Doe v. Bausch & Lomb, Inc.

• Decision Date: 11 March 2020
• Docket Number: 3:18-CV-000352 (KAD)
• Citation: 443 F.Supp.3d 259
• Court: U.S. District Court — District of Connecticut
• Parties: DOE, et al, Plaintiffs, v. BAUSCH & LOMB, INC., et al, Defendants.

443 F.Supp.3d 259

DOE, et al, Plaintiffs,

v.BAUSCH & LOMB, INC., et al, Defendants.

3:18-CV-000352 (KAD)

United States District Court, D. Connecticut.

Signed March 11, 2020

Fabrice N. Vincent, Pro Hac Vice, Sarah R. London, Lieff Cabraser Heimann & Bernstein, LLP, San Francisco, CA, Wendy R. Fleishman, Pro Hac Vice, Lieff, Cabraser, Heimann & Bernstein, LLP, New York, NY, Glenn A. Duhl, Hugh W. Cuthbertson, Zangari Cohn Cuthbertson Duhl & Grello P.C., New Haven, CT, for Plaintiffs.

Adam C. Martin, Thomas Henry Balestracci, Cetrulo LLP, Boston, MA, Dan Smulian, Greenberg Traurig, LLP, Robert Kirshenberg, Sarah Richardson, Toby S. Soli, Greenberg Traurig, P.A., New York, NY, Lori G. Cohen, Greenberg Traurig, P.A., Atlanta, GA, for Defendants.

MEMORANDUM OF DECISION ON THE DEFENDANTS' MOTION TO DISMISS (ECF NO. 95) AND PLAINTIFFS' MOTION FOR LEAVE TO AMEND THE COMPLAINT (ECF NO. 126)

Kari A. Dooley, United States District Judge:

This is a products liability action involving the Trulign Toric intraocular lens ("Trulign Lens" or "Trulign Lenses"). The Trulign Lenses, manufactured by Defendant Bausch & Lomb, Incorporated ("B & L") for the treatment of cataracts, are Class III medical devices approved for sale by the United States Food & Drug Administration ("FDA"). In the Second Amended Complaint ("SAC"), Marjorie Glover and her husband, Charles Glover, (individually, "Mrs. Glover" and "Mr. Glover," and, collectively, the "Plaintiffs") assert ten causes of action against Defendants,¹ each arising out of alleged complications resulting from the implantation of a Trulign Lens in each of Mrs. Glover's eyes. Defendants filed a motion to dismiss this action on a variety of bases pursuant to Rule 12(b)(2), Rule 12(b)(6), and Rule 9(b). Following the filing of the motion to dismiss, the Plaintiffs sought leave to amend the complaint to add an additional cause of action under the Connecticut Unfair Trade Practices Act ("CUTPA"), to which the Defendants objected. This memorandum of decision addresses both motions.

For the reasons set forth in this decision, the Defendants' Motion to Dismiss is GRANTED and the Plaintiffs' Motion for Leave to Amend is DENIED.

Allegations and Background

The following is alleged in the SAC. The Trulign Lens is the latest in a line of "accommodating" lenses that are surgically implanted in the eyes to replace one's natural lens after the natural lens is removed during cataract surgery

. It is a Class III medical device that was required to pass the FDA's rigorous premarket approval process before it could be sold to the public.

Mrs. Glover underwent two successive cataract surgeries

in 2014 during which her physician surgically implanted a Trulign Lens in each eye. Mrs. Glover was diagnosed ultimately with Z-Syndrome in both of her eyes. This asymmetric vaulting, known as "Z-Syndrome," is a post-operative complication unique to the Trulign Lens and its predecessor, the Crystalens lenses, and occurs when one haptic of the Lens pulls forward, while the other remains either in the normal position or is pushed backward, resembling the letter "Z" with the tilted optic in the middle. As a result, Mrs. Glover has had additional surgeries and other extensive treatment over the course of the years following the implant surgery. She has suffered significant vision impairment, including the loss of visual acuity in both eyes, complete loss of depth perception, extreme photosensitivity, limited ability to see at night and double vision. She also suffers continuously from the loss of balance, vertigo, headaches, extreme eye pain, eye fatigue and tearing. Plaintiffs allege that Mrs. Glover's injuries are caused by the Trulign Lenses.

Plaintiffs further allege that Defendants knew of the unique risk of Z-Syndrome posed by the Trulign Lenses while developing, seeking approval for and marketing the product. However, Plaintiffs allege, Defendants made misrepresentations to the FDA, including that Z-Syndrome could be successfully treated, while the FDA considered approval of the lenses. Post-approval, Plaintiffs claim that Defendants failed to conduct post-market surveillance and to file adverse event reports with the FDA regarding known incidents of Z-Syndrome. Ultimately, Defendants failures caused the FDA-approved labeling on the Trulign Lenses to mislead ophthalmologists and their patients regarding Z-Syndrome. If Defendants had not failed in their obligations to the FDA, Mrs. Glover would not have suffered the injuries described above because she and her physician would not have selected the Trulign Lenses.

