Henry v. Angelini Pharms, Inc.

• Court: District Court, E.D. California
• Decided: March 31, 2020
• Docket: 2:17-cv-02593
• Status: Unknown

Opinion

1 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT 9 EASTERN DISTRICT OF CALIFORNIA 10 11 TOBY HENRY, No. 2:17-cv-02593-TLN-KJN 12 Plaintiff, 13 v. ORDER 14 ANGELINI PHARMA, INC.; TEVA PHARMACEUTICALS USA, INC.; and 15 ENDO VENTURES LIMITED, 16 Defendants. 17 18 This matter is before the Court on Defendants Angelini Pharma, Inc. (“Angelini Pharma”) 19 and Endo Ventures Limited’s (“Endo Ventures”) (collectively, “Defendants”) Motions to 20 Dismiss. (ECF Nos. 55, 56.) Plaintiff Toby Henry (“Plaintiff”) filed oppositions. (ECF Nos. 62, 21 63.) Defendants filed replies. (ECF Nos. 67, 68.) Also before the Court is Plaintiff’s Motion to 22 Strike Angelini Pharma’s reply. (ECF No. 69.) For the reasons set forth below, the Court 23 GRANTS Defendants’ Motions to Dismiss and DENIES Plaintiff’s Motion to Strike. 24 /// 25 /// 26 /// 27 /// 28 /// 1 I. FACTUAL AND PROCEDURAL BACKGROUND 2 Plaintiff, a California resident, consumed a generic intermediate release formulation of 3 trazodone hydrochloride1 after his physician prescribed the drug for insomnia. (ECF No. 49 at 2.) 4 After taking a 50-milligram dose of the drug on December 13, 2015, Plaintiff states that he 5 developed a prolonged penile erection, also known as a priapism, which lasted over 24 hours. 6 (Id.) Plaintiff alleges that he was unaware that trazodone carried a risk of priapism and that he 7 was also unaware of the danger of erectile dysfunction from a prolonged erection lasting greater 8 than six hours. (Id.) As such, Plaintiff did not seek medical attention for over 24 hours and is 9 now impotent. (Id.) 10 By way of history, Plaintiff alleges that Desyrel, the brand-name intermediate release 11 formulation of trazodone, was brought to market in the United States in the early 1980s. (Id. at 12 9.) According to Plaintiff, the Desyrel package insert included a warning about priapism in a 13 very prominent position: at the top of the warnings section and in capital letters. (Id.) Plaintiff 14 alleges this prominent warning about priapism initially continued after Desyrel was replaced by 15 its generic equivalent, but the priapism warning eventually diminished sometime in 2012. (Id. at 16 10.) For example, Plaintiff alleges that the once-prominent priapism warning was no longer the 17 highest listed, no longer capitalized, and was characterized as “rare” on the package insert for the 18 trazodone he consumed in 2015. (Id.) 19 Plaintiff asserts claims of strict liability, negligence, breach of implied warranty, breach of 20 express warranty, negligent misrepresentation, negligence per se, and punitive damages against 21 Defendant Teva Pharmaceuticals USA, Inc. (“Teva”), which is the manufacturer of the generic 22 trazodone he ingested, as well as Defendants Angelini Pharma and Endo Ventures, which are 23 companies that were involved “in some meaningful way” with Oleptro, a brand-name extended 24 release formulation of trazodone. (Id. at 2–3.) 25 Endo Ventures is the successor-in-interest of Labopharm Inc., the original Oleptro FDA 26 New Drug Application (“NDA”) holder, and Angelini Pharma is the current NDA holder for 27 1 Hereinafter, the Court will refer to trazodone hydrochloride as “trazodone” and will 28 specify between generic and brand versions when necessary. 1 Oleptro. (Id. at 4–5.) Endo Ventures is an Irish pharmaceutical company with headquarters in 2 Ireland and a United States headquarters in Pennsylvania. (Id. at 4.) Plaintiff alleges that Endo 3 Ventures placed Oleptro into the United States stream of commerce, including California. (Id.) 4 Angelini Pharma is a pharmaceutical company incorporated in Delaware and headquartered in 5 Maryland, and Plaintiff alleges that the company has systematic and continuous contacts to 6 California through marketing and placing Oleptro and other healthcare products into the stream of 7 commerce. (Id. at 3–4.) 8 Plaintiff alleges that Oleptro is “virtually identical” to the drug that caused his injury 9 because other than being an extended release version, it has the same chemical formulation as the 10 generic trazodone he took. (Id. at 11.) According to Plaintiff, Oleptro’s warning regarding 11 priapism was inadequate and based on false and misleading representations. (Id. at 14, 19.) 