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Leon v. URL Pharma, Inc.

United States District Court, C.D. California
Sep 15, 2023
692 F. Supp. 3d 973 (C.D. Cal. 2023)

Opinion

Case No.: 2:22-cv-08539-MEMF-PVC

2023-09-15

Richard LEON, individually and as Personal Representative of the Estate of Juanita Leon, deceased, Plaintiff, v. URL PHARMA, INC.; United Research Laboratories, Inc.; Mutual Pharmaceutical Company, Inc.; Sun Pharmaceutical Industries, Inc.; Sun Pharmaceutical Holdings USA, Inc.; Sun Pharmaceutical Industries Limited, Defendants.

Kimberly Sue Trimble, Singleton Schreiber LLP, Westlake Village, CA, Lennie F. Bollinger, Pro Hac Vice, Wormington and Bollinger, McKinney, TX, for Plaintiff. Clem C. Trischler, Pro Hac Vice, Jason M. Reefer, Pro Hac Vice, Pietragallo Gordon Alfano Bosick and Raspanti LLP, Pittsburgh, PA, David P. Koller, Josephine D. Far, Tarifa Belle Laddon, Faegre Drinker Biddle and Reath LLP, Los Angeles, CA, for Defendants Mutual Pharmaceutical Company, Inc., Sun Pharmaceutical Industries Limited.


Kimberly Sue Trimble, Singleton Schreiber LLP, Westlake Village, CA, Lennie F. Bollinger, Pro Hac Vice, Wormington and Bollinger, McKinney, TX, for Plaintiff. Clem C. Trischler, Pro Hac Vice, Jason M. Reefer, Pro Hac Vice, Pietragallo Gordon Alfano Bosick and Raspanti LLP, Pittsburgh, PA, David P. Koller, Josephine D. Far, Tarifa Belle Laddon, Faegre Drinker Biddle and Reath LLP, Los Angeles, CA, for Defendants Mutual Pharmaceutical Company, Inc., Sun Pharmaceutical Industries Limited.

ORDER DENYING DEFENDANT SUN PHARMACEUTICAL INDUSTRIES, INC.'S MOTION TO DISMISS [ECF NO. 22]

MAAME EWUSI-MENSAH FRIMPONG, United States District Judge

Before the Court is the Motion to Dismiss filed by Defendant Sun Pharmaceutical Industries, Inc. ECF No. 22 (the "Motion"). For the reasons stated herein, the Court hereby DENIES the Motion to Dismiss.

I. Background

A. Factual Background

Unless otherwise indicated, the following factual background is derived from Plaintiff's Complaint. ECF No. 1 ("Compl."). For the purposes of this Motion, the Court treats these factual allegations as true, but at this stage of the litigation, the Court makes no finding on the truth of these allegations and is therefore not—at this stage—finding that they are true.

Decedent Juanita Leon sought care from her doctor in April 2020 for a possible infection in her leg. Compl. ¶ 1. Her doctor—relying in part on the labeling information for Bactrim, a sulfamethoxazole-trimethoprim ("SMX-TMP") drug—prescribed her brand-name Bactrim to treat the infection. Compl. ¶¶ 1, 20, 136. Defendant Sun Pharmaceuticals Industries, Inc. ("Sun Pharma") is the innovator, New Drug Application ("NDA") holder, and Reference Listed Drug ("RLD") holder for Bactrim. Id. ¶¶ 1, 39. Although Juanita Leon's doctor prescribed her brand-name Bactrim, her prescription was filled with a generic version of Bactrim, which she consumed. Id. ¶ 20. On April 2, 2020, Juanita Leon began experiencing symptoms from consuming the drug and had to be sent to the hospital. Id. ¶ 21. Her condition deteriorated, and on April 12, 2020, she died as a result of Steven-Johnson syndrome ("SJS"), toxic epidermal necrolysis ("TEN"), and related conditions induced by the generic SMX-TMP drug she had ingested. Id. ¶¶ 21-25.

