Gary Carter, Plaintiff, vs. App pharmaceuticals, llc, et al., Defendants

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2013 U.S. Dist. LEXIS 147671, *

Gary Carter, Plaintiff, vs. APP Pharmaceuticals, LLC, et al., Defendants.
No. CV-10-02573-PHX-ROS
2013 U.S. Dist. LEXIS 147671

July 29, 2013, Decided

August 13, 2013, Filed

COUNSEL: [*1] For Gary Carter, Plaintiff: Daniel Robert Lapinski, Philip A Tortoreti, Satish V Poondi, Wilentz Goldman & Spitzer PA, Woodbridge, NJ; Frances Tomes, Tomes & Hanratty PC, Freehold, NJ; Michael William Pearson, Curry Pearson & Wooten PLC, Phoenix, AZ; Neal R Lewis, Lewis & Associates, Orland, IN.
For B. Braun Medical Incorporated, named as: B. Braun Medical, Inc., Defendant: Daniel E Tranen, Geoffrey M Coan, Hinshaw & Culbertson LLP, Boston, MA; Darrell S Dudzik, Hinshaw & Culbertson LLP, Phoenix, AZ.
For Cardinal Health 110 Incorporated, named as: Cardinal Health 110, Inc., Defendant: Daniel E Tranen, Geoffrey M Coan, Hinshaw & Culbertson LLP, Boston, MA; Darrell S Dudzik, Hinshaw & Culbertson LLP, Phoenix, AZ; Kathleen E Kelly, Hinshaw & Culbertson LLP - Boston, MA, Boston, MA.
JUDGES: Roslyn O. Silver, Chief United States District Judge.
OPINION BY: Roslyn O. Silver

Defendants B. Braun Medical Inc. ("B. Braun") and Cardinal Health 110, Inc., ("Cardinal Health") have filed a Motion for Summary Judgment under Fed.R.Civ.P. 56 as to all of Plaintiff's claims against them. (Doc. 154). For the reasons that follow, these remaining Defendants' Motion for Summary Judgment is granted. 1
1 Former named [*2] Defendants Hospira Worldwide, Inc., AmerisourceBergen Drug Corporation, Baxter Healthcare Corporation, and APP Pharmaceuticals, LLC, have been dismissed. (Doc. 83, 90, 100 & 201).

Plaintiff has asserted claims for strict liability/failure to warn (Count I), strict liability/design defect (Count II), and negligence (Count III). (Doc. 1, Compl.; Doc. 57, Order; Doc. 70 ¶ 1). 2 Plaintiff alleges that while hospitalized following a motorcycle accident, he was administered heparin and developed heparin-induced thrombocytopenia ("HIT") which resulted in amputation of his forearm. Plaintiff alleges he suffered injury as a direct and proximate result of Defendants' failure to warn of the dangers associated with heparin use. (Compl. ¶¶ 11-36). Jurisdiction is based on diversity. 28 U.S.C. § 1332. (Id. ¶ 9). Federal courts sitting in diversity look to the forum state's choice of law rules to determine the controlling substantive law. Mazza v. Am. Honda Motor Co., 666 F.3d 581, 589 (9th Cir. 2012). The parties agree that Arizona law applies to Plaintiff's state law claims.
2 Plaintiff alleged claims for breach of express and implied warranty in his Complaint. (Compl. at ¶¶ 56-63). These [*3] claims were dismissed as to Cardinal Health. (Doc. 57, Order). Plaintiff stated in the Joint Status Report and Discovery Plan that he was asserting claims for strict liability and negligence. (Doc. 70 ¶ 1).
A. Background Facts

In 2008, B. Braun manufactured and sold a product that contained 1000 units of heparin sodium in 500 ML of saline packaged in an Excel® bag. (Doc. 155, Defs.' Statement of Facts ("DSOF") ¶ 1, Ex. 1, Stolarick Decl. ¶ 2). The B. Braun heparin product is solely used to maintain patency 3 in catheter lines, referred to as a "heparin flush." (DSOF ¶ 2, Stolarick Decl., Ex. B). In 2008, B. Braun's heparin product label contained the following warning regarding heparin-induced thrombocytopenia ("HIT") and heparin-induced thrombocytopenia and thrombosis ("HITT"):

