It is hornbook law in Pennsylvania that "[t]here are four elements to a cause of action for negligence: a duty of care, a breach of that duty, a causal connection between the defendant's conduct and the resulting injury, and damages." Zeidman v. Fisher, 980 A.2d 637, 639-40 (Pa.Super.Ct.2009) (citing Morena v. S. Hills Health Sys., 501 Pa. 634, 462 A.2d 680, 684 n. 5 (1983)). "The primary element in any negligence cause of action is that the defendant
The Court recognizes that no courts within the Third Circuit have directly ruled on the requisite specificity with which a plaintiff must plead parallel claims. According to the pleading standards set forth in Iqbal and Twombly, however, Plaintiff's broad references to federal regulations are insufficient to establish the duty element of a negligence state law claim which would parallel a violation of federal law. See In re Medtronic, 592 F.Supp.2d at 1157-1158; Wolicki-Gables, 634 F.3d at 1301; Ilarraza v. Medtronic, Inc., 677 F.Supp.2d 582, 588 (E.D.N.Y.2009); Horowitz, 613 F.Supp.2d at 280; Parker, 584 F.Supp.2d at 1301. To state a plausible cause of action that avoids MDA preemption, a plaintiff must allege "more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do." Twombly, 550 U.S. at 555, 127 S.Ct. 1955. Moreover, a plaintiff must plead "enough facts to state a claim to relief that is plausible on its face." Id. at 570, 127 S.Ct. 1955. "The plausibility standard is not akin to a `probability requirement,' but it asks for more than a sheer possibility that a defendant has acted unlawfully." Iqbal, 129 S.Ct. at 1949 (internal citations omitted). Courts within the Third Circuit closely adhere to the pleading standards set forth in Iqbal and Twombly. See Warren Gen. Hosp. v. Amgen Inc., 643 F.3d 77, 84 (3d Cir.2011) (quoting Fowler, 578 F.3d at 210). As the United States District Court for the Western District of Kentucky remarked in White v. Stryker Corp., 818 F.Supp.2d at 1036-37, "In the context of MDA preemption, Twombly and Iqbal make a plaintiff's job more difficult than it would be in a typical product liability case."
The FDA acknowledges that the CGMPs "are intended to serve only as `an umbrella quality system,' providing `general objectives' medical-device manufacturers must seek to achieve." In re Medtronic, 592 F.Supp.2d at 1157 (quoting FDA Device Advice, Good Manufacturing Practices (CGMP)/Quality System (QS) Regulation, available at http://www.fda. gov/cdrh/devadvice/32.html# flexibility (last visited Jan. 2, 2009))
As this area of law continues to develop, some courts have found that references to particular CGMPs can serve as a basis for a parallel claim. See Howard v. Sulzer Orthopedics, Inc., 382 Fed.Appx. 436, 440-41 (6th Cir.2010); Bausch v. Stryker Corp., 630 F.3d 546, 555-56 (7th Cir.2010); Gelber v. Stryker Corp., 788 F.Supp.2d 145, 159 (S.D.N.Y.2011). In a recent decision, Bass v. Stryker Corp., the United States Court of Appeals for the Fifth Circuit held that the plaintiff had pled parallel claims when the same CGMPs that Plaintiff references in the instant matter, 21 C.F.R. §§ 820.20(a), 820.20(b)(2), and 820.70(e), were cited in the plaintiff's amended complaint. Bass, 669 F.3d at 509-10, 511-12. As an initial matter, the court acknowledged that "the circuits are not in complete agreement as to what constitutes a sufficient pleading with regard to a CGMP." Id. at 511. The court then went on to explain that "reliance on CGMPs" is not critical to successfully pleading a parallel claim. Id. at 511-12. Rather, the essential elements to a parallel claim are "the existence of a manufacturing defect caused by a violation of federal regulations and allegations connecting a defect in the manufacture of the specific device to that plaintiff's specific injury."