On July 5, 2018, Defendants filed a Motion to Dismiss pursuant to Rule 12(b)(2), Rule 12(b)(6), and Rule 9(b).² The Court held oral argument on the Motion to Dismiss on January 17, 2019. After oral argument, the parties filed multiple submissions supplementing their arguments. On July 16, 2019, Plaintiffs moved to amend their complaint pursuant to Rule 15(a)(2) to add a claim under CUTPA, to which the Defendants objected. The issues raised in the parties' motions are addressed as is necessary below.

Personal Jurisdiction

Defendants B & L Holdings, VPNA, VPI, and Bausch Health ("Jurisdictional Defendants") move to dismiss all claims against them for lack of personal jurisdiction. To survive a motion to dismiss filed pursuant to Rule 12(b)(2), "plaintiff must make a prima facie showing that jurisdiction exists." SPV Osus Ltd. v. UBS AG , 882 F.3d 333, 342 (2d Cir. 2018) (internal quotation marks omitted). "Prior to discovery, a plaintiff may defeat a motion to dismiss based on legally sufficient allegations of jurisdiction." Metro. Life Ins. Co. v. Robertson-Ceco Corp. , 84 F.3d 560, 566 (2d Cir. 1996). However, "[v]ague and conclusory allegations ... are not enough to establish personal jurisdiction." Rivera v. Armstrong , 2007 WL 683948, at *1 (D. Conn. Mar. 2, 2007) (internal quotation marks and citations omitted).

In order to establish personal jurisdiction over the Jurisdictional Defendants, Plaintiffs must show that the Jurisdictional Defendants (1) are subject to personal jurisdiction under Connecticut's long-arm statute and (2) that exercising personal jurisdiction over them is consistent with the Due Process Clause of the Fourteenth Amendment. See , e.g. , Sonera Holding B.V. v. Cukurova Holding A.S. , 750 F.3d 221, 224 (2d Cir. 2014). For the Court's exercise of personal jurisdiction to satisfy due process, a non-resident must have sufficient "minimum contacts" with the forum state "such that maintenance of the suit ‘does not offend traditional notions of fair play and substantial justice.’ " World-Wide Volkswagen Corp. v. Woodson , 444 U.S. 286, 291–92, 100 S.Ct. 559, 62 L.Ed.2d 490 (1980) (quoting Int'l Shoe Co. v. Washington , 326 U.S. 310, 316, 66 S.Ct. 154, 90 L.Ed. 95 (1945) ) (internal quotation marks omitted). To avoid offending traditional notions of fair play and substantial justice, the non-resident's contacts with the forum must establish either general or specific jurisdiction.³ See Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco Cty. , ––– U.S. ––––, 137 S. Ct. 1773, 1779–80, 198 L.Ed.2d 395 (2017). The non-resident's contacts with the forum establish specific jurisdiction when the non-resident "has purposefully directed his activities at residents of the forum, and the litigation results from alleged injuries that arise out of or relate to those activities." Burger King Corp. v. Rudzewicz , 471 U.S. 462, 472, 105 S.Ct. 2174, 85 L.Ed.2d 528 (1985) (internal citations and quotation marks omitted). " ‘It is essential in each case that there be some act by which the defendant purposefully avails itself of the privilege of conducting activities within the forum State, thus invoking the benefits and protections of its laws.’ " MacDermid, Inc. v. Deiter , 702 F.3d 725, 730 (2d Cir. 2012) (quoting Burger King Corp. , 471 U.S. at 475, 105 S.Ct. 2174 ) (brackets omitted).

Plaintiffs' allegations regarding the Jurisdictional Defendants' contacts with Connecticut are, at best, vague. In their SAC, Plaintiffs state:

This Court has personal jurisdiction over Defendants because they transact business in the United States, including in the District of Connecticut; have substantial aggregate contacts with the United States, including within this District; engaged and are engaging in conduct that has and had a direct, substantial, reasonably foreseeable, and intended effect of causing injury to persons throughout the United States, and specifically in this District where the devices were sold to Plaintiff's doctor; and, Defendants purposely availed themselves of the laws of the United States.

(ECF No. 93 ¶ 36). Similarly, throughout the SAC, Plaintiffs make factual allegations regarding the Defendants collectively or only with respect to "Bausch & Lomb." For example, Plaintiffs allege, "Although Defendants have recently acknowledged some of the risks and dangers of Z Syndrome and some related complications resulting from the Lenses in the 2016 Instructions for Use, Defendants did not disclose and still have not fully disclosed the seriousness of the issue," (Id. ¶ 135), and, "Bausch & Lomb knew, and/or had reason to know, that its representations and suggestions to ophthalmologists that Trulign Lenses were safe and effective for use in the eyes were materially false and misleading." (Id. ¶ 152). Such vague allegations levied against the Jurisdictional Defendants do not satisfy Plaintiffs' burden.

However, Plaintiffs argue that personal jurisdiction is established as to the Jurisdictional Defendants because B & L's contacts with Connecticut may be imputed to the Jurisdictional Defendants insofar as B & L is their "alter ego." Plaintiffs summarily assert that "there existed a unity of interest in ownership between certain Defendants and other certain Defendants such that any individuality and separateness between the certain Defendants has ceased and these Defendants are the alter ego of...