The Complaint refers to Defendants generally (including defendants that have been dismissed) as being the owners of Bactrim, but for the purposes of this Motion, the Court will interpret the allegations specifically as to Sun Pharma, the movant. As the parties clarify in their briefing, Defendant Mutual Pharmaceutical Company, Inc., the other remaining Defendant in the case, merged with Sun Pharma in 2020 and no longer exists as an independent entity. Motion at 6.

Sun Pharma claims that Juanita Leon was prescribed a generic version of Bactrim, but Leon has reaffirmed that the prescription was for the brand-name Bactrim. Motion at 6; Opposition at 13. At this stage, the Court must draw inferences in favor of the plaintiff, and therefore proceeds under the premise that Juanita Leon was prescribed the brand-name Bactrim. Compl. ¶ 20.

Under FDA regulations, when a new drug is developed, the manufacturer must file a NDA and obtain approval to market and sell it. Id. ¶¶ 28-31. NDA holders must continuously monitor the drug's safety, annually review all adverse drug experiences they receive from any source, and assess whether any labeling should be changed. Id. ¶ 32. As the drug's owner, Sun Pharma was responsible for the marketing, safety-surveillance, regulatory reporting, and labeling of the brand-name Bactrim drug. Id. ¶ 39. By law, generic drugs are required to include the same warning and safety information on their labels as the brand-name drug. Id. Thus, the warnings on the generic SMX-TMP drug that Juanita Leon ingested were the same as those on Bactrim's label. Id.

B. Procedural History

On November 22, 2022, Plaintiff Richard Leon ("Leon"), Juanita Leon's son, filed suit against Defendants URL Pharma, Inc., United Research Laboratories, Inc., Mutual Pharmaceutical Company, Inc., Sun Pharmaceutical Industries, Inc., Sun Pharmaceutical Holdings, USA, Inc., and Sun Pharmaceutical Industries Limited on behalf of himself and Juanita Leon's estate bringing claims for: (1) negligence and negligent failure to warn; (2) negligent misrepresentation; (3) gross negligence; and (4) fraud and fraudulent concealment. See generally Compl. Leon brings his claims under a theory of "innovator liability," whereby he seeks to hold Sun Pharma liable for the deficient labeling and warnings of the generic version of Bactrim. Id. at ¶ 3, n.1. Innovator liability (sometimes called "warning label liability") has been affirmed by California courts and arises from FDA regulations that hold a brand-name drug manufacturer responsible "for the accuracy and adequacy of its label 'as long as the drug is on the market.' " T.H. v. Novartis Pharms. Corp., 4 Cal.5th 145, 226 Cal.Rptr.3d 336, 407 P. 3d 18, 23 (2017); see also Conte v. Wyeth, Inc., 168 Cal.App.4th 89, 85 Cal. Rptr. 3d 299, 319-18 (2008).

On February 21, 2023, the parties stipulated to the dismissal of Defendants URL Pharma, Inc., United Research Laboratories, Inc., Sun Pharmaceutical Holdings, USA, Inc., and Sun Pharmaceutical Industries, Limited, leaving Sun Pharma and Mutual Pharmaceutical Co., Inc. as the two remaining Defendants in this case.

On May 18, 2023, Sun Pharma brought this Motion to Dismiss under Federal Rules of Civil Procedure 12(b)(2) for lack of personal jurisdiction. ECF No. 22 ("Motion"). On June 22, 2023, Leon filed an opposition to the Motion. ECF No. 30 ("Opposition"). On June 29, 2023, Sun Pharma filed its reply. ECF No. 31 ("Reply"). On July 21, 2023, the parties stipulated to strike Section II.C of Sun Pharma's reply. ECF No. 32. On Sepember 7, 2023, the Court held a hearing on the Motion.

Accordingly, the Court does not consider this portion of Sun Pharma's argument.

