ALMOND

v.

COLOPLAST A/S

This matter is before the Court on Defendant Coloplast A/S’s Motion to Dismiss, Dkt. 44, Plaintiff Brenda Almond’s Amended Complaint, Dkt. 23. Almond filed a response, Dkt. 46, and Coloplast A/S replied, Dkt. 53. After conducting a hearing on December 8, 2020, the Court allowed the parties to conduct limited jurisdictional discovery. Dkt. 56. The Court then held a second hearing on March 25, 2021, and Coloplast A/S filed a supplemental brief, Dkt. 86. With the benefit of full briefing, oral arguments, and the limited jurisdictional discovery conducted by the parties, the Court grants Coloplast A/S’s Motion to Dismiss for lack of personal jurisdiction.

BACKGROUND

This case concerns the Altis Single Incision Sling System (“Altis”), a surgical mesh device designed for implantation in a woman’s groin and vaginal region to treat pelvic organ prolapse and stress urinary incontinence. Dkt. 23 at 3, 4. On September 25, 2014, Plaintiff Almond received a surgical implant of the

Altis device to treat her stress urinary incontinence. Id. at 8. This procedure was completed at Florida Hospital Carrollwood in Tampa, Florida. Id. Plaintiff claims the Altis device was defective because it eroded and exposed portions of mesh. Id. at 9. This led Plaintiff to experience several health issues,

including lower abdominal pain, recurrent urinary tract infections, and chronic vaginal discharge and odor. Id. Plaintiff underwent another surgery in March 2017 to have the exposed and eroded portions of the Altis device removed from her body. Id. She says she will likely need future medical care and treatment to fix these issues, including future corrective surgery. Id. Plaintiff filed the operative Amended Complaint on June 30, 2020. Dkt. 23. Importantly, Plaintiff Almond sued three defendants: (1) Coloplast Corp.; (2)

Coloplast Manufacturing US, LLC; and (3) Coloplast A/S. At issue today is whether this Court has personal jurisdiction over Coloplast A/S. Dkt. 23 at 1. Coloplast A/S is a foreign corporation incorporated and operating in

Denmark. Dkt. 23 at 1. It does not have any offices in the United States, and it maintains its business records exclusively in Denmark. Dkt. 44 at 2. Coloplast A/S is the parent company of Coloplast Corp. and Coloplast Manufacturing LLC (“the subsidiaries”)—both of which are Delaware corporations with their principal places of business in Minnesota. Dkt. 23 at 1–2. The subsidiaries have a distinct and independent management structure from Coloplast A/S. Dkt. 44 at 2. Each subsidiary maintains separate profits and losses from other Coloplast entities, and they maintain their own books and records. Id. at 3. Each company observes all corporate formalities. Id. The parent does not guarantee the subsidiaries’ loans or obligations. Id. at 8–9. No employee in Coloplast Corp.’s Interventional Urology business unit reports to any employee of Coloplast A/S about product development, distribution, marketing, clinical, regulatory affairs, or sales. Id. at 3. Coloplast A/S owns the intellectual property rights to the Altis device. Dkt. 89-1 at 76. It submitted a 510(k) application¹ to the U.S. Food and Drug

Administration (FDA) in 2012, listing itself as the “Applicant” and “Owner/Operator” of the Altis device. Dkt. 52, Ex. 1 at 2, 14. Coloplast A/S licenses the intellectual property rights for the Altis device to Coloplast Corp. Dkt.

44-1 ¶ 28.

United States. Dkt. 44-1 ¶ 24. However, because it owns the intellectual property rights to the Altis device, Coloplast A/S’s name and logo appear on the Instructions for Use (IFU) that accompany Altis devices, including the IFU for the device implanted into Plaintiff. Id. at ¶ 28. The IFU lists Coloplast A/S as the

“manufacturer.” Id. Defendant Coloplast A/S now moves for dismissal for lack of personal jurisdiction. Dkt. 44. Plaintiff Almond concedes that Florida does not have general jurisdiction over Coloplast A/S.² Thus, the remaining inquiry is whether there is specific jurisdiction over Coloplast A/S.

