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Rosenberg v. C.R. Bard, Inc.

United States District Court, E.D. Pennsylvania

June 25, 2019

C.R. BARD, INC., Defendant.


          EDUARDO C. ROBRENO, J.


         In this products liability case, an individual asserts both negligence and strict liability claims against a prescription medical device manufacturer. In doing so, the Court is presented with an important question of state law that has often been raised but has effectively evaded review by the Pennsylvania Supreme Court: does Pennsylvania law recognize a strict liability claim for a manufacturing defect of a prescription medical device?

         The Court predicts that the answer to this question is “no.” But given the growing debate among federal district courts regarding this issue, the Court certifies the question to the Third Circuit.


         Plaintiff Sarah Rosenberg suffered from stress urinary incontinence (“SUI”) that required surgical intervention. Compl. ¶¶ 1, 7, ECF No. 1. On November 12, 2012, Plaintiff's doctors implanted Defendant C.R. Bard, Inc.'s Align synthetic mesh system in Plaintiff to treat her SUI. Id. ¶ 7. Following this procedure, Plaintiff began experiencing complications such as severe lower quadrant pain, dyspareunia, and mesh erosion. Id. ¶ 8. According to Plaintiff, these complications required further medical care and treatment, including surgical interventions. Id. Plaintiff alleges that she is more likely than not to need to undergo additional procedures related to complications that she attributes to Defendant's pelvic mesh system. See Id. ¶ 21.

         Plaintiff alleges that she neither knew nor could have reasonably known that her complications were related to design or manufacturing defects of the pelvic mesh system until July 27, 2017. Id. ¶ 9. Further, Plaintiff alleges that, despite safety communications from the FDA in 2011 observing the risks associated with pelvic mesh systems as well as various reports from physicians, patients, and the World Health Organization noting complications from pelvic mesh implantation, Defendant continued to advertise and promote its pelvic mesh system as a safe and effective treatment for SUI and pelvic organ prolapse. Id. ¶¶ 10-15, 17. According to Plaintiff, Defendant knew that its pelvic mesh system had a defect attributable to erosion, shrinkage, and/or hardening of the mesh material and that there could be life-changing and irreversible complications from pelvic mesh removal. Id. ¶ 16. Plaintiff further alleges that Defendant failed to provide sufficient warnings of the risks of pelvic mesh implantation and concealed the known risks associated with pelvic mesh implantation. Id. ¶¶ 17-22.

         Plaintiff filed a complaint against Defendant, originally bringing thirteen causes of action, including strict liability, negligence, and fraud. ECF No. 1. Defendant then filed a motion to dismiss for failure to state a claim. ECF No. 6. In her response in opposition to Defendant's motion to dismiss, Plaintiff abandoned all but three of her original causes of action: (1) strict liability for design and manufacturing defects, (2) strict liability for failure to warn, and (3) negligence. ECF No. 10. Plaintiff's abandoned claims (Counts IV-XIII) will be dismissed with prejudice.

         The Court heard argument on Defendant's motion to dismiss, and the motion is now ready for disposition.


         A party may move to dismiss a complaint for failure to state a claim upon which relief can be granted. Fed.R.Civ.P. 12(b)(6). When considering such a motion, the Court must “accept as true all allegations in the complaint and all reasonable inferences that can be drawn therefrom, and view them in the light most favorable to the non-moving party.” DeBenedictis v. Merrill Lynch & Co., 492 F.3d 209, 215 (3d Cir. 2007) (internal quotation marks removed). To withstand a motion to dismiss, the complaint's “[f]actual allegations must be enough to raise a right to relief above the speculative level.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). This “requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Id. Although a plaintiff is entitled to all reasonable inferences from the facts alleged, a plaintiff's legal conclusions are not entitled to deference, and the Court is “not bound to accept as true a legal conclusion couched as a factual allegation.” Papasan v. Allain, 478 U.S. 265, 286 (1986).

         The pleadings must contain sufficient factual allegations so as to state a facially plausible claim for relief. See, e.g., Gelman v. State Farm Mut. Auto. Ins. Co., 583 F.3d 187, 190 (3d Cir. 2009). “‘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. (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)). In deciding a Rule 12(b)(6) motion, the Court limits its inquiry to the facts alleged in the complaint and its attachments, matters of public record, and undisputedly authentic documents if the plaintiff's claims are based upon these documents. See Jordan v. Fox, Rothschild, O'Brien & Frankel, 20 F.3d 1250, 1261 (3d Cir. 1994); Pension Benefit Guar. Corp. v. White Consol. Indus., Inc., 998 F.2d 1192, 1196 (3d Cir. 1993).

         Before dismissing a complaint as deficient, the Court should grant leave to amend. See Fletcher-Harlee Corp. v. Pote Concrete Contractors, Inc., 482 F.3d 247, 252 (3d Cir. 2007). The Third Circuit has previously held that “[d]ismissal without leave to amend is justified only on the grounds of bad faith, undue delay, prejudice, or futility.” Alston v. Parker, 363 F.3d 229, 236 (3d Cir. 2004).


         Defendant moves to dismiss Plaintiff's complaint for two reasons: (1) Pennsylvania law bars all strict liability claims for prescription medical devices, and (2) Plaintiff's negligence claim is insufficiently pleaded. Each argument is discussed in turn.

         A. Pennsylvania Law Bars All Strict Liability Claims for Prescription Products

         1. Pennsylvania's Strict Liability Law

         As a general matter, Pennsylvania has adopted the strict liability formulation set out in Section 402A of the Restatement (Second) of Torts. Tincher v. Omega Flex, Inc., 104 A.3d 328, 394-99 (Pa. 2014); Webb v. Zern, 220 A.2d 853, 854 (Pa. 1966). Pursuant to Section 402A, a plaintiff may recover under a theory of strict liability if his or her injury was caused by a product in “a defective condition unreasonably dangerous to the user or consumer.” Restatement (Second) Torts § 402A; see also Phillips v. A-Best Prods. Co., 665 A.2d 1167, 1170 (Pa. 1995). A plaintiff may establish a “defective condition, ” and thus assert a strict liability claim, by showing that the product suffered from a design defect, failure-to-warn defect, or manufacturing defect. Id.

         There are, however, situations where strict liability is unavailable as an avenue of relief for plaintiffs alleging harm caused by a product. Specifically, pursuant to comment k of Section 402A, manufacturers of “unavoidably unsafe products” are exempted from strict liability to the extent that the product at issue is “properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.” See Restatement (Second) of Torts § 402A cmt. k (emphasis in original). ...

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