Regwan v. Abbott Labs.

• Docket Number: B319606
• Decision Date: 21 December 2023
• Parties: JUDY REGWAN, Plaintiff and Appellant, v. ABBOTT LABORATORIES, INC., Defendant and Respondent.
• Court: California Court of Appeals Court of Appeals

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JUDY REGWAN, Plaintiff and Appellant, v. ABBOTT LABORATORIES, INC., Defendant and Respondent.

B319606

California Court of Appeals, Second District, Second Division

December 21, 2023

NOT TO BE PUBLISHED

APPEAL from a judgment of the Superior Court of Los Angeles County. No. BC711263 Daniel M. Crowley, Judge. Affirmed.

Joseph Farzam Law Firm, Joseph F. Farzam; Law Office of Ted W Pelletier and Ted W. Pelletier for Plaintiff and Appellant.

Winston & Strawn, Andrew E. Tauber, Alexander H. Cote Mayer Brown, Daniel L. Ring and Joseph J. Vescera for Defendant and Respondent.

LUI P. J.

Judy Regwan (Regwan) appeals from a judgment of dismissal after the trial court sustained, without leave to amend, the demurrer of Abbott Laboratories, Inc. (Abbott) to Regwan's first amended complaint. Regwan's lawsuit stemmed from serious injuries she suffered during the implantation of a medical device manufactured by Abbott. Reviewing de novo, we conclude Regwan's negligence claim against Abbott is expressly preempted by federal law. We affirm the judgment of dismissal.

FACTS AND PROCEDURAL BACKGROUND

I. Facts

In 2017, Regwan underwent cardiac surgery to implant a MitraClip to repair a damaged heart valve. The device was made and sold by Abbott. The implantation procedure requires the continuous flow of intravenous saline to the heart. During Regwan's procedure, the saline bag ran dry, causing her to suffer an air embolism and serious brain injury.

II. Procedural Background

A. Original Complaint

In 2018, Regwan sued the hospital, the surgeon, other physicians, and Does 1-100 for medical malpractice. Two years later, Regwan added Abbott as Doe 1 by a form amendment, thereby asserting a medical malpractice claim against Abbott based on the surgeon's alleged negligence.

B. First Amended Complaint

In February 2020, Regwan filed a first amended complaint for medical malpractice, this time against the hospital and the surgeon alone. Regwan added negligence and products liability causes of action against Abbott after learning that an Abbott representative attended the surgery and was "responsible for the flow of saline."

C. Demurrer

Abbott demurred to the first amended complaint, arguing it was time-barred, failed to allege facts sufficient to state any cause of action, and was preempted by federal law.

Regwan failed to timely and substantively oppose the demurrer. Her position was the demurrer was mooted by the filing of a second amended complaint.

At the hearing, the trial court rejected Regwan's argument because no second amended complaint had been filed and, in any event, its filing would have been untimely at this late date. The court then sustained the demurrer without leave to amend, finding Regwan's negligence and products liability causes of action against Abbott failed as a matter of state law. The court also ruled the products liability cause of action was preempted by federal law. The court did not reach Abbott's argument that Regwan's negligence cause of action was federally preempted. The court dismissed the first amended complaint against Abbott and entered a judgment of dismissal. Regwan timely filed this appeal.

DISCUSSION

Regwan's sole contention on appeal is the judgment of dismissal should be reversed as to her negligence cause of action against Abbott.^[1] We disagree, concluding the claim is federally preempted.^[2] Preliminarily, we note medical device representatives, like Abbott's, have been attending device-dependent procedures for some years. This is particularly true of orthopedic, trauma, and cardiovascular surgeries. These days, as baby boomers age and advances in medical technologies rapidly increase, medical device representatives may have greater knowledge about their products than the doctors who implant them. Consequently, medical device representatives are more frequently in the operating room at the surgeons' behest to provide advice and technical support about their product and/or its implantation. This practice can expose the medical device manufacturer and its representative to liability. (See Jacxsens et al., Medical Device Law: Beyond the Basics: Expanding Theories of Liability and Defenses for Claims Involving Medical Device Sales Representatives (Jan. 2013) 39 William Mitchell L.Rev. 1087, 1088-1090, and cases cited therein.)

