McGrain v. C.R. Bard, Inc.

551 F.Supp.3d 529

Denise MCGRAIN, Plaintiff

v.C.R. BARD, INC., et al., Defendants

CIVIL ACTION NO. 21-1539

United States District Court, E.D. Pennsylvania.

Filed July 30, 2021

Shawn M. Sassaman, Bern Ripka Cappelli, Conshohocken, PA, for Plaintiff.

A. Michael Pratt, Brian T. Feeney, Greenberg Traurig, LLP, Philadelphia, PA, for Defendants.

MEMORANDUM OPINION

NITZA I. QUIÑONES ALEJANDRO, J.

INTRODUCTION

Denise McGrain ("Plaintiff") filed this personal injury action against C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. (collectively, "Defendants"), asserting the following causes of action; to wit : negligence (Count I), strict liability (Counts II-IV), breach of express warranty (Count V), breach of implied warranty of merchantability (Count VI), fraudulent misrepresentation (Count VII), fraudulent concealment (Count VIII), negligent misrepresentation (Count IX), and unjust enrichment (Count X). In the complaint, Plaintiff avers that in 2003 she had a Bard G2 IVC filter ("IVC filter") device surgically implanted to treat certain medical conditions, and that in 2020 a CT abdomen scan showed two struts of the IVC filter perforating the wall of her inferior vena cava. Plaintiff further avers that the IVC filter was designed, manufactured, marketed, and distributed by Defendants.¹

Before this Court is Defendants’ motion to dismiss for failure to state a claim filed pursuant to Federal Rule of Civil Procedure ("Rule") 12(b)(6), [ECF 3], in which Defendants argue that all of Plaintiff's claims should be dismissed because, inter alia , either they are not recognized under Pennsylvania law or Plaintiff has failed to allege sufficient facts to render the claims plausible. Plaintiff opposes Defendants’ motion. [ECF 8]. The issues raised by the parties have been fully briefed and are ripe for disposition. For the reasons set forth herein, Defendants’ motion to dismiss is granted in its entirety. Nevertheless, Plaintiff is granted leave to amend her complaint, but only with respect to those claims premised on negligence (Count I), breach of express warranty (Count V), fraudulent misrepresentation (Count VII), and negligent misrepresentation (Count IX).

BACKGROUND

When ruling on a motion to dismiss, this Court must accept as true the well-pleaded, relevant allegations in the operative complaint. Fowler v. UPMC Shadyside , 578 F.3d 203, 210 (3d Cir. 2009). Briefly, the salient facts relevant to Defendants’ motion to dismiss are:

Plaintiff suffered from pulmonary embolus and deep vein thrombosis. [ECF 1 ¶¶ 30-31]. In 2003, Plaintiff underwent surgery at University of Pennsylvania Hospital and had a Bard G2 IVC filter implanted for the purpose of treating these conditions. [ECF 1 ¶¶ 30-31]. The Bard G2 IVC filter was designed, manufactured, marketed, and distributed by Defendants. [ECF 1 ¶¶ 8-11, 36-37].

On February 17, 2020, Plaintiff underwent a CT abdomen scan which "showed results of an intact retrievable infrarenal IVC filter ... with two struts perforating through the wall of the inferior vena cava by up to 5 mm." [ECF 1 ¶¶ 33-34]. Plaintiff avers that she "experiences pain and discomfort in her abdominal area." [ECF 1 ¶ 35].

LEGAL STANDARD

As noted, when considering a motion to dismiss for failure to state a claim pursuant to Rule 12(b)(6), the court "must accept all of the complaint's well-pleaded facts as true, but may disregard any legal conclusions." Fowler , 578 F.3d at 210. The court must determine "whether the facts alleged in the complaint are sufficient to show that the plaintiff has a ‘plausible claim for relief.’ " Id. at 211 (quoting Ashcroft v. Iqbal , 556 U.S. 662, 679, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) ). The complaint must do more than merely allege the plaintiff's entitlement to relief; it must "show such an entitlement with its facts." Id. (citations omitted). "[W]here the well-pleaded facts do not permit the court to infer more than the mere possibility of misconduct, the complaint has alleged-–but it has not ‘show[n]’-–‘that the pleader is entitled to relief.’ " Iqbal , 556 U.S. at 679, 129 S.Ct. 1937 (quoting Fed. R. Civ. P. 8(a) ) (alterations in original). "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id. at 678, 129 S.Ct. 1937 (citing Bell Atlantic Corp. v. Twombly , 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) ). "Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements do not suffice." Id. To survive a motion to dismiss under Rule 12(b)(6), "a plaintiff must allege facts sufficient to ‘nudge [his] claims across the line from conceivable to plausible.’ " Phillips v. County of Allegheny , 515 F.3d 224, 234 (3d Cir. 2008) (quoting Twombly , 550 U.S. at 570, 127 S.Ct. 1955 ).