12 Plaintiff further alleges it was reasonably foreseeable that generic trazodone manufacturers would 13 follow the Oleptro product labeling. (Id.) Finally, Plaintiff alleges that Teva, the manufacturer of 14 the generic trazodone Plaintiff ingested, did in fact change its warning label to match the Oleptro 15 packaging because Teva considered Oleptro to be an “innovator” in trazodone medications. (Id. 16 at 20.) 17 II. STANDARD OF LAW 18 Federal Rule of Civil Procedure (“Rule”) 12(b)(2) allows a party to file a motion to 19 dismiss for lack of personal jurisdiction. Plaintiff has the burden of establishing that the Court 20 has personal jurisdiction over Defendant. In re W. States Wholesale Nat. Gas Antitrust Litig., 715 21 F.3d 716, 741 (9th Cir. 2013), aff’d sub nom., Oneok, Inc. v. Learjet, Inc., 135 S. Ct. 1591 (2015). 22 Where the Court does not hold an evidentiary hearing and the motion is based on the written 23 materials, Plaintiff need only establish a prima facie showing of personal jurisdiction. 24 Schwarzenegger v. Fred Martin Motor Co., 374 F.3d 797, 800 (9th Cir. 2004). In such a case, 25 “[u]ncontroverted allegations in the complaint must be taken as true” and “[c]onflicts between 26 parties over statements contained in affidavits must be resolved in the plaintiff’s favor.” Id. 27 If there is no applicable federal statute governing personal jurisdiction, the Court applies 28 the law of the state in which it sits. Love v. Associated Newspapers, Ltd., 611 F.3d 601, 608–09 1 (9th Cir. 2010). “California’s long-arm jurisdiction statute is coextensive with federal due 2 process requirements.” Id. Due process requires that for nonresident defendants to be subject to 3 the Court’s jurisdiction, defendants “have certain minimum contacts with [the forum state] such 4 that the maintenance of the suit does not offend traditional notions of fair play and substantial 5 justice.” Int’l Shoe Co. v. Washington, 326 U.S. 310, 316 (1945) (citation omitted). 6 The strength of contacts required depends on which of the two categories of personal 7 jurisdiction a litigant invokes: general jurisdiction or specific jurisdiction. A court may assert 8 general personal jurisdiction over corporations “when their affiliations with the State are so 9 ‘continuous and systematic’ as to render them essentially at home in the forum State.” Goodyear 10 Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915, 919 (2011). A corporation will primarily 11 be “at home” for the purposes of general jurisdiction in two paradigmatic forums: its place of 12 incorporation and its principal place of business. Daimler AG v. Bauman, 571 U.S. 117, 137 13 (2014). General jurisdiction is not limited to these two forums but will only be available 14 elsewhere in the “exceptional case” where a corporation’s affiliations with a forum are “so 15 substantial and of such a nature as to render the corporation at home in that State.” Id. at 139; see 16 also Martinez v. Aero Caribbean, 764 F.3d 1062, 1070 (9th Cir. 2014). 17 Specific jurisdiction is satisfied when the defendant’s activities are directed toward the 18 forum state and the defendant’s liability arises out of or relates to those activities. Daimler, 571 19 U.S. at 127. In the Ninth Circuit, courts employ a three-part test to determine whether a 20 defendant’s contacts suffice to establish specific jurisdiction: “(1) the nonresident defendant must 21 have purposefully availed himself of the privilege of conducting activities in the forum by some 22 affirmative act or conduct; (2) plaintiff’s claim must arise out of or result from the defendant’s 23 forum-related activities; and (3) exercise of jurisdiction must be reasonable.” Roth v. Garcia 24 Marquez, 942 F.2d 617, 620–21 (9th Cir. 1991) (emphasis omitted). Plaintiff bears the burden of 25 satisfying the first two prongs, and if they are met, the burden shifts to Defendant “to set forth a 26 ‘compelling case’ that the exercise of jurisdiction would not be reasonable.” Mavrix Photo, 647 27 F.3d at 1228. 