II. Applicable Law

Under Federal Rule of Civil Procedure 12(b)(2), a party may file a motion to dismiss a complaint for lack of personal jurisdiction. Fed. R. Civ. P. 12(b)(2). In the face of a 12(b)(2) motion, "the plaintiff bears the burden of demonstrating that the court has jurisdiction." In re W. States Wholesale Nat. Gas Antitrust Litig. (Western States), 715 F.3d 716, 741 (9th Cir. 2013). In determining whether a complaint lacks personal jurisdiction, a court may consider evidence presented in affidavits and may order discovery on the jurisdictional issues. Doe v. Unocal Corp., 248 F.3d 915, 922 (9th Cir. 2001), overruled on other grounds as discussed in Williams v. Yamaha Motor Co., 851 F.3d 1015, 1024 (9th Cir. 2017).

"However, 'when a district court acts on a defendant's motion to dismiss without holding an evidentiary hearing, the plaintiff need make only a prima facie showing of jurisdictional facts to withstand the motion to dismiss. That is, the plaintiff need only demonstrate facts that if true would support jurisdiction over the defendant.' " Id. (quoting Ballard v. Savage, 65 F.3d 1495, 1498 (9th Cir. 1995)). Under such circumstances, a district court must accept the uncontroverted allegations in the plaintiff's complaint as true. Brayton Purcell LLP v. Recordon & Recordon, 606 F.3d 1124, 1127 (9th Cir. 2010). Although the court may not assume the truth of allegations in a pleading that are contradicted by affidavit, conflicts between the facts contained in the parties' affidavits must be resolved in the plaintiff's favor for purposes of deciding whether a prima facie case for personal jurisdiction exists. Mavrix Photo, Inc. v. Brand Techs., Inc., 647 F.3d 1218, 1223 (9th Cir. 2011); Unocal, 248 F.3d at 922.

Moreover, when no applicable federal statute governing personal jurisdiction exists, as is the case here, the district court applies the law of the state in which the district court sits. Picot v. Weston, 780 F.3d 1206, 1211 (9th Cir. 2015) (citing Daimler AG v. Bauman, 571 U.S. 117, 125, 134 S.Ct. 746, 187 L.Ed.2d 624 (2014)). Accordingly, the Court looks to "California's long-arm statute [which] allows the exercise of personal jurisdiction to the full extent permissible under the U.S. Constitution." Id. at 1211 (quoting Daimler, 571 U.S. at 125, 134 S.Ct. 746); see also Cal. Civ. Proc. Code § 410.10.

Due process allows courts to exercise jurisdiction only over a defendant who has "certain minimum contacts with [the forum] such that the maintenance of the suit does not offend traditional notions of fair play and substantial justice." Int'l Shoe Co. v. Washington, 326 U.S. 310, 316, 66 S.Ct. 154, 90 L.Ed. 95 (1945) (internal quotation marks omitted). Personal jurisdiction may be either general or specific. See Picot, 780 F.3d at 1211; Morrill v. Scott Fin. Corp., 873 F.3d 1136, 1141-42 (9th Cir. 2017); see also Helicopteros Nacionales de Colombia, S.A. v. Hall, 466 U.S. 408, 414 nn.8-9, 104 S.Ct. 1868, 80 L.Ed.2d 404 (1984). The "minimum contacts" test requires a determination of reasonableness by the court by weighing the facts of each case "to determine whether the requisite 'affiliating circumstances' are present." Kulko v. Superior Ct. of Cal. ex rel. City & County of San Francisco, 436 U.S. 84, 92, 98 S.Ct. 1690, 56 L.Ed.2d 132 (1978) (quoting Hanson v. Denckla, 357 U.S. 235, 246, 78 S.Ct. 1228, 2 L.Ed.2d 1283 (1958)).

A. General Jurisdiction

"General jurisdiction exists when a defendant is domiciled in the forum state or his activities there are 'substantial' or 'continuous and systematic.' " Panavision Int'l, L.P. v. Toeppen, 141 F.3d 1316, 1320 (9th Cir. 1998) (quoting Helicopteros, 466 U.S. at 414-16, 104 S.Ct. 1868), modified, Yahoo! Inc. v. La Ligue Contre Le Racisme Et L'Antisemitisme, 433 F.3d 1199, 1207 (9th Cir. 2006). The Ninth Circuit has recognized this as "an exacting standard, as it should be, because a finding of general jurisdiction permits a defendant to be haled into court in the forum state to answer for any of its activities anywhere in the world." Schwarzenegger v. Fred Martin Motor Co., 374 F.3d 797, 801 (9th Cir. 2004); see also Bancroft & Masters, Inc. v. Augusta Nat. Inc., 223 F.3d 1082, 1086 (9th Cir. 2000) (noting that the standard for establishing general jurisdiction is "fairly high" and requires contacts "that approximate physical presence").

