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Kester v. Zimmer Holdings

June 16, 2010


The opinion of the court was delivered by: Terrence F. McVerry United States District Court Judge


Pending before the court are the MOTION OF APP PHARMACEUTICALS, LLC, APP PHARMACEUTICALS, INC., ABRAXIS BIOSCIENCE, LLC, AND ABRAXIS BIOSCIENCE, INC. TO DISMISS UNDER FEDERAL RULE OF CIVIL PROCEDURE 12(B)(6) (collectively, "APP" or the "APP Defendants") (Doc. No. 59) with brief in support (Doc. No. 60), the MOTION OF HOSPIRA INC. TO DISMISS UNDER FEDERAL RULE OF CIVIL PROCEDURE 12(B)(6) (Doc. No. 62) with brief in support (Doc. No. 63), and the MOTION OF ZIMMER HOLDINGS, INC. TO DISMISS UNDER FEDERAL RULE OF CIVIL PROCEDURE 12(B)(6) (Doc. No. 72) with brief in support (Doc. No. 73). Plaintiff filed Responses in Opposition to the Motions to Dismiss against Defendants Hospira (Doc. No. 67) and APP (Doc. No. 68). Plaintiff also contests Zimmer‟s Motion to Dismiss but filed her Opposition to Zimmer‟s Motion to Dismiss (Doc. No. 48) prior to the District Court for the Eastern District of Pennsylvania granting Zimmer‟s Motion to Transfer Venue (Doc. No. 55). Only Hospira (Doc. No. 81) and the APP Defendants (Doc. No. 80) filed a Reply in Response to Plaintiff‟s Opposition. Accordingly, the motions are now fully briefed and ripe for disposition.

Factual Background

This case arises out of the health conditions allegedly suffered by Plaintiff, which occurred subsequent to her shoulder surgery on November 13, 2007. The Complaint alleges that Plaintiff‟s orthopedic surgeon implanted a Zimmer*fn1 ambulatory postoperative "pain pump" into her shoulder that continuously injected "pain relief medication" into her glenohumeral shoulder joint following the procedure. As a result, Plaintiff contends that she was diagnosed with chondrolysis and experienced loss of range of motion and the functional use of her arm, as well as other associated injuries.

According to Plaintiff, glenohumeral chondrolysis is the "progressive destruction of articular cartilage in the glenohumeral joint (the joint that connects the arm to the shoulder) leading to secondary joint space narrowing, which results in constant pain and loss of full use of the shoulder and/or arm." (Compl. at ¶ 25). The condition apparently has no effective treatment and most individuals affected must have shoulder replacement surgery. (Compl. at 34).

The Complaint states that postarthroscopic glenohumeral chondrolysis was first widely identified in 2004 and an epidemiological correlation between the use of pain pumps after arthroscopic shoulder surgery and glenohumeral chondrolysis was established in 2007. (Compl. at ¶¶ 26-27) (internal citations omitted). This correlation allegedly provides support to studies that established Bupivacaine is cytoxic to chondrocytes in animals and the continuous injection of anesthetic medications into the shoulder causes the destruction of chondrocytes, resulting in the condition known as glenohumeral chondrolysis. (Compl. at ¶¶ 29-30). Plaintiff claims that the Defendants failed to recognize this correlation despite the wealth of scientific information available.

APP Defendants allegedly "research, develop, manufacture, and market pharmaceutical products, including Sensorcaine (generically, Bupicavaine), which is an anesthetic drug used in the pain pumps manufactured by Defendant Pain Pump Manufactures." (Compl. at ¶ 14). Likewise, the Complaint states Hospira, Inc. ("Hospira) "researches, develops, manufactures, and markets pharmaceutical products, including Marcaine, which is Defendant Hospira Inc.‟s "brand name for the generic anesthetic, Bupivacaine, used in pain pumps manufactured by Defendant Pain Pump Manufacturers." (Compl. at ¶ 11). However, an averment in the Complaint also submits testimony from a witness for Astrazeneca Pharmaceuticals, another manufacturer of Bupivacaine not named in this action, who indicates that he or she has "heard them interchange" Marcaine for Sensorcaine. (Compl. at ¶ 24).

