TERRENCE F. McVERRY, 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 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.
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.,
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
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
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.)
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. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (citing Papasan v. Allain, 478 U.S. 265, 286, 106 S.Ct. 2932, 92 L.Ed.2d 209 (1986)) (alterations in original).
The Court must accept as true all wellpleaded 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 plausible claim for relief survives a motion to dismiss." Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 1950, 173 L.Ed.2d 868 (2009) (
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.
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, 127 S.Ct. 1955 (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, 127 S.Ct. 1955).
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, 58 S.Ct. 817, 82 L.Ed. 1188 (1938), including its choice of law rules, Klaxon Co. v. Stentor Elec. Mfg. Co., 313 U.S. 487, 496, 61 S.Ct. 1020, 85 L.Ed. 1477 (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 action advocated by Plaintiff.
Before considering the claims set forth by Plaintiff, the Court must determine whether to consider a document submitted by Defendants, specifically the Enbrel Package Insert. (See Document Nos. 19-1, 19-2.)
Neither 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,
Plaintiff's first claim against Defendants is a negligence claim. (Compl. at 10-12:259-332.) Plaintiff avers that "Defendants had a duty to Plaintiff and other consumers of their drug to exercise reasonable care in order [to] properly design, manufacture, produce, test, study, inspect, mix, label, market, advertise, sell, promote and distribute this product." (Compl. at 11:265-8.) The Complaint contains a vague laundry list of fifteen (15) generalized alleged breaches of duty. However, Plaintiff fails to specifically allege what type of negligence theory he is pursuing.
As an initial matter, Plaintiff seems to bring a claim on the basis of negligent failure to test and negligent marketing. However, Pennsylvania does not recognize claims for negligent failure to test or negligent marketing. (See Document No. 19 at 11.) See Viguers v. Philip Morris USA, Inc., 837 A.2d 534, 541 (Pa.Super.2003) ("negligent failure to test" is not a viable cause of action recognized by our courts.); Wolfe v. McNeil-PPC, Inc., 773 F.Supp.2d 561, 570 (E.D.Pa.2011) (stating that Pennsylvania does not recognize a tort for negligent marketing.). Thus, the Court will only consider Plaintiff's negligence claim under failure-to-warn and design/manufacture theories.
In a products liability case involving a pharmaceutical drug, Pennsylvania courts have adopted the "learned intermediary doctrine" and have stated:
Daniel v. Wyeth Pharms., Inc., 15 A.3d 909, 924 (Pa.Super.2011) (quoting Taurino v. Ellen, 397 Pa.Super. 50, 579 A.2d 925, 927 (1990), appeal denied, 527 Pa. 603, 589 A.2d 693 (1991)). Thus, by warning a consumer's physician, the manufacturer will have discharged its duty to the consumer.
In regard to his failure-to-warn claim, Plaintiff alleges, inter alia, that Defendants permitted Enbrel to be sold without adequate warnings, as well as ignoring and/or understating the infection risk to those taking Enbrel. (Compl. at 11:278-302.) Other than a vague reference that the FDA demanded a "strengthened" black box warning in 2008, Plaintiff does not describe the alleged failure-to-warn. Plaintiff also does not describe the differences between the "black box" warning on the Enbrel package before and after the FDA's demand.
(Document No. 19-2 at 11.) (Capitalization and bold in original, emphasis added) (See Document No. 19-2 at 13, 15-16.) Similar warnings are also located throughout the Package Insert. Plaintiff's conclusory averments that Defendants failed to adequately warn, ignored and/or understated the risks and side effects associated with the use of Enbrel, or that a prescribing doctor or customer "would not have known that for some customers, ingesting the drug could be fatal, or cause extreme illness" appear to be contradicted by the actual text of the Package Insert. (Compl. at 9:219-21.); See (Document No. 19-2 at 11); Parkinson, 315 F.Supp.2d at 748 (stating that a pharmaceutical drug company can only be liable for a "failure-to-warn" if reasonable care is not exercised to inform those taking the drug of the dangers which come with taking the drug). At a minimum, Plaintiff has failed to plead facts regarding how this warning was not reasonable. Plaintiff has also failed to plead facts showing that Defendants did not properly discharge their duty by warning Decedents physician through the Package Insert or otherwise. He has also failed to provide any facts about how the change in the "black box" warning affected her choice to either continue taking Enbrel, or stop taking it. Without these facts, the Plaintiff cannot sufficiently state a cause of action for lack of both breach of duty and causation. Thus, Plaintiff fails to state a claim for negligent failure-to-warn.
