Scott v. CIBA Vision Corp.

• Decision Date: 15 September 1995
• Docket Number: No. H012313,H012313
• Citation: 44 Cal.Rptr.2d 902,38 Cal.App.4th 307
• Court: California Court of Appeals Court of Appeals
• Parties: , Prod.Liab.Rep. (CCH) P 14,351, 95 Cal. Daily Op. Serv. 7339, 95 Daily Journal D.A.R. 12,473 Leslie SCOTT, Plaintiff and Appellant, v. CIBA VISION CORPORATION, Defendant and Respondent.

Page 902

44 Cal.Rptr.2d 902

38 Cal.App.4th 307, Prod.Liab.Rep. (CCH) P 14,351,

95 Cal. Daily Op. Serv. 7339,

95 Daily Journal D.A.R. 12,473

Leslie SCOTT, Plaintiff and Appellant, v. CIBA VISION CORPORATION, Defendant and Respondent.

No. H012313.

Court of Appeal, Sixth District, California.

Sept. 15, 1995.

Review Denied Dec. 21, 1995.

Jonathan D. Gordon, Law Offices of Jonathan D. Gordon, Pleasant Hill, for appellant.

Diane S. Rice, Norma I Loza, Thomas M. Peterson, and Brobeck, Phleger & Harrison, San Francisco, for respondent.

BAMATTRE-MANOUKIAN, Associate Justice.

Plaintiff Leslie Scott (Scott) appeals from a summary judgment entered in favor of CIBA Vision Corporation (CIBA). CIBA manufactures and distributes a contact lens cleaning product called AOSEPT. The trial court determined that Scott's products liability claims against CIBA, based on inadequate warnings on the AOSEPT bottle, were preempted by the Medical Device Amendments to the federal Food, Drug and Cosmetic Act (the Act). (21 U.S.C. § 360c, et seq.) We agree and consequently we affirm the judgment.

STATEMENT OF FACTS

CIBA manufactures and markets a contact lens cleaning and disinfecting system for use with soft contact lenses. The product includes a cleaning solution called AOSEPT, which contains hydrogen peroxide, a lens cup and holder and a neutralizing agent. The lenses are cleaned and disinfected by placing them in the lens holder for a number of hours with the AOSEPT and the neutralizing agent. The label on the AOSEPT bottle warns the user: "DO NOT PUT AOSEPT TM SOLUTION THAT HAS NOT BEEN NEUTRALIZED IN YOUR EYE." The instructions for use of the product contain similar warnings.

CIBA also manufactures and markets a sterile saline solution product, which is used as a neutralizing rinse and is compatible with eye contact. The AOSEPT and the saline solution were sold in similar plastic bottles with white tops.

On August 1, 1991, plaintiff Scott mistakenly rinsed her contact lens with the AOSEPT solution, believing it to be the saline solution. She placed the lens directly into her eye, causing eye injuries.

STATEMENT OF THE CASE

On July 29, 1992, Scott filed a products liability complaint against CIBA, alleging that she had used the product in a manner which was reasonably foreseeable as involving a substantial danger and that adequate warnings of the danger were not given. Her complaint included causes of action for strict liability, negligence and breach of implied warranty. She claimed CIBA was aware that consumers of its product would have difficulty distinguishing between the AOSEPT bottle and the saline solution bottle when their contact lenses were removed. She alleged further that around the time of her injury CIBA had begun to market the AOSEPT solution with a red top on the bottle, to distinguish it at a glance from the saline solution; however CIBA also continued to market the solution in the old bottle, knowing that its failure to properly warn consumers or to put distinctive markings on the bottles was causing injuries. These facts, she alleged, showed CIBA was guilty of malice, fraud and oppression, entitling her to punitive damages.

On July 9, 1993, CIBA filed a motion for summary judgment on the ground that AOSEPT was a Class III medical device regulated exclusively by the Food and Drug Administration. CIBA contended that under the preemption provision of the 1976 Medical Device Amendments (the MDA), 21 United States Code section 360k (hereafter § 360k), state claims relating to the safety of the device were preempted by the federal regulatory scheme.

The motion was fully briefed by both sides and following oral argument on August 10, 1993, the court issued a minute order, dated August 13, 1993, granting the motion. By letter to the court, counsel for Scott objected that he had not been allowed to respond at oral argument to matters raised for the first time in CIBA's reply brief. In response to the letter, the court vacated its order and scheduled further oral argument, which was held October 28, 1993.

On December 20, 1993, the court issued a second minute order granting summary judgment to CIBA on the ground that Scott's state law tort claims were preempted by the MDA. The court also denied Scott's request to continue the matter until further discovery

was completed. Judgment was entered January 10, 1994.

STANDARD OF REVIEW

The question whether Scott's claims are preempted turns on the interpretation and application of the preemption clause of the MDA. (§ 360k.) Statutory interpretation is a judicial function involving only questions of law. (Sutco Construction Co. v. Modesto High School Dist. (1989) 208 Cal.App.3d 1220, 1228, 256 Cal.Rptr. 671.) On appeal we independently review the trial court's determination. (Melamed v. City of Long Beach (1993) 15 Cal.App.4th 70, 76, 18 Cal.Rptr.2d 729.) If the preemption provision applies to Scott's product liability claims, CIBA has established a complete defense and summary judgment was appropriate. (Code Civ.Proc., § 437c.)

In regard to Scott's claim that the trial court erred in denying her a continuance, we find that a continuance was not mandatory because the conditions of section 437c, subdivision (h) were not met. We therefore review the court's denial of a continuance under the abuse of discretion standard. (Mahoney v. Southland Mental Health Associates Medical Group (1990) 223 Cal.App.