28 /// 1 III. ANALYSIS 2 As a preliminary matter, Plaintiff moves to strike Angelini Pharma’s reply brief for 3 exceeding the page limit. Arguably a motion to strike is not the proper mechanism for 4 challenging the length of the reply. See Fed. R. Civ. P. 12(f) (“The court may strike from a 5 pleading an insufficient defense or any redundant, immaterial, impertinent, or scandalous 6 matter.”). Nor is it clear to the Court that Angelini Pharma’s use of objections was intended to 7 exceed the page limit set forth in the Court’s scheduling order. However, regardless of whether 8 Angelini Pharma did in fact exceed the page limit, the Court would arrive at the same conclusions 9 even if it ignores Angelini Pharma’s reply entirely. Therefore, the Court need not and does not 10 consider Angelini Pharma’s reply brief or objections and DENIES Plaintiff’s motion to strike as 11 moot. (ECF No. 69.) 12 Turning now to the motions to dismiss, Defendants argue that the Court lacks general or 13 specific personal jurisdiction over them pursuant to Rule 12(b)(2).2 In opposition, Plaintiff argues 14 only that the Court has specific jurisdiction over Defendants. In the alternative, Plaintiff asks the 15 Court to transfer the entire action to Maryland rather than dismiss should the Court conclude that 16 it lacks personal jurisdiction over Angelini Pharma and Endo Ventures. The Court will address 17 general jurisdiction, specific jurisdiction, and transfer in turn. 18 A. General Jurisdiction 19 Defendants argue that they are not “at home” in California for several reasons. Angelini 20 Pharma asserts that it is incorporated in Delaware and its principal place of business is in 21 Maryland. Angelini Pharma also asserts it has no operations, offices, or employees in California. 22 Further, Angelini Pharma asserts that it did not supply the generic or brand-name version of the 23 drug Plaintiff took but regardless, selling products in the forum, without more, is insufficient to 24 establish general jurisdiction. Angelini Pharma asserts it ships its healthcare products nationwide, 25 including to California, but its 2017 sales in at least seven other states far exceeded sales in 26

27 2 Defendants also argue that Plaintiff fails to state a plausible claim for relief under Rule 12(b)(6). Because, as will be discussed, the Court lacks personal jurisdiction over Defendants, 28 the Court need not and does not reach Defendants’ Rule 12(b)(6) arguments. 1 California. For its part, Endo Ventures simply argues that it is an Irish limited liability company 2 with its principal place of business in Ireland and any California business does not suffice to 3 establish general jurisdiction. 4 In opposition, Plaintiff fails to respond to Defendants’ arguments regarding general 5 jurisdiction. As discussed, a corporation will be “at home” for the purposes of general 6 jurisdiction in its place of incorporation and its principal place of business. Daimler, 571 U.S. at 7 137. Here, it is undisputed that Angelini Pharma is incorporated in Delaware and its principal 8 place of business is in Maryland. It is also undisputed that Endo Ventures is an Irish company 9 with headquarters in Ireland and a United States headquarters in Pennsylvania. Plaintiff makes no 10 effort to show that Defendants’ contacts with California are “so substantial and of such a nature 11 as to render the corporation[s] at home in that State.” Id. at 139. Rather, it appears Defendants’ 12 only alleged continuous contacts with California are shipments and marketing of Oleptro and 13 other healthcare products to the state, which is insufficient without more to establish general 14 jurisdiction. See id. Thus, the Court lacks general jurisdiction over Defendants. 15 B. Specific Jurisdiction 16 Angelini Pharma argues that Plaintiff fails to show any connection between the forum, the 17 underlying controversy, and an activity by Angelini Pharma in California. Angelini Pharma 18 argues that even if Plaintiff can show it was involved in the warning label for Oleptro, those 19 actions would have taken place in Maryland or New Jersey, and its distribution of other 20 healthcare products to California residents is unrelated to Plaintiff’s claims. Endo Ventures 21 similarly argues that there is no connection between Endo Ventures, Plaintiff, and California, 22 especially considering that Endo Ventures was no longer the NDA holder for Oleptro in 2011 — 23 the year before Teva allegedly changed its package insert for the generic trazodone taken by 24 Plaintiff. 