"[T]he determination of whether a product was negligently designed turns on whether `an alternative, feasible, safer design would have lessened or eliminated the injury plaintiff suffered.'" Aaron v. Wyeth, No. 07-927, 2010 WL 653984, at *11, 2010 U.S. Dist. LEXIS 14581, at * 31 (W.D.Pa. Feb. 19, 2010) (emphasis in original) (quoting Berrier v. Simplicity Mfg., 563 F.3d 38, 64 (3d Cir.2009)). Plaintiff fails to plead facts sufficient to satisfy the pleading standard in regard to an alternative, feasible, and safer design. Plaintiff does conclusorily state that Decedent would have used another treatment regimen that was safer than Enbrel (See Compl. at 5:134-5, 8:201, 12:326.). However, baldly stating that there are safer alternatives to Enbrel, without providing factual support that they exist, is insufficient to survive a 12(b)(6) motion. See Leonard v. Taro Pharmaceuticals USA, Inc., No. 10-1341, 2010 WL 4961647, at *5-6, 2010 U.S. Dist. LEXIS 127892 at *15 (W.D.Pa. Dec. 2, 2010) (stating that plaintiff failed to plead sufficient facts for negligent design of a pharmaceutical drug to show that one drug sufficiently differed from others of the same kind). Thus, because Plaintiff has failed to sufficiently plead that there exists an alternative, feasible, and safer design, the Court finds that he has failed to state a claim for negligent design/manufacture.
Plaintiff's recitation of specific negligent acts committed by Defendants is little more than a list of legal conclusions regarding Defendants' failure to test, market, warn, design, and manufacture. Pennsylvania law does not recognize negligent testing or negligent marketing theories. Likewise, Plaintiff's failure-to-warn theory lacks facts regarding breach of duty and causation, and appears to be contradicted by the Enbrel Package Insert supplied by Defendants, which outlines the serious risks of infection and other adverse effects which may be caused by taking Enbrel. Furthermore, his negligent design/manufacture theory fails due to a failure to identify a safer, feasible alternative.
Thus, Defendants' Motion to Dismiss Count I of the Complaint will be
Plaintiff also asserts two strict product liability claims against the Defendants based on design defect and failure-to-warn theories. (Compl. at 13-14:350-76.) In his Complaint, Plaintiff avers not only that Enbrel "reached [Decedent] without substantial change in its condition," "was dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchased it," and that "the risks of Enbrel outweighed its utility" (Compl. at 13:339-46.), but also that Defendants "failed to warn of the true risks and dangers, and of the symptoms, scope and severity of the potential side effect[s] of the drug [Decedent] ingested." (Compl. at 13:359-61.)
