In re Essure Product Cases

CourtCalifornia Court of Appeal
DecidedDecember 22, 2023
DocketA166579
StatusPublished

This text of In re Essure Product Cases (In re Essure Product Cases) is published on Counsel Stack Legal Research, covering California Court of Appeal primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re Essure Product Cases, (Cal. Ct. App. 2023).

Opinion

Filed 12/22/23 CERTIFIED FOR PARTIAL PUBLICATION*

IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA

FIRST APPELLATE DISTRICT

DIVISION THREE

In re ESSURE PRODUCT CASES.

LHC GROUP, INC., A166579 Plaintiff and Appellant, v. (Alameda County Super. Ct. BAYER CORPORATION, No. RG16804878)

Defendant and Respondent.

LHC Group, Inc. (LHC) is the administrator of a self-insured employee welfare benefit plan, LHC Group Benefit Plan (Plan), which is governed by the Employment Retirement Income Security Act of 1974 (ERISA). (29 U.S.C. § 1001.) LHC — on behalf of itself and as a subrogee of Plan participants — sued Bayer Corporation (Bayer) seeking damages related to the manufacture and sale of Essure, an allegedly defective birth control device. The trial court sustained Bayer’s demurrer without leave to amend, concluding ERISA preempts LHC’s claims because they relate to an employee benefit plan. (29 U.S.C. § 1144(a).) It further concluded that, due to

* Pursuant to California Rules of Court, rules 8.1105(b) and 8.1110, this

opinion is certified for publication with the exception of parts II and III of the Discussion section. 1 differences in implanting the devices and injuries, LHC misjoined participants’ claims into a single case. Finally, the court struck LHC’s claims for punitive damages because they are not authorized under the Plan’s subrogation clause. LHC appealed. In the published portion of our opinion, we hold LHC’s state law claims do not “relate to” an ERISA plan and are therefore not preempted by ERISA. We reverse the order dismissing the complaint but affirm the order striking the request for punitive damages. BACKGROUND1 In April 2021, LHC filed a complaint against Bayer alleging tort claims such as negligence, strict products liability, concealment, and negligent misrepresentation, as well as quasi-contract and unjust enrichment claims related to Essure, a permanent female birth control implanted into the patient’s fallopian tubes through a disposable delivery system. According to LHC, Bayer failed to comply with its responsibilities to warn about apparent serious health risks after the device was approved for sale. Specifically, Bayer received — but did not disclose — thousands of complaints of serious injuries, such as perforation of the uterus or fallopian tubes, device migration or fracture, prolonged bleeding, and unintended pregnancies. In addition, Bayer failed to disclose to the U.S. Food and Drug Administration (FDA) that the frequency and severity of these complications were greater than expected, and Essure must be removed through major surgery. Upon becoming aware of this information, the FDA categorized Essure as a restricted device. In 2016, it required Essure to include a “black box

1 The following facts are based on the allegations in LHC’s complaint

because this appeal follows a ruling on a demurrer. (Doe v. Google, Inc. (2020) 54 Cal.App.5th 948, 952.) 2 warning and Patient Decision Checklist” — to notify patients and physicians of serious health risks — and additional warnings regarding long-term risks — device removal could require surgery, removal of fallopian tubes, or hysterectomy. In July 2018, Bayer notified the FDA it would no longer sell or distribute Essure in the United States after December 2018. LHC brought its claims both as its participants’ subrogee and in its own right. Relevant here, the Plan included a subrogation clause noting “each Covered Person agrees that the Plan will have the right of subrogation with respect to the full amount of benefits paid to or on behalf of a Covered Person as the result of an injury, illness, disability or death that is or may be the responsibility of any Third Party.” LHC sought medical expenses it actually paid for injured Plan participants, damages LHC itself suffered, and punitive damages. Attached to the complaint were participant identification numbers and the associated total costs resulting from Essure injuries. It did not seek any declaratory or injunctive relief, or any relief from or against Plan participants. Bayer filed a demurrer, which the trial court sustained without leave to amend. The court concluded ERISA preempted LHC’s claims because they “relate to” the Plan — the subrogation clause — and the court would need to interpret the Plan to determine LHC’s ability to sue Bayer on behalf of Plan participants. The court also found LHC’s claims had an impermissible connection with the Plan because they interfere both with the ability of Plan participants to assert claims on their own behalf and uniform plan administration. In addition, the court determined LHC’s claims on behalf of 231 injured women were misjoined into a single case. LHC’s ability to recover on behalf of each Plan participant “would depend on whether each plan participant had a meritorious claim against Bayer.” Finally, the court

3 struck LHC’s request for punitive damages, noting LHC, as a subrogee, could only recover as damages actual payments for medical expenses it made to Plan participants related to their injuries. DISCUSSION LHC contends the trial court erred in sustaining the demurrer. Rulings on a demurrer are reviewed de novo, assuming the truth of the factual allegations and those reasonably inferred from the pleadings. (Regents of University of California v. Superior Court (2013) 220 Cal.App.4th 549, 558.) We also review de novo whether ERISA preempts state law — an issue of statutory construction and an affirmative defense that would entirely bar the state claims. (Morris B. Silver M.D., Inc. v. International Longshore & Warehouse etc. (2016) 2 Cal.App.5th 793, 805 (Silver); Port Medical Wellness Inc. v. Connecticut General Life Insurance Co. (2018) 24 Cal.App.5th 153, 171–172.) LHC bears the burden of demonstrating the court erroneously sustained the demurrer. (Keyes v. Bowen (2010) 189 Cal.App.4th 647, 655.) I. LHC argues the trial court erred by concluding ERISA preempts its claims because they “relate to” — have a “reference to” or “connection with” — an ERISA plan. We agree. “ERISA is a comprehensive statute designed to promote the interests of employees and their beneficiaries in employee benefit plans.” (Shaw v. Delta Air Lines, Inc. (1983) 463 U.S. 85, 90 (Shaw).) It contains expansive preemption provisions, designed to ensure employee benefit plan regulation is an exclusively federal concern. (29 U.S.C. § 1144; Marshall v. Bankers Life & Casualty Co. (1992) 2 Cal.4th 1045, 1050; Ingersoll-Rand Co. v. McClendon (1990) 498 U.S. 133, 138 (Ingersoll-Rand).) At issue here, ERISA preempts “any and all State laws insofar as they . . . relate to any employee benefit

4 plan,” with exceptions not relevant here.2 (29 U.S.C. § 1144(a), (b)(2)(A).) Any state-law claim that falls within the scope of ERISA’s remedies “is preempted as conflicting with the intended exclusivity of the ERISA remedial scheme.” (Paulsen v. CNF Inc. (9th Cir. 2009) 559 F.3d 1061, 1084 (Paulsen).) There are two categories of state laws conflict-preempted under ERISA: if it has a “reference to” an ERISA plan, or “if it has a connection with” such a plan. (Shaw, at pp.

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Bluebook (online)
In re Essure Product Cases, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-essure-product-cases-calctapp-2023.