25 In opposition, Plaintiff argues that the Court has specific jurisdiction because “although 26 Plaintiff’s claims may not have arisen out of Defendants’ contact with California, Plaintiff’s 27 claim is almost certainly related to Defendant’s contact with California.” (ECF No. 62 at 11.) 28 Plaintiff hinges this assertion on the conduct of one individual: Scot Van Steenburg. Plaintiff 1 contends for the first time in his oppositions that between July 2010 and October 2011, Angelini- 2 Labopharm — a joint venture between Labopharm (a company to which Endo Ventures is a 3 successor-in-interest) and Angelini Pharma — employed Van Steenburg to market and sell 4 Oleptro in the Los Angeles area. Plaintiff argues that “it is almost certain that [Van Steenburg] 5 would have been well versed in the occurrence of side-effects of Oleptro . . . [and that] he would 6 have relied upon information presented to the FDA in his discussions with practitioners, including 7 the rate of occurrence of the priapism side-effect.” (Id.) In other words, Plaintiff argues that 8 Defendants, through Van Steenburg, promoted and/or marketed Oleptro in California, and in 9 doing, so perpetuated a misrepresentation about the number of priapism cases linked to trazodone. 10 The Court notes that Plaintiff’s assertion appears to be based solely on a LinkedIn search by 11 Plaintiff’s counsel that resulted in Van Steenburg’s profile. 12 As noted, courts in the Ninth Circuit employ a three-part test to determine whether a 13 defendant’s contacts establish specific jurisdiction: “(1) the nonresident defendant must have 14 purposefully availed himself of the privilege of conducting activities in the forum by some 15 affirmative act or conduct; (2) plaintiff’s claim must arise out of or result from the defendant’s 16 forum-related activities; and (3) exercise of jurisdiction must be reasonable.” Roth, 942 F.2d at 17 620–21. Plaintiff bears the burden of satisfying the first two prongs, and if they are met, the 18 burden shifts to Defendants to set forth a “compelling case” that the exercise of jurisdiction would 19 not be reasonable. Id. 20 Plaintiff has not met his burden to show that his claim arose, resulted from, or was even 21 related to Defendants’ forum-related activities. Plaintiff’s claim arises from taking a drug in 22 California that was not manufactured by Angelini Pharma or Endo Ventures. As the Court 23 understands it, Plaintiff’s claim against moving Defendants is that he was injured because Teva, 24 the manufacturer of the drug Plaintiff took, allegedly relied on inadequate warnings and 25 misrepresentations about Oleptro in creating the warning label for the drug taken by Plaintiff. 26 The trouble with this attenuated legal theory is that there is nothing that ties Plaintiff’s claim to 27 Defendants’ activities in California. The only California-specific action Plaintiff offers is Van 28 Steenburg’s alleged marketing and selling of Oleptro in the Los Angeles area in 2010–2011 — at 1 least a year before Plaintiff alleges the prominent warning label for trazodone diminished — and 2 Plaintiff merely alleges that Van Steenburg likely perpetuated misrepresentations about the side 3 effects of trazodone during that time. Plaintiff does not include any of these allegations in the 4 operative complaint, and the relatively barebones, speculative, and unsubstantiated information 5 derived from Van Steenburg’s LinkedIn page is not sufficient to tether Angelini Pharma and 6 Endo Ventures to California. Even assuming — without having any way of knowing — that 7 Plaintiff’s assertions about Van Steenburg are true, Plaintiff fails to explain how the actions of a 8 single salesman in California, marketing and selling a drug Plaintiff did not take to an unknown 9 number of practitioners, four to five years before an injury that was caused by a different drug 10 manufactured by Teva, has anything to do with Plaintiff’s claims. Put another way, even if Van 11 Steenburg perpetuated misrepresentations about the side effects of trazodone during his year as an 12 Oleptro salesman, there is no indication that Van Steenburg’s conduct had any effect on how 13 Teva eventually labeled the trazodone product that allegedly harmed Plaintiff. 