The Court declines to follow the reasoning set forth in Bass. In Riegel, the Supreme Court stated that parallel claims arise out of "violations of FDA regulations" because the state duties would "`parallel,' rather than add to, federal requirements." Riegel, 552 U.S. at 330, 128 S.Ct. 999 (citing Lohr, 518 U.S. at 495, 513, 116 S.Ct. 2240). Under the premarket approval process, the FDA imposes federal "requirements" that are "specific to individual devices." Riegel, 552 U.S. at 322-23, 128 S.Ct. 999. Allowing a plaintiff to plead non-specific regulations as a basis for a parallel claim is inconsistent with the Supreme Court's reasoning in Riegel, as well as the pleading requirements articulated in Twombly, Iqbal, and Fowler. See Riegel, 552 U.S. at 322-23, 330, 128 S.Ct. 999; Twombly, 550 U.S. at 555, 570, 127 S.Ct. 1955; Iqbal, 129 S.Ct. at 1949; Fowler, 578 F.3d at 210-11. This Court requires
In Howard, an unpublished opinion, the United States Court of Appeals for the Sixth Circuit held that a citation to a CGMP addressing manufacturing material, 21 C.F.R. § 820.70(h), was a sufficient foundation on which to base a parallel claim. See Howard, 382 Fed.Appx. at 440-41. The court read this CGMP to require actual removal of manufacturing material when it "`adversely affect[s] the device's quality.'" Id. at 440 (quoting 21 C.F.R. § 820.70(h)). This CGMP is distinguishable from the general regulations Plaintiff claims were violated in this case. (See Docket No. 1-3 at 13-14). The CGMPs allegedly violated by Stryker do not similarly prescribe a specific course of action that a manufacturer must take and impose liability when the manufacturer fails to do so. (See id.).
The United States Court of Appeals for the Seventh Circuit adopted a comparable approach in Bausch, 630 F.3d at 555-56. Although the plaintiff in Bausch did not allege any violations of CGMPs in her complaint, the court held that such violations could serve as a basis for a parallel claim. Id. (See also Bausch Complaint at No. 08-04248, Docket No. 1). The court went a step further than the Howard court, though, and declined to differentiate between "general requirements and `concrete, device-specific' requirements," as violations of both could feasibly survive preemption. Bausch, 630 F.3d at 555. The court expressed its underlying motivation for this liberal pleading standard, stating, "Defendants' proposed distinction between concrete, product-specific requirements and more general requirements would also leave injured patients without a remedy for a wide range of harmful violations of federal law." Id.
This Court finds the Bausch court's rationale to be unpersuasive and declines to follow its holding. First, in Riegel, 552 U.S. at 318, 128 S.Ct. 999, the Supreme Court acknowledged that the PMA process does not certify the absolute safety of medical devices; rather, the process entails the balancing of risks and benefits by the FDA throughout the approval process. See also Banner v. Cyberonics, Inc., No. 08-0741, 2010 WL 455286, at *4, 2010 U.S. Dist. LEXIS 9393, at *10 (D.N.J. Feb. 4, 2010) (stating, "Thus, if the FDA approves a manufacturing process and the defendant-manufacturer conforms with it, a device thereby produced that nevertheless does not function as intended does not give rise to liability"). Second, pursuant to the premarket approval process, medical device manufacturers must adhere to device-specific requirements. See Riegel, 552 U.S. at 322-23, 128 S.Ct. 999. As such, violations of same, and not merely any requirement, properly serve as the basis of a parallel claim. See id. at 322-23, 330, 128 S.Ct. 999. Third, as stated previously, such a liberal pleading standard is in conflict with Twombly and Iqbal, as well as Third Circuit precedent interpreting same, including Fowler. See Twombly, 550 U.S. at 555, 570, 127 S.Ct. 1955; Iqbal, 129 S.Ct. at 1949; Fowler, 578 F.3d at 210-11.
In the instant case, the CGMPs cited by Plaintiff direct Stryker to have a "quality policy" in place, "adequate resources" to meet this quality policy, and "procedures to prevent [contamination] [sic]" of the devices that it manufactures. (See Docket No. 1-3 at 13-14). These regulations are not only general; they apply to all Class III PMA medical devices. See In re Medtronic, 592 F.Supp.2d at 1157-58; Horowitz,
Similarly, Plaintiff's references to a warning letter and a voluntary recall notice do not establish an applicable standard of care to support a well-pled negligence claim. See Horowitz, 613 F.Supp.2d at 280; Parker, 584 F.Supp.2d at 1302. Plaintiff states that the November 28, 2007 warning letter establishes that Stryker violated CGMPs in its Mahwah, New Jersey facilities between June 1, 2007 and July 12, 2007. (See Docket No. 1-3 at ¶¶ 19, 25-30). Additionally, Plaintiff claims that Stryker initiated a June 12, 2008 recall of some of its hip devices, allegedly including Plaintiff's own device. (See id. at ¶ 20). Plaintiff appears to assert that these facts establish that Stryker manufactured the Trident System in a negligent manner thus causing the failure of his hip prosthesis, his pain, and the necessary revision surgery. (See id. at ¶¶ 19-20).
