Mize v. Mentor Worldwide LLC

51 Cal.App.5th 850

265 Cal.Rptr.3d 468

Rexina MIZE et al., Plaintiffs and Appellants,

v.MENTOR WORLDWIDE LLC, Defendant and Respondent.

2d Civil No. B295829

Court of Appeal, Second District, Division 6, California.

Filed July 2, 2020

Law Office of Martin N. Buchanan, Martin N. Buchanan, Oceanside; Lenze Lawyers and Jennifer A. Lenze, for Plaintiffs and Appellants.

Tucker Ellis, Peter L. Choate, Monee T. Hanna, Los Angeles, and Dustin B. Rawlin, for Defendant and Respondent.

TANGEMAN, J.

This case is about preemption and causation: whether the Medical Device Amendments (MDA) to the federal Food, Drug, and Cosmetic Act (FDCA) preempt the state-law products liability claims at issue here, and whether Rexina Mize and her husband, Minh Nguyen, sufficiently pled causation to survive Mentor Worldwide LLC's demurrer to those claims. We conclude that the tort claims in this case survive preemption because they are " ‘ " ‘premised on conduct that both (1) violates the [MDA] and (2) would give rise to a recovery under state law even in the absence of the [MDA].’ " ’ [Citation.]" ( Glennen v. Allergan, Inc. (2016) 247 Cal.App.4th 1, 11-12, 202 Cal.Rptr.3d 68 ( Glennen ).) We further conclude that Mize and Nguyen pled the requisite " ‘causal connection’ " between their injuries and Mentor's tortious acts to survive a demurrer. ( Rannard v. Lockheed Aircraft Corp. (1945) 26 Cal.2d 149, 156, 157 P.2d 1 ( Rannard ).) Because the trial court reached contrary conclusions, we reverse.

FACTUAL AND PROCEDURAL HISTORY¹

The Medical Device Amendments of 1976

Since 1976, the MDA has required the Food and Drug Administration (FDA) to provide "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 devices receiving the most federal oversight are those in Class III." ( Id . at p. 317, 128 S.Ct. 999.) Such devices include those that pose potentially unreasonable risks of illness or injury. ( Ibid. ) Breast implants are assigned to Class III.

A Class III device must undergo premarket approval to "provide reasonable assurance of its safety and effectiveness." ( 21 U.S.C.² § 360c(a)(1)(C).) "Premarket approval is a ‘rigorous’ process." ( Riegel , supra , 552 U.S. at p. 317, 128 S.Ct. 999.) It includes submission of an application that includes studies of the device's safety and effectiveness, a statement of its components and principles of operation, a description of its manufacturing methods, samples of the device, and proposed labels. ( Id . at pp. 317-318, 128 S.Ct. 999.) The FDA will grant premarket approval "only if it finds there is a ‘reasonable assurance’ of the device's ‘safety and effectiveness.’ " ( Ibid . ) Once it does, "the MDA forbids the manufacturer to make ... changes in design specifications, manufacturing processes, labeling, or any other attribute that would affect safety or effectiveness." ( Id . at p. 319, 128 S.Ct. 999.)

Before obtaining premarket approval, a Class III device manufacturer may apply to use the device in clinical tests pursuant to an investigational device exemption (IDE). (§ 360j(g).) To qualify for an IDE, the manufacturer must submit an application and investigational plan for the device.

(See 21 C.F.R. §§ 812.20(b), 812.25.) The FDA must then determine that the benefits to test participants and the knowledge to be gained from the tests outweigh the device's risks. ( 21 C.F.R. § 812.30.) If the FDA approves an IDE application, few changes to the investigational plan are permitted. ( 21 C.F.R. § 812.35(a)(1).)

Mentor's MemoryGel breast implants

In the early 1990's, Mentor applied for an IDE to permit clinical testing of its MemoryGel silicone breast implants. The FDA granted Mentor's application and approved three studies: an adjunct study for patients undergoing either breast reconstruction after a mastectomy or breast implant revision,³ approved in July 1992; a core study, approved in August 1992; and an IDE study, approved in August 2000.

In 1998, the FDA sued Mentor, alleging that the company failed to meet manufacturing quality standards, destroyed evidence of its implants’ high rupture rates, sold contaminated implants, and failed to comply with FDA-mandated design and materials specifications. The FDA and Mentor entered into a consent decree to address the alleged violations, which required the company to remedy the deficiencies, comply with federal law, and adhere to good manufacturing practices. If Mentor complied with the terms of the decree for five years, the FDA would not oppose a petition to dissolve it.⁴

Mize's breast implants

Two years after the FDA and Mentor finalized the consent decree, Mize underwent a bilateral breast augmentation, receiving MemoryGel breast implants as part of Mentor's adjunct study. Mize did not meet the study's criteria because she did not need breast reconstruction or implant revision. She was unaware she was participating in the study, and did not know that her implants had not been approved for sale by the FDA.