I. Demurrer and Standard of Review

In assessing whether a demurrer was properly sustained, we independently ask" 'whether the [operative] complaint states facts sufficient to constitute a cause of action.'" (Loeffler v. Target Corp. (2014) 58 Cal.4th 1081, 1100, quoting City of Dinuba v. County of Tulare (2007) 41 Cal.4th 859, 865; see also Lee v. Hanley (2015) 61 Cal.4th 1225, 1230 [de novo review].) In answering this question, we" 'assume the truth of the complaint's properly pleaded or implied factual allegations.'" (Loeffler, at p. 1100, quoting Schifando v. City of Los Angeles (2003) 31 Cal.4th 1074, 1081.)

II. Forfeiture

At the outset, Abbott maintains Regwan has forfeited her contention that Abbott is liable under the negligent-undertaking theory because she failed to oppose the demurrer on this ground. We reject Abbott's argument. As the legal sufficiency of a proposed amended complaint is a question of law reviewable de novo (Lee v. Hanley, supra, 61 Cal.4th at p. 1230), and the complaint is invulnerable to a general demurrer if, on any theory, it states a cause of action (Quelimane Co. v. Stewart Title Guaranty Co. (1998) 19 Cal.4th 26, 38), forfeiture is inapplicable here. (See People v. Lexington National Ins. Corp. (2010) 181 Cal.App.4th 1485, 1491-1492.)

III. Federal Preemption

Abbott argues that, even if Regwan's state law claim is not forfeited, it is nonetheless preempted by the Medical Device Amendments of 1976 (21 U.S.C. § 360c et seq.) (MDA).

A. The MDA and Class III Medical Devices

In 1976, the MDA amended the Food, Drug, and Cosmetic Act to require "detailed federal oversight" of medical devices. (Riegel v. Medtronic, Inc. (2008) 552 U.S. 312, 316 [128 S.Ct. 999, 169 L.Ed.2d 892] (Riegel).) The most intense level of scrutiny is reserved for Class III medical devices because they pose the greatest risk of injury or illness. (Id. at p. 317.) A Class III medical device must undergo a "rigorous" premarket approval process (ibid.) to "provide reasonable assurance of its safety and effectiveness." (21 U.S.C. § 360c(a)(1)(C)(i)(II).) The MitraClip is a Class III medical device.

The premarket approval process for a Class III medical device requires the device manufacturer to submit an application that presents all available scientific knowledge concerning investigations into the device's safety and effectiveness; detailed information regarding its design, components, ingredients, properties, and principles of operation; a full description of manufacturing methods and facilities; any applicable performance standards; samples of the device; specimens of proposed labeling; and other information deemed relevant by the Food and Drug Administration (FDA). (21 U.S.C. § 360e(c)(1).) Once the application has been approved, the manufacturer is prohibited from manufacturing, packaging, storing, labeling, distributing, or advertising the device in a manner inconsistent with any conditions to approval specified in the premarket approval order for the device. (21 C.F.R. § 814.80 (2023).) Moreover, before making any changes that may affect the safety or effectiveness of an approved device, the manufacturer must generally submit a supplemental request for FDA review and approval. (21 C.F.R. 814.39 (2023).)

B. The MDA's Express Preemption Provision and Riegel

Federal preemption is rooted in the Supremacy Clause of the Constitution, which states the law of the United States "shall be the Supreme Law of the Land." (U.S Const., art. VI, cl. 2.) State laws are expressly preempted under the Supremacy Clause when Congress defines "the extent to which its enactments preempt state law." (English v. General Electric Co. (1990) 496 U.S. 72, 78 [110 S.Ct. 2270, 110 L.Ed.2d 65].) Abbott posits express preemption applies here.

The MDA contains an express preemption provision in which Congress has decreed 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).) The term "any [state] requirement" is intended to encompass common law duties as well as duties created by statutory law. (Riegel, supra, 552 U.S. at p. 324; accord, Quishenberry v. United Healthcare, Inc. (2023) 14 Cal.5th 1057, 1067-1068; Roberts v. United Healthcare Services, Inc. (2016) 2 Cal.App.5th 132, 145.)

With this preemptive provision, Congress established a centralized regulatory scheme. In other words, because different or additional state-law requirements are expressly preempted, medical device manufacturers face only one standard of care, which is the federal standard of care. Manufacturers are thus not subjected to a multitude of differing regulations that could discourage innovation or drive potentially beneficial devices from the market. (See Riegel, supra, 552 U.S. at p. 326 [inferring the preemption provision indicates "the solicitude for those injured by FDA-approved devices . . . was overcome in Congress's estimation by solicitude for those who would suffer without new medical devices if juries were allowed to apply the tort law of 50 States"].)

Riegel supra, 552...