I. INTRODUCTION
In this аction, 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,
II. BACKGROUND
A. Factual Background
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 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 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
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.
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.,
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.
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,
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,
However, nothing in Twombly or Iqbal chаnged 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,
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.,
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,.,
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.,
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
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. аt 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 Plaintiffs 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 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,
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.
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.”
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.,
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,
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,
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.
Although many courts have held that negligence claims are expressly preempted as well, further analysis of Plaintiffs
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,
Before a Class III medical device enters the market, the device’s manufacturer must, obtain FDA approval. Medtronic, Inc. v. Lohr,
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,
The majority of Class III devices do not undergo this intensive PMA review. Rie
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,
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,
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,
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 dеvice, 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.
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.). Alsо, 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,
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.
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.,
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 thе 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.
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,
This Court is persuaded by this authority and finds that the Trident System, in its entirety, received premarket approval. See, inter alia, Cornwell,
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,
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,
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 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.
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.,
Therefore, it is evident that Pennsylvania state law imposes its own standards on the merchantability of goods. See Turney Media Fuel, Inc.,
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,
Plaintiffs 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 Plaintiffs 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 Plaintiffs 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)
3. Parallel Claims Based on Federal Requirements
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,
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.,
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,
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:
1. failing to ensure the quality policy is understood, implemented and maintained at all levels of the organization, 21 C.F.R. § 820.20(a);
2. failing to provide adequate resources, including trained personnel for management, performance of work and assessment activities, including internal quality audits necessary to comply with the federal regulations as required by 21 C.F.R. § 820.20(b)(2); and
3. failing to establish and maintain procedures to prevent [contamination] [sic] of equipment or product by substances that could reasonably be anticipated to have an adverse effect on product quality as required by 21 C.F.R. § 820.70(e).
(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,
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, Plaintiffs broad references to federal regulations are insufficient to establish the duty element of a negligence state lаw claim which would parallel a violation of federal law. See In re Medtronic,
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,
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.,
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,
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,
The United States Court of Appeals for the Seventh Circuit adopted a comparable approach in Bausch,
This Court finds the Bausch court’s rationale to be unpersuasive and declines to follow its holding. First, in Riegel,
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,
Similarly, Plaintiffs 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,
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,
Absent an illustration of Stryker’s precise duty to Plaintiff, Plaintiff cannot plead a cause of action for negligence under Pennsylvania law. See Althaus,
To the extent that Plaintiff relies on the same violations of federal regulations to establish res ipsa loquitur, it logically follows that Plaintiffs 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.,
(1) It may be infеrred that harm suffered by the plaintiff is caused by negligence of the defendant when
(a) the event is of a kind which ordinarily does not occur in the absence of negligence;
(b) other responsible causes, including the conduct of the plaintiff and third persons, are sufficiently eliminated by the evidence; and
(c) the indicated negligence is within the scope of the defendant’s duty to the plaintiff.
Rest. (Second) of Torts § 328D; see also Gilbert,
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,
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,
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 in
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,
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.,
In Purcel v. Advanced Bionics Corp., No. 3:07-CV-1777-M,
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,
In support of his parallel claims argument, Plaintiff also quotes from Heisner,
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 Plaintiffs 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
C. Breach of Express Warranty (Count III)
Stryker next argues that Plaintiffs 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.,
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 bаrgain, 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 Plaintiffs 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,
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.
D. Punitive Damages
Plaintiffs Complaint contains a request for punitive damages
E. Discovery
In Plaintiffs 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,
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/Regulatorylnformation/foi/default.htm (last visited Feb. 26, 2012) (providing an overview of how FOIA requests are made to the FDA).
Finally, the Court finds Plaintiffs 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,
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.
F. Leave to Amend
As indicated, the Court has ruled that all of Plaintiffs claims and his request for punitive damages are dismissed, with prej
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,
In this Court’s estimation, leave to amend is not required because any amendment of Plaintiffs Complaint would be futile. Plaintiffs 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.
V. CONCLUSION
Based on the foregoing, Stryker’s Motion to Dismiss is granted and Plaintiffs claims are dismissed, with prejudice. The Court dismisses with prejudice all of Plaintiffs 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 Plaintiffs 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.
Notes
. Two Defendants, Stryker Orthoppedics [sic], a division of Howmedica Osteonics Corporation, and Stryker Orthopedics, a division of Howmedica Osteonics Corporation, were never properly served with the Complaint. (See Docket No. 13). Plaintiff failed to respond to the Court's Amended Order to Show Cause as to why service was not effectuated on these Defendants within 120 days of the filing of the Complaint. (See Docket No. 14). Accordingly, Stryker Orthoppedics [sic] and Stryker Orthopedics are dismissed, without prejudice, pursuant to Fed. R. Civ. P. 4(m) for failure of Plaintiff to make service. (See id.).