After her breast augmentation, Mize began to experience a variety of health problems, including chronic fatigue, muscle and bone pain, joint swelling and stiffness, memory loss, and numbness. Her vision deteriorated, and she had to get prescription eyeglasses. She lost several business opportunities and abandoned her music career.

None of Mize's doctors connected her health problems to her implants.

Premarket approval

In August 2003, a federal court dissolved Mentor's consent decree with the FDA. Four months later, Mentor sought premarket approval for its MemoryGel implants. The FDA approved Mentor's application in November 2006. As a condition of approval, the FDA required Mentor to conduct six studies that would document the safety and effectiveness of its implants and answer questions the earlier clinical trials did not answer. As part of these studies, Mentor had to submit adverse event reports, either as individual medical device reports that would be stored in the FDA's publicly accessible Manufacturer and User Facility Device Experience (MAUDE) database (for deaths and unusual adverse events), or as postmarket spreadsheet reports that would not be included in the database (for well-known or expected adverse events, including implant rupture).

Mentor failed to properly perform the six studies. It did not follow up with enough study participants and did not fully report the myriad adverse events—such as silicone toxicity, implant removal, autoimmune complaints, ruptures, and inflammation—documented in the studies. According to Mize, the FDA would have included the adverse events in the MAUDE database had Mentor properly reported them.

The removal of Mize's implants and ensuing lawsuit

In December 2016, an MRI revealed that Mize's breast implants had ruptured. She had them removed the following month. After their removal, Mize's mental clarity improved. She no longer suffered from chronic fatigue, and no longer needed her prescription eyeglasses.

Mize and Nguyen sued Mentor. In the third amended complaint, Mize alleged causes of action for negligence and negligence per se based on Mentor's negligent failure to warn and negligent manufacturing, strict products liability for failure to warn, and strict products liability for manufacturing defects. Nguyen alleged a derivative cause of action for loss of consortium.

In support of her manufacturing defect claims, Mize alleged that Mentor: (1) manufactured its MemoryGel implants in a manner that "differed from the specifications agreed to by the FDA"; (2) "us[ed] materials and components [that] differed from those approved by the FDA"; (3) "fail[ed] to follow good manufacturing practices"; (4) "fail[ed] to properly meet the applicable standard of care by not complying with applicable federal regulations and ... manufacturing protocols approved by the FDA"; (5) distributed its implants "in violation of the terms of the IDE and applicable federal law"; (6) "negligently incorporat[ed] components and/or materials into its ... [i]mplants that could not stand up to normal usage and/or [that] differed from those [that] were commercially reasonable and/or fail[ed] to use the components and/or materials approved by the FDA"; (7) "fail[ed] to exercise reasonable care in inspecting and testing of the product"; (8) "fail[ed] to exercise reasonable care in its manufacturing, quality control, and quality assurance processes"; and (9) "was negligent in its recordkeeping and did not disclose manufacturing flaws."

In support of her failure-to-warn claims, Mize alleged that Mentor breached its duty to report to the FDA, as part of the IDE clinical tests and the six postapproval studies, "adverse events similar to the injuries [she] suffered" despite having "knowledge and possession of information" that its MemoryGel implants were dangerous.

Mentor also did not ensure that the FDA-mandated studies were properly performed and did not ensure follow-up with enough study participants. "Accordingly, the information ... the FDA [sought] regarding adverse events and device failures was never gathered." Had it been gathered and reported, doctors would have seen and relayed it to Mize, who would have then had her implants removed.

The demurrer

Mentor demurred to the complaint. It asserted that Mize's claims were preempted by federal law and insufficiently pled, and that Nguyen's claim failed because it was derivative of his wife's.

The trial court agreed with Mentor. As to the manufacturing defect claims, the court found that they were impliedly preempted because they "hinge[d] entirely on conduct that allegedly violated federal law." Even if they were not, the allegations that underlay the claims all preceded the 1998 consent decree between Mentor and the FDA. But Mize did not allege that her implants were manufactured prior to the decree. And if they were manufactured after, the decree showed that Mentor promised to change any faulty manufacturing...