Plaintiff collectively refers to APP and Hospira as "Defendant Anesthetic Manufacturers." (Compl. at ¶ 15). Additionally, "Pain Pump Manufacturers"*fn2 allegedly "designed, manufactured, marketed, and distributed "pain pumps‟" that deliver a continuous dose of pain relief medication. (Compl. at ¶ 19). The Complaint notes the "pain relief medication" is "generically named Bupivacaine" and "flows directly into the glenohumeral joint. . . . following arthroscopic or open shoulder surgery." (Compl. at ¶ 20). The Complaint also alleges, "[a]t all relevant times, Defendant Anesthetic Manufacturers designed, manufactured, marketed, and distributed Bupivacaine and Bupivacaine mixed with epinephrine (hereinafter "Bupivacaine products‟) under various trade names, for use in orthopedic surgery, specifically arthroscopic surgery." (Compl. at ¶ 21).

However, Plaintiff also claims that Bupivacaine products are "commonly used in pain pump devices, including the pain pump used following Plaintiff‟s shoulder surgery." (Compl. at ¶ 22). There is not a single averment in the Complaint as to the use of either Marcaine or Sensorcaine in the pain pump inserted into Plaintiff‟s shoulder. Rather, the Complaint generically alleges that Plaintiff has "sustained severe and permanent personal injuries" as a result of the "manufacture, marketing, advertising, promotion, distribution, and/or sale of pain pumps containing Bupivacaine and/or Bupivacaine with Epinephrine to the Plaintiff." (Compl. at ¶ 36).

The Complaint alleges the following causes of action: (1) negligence and negligence per se; (2) strict products liability; (3) breach of express warranty; (4) breach of implied warranty;*fn3 (5) fraudulent misrepresentation; (6) fraudulent concealment; (7) negligent misrepresentation; (8) fraud and deceit; and (9) violation of Pennsylvania Unfair Trade Practices Act and Consumer Protection Law ("UTPCPL").*fn4

Defendants argue that all of these claims should be dismissed for failure to state a claim. In the interest of judicial economy, the Court will not address every defense raised by each individual Defendant. Given the collective averments scattered throughout the Complaint, the parties‟ incorporation of various arguments by reference, and the requirement to provide a curative amendment, it would be wasteful and repetitious to address each Defendant seriatim.

Specifically, the Court will only address a defendant‟s legal challenge if all co- defendants raise the defense, if a party individually raises the defense and its application would be dispositive of a collectively asserted claim, or if the Court takes judicial notice in order to promote efficiency and preserve resources if Plaintiff files an amended complaint.

In turn, the Defendants separately or collectively assert variations of the following: (1) that the negligence claim must fail because there is no casual connection between Defendants product and the alleged injury based on Plaintiff‟s failure to identify the medication or the specific manufacturer or distributor of the medication; (2) that Pennsylvania law bars a strict liability cause of action against a prescription drug manufacturer based on an alleged failure to warn; (3) that the breach of express warranty claim must fail because it is devoid of any factual matter to support or identify the existence of an express warranty; (4) that Pennsylvania law bars a plaintiff from asserting a breach of implied warranty cause of action against a prescription drug manufacturer; (5) that the misrepresentation and fraud-based claims must fail because the allegations are not pled with the requisite particularity; and (6) Plaintiff‟s UTPCPL claim is barred by the learned intermediary doctrine. Defendants also allege that Plaintiff‟s product liability and negligence claims, as asserted in Counts I, II, and V-VIII are barred by the applicable statute of limitations.

Motion to Dismiss Pursuant to Fed. R. Civ. P. 12(b)(6)

Defendants have raised numerous legal challenges to the Complaint. The Court will first address Defendants' contention that the Court should dismiss Plaintiff's Complaint pursuant to Fed. R. Civ. P. 12(b)(6), insofar as such would initially be dispositive of all claims.

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*fn5 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 assume 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 ...

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