The warning letter and voluntary recall notice do not, however, establish any duty that Stryker had to Plaintiff in manufacturing the Trident System. Nor do they indicate that Stryker breached any alleged duty by failing to comply with the PMA process. See Parker, 584 F.Supp.2d at 1301. Instead, the warning letter and voluntary recall evidence that the FDA purportedly acknowledged some deviation from the CGMPs, and subsequently, Stryker recalled Trident System devices. (See Docket No. 1-3 at ¶¶ 19-20, 25-30). It is also unclear in the Complaint how an alleged voluntary recall conducted by Stryker, and not mandated by the FDA, supports a finding that Stryker failed to comply with the PMA process. (See id. at ¶ 22).
Absent an illustration of Stryker's precise duty to Plaintiff, Plaintiff cannot plead a cause of action for negligence under Pennsylvania law. See Althaus, 756 A.2d at 1168; Zeidman, 980 A.2d at 639-40. Plaintiff's purported parallel claim for negligence falls short of being "specifically stated in the initial pleadings." Wolicki-Gables, 634 F.3d at 1301. Although Plaintiff acknowledges that Stryker must comply with the specific regulations that apply to the Trident System as a PMA device, he does not outline what these regulations are or how Stryker allegedly violated same. (See Docket No. 1-3 at ¶ 18). Because Plaintiff pled his negligence claim in a very general manner, he has failed to state a claim for negligence that survives preemption. See Twombly, 550 U.S. at 555, 570, 127 S.Ct. 1955; Iqbal, 129 S.Ct. at 1949; Fowler, 578 F.3d at 210-11.
To the extent that Plaintiff relies on the same violations of federal regulations to establish res ipsa loquitur, it logically follows that Plaintiff's claim based on res ipsa loquitur similarly fails as a parallel claim. (See Docket No. 1-3 at 16-17).
"Res ipsa loquitur, meaning literally `the thing speaks for itself,' is `a shorthand expression for circumstantial proof of negligence — a rule of evidence.'" Quinby v. Plumsteadville Family Practice, Inc., 589 Pa. 183, 907 A.2d 1061, 1071 (2006) (quoting Gilbert v. Korvette, Inc., 457 Pa. 602, 327 A.2d 94, 99 (1974)). It "allows juries to infer negligence from the circumstances surrounding the injury." Quinby, 907 A.2d at 1071. Pennsylvania has adopted the doctrine of res ipsa loquitur set forth in RESTATEMENT (SECOND) OF TORTS § 328D:
REST. (SECOND) OF TORTS § 328D; see also Gilbert, 327 A.2d at 100.
This Court has already determined that Plaintiff is unable to maintain a claim for negligence. As such, this Court declines to infer the existence of such negligence in accordance with the doctrine of res ipsa loquitur under Pennsylvania law. See Quinby, 907 A.2d at 1071. Finding res ipsa loquitur here would require the Court to rely on even fewer facts than Plaintiff pled in support of his negligence claim by inferring the existence of negligence from an event that "is of a kind which ordinarily does not occur in the absence of negligence." REST. (SECOND) OF TORTS § 328D.
Plaintiff also fails to rule out "other responsible causes, including the conduct of the plaintiff and third persons" as potential causes of his alleged injuries. REST. (SECOND) OF TORTS § 328D(1)(b); see also REST. (SECOND) OF TORTS § 328D cmt. f (stating, "It is never enough for the plaintiff to prove that he was injured by the negligence of some person unidentified. It is still necessary to make the negligence point to the defendant"). "[T]he critical inquiry as to whether this subsection of § 328D is satisfied is whether a particular defendant is the responsible cause of the injury." Quinby, 907 A.2d at 1072-73 (citing Jones v. Harrisburg Polyclinic Hosp., 496 Pa. 465, 437 A.2d 1134, 1139 (1981); Gilbert, 327 A.2d at 101).