B. Specific Jurisdiction

Even if a defendant has not had continuous and systematic contacts with the state sufficient to confer general jurisdiction, a court may exercise specific jurisdiction over the defendant. Picot, 780 F.3d at 1211. Specific jurisdiction exists where the claim for relief arises directly from a defendant's contacts with the forum state. AT&T Co. v. Compagnie Bruxelles Lambert, 94 F.3d 586, 588 (9th Cir. 1996). Jurisdiction is proper "where the contacts proximately result from actions by the defendant himself that create a 'substantial connection' with the forum State." Burger King Corp. v. Rudzewicz, 471 U.S. 462, 475, 105 S.Ct. 2174, 85 L.Ed.2d 528 (1985). For a court to exercise specific jurisdiction over a defendant:

(1) The non-resident defendant must purposefully direct his activities or consummate some transaction with the forum or resident thereof; or perform some act by which he purposefully avails himself of the privileges of conducting activities in the forum, thereby invoking the benefits and protections of its laws; (2) the claim must be one which arises out of or relates to the defendant's forum-related activities; and (3) the exercise
of jurisdiction must comport with fair play and substantial justice, i.e. it must be reasonable.
Picot, 780 F.3d at 1211.

The plaintiff bears the burden of satisfying the first two prongs of this test. Schwarzenegger, 374 F.3d at 802. If the plaintiff does so, the burden then shifts to the defendant to show why the exercise of personal jurisdiction would not be reasonable and fair under the third prong. Id.

III. Discussion

Sun Pharma's sole contention in its Motion is that the Court lacks personal jurisdiction over it. The Court finds that while general jurisdiction is lacking, Leon has adequately pleaded facts that are sufficient to establish specific personal jurisdiction over Sun Pharma for the claims at issue.

A. General Jurisdiction

The Court does not find general jurisdiction over Sun Pharma based on the facts before it. The Supreme Court has explained that the "paradigm all-purpose forums for general jurisdiction are a corporation's place of incorporation and principal place of business." Daimler AG, 571 U.S. at 118, 134 S.Ct. 746. Sun Pharma is a Delaware corporation. Compl. ¶ 11. Its principal place of business is in New Jersey. Declaration of Josephine D. Far, ECF No. 22-2, Ex. A ("Dowell Decl.") at ¶ 12. While these are not the only ways to find general jurisdiction over a company, it is rare for general jurisdiction to be satisfied in other ways. See BNSF Ry. Co. v. Tyrrell, 581 U.S. 402, 413, 137 S.Ct. 1549, 198 L.Ed.2d 36 (2017) (noting that outside of these two forums, general jurisdiction is only established in an "exceptional case" where "a corporate defendant's operations in another forum 'may be so substantial and of such a nature as to render the corporation at home in that State' "); see also Martinez v. Aero Caribbean, 764 F.3d 1062, 1070 (9th Cir. 2014) (explaining that "Daimler makes clear the demanding nature of the standard for general personal jurisdiction over a corporation").

The Court recognizes that the state of the current law is such that the Ninth Circuit has "regularly [ ] declined to find general jurisdiction even where the contacts were quite extensive." Amoco Egypt Oil Co. v. Leonis Nav. Co., Inc., 1 F.3d 848, 851 n.3 (9th Cir. 1993). Although Leon lists various activities that Sun Pharma took in California, the Court cannot consider these in a vacuum, but rather must consider them in light of Sun Pharma's activities "in their entirety, nationwide and worldwide." Daimler AG, 571 U.S. at 139 n.20, 134 S.Ct. 746 ("A corporation that operates in many places can scarcely be deemed at home in all of them."). Here, Sun Pharma's main operations (including but not limited to maintaining offices, manufacturing products, having a physical space) are not located in California (and accordingly, it is logical to assume they take place elsewhere). See generally Dowell Decl. The fact that Sun Pharma may have licenses, registration, and other lawsuits against it in California does not render its contacts with the State "so 'continuous and systematic' as to render [it] essentially at home" here, in light of the consideration that Sun Pharma's main operations are located outside of the State. Daimler AG, 571 U.S. at 139, 134 S.Ct. 746. Accordingly, the Court declines to find general jurisdiction over Sun Pharma.

