Judge: Daniel M. Crowley, Case: 21STCV02108, Date: 2022-08-11 Tentative Ruling

Case Number: 21STCV02108    Hearing Date: August 11, 2022    Dept: 28

Defendant Medtronic, Inc’s Demurrer

Having considered the moving, opposing and reply papers, the Court rules as follows. 

BACKGROUND

On January 19, 2021, Plaintiffs Estate of Robert Gregory Comatov, by and through his successor in Interest, Denna Comatov (“Estate”) and Denna Comatov (“Comatov”) filed this action against Defendants Keck Hospital of USC (“USC”) and Armin Kiankhooy, M.D. (“Kiankhooy”) for negligence (medical malpractice) and survivors claims.

On December 6, 2021, Plaintiffs filed the First Amended Complaint, adding Defendant Medtronic, Inc. (“Medtronic”) and causes of action for strict liability and negligence. 

On June 29, 2022, Plaintiffs filed the Second Amended Complaint.

On July 20, 2022, Kiankhooy and USC filed an answer. 

On June 5, 2022, Medtronic filed a demurrer to be heard on August 11, 2022. On July 29, 2022, Plaintiffs filed an opposition. On August 4, 2022, Medtronic filed a reply.

Trial is currently set for April 20, 2023

PARTY’S REQUESTS

Medtronic requests the Court sustain the demurrer to the third through fifth causes of action on the basis that these are barred by federal preemption and that that there are insufficient facts sufficient to constitute the argued causes of action.

Medtronic also requests the Court take judicial notice of the requested FDA approval of the subject product.

Plaintiffs requests the Court not take judicial notice.

LEGAL STANDARD

CCP § 430.10 states: “The party against whom a complaint or cross-complaint has been filed may object, by demurrer or answer as provided in Section 430.30, to the pleading on any one or more of the following grounds: (a) The court has no jurisdiction of the subject of the cause of action alleged in the pleading; (b) The person who filed the pleading does not have the legal capacity to sue; (c) There is another action pending between the same parties on the same cause of action; (d) There is a defect or misjoinder of parties; (e) The pleading does not state facts sufficient to constitute a cause of action; (f) The pleading is uncertain. As used in this subdivision, “uncertain” includes ambiguous and unintelligible; and (g) In an action founded upon a contract, it cannot be ascertained from the pleading whether the contract is written, is oral, or is implied by conduct.”

A demurrer for sufficiency tests whether the complaint states a cause of action.  (Hahn v. Mirda (2007) 147 Cal. App. 4th 740, 747.)  When considering demurrers, courts read the allegations liberally and in context.  (Taylor v. City of Los Angeles Dept. of Water and Power (2006) 144 Cal. App. 4th 1216, 1228.)  In a demurrer proceeding, the defects must be apparent on the face of the pleading or by proper judicial notice.  (CCP § 430.30(a).)  A demurrer tests the pleadings alone and not the evidence or other extrinsic matters.  (SKF Farms v. Superior Court (1984) 153 Cal. App. 3d 902, 905.)  Therefore, it lies only where the defects appear on the face of the pleading or are judicially noticed.  (Id.)  The only issue involved in a demurrer hearing is whether the complaint, as it stands, unconnected with extraneous matters, states a cause of action.  (Hahn, 147 Cal.App.4th at 747.)

“A product has a manufacturing defect if it differs from the manufacturer’s intended result or from other ostensibly identical units of the same product line. In other words, a product has a manufacturing defect if the product as manufactured does not conform to the manufacturer’s design.” (Garrett v. Howmedica Osteonics Corp. (2013) 214 Cal.App.4th 173, 190.)