Defendants argue that the strict liability claims should be dismissed because, under Pennsylvania law, strict liability claims against a pharmaceutical company for design/manufacturing defect and failure-to-warn are not cognizable. (See Document No. 19 at 7-9.) Rather, product liability claims against pharmaceutical companies can only be brought as negligence claims. (Document No. 19 at 7-9.) In response, Plaintiff failed to address the merits of Defendants' legal argument, and only asks the Court not to dismiss the claims because his Complaint is sufficiently pled to
Product Liability claims against a pharmaceutical company, under Pennsylvania law, can only be brought under a theory of negligence, not strict liability. The Supreme Court of Pennsylvania has stated that "in cases where a failure to provide sufficient warnings relative to prescription drugs has been alleged, negligence is the only recognized basis for recovery." Hahn v. Richter, 543 Pa. 558, 673 A.2d 888, 889 (1996). The Court further reasoned that Restatement (Second) of Torts § 402A, cmt. k (1965), which is titled "Unavoidably unsafe products," does not apply strict liability to "products such as prescription drugs, which, although dangerous in that they are not without medical risks, are not deemed defective and unreasonably dangerous when marketed with proper warnings." Hahn, 673 A.2d at 889-90 (citing Restatement (Second) of Torts § 402A, cmt. k (1965)); Accord Incollingo v. Ewing, 444 Pa. 263, 282 A.2d 206, 219-20 (1971) (stating strict liability was not applicable to a case involving a prescription drug manufacturer's alleged failure to properly warn physicians of the dangers involved with taking the drug); Baldino v. Castagna, 505 Pa. 239, 478 A.2d 807 (1984) (reaffirmed that the basis for liability, when a prescription drug manufacturer failed to adequately warn of the potential dangers of the drug, was a reasonable care standard and not strict liability); Mazur v. Merck & Co., Inc., 964 F.2d 1348, 1353-55 (3d Cir.1992) (stating prescription drug manufacturer's liability is determined through a negligence theory, not a strict liability theory); Parkinson, 315 F.Supp.2d at 748 (stating "that, as with inadequate warnings, the only recognized basis of liability for an improperly prepared product likewise is negligence").
In the present case, Plaintiff attempts to bring claims against a manufacturer of a prescription drug under the strict product liability theories of design defect and failure-to-warn. The Court finds and rules that Plaintiff has failed to state a cognizable strict products liability claim under Pennsylvania law. Accordingly, Defendants' Motion to Dismiss Claims II and III of the Complaint will be
Plaintiff claims that Defendants are also liable for breach of express and/or implied warranties. (See Compl. at 14-16.) Defendants respond by arguing that: (1) a pharmaceutical manufacturer cannot be held liable for claims not sounding in negligence, and (2) Plaintiff has failed to allege sufficient facts to state a claim for either breach of express or implied warranty. (See Document No. 19 at 9-11.) In his Brief in Opposition, Plaintiff does not address Defendants' legal arguments but contends only that the facts presented sufficiently state a claim. (See Document No. 20.)
As with Plaintiff's strict product liability claims, his attempt to assert claims for breach of express and/or implied warranties must fail. As noted above, the Supreme Court of Pennsylvania has ruled that a pharmaceutical manufacturer cannot be held liable for a claim that is not based in negligence. See Hahn, 673 A.2d at 888. Furthermore, "Pennsylvania state and federal courts have interpreted Hahn broadly to bar all non-negligence based claims asserted against a manufacturer of prescription drugs." Leonard v. Taro Pharmaceuticals
Thus, the Court finds and rules that claims for breach of express and/or implied warranties against a manufacturer of prescription drugs are not cognizable under Pennsylvania law and Defendants' Motion to Dismiss counts IV and V of the Complaint will be
In Count VI, Plaintiff asserts a claim for gross negligence and seeks punitive damages. Defendants aver that Plaintiff has failed to plead sufficient facts to support a claim for punitive damages. (Document No. 19 at 16.) Specifically, Defendants state that "Plaintiff has failed to allege how Defendants acted in such a way that was `so outrageous as to demonstrate willful, wanton or reckless conduct.'" (Document No. 19 at 16) (citing Hutchison ex rel. Hutchison v. Luddy, 582 Pa. 114, 870 A.2d 766, 771 (2005)). In response, Plaintiff argues that dismissing his punitive damages claim would be improper at this time. (Document No. 20 at 12-14.) He further argues that his punitive damages claim, as well as all of his other claims, are entitled to be tested in discovery. The Court does not find Plaintiff's argument persuasive.
