Case Name: Marc Besse, et al. v. Insightec, LTD, et al.
Case No.: 17CV319427

I. Background

This is a products liability and negligence action filed by plaintiffs Marc Besse (“Besse”) and Kristen Besse (collectively “Plaintiffs”) against defendants Insightec, Ltd. and Insightec, Inc. (collectively “Insightec”), the manufacturers of gel pads used in medical procedures, and Stanford Health Care (“Stanford), a health care corporation that provided medical services to Besse.

As alleged in the First Amended Complaint (“FAC”), Besse had a benign tumor in his right shoulder for many years. (FAC, ¶ 19.) Around the end of 2015, after several MRI tests, Besse was referred to the interventional radiology department at Stanford. (Id. at ¶ 19.) There, the doctor recommended that Besse try a “new procedure” using high intensity focused ultrasound (“HIFU”) instead of a more traditional treatment route such as surgery. (Ibid.) Besse agreed and waited several months for his health insurance to approve the procedure. (Ibid.) In February 2016, Besse underwent the HIFU procedure during which time the gel pad used to control the intensity of the HIFU machine failed, resulting in severe burns and muscle damage. (Id. at ¶ 19.)

Plaintiffs’ FAC asserts three causes of action for: (1) strict products liability, (2) negligence, and (3) loss of consortium.

Insightec demurs to the FAC and filed an accompanying request for judicial notice in support. Plaintiffs oppose the demurrer.

II. Demurrer

Insightec demurs to the FAC in its entirety as well as to the first and second causes of action for strict products liability and negligence on the ground of failure to state facts sufficient to constitute a cause of action. (See Code Civ. Proc., § 430.10, subd. (e).)

A. Preliminary Issues

At the outset, the Court observes there is some lack of clarity in Insightec’s presentation of the demurrer. Though Insightec clearly indicates in the demurrer itself that it is demurring on the ground of failure to state sufficient facts, it states in its notice that the demurrer is made “on the grounds that Plaintiffs’ FAC fails to state facts sufficient to constitute a cause of action, is uncertain, and is preempted by federal law.” (Not. of Dem. at p. 2:9-10.)

The demurrer on the ground of uncertainty is defective because this ground is not enumerated in the demurrer itself. (See Cal. Rules of Court, rule 3.1320(a) [each ground of demurrer must be in a separate paragraph and state whether it applies to the entire pleading or to specified causes of action]; Code Civ. Proc., § 430.60 [a demurrer must distinctly specify the grounds for any objections to the complaint].) Even if the Court were to disregard this defect, Insightec does not elaborate on its contention that the FAC is uncertain. The standard for uncertainty is that the allegations of the pleading must be so unintelligible the defendant cannot reasonably respond, i.e., he or she cannot reasonably determine what issues must be admitted or denied, or what counts or claims are directed against him or her. (Khoury v. Maly’s of Calif., Inc. (1993) 14 Cal.App.4th 612, 616.) Insightec does not discuss this standard in any way. As such, the demurrer for uncertainty is unsubstantiated. (See, e.g., People v. Dougherty (1982) 138 Cal.App.3d 278, 282; see also Cal. Rules of Court, rule 3.1113(b) [supporting memorandum must include a discussion of legal authority in support of the position advanced].) The demurrer on the ground of uncertainty is therefore OVERRULED.

With respect to the “ground” the FAC is preempted by federal law, preemption is not an enumerated ground for demurrer. (See Code Civ. Proc., § 430.10.) Rather, it is a basis for arguing the pleading fails to state sufficient facts to constitute a cause of action, which Insightec itself appears to understand. (See, e.g., Dem. at p. 3:5-7 [“The FAC fails to state facts sufficient to constitute any cause of action against Insightec as it is preempted by federal law, including by [sic] not limited to, 21 U.S.C. section 360k(a). (Code Civ. Proc., § 430.10(e).)”].)

The Court will now address the demurrer on the ground of failure to state facts sufficient to constitute a cause of action.

