Mortier v. LivaNova USA, Inc.

CourtDistrict Court, D. Minnesota
DecidedMay 12, 2022
Docket0:19-cv-03140
StatusUnknown

This text of Mortier v. LivaNova USA, Inc. (Mortier v. LivaNova USA, Inc.) is published on Counsel Stack Legal Research, covering District Court, D. Minnesota primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Mortier v. LivaNova USA, Inc., (mnd 2022).

Opinion

UNITED STATES DISTRICT COURT DISTRICT OF MINNESOTA

Todd J. Mortier, as Member Representative File No. 19-cv-3140 (ECT/DTS) of the former Members of Caisson Interventional, LLC,

Plaintiff, OPINION AND ORDER v.

LivaNova USA, Inc.,

Defendant.

Elizabeth A. Patton, Fox Rothschild LLP, Minneapolis, MN; R. James Kravitz, Fox Rothschild LLP, Lawrenceville, NJ; and Dennis B. Johnson, Chestnut Cambronne PA, Minneapolis, MN, for Plaintiff Todd J. Mortier, as Member Representative of the former Members of Caisson Interventional, LLC.

Isaac B. Hall, Cb Baga, and Larry E. LaTarte, Faegre Drinker Biddle & Reath LLP, Minneapolis, MN; and Heather Carson Perkins, Faegre Drinker Biddle & Reath LLP, Denver, CO, for Defendant LivaNova USA, Inc.

In this diversity case, Plaintiff Todd J. Mortier, representing the members and option-holders of an LLC formed to develop a medical device, asserts breach-of-contract and quasi-contract claims under Delaware law against the LLC’s business partner, LivaNova USA, Inc. The gist of Mortier’s claims is that LivaNova breached express and implied contract terms that, Mortier says, required LivaNova to do more than it did to develop the medical device. LivaNova has moved for summary judgment, and the motion will be granted. The relevant contract terms cannot reasonably be understood as Mortier advocates. Considered against their correct interpretation, the record evidence Mortier identifies does not show a trial-worthy question concerning the contract’s breach. And the contract’s detailed and reticulated nature forecloses Mortier’s assertion of quasi-contract claims.

I The TMVR device. In early 2011, Mortier and his colleague Cyril J. Schweich, Jr. developed an idea for a less-invasive treatment for mitral valve disease, a heart condition which is otherwise primarily treated with open-heart surgery. ECF No. 142 ¶ 2. Mortier and Schweich’s transcatheter mitral valve replacement (or “TMVR”) system would treat

mitral valve regurgitation with a small remote-controlled device. ECF No. 114-15. As designed, the remote-controlled TMVR device would be inserted into a patient’s vein through an incision in the groin, from which it would travel to the patient’s heart. ECF No. 114-15. Then, a doctor would use the remote control to land the device in the diseased valve opening and anchor it in place with the device’s flared feet. Id.; Compl. [ECF No.

1-1] ¶ 28. Mortier and Schweich present the TMVR device to LivaNova, and a new organization is formed to develop the device. Later that year, Mortier and Schweich presented their idea to LivaNova, a multi-national medical device company.1 ECF No. 146-5. By 2012, Mortier and Schweich had developed a TMVR design concept and filed

a provisional patent application. ECF No. 144-4 at 84–85, 105. On July 4, 2012, they

1 Mortier and Schweich actually met with LivaNova’s predecessor, Sorin Group. LivaNova was formed when Sorin merged with Cyberonics, Inc. Hereafter, “LivaNova” refers to the entire LivaNova organization. See ECF No. 116-3; Compl. ¶¶ 12–14, 31. executed a term sheet with LivaNova and created a new company, Caisson Interventional, LLC, to develop the TMVR system. Id. at 105. Caisson and LivaNova enter initial agreements regarding the TMVR device’s

