Gross v. Stryker Corp.

• Decision Date: 14 March 2012
• Docket Number: Civil No. 11–1229.
• Parties: Donald GROSS, Plaintiff, v. STRYKER CORPORATION t/a/d/b/a Stryker Howmedica Osteonics; Stryker Orthoppedics, a Division of Howmedica Osteonics Corporation; and Stryker Orthopedics, a Division of Howmedica Osteonics Corporation, Defendants.
• Court: U.S. District Court — Western District of Pennsylvania

858 F.Supp.2d 466

Donald GROSS, Plaintiff,

v.STRYKER CORPORATION t/a/d/b/a Stryker Howmedica Osteonics; Stryker Orthoppedics, a Division of Howmedica Osteonics Corporation; and Stryker Orthopedics, a Division of Howmedica Osteonics Corporation, Defendants.

Civil No. 11–1229.

United States District Court,

W.D. Pennsylvania.

March 14, 2012.

Thomas E. Fitzgerald, Pittsburgh, PA, for Plaintiff.

Constantine J. Passodelis, Jason A. Rosenberger, JonesPassodelis PLLC, Pittsburgh, PA, for Defendants.

MEMORANDUM OPINION

NORA BARRY FISCHER, District Judge.

I. INTRODUCTION

In this action, Plaintiff Donald Gross (“Plaintiff”) brings multiple medical device liability claims against Defendants Stryker Corporation t/a/d/b/a Stryker Howmedica Osteonics (“Stryker”); Stryker Orthoppedics [sic], a division of Howmedica Osteonics Corporation; and Stryker Orthopedics, a division of Howmedica Osteonics Corporation,¹ whereby he seeks to recover damages, including punitive damages, arising from the surgical implantation of an artificial hip prosthesis known as the Trident System. ( See Docket No. 1–3). Plaintiff alleges that due to a defect present in a component of the Trident System prosthesis he received, he suffered an infection at the operation site, experienced severe left hip pain, and required a revision procedure to replace the defective device. ( See id. at ¶¶ 4–8, ¶ 23). He brings claims sounding in strict liability based on manufacturing defect and marketing defect theories (Count I), negligence and res ipsa loquitur (Count II), as well as breach of express and implied warranties (Count III). ( See id. at 13–18). Stryker moves to dismiss the Complaint under Rule 12(b)(6) on the grounds that it is not a proper party to this litigation ² and Plaintiff's claims are all expressly preempted by the Medical Device Amendments of 1976 (“MDA”), 21 U.S.C. § 360k, to the Federal Food, Drug and Cosmetics Act (“FDCA”). ( See Docket No. 8). Alternatively, Stryker argues that Plaintiff failed to adequately plead cognizable parallel claims and that Plaintiff's purported strict liability and breach of express warranty claims fail to state claims upon which relief can be granted. ( See id.). Upon consideration of all the parties' submissions and for the reasons outlined herein, Stryker's Motion to Dismiss under Rule 12(b)(6) is granted and all of Plaintiff's claims against Stryker are dismissed, with prejudice.

II. BACKGROUNDA. Factual Background³

On October 20, 2007, Plaintiff underwent a left hip arthroplasty⁴ performed by Dr. Ari Pressman, M.D., at Mercy Hospital in Pittsburgh, PA. (Docket No. 1–3 at ¶ 3). Plaintiff's left hip was replaced with an artificial hip prosthesis called the Trident System, which Stryker allegedly designed, manufactured, and marketed. ( Id.). The Trident System is comprised of a ceramic-on-ceramic acetabular ⁵ bearing couple. ( Id. at ¶ 11). This ceramic-on-ceramic acetabular bearing couple is itself made up of (1) an alumina ceramic insert (alternatively, “socket liner”) and (2) an alumina ceramic femoral head (alternatively, “ball”). ( Id.). The Trident System is used with a metal acetabular shell (alternatively, “metal acetabular cup” or “socket”) and a metal femoral stem (alternatively, “hip stem”). ( Id.). Plaintiff's suit focuses on the allegedly defective metal acetabular cup component of the Trident System. ( Id. at ¶¶ 6–7, ¶ 23).

After his hip replacement surgery, Plaintiff claims that he experienced an infection at the operation site and needed antibiotic intervention. ( Id. at ¶ 4). Plaintiff suffered left hip pain for approximately one year after surgery, which he contends “incrementally increas[ed]” until about October 2008, when an X-ray revealed a dislocation of 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 ⁶ on approximately February 3, 2003. ( Id. at ¶ 12). Prior to receiving approval through the PMA process for the entire prosthesis, individual components of the Trident System were approved by the FDA pursuant to either the PMA or the § 510(k) processes.⁷ ( Id. at ¶¶ 12–15). Notably, earlier generations of the Trident acetabular shell received FDA approval pursuant to the § 510(k) process on December 11, 1998, August 4, 2000, and December 5, 2001. ( Id. at ¶ 13).

