SCHMEHL, District Judge.
Before the Court is the motion to dismiss of Defendants, Synthes USA Products, LLC, Synthes Spine Company, LP, Synthes Spine, Inc., Synthes USA HQ, Inc., and Synthes North America, Inc. ("Defendants"). Plaintiffs, James P. Wilson and Jacquelyn H. Wilson ("Plaintiffs") have opposed the motion, and Defendants have filed a reply and a "Notice of Supplemental Authority." Further, Plaintiffs have filed their own "Notice of Supplemental Authority." Having read the parties' briefing, I will grant Defendants' motion to dismiss in part and deny it in part.
Plaintiffs filed this products liability action against Defendants in the Philadelphia County Court of Common Pleas on March 14, 2014, and on August 14, 2014, Defendants removed the matter to this Court. Thereafter, Defendants filed a Motion to Dismiss, claiming Plaintiffs' Complaint does not set forth a plausible cause of action against Defendants and therefore, should be dismissed. Specifically, Plaintiffs' Complaint asserts four claims against Defendants: 1) strict liability; 2) negligence; 3) negligence per se; and 4) loss of consortium. (See Compl.)
On March 16, 2010, James Wilson's doctor implanted two N-Hance spinal fixation rods manufactured by Defendants in an attempt to repair Mr. Wilson's back injuries.
To survive a motion to dismiss under Rule 12(b)(6), a plaintiff must allege facts that "`raise a right to relief above the speculative level.'" Victaulic Co. v. Tieman, 499 F.3d 227, 234 (3d Cir.2007) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007.)) In determining whether a complaint is sufficient, the court must accept all factual allegations as true, construe the complaint in the light most favorable to the plaintiff, and determine whether, under any reasonable reading, the plaintiff may be entitled to relief. Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir.2009) (citing Phillips v. County of Allegheny, 515 F.3d 224, 233 (3d Cir. 2008)).
Although "conclusory" or "bare-bones allegations" will not survive a motion to dismiss, Fowler, 578 F.3d at 210, a complaint may not be dismissed merely because it appears unlikely that the plaintiff can prove those facts or will ultimately prevail on the merits. Phillips, 515 F.3d at 231. Nonetheless, to survive a Rule 12(b)(6) motion, the complaint must provide "enough facts to raise a reasonable expectation that discovery will reveal evidence of the necessary element." Id. at 234 (quoting Twombly, 550 U.S. at 556, 127 S.Ct. 1955) (internal quotations omitted).
Defendants move to dismiss Plaintiffs' claims due to allegedly insufficiently pled manufacturing defect claims and negligence claims. Defendants also argue that Plaintiffs' strict liability claims should be dismissed, claiming that Pennsylvania law bars the application of strict liability to an allegedly defective medical device. Defendants also argue that Pennsylvania law does not recognize a negligent marketing claim. For the reasons that follow, I will dismiss Plaintiffs' strict liability and negligent marketing claims. The remainder of Plaintiffs' claims will be permitted to remain.
Defendants claim that Plaintiffs' strict liability claims must be dismissed because Pennsylvania law does not recognize a strict liability cause of action against the manufacturer of a medical device, such as the N-Hance rods used on Mr. Wilson. (Def's Mtn, p. 3.) Defendants argue that "[p]roduct liability claims against a medical device company, under Pennsylvania law, can only be brought under a theory of negligence, not strict liability." (Id.) Defendants contend that the Pennsylvania Supreme Court has held that prescription drugs are "unavoidably unsafe" and are therefore excluded from strict liability claims under Comment k to the Restatement (Second) of Torts § 402A (Hahn v. Richter, 543 Pa.558, 673 A.2d 888, 891 (1996)), and that this reasoning has been consistently applied by Pennsylvania state and federal courts to medical device cases, leading to a finding that plaintiffs may not assert strict liability claims against medical device manufacturers. (Defs' Mtn, p. 4.)
Comment k of the Restatement (Second) of Torts, § 402A states:
Restatement (Second) of Torts, § 402A, comment k. Pennsylvania has adopted comment k of the Restatement (Second) § 402A to exempt prescription drugs from the imposition of strict liability on manufacturers selling these drugs. Hahn v. Richter, 543 Pa. 558, 673 A.2d 888, 889-90 (1996); Soufflas v. Zimmer, Inc., 474 F.Supp.2d 737, 749 (E.D.Pa.2007) (Robreno, J.) (internal quotation omitted). Although the Pennsylvania Supreme Court has not yet addressed whether comment k extends to prescription medical devices, the Pennsylvania Superior Court has held that there is "no reason why the same rational[e] applicable to prescription drugs may not be applied to medical devices." Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa.Super.2006). Further, numerous federal courts have applied the Superior Court's reasoning in Hahn to medical device cases, finding that plaintiffs may not assert strict liability claims against manufacturers of medical devices. Horsmon v. Zimmer Holdings, Inc., 2011 WL 5509420 (W.D.Pa. Nov. 10, 2011); Soufflas v. Zimmer, Inc., 474 F.Supp.2d at 749-750; Parkinson v. Guidant Corp., 315 F.Supp.2d 741, 747 (W.D.Pa.2004); Kester v. Zimmer Holdings, Inc., No. 10-523, 2010 WL 2696467, at *9 (W.D.Pa., June 16, 2010) (McVerry, J.); Geesey v. Stryker Corp., 2010 WL 3069630 (E.D.Pa. Aug. 4, 2010) (Slomsky, J.); Runner v. C.R. Bard, et al., No. 14-5259, 108 F.Supp.3d 261, 2015 WL 3513424 (E.D.Pa. June 3, 2015) (Dalzell, J.). But see Bergstresser v. Bristol-Myers Squibb Co., No. 12-1464, 2013 WL 1760525, *3 (M.D.Pa. Apr. 24, 2013) (allowing a strict liability claim based upon an alleged manufacturing defect in a prescription drug to proceed); Doughtery v. C.R. Bard, Inc., 2012 WL 2940727 at *2 (E.D.Pa. July 18, 2010) (finding that strict liability claims involving a manufacturing defect in prescription drug and device cases are not clearly barred in Pennsylvania); Tatum v. Takeda Pharmaceuticals North America, Inc., No. 12-1114, 2012 WL 5182895, *2 (E.D.Pa. Oct. 19, 2012) ("concluding that strict liability claims for manufacturing defects in a prescription drug are not prohibited"); Killen v. Stryker Corp., No. 11-1508, 2012 WL 4498865, *4 (W.D.Pa. Sept. 28, 2012) (denying a motion to dismiss the plaintiff's strict liability claim for a manufacturing defect in a medical device case); Kline v. Zimmer Holdings, No. 13-513, 2013 WL 3279797 (W.D.Pa. June 27, 2013) (permitting a strict liability manufacturing defect claim to proceed against a medical device manufacturer).
