Jessen v. Mentor Corp.

• Decision Date: 16 January 2008
• Docket Number: No. B191278.,B191278.
• Citation: 71 Cal.Rptr.3d 714,158 Cal.App.4th 1480
• Court: California Court of Appeals Court of Appeals
• Parties: David JESSEN, Plaintiff and Appellant, v. MENTOR CORPORATION, Defendant and Respondent.

71 Cal.Rptr.3d 714

158 Cal.App.4th 1480

David JESSEN, Plaintiff and Appellant, v. MENTOR CORPORATION, Defendant and Respondent.

No. B191278.

Court of Appeal, Second District, Division 7.

January 16, 2008.

As Modified on Denial of Rehearing February 6, 2008.

Gary Rand & Suzanne E. Rand-Lewis and Suzanne E. Rand-Lewis, Van Nuys, for Plaintiff and Appellant.

Kalland & Romag and James J. Romag for Defendant and Respondent.

PERLUSS, P.J.

David Jessen appeals from the judgment entered after the trial court granted summary judgment in favor of Mentor Corporation in this product liability action. We affirm.

FACTUAL AND PROCEDURAL BACKGROUND

On October 10, 2003 Jessen had a cancerous testicle removed and replaced with a testicular prosthesis, a Class III medical device, designed, manufactured, labeled and sold by Mentor as the Mentor Saline-Filled Testicular Prosthesis. The prosthesis, which had been shipped unfilled, was not filled with saline solution prior to implantation as directed in the enclosed instructions. The prosthesis became deformed, causing Jessen pain, and ultimately had to be replaced.

On October 15, 2004 Jessen filed a form complaint against Mentor alleging causes of action for strict liability, negligence and breach of warranty.¹ The essence of Jessen's claims is that Mentor failed to include a warning on the outer packaging of the prosthesis that it must be filled prior to implantation.² On June 2, 2006 the trial court granted Mentor's motion for summary judgment on the ground Jessen's state law claims were preempted by federal law.³

CONTENTIONS

Jessen contends there is a triable issue of fact whether the testicular prosthesis is a Class III medical device subject to federal preemption and, even if it is, his claims are not preempted.

DISCUSSION

1. Standard of Review

We review the trial court's grant of summary judgment de novo and decide independently whether the parties have met their respective burdens and whether facts not subject to triable dispute warrant judgment for the moving party as a matter of law. (Intel Corp. v. Hamidi (2003) 30 Cal.4th 1342, 1348, 1 Cal.Rptr.3d 32, 71 P.3d 296; Guz v. Bechtel National, Inc. (2000) 24 Cal.4th 317, 334, 100 Cal.Rptr.2d 352, 8 P.3d 1089; Code Civ. Proc., § 437c, subd. (c).) We also review de novo any underlying issues of statutory construction. (Earner v. Leeds (2000) 24 Cal.4th 676, 683, 102 Cal.Rptr.2d 97, 13 P.3d 704.)

When a defendant moves for summary judgment on the ground there is an affirmative defense to the action, the burden shifts to the plaintiff to show there is one or more triable issues of material fact regarding the defense after the defendant meets the burden of establishing all the elements of the affirmative defense. (Code Civ. Proc., § 437c, subds. (o)(2) & (p)(2); Mirzada v. Department of Transportation (2003) 111 Cal.App.4th 802, 806-807 4 Cal.Rptr.3d 205 [once defendant establishes the existence of an affirmative defense, burden on summary judgment shifts to the plaintiff to produce evidence establishing a triable issue of material fact refuting the defense]; Consumer Cause, Inc. v. SmileCare (2001) 91 Cal.App.4th 454, 468-69, 110 Cal.Rptr.2d 627; Consumer Cause, at p. 486, 110 Cal.Rptr.2d 627 (dis. opn. of Vogel (Miriam A.), J.) ["[W]hen a defendant moves for summary judgment based upon an affirmative defense, the defendant has the initial burden of production—that is, to make a prima facie showing in support of its affirmative defense.... Once that is done, the burden shifts to the plaintiff to present evidence sufficient to create a triable issue of fact as to the affirmative defense relied on by the defendant"]; see also Huynh v. Ingersoll-Rand (1993) 16 Cal.App.4th 825, 830, 20 Cal.Rptr.2d 296.) If Jessens claims are preempted, Mentor "`has established a complete defense and summary judgment was appropriate.'" (Armstrong v. Optical Radiation Corp. (1996) 50 Cal.App.4th 580, 585, 57 Cal.Rptr.2d 763 (Armstrong).)

On review of an order granting summary judgment, we view the evidence in the light most favorable to the opposing party, liberally construing the opposing party's evidence and strictly scrutinizing the moving party's. (O'Riordan v. Federal Kemper Life Assurance (2005) 36 Cal.4th 281, 284, 30 Cal.Rptr.3d 507, 114 P.3d 753.)