Heparin-induced Thrombocytopenia (HIT) and Heparin-induced Thrombocytopenia and Thrombosis (HITT): Heparin-induced Thrombocytopenia (HIT) is a serious antibody-mediated reaction resulting from irreversible aggregation of platelets. HIT may progress to the development of venous and arterial thromboses, a condition referred to as Heparin-induced Thrombocytopenia and Thrombosis (HITT). Thrombotic events may also [*4] be the initial presentation for HITT. These serious thromboembolic events include deep vein thrombosis, pulmonary embolism, cerebral vein thrombosis, limb ischemia, stroke, myocardial infarction, mesenteric thrombosis, renal arterial thrombosis, skin necrosis, gangrene of the extremities that may lead to amputation, and possibly death. Thrombocytopenia of any degree should be monitored closely. If the platelet count falls below 100,000/mm or if recurrent thrombosis develops, the heparin product should be promptly discontinued and alternative anticoagulants considered if patients require continued anticoagulation.

(DSOF ¶ 3, Stolarick Decl., Ex. B).
3 The term "patency" refers to "the state of being open or unobstructed." Webster's New College Dictionary at 1055 (2007 ed.).

Cardinal Health, who distributes B. Braun products to healthcare facilities, sold B. Braun's heparin flush product to St. Joseph's Hospital regarding the events alleged. (DSOF ¶¶ 26-27, Ex. 7, Sparks Decl. ¶¶ 3 & 5). Cardinal Health does not manufacture heparin products and has no role in heparin product labeling. (DSOF ¶ 28, Sparks Decl. ¶¶ 6-7).

B. Braun's heparin product was approved by the Food and Drug Administration [*5] ("FDA") under a New Drug Application ("NDA") filed pursuant to 21 U.S.C. § 355(b)(2). (DSOF ¶¶ 6 & 9, Stolarick Decl. ¶ 4). B. Braun submitted an NDA because the drug's container was a new mechanism for delivery but the heparin sodium incorporated into B. Braun's heparin flush is the same as that contained in the product of the reference listed drug ("RLD") holder. (DSOF ¶ 7, Stolarick Decl. ¶ 6). 4 B. Braun states it was not required to, and did not, conduct additional clinical, safety and efficacy studies of the heparin sodium drug to acquire FDA approval. (DSOF ¶ 9, Stolarick Decl. ¶ 5). According to B. Braun, its reliance on the RLD required that it use a label identical to the RLD holder's label approved by the FDA. (DSOF ¶¶ 10 & 12, Stolarick Decl. ¶ 9). The RLD identified for heparin sodium in the FDA "Orange Book" is a heparin product manufactured by Baxter Healthcare Corporation ("Baxter Healthcare"), not B. Braun. (DSOF ¶¶ 7, 11, Stolarick Decl. ¶ 7). 5 According to B. Braun, it was required to match its warnings with Baxter Healthcare's warning label, including any updates. (DSOF ¶¶ 10-13, Stolarick Decl. ¶¶ 9-13).
4 B. Braun states it "does not manufacture the heparin API [*6] used in its products. B. Braun mixes unfractionated heparin (API) with saline and places the mixture into the Excel® container, which it does manufacture. B. Braun then sells a premixed heparin flush solution in its Excel® container." (Doc. 198, Defs.' Reply to Pl.'s Controverting SOF at 10 ¶ 9).

5 The "Orange Book" is the "commonly referred" to name for the Approved Drug Products with Therapeutic Equivalence Evaluations list in which FDA publishes the names of approved drugs and their associated patent information. AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1045 (Fed. Cir. 2010). "Listed drug status is evidenced by the drug product's identification as a drug with an effective approval in the current edition of FDA's 'Approved Drug Products with Therapeutic Equivalence Evaluations' (the list) or any current supplement thereto, as a drug with an effective approval." 21 C.F.R. § 314.3(b).

Plaintiff Gary Carter was admitted to St. Joseph's Hospital on November 23, 2008 as a result of injuries sustained in a motorcycle accident. (Doc. 166, Pl.'s Counter Statement of Facts ("PCSOF") ¶ 55; Doc. 179 & 186, Ex. 37, Medical Records at GC2036-2038, GC2032). While Plaintiff was in the Intensive [*7] Care Unit on November 23, an arterial line was placed in his left forearm and he received, among other treatments, a heparin flush product manufactured by B. Braun. (PCSOF ¶ 57; DSOF ¶¶ 15-16). Plaintiff received another heparin flush product manufactured by B. Braun on November 28, 2008. (PCSOF ¶ 59; DSOF ¶ 15). Plaintiff was administered low molecular weight heparin ("LMWH") on November 29, 2008. (PCSOF ¶ 60).