. For further discussion of this issue, see section IV(A).
. In evaluating a Motion to Dismiss, this Court must accept the Plaintiffs allegations as true and construe them in favor of the Plaintiff. Phillips v. County of Allegheny,
. Arthoplasty is the "[c]reation of an artificial joint to correct advanced degenerative arthritis.” Stedman's Medical Dictionary 161 (28th ed.2000). It "restorefs] as far as possible the integrity and functional power of a joint.” Id.
. Acetabular refers to the acetabulum, which is “[a] cup-shaped depression on the external surface of the hip bone, with which the head of the femur articulates.” Stedman's Medical Dictionary 11 (28th ed.2000).
. The premarket approval process is described in section (IV)(C)(1).
. Approval of medical devices through the § 510(k) process is described in section (IV)(C)(1).
. Title 21, C.F.R., Part 820 contains the Current Good Manufacturing Practice ("CGMP”) requirements for Quality System regulation. These requirements:
govern the methods used in, and the facilities and controls used for, the design manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act). This part establishes basic requirements applicable to manufacturers of finished medical devices. If a manufacturerengages in only some operations subject to the requirements in this part, and not in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged.
21 C.F.R. 820.1(a)(1).
. According to the FDA's official website, an FDA Form 483 is "issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement [sic] may constitute violations of the Food Drug and Cosmetic Act and related Acts.” FDA, Inspections, Compliance, Enforcement, and Criminal Investigations: FDA Form 483 Frequently Asked Questions, http://www.fda.gov/ICECI/Enforcement Actions/ucm256377.htm (last visited Jan. 6, 2011). A Form FDA 483 is not "a final Agency determination of whether any condition is in violation of the [Food Drug & Cosmetic Act] or any of its relevant regulations.” Id.
. Plaintiff cites to "Exhibit B” (Docket No. 1-3 at 31-33) in support of the contention that his own Trident System prosthesis was included in the June 18, 2008 recall. Exhibit B is an exhaustive list of serial numbers for various Trident System components. (See id.). At the bottom of Exhibit B is the Internet address, http://www.fda.gov/Safety/ Recalls/EnforcementReports/2008/ucm 120511.htm, which links to a page on the FDA's official website, entitled "Enforcement Report for June 18, 2008.” Plaintiff did not highlight or circle the serial numbers of his own Trident System prosthesis on this list. (See Docket No. 1-3 at 31-33). Upon the Court's review of Exhibit B, the pertinent serial numbers, 508-11-64G and 690-10-28H, could not be found. (See id.).
. "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.” Haniotakis v. Nassan,
. Plaintiff has not submitted any medical records or reports in support of this allegation.
. The Supreme Court described in Riegel v. Medtronic, Inc.,
. In its Notice of Removal, Defendant Stryker indicates that it was named twice in the Caption, albeit with different spellings. (Docket No. 1 at ¶ 1 n. 1).
. Plaintiff failed to effectuate service on Defendants Stryker Orthoppedics [sic], a division of Howmedica Osteonics Corporation, and Stryker Orthopedics, a division of Howmedica Osteonics Corporation, within 120 days of filing his Complaint. (See Docket Nos. 13-14). As discussed in more detail,
. Erica Visokey identifies herself as Counsel for Stryker Legal. (See Docket No. 8-1 at ¶ 1).
. See Practices and Procedures of Judge Nora Barry Fischer, § II.A, available at: http:// www.pawd.uscourts.gov/Documents/Judge/ fischer_pp.pdf (effective March 23, 2010).
. Counsel have a duty of candor to the Court pursuant to Rule 3.3 of the Pennsylvania Rules of Professional Conduct. Pa. Rules of Prof’l Conduct r. 3.3 (2012). This duty of candor requires counsel to "recognize the existence of pertinent legal authorities,” which includes advising the Court of changes in law. See id. at cmt. 4.
. “[0]nce a case has been removed to federal court, it is settled that federal rather than state law governs the future course of proceedings, notwithstanding state court orders issued prior to removal.” Granny Goose Foods, Inc. v. Brotherhood of Teamsters & Auto Truck Drivers,
. Plaintiff's breach of express warranty and breach of implied warranty claims at Count III will be discussed separately because of the vastly different manner in which each claim is pled. (See Docket No. 1-3 at 17-18).