On November 28, 2007, the FDA issued a warning letter to Stryker after inspecting its Mahwah, New Jersey facilities in June and July of 2007. ( Id. at ¶¶ 19, 25–30). According to the warning letter that Plaintiff attached to his Complaint, the FDA investigation revealed that the Trident System devices were “adulterated,” meaning “that the methods used in, or the facilities or controls used for their manufacture, packing, storage, or installation [were] not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of General Regulations (C.F.R.), Part 820.” ⁸ ( Id.at 25). Prior to receiving this warning letter, Stryker received a Form FDA 483,⁹ List of Inspectional Observations, identifying problems related to the production of the Trident System. ( Id. at ¶ 19).

On June 12, 2008, Stryker allegedly recalled certain Trident metal acetabular shells that were manufactured at its Mahwah, New Jersey facilities between January 2000 and December 2007. ( Id. at ¶ 20). Plaintiff claims that his hip prosthesis bearing the serial numbers of 508–11–64G and 690–10–28H ¹⁰ was included in this recall. ( Id. at ¶ 23). The recall occurred after an investigation revealed the presence of excessive bioburden and viable microorganisms in the devices' final rinse tank, thereby contaminating the devices and leaving behind impermissible, excessive manufacturing residuals. ( Id. at ¶ 20).

In describing these residues, Plaintiff states that they are not an acceptable part of the manufacturing process for any hip device and are ostensibly direct evidence of an adulterated device. ( Id.). Plaintiff notes in his Complaint that he has not yet determined ¹¹ whether the residues on the hip prosthesis were foreign bodies or native material from the manufacturing process. ( Id.). Despite this uncertainty, Plaintiff alleges that orthopedic surgeons have expressed the opinion that when such residues remain on the back of the acetabular cup, “boney ingrowth” is inhibited and the cup is not held securely into the socket. ( Id. at ¶ 23). ¹² Plaintiff further avers that when his own hip prosthesis was removed, the back of his Trident metal acetabular cup had fractured, which caused the cup to loosen thereby necessitating the revision surgery. ( Id.). Plaintiff also claims that by recalling the Trident acetabular devices, Stryker admitted the cup was manufactured in a way that violated certain federal regulations and requirements. ( Id.).¹³

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 t/a/d/b/a Stryker Howmedica Osteonics, Stryker Orthoppedics [sic], and Stryker Orthopedics.¹⁴ ( See Docket No. 1 at ¶ 1). Stryker Corporation appeared. ( See id.). Stryker Corporation is a Michigan corporation with a principal place of business in Kalamazoo, Michigan. (Docket No. 1–3 at ¶ 2; Docket No. 8–1 at ¶ 1). As the Court has noted, Plaintiff undertook no discovery in aid of filing the Complaint. Instead, on July 26, 2011, Stryker served a Praecipe of Rule to File Complaint on Plaintiff, and on August 27, 2011, Stryker was served with the Complaint. ( See Docket No. 1–2.). Stryker has admitted that Howmedica Osteonics Corporation is a wholly-owned subsidiary of Stryker Corporation. (Docket No. 1 at ¶ 4 n. 2). Yet, Stryker maintains Howmedica Osteonics Corporation was never served with a copy of the Complaint.¹⁵ (Docket No. 1 at ¶ 4 n. 2; Docket No. 8 at 15 n. 3).

Plaintiff asserts claims sounding in strict liability for manufacturing and marketing defects (Count I), negligence and res ipsa loquitur (Count II), as well as breach of express and implied warranties (Count III). (Docket No. 1–3 at 13–18). Plaintiff also seeks punitive damages due to Stryker's alleged gross negligence or, alternatively, Stryker's “fraud, oppression, and malice.” ( Id. at 19–22).

On September 26, 2011, Stryker filed a petition for removal from state court, premised on diversity jurisdiction. ( See Docket No. 1 at 1, ¶¶ 4–7). A week later, Stryker filed a Motion to Dismiss for failure to state a claim under Rule 12(b)(6) and an accompanying brief in support. ( See Docket Nos. 7–8). At Exhibit A to Stryker's brief in support, Stryker filed a Certification by Erica Visokey,¹⁶ in which she states, “Stryker Corporation does not design, manufacture, assemble, equip, test, inspect, service, maintain, repair, advertise, market or sell the Trident0 Ceramic on Ceramic Acetabular System or any of its components.” ( See Docket No. 8–1 at ¶ 3). Plaintiff filed a Response (Docket No. 10), and Stryker replied to said Response (Docket No. 11). Plaintiff did not file a surreply nor seek to do so by way of a motion for leave, despite Stryker's preliminary statement that Plaintiff did not address all of Stryker's arguments. ( See Docket No. 11 at 5). Nor has either party requested...