By November 30, 2008, Plaintiff's platelet count had dropped, he showed signs of necrosis to his left upper extremity that continued to worsen, and he was diagnosed with development of a blood clot in his left hand. (PCSOF ¶¶ 61-62; DSOF ¶ 17, Ex. 4, Mankin Dep. at 46-48). Plaintiff received several doses of heparin on December 1-2, 2008. (PCSOF ¶¶ 64-65). A December 1, 2008 HIT Panel recommended by Dr. James Mankin came back positive for HIT on December 2, 2008 and heparin was discontinued. (PCSOF ¶¶ 63-64; DSOF ¶ 18). On December 1 or 2, 2008, Plaintiff underwent surgery on his left hand but blood flow could not be reestablished. (PCSOF ¶¶ 64, 66; DSOF ¶¶19-21, Ex. 3, Tomeh Dep. at 151-52 & Ex. 5, Zoldos Dep. at 111). On December 26, 2008, Plaintiff's hand up to his forearm [*8] was amputated. (Zoldos Dep. at 134-35). It appeared to Plaintiff's treating physician, Dr. Salaheddine Tomeh, upon his review of Plaintiff's medical records, that Plaintiff "had HIT, which is heparin induced thrombocytopenia, that caused his hand arteries to clot." (PCSOF ¶ 68; Doc. 155, Ex.3, Tomeh Dep. at 117).

St. Joseph Hospital at the time had a protocol for the routine use of a heparin flush product to maintain patency of arterial lines. (DSOF ¶ 23, Ex. 6, Feldman Aff. ¶ 6). This protocol was developed by a hospital committee based on available scientific and medical literature, best practices, and the standard of care for patients who used the arterial lines. (DSOF ¶ 25, Ex. 6, Feldman Aff. ¶ 8). According to Defendants, the use of a heparin flush in an arterial line was authorized without a specific order from a physician. (DSOF ¶ 24, Ex. 6, Feldman Aff. ¶ 7).
A. The Summary Judgment Standard

Summary judgment is appropriate where "the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(a). When determining whether a genuine dispute exists, the evidence of the non-moving party [*9] is to be believed, and all reasonable inferences drawn in its favor. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255-56, 106 S. Ct. 2505, 91 L. Ed. 2d 202 (1986). "[A] party seeking summary judgment always bears the initial responsibility of informing the district court of the basis for its motion, and identifying those portions of the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, which it believes demonstrate the absence of a genuine issue of material fact." Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S. Ct. 2548, 91 L. Ed. 2d 265 (1986) (internal citations omitted).
B. Preemption of Plaintiff's Claims

B. Braun and Cardinal Health contend Plaintiff's claims are preempted by federal law. (Doc. 154 at 5, 8). B. Braun argues it is not the brand manufacturer or RLD holder for heparin sodium; that is Baxter Healthcare. (Id. at 4-7). B. Braun contends it received approval for its heparin product packaged in the Excel® bag under an NDA filed in accordance with 21 U.S.C. § 355(b)(2) but only because the container was a new mechanism for delivery of its heparin product. (Id. at 4). According to B. Braun, while it was not required to conduct clinical and efficacy studies of its heparin [*10] sodium drug, it was required to implement a warning label identical to the FDA-approved RLD label for heparin sodium, and B. Braun could only update its label to match the FDA-approved RLD label, that is, the Baxter Healthcare label. (Id. at 4). B. Braun contends it did not design the heparin sodium drug administered to Plaintiff and therefore it had to follow the RLD's labeling for the heparin drug administered through its Excel® bag. (Id. at 6). B. Braun argues the rationale of PLIVA, Inc. v. Mensing, 131 S.Ct. 2567, 2574, 180 L. Ed. 2d 580 (2011), should be extended to preempt Plaintiff's claims because under federal regulations it must implement a label with the same warning as the RLD warnings. (Id. at 5-8).