. Many plaintiffs with medical device liability claims arising from the installation of the Trident System hip prosthesis have named Stryker Corporation as the defendant. See e.g. Rhynes v. Stryker Corp., No. 10-5619 SC,
. Stryker maintains in its latest brief that Plaintiff did not respond to the facts set forth by Ms. Visokey. (Docket No. 17 at 5). However, in his Response brief, Plaintiff requests the Court to convert Stryker’s Motion to Dismiss into a motion for summary judgment. (Docket No. 10 at 14-16). Plaintiff argues that Stryker "request[s] the court to consider matters outside the pleadings,” which is impermissible at the motion to dismiss stage. (Id. at 14). No "matters outside the pleadings” will be considered in resolving this Motion, except for matters that the Court may take judicial notice of at this stage. See Lum v. Bank of Am.,
. Stryker alternatively argues that Plaintiff's strict liability claims are subject to dismissal based on express preemption grounds under 21 U.S.C. § 360k of the Medical Device Amendments of 1976. (See Docket No. 8 at 20-21). Because these claims can be dismissed by virtue of their inability to survive under Pennsylvania law, the Court declines to undertake the alternative analysis of this claim.
. For § 402A to apply, the seller must be “[ (a) ] engaged in the business of selling such a product, and (b) [the product] is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.” Restatement (Second) of Torts § 402A(1). This rule applies even though "(a) the seller has exercised all possible care in the preparation and sale of his product, and (b) the user or consumer has not bought the product from or entered into any contractual relation with the seller.” Id. at § 402A(2).
. Further discussion of the FDA approval process can be found in section IV(C)(2)(a).
. A matter of public record may be considered by the court when adjudicating a motion to dismiss. See Lum v. Bank of Am.,
. Even though Stryker raises the argument that all of Plaintiff’s claims are expressly preempted, analysis of Plaintiff’s claims for strict liability (Count 1) and breach of express warranty (Count III) within this context is unnecessary. This Court has already disposed of Plaintiff's strict liability claims in section IV(B) and will, in turn, dispose of the breach of express warranty claim in section IV(D).
. This Court must judge the Complaint based on allegations in same and not on new allegations that are alleged in a party's brief or at oral argument. See Jordan v. Fox, Rothschild, O'Brien & Frankel,
. Without additional details provided by the Plaintiff, it is unclear whether this testimony is a matter of public record. (See Docket No. 10 at 12).
. Plaintiff could have made a Freedom of Information Act (“FOIA”) request to obtain this information from the FDA. For further discussion of the FOIA, see section IV(E).
. Stryker also provides the Court with citations to two bench opinions and attaches copies of these opinions to its moving brief. (See Docket No. 8 at 18; Docket No. 8-2; Docket No. 8-3). They are: Van Dyke v. Howmedica Osteonics Corp., No. 09-cv-78-BU-SHE (D.Mont. Apr. 23, 2010) (Haddon, J.) (Docket No. 8-2); Hayes v. Howmedica Ostenoics Corp., No. 08-cv-6104,
. See section IV(C)(2)(a) infra.
. Stryker asserts that all of Plaintiffs claims are expressly preempted by the MDA. (See Docket No. 8 at 20-21). This Court limits her discussion in this section to Plaintiff's claims for negligence and res ipsa loquitur (Count II) and breach of implied warranty (Count III).
. Alternatively, Plaintiffs breach of implied warranty claim can be dismissed because Pennsylvania law does not recognize these claims for medical devices. See Horsmon v. Zimmer Holdings, Inc., No. 11-1050,
. The other subparagraphs to paragraph 2 in Plaintiff’s claim for negligence assert breaches of Plaintiff’s alleged duty to Stiyker but. do not reference violations of federal regulations. (See Docket No. 1-3 at 16). Plaintiff claims that Stryker was negligent in:
(b) placing the Trident acetabular cup into the stream of commerce when it contained unsafe manufacturing residuals and/or bacteria;
(c) placing a hip prosthesis into the stream of commerce that was not sterile;
(d) manufacturing a hip prosthesis that was not sterile;
(e) failing to warn consumers in general, and Plaintiff or her [sic] physicians specifically, of the risk that the hip prostheses could become loose because it contained manufacturing residuals that impeded boney ingrowth.
(Id.). These claims are premised on common law negligence standards, which are expressly preempted by the MDA. See Riegel v. Medtronic, Inc.,
. As previously explained, CGMP regulations “govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices inlended for human use.” 21 C.F.R. § 820.1(a)(1). They exist "to ensure that finished devices will be safe and effective and otherwise in compliance with the [FDCA].” Id.
. This Internet address redirects to FDA, Device Advice: Comprehensive Regulatory Assistance, http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/defatdt.htm (last visited Feb. 26, 2012).