In his Complaint, Plaintiff claims that he "immediately suffered an infection ath [sic] operation site which required intensive anti biotic [sic] intervention." (Docket No. 1-3 at ¶ 4). Furthermore, after experiencing left hip pain for the year following his hip replacement surgery, Plaintiff avers, "Dr. Pressman informed
Furthermore, as this Court explained previously, the PMA process under which the Trident System was approved does not guarantee that a medical device will be free of risks. See Riegel, 552 U.S. at 318, 128 S.Ct. 999; Banner, 2010 WL 455286, at *4, 2010 U.S. Dist. LEXIS 9393, at *10. Medical devices, even Class III medical devices receiving rigorous premarket approval, inherently carry risks and the potential for harm to consumers, and negligence on behalf of the manufacturer is not necessarily the source of this harm. See Funk, 673 F.Supp.2d at 531-32 (holding that a medical device "could have failed for a variety of reasons and therefore its failure did not `speak for itself' and establish the defendants' negligence").
In support of his argument that all claims alleged in the Complaint are parallel claims, Plaintiff provides citations to authority from outside of the Third Circuit, as no courts within the Third Circuit have directly ruled on this point. (See Docket No. 10 at 7-8, 13-14). One such case, Hofts v. Howmedica Osteonics Corp., 597 F.Supp.2d 830 (S.D.Ind.2009), has received a varied treatment by other courts. See e.g. Lewkut, 724 F.Supp.2d at 658 n. 3 (stating, "Because the reasoning in Hofts
In Purcel v. Advanced Bionics Corp., No. 3:07-CV-1777-M, 2008 WL 3874713, 2008 U.S. Dist. LEXIS 62131 (N.D.Tex. Aug. 13, 2008), the plaintiffs successfully pled parallel claims but premised them on specific violations of the PMA process in addition to violations of CGMPs. Notably, in Purcel, the FDA had filed a prior suit against the defendant for these same alleged violations. Id. at *1-2, 2008 U.S. Dist. LEXIS 62131 at *4. No such facts are pled in the instant case, so the outcome in Purcel is distinguishable. (See Docket No. 1-3).
Additionally, a prescription drug rather than a device was at issue in another case cited by Plaintiff, Bolin v. SmithKline Beecham Corp., No. 08-60523-CIV-COHN, 2008 WL 3286973, 2008 U.S. Dist. LEXIS 60241 (S.D.Fla. Aug. 7, 2008). Express preemption under the MDA does not apply to prescription drugs. See Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187, 1196, 173 L.Ed.2d 51 (2009). Bolin, therefore, has no application to this case. (See Docket No. 1-3).
In support of his parallel claims argument, Plaintiff also quotes from Heisner, 2008 WL 2940811, at *12-13, 2008 U.S. Dist. LEXIS 60569, at *12-13, a case in which the defendant's Rule 12(b)(6) motion was granted for failing to properly allege parallel claims not preempted by the MDA. Stryker agrees with the dicta Plaintiff quoted from Heisner, 2008 WL 2940811, at *4-5, 2008 U.S. Dist. LEXIS 60569, at *12-13, which states, "Defendant's action or inaction in its efforts to take part in the PMA process or implement its results" serve as the basis for a parallel claim. (See Docket No. 11 at 9). This Court has discussed previously that Plaintiff failed to allege any violation of the PMA process by Stryker, and thus, the Court could not find that Plaintiff properly pled a parallel claim. Therefore, this quote from Heisner does not support Plaintiff's position.
In sum, this Court finds that Plaintiff has not adequately pled a parallel violation of federal law in his negligence and res ipsa loquitur state law claims at Count II. Plaintiff has even conceded that his res ipsa loquitur claim fails as a purported parallel claim. (Docket No. 16 at 6). This Court has already determined that Plaintiff's breach of implied warranty claim at Count III has been expressly preempted because it imposes requirements that are different, or in addition to, the applicable
Stryker next argues that Plaintiff's Complaint failed to state a claim for breach of express warranty, thus demanding its dismissal.