In Mensing, the Supreme Court held that federal drug regulations applicable to generic drug manufacturers conflict with and preempt state-law claims based on failure to provide adequate warning labels. Id., 131 S.Ct. at 2572-73. The Supreme Court explained that federal regulations enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984 ("the Hatch-Waxman Amendments"), require generic drug manufacturers to provide the same warning label as that provided by the brand [*11] name drug. This "federal duty of 'sameness'" requires "generic drug labels be the same at all times as the corresponding brand-name drug labels." Id. at 2574-75, 2578. As considered in Mensing, "'generic drug' refers to a drug designed to be a copy of a reference listed drug (typically a brand-name drug), and thus identical in active ingredients, safety, and efficacy." Id. at 2574 n.2.

Plaintiff responds that B. Braun's heparin flush product is not a generic product but was approved under an NDA pursuant to 21 U.S.C. § 355(b), while generic drugs are approved under 21 U.S.C. § 355(j). Plaintiff argues that preemption under Mensing does not apply (Doc. 205 at 6, 9-10), noting Mensing's discussion that "a brand-name manufacturer seeking new drug approval is responsible for the accuracy and adequacy of its label." Mensing, 131 S.Ct. at 2574. Plaintiff argues that B. Braun is its own RLD, that the packaging and labeling of its heparin product is unique, and B. Braun could have modified its heparin package insert through the FDA's "Changes Being Effected" ("CBE") 6 regulations but chose not to. (Doc. 205 at 6). Plaintiff cites a July 5, 2007 e-mail from B. Braun's label analyst Kathleen [*12] Holdren sent to B. Braun's heparin consultant in which Holdren stated:
6 The FDA's "Changes Being Effected," or CBE, process permits a drug manufacturer without prior preapproval to add to or strengthen a warning label. See Mensing, 131 S.Ct. at 2575.

(Doc. 205 at 9, citing PCSOF ¶ 51).

Plaintiff additionally argues B. Braun's label is different in three respects from Baxter Healthcare's label. First, in 2007 Baxter Healthcare removed from its label any reference to "white clot syndrome." (Doc. 205 at 11, n.7 & Doc. 186, Ex. 35, Baxter Healthcare Label). 7 B. Braun opted not to revise its label and ignored not only that label change but also the concerns of B. Braun's medical expert who stated:
7 Defendants object that Plaintiff relies on a Baxter Healthcare label that is not dated or authenticated. (Doc. 197 at 6). The Court may consider the Baxter Healthcare label as it is a matter of public record. Mills v. Bristol-Myers Squibb Co., No. CV 11-968-PHX-FJM, 2011 U.S. Dist. LEXIS 90357, 2011 WL 3566131 at, *3 n.2 (D. Ariz. Aug. 12, 2011).

(Doc. 205 at 12, citing PCSOF ¶ 52). Second, the Baxter Healthcare label states, "Thrombocytopenia has been reported to occur in patients receiving heparin with a reported [*13] incidence of up to 30%." (Doc. 205; Doc. 186, Ex. 35). The B. Braun label in contrast states: "Thrombocytopenia has been reported to occur in patients receiving heparin with a reported incidence of 0 to 30%." (Doc. 205 at 12). Third, the B. Braun label states, "if continued heparin therapy is essential, administration of heparin from a different organ source can be reinstituted with caution," but the Baxter Healthcare label does not contain this statement. (Doc. 205 at 11-12).

Plaintiff has not disputed the following facts contained in the declaration of B. Braun's corporate official Rebecca Stolarick: (1) the FDA approved B. Braun's NDA filed pursuant to § 355(b)(2) allowing it to market and sell its heparin product; (2) B. Braun submitted an NDA because the drug's container was a new mechanism for delivery of the drug but the heparin sodium used in the Excel® container is the same as the RLD holder's (Baxter Healthcare) heparin sodium; and (3) B. Braun was not required to, and did not, conduct additional clinical, efficacy, and safety studies of the heparin sodium drug to acquire FDA approval. (Doc. 155, Ex. 1, Stolarick Decl. ¶¶ 1, 4-7).