“A manufacturer, distributor, or retailer is liable in tort if a defect in the manufacture or design of its product causes injury while the product is being used in a reasonably foreseeable way.” (Soule v. General Motors Corp. (1994) 8 Cal.4th 548, 560.) “[U]nder the risk/benefit test, the plaintiff may establish the product is defective by showing that its design proximately caused his injury and the defendant then fails to establish that on balance the benefits of the challenged design outweigh the risk of danger inherent in such design. In such case, the jury must evaluate the product’s design by considering the gravity of the danger posed by the design, the likelihood such danger would occur, the feasibility of a safer alternative design, the financial cost of an improved design, and the adverse consequences to the consumer resulting from an alternative design. ‘In such cases, the jury must consider the manufacturer’s evidence of competing design considerations . . . , and the issue of design defect cannot fairly be resolved by standardless reference to the “expectations” of an “ordinary consumer.” ’ ” (Saller v. Crown Cork & Seal Co., Inc. (2010) 187 Cal.App.4th 1220, 1233

Defendants cannot be found liable on the basis that an allegedly inadequate warning was not read or relied upon by Plaintiff before Plaintiff utilized the product. (Conte w. Wyeth, Inc. (2009) 168 Cal.App.4th 89, 112.)

Under Evidence Code § 452, judicial notice may be taken of: (c) official acts of the legislative, executive and judicial departments of the federal government and (h) facts that are not reasonably subject to dispute. The Court will take judicial notice of these matters, as long as the adverse party is given sufficient notice and sufficient information is given to the Court. Evidence Code § 453.  

DISCUSSION

Judicial Notice

The Court takes judicial notice of the request documents, as they are official acts of a federal agency that are not reasonably subject to dispute. Judicial notice is only granted as to the existence of the documents, not as to the truth of the matter asserted inside.

Demurrer

Plaintiffs’ FAC alleges that from July 2019 to December 2019, Decedent consulted Defendants for medical care and treatment of his cardiac statement and other conditions, including conditions that involved medical and surgical procedures, resulting in his death via cardiac arrest. The FAC specifically alleges that Medtronic’s Medtronic Percepta CRT-P MRI SureScan (“Percepta Device”), which was implanted into Decedent, failed, resulting in Decedent’s heart attack. The FAC further alleges that Medtronic was aware, or should have been aware, of these risks but continued to sell these without proper warning.

Medtronic argues that as the Percepta Device is a Class III medical device that received Premarket Approval by the US FDA, any state-law tort claim that imposes requirements that are “different from, or in addition to” the requirements imposed on Medtronic as part of the subject Premarket Approval are preempted. Riegel v. Medtronic, Inc. (2008) 552 U.S. 312, 317. Specifically, Medtronic argues that this preempts design defect and failure to warn theories, but not Plaintiffs’ manufacturing defect theory. Under 21 U.S.C. § 337(a), the FDA has the sole authority to enforce and investigate violations of the FDCA, which would include any alleged design defects of failure to warn. Effectively these claims are barred from state law causes of action as it would effectively impose different design and warnings than those approved by the FDA. Riegel, 327-330.

Plaintiffs argue that Medtronic misinterprets Riegel’s findings; the Riegel Court indicated that there is a two-step analysis to determine if a claim is preempted under 21 U.S.C. §360k(a). First, the Court must determine if the FDA has established requirements for the medical device at issue. Second, the Court must determine if the state law claims seek to impose requirements that relate to safety and effectiveness that differ or add to the FDA requirements. Plaintiffs argue that their claims are parallel claims that are not preempted. However, Plaintiffs do not actually articulate how the claims are parallel. For example, Plaintiffs SAC provides that the FDA was on notice as to the potential issues; therefore, the FDA would have had adequate knowledge to dictate what warnings should and should not have been given. Any allegation that Medtronic should have acted otherwise would constitute a different or additive requirement. As such, the Court sustains the demurrer, with leave to amend.

CONCLUSION

Defendant Medtronic, Inc’s Demurrer is SUSTAINED, with 30 days leave to amend.

            Moving party is ordered to give notice of this ruling.

Moving Party is ordered to file the proof of service of this ruling with the Court within five days.

The parties are directed to the header of this tentative ruling for further instructions.