Defendants rely on Terrell v. Davol, No. 13-5074, 2014 WL 3746532 (E.D.Pa. July 30, 2014), a recent case in which Judge Slomsky acknowledged that there is a split among federal courts regarding the application of strict liability in medical device cases and that some courts have allowed strict liability manufacturing defect claims only to proceed. Terrell v. Davol, 2014 WL 3746532 at *5. In analyzing this issue, Judge Slomsky reviewed the relevant case law and determined that the Pennsylvania Supreme Court had recently resolved this split in Lance v. Wyeth, 624 Pa. 231, 85 A.3d 434, 453 (2014), where it reiterated the long-standing principle that all strict liability claims are barred in prescription drug cases, and failed to exempt a manufacturing defect claim from this bar. Terrell, 2014 WL 3746532, at *5. Judge Slomsky then predicted that the Pennsylvania Supreme Court would conclude that all strict liability claims are also barred in medical device cases. Id.
Next, Defendants argue that Plaintiffs have failed to adequately plead their negligence claims under Fed.R.Civ.P. 8(a)(2), and that Plaintiffs have relied on "conclusory and boilerplate allegations, devoid of any factual support." (Defs' Mtn, pp. 5-6.) Specifically, Defendants take issue with Plaintiffs' pleading of their manufacturing defect, negligent marketing, negligent design and failure to warm claims. I will analyze each of these issues in turn.
Defendants contend that the allegations in Plaintiffs' Complaint regarding a manufacturing defect are deficient because they fail to identify how the device deviated from the manufacturer's intended design or how the device deviated from other identical products. (Defs' Mtn, p. 9.) Plaintiffs' Complaint alleges that "Defendants
Although these allegations of Plaintiffs' Complaint are not extremely specific, I find that when the complaint is read as a whole, there is sufficient specificity as to the alleged manufacturing defect to meet the Rule 8 requirement of a "short and plain statement of the claim." Specifically, paragraphs 18 through 26 of Plaintiffs' Complaint, when viewed "in the light most favorable to the non-moving party," contain enough factual specificity regarding the defect in this matter to allow this claim to proceed. Therefore, I will deny Defendants' Motion to Dismiss on the manufacturing defect claim.
Next, Defendants claim that Plaintiffs' Complaint is unclear as to what kind of negligence claim they are asserting for "marketing and/or selling a defective and unreasonably dangerous product," as Pennsylvania "recognizes only a very narrow claim for negligent marketing when a manufacturer over-promotes a drug that nullifies adequate warnings." (Defs' Mtn, p. 13.) Plaintiffs do not argue that their broad negligent marketing claim should be permitted to remain, and their Complaint contains no allegations regarding Defendants' alleged "over-promotion" of the N-Hance System that would be recognized in Pennsylvania as a valid negligent marketing claim. Accordingly, I will grant Defendants' Motion to Dismiss as to any negligent marketing claim being alleged by Plaintiffs.
Defendants claim that for a negligent design theory to survive a motion to dismiss, "at a minimum, federal pleading standards require Plaintiffs to specify the nature of the alleged product defect," and that Plaintiffs here have failed to identify the alleged design defect in the Synthes device. (Defs' Mtn, pp. 14-15.)
As to the negligent design claim, Plaintiffs' Complaint states as follows:
(Compl., ¶ 17.)
I find this paragraph of Plaintiffs' Complaint is sufficiently specific to identify the alleged design defect in Defendants' product. No greater specificity is required, and I will therefore deny Defendants' Motion to Dismiss as to the negligent design claim.
Defendants also move to dismiss Plaintiffs' failure to warn claim, alleging that Plaintiffs failed to address how Defendants breached a duty to Plaintiffs' doctor and how a better warning would have affected his doctor's choice of device. (Defs' Mtn, p. 16.) It is well-established that a "manufacturer's duty to warn is directed to physicians." Lance v. Wyeth, 624 Pa. 231, 85 A.3d 434, 438 n. 6 (2014). Plaintiffs'
Lastly, Defendants argue that Plaintiffs' negligence per se claim fails as a matter of law, as "Plaintiffs' claim for negligence per se is based on Synthes' alleged violations of the Federal Food, Drug and Cosmetic Act ("FDCA") and it implementing regulations," and that the FDCA "forbids private causes of action." (Defs' Mtn at pp. 17-18, citing Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001)). I will deny Defendants' Motion to Dismiss as to Plaintiffs' negligence per se claims without prejudice, and allow Defendants to reassert this issue at the time of summary judgment, if warranted.
For the foregoing reasons, Defendants' Motion to Dismiss Plaintiff's Complaint is granted in part and denied in part.