14 For all these reasons, the Court finds that it lacks specific jurisdiction over Angelini 15 Pharma and Endo Ventures. The Court further finds that amendment would be futile. Therefore, 16 the Court GRANTS Defendants’ motions to dismiss with prejudice. 17 C. Transfer 18 Plaintiff asks the Court in the alternative to transfer this action to the District of Maryland 19 pursuant to 28 U.S.C. § 1631 rather than dismiss Angelini Pharma and Endo Ventures should the 20 Court find that it lacks personal jurisdiction over them.3 Section 1631 states in relevant part: 21 Whenever a civil action is filed in a court and that court finds that there is a want of jurisdiction, the court shall, if it is in the interest of 22 justice, transfer such action or appeal to any other such court in which the action or appeal could have been brought at the time it was filed. 23 24 To transfer a case pursuant to 28 U.S.C. § 1631, the transferor court must lack 25 jurisdiction, the transferee court must be able to exercise jurisdiction, and the transfer must serve 26

27 3 On March 6, 2020, the Court ordered the parties to file supplemental briefs in support or opposition of the transfer of this action pursuant to 28 U.S.C. § 1631. All four parties submitted 28 supplemental briefs, which the Court has read and considered. 1 the interests of justice. Rodriguez-Roman v. INS, 98 F.3d 416, 424 (9th Cir. 1996). A case can 2 only be transferred to a district where it originally “could have been brought.” 28 U.S.C. § 1631. 3 “This means the transferee court must have subject matter jurisdiction, proper venue, and 4 defendant must be subject to personal jurisdiction and be amenable to service of process in that 5 district.” Kennedy v. Phillips, C11-1231-MJP, 2012 WL 261612, at *4 (W.D. Wash. Jan. 30, 6 2012) (citing Shapiro v. Bonanza Hotel Co., 185 F.2d 777, 780 (9th Cir. 1950)). “In cases 7 involving multiple defendants, the transferee district must be one in which personal jurisdiction 8 and venue requirements would have been satisfied as to all defendants.” Id. (emphasis in 9 original). In deciding whether to transfer rather than dismiss, courts consider whether the failure 10 to transfer would prejudice the litigant and other equitable factors. Cruz-Aguilera v. I.N.S., 245 11 F.3d 1070, 1074 (9th Cir. 2001). 12 Plaintiff argues that Maryland has personal jurisdiction over all Defendants. With respect 13 to Angelini Pharma, Plaintiff argues that Angelini Pharma’s principal place of business is in 14 Maryland. With respect to Teva, Plaintiff argues that his claim relates to Teva’s contacts with 15 Maryland because (1) Teva submitted an Abbreviated New Drug Application (“ANDA”) to the 16 FDA in Maryland for the generic drug that allegedly caused Plaintiff’s injuries, and (2) the 17 ANDA filing is “tightly tied, in purpose and planned effect, to the deliberate making of sales” in 18 Maryland. (ECF No. 86 at 3 (citing Acorda Therapeutics, Inc. v. Mylan Pharms., 817 F.3d 755, 19 760 (Fed. Cir. 2016).) With respect to Endo Ventures, Plaintiff argues that Endo Ventures, as 20 successor-in-interest to Labopharm, is subject to specific jurisdiction because it was responsible 21 for the diminished priapism warning submitted to the FDA in Maryland for Oleptro. Finally, 22 Plaintiff asserts it is in the interest of justice to transfer the action because his action would be 23 barred by the statute of limitations without a transfer. 24 Plaintiff’s argument that Maryland has specific jurisdiction over Endo Ventures and Teva 25 rests almost entirely on their submissions to the FDA. The parties do not cite a case directly on 26 point, but Zeneca Ltd. v. Mylan Pharm., Inc., 173 F.3d 829 (Fed. Cir. 1999), is instructive. In 27 Zeneca, a patentee alleged that a drug manufacturer infringed its patent by filing an ANDA for a 28 generic version of the patented drug. Id. at 830. The defendant’s only contact with Maryland 1 was the act of filing the ANDA with the FDA in Maryland. Id. The court concluded that 2 Maryland lacked personal jurisdiction due to the “government contacts” exception, which 3 provides that “entry into the District of Columbia by nonresidents for the purpose of contacting 4 federal government agencies is not a basis for the assertion of in personam