DISCUSSION

Defendants argue that all of Plaintiff's claims should be dismissed because, inter alia , either they are not recognized under Pennsylvania law or Plaintiff has failed to allege sufficient facts to satisfy the plausibility requirement. Each argument is discussed in turn.

Products Liability – Strict Liability

At Counts II-IV of the complaint, Plaintiff asserts strict liability claims premised on the IVC filter's alleged design, manufacturing, and warning defects. Defendants move to dismiss these strict liability claims on the basis that, under Pennsylvania law,² such claims are not legally cognizable against a medical device manufacturer. In her response, Plaintiff appears to concede that her strict liability design and warning defect claims are, in fact, precluded, acknowledging that "federal courts have found that ... Pennsylvania law prohibits strict liability claims based on a ‘design’ defect or a ‘failure to warn.’ " [ECF 8 at 11]. Indeed, this Court has previously held that such claims are barred under Pennsylvania law. Lopez v. Ethicon , 2020 WL 5569770, at *5 (E.D. Pa. Sept. 17, 2020) (Quiñones, J.) (predicting that the Pennsylvania Supreme Court would bar strict liability claims for design defect and failure to warn against manufacturers of prescription medical devices). Plaintiff provides this Court with no reason why it should depart from its previous holding.³ Accordingly, this Court holds, as it did in Lopez , that Pennsylvania law precludes strict liability claims for design and/or warning defects against medical device manufacturers.

Plaintiff argues, however, that her strict liability manufacturing defect claim is viable. As this Court observed in Lopez , a split exists among federal district courts applying Pennsylvania law as to whether such a claim is cognizable against a medical device manufacturer.⁴ Lopez, 2020 WL 5569770 at *5 n.3. While this Court did not address this particular split in Lopez , it does so here and holds that Plaintiff's strict liability manufacturing defect claim is also barred for the reasons that follow.

As recently recognized by the Third Circuit in Ebert , the Pennsylvania Supreme Court has not directly addressed the issue of whether strict liability applies to manufacturing defect claims against medical device manufacturers. Ebert , 2021 WL 2655690. The Pennsylvania Supreme Court has held broadly, however, that "Comment k [to § 402A of the Restatement (Second) of Torts] ... denies application of strict liability to products such as prescription drugs."⁵ Hahn v. Richter, 543 Pa. 558, 673 A.2d 888, 889 (1996). The Pennsylvania Supreme Court reiterated its broad statement in Lance v. Wyeth , 624 Pa. 231, 85 A.3d 434 (2014), holding that "for policy reasons, this Court has declined to extend strict liability into the prescription drug arena." Id. at 438. Although in Hahn and Lance the Pennsylvania Supreme Court addressed the issue only in the prescription drug context, the Pennsylvania Superior Court has applied the same reasoning to bar strict liability claims against manufacturers of medical devices. Creazzo v. Medtronic, Inc. , 903 A.2d 24, 31 (Pa. Super. Ct. 2006) (finding "no reason why the same rational[e] applicable to prescription drugs may not be applied to medical devices"). Consistent with these holdings, many federal courts, including this one, have predicted that the Pennsylvania Supreme Court would extend Comment k to medical devices. Lopez , 2020 WL 5569770 at *5 ; see also Ebert , 2021 WL 2655690, at *4 (collecting cases).

Plaintiff argues, however, that Comment k's exemption from strict liability does not extend to manufacturing defects. In support of this argument, Plaintiff cites the Pennsylvania Supreme Court's decision in Tincher , 628 Pa. 296, 104 A.3d 328, for the proposition that "[n]o product is expressly exempt [from strict liability] and, as a result, the presumption is that strict liability may be available with respect to any product, provided that the evidence is sufficient to prove a defect." Id. at 386. Plaintiff's reliance on Tincher is misplaced. In Tincher , the Pennsylvania Supreme Court did not address strict liability claims in the context of either prescription drugs or medical devices; rather, it addressed the viability of homeowners’ strict liability claims against the manufacturer of a fireplace component. Id. at 335-36. As such it is inapposite. Moreover, while the Tincher Court expressly overruled another Pennsylvania Supreme Court opinion, it did not overrule Hahn or Lance . Id. at 328 (expressly overruling Azzarello v. Black Brothers Co. , 480 Pa. 547, 391 A.2d 1020 (1978) ); see also Lopez , 2020 WL 5569770 at *5. In fact, the Tincher Court specifically noted an exception to the general proposition that "no product is expressly exempt" by immediately following this broad statement with a "but see" citation to Hahn . 104 A.3d at 328 (noting that a "manufacturer [is] immune from strict liability defective design claim premised upon sale of prescription drugs without adequate warning"); see also Kohn v. Ethicon , 2020 WL 733126, at *4 (E.D....