. The Court also notes that the plaintiff in Bass pled his injury with more рrecision than the Plaintiff in the instant matter. In Bass, the plaintiff alleged, “On or about July 29, 2009, due to continued severe left him pain, Plaintiff underwent a revision of his left total hip replacement. During the procedure, the surgeon confirmed that the acetabular component had failed in that it was grossly loose. Plaintiff’s failed Stryker Trident PSL Shell was revised.” (Bass First Amended Complaint at No. 09-cv-00632-Y, Docket No. 13 at ¶ 26). In the instant matter, however, the Plaintiff avers, “On October, 2008, the Plaintiff underwent a subsequent operation for revision surgery where it was discovered that the liner had fractured and needed to be removed and changed.” (Docket No. 1-3 at ¶ 8). To the extent the Bass court held that the plaintiff pled “allegations connecting a defect in the manufacture of the specific device to that plaintiff's specific injury,” the instant matter is distinguishable. See Bass v. Stryker Corp.,
. Because res ipsa loquitur is a rule of evidence, " ‘[i]t does not have to be pleaded in the complaint or noticed by specific designation to the adverse party as a pre-trial or at a trial, since it is neither a cause of action nor a ground for recovery, nor an issue.’ ” Hollywood Shop, Inc. v. Pa. Gas & Water Co.,
. The Summary of Safety and Effectiveness Data for the Trident System warns of the possibility of infection as an adverse effect of Trident System implantation. See FDA, Summary of Safety and Effectiveness Data, available at http://www.accessdata.fda.gov/cdrh_ docs/pdFPOOOO 13b.pdf (last visitéd Feb. 26, 2012). Moreover, the Summary lists infection as a contraindication, id., meaning "a specific situation in which a drug, procedure, or surgery should NOT be used, because it may be harmful to the patient,” MedlinePlus, Contraindications, available at http://www. nlm.nih.gov/medlineplus/ency/article/002314. htm (last visited Feb. 26, 2012).
. Under Pennsylvania law:
Contributory negligence is conduct on the part of a plaintiff which falls below the standard [of care] to which he should conform for his own protection and which is a legally contributing cause, cooperating with the negligence of the defendant, in bringing about the plaintiffs harm. Contributory fault may stem either from a plaintiff’s carelеss exposure of himself to danger or from his failure to exercise reasonable diligence for his own protection.
Angelo v. Diamontoni,
. In his responding brief to Stryker’s Motion to Dismiss, Plaintiff states, "Despite following all of his surgeon’s instructions after his surgery including rehabilitative programs, Plaintiff began to experience a site infection in the left him at the site of the operation which required hospitalization.” (Docket No. 10 at 4). Plaintiff did not plead these facts in his Complaint and mentions them for the first time in his responding brief. (See Docket No. 1-3; Docket No. 10 at 4). Again, this Court must judge the Complaint based on allegations in same and not on new allegations that are alleged in a party’s brief or at oral argument. See Jordan v. Fox, Rothschild, O’Brien & Frankel,
. The Court notes that Stryker offers an alternative argument for the dismissal of Plaintiff’s breach of express warranty claim based on express preemption grounds under 21 U.S.C. § 360k of the Medical Device Amendments of 1976. (See Docket No. 8 at 22-24). Because the claim for breach of express warranty can be dismissed on the basis of its inadequate pleading, analysis of this claim in the context of the alternative argument is unnecessary.
. It is unlikely that Stryker made an express warranty that induced Plaintiff to select the Trident System hip prosthesis for his hip replacement procedure. Rather, Plaintiff's orthopedic surgeon read or should have read any warranties on the Trident System's labels or package inserts when selecting and prescribing this prosthesis to Plaintiff. Under Pennsylvania’s "learned intermediary doctrine,” a prescription drug or prescription medical device manufacturer has a duty “to exercise reasonable care to inform the one for whose use the product is supplied of the facts which make the product is supplied of the facts which make the product likely to be dangerous.” Rosci v. AcroMed, Inc.,
. Pennsylvania has adopted Restatement (Second) of Torts § 908 and the accompanying comments regarding punitive damages. See Martin v. Johns-Manville Corp.,
. To the extent that Plaintiff alleges fraud, he "must state with particularity the circumstances constituting fraud” in accordance with Fed. R. Civ. P. 9(b). Plaintiff fails to do so in his Complaint. (See Docket No. 1-3).
. Plaintiff’s attorney could have also called the phone number listed on the FDA’s official website to inquire about obtaining the information that he sought. See FDA, U.S. Food and Drug Administration, available at http:// www.fda.gov/default.htm (last accessed Jan. 30, 2012).
. Pa. R. Civ. P. 4001(c) provides:
Subject to the provisions of this chapter, any party may take the testimony of any person, including a party, by deposition upon oral examination or written interrogatories for the purpose of discovery, or for preparation of pleadings, or for preparation or trial of a case, or for use at a hearing upon petition, motion or rule, or for any combination of the foregoing purposes.
(emphasis added).