Leon submits that the Court should consider the actions of other Defendants when evaluating jurisdiction over Sun Pharma since they have merged into Sun Pharma. Opposition at 9 n.4. Sun Pharma does not appear to object to this, and the Court will do so.

B. Specific Jurisdiction

Nevertheless, the Court finds specific jurisdiction over Sun Pharma as (1) Sun Pharma purposefully availed itself of the California market, (2) Leon's claims arise out of or relate to Sun Pharma's in-state activities, and (3) it is not unreasonable to exercise jurisdiction over Sun Pharma.

i. Sun Pharma purposefully availed itself of the forum.

Specific jurisdiction is only appropriate where a "defendant purposefully avails itself of the privilege of conducting activities within the forum State, thus invoking the benefits and protections of its laws." Hanson v. Denckla, 357 U.S. 235, 253, 78 S.Ct. 1228, 2 L.Ed.2d 1283 (1958). Purposeful availment is found where "the defendant has taken deliberate action within the forum state or if [it] has created continuing obligations to forum residents." Ballard v. Savage, 65 F.3d 1495, 1498 (9th Cir. 1995). Purposeful direction is also a relevant analysis for claims sounding in tort. Glob. Commodities Trading Grp., Inc. v. Beneficio de Arroz Choloma, S.A., 972 F.3d 1101, 1107 (9th Cir. 2020) (explaining that under both purposeful availment and purposeful direction, the question is "whether defendants have voluntarily derived some benefit from their interstate activities such that they 'will not be haled into a jurisdiction solely as a result of 'random, fortuitous, or attenuated' contacts.' ").

While Sun Pharma lists a number of things it does not do in California, it notably does not dispute that it markets and sells Bactrim in California. See generally Dowell Decl. In fact, Sun Pharma has made payments totaling $405,402.28 in 2021 alone to California physicians and medical professionals, presumably in furtherance of marketing and selling its drug. ECF No. 30-1, Declaration of Lennie F. Bollinger in Support of Opposition ("Bollinger Decl."), ¶ 23. Sun Pharma is registered and licensed to sell Bactrim in California and communicates regularly with the California Board of Pharmacy regarding the sale and distribution of its drugs. Id. ¶¶ 4, 5, 7, 14, 15. There is no question that Sun Pharma has purposefully availed itself of the California market and its citizens, and derives benefits, including economic gain from such availment. See Schwarzenegger, 374 F.3d at 803 (purposeful direction "usually consists of evidence of the defendant's actions outside the forum state that are directed at the forum, such as the distribution in the forum state of goods originating elsewhere").

While Sun Pharma asserts it does not sell products "directly to patients," it does not dispute that its products do end up in the California market through intentional acts on the part of the company, whether through its distributors or sales to hospitals, physicians, and other medical groups. Dowell Decl. ¶ 15. Sun Pharma also contends that under the innovator liability theory, it could be subject to suit even if it never sold Bactrim in California. Motion at 4. Given that those facts are not before this Court, this Court declines to opine on that factual scenario.

ii. Leon's claims relate to Sun Pharma's forum-related activities.