There are generally three kinds of applications [*14] that may be used to obtain FDA approval. Ethypharm S.A. France v. Abbott Labs., 707 F.3d 223, 226-28 (3d Cir. 2013). Regarding the first kind of application, the manufacturer of a new branded drug may submit an NDA under 21 U.S.C. §§ 355(a), (b)(1). Id. at 226-27. Once approved, information about the branded drug is published by the FDA in the "Orange Book." Id. at 226. If, as Plaintiff argues, B. Braun's heparin flush product was approved pursuant to an NDA under 21 U.S.C. § 355, B. Braun would have been required to file an application with the FDA that included "examples of the proposed label for the drug and clinical data demonstrating that the drug is safe and effective for use." AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1045 (Fed. Cir. 2010) (citing 21 U.S.C. § 355(b)(1)). As explained in Wyeth v. Levine, 555 U.S. 555, 129 S. Ct. 1187, 173 L. Ed. 2d 51 (2009), "manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times." 555 U.S. at 579. Under certain circumstances, a drug manufacturer may make label changes using the CBE process which allows them to "add or strengthen contraindications, warnings or precautions" without waiting for FDA-preapproval if they simultaneously file [*15] a supplemental application with the FDA. Mensing, 131 S.Ct at 2575 (citing 21 C.F.R. § 314.70(c)(6) & Wyeth, 555 U.S. at 568).

The second kind of application "provides for the introduction of generic versions of previously approved branded drugs." Ethypharm S.A. France, 707 F.3d at 227. The "generic manufacturer may submit an Abbreviated New Drug Application ("ANDA") to the FDA." Id. (citing 21 U.S.C. § 355(j)). "A drug that follows the ANDA pathway seeks to rely on research conducted by a third party - - the maker of the listed drug - - in order to meet the approval requirements." Watson Labs., Inc. v. Sebelius, No. 12-1344 (ABJ), 2012 U.S. Dist. LEXIS 185685, 2012 WL 6968224 at, *2 (D.D.C. Oct. 22, 2012). Under the ANDA process, "the generic manufacturer [may] incorporate efficacy and safety data submitted to the FDA in the NDA for a branded drug, so long as the generic drug is shown to be bioequivalent to that branded drug." Ethypharm S.A. France, 707 F.3d at 227. The applicant must file information that shows, inter alia, the labeling of the generic drug is the same as that of the listed drug. AstraZeneca LP vs. Apotex, Inc., 633 F.3d at 1045-46 (citing 21 U.S.C. § 355(j)(2)(A)(v)). 8
8 The FDA-approved brand [*16] name drug is the "reference listed drug." ViroPharma, Inc. v. Hamburg, 777 F. Supp. 2d 140, 143 (D.D.C. 2011). It therefore does not appear that B. Braun could be its "own RLD" as suggested in the Holdren e-mail.

The third kind of application is based on 21 U.S.C. § 355(b)(2) (§ 505(b)(2) of the FDCA). Ethypharm S.A. France, 707 F.3d at 227 (referring to § 505(b)(2) of the Food, Drug, and Cosmetics Act ("FDCA"), codified at 21 U.S.C. § 355(b)(2)). This kind of application has been referred to as a "paper NDA." AstraZeneca LP v. Breath Ltd., No. CV08-1512 (RMB/AMD), 2013 U.S. Dist. LEXIS 49375, 2013 WL 1385224 at, *2 (D.N.J. Apr. 3, 2013) (referring to a "'505(b)(2) application,'" as a "'paper NDA.'") (citing AstraZeneca LP v. Apotex, Inc., 633 F.3d at 1045 & 21 U.S.C. §§ 355(b)(2)). Under the § 505(b)(2) procedure, "a drug manufacturer may file an NDA for a drug that is not entirely new but is not simply a generic version of a branded drug." Ethypharm S.A. France, 707 F.3d at 227. The applicant provides certain information that allows it to avoid preclinical and human studies necessary to achieve a full NDA and shows the drug's approval will not infringe a valid patent. Id. This § 355(b)(2) pathway is consistent [*17] with B. Braun's undisputed facts based on the Stolarick Declaration discussed above regarding the manner in which the FDA approved its heparin flush product. The facts further show the RLD holder of heparin sodium is Baxter Healthcare.

The undisputed facts do not support Plaintiff's argument that B. Braun filed a full NDA under § 355(b). B. Braun may have filed an NDA but it was without supporting clinical and other information demonstrating the heparin flush product was safe and effective. The Court therefore concludes the undisputed facts show B. Braun's heparin flush product was approved pursuant to the "505(b)(2) paper NDA" application process under 21 U.S.C. § 355(b)(2) as B. Braun contends. The Court further concludes, however, Plaintiff's claims are not preempted based on Mensing. B.Braun has not shown based on clear authority that its heparin flush product is a generic drug or that it was required to "match" the Baxter Healthcare label in all respects regarding its product. Defendants are not entitled to summary judgment based on preemption of Plaintiff's claims.
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