Judge: Colin Leis, Case: 20STCV14428, Date: 2022-08-15 Tentative Ruling

Case Number: 20STCV14428    Hearing Date: August 15, 2022    Dept: 3

SUPERIOR COURT OF CALIFORNIA

COUNTY OF LOS ANGELES – NORTHEAST DISTRICT

DEPARTMENT 3

MOVING PARTY:                Defendant Abiomed, Inc.

RESPONDING PARTY:       Plaintiffs Marlen Tchakerian, Raffi Tchakerian, and Tania Avakian

Defendant Abiomed, Inc.’s Demurrer to Plaintiffs’ Complaint

The court considered the moving papers, opposition, and reply filed in connection with this motion.

BACKGROUND

            Plaintiffs Marlen Tchakerian, Raffi Tchakerian, and Tania Avakian filed this wrongful death action on April 14, 2020 arising out of the death of Antranik Tchakerian (“Decedent”), who died on April 21, 2019 following an angiography/angioplasty procedure performed at Glendale Memorial Hospital & Health Center. During the angioplasty, the surgeons inserted and deployed an Impella device, which is designed to act as a mechanical heart pump. Plaintiffs allege that the Impella device was “in some manner defective and dangerous, and that its defective condition resulted in a harmful misuse or malfunction . . . that was a substantial or concurrent factor in causing Decedent’s death.” (Compl., ¶ 25.) Defendant Abiomed, Inc. (“Abiomed”) manufactures the Impella device. (Compl., ¶ 5.)

Abiomed demurs to the complaint on the basis that the complaint fails to state facts sufficient to constitute a cause of action against Abiomed.

REQUEST FOR JUDICIAL NOTICE

            The court grants Abiomed’s request for judicial notice as to Exhibits A and B.

LEGAL STANDARD

A demurrer can be used only to challenge defects that appear on the face of the pleading under attack or from matters outside the pleading that are judicially noticeable. (Blank v. Kirwan (1985) 39 Cal.3d 311, 318.) “To survive a demurrer, the complaint need only allege facts sufficient to state a cause of action; each evidentiary fact that might eventually form part of the plaintiff’s proof need not be alleged.” (C.A. v. William S. Hart Union High School Dist. (2012) 53 Cal.4th 861, 872.) For the purpose of testing the sufficiency of the cause of action, the demurrer admits the truth of all material facts properly pleaded. (Aubry v. Tri-City Hospital Dist. (1992) 2 Cal.4th 962, 966-967.) A demurrer “does not admit contentions, deductions or conclusions of fact or law.” (Daar v. Yellow Cab Co. (1967) 67 Cal.2d 695, 713.)

DISCUSSION

The Impella is a Class III medical device approved by the FDA under the Premarket Approval process. (RFJN, Exs. A, B.) And under the Medical Device Amendments (“MDA”) to the federal Food, Drug, and Cosmetic Act (“FDCA”), manufacturers of premarket approved devices are protected from most tort liability because claims related to these devices are preempted, either expressly or impliedly. (Coleman v. Medtronic, Inc. (2014) 223 Cal.App.4th 413, 423-427.) “In order to state a claim that avoids both express and implied preemption, a plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by [21 U.S.C.] § 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under [Buckman Co. v. Plaintiffs’ Legal Comm. (2001) 531 U.S. 341, 353, 121 S.Ct. 1012, 148 L.Ed.2d 854]).” (Id. at p. 437 [emphasis in original; internal quotations omitted].) “Stated differently, to survive both express and implied preemption, a state law cause of action ‘must be premised on conduct that both (1) violates the FDCA and (2) would give rise to a recovery under state law even in the absence of the FDCA.” (Ibid.)

Here, the allegation that the Impella was “in some manner defective and dangerous” fails to establish either element sufficiently to pass through the narrow gap between express and implied preemption. There are no allegations that Abiomed violated the FDCA in its manufacturing of the Impella, and there are no allegations supporting a negligence claim against Abiomed independent of violations of the FDCA. (Coleman v. Medtronic, Inc., supra, 223 Cal.App.4th at p. 435 [“[I]f a plaintiff pleads that a manufacturer of a Class III medical device failed to comply with either the specific processes and procedures that were approved by the FDA or the [Current Good Manufacturing Practices] themselves and that this failure caused the injury, the plaintiff will have pleaded a parallel claim.”].)

CONCLUSION

Based on the foregoing, the court sustains Abiomed’s demurrer, with leave to amend.

The court orders Plaintiffs to file and serve an amended complaint, if any, within 20 days of the date of this order. If no amended complaint is filed within 20 days, the court orders Abiomed to file and serve a proposed judgment of dismissal within 30 days of the date of this order.

Abiomed is ordered to give notice of this ruling.

IT IS SO ORDERED.

DATED:  August 15, 2022

_____________________________

Colin Leis

Judge of the Superior Court