Sun Pharma's main contention is with the second factor of the specific jurisdiction test. Motion at 14. Specifically, Sun Pharma argues that Leon cannot establish that his claims arise out of or relate to Sun Pharma's actions in the State, as the claims stem from labeling decisions which did not occur in California. Id. at 15. Just as with the defendant in Quinn-White, Sun Pharma's arguments rest on a fundamental mischaracterization of Leon's claims. See Quinn-White v. Novartis Pharm. Corp., No. 2:16-cv-04300-PSG-AGR, 2018 WL 6133637 (C.D. Cal. March 7, 2018). In addition, Sun Pharma conflates the basis for liability—innovator liability—with the second prong of the specific jurisdiction test. Sun Pharma asserts that Leon's claim is based solely upon the decisions Sun Pharma made at its headquarters to include or not include certain information on the label and to modify or not modify the label. And, perhaps Sun Pharma is correct that the theory of innovator liability would make Sun Pharma liable for those decisions even without it taking any other actions with respect to brand-name Bactrim or the generic version. But a plain reading of the Complaint demonstrates that Leon alleges much more than this. He alleges that Sun Pharma marketed brand-name Bactrim in California and transmitted substantial (false) information about brand-name Bactrim to doctors in California. It was in reliance upon this allegedly false information about brand-name Bactrim—directed by Sun Pharma at the California market through the brand-name label, Sun Pharma's online websites and information, presentations to the hospital, continuing medical education conferences, and written materials provided by Sun Pharma to various physician groups and hospitals—that Juanita Leon's doctor prescribed her brand-name Bactrim. See Compl. ¶¶ 20, 136, 175.

Here, Leon's claims arise out of Sun Pharma's sales and marketing activities that are aimed at the California market. And to the extent that Sun Pharma's sales and marketing of Bactrim relied on its deficient labeling, which presumably it did, this is clearly also related to a cause of action regarding the deficient labeling no matter where the actual labeling happened. This view is in line with other California district court decisions. See, e.g., Whaley v. Merck & Co., Inc., No. 3:21-cv-01985-H-BLM, 2022 WL 1153151 (S.D. Cal. Apr. 11, 2022); Haddad v. Merck and Co., Inc., No. 2:22-cv-02151-DMG-MAA, 2022 WL 17357779 (C.D. Cal. Aug. 11, 2022) (in distinguishing Zantac, explaining that "the forum activities need not be necessary to [a plaintiff's] claims" under the standard set by Ford Motor Co. v. Mont. Eighth Jud. Dist. Ct., 592 U.S. 351, 141 S. Ct. 1017, 209 L.Ed.2d 225 (2021)). As in Ford, Sun Pharma has "systematically served" the California market for Bactrim. Ford Motor Co., 141 S. Ct. at 1028 (noting that "Ford had advertised, sold, and served [the car models at issue]" in the forum states). The Court's holding here is not an expansion of specific jurisdiction such that "anything goes," because here, "there is a 'strong relationship among the defendant, the forum, and the litigation'—the 'essential foundation' of specific jurisdiction." Id. at 1026, 1028. Therefore, the Court finds that Leon's claims are sufficiently related to Sun Pharma's in-state activities to meet this prong.

Sun Pharma also relies on Henry, but the Court notes that in Henry, the plaintiff "hinge[d] the assertion on the conduct of one individual"—"a single salesman in California, marketing and selling . . . to an unknown number of practitioners, four or five years before [the] injury." Henry v. Angelini Pharma, Inc., No. 2:17-cv-02593-TLN-KJN, 2020 WL 1532174 (E.D. Cal. Mar. 31, 2020). Here, Leon alleges, and Sun Pharma does not dispute, that Sun Pharma engaged in significant sales and marketing in California, based on its deficient labeling. Moreover, Henry was decided prior to Ford and did not have the benefit of Ford's clarification of specific jurisdiction.

