United States District Court, E.D. Pennsylvania
MARY A. McLAUGHLIN, District Judge.
This action arises from the malfunction of the plaintiff's penile inflatable implant,  a Titan OTR Inflatable Penile Implant ("Titan implant"), which is manufactured by the defendant. The plaintiff, John Starks, sued the defendant, Coloplast Corp., for negligence, strict products liability, breach of warranties, and breach of contract. The Court considers here a motion to dismiss by Coloplast pursuant to Federal Rule of Civil Procedure 12(b)(6). For the reasons that follow, the Court will grant Coloplast's motion, dismiss the negligence, strict liability, and breach of implied warranty claims with prejudice, and dismiss the breach of express warranty and breach of contract claims without prejudice.
A. Premarket Approval of the Titan Implant
The Court relies on the publicly available U.S. Food and Drug Administration ("FDA") documents attached to Coloplast's motion to dismiss on the issue of the premarket approval of the Titan implant.
The Titan implant, which was originally called the Mentor Alpha I Inflatable Penile Prosthesis, received premarket approval from the FDA on July 14, 2000. The original premarket approval application for the implant was submitted by Mentor Corporation. Def.'s Mot., Ex. 1.
Since 2000, both Mentor and Coloplast have submitted several supplements to the original premarket approval, all of which have been approved by the FDA. On June 14, 2002, the FDA approved a supplemental premarket approval application that allowed the Titan implant to incorporate a hydrophilic coating. Def.'s Mot., Ex. 5. On January 14, 2003, the FDA approved another supplemental premarket approval application that allowed further hydrophilic coating of the implant and marketing of the device under a different name-the "Mentor Titan Inflatable Penile Prosthesis." Def.'s Mot., Ex. 6. Lastly, on June 13, 2008, the FDA approved a supplemental premarket approval application submitted by Coloplast that allowed several modifications to the device, as well as marketing of the device under the trade name "Titan OTR Inflatable Penile Prosthesis." Def.'s Mot., Ex. 7.
B. Starks's Titan Implant
Starks was admitted to Hahnemann University Hospital in Philadelphia on or about March 15, 2010. Starks's urologist, Bruce Garber, MD, surgically implanted the Titan implant into Starks's penis at that time. Compl. ¶ 3.
On or about January 25, 2012, Starks's Titan implant stopped working, leaked, and "otherwise would not operate." Id . ¶ 6. Dr. Garber reported that the Coloplast penile implant "malfunctioned due to a fluid leak." Id . ¶ 7.
Starks underwent another surgery on March 20, 2012, at Lankenau Medical Center to remove the Titan implant and have another penile device implanted. Id . ¶ 8. Surgeon Max Ahn, MD, examined the implant and described the malfunction as a result of "a break in the tubing of the right corporal cylinder." Id . ¶ 9.
As a result of the malfunction in his Titan implant, Starks was forced to undergo additional surgery to remove the implant and have a new one implanted and is now subject to the related medical bills. He also suffered from post-surgical pain, additional scar tissue, other pain and suffering, loss of the pleasures of life, including his sexual life, embarrassment and humiliation, and impairments of his bodily functions. Id . ¶ 10.
C. Procedural History
Starks initially filed this action in the Court of Common Pleas of Philadelphia County on May 31, 2013. Coloplast was served with the complaint on June 4, 2013, and Coloplast timely removed the case to the Eastern District of Pennsylvania on July 2, 2013.
Coloplast filed its motion to dismiss on July 23, 2013, and briefing on that motion was completed with Coloplast's reply brief, filed on August 13, 2013.
II. Legal Standard
A motion to dismiss filed pursuant to Federal Rule of Civil Procedure 12(b)(6) tests the sufficiency of the complaint. Conley v. Gibson , 355 U.S. 41, 45 (1957), abrogated in other respects by Bell Atl. Corp. v. Twombly , 550 U.S. 544 (2007). A claim may be dismissed under Rule 12(b)(6) for "failure to state a claim upon which relief can be granted."
Generally, in ruling on a motion to dismiss, the court relies on the complaint, attached exhibits, and matters of public record. Pension Benefit Guar. Corp., 998 F.2d at 196. FDA reports published on the FDA website are public records that the court may judicially notice. McGehean, 2009 WL 3172763, at *2.
Although Rule 8 of the Federal Rules of Civil Procedure requires only that the complaint contain "a short and plain statement of the claim showing that the pleader is entitled to relief" to "give the defendant fair notice of what the... claim is and the grounds upon which it rests, " the plaintiff must provide "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 (quoting Fed.R.Civ.P. 8(a)(2) and Conley , 355 U.S. at 47). Similarly, naked assertions ...