jurisdiction.” Id. at 5 831. The court emphasized that “[a]llowing jurisdiction based solely on the submission of [the 6 ANDA] would allow for the creation of a national judicial forum in Maryland for generic drug 7 infringement cases” and “[Defendant’s] contact with Maryland arose out of the mere fortuity that 8 the government agency that must receive the Petition is located in Maryland.” Id. at 832. In 9 other words, the Zeneca court essentially found that the defendant’s contacts were with the 10 federal government agency located in Maryland, not the state of Maryland itself. Id. 11 Plaintiff relies on Acorda for a contrary conclusion. In Acorda, a brand name drug 12 manufacturer brought a patent infringement claim against a generic drug manufacturer. 817 F.3d 13 at 757–58. At issue was whether Delaware could assert personal jurisdiction based solely on the 14 defendant’s ANDA filing in Maryland — the defendant had not yet begun marketing the drugs in 15 Delaware. Id. at 759–60. The Acorda court held that Delaware had specific jurisdiction based on 16 the ANDA, which the defendant filed “for the purpose of engaging in that injury-causing and 17 allegedly wrongful marketing conduct in Delaware.” Id. at 760. The court reasoned that within 18 the unique context of patent infringement claims, “the ANDA filings [were] tightly tied in 19 purpose and planned effect, to the deliberate making of sales in Delaware” and the suit was 20 “about whether that in-state activity [would] infringe valid patents.” Id. 21 The Court emphasizes that neither party cites controlling Ninth Circuit authority on this 22 issue. Further, unlike Zeneca and Acorda, the instant action is not a patent infringement case, and 23 therefore the unique issues at play in those cases are distinct from the issues before this Court. 24 However, the Court shares the Zeneca court’s concerns that asserting jurisdiction in this case 25 would be contrary to the “policy against the creation of national supercourts” in Maryland and 26 may offend due process. Zeneca, 173 F.3d at 831. Here, Plaintiff is a California resident who 27 was prescribed Teva’s generic trazodone by his physician in California, the drug was dispensed 28 and ingested in California, and the resulting injury occurred in California. The Court declines to 1 find that Teva and Endo Ventures are subject to specific jurisdiction in Maryland based on 2 nothing more than their FDA filings and the unsubstantiated possibility that Teva also sold its 3 drug in Maryland. Based on the limited information before this Court, it is not clear that 4 Maryland can exercise personal jurisdiction over all Defendants. 5 Moreover, transfer to the District of Maryland is not in the interest of justice. While 6 Maryland arguably has personal jurisdiction over Angelini Pharma since Angelini Pharma’s 7 principal place of business is in Maryland, it is unclear whether Maryland could exercise personal 8 jurisdiction over Teva and Endo Ventures. Plaintiff also fails to argue that Maryland would be a 9 proper venue. Notably, Plaintiff does not request that the Court sever the claims, but such a 10 request would have been unavailing regardless. Based on the overlap in legal and factual issues 11 as to all Defendants, transfer would only result in the same or similar issues being litigated in the 12 Eastern District of California and the District of Maryland. Duplicative litigation does not 13 promote the interests of justice. Finally, Plaintiff will not be unduly prejudiced because he may 14 continue to seek relief against Teva before this Court. For all these reasons, the Court DENIES 15 Plaintiff’s request to transfer and DISMISSES Angelini Pharma and Endo Ventures from the 16 action with prejudice. 17 IV. CONCLUSION 18 For the foregoing reasons, Defendants’ Motions to Dismiss are hereby GRANTED. (ECF 19 Nos. 55, 56.) The Court DENIES Plaintiff’s request to transfer the action to the District of 20 Maryland and DISMISSES Angelini Pharma and Endo Ventures from the action with prejudice. 21 Further, Plaintiff’s Motion to Strike is DENIED as moot. (ECF No. 69.) The remaining parties 22 are ordered to file a joint status report within thirty (30) days of the date of electronic filing of this 23 Order. 24 IT IS SO ORDERED. 25 DATED: March 30, 2020 26 27 28