development. On September 14, 2012, Caisson and LivaNova inked two agreements. First, the two companies agreed that LivaNova would fund Caisson in set amounts in exchange for equity, as development and regulatory approval of the TMVR device met certain milestones. ECF No. 116-3. On the same day, Caisson, Mortier, Schweich, and LivaNova entered an Option Agreement, which provided LivaNova with the option to purchase the

remaining equity in Caisson upon the achievement of a CE Mark.2 ECF No. 116-4. Over the next four years, Caisson met a number of milestones, and LivaNova provided funds in accordance with the agreement. Compl. ¶¶ 46–52. LivaNova acquires Caisson’s remaining equity, and the Parties assent to the at- issue contract. Although Caisson had not yet acquired a CE Mark for the TMVR system,

in September 2016 the parties agreed that LivaNova would acquire the remaining Caisson equity. At this point, LivaNova had invested $23 million in Caisson and owned 49.1% of its stock. ECF No. 104-1 ¶ 107. On May 2, 2017, LivaNova purchased the remaining equity in Caisson, and the parties memorialized the purchase and related obligations in a Unit Purchase Agreement (“UPA”). ECF No. 143-1. The UPA provided that LivaNova

would pay up to $72 million for Caisson, in addition to $18 million in employee retention payments. Id. § 3.1. As with the parties’ previous agreements, the purchase price included

2 To be sold in the European Union, a medical device must obtain a CE (Conformitè Europëene) Mark, which specifies that a product conforms to the European Norms or standards and the European Medical Device Regulations. ECF No. 104-1. several “milestone” payments contingent on Caisson’s device accomplishing regulatory approvals, including payments to members and option-holders of $9 million after CE Mark approval, $9 million after premarket authorization (“PMA”) by the United States Food and

Drug Administration (“FDA”),3 and twenty percent of the net sales of covered products worldwide until the earlier of: 1) payments totaled $21,600,000, or 2) ten years from the date of the first commercial sale (“the earn-out payments”). Id. LivaNova has paid the members and option-holders of Caisson more than $32 million under this section but has not paid the remaining $39.6 million for CE Mark approval, PMA, and earn-out payments.

Compl. ¶¶ 67-73; Answer [ECF No. 9] ¶¶ 67-73. The UPA’s especially relevant provisions. As relevant for this litigation, the UPA contains two provisions that ostensibly set forth LivaNova’s obligations following its purchase of Caisson. First, Section 4.3 of the agreement described the efforts LivaNova agreed to undertake to facilitate the milestone payments described above. Second, Section

7.13 guaranteed essentially that LivaNova had adequate financial resources to satisfy its obligations under the agreement. The UPA limited all representations and warranties of LivaNova and its members to twenty-four months from the effective date of the agreement, unless otherwise provided. ECF No. 143-1 § 8.7. The Caisson team’s 2017 and 2018 operations. After executing the UPA, the

Caisson team continued work on the TMVR device while operating independently within LivaNova. ECF No. 144-1 at 62–63. Throughout 2017 and 2018, LivaNova staffed and

3 The FDA requires pre-market approval for high-risk medical devices sold in the United States. ECF No. 104-1 ¶ 91. A clinical trial involving human subjects is usually required to gather data demonstrating safety and effectiveness. Id. funded the Caisson team at lower levels than it had originally budgeted. For example, LivaNova hired fifteen fewer employees for the Caisson team than originally budgeted in 2017, and twelve fewer in 2018. ECF No. 144-10 at 96–97; ECF No. 147. Further, the

Caisson team’s funding was approximately $5 million below the original budget in 2017 and was $4.479 million less than originally budgeted in 2018. ECF No. 147-3; ECF No. 144-10 at 100. Patient deaths occur in TMVR clinical trials and are investigated. In the fall of 2018, two patients died in clinical trials of the TMVR device, with a third experiencing

serious adverse effects. As a result, the team paused the clinical trial and notified the FDA of the halt. ECF No. 119-5. A root-cause analysis determined that the injury and deaths were caused by the device’s anchor system. ECF No. 119-3. The Caisson team determined that the device required redesign. ECF No. 114-17.

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