Blanco v. Baxter Healthcare Corp.

• Citation: 158 Cal.App.4th 1039,70 Cal.Rptr.3d 566
• Decision Date: 11 January 2008
• Docket Number: No. G038255.,G038255.
• Court: California Court of Appeals
• Parties: Michael BLANCO et al., Plaintiffs and Appellants, v. BAXTER HEALTHCARE CORPRATION et al., Defendants and Respondents.

70 Cal.Rptr.3d 566

158 Cal.App.4th 1039

Michael BLANCO et al., Plaintiffs and Appellants, v. BAXTER HEALTHCARE CORPRATION et al., Defendants and Respondents.

No. G038255.

Court of Appeal, Fourth District, Division 3.

January 11, 2008.

Magaña, Cathcart & McCarthy, Brian R. Magaña and Anne M. Huarte, Los Angeles, for Plaintiffs and Appellants.

Drinker, Biddle & Reath, Alan J. Lazarus, San Francisco, and Kathryn N. Forgie, for Defendants and Respondents.

OPINION

O'LEARY, J.

Plaintiffs appeal from a judgment after the trial court granted defendants' motion for summary judgment in a wrongful death action concerning a bileaflet mitral heart valve. The court granted defendants' motion for summary judgment on the ground the Medical Device Amendments (MDA), title 21 United States Code section 360k(a) (section 360k(a)), preempted plaintiffs' state common law causes of action. Plaintiffs argue the court erroneously concluded section 360k(a) preempted the state common law causes of action because a state law remedy for a manufacturing defect does not impose a state requirement "different from, or in addition to" a federal requirement relating to a device's safety or effectiveness. We disagree and affirm the judgment.

FACTS

In 1982, 18-year-old Claudia Blanco (Claudia) was diagnosed with mitral valve stenosis—narrowing/blocking of the heart's mitral valve that prevents the valve from properly opening and, therefore, obstructs blood flow between the left chambers of the heart. Around the same time, Hemex Scientific, Inc. (Hemex), developed prototypes for new mechanical mitral and aortic heart valves. Hemex subsequently applied for an investigational device exemption (IDE) with the United States Food and Drug Administration (FDA) to conduct "clinical trials involving implantation of the device into humans[.]" In April 1984, the FDA approved the IDE, which "allowed 15 identified medical centers to implant the devices in up to 500 patients" to "evaluate the safety and effectiveness of the device, and to establish design parameters, performance standards, and manufacturing/quality control protocols in [preparation for] potential commercial distribution of the device[.]"

In February 1985, Hemex applied for a premarket approval (PMA) application with the FDA. The MDA divides medical devices into three classes, Class I, Class II, and Class III.¹ (21 U.S.C. § 360c(a).) Class III devices are those that are "for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health," or "presents a potential unreasonable risk of illness or injury[.]" (21 U.S.C. § 360c(a)(1)(C).) The FDA must approve a Class III device, like the valve, before the device may be commercially distributed. (21 C.F.R. § 870.3925(b).) Subject to two statutory exceptions not relevant here,² Class III devices must receive premarket approval through the PMA process "to provide reasonable assurance of [its] safety and effectiveness...." (21 U.S.C. §§ 360c(a)(l)(C), 360e(d)(2); 21 C.F.R. § 814.1 et seq.)

The MDA requires the PMA application to contain the following information: full reports on investigations concerning whether the device is safe and effective; statements of the device's components, ingredients, and properties and principle or principles of operation; descriptions of the methods, facilities, and controls used for the manufacture, processing, packing, and installation of device; any performance standard which would be applicable to the device if it were a Class II device and information the device meets such performance standard; device samples; proposed label specimens; and other information the FDA may require. (21 U.S.C. § 360e(c).)

FDA regulations require the PMA application to contain the following additional information: nonclinical laboratory studies, clinical investigations involving humans, indications for use, device description, alternative practices and procedures, marketing history, summary of studies, conclusions drawn from the studies, a complete description of the device, performance standards, technical reports, proposed labeling, and environmental assessment. (21 C.F.R. § 814.20(b).) The FDA conducts an in-depth review of the PMA and approves denies, or denies while identifying measures to place the PMA in approvable form. (21 U.S.C. § 360e(d); 21 C.F.R. § 814.44(c).) FDA approval of a PMA does not end its oversight of the Class III device. (Horn v. Thoratec Corp. (3d Cir. 2004) 376 F.3d 163, 172 (Horn) ["... For [PMA devices], after a very lengthy process involving thousands of pages of documentation and many hours of expert analysis, and often including substantial give-and-take between the agency and the manufacturer, FDA approves a new device, including detailed specifications for its design, manufacture, performance, labeling, and use. Any of these specifications may be changed in [a] way that affects safety and effectiveness only with FDA's authorization"]; see also 21 C.F.R. §§ 814.39, 814.80, 814.82, 814.84.) The PMA process has been described as "rigorous," requiring "[manufacturers [to] submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews, spending an average of 1,200 hours on each submission." (Medtronic, supra, 518 U.S. at p. 477, 116 S.Ct. 2240.)