Under the Pennsylvania Commercial Code, "[a]ny affirmation of fact or promise made by the seller to the buyer which relates to the goods and becomes part of the basis of the bargain creates an express warranty that the goods shall conform to the affirmation or promise." 13 Pa.C.S. § 2313(a)(1). A promise becomes the basis of the bargain if the plaintiff can prove "that she read, heard, saw or knew of the advertisement containing the affirmation of facts or promise." Parkinson v. Guidant Corp., 315 F.Supp.2d 741, 752 (W.D.Pa.2004) (quoting Cipollone v. Liggett Group, Inc., 893 F.2d 541, 567 (3d Cir.1990), rev'd on other grounds, 505 U.S. 504, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992)). "[A]n express warranty must be `directed at consumers in order to induce purchases of the product.'" Sowers v. Johnson & Johnson Med., 867 F.Supp. 306, 314 (E.D.Pa.1994) (quoting Kenepp v. Am. Edwards Lab., 859 F.Supp. 809, 817 (E.D.Pa.1994)).
Plaintiff has not alleged any "affirmation of fact or promise" made by Stryker that relates to the Trident System that would amount to an express warranty. (See Docket No. 1-3). Additionally, Plaintiff has not pled any details regarding the content of any express warranty, how it was made, that it became the basis of the bargain, or that it was directed at Plaintiff. (See id.). Moreover, Plaintiff has not responded to Stryker's challenge to his breach of express warranty claim in any fashion. (See Docket No. 10; Docket No. 11 at 5).
Even construing Plaintiff's claim liberally, he has not set forth the elements of a breach of express warranty cause of action. (See id.). As was previously discussed, "only a complaint that states a plausible claim for relief survives a motion to dismiss." Iqbal, 129 S.Ct. at 1950 (emphasis added). Furthermore, "a plaintiff's 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." Twombly, 127 S.Ct. at 1964-65. Plaintiff's passing mention of a breach an express warranty, without factual allegations supporting this claim, demonstrates that the claim does not rise above the level of a mere "label" or "conclusion." Without any indication that an express warranty was made and without providing the content of any alleged warranty, it is impossible to find that an express warranty exists, let alone that a breach occurred.
Because Plaintiff has failed to state a plausible claim for breach of express warranty under Pennsylvania law and has not provided the court with any argument to the contrary, his claim for breach of express warranty at Count II is likewise dismissed, with prejudice.
Plaintiff's Complaint contains a request for punitive damages
In Plaintiff's Response brief, he asks the Court to convert Stryker's Motion to Dismiss into a motion for summary judgment and defer ruling on the motion until Plaintiff has obtained discovery. (Docket No. 10 at 14-16). Plaintiff seeks discovery on the PMA application and "other documents which are in the exclusive possession, custody, and control of Defendants Stryker that would provide definitive information on the approval process"; documents and depositions related to the testimony of Stryker's representatives who testified before the PMA panel; and information related to manufacturing processes utilized for the Trident acetabular cup and safety analyses conducted by Stryker in response to the FDA warnings. (Id. at 15-16).
No discovery is necessary here because, even after discovery, Plaintiff would still not be able to allege any viable claims against Stryker. In fact, numerous district courts across the country have dismissed very similar actions in their entirety at the motion to dismiss stage. See e.g., inter alia, Rhynes, 2011 WL 5117168, 2011 U.S. Dist. LEXIS 58286; Cornwell, 2010 WL 4641112, 2010 U.S. Dist. LEXIS 116824; Lewkut, 724 F.Supp.2d 648; Anthony, 2010 WL 1387790, 2010 U.S. Dist. LEXIS 31031. Additionally, in Delaney, 2009 WL 564243, at *3-4, 2009 U.S. Dist. LEXIS 16865, at *10, the court declined to grant the plaintiff an opportunity to obtain additional discovery "to determine if all or only part of the Trident [System] was subject to the PMA process," because the defendant "ha[d] sufficiently demonstrated" that the entire Trident System received premarket approval.
Additionally, Plaintiff has already accessed some information from the FDA regarding the Trident System, as evidenced by the direct reference Plaintiff makes to "FDA documents" in his Complaint. (See Docket No. 1-3 at ¶ 14). To obtain additional information from the FDA to aid in drafting his Complaint, Plaintiff could have submitted a Freedom of Information Act ("FOIA") request. See 5 U.S.C. § 552; see also FDA, Freedom of Information, available at http://www.fda. gov/RegulatoryInformation/foi/default.htm (last visited Feb. 26, 2012) (providing an overview of how FOIA requests are made to the FDA).