2. Law Governing Federal Preemption of State Law Claims Involving Medical Devices

The Medical Device Amendments of 1976 (21 U.S.C. § 360c et seq.) (MDA) to the Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) enacted "`to provide for the safety and effectiveness of medical devices intended for human use'" (Medtronic, Inc. v. Lohr (1996) 518 U.S. 470, 474, 116 S.Ct. 2240, 135 L.Ed.2d 700 (Medtronic )), classify medical devices into three categories based on the risk they pose to the public. (21 U.S.C. § 360c; Medtronic, at p. 476, 116 S.Ct. 2240; Armstrong, supra, 50 Cal.App.4th at p. 585, 57 Cal. Rptr.2d 763.) Class III medical devices, which pose the greatest risk, are subject to the most stringent controls. (Scott v. CIBA Vision Corp. (1995) 38 Cal.App.4th 307, 315, 44 Cal.Rptr.2d 902 (Scott).) Examples of Class III devices include pacemakers (21 C.F.R. § 870.3610), silicone inflatable breast prostheses (21 C.F.R. § 878.3530) and "solid or gel-filled silicone rubber prostheses] that [are] implanted surgically to resemble a testicle" (21 C.F.R. § 876.3750; see Goldsmith v. Mentor Corp. (D.N.H.1995) 913 F.Supp. 56, 59 [no triable issue of fact whether Mentor large testicular prosthesis, which contained reinforced, molded silicone elastomer, was Class III medical device] ).⁴

"Before a new Class III device may be introduced to the market, the manufacturer must provide the [Food and Drug Administration (FDA) ] with a `reasonable assurance' that the device is both safe and effective. See 21 U.S.C. § 360e(d)(2). Despite its relatively innocuous phrasing, the process of establishing this `reasonable assurance,' which is known as the `premarket approval,' or `PMA' process, is a rigorous one. Manufacturers must 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.) A product's labeling is also within the purview of the PMA process. (21 U.S.C. § 360e(d)(2)(A), (B), (D); Steele v. Collagen Corp. (1997) 54 Cal.App.4th 1474, 1488, 63 Cal.Rptr.2d 879 (Steele) ["`"FDA retains rigid control over the entirety of the labeling and packaging of class III products"'"; "the product's sponsor must submit a proposed label to the FDA for analysis and review prior to gaining PMA for the product"]; accord, Scott, supra, 38 Cal.App.4th at p. 318, 44 Cal.Rptr.2d 902.)

Once a product has received premarket approval, it may be marketed (Scott, supra, 38 Cal.App.4th at p. 315, 44 Cal.Rptr.2d 902); but the product is subject to the federal, device-specific requirement of adhering to the standards contained in its individual, federally approved PMA. (See Riegel v. Medtronic, Inc. (2nd Cir.2006) 451 F.3d 104, 118, cert, granted June 25, 2007, ___ U.S. ___, 127 S.Ct. 3000, 168 L.Ed.2d 725.) The manufacturer cannot make any changes that may affect the safety or effectiveness of the device without further FDA approval. "Any subsequent changes in the product require submission of a PMA supplement application. (21 C.F.R. § 814.39.)" (Ibid.) "While the design or labeling of a device may be changed to enhance the safety without prior approval from the FDA, the manufacturer must submit to the FDA a PMA supplement and obtain acknowledgment from the FDA of receipt of the supplement. (21 C.F.R. § 814.39 (1996).) The device is still subject to withdrawal from the market if the FDA determines any changes have rendered it unsafe or the labeling inadequate." (Steele, supra, 54 Cal.App.4th at p. 1488, 63 Cal.Rptr.2d 879.)

The MDA includes an express preemption provision,⁵ which "prohibits states from imposing `any requirement ... which is different from, or in addition to,' federal requirements relating to the safety or effectiveness of medical devices intended for human use. (21 U.S.C. § 360k)"⁶ (Evraets v. Intermedics Intraocular, Inc. (1994) 29 Cal.App.4th 779, 785, 34 Cal. Rptr.2d 852.) The FDA has promulgated an interpretative regulation providing, "State or local requirements are preempted only when the [FDA] has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific [FDA] requirements." (21 C.F.R. § 808.1(d).) A state law requirement may be "established by statute, ordinance, regulation, or court decision" (21 C.F.R. § 808.1(b)); thus, state common law claims may be preempted by the MDA. (Armstrong supra, 50 Cal.App.4th at p. 587, 57 Cal.Rptr.2d 763.)⁷

A majority of California and federal courts have concluded all state common law claims relating to the safety or effectiveness of a device, other than those based on a violation of FDA requirements, are preempted.⁸ (See, e.g., Blanco v. Baxter Healthcare Corp. (2008) 158 Cal. App.4th 1039, ___, 70 Cal.Rptr.3d 566 [although "Medtronic court was fractured] ... five Justices agreed `state common-law damages actions do impose "requirements" and are therefore preempted where such requirements would differ from those imposed' by the MDA"]; Steele, supra, 54 Cal.App.4th at p. 1489, 63 Cal.Rptr.2d 879 ["state requirements in the form of standards of care or behavior are preempted and cannot form the basis of a state common law claim for damages if they are different from or in addition to the specific federal requirements arising from the PMA process"]; Scott, supra, 38 Cal.App.4th at pp. 318-319, 44 Cal.Rptr.2d 902["[r]ecent cases ... illustrate the complete preemptive effect of the PMA...