In order to constitute "gross negligence," the defendants' behavior "must be flagrant, grossly deviating from the ordinary standard of care." Tipton v. Viaquest Behavioral Health of Pa., LLC, No. 10-3573, 2010 WL 5258473, at *5-6, 2010 U.S. Dist. LEXIS 136019 at *15-16 (E.D.Pa. Dec. 23, 2010) (citing Albright v. Abington Mem. Hosp., 548 Pa. 268, 696 A.2d 1159, 1164 (1997)). Furthermore, "[u]nder Pennsylvania law, degrees of negligence are not generally recognized. See Ferrick Excavating & Grading Co. v. Senger Trucking Co., 506 Pa. 181, 191, 484 A.2d 744, 749 (1984). Rather, the term "gross negligence" refers to a standard of care, rather than to a separate claim." Floyd v. Brown & Williamson Tobacco Corp., 159 F.Supp.2d 823, 828 (E.D.Pa. 2001). Similarly, punitive damages are not an independent cause of action, and may only be recovered if there is a valid underlying claim. See Kirkbride v. Lisbon Contractors, Inc., 521 Pa. 97, 555 A.2d 800, 802 (1989) (stating that "[i]f no cause of action exists, then no independent action exists for a claim of punitive damage since punitive damages is only an element of damages. To this extent, punitive damages must, by necessity, be related to the injury-producing cause of action."). Plaintiff can only maintain this action, with an underlying injury-producing claim, if additionally, evidence of outrageous conduct exists.
Nelson v. Wyeth, No. 1670, 2007 Phila. Ct. Com. Pl. LEXIS 316, at *18 (Pa.C.P.2007) (citing Chambers v. Montgomery, 411 Pa. 339, 192 A.2d 355, 358 (1963)). Here, Plaintiff has failed to allege conduct by any Defendant which was so outrageous as to support imposing punitive damages and the Complaint fails to satisfy the pleading standard of Twombly, Fowler, and Phillips. Furthermore, with all other claims being dismissed, Plaintiff's claim for punitive damages cannot stand alone.
It is difficult to envision facts that would support a claim for punitive damages in this case, but Plaintiff will be given an opportunity to do so. Therefore, Defendants' Motion to Dismiss Count VI of the Complaint ("gross negligence") will be
The Complaint asserts claims for wrongful death and survival action. Wrongful death actions accrue directly to certain beneficiaries—i.e. the spouse, children, or parents—of a decedent who has been wrongfully killed. Pennsylvania's wrongful death statute states, in pertinent part: "`An action may be brought ... to recover damages for the death of an individual caused by the wrongful act or neglect or unlawful violence or negligence of another ....' 42 Pa.C.S.A. § 8301 (2007)." Francis v. Northumberland Co., 636 F.Supp.2d 368, 393 (M.D.Pa.2009). Furthermore, "[a]s distinguished from the wrongful death statutes, the survival statutes do not create a new cause of action; they simply permit a personal representative to enforce a cause of action which had already accrued to the deceased before his death." McGowan v. Univ. of Scranton, 759 F.2d 287, 295 (3d Cir.1985). Plaintiff's wrongful death claim and survival action are legitimate as mechanisms for recovery. They cannot be brought, however, as claims in-and-of themselves, because an underlying claim, such as negligence, is needed for these claims to be cognizant. See id. Thus, because Defendants' Motion to Dismiss will be
If a complaint is subject to Rule 12(b)(6) dismissal, a district court must permit a curative amendment unless such an amendment would be inequitable or futile. Alston v. Parker, 363 F.3d 229, 235 (3d Cir.2004); accord Grayson v. Mayview State Hosp., 293 F.3d 103 (3d Cir.2002). A district court must provide the plaintiff with this opportunity even if the plaintiff does not seek leave to amend. Id. In this case, Plaintiff has requested leave to amend, and Defendants do not oppose that request. The district court may dismiss the action if the plaintiff does not file a second amended complaint within that time, or if the plaintiff files a notice of his intent to stand on the complaint as filed.
Plaintiff's non-negligence claims are barred as a matter of law and it would be futile and inequitable to permit further amendments as to those causes of action. However, Plaintiff's negligence claim is potentially cognizable, although the Court has determined that insufficient facts have
Defendants have raised numerous meritorious legal challenges. If Plaintiff chooses to file a second amended complaint, it will be important to address all of these alleged shortcomings to assure that the amended complaint contains sufficient factual allegations to render the claim(s) "plausible" in compliance with the pleading standard set forth and explained in Twombly, Fowler and Phillips.
In summary, Defendants' Motions to Dismiss the Complaint will be
An appropriate Order follows.
AND NOW, this 18th day of August, 2011, for the reasons set forth in the foregoing Memorandum Opinion, it is hereby