Finally, the Court finds Plaintiff's request for discovery to be inapposite to Rule 8 and Rule 11(b) of the Federal Rules of Civil Procedure. Rule 8, which requires a pleading to contain "a short and plain statement of the claim showing that the pleader is entitled to relief," "does not unlock the doors of discovery for a plaintiff armed with nothing more than conclusions." Iqbal, 129 S.Ct. at 1953; see also Timmons v. Linvatec Corp., 263 F.R.D. 582, 585 (C.D.Cal.2010) (stating, "[A] plaintiff who fails to meet the pleading requirements of Rule 8 is not entitled to conduct discovery with the hope that it might permit her to state a claim"). In addition, Rule 11(b) requires a pleading to be a representation of "the best of the person's knowledge, information, and belief, formed after an inquiry reasonable under the circumstances." FED. R. CIV. P. 11(b); see also Haniotakis v. Nassan, 727 F.Supp.2d 388, 411 (W.D.Pa.2010) (stating, "An attorney must conduct a reasonable inquiry before filing a lawsuit, and cannot pursue the action unless he or she reasonably believes that facts exist to support the allegations"). Allowing Plaintiff to "file first and investigate later," contradicts the reasonable inquiry requirement in Rule 11(b). See Timmons, 263 F.R.D. at 585; Kester, 2010 WL 2696467, at *7-8, 2010 U.S. Dist. LEXIS 59869, at *22-23; see also 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)).
Even though Plaintiff requests the opportunity to conduct discovery in this matter, this Court has already established that the Trident System is a Class III medical device receiving premarket approval in its entirety. Consequently, this Court declines to convert Stryker's Motion to Dismiss into a motion for summary judgment and will not defer its ruling until Plaintiff has obtained discovery.
As indicated, the Court has ruled that all of Plaintiff's claims and his request for punitive damages are dismissed, with prejudice.
Rule 15(a) of the Federal Rules of Civil Procedure dictates that "[a] party may amend its pleading once as a matter of course" if "the pleading is one to which a responsive pleading is required." The "grant or denial of an opportunity to amend is within the discretion of the District Court." Foman v. Davis, 371 U.S. 178, 182, 83 S.Ct. 227, 9 L.Ed.2d 222 (1962). "Among the grounds that justify a denial of leave to amend are undue delay, bad faith, dilatory motive, prejudice and futility." Shane v. Fauver, 213 F.3d 113, 115 (3d Cir.2000) (quoting In re Burlington Coat Factory Sec. Litig., 114 F.3d 1410, 1434 (3d Cir.1997)). Allowing an amendment would be futile if "the complaint, as amended, would fail to state a claim upon which relief could be granted." Shane, 213 F.3d at 115 (citing In re Burlington Coat Factory Sec. Litig., 114 F.3d at 1434). "In assessing `futility,' the District Court applies the same standard of legal sufficiency as applies under Rule 12(b)(6)." Shane, 213 F.3d at 115 (citing, inter alia, In re Burlington Coat Factory Sec. Litig., 114 F.3d at 1434).
In this Court's estimation, leave to amend is not required because any amendment of Plaintiff's Complaint would be futile. Plaintiff's strict liability claims against Stryker are not viable under Pennsylvania law. He has not set forth any facts supporting a breach of express warranty claim. Finally, his remaining claims are expressly preempted, do not meet the narrow exception of parallel claims, or are conceded. For these reasons, the Court declines to grant Plaintiff the opportunity to amend.
Based on the foregoing, Stryker's Motion to Dismiss is granted and Plaintiff's claims are dismissed, with prejudice. The Court dismisses with prejudice all of Plaintiff's claims: strict liability based on manufacturing defect and marketing defect theories (Count I), negligence and res ipsa loquitur (Count II), and breach of express and implied warranties (Count III), as well as Plaintiff's request for punitive damages. Finally, the Court declines to grant Plaintiff the opportunity to obtain discovery and amend his Complaint given the facts of this case and controlling authority. An appropriate Order follows.
21 C.F.R. 820.1(a)(1).
(Id.). These claims are premised on common law negligence standards, which are expressly preempted by the MDA. See Riegel v. Medtronic, Inc., 552 U.S. 312, 324-25, 327-28, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008); Williams v. Cyberonics, Inc., 388 Fed.Appx. 169, 171 (3d Cir.2010).
Angelo v. Diamontoni, 871 A.2d 1276, 1280-81 (Pa.Super.Ct.2005) (citing Columbia Med. Group, Inc. v. Herring & Roll, P.C., 829 A.2d 1184, 1192 (Pa.Super.Ct.2003)).
(emphasis added).