LEGAL STANDARD

Whether a federal court has personal jurisdiction over a defendant is a question of law. Consol. Dev. Corp. v. Sherritt, Inc., 216 F. 3d 1286, 1291 (11th Cir. 2000) (citing Sculptchair, Inc. v. Century Arts, Ltd., 94 F. 3d 623, 626 (11th Cir. 1996)). The plaintiff bears the burden of proof to establish personal

“plaintiff’s complaint and supporting evidence conflict with the defendant’s affidavits, the court must construe all reasonable inferences in favor of the plaintiff.” Id. at 1269 (citing Madara v. Hall, 916 F. 2d 1510, 1514 (11th Cir. 1990)). A court must conduct a two-step analysis when evaluating whether it has personal jurisdiction over a defendant. See Madara, 916 F. 2d at 1514. First, the court must determine whether the plaintiff has alleged facts sufficient to establish a basis for jurisdiction under Florida’s long-arm statute. Id. This analysis requires application of Florida law. Id. Second, if the answer is yes, then the court must determine whether the exercise of jurisdiction satisfies the Due Process Clause of the Fourteenth Amendment to the U.S. Constitution. Id. “Only if both prongs of the analysis are satisfied may a federal or state court exercise personal jurisdiction over a nonresident defendant.” Id.

DISCUSSION

I. The Florida Long-Arm Statute

Plaintiff Almond argues personal jurisdiction is present pursuant to Fla. Stat. § 48.193(1)(a)(6)(b). Dkt. 46 at 4. Under that subsection, a nonresident defendant can submit itself to personal jurisdiction in Florida by: 6. Causing injury to persons or property within this state arising out of an act or omission by the defendant outside this state, if, at or about the time of the injury . . .

b. Products, materials, or things processed, serviced, or manufactured by the defendant anywhere were used or consumed within this state in the ordinary course of commerce, trade, or use.

§ 48.193(1)(a)(6)(b). “Arising from” requires a “direct affiliation, nexus, or substantial connection” between the basis for the cause of action and the defendant’s activity in the state. Wells Fargo Equip. Fin., Inc. v. Bacjet, LLC, 221 So. 3d 671, 675 (Fla. 4th DCA 2017). Courts should strictly construe the long-arm statute in favor of non-resident defendants. See Blumberg v. Steve Weiss & Co., Inc., 922 So. 2d 361, 363 (Fla. 3d DCA 2006). Here, the parties do not dispute that the location of the alleged injury was in Florida. Thus, the remaining question is whether Coloplast A/S “processed, serviced, or manufactured” Altis devices used in Florida at or around the time Plaintiff Almond was injured. Plaintiff offers the following two points to buttress her argument that the Florida long-arm statute is satisfied: (1) Coloplast A/S submitted a 510(k) Application to the FDA that listed Coloplast A/S as the “applicant” and “Owner/Operator” of the Altis device; and (2) Coloplast A/S was listed as a “manufacturer” on the IFU for the Altis device implanted into Plaintiff. Dkt. 46 at 4. For the reasons explained below, the Court holds that Plaintiff has failed to establish jurisdiction under § 48.193(1)(a)(6)(b). The “manufactured” inquiry can be readily handled. According to the jurisdictional discovery conducted by the parties, Coloplast A/S has never manufactured Altis devices in the United States.³ See Dkt. 89-1 at 79 (“Q: Has Coloplast A/S ever been involved in any aspect of the manufacturer [sic] of Altis? A: They have not, no.”). Rather, it is Coloplast Corp.—the American subsidiary of

Coloplast A/S—that has manufactured all Altis devices since they hit the United States market.4 See Hr’g Tr., p. 4 (“At all points in time Coloplast Corp. and its

510(k) application. However, Coloplast A/S has never actually manufactured the Altis sling. Coloplast A/S is only listed as the manufacturer on the IFU because it owns the intellectual property associated with the Altis sling. Dkt. 89-1 at 76. The same is true for the 510(k) application. Id. at 21. At all times Coloplast Corp. and

Coloplast Corp.’s American contractor have manufactured these devices. Id. at 77. The mere labeling of Coloplast A/S as a manufacturer and owner/operator for intellectual property purposes is not enough to trigger the manufacturing prong of

§ 48.193(1)(a)(6)(b). Because Coloplast A/S never manufactured Altis devices, Coloplast A/S is subject to jurisdiction under Florida’s long-arm statute only if it “processed or serviced” such devices. The Court concludes it did not. First, Coloplast A/S did not “process” Altis devices as defined by Florida law. The term “processed” in § 48.193(1)(a)(6)(b) contemplates the “conduct of a wholesaler in bringing together large quantities of goods for shipment.” Blumberg, 922 So. 2d at 364 (quoting Wetzel v. Fisherman’s Wharf of Pompano Beach, Inc., 771 So. 2d 1195, 1198 (Fla. 4th DCA 2000)). Examples of “processing” include inspecting, packaging, testing, and distributing products. See Chatham Steel Corp. v. Brown, 858 F. Supp. 1130, 1145–46 (N.D. Fla. 1994) (citing Murante v. Pedro Land, Inc., 761 F. Supp. 786, 789 (S.D. Fla. 1991)). Here, Coloplast A/S did not act as a wholesaler for Altis devices. It does not inspect, package, test, or sterilize the devices before they hit the Florida market. See Dkt. 89-1 at 79 (“Q: Does Coloplast A/S have any involvement in the manufacturing, sterilization or packaging of Altis? A: They do not, not at all.”). Nor does Coloplast A/S have any involvement in the distribution of Altis devices.