In February 1986, the FDA notified Hemex that its PMA was "administratively acceptable and therefore, suitable for filing." The FDA, however, indicated Hemex had to provide additional information on a "fractured valve," including reports from the surgeon, a pathologist, and Hemex, change its labeling, and open its manufacturing facility for inspection.

Three months later, the FDA informed, Hemex the PMA was "approvable" subject to reports on "valve failures" during clinical trials and a FDA inspection of manufacturing facilities. In August 1986, the FDA notified Hemex that it approved Hemex's PMA, and Hemex could begin production and marketing of the valve, subject to "`conditions of approval,'" including approved labeling,³ advertisements, PMA supplement, post-approval reports, and adverse reaction and device defect reporting.

Four months later, American Edwards Division of American Hospital Supply Corporation, a wholly owned subsidiary of Baxter-Travenol Laboratories, Inc. (Baxter), purchased Hemex (hereafter, referred to as Baxter). Baxter sold the valve under the name "'Edwards-Duromedics Mitral Bileaflet Valve Model 9120'" (the Valve). The Valve was available only pursuant to a licensed physician's prescription.

On December 2, 1987, Claudia underwent surgery to repair her mitral valve, but it was unsuccessful. Three days later, surgeons replaced her natural mitral valve with the Valve, serial number 26785, which had been inspected, tested, and certified for release.

Between August 1986 and May 1988, Baxter received "several reports" of possible Valve failures involving leaflet fracture and/or escape. By "May 1988, there were 12 reported incidents of leaflet escapes[,]" after May 1988, 27 reported incidents of leaflet escapes, and by August 1994, 39 out of 20,000 Valves failed. Thirty-two out of the 39 failures involved mitral valves.

In May 1988, Baxter voluntarily suspended marketing of the Valve as a precautionary measure and notified hospital administrators and clinicians of its action. Two weeks later, the FDA reclassified the voluntary suspension as a "'Class I Recall'"⁴ The FDA administered recall required Baxter to notify Valve distributors and vendors of the recall and directed them to notify all vendors, hospitals, doctors, and patients of the recall.

In April 1989, the FDA notified Baxter the recall was completed, and therefore, terminated. In May 1991, Claudia underwent emergency surgery to remove a blood clot from her Valve after giving birth to her son. In February 1993, Baxter sent Claudia a letter informing her of reported problems with the Valves, but because of the unlikelihood of leaflet escape, Baxter did not recommend elective replacement of the Valve. The letter also asked her to enroll in a registry program, which was designed to provide information on the Valve. Baxter stopped marketing the Valve, which by that time was called "Tekna" valve, in 1996.

In December 2002, 38-year-old Claudia was visiting her dying mother in Georgia while her husband and 11-year-old developmentally disabled son remained home. Late one evening, she experienced chest pain, nausea, and shortness of breath. She was taken to the hospital and diagnosed with acute failure of her prosthetic mitral valve. She underwent emergency surgery, but died. The cause of death was "severe pulmonary edema with cardiorespiratory failure secondary to sudden severe mitral regurgitation." An autopsy revealed "two missing leaflet fragments of the [V]alve in the right common iliac artery." Subsequent evaluation of the Valve by a Baxter engineer revealed "the leaflet escape was due to central leaflet fracture that initiated at an erosion/cavitation leaflet pit."

Michael and Jonathon Blanco (hereafter, referred to collectively and in the singular as Blanco) filed a complaint against Baxter alleging causes of action for the following:

(1) negligence, (2) strict liability, (3) breach of express warranty, and (4) breach of implied warranty. Baxter answered.

Baxter filed a motion for summary judgment, or alternatively, summary adjudication, based on the theory the MDA preempted Blanco's state common law causes of action. The summary judgment motion was supported by declarations from Allison Mezzanatto, Robert Stobie, and Thomas Moore. Blanco opposed the motions. Blanco's opposition was supported by a declaration from attorney, Brian Magaña. Blanco objected to Mezzanatto's declaration.

Baxter replied, supported by another declaration from Moore. Baxter responded to Blanco's objection to Mezzanatto's declaration.

The trial court granted Baxter's motion for...