The opinion of the court was delivered by: William M. Skretny Chief Judge United States District Court
Plaintiff Desabio commenced this action in New York State Supreme Court, County of Erie, on or about February 20, 2009, alleging claims for breach of express warranty, carelessness and negligence, and breach of implied warranty relating to an allegedly defective hip prosthesis he received. Defendants, the alleged manufacturers and sellers of the prosthesis, removed the action to this Court, and subsequently moved for partial dismissal and for a more definite statement. In response, Plaintiff amended his Complaint, asserting claims for negligent design and/or manufacture, breach of warranty, and res ipsa loquitur. (Docket No. 12.)
Now before the Court are Defendants' Motion to Dismiss the Amended Complaint in its entirety (Docket No. 10), and Plaintiff's Motion to Amend/Correct Amended Complaint (Docket No. 14). Plaintiff seeks to revise his negligence claim to allege a failure to comply with Food and Drug Administration ("FDA") standards in the manufacturing process. The motions are fully briefed,*fn1 and the Court finds that no oral argument is necessary. For the reasons discussed below, Plaintiff's motion is denied, and Defendants' motion is granted.
This case involves an artificial hip prosthesis, known as the TridentTM System,*fn2 which has been classified by the FDA as a Class III medical device. According to Plaintiff, after the Trident System was implanted, in or about April 12, 2005, the device squeaked and he "suffered severe grinding and pain." (Docket No. 12 ¶¶ 9, 12.) In his Amended Complaint, Plaintiff asserts claims for negligent design and/or manufacture, breach of warranty, and res ipsa loquitur.
Defendants urge that these common law claims must be dismissed because they are preempted by the Medical Device Amendments of 1976 ("MDA"), 21 U.S.C. § 360k, to the Federal Food, Drug and Cosmetics Act ("FDCA"), and also because Plaintiff has failed to adequately plead them.
In response, Plaintiff contends that his negligence and res ipsa loquitur claims implicitly assert violations of FDA standards, and that his breach of warranty claim survives as a "parallel claim." Alternatively, Plaintiff seeks leave to amend his negligence claim to specifically reference the FDA and thereby purportedly cure any pleading defect.
Defendants argue that Plaintiff has not presented any "parallel claim" and that his proposed second amended pleading is insufficient to salvage his negligence claim.
A. Applicable Standards of Review
Federal pleading standards are generally not stringent. Rule 8 requires only a short and plain statement of a claim. FED. R. CIV. P. 8(a)(2). But the plain statement must "possess enough heft to show that the pleader is entitled to relief." Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 557, 127 S. Ct. 1955, 167 L. Ed. 2d 929 (2007) (internal quotation marks omitted).
When determining whether a complaint states a claim, the court must construe it liberally, accept all factual allegations as true, and draw all reasonable inferences in the plaintiff's favor. ATSI Commc'ns, Inc. v. Shaar Fund, Ltd., 493 F.3d 87, 98 (2d Cir. 2007); Goldstein v. Pataki, 516 F.3d 50, 56 (2d Cir. 2008). Legal conclusions, however, are not afforded the same presumption of truthfulness. See Ashcroft v. Iqbal, __ U.S. __, 129 S.Ct. 1937, 1949, 173 L. Ed. 2d 868 (2009) ("the tenet that a court must accept as true all of the allegations contained in a complaint is inapplicable to legal conclusions").
"To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face.'" Iqbal, 129 S.Ct. at 1945 (quoting Twombly, 550 U.S. at 570). Labels, conclusions, or "a formulaic recitation of the elements of a cause of action will not do." Twombly, 550 U.S. at 555. Facial plausibility is present when the factual content of the complaint allows for a reasonable inference that the defendant is liable for the misconduct alleged. Iqbal, 129 S.Ct. at 1949. The plausibility standard is not, however, a probability requirement; the pleading must show, not merely allege, that the pleader is entitled to relief. Id. at 1950; FED. R. CIV. P. 8(a)(2). Well-pleaded allegations in the complaint must nudge the claim "across the line from conceivable to plausible." Twombly, 550 U.S. at 570.
A two-pronged approach is thus used to examine the sufficiency of a complaint. First, statements that are not entitled to the assumption of truth - such as conclusory allegations, labels, and legal conclusions - are identified and stripped away. See Iqbal, 129 S.Ct. at 1950. Second, well-pleaded, non-conclusory factual allegations are presumed true and ...