Id. at 80 (“Q: Does Coloplast A/S have any involvement whatsoever in the distribution of Altis throughout the United States? A: They do not, no.”). These processes were instead all performed by Coloplast Corp. Id. at 79–80. Plaintiff does not explain how the 510(k) application or the IFU fit into this definition of “processing” under Florida law, and the Court has not found any case law supporting that position. As such, long-arm jurisdiction cannot rest on this basis.

Second, Coloplast A/S did not “service” Altis devices as interpreted by Florida law. “The [long-arm] statute’s use of the term ‘serviced’ connotes some hands-on contact with the product before it comes into the possession of the ultimate consumer.” Plantation-Pioneer Indus. Corp. v. Koehler, 689 So. 2d 1293, 1295 (Fla. 4th DCA 1997); see also Hatton v. Chrysler Can., Inc., 937 F. Supp. 2d 1356, 1364 (M.D. Fla. 2013) (finding defendant “serviced” a vehicle under the long-arm statute by assembling the vehicle). Even possession of the product is not enough by itself to constitute “service” under the long-arm statute; the defendant must make some hands-on modification to the product before it enters the Florida market. See Chatham Steel Corp., 858 F. Supp. at 1145–46 (refusing to find that defendant “serviced” a product by merely taking possession of it, without making any physical alteration to it prior to product entering Florida); see also Craker v. Rammtlc, LLC, No. 09-10078-CIV, 2010 WL 11575069, at *5 (S.D. Fla. Nov. 4, 2010) (same).

Here, Plaintiff Almond makes no allegation that Coloplast A/S had any hands-on contact with Altis devices or physically altered such devices before they entered the Florida market. Instead, the discovery shows this was all performed by

Coloplast Corp. and Coloplast Corp.’s American contractor. The Court will not exert personal jurisdiction over Coloplast A/S based on the actions of its subsidiary alone. See Meier, 288 F. 3d at 1272. Moreover, Plaintiff does not show how the

IFU or the 510(k) application constitute “servicing” under Florida law, and the Court has not found any cases supporting this position. In sum, the Court concludes Coloplast A/S did not engage in “processing or servicing” under § 48.193(1)(a)(6)(b). See Andrew v. Radiancy, Inc., No. 16-cv- 1061-Orl-37GJK, 2017 WL 2692840, at *3–4 (M.D. Fla. June 22, 2017) (finding there was no personal jurisdiction pursuant to § 48.193(1)(a)(6)(b) over a parent company that “did not manufacture, distribute, or sell” the offending device);

Pratte v. Wuebbels, No. 7-cv-775-Orl-19DAB, 2008 WL 423409, at *3 (M.D. Fla. Feb. 13, 2008) (same). Unlike the cases relied on by Plaintiff, this is not a case where the defendant made the product at issue and put it into the stream of commerce. Coloplast A/S has never manufactured, serviced, processed, distributed, packaged, sterilized, marketed, or sold Altis devices in the United States. In fact, Coloplast A/S does not sell, market, or advertise any female pelvic surgical implants in the United States. Dkt. 44-1 ¶ 24. Likely recognizing these limitations,

Plaintiff bases her long-arm argument on the fact that the IFU and the 510(k) application list Coloplast A/S as the manufacturer and owner/operator of the Altis device. But this connection does not fit into the requirements of §

48.193(1)(a)(6)(b) as defined by Florida law. As a final note, Coloplast A/S is a foreign business incorporated and operating in Denmark. It has no office in the State of Florida or anywhere else in the United States. Given Coloplast A/S’s insufficient connections to the State of Florida, as well as its minimal contact with Altis devices, the Court concludes that the claims against Coloplast A/S must be dismissed without prejudice.⁵ The Court need not address the due process inquiry because Plaintiff Almond has failed to satisfy the Florida long-arm statute.

CONCLUSION

The Court GRANTS without prejudice Defendant Coloplast A/S’s Motion to Dismiss (Dkt. 44) for lack of personal jurisdiction. The clerk is directed to terminate Coloplast A/S from the case. Plaintiff Almond is no longer entitled to pursue these claims against Coloplast A/S in a Florida court and is therefore foreclosed from amending her complaint to add Coloplast A/S back as a party to this action. DONE AND ORDERED at Tampa, Florida, on May 21, 2021.

/s/ William F. Jung

WILLIAM F. JUNG

UNITED STATES DISTRICT JUDGE