Salvio v. Amgen, Inc.

810 F. Supp. 2d 745, 2011 U.S. Dist. LEXIS 92558, 2011 WL 3651314
CourtDistrict Court, W.D. Pennsylvania
DecidedAugust 18, 2011
DocketNo. 2:11-cv-00553
StatusPublished
Cited by19 cases

This text of 810 F. Supp. 2d 745 (Salvio v. Amgen, Inc.) is published on Counsel Stack Legal Research, covering District Court, W.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Salvio v. Amgen, Inc., 810 F. Supp. 2d 745, 2011 U.S. Dist. LEXIS 92558, 2011 WL 3651314 (W.D. Pa. 2011).

Opinion

MEMORANDUM OPINION AND ORDER OF COURT

TERRENCE F. MeVERRY, District Judge.

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 Plaintiffs First Amended Complaint for Failure to State a Claim Pursuant to Fed.R.Civ.P. 12(b)(6) (Document No. 19); Plaintiffs 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 Plaintiffs First Amended Complaint for Failure to State a Claim (Document No. 21). Accordingly, the motions are now fully briefed and ripe for disposition.

Factual Background1

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.,2 Wyeth, LLC, and Pfizer, Inc.,3 are respon[748]*748sible. (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 Enbrel4 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 2005.5 At an unspecified date, apparently after years of taking the drug, she developed mucormycosis,6 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 in[749]*749fections 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, Plaintiffs 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) Plaintiffs 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) Plaintiffs 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 surviv- or 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] plaintiffs 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. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (citing Papasan v. Allain,

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Cite This Page — Counsel Stack

Bluebook (online)
810 F. Supp. 2d 745, 2011 U.S. Dist. LEXIS 92558, 2011 WL 3651314, Counsel Stack Legal Research, https://law.counselstack.com/opinion/salvio-v-amgen-inc-pawd-2011.