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Benjamin P. Salvio, Individually and As Administrator of the Estate of v. Amgen Inc.

February 15, 2012


The opinion of the court was delivered by: McVerry, J.


Now pending before the court is DEFENDANTS' MOTION TO DISMISS PLAINTIFF'S SECOND AMENDED COMPLAINT FOR FAILURE TO STATE A CLAIM (Document No. 25), with Memorandum of Law in Support of Defendants' Motion to Dismiss Plaintiff's Second Amended Complaint for Failure to State a Claim (Document No. 26); Plaintiff's Opposition to Defendants' Motion to Dismiss Plaintiff's Second Amended Complaint for Failure to State a Claim and MOTION TO AMEND (Document No. 27); and Reply in Support of Defendants' Motion to Dismiss Plaintiff's Second Amended Complaint for Failure to State a Claim (Document No. 29). The motion has been fully briefed and is ripe for disposition. Factual and Procedural History*fn1

The background of this case is fully set forth in the August 18, 2011 Memorandum Opinion and Order of this Court (Document No. 23). In short, the case arises from the death of Janine M. Tragesser ("Decedent"). Plaintiff Benjamin P. Salvio, individually and as the administrator of Decedent's estate, alleges that Defendants Amgen Inc., Immunex, Inc., Wyeth, LLC, and Pfizer, Inc.*fn2 (collectively, "Defendants") were "engaged in the design, manufacture, production, testing, study, inspection, mixture, labeling, marketing, advertising, sales, promotion, and/or distribution of pharmaceutical products, including Enbrel." (Second Amend. Compl. at 2-3). Decedent, who suffered from rheumatoid arthritis and had a history of diabetes, took Enbrel continuously between October 2005 and March 2008, when she became ill. (Second Amend. Compl. at 4-5:118-126, 8:245). At that time, Decedent allegedly contracted mucormycosis,*fn3 a fungal infection of the sinuses, brain, and lungs, which typically attacks those with weakened immune systems. (Second Amend. Compl. at 5: 127-129). Unfortunately, she died from complications related to her infection on May 13, 2010. (Second Amend. Compl. at 9:262-63).

This Court dismissed Plaintiff's Amended Complaint by Memorandum Opinion and Order of August 18, 2011. However, the Court granted Plaintiff leave to amend "to correct technical errors and to clarify legal and factual assertions in support of a negligence claim, including punitive damages, if warranted." Salvio v. Amgen Inc., 2011 WL 3651314, at *11 (W.D. Pa. Aug. 18, 2011). In doing so, the Court cautioned that "[i]f Plaintiff chooses to amend, it will be essential to plead facts that there was a safer product on the market in regard to his design/manufacturing defect claim, and to overcome the learned intermediary doctrine." Id.

Since the date of that ruling, Plaintiff has filed a Second Amended Complaint (Document No. 24), which alleges the following claims against all of the Defendants: negligent failure to warn, negligent design/manufacture, and punitive damages. In addition, Plaintiff brings a survival action and a wrongful death action, pursuant to 42 Pa. C.S.A. §§ 8301 and 8302.

On September 15, 2011, Defendants filed the instant Motion to Dismiss. They argue that Plaintiff has failed to state a claim for either negligent failure to warn or negligent design/manufacture because: (1) Enbrel's Package Insert adequately warned of the risk of consuming the drug; and (2) Plaintiff failed to allege the existence of a feasible alternative, safer design. Additionally, Defendants contend that Plaintiff's punitive damages claim fails because he has failed to adequately plead the degree of intent necessary to sustain an award for punitive damages.

Standard of Review

A motion to dismiss pursuant to Fed. R. Civ. P. 12(b)(6) challenges the legal sufficiency of a complaint. The Court must accept as true all well-pleaded facts and allegations, and must draw all reasonable inferences therefrom in favor of the plaintiff. However, as the Supreme Court made clear in Bell Atlantic Corp. v. Twombly, 550 U.S. 554, 555 (2007), the "factual allegations must be enough to raise a right to relief above the speculative level." Id. The Supreme Court has subsequently broadened the scope of this requirement, stating that "only a complaint that states a plausibleclaim for relief survives a motion to dismiss." Ashcroft v. Iqbal, 129 S. Ct. 1937, 1950 (2009) (emphasis added).

A district court must conduct a two-part analysis when presented with a motion to dismiss for failure to state a claim. First, the Court must separate the factual and legal elements of the claim. Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir. 2009). Although the Court "must accept all of the complaint's well-pleaded facts as true, [it] may disregard any legal conclusions." Id. at 210-211. Second, the Court "must then determine whether the facts alleged in the complaint are sufficient to show that the plaintiff has a 'plausible claim for relief.' In other words, a complaint must do more than allege the plaintiff's entitlement to relief. A complaint has to 'show' such an entitlement with its facts." Id. at 211 (citing Iqbal, 129 S. Ct. at 1949). The determination of "plausibility" will be "'a context-specific task that requires the reviewing court to draw on its judicial experience and common sense.'" Id. at 211 (quoting Iqbal, 129 S. Ct. at 1950).

Legal Analysis

At the outset, the Court notes that jurisdiction in this case is based on the diverse citizenship of the parties. 28 U.S.C. § 1332(a). Pursuant to 28 U.S.C. § 1332(a), district courts "have original jurisdiction of all civil actions where the matter in controversy exceeds the sum or value of $75,000, exclusive of interest, and is between . . . citizens of different States." Id. Complete diversity requires that, in cases with multiple plaintiffs or multiple defendants, no plaintiff be a citizen of the same state as any defendant. Zambelli Fireworks Mfg. Co. v. Wood, 592 F.3d 412, 419 (3d Cir. 2010).

Federal courts in diversity actions must apply the substantive laws of the forum state. Erie R.R. Co. v. Tompkins, 304 U.S. 64, 78 (1938). Here, all parties presume that Pennsylvania law controls the allegations set forth in Plaintiff's Second Amended Complaint, as will the Court.

Defendants have moved for the dismissal of the Second Amended Complaint in its entirety. The Court will address each of Plaintiff's claims seriatim.

A. Documents Considered on Judicial Review

Before addressing Plaintiff's claims, the Court must determine whether to consider the Enbrel Package Insert, which Defendants have attached as an exhibit to their Motion to Dismiss. Plaintiff argues that the Court should not consider the Package Insert in determining the plausibility of Plaintiff's claims. As this Court noted in its Memorandum Opinion of August 18, 2011, "[n]either party disputes the authenticity of the attached document. Furthermore, Plaintiff makes reference to, and thus incorporates by reference, the Enbrel Package Insert in his Complaint, stating 'Defendants purposely ignored and/or understated the risk of such serious infections . . . due to Enbrel's use in its labels, package inserts, advertisements, marketing and other promotional materials.'" The United States Court of Appeals for the Third Circuit has made clear that "a court may consider any undisputedly authentic document that a defendant attaches as an exhibit to a motion to dismiss if the plaintiff's claims are based on the document." Pension Benefit Guar. Corp. v. White Consol. Industries, 998 F.2d 1192, 1196 (3d Cir. 1993) (internal citations omitted). Here, the authenticity of the Enbrel Package Insert is undisputed and both parties have discussed its content at length.

It is well-established that a plaintiff with a legally deficient claim cannot avoid a motion to dismiss simply by failing to attach the dispositive document. Id. In this case, Plaintiff has asserted that the warning is inadequate. It is axiomatic that the Court cannot resolve this claim without making reference to the actual warning. Accordingly, the Court's reading of the Second Amended Complaint "is informed by [the Package Insert] . . . of ...

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