B. Merits of the Motion

The sole argument Insightec raises is that Plaintiffs’ strict products liability and negligence causes of action are preempted by federal law, and the claim for loss of consortium fails because it depends on the viability of those claims. Specifically, it argues this action is preempted by the Medical Device Amendments (“MDA”) (21 U.S.C. § 360c, et seq.) because the claims arise out of the use of a Class III medical device – the ExAblate® System – whose design, manufacturing method, and labeling were specifically approved by the Food and Drug Administration (“FDA”).

The MDA was enacted by Congress in 1976 to create a regime of detailed federal oversight over medical devices and sweep back state regulation of those devices. (Riegel v. Medtronic, Inc. (2008) 552 U.S. 312, 316 (“Riegel”).) As such, the MDA included an express preemption provision in section 360k(a) (“Section 360k(a)”) stating in relevant part that “no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement – (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.” (21 U.S.C. § 360k(a).) In considering the scope of this provision, the United States Supreme Court in Riegel articulated a two-part test to determine if the MDA preempts common law claims. (McGuan v. Endovascular Techs., Inc. (2010) 182 Cal.App.4th 974, 982 (“McGuan”), citing Riegal, supra, 552 U.S. at 322.) Specifically, a court must consider “(1) whether the Federal Government has established requirements applicable to the [medical device at issue], and (2) if so, whether the common-law claims are based upon [state] requirements with respect to the device that are different from, or in addition to the federal ones, and that relate to safety and effectiveness.” (Ibid., internal quotation marks omitted.) Under the first prong of the analysis, premarket approval of a medical device by the FDA constitutes the imposition of federal requirements applicable to that device. (McGuan, supra, 182 Cal.App.4th at 982, citing Riegel, supra, 552 U.S. at 323.)

Here, Insightec contends MDA preemption applies because federal requirements have been established for the ExAblate® System through the FDA’s premarket approval of it as a Class III medical device. Because Plaintiffs’ strict products liability and negligence claims purportedly seek to impose state requirements that differ from the federal ones, Insightec argues the claims are preempted. In support, it requests judicial notice of: (1) the FDA’s premarket approval (“PMA”) letter for its ExAblate® System; (2) the FDA’s Summary of Safety and Effective Data (“SSED”) for its ExAblate® System ; and (3) the FDA’s Label and ExAblate® System Information for Prescribers.

Insightec’s approach is flawed because it is predicated on an extrinsic fact that does not appear on the face of the pleading, namely that Plaintiffs’ claims arise out of the use of the ExAblate® System. There is no reference, however, to the ExAblate® System anywhere in the FAC. Instead, Plaintiffs repeatedly allege Besse’s injuries stemmed from a manufacturing, design, or other defect in “gel pads, and/or other component parts” that were used in the HIFU procedure. (See FAC, ¶¶ 11-14; 19; 27-31.) While Insightec asserts these gel pads were part of the ExAblate® system, this is a fact extrinsic to the pleading which Insightec does not otherwise attempt to establish by judicial notice. Instead, Insightec assumes this fact is true and predicates its argument relating to MDA preemption on this assumption. Since the purported fact that the gel pads used in Besse’s procedure were part of the ExAblate® system is extrinsic to the FAC, it cannot be considered on demurrer. (See Price v. Dames & Moore (2001) 92 Cal.App.4th 355, 359; Knickerbocker v. City of Stockton (1988) 199 Cal.App.3d 235, 239, fn. 9 [extrinsic matters may not be considered on demurrer].) As such, it is not apparent from the face of the pleading that the medical device used in Besse’s procedure was subject to any federal requirements that could result in preemption of Plaintiffs’ claims under the MDA.

Thus, there is no basis for concluding at this juncture that Plaintiffs’ claims are preempted. The demurrer to the FAC in its entirety and the first and second causes of action individually on the ground of failure to state sufficient facts is therefore OVERRULED.