Sun Pharma relies on non-binding authority from a Florida district court in support of its argument, which held in superficially similar circumstances that the defendants' contacts did not sufficiently relate to the plaintiff's claims. In re: Zantac (Ranitidine) Prods. Liab. Litig., 546 F. Supp. 3d 1192, 1212 (S.D. Fla. 2021). Zantac looked to the specific duty set forth by California law under the innovator liability theory, and stated that since liability under this theory stems solely from the defendant's failure to update the drug's label, activities like sales and marketing unrelated to the labeling decisions are unnecessary to support the claim, and therefore irrelevant to the specific jurisdiction analysis. Id. at 1213. This is the argument that Sun Pharma sets forth here. Motion at 17. However, Sun Pharma's focus on where exactly its labeling occurred is misplaced, and the Court is not aware of any binding authority supporting such a narrow view of specific jurisdiction. Rather, as the Supreme Court held in Ford Motor Co., such a strict causal relationship is not required. Ford Motor Co., 141 S. Ct. at 1026 ("None of our precedents has suggested that only a strict causal relationship between the defendant's in-state activity and the litigation will do.").

Importantly, it does not appear that in Zantac there was an allegation that the patients at issue were prescribed brand-name Zantac based upon the defendant's marketing of brand-name Zantac. The case appears to be distinguishable on this basis alone.

Sun Pharma acknowledged that Leon alleged other facts beyond the label itself, but contends that because Sun Pharma is pursuing innovator liability, the Court must treat innovator liability as an "overlay" on top of the allegations in the Complaint and therefore examine the Complaint through the narrow lens of the minimum facts needed for innovator liability. This appears contrary to law. It is not the case that Leon has alleged facts wholly unrelated to its causes of action. Whether or not Leon could pursue his claims in the absence of facts beyond the label is of no moment. Here, Leon has alleged facts beyond the label—facts which form part of the basis for each of the claims alleged. No authority that is binding on this Court dictates that this Court must disregard these facts because of Leon's citation to T.H. and his reliance upon innovator liability.

As was emphasized at the hearing, innovator liability is merely a unique application of the traditional bases of liability stemming from negligent misrepresentation. See generally, T.H., 226 Cal.Rptr.3d 336, 407 P. 3d at 28-30 (applying the decades-old Rowland factors in determining whether to depart from the general rule regarding product liability). Accordingly, the Court sees no reason to artificially narrow its inquiry and refuse to consider other facts—beyond the label itself—that are logically part of the duty of care established by California law. See Conte, 168 Cal. App. 4th at 95, 85 Cal.Rptr.3d 299 (2008) (holding that the "duty of care in disseminating product information extends to those patients who are injured by [the generic drug] as a result of prescriptions written in reliance on [the brand-name drug's] product information" (emphasis added)). These would include the sales and marketing practices that it is alleged Sun Pharma also used to make its purported misrepresentations. Therefore, the Court finds that these facts are jurisdictionally relevant.

iii. It is reasonable for the Court to exercise jurisdiction over Sun Pharma here.

Finally, the Court considers whether the exercise of personal jurisdiction over Sun Pharma as to Leon's claims offends the traditional notions of fair play and substantial justice, and finds that it does not. Burger King Corp., 471 U.S. at 476, 105 S.Ct. 2174. Courts should "evaluate 'the burden on the defendant,' 'the forum State's interest in adjudicating the dispute,' 'the plaintiff's interest in obtaining convenient and effective relief,' 'the interstate judicial system's interest in obtaining the most efficient resolution of controversies,' and the 'shared interest of the several States in furthering fundamental substantive social policies.' " Id. at 477, 105 S.Ct. 2174 (noting that "[t]hese considerations sometimes serve to establish the reasonableness of jurisdiction upon a lesser showing of minimum contacts than would otherwise be required"). It is the defendant's burden to establish that personal jurisdiction in this case would be unconstitutional. Id. at 482, 105 S.Ct. 2174.

Sun Pharma mistakenly contends that Leon must establish this third element, but that is not the law. Motion at 14; see Axiom Foods, Inc. v. Acerchem Int'l., Inc., 874 F.3d 1064, 1068-69 (9th Cir. 2017) (explaining that if the plaintiff satisfies the first two prongs of the test, "the burden then shifts to the defendant to 'present a compelling case' that the exercise of jurisdiction would not be reasonable"). Since Leon has satisfied the first two prongs (purposeful availment and that Leon's claims relate to forum-related activities), Sun Pharma has the burden of establishing that the exercise of jurisdiction is unreasonable or otherwise unfair.

Here, Sun Pharma does not present any arguments with regards to these factors, merely declaring that it would be unfair for Sun Pharma to be sued for injuries attributed to another's product. Motion at 19. But, the injuries Leon complains of are not attributed to the generic version of Bactrim—Leon alleges that the injuries arise from Sun Pharma's negligence, not of another's. As the Supreme Court has explained, "if the sale of a product . . . is not simply an isolated occurrence, but arises from the efforts of the manufacturer or distributor to serve directly or indirectly, the market for its product in other States, it is not unreasonable to subject it to suit in one of those States if its allegedly defective merchandise has there been the source of injury." World-Wide Volkswagen Corp. v. Woodson, 444 U.S. 286, 297, 100 S.Ct. 559, 62 L.Ed.2d 490 (1980). Here, the defective merchandise is the alleged defective labeling and all of the California-based—and allegedly false—sales and marketing information, and the labeling and the allegedly false information are the source of the injury complained of. Id. at 298, 100 S.Ct. 559 (instructing that a state "does not exceed its powers under the Due Process Clause if it asserts personal jurisdiction over a corporation that delivers its products into the stream of commerce with the expectation that they will be purchased by consumers in the forum State"). Although Sun Pharma would have this Court believe that it merely places the label on Bactrim and takes no other action to market it in California, this is contrary to the allegations in the Complaint. See Reply at 5. Sun Pharma delivered its allegedly false representations about Bactrim, along with brand-name Bactrim and its deficient labeling into the California market. Similarly, the alleged failure to warn doctors about brand-name Bactrim took place in California. And according to Leon's Complaint, which the Court must treat as true at this stage, had the label or the sales and marketing information accurately disclosed the risks of brand-name Bactrim, and had Sun Pharma not failed to correct the false and misleading information about brand-name Bactrim they had disseminated to doctors, Juanita Leon's doctor would not have prescribed her brand-name Bactrim. Compl. at ¶¶ 140, 142. In light of all of this, it is fair for Sun Pharma to be sued in this State for injuries arising from the same. Burger King Corp., 471 U.S. at 476, 105 S.Ct. 2174 (where a defendant "manifestly has availed [itself] of the privilege of conducting business [in the forum state] . . . it is presumptively not unreasonable to require [it] to submit to the burdens of litigation in that forum as well").

Regardless, the Court briefly addresses the factors of reasonableness. Sun Pharma does not contend there would be any burden on it from litigating in California, and the Court notes that Sun Pharma has a history of litigation in the State. Bollinger Decl. ¶¶ 12, 13, 19-21. Moreover, California undisputedly has an interest in adjudicating this dispute. Burger King Corp., 471 U.S. at 473, 105 S.Ct. 2174 ("A State generally has a 'manifest interest' in providing its residents with a convenient forum for redressing injuries inflicted by out-of-state actors."). In fact, California courts have expressly affirmed the theory of innovator liability as one means of redressing injuries suffered by Californians. T.H., 226 Cal.Rptr.3d 336, 407 P.3d at 30 (holding that "a brand-name drug manufacturer has the duty under California law to warn of the risks about which it knew or reasonably should have known, regardless of whether the consumer is prescribed the brand-name drug or its generic 'bioequivalent' "). And Leon certainly has an interest in obtaining relief in his forum of choice. Finally, as the injuries occurred in California, it would be most efficient to resolve the dispute here.

Accordingly, the Court finds it reasonable to exercise specific jurisdiction over Sun Pharma.

IV. Conclusion

For the foregoing reasons, the Court hereby ORDERS that Defendant's Motion to Dismiss is DENIED.

IT IS SO ORDERED.


Summaries of

Leon v. URL Pharma, Inc.

United States District Court, C.D. California
Sep 15, 2023
692 F. Supp. 3d 973 (C.D. Cal. 2023)
Case details for

Leon v. URL Pharma, Inc.

Case Details

Full title:Richard LEON, individually and as Personal Representative of the Estate of…

Court:United States District Court, C.D. California

Date published: Sep 15, 2023

Citations

692 F. Supp. 3d 973 (C.D. Cal. 2023)