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

August 18, 2011


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


Pending before the Court is Defendants' MOTION TO DISMISS PURSUANT TO FEDERAL RULE OF CIVIL PROCEDURE 12(B)(6) (Document No. 18) with Memorandum of Law in Support of Defendants' Motion to Dismiss Plaintiff's First Amended Complaint for Failure to State a Claim Pursuant to Fed. R. Civ. P. 12(b)(6) (Document No. 19); Plaintiff's Opposition to Motion to Dismiss Pursuant to FRCP 12(b)(6) and MOTION TO AMEND (Document No. 20); and a Reply in Support of Defendants' Motion to Dismiss Plaintiff's First Amended Complaint for Failure to State a Claim (Document No. 21). Accordingly, the motions are now fully briefed and ripe for disposition.

Factual Background*fn1

The present case arises from the death of Janine M. Tragesser ("Decedent") on May 13, 2010. (Compl. at 2:55-6.) Subsequent to Ms. Tragesser's death, on July 26, 2010, the Orphans' Court of Westmoreland County, Pennsylvania, appointed her son, Benjamin P. Salvio ("Plaintiff"), as administrator of her estate. (Compl. at 2:57-9.) Plaintiff has filed an eight-count Amended Complaint against four (4) pharmaceutical companies ("Defendants" collectively) for the death of his mother, alleging that Defendants Amgen, Inc., Immunex, Inc.,*fn2 Wyeth, LLC, and Pfizer, Inc.,*fn3 are responsible. (See Compl. at 3-4:93-101). Plaintiff claims that 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, throughout the United States and internationally[.]" (Compl. at 2-3.) Plaintiff further claims that Defendants failed to "adequately disclose the true health consequences, risks, and side effects which result from the ingestion of this drug, including the risk of fatal fungal infections" which can lead to death. (Compl. at 7-8:192-4.) He also claims that Defendants' warnings about the risks of taking Enbrel were not only materially false, but also misleading and incomplete. (Compl. at 8:213-4.)

Enbrel hit consumer markets on or about November 2, 1998. (Compl. at 6:156-7.) After its introduction into the market, Defendants began receiving reports of a number of adverse effects afflicting patients taking Enbrel. (Compl. at 6:158-9.) These include, but are not limited to: "serious infections requiring hospitalizations, infections leading to death, increased tuberculosis, increased rates of cancer, including cancer in teenage patients, and congestive heart failure." (Compl. at 6:159-61.) Furthermore, within the first five (5) months on the market, post-marketing reports documented thirty (30) individuals who suffered from serious infections, including six (6) deaths, stemming from the use of Enbrel. (Compl. at 6:163-4.) A large portion of these cases occurred in patients who already had one or more potential risk factors of infections, including diabetes, active infections, or a history of chronic recurrent infections. (Compl. at 6:165-7.)

Decedent first became aware of Enbrel*fn4 through "direct-to-consumer" media advertising and, no later than 2005, she asked her doctor to prescribe Enbrel to alleviate the pain caused by her rheumatoid arthritis. (Compl. at 4:115-9.) Decedent's doctor prescribed Enbrel to her in 2005.*fn5 At an unspecified date, apparently after years of taking the drug, she developed mucormycosis,*fn6 a fungal infection of the sinuses, brain, and lungs, which frequently affects individuals who have weak immune systems, or diabetes, which weakens an individual's immune system. (Compl. at 5:122-5.) The Complaint reflects that no one ever informed Decedent that taking Enbrel could cause such an infection. (Compl. at 5:132-3.) It further alleges that the mucormycosis caused the Decedent to experience "significant respiratory problems" which "severely damag[ed] her lungs, making it painful and difficult even to talk[.]" (Compl. at 5:124-6.) During her illness, Decedent made over twenty (20) hospital visits, incurring medical bills for her treatment totaling over 2.5 million dollars. (Compl. at 5:127-8.)

In 2008, three (3) years after Decedent began taking Enbrel, the Federal Drug Administration ("FDA") made the Defendants "strengthen [the] 'black box' warning about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with Enbrel." (Compl. at 5:129-32.) Subsequent to the strengthening of the "black box" warning, Decedent continued to suffer from the debilitating effects of the mucormycosis, as well as a number of other severe medical problems, and had "a very poor quality of life[.]" (Compl. at 5:136-7.) Plaintiff avers that if Decedent had been informed about these side effects of Enbrel prior to her being prescribed the drug, she would not have taken it.

(Compl. at 5:132-5.)

In anticipation of the Defendants "taking responsibility" for Decedent's medical problems, she entered into a tolling agreement, which permitted the Defendants to review her medical records and contentions from February 24, 2010, until March 28, 2011. (Compl. at 5:138-41.) Sadly, on May 13, 2011, Decedent passed away from complications related to her medical condition, which the Complaint states is directly related to her having taken Enbrel. (Compl. at 5:142-3.)

The Complaint states the following causes of action against all Defendants: (1) negligence; (2) strict products liability (design and failure to warn); (3) breach of express warranty; (4) breach of implied warranty; (5) gross negligence/punitive damages and; (6) a wrongful death claim. (Compl. at 10-17.) Plaintiff also brings a survival action. (Compl. at 17-9.) However, Plaintiff's wrongful death claim and survival action are mechanisms by which Plaintiff can bring this action, based upon the underlying claims articulated above. Defendants, in response, assert the following defenses: (1) Plaintiff's strict liability and breach of warranty claims are not cognizable under Pennsylvania law; (2) Plaintiff failed to state a claim for negligence because of insufficient pleadings and because the Enbrel Package Insert specifically warned that Enbrel had a side effect of infection; (3) Plaintiff's failed to state a claim for gross negligence/punitive damages due to insufficient pleadings; and (4) because all claims should be dismissed, Plaintiffs wrongful death claim and survivor action should be dismissed because they cannot stand by themselves. (See Document No. 19.)

Standard of Review

A motion to dismiss pursuant to Fed. R. Civ. P. 12(b)(6) challenges the legal sufficiently of the complaint filed by Plaintiff. The United States Supreme Court has held that "[a] plaintiff's obligation to provide the 'grounds' of his 'entitle[ment] to relief' requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do." Bell Atlantic Corp. v. Twombly, 550 U.S. 554, 555 (207) (citing Papasan v. Allain, 478 U.S. 265, 286 (1986)) (alterations in original).

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 Twombly, 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, -- U.S. --, 129 S. Ct. 1937, 1950 (2009) (emphasis added).

Thus, after Iqbal, a district court must conduct a two-part analysis when presented with a motion to dismiss for failure to state a claim. Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir. 2009). First, the Court must separate the factual and legal elements of the claim. Id. 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 for "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).

As a result, "pleading standards have seemingly shifted from simple notice pleading to a more heightened form of pleading, requiring a plaintiff to plead more than the possibility of relief to survive a motion to dismiss." Id. at 211. That is, "all civil complaints must now set out 'sufficient factual matter' to show that the claim is facially plausible. This then 'allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.'" Id. at 210 (quoting Iqbal, 129 S. Ct. at 1948).

However, nothing in Twombly or Iqbal changed the other pleading standards for a motion to dismiss pursuant to Fed. R. Civ. P. 12(b)(6) and the requirements of Fed. R. Civ. P. 8 must still be met. See Phillips v. Co. of Allegheny, 515 F.3d 224, 231 (3d Cir. 2008) (internal citations omitted). Fed. R. Civ. P. 8 requires a showing, rather than a blanket assertion, of entitlement to relief, and "contemplates the statement of circumstances, occurrences, and events in support of the claim presented and does not authorize a pleader's bare averment that he wants relief and is entitled to it." Twombly, 550 U.S. at 555 n.3 (internal citations and quotations omitted). Additionally, the Supreme Court did not abolish the Fed. R. Civ. P. 12(b)(6) requirement that "the facts must be taken as true and a complaint may not be dismissed merely because it appears unlikely that the plaintiff can prove those facts or will ultimately prevail on those merits." Phillips, 515 F.3d at 231(citing Twombly, 550 U.S. at 553).

Legal Analysis

As a preliminary matter, the Court notes that jurisdiction in this case rests on the diversity 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. See Zambelli Fireworks Mfg. Co. v. Wood, 592 F.3d 412, 419 (3d Cir. 2010).

Further, a federal court sitting in diversity must apply the substantive law of the state in which it sits, Erie R.R. Co. v. Tompkins, 304 U.S. 64, 78 (1938), including its choice of law rules, Klaxon Co. v. Stentor Elec. Mfg. Co., 313 U.S. 487, 496 (1941). All parties presume that Pennsylvania law applies to this case, as will the Court.

Defendants contend that the Complaint should be dismissed in its entirety. The Court will address each cause of ...

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