EDUARDO C. ROBRENO, District Judge.
Defendant prescription medical device manufacturer moved to dismiss Counts I-VII and IX because, inter alia, Pennsylvania law does not impose liability for harm caused by a prescription device manufacturer under theories not based on negligence. For the reasons that follow, the Court will grant the motion and dismiss Counts I-VII and IX.
On August 26, 2009, Marina Kee ("Plaintiff") complained to Robert E. Booth, Jr., M.D., ("Dr. Booth") of knee pain. Compl. ¶ 23, ECF No. 1. Dr. Booth diagnosed Plaintiff with advanced degenerative arthritis of both knees and recommended total knee replacement. Id. ¶¶ 24-25. On September 29, 2009, Plaintiff underwent bi-lateral total knee arthroplasties at Bryn Mawr Hospital, where Dr. Booth implanted the Zimmer NexGen, Legacy Posterior Stabilized flex knee system ("LPS System"). Id. ¶ 27. Zimmer, Inc., ("Defendant") designs, manufactures, and distributes the LPS System. Id. ¶¶ 7-10.
In January, 2011, Plaintiff complained of left knee pain; two doctors diagnosed her with apparent loosening of the tibial component implanted by Dr. Booth on September 29, 2009. Id. ¶¶ 28-29. On February 21, 2011, Eric A. Levicoff, M.D., an orthopedic specialist, recommended knee replacement. Id. ¶ 30. On March 18, 2011, Plaintiff underwent the surgery. Id. ¶ 31.
On August 24, 2011, Plaintiff commenced a civil action in the Court of Common Pleas of Philadelphia County by filing a writ of summons. Notice of Removal ¶ 1, ECF No. 1. On December 5, 2011, Plaintiff filed a Complaint asserting the following nine counts: defective design (Count I); failure to warn (Count II); violation of Pennsylvania Unfair Trade Practices and Consumer Protection Law ("UTPCPL") (Count III); fraud (Count IV); breach of implied warranty of fitness (Count V); breach of implied warranty of merchantability (Count VI); breach of express warranty (Count VII); negligent design and manufacture (Count VIII); and punitive damages (Count IX). Compl ¶¶ 32-109.
Defendant removed to the U.S. District Court for the Eastern District of Pennsylvania invoking this Court's diversity jurisdiction.
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, 127 S.Ct. 1955, 167 L.Ed.2d 929 (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, 106 S.Ct. 2932, 92 L.Ed.2d 209 (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, 129 S.Ct. 1937, 173 L.Ed.2d 868 (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 complainant'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., 998 F.2d 1192, 1196 (3d Cir.1993).
Defendant moves to dismiss Counts I-VII and IX. Federal courts sitting in diversity generally apply the substantive law of the forum state. See Erie R.R. Co. v. Tompkins, 304 U.S. 64, 78, 58 S.Ct. 817, 82
Defendant moves to dismiss all non-negligence claims pursuant to comment k to the Restatement (Second) of Torts § 402A (1965). Pennsylvania adopted comment k of § 402A, which imposes strict liability on sellers of unreasonably dangerous products. See Hahn v. Richter, 543 Pa. 558, 673 A.2d 888, 889-91 (1996). Comment k, however, provides an exception to imposition of strict liability for "unavoidably unsafe products." See Restatement (Second) of Torts § 402A cmt k. In Hahn, the Pennsylvania Supreme Court held that "where the adequacy of warnings associated with prescription drugs is at issue, the failure of the manufacturer to exercise reasonable care to warn of dangers, i.e., the manufacturer's negligence, is the only recognized basis of liability." Id. at 891; see also Kline v. Pfizer, Inc., No. 08-3238, 2008 WL 4787577, at *2-3 (E.D.Pa. Oct. 31, 2008) (dismissing claims based on strict products liability, breach of express and implied warranties, and fraudulent misrepresentation against drug manufacturer because, under Pennsylvania law, negligence is sole cause of action for failure to warn).
And, although the Pennsylvania Supreme Court has not yet extended Hahn to prescription medical device manufacturers, the Pennsylvania Superior Court has done so. See, e.g., Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa.Super.Ct.2006) (applying comment k to medical devices). Numerous federal district courts, including this Court, have predicted that the Pennsylvania Supreme Court would, if faced with the issue, similarly extend comment k to prescription medical devices. See Horsmon v. Zimmer Holdings, Inc., No. 11-1050, 2011 WL 5509420, at *2 (W.D.Pa. Nov. 10, 2011) (Bissoon, J.) (predicting that Pennsylvania Supreme Court would apply comment k to prescription medical devices); Soufflas v. Zimmer, Inc., 474 F.Supp.2d 737, 750 (E.D.Pa.2007) (Robreno J.) (same); Davenport v. Medtronic, Inc., 302 F.Supp.2d 419, 442 (E.D.Pa.2004) (Kelly, J.) (same); Parkinson v. Guidant Corp., 315 F.Supp.2d 741, 747 (W.D.Pa.2004) (Diamond, J.) (same); Murray v. Synthes (U.S.A.), Inc., No. 95-7796, 1999 WL 672937, at *6-8 (E.D.Pa. Aug. 23, 1999) (Hutton, J.) (same); Burton v. Danek Med., Inc., No. 95-5565, 1999 WL 118020, at *7 (E.D.Pa. Mar. 1, 1999) (Kelly, J.) (same); Taylor v. Danek Med., Inc., No. 95-7232, 1998 WL 962062, at *7 (E.D.Pa. Dec. 29, 1998) (Broderick, J.) (same). Therefore, as a matter of Pennsylvania law, there is no strict liability for harm caused by medical devices.
Defendant moves to dismiss Plaintiff's breach-of-warranty claims because Plaintiff failed to plead notice pursuant to Pennsylvania law. Where tender is accepted, a buyer must "within a reasonable time after he discovers or should have discovered any breach notify the seller of breach or be barred from any remedy." 13 Pa. Cons.Stat. Ann. § 2607(c)(1) (West 2012). "[T]he purpose of notification under § 2607(c) is to allow the seller an opportunity to resolve the dispute regarding an alleged breach before the buyer initiates a lawsuit." Am. Fed'n of State Cnty. & Mun. Emps. ("AFSCME") v. Ortho-McNeil-Janssen Pharm., Inc., No. 08 -5904, 2010 WL 891150, at *6 (E.D.Pa. Mar. 11, 2010). Plaintiff bears the burden to prove compliance with § 2607 before recovering for breach of warranty. See Vanalt Elec. Constr. Inc. v. Selco Mfg. Corp., 233 Fed.Appx. 105, 108-10 (3d Cir. 2007). In context of a motion to dismiss, Plaintiff must "plead, at a minimum, ... that [she] provided reasonable notification... to state a viable claim for recovery ... or be barred from any remedy." AFSCME, 2010 WL 891150, at *7 (internal
In response, Plaintiff argues that she is not a "buyer" under § 2607(c)
Defendant moves to dismiss Plaintiff's claim alleging a violation of the UTPCPL because the learned intermediary doctrine precludes Plaintiff from establishing the elements of reliance and causation necessary for such a claim. The UTPCPL prohibits "unfair methods of competition" and "unfair or deceptive acts or practices." 73 Pa. Stat. Ann. § 201-3 (West 2012). The UTPCPL provides various definitions of unfair methods of competition, including one catch-all provision. See id. § 201-4. "The statute creates a private right of action in persons upon whom unfair methods of competition and unfair or deceptive acts or practices are employed and who, as a result, sustain an ascertainable loss." Hunt v. U.S. Tobacco Co., 538 F.3d 217, 221 (3d Cir.2008) (quotation and editorial marks removed).
Under Pennsylvania law, a consumer does not have a cause of action under the UTPCPL against the manufacturer of prescription drugs because prescription drug manufacturers do not have a duty to disclose information directly to consumers. Permitting a cause of action under UTPCPL would result in effectively making prescription drug manufacturers absolute guarantors of any anticipated effects of the drug. See Heindel v. Pfizer, Inc., 381 F.Supp.2d 364, 384 (D.N.J.2004) (citing Albertson v. Wyeth Inc., No. 2944 Aug. Term 2002, 0007, 2003 WL 21544488, at *11-12 (Pa.Ct.Com.Pl. July 8, 2003); Luke v. Am. Home Prods. Corp., No. 1998-C-01977, 1998 WL 1781624, at *8 (Pa.Ct.Com.Pl. Nov. 18, 1998)). This is so because a claim under the UTPCPL requires proof of causation and reliance, and the "learned intermediary doctrine breaks the chain in terms of reliance, [because] the patient cannot obtain prescription drugs without the physician no matter what [the patient] believe[s] about them." Id. In other words, "a private right of action under the UTPCPL requires proof of justifiable reliance and causation, and such requirements cannot be present when the defendant is a pharmaceutical company that did not sell its product directly to the patient." Kester, 2010 WL 2696467, at *14. The same reasoning extends to manufacturers of prescription medical devices. See id. at *14-15 (dismissing UTPCPL claim against prescription medical device manufacturer). Therefore, the learned intermediary doctrine breaks the chain of causation and reliance with respect to Plaintiff's UTPCPL claim. See id.
Defendant moves to dismiss Plaintiff's fraud and UTPCPL claims under Rule 9(b). Under Pennsylvania law, "to establish common law fraud, a plaintiff must prove: (1) misrepresentation of a material fact; (2) scienter; (3) intention by the declarant to induce action; (4) justifiable reliance by the party defrauded upon the misrepresentation; and (5) damage to the party defrauded as a proximate result." Colaizzi v. Beck, 895 A.2d 36, 39 (Pa.Super.Ct.2006). "In alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake. Malice, intent, knowledge, and other conditions of a person's mind may be alleged generally." Fed.R.Civ.P. 9(b). Rule 9(b) requires the following:
Frederico v. Home Depot, 507 F.3d 188, 200 (3d Cir.2007) (internal quotation and editorial marks and citation removed).
Plaintiff fails to allege a claim of fraud with sufficient particularity. Plaintiff generally alleges Defendant knew or should have known of the LPS System's "defective nature" and "risk of failure and complication associated with the product," but failed to disclose those facts to the public, its sales representatives, its distributors and customers, doctors, and Plaintiff. Compl. ¶¶ 65-67. Furthermore, Plaintiff alleges Defendant "[m]isled [its] customer base and the consuming public" by failing to notify them of an increased risk of aseptic loosening and total arthroplasty failure after it learned of the malfunction. Id. ¶ 68. Instead, Defendant concealed these facts. Id. ¶ 69. And Plaintiff's allegations under the UTPCPL are similarly vague. There, Plaintiff alleges Defendant mislead and deceived consumers by failing to disclose that the LPS System did not
Plaintiff fails to allege facts supporting the nature of her reliance or specific representations Defendant made relating to the reliance. Plaintiff fails to allege facts indicating the date, time, and place of the alleged fraud, or, alternatively, inject any precision or measure of substantiation into her fraud allegations that would "place the defendant on notice of the precise misconduct with which it is charged." Frederico, 507 F.3d at 200; see also Kester, 2010 WL 2696467, at *13-14 (dismissing fraud-based claim against prescription medical device manufacturer when plaintiff failed to allege claim with sufficient particularity under Rule 9(b)). Therefore, the Court will dismiss Counts III and IV.
Defendant moves to dismiss Count IX for punitive damages because Plaintiff failed to allege conduct necessary to support an award of punitive damages. First, under Pennsylvania law, there is no independent cause of action for punitive damages; instead, Plaintiff may include a demand for punitive damages within her demand for relief, not as a separate claim.
Furthermore, under Pennsylvania law, punitive damages are an "extreme remedy available in only the most exceptional matters." Phillips v. Cricket Lighters, 584 Pa. 179, 883 A.2d 439, 445 (2005) (internal quotation marks removed). Punitive damages are not awarded to compensate the plaintiff but are intended to punish the defendant for egregious behavior and are only available "when the plaintiff has established that the defendant has acted in an outrageous fashion due to either the defendant's evil motive or his reckless indifference to the rights of others." Id. at 445 (internal quotation marks removed). A showing of mere negligence or even gross negligence is insufficient for an award of punitive damages. Id. at 445-46 Rather, a plaintiff must show "the defendant's acts amounted to intentional, willful, wanton or reckless conduct." Id. at 446 (internal quotation marks removed).
Plaintiff does not allege facts that, if proven, show Defendant acted in an outrageous fashion and with a willful disregard of Plaintiff's rights. Plaintiff alleges harm from the malfunction of a prescription medical device and fails to muster any facts indicating that Defendant acted with reckless indifference to Plaintiff's rights. Therefore, the Court will dismiss Count IX. See Saltzman v. TD Bank, No. 10-3265, 2011 WL 1193112, at *8-9 (E.D.Pa. Mar. 29, 2011) (dismissing claim for punitive damages when plaintiff failed to allege outrageous conduct).
For the foregoing reasons, the Court will grant the motion to dismiss and dismiss Counts I-VII and IX. The case shall proceed against Defendant on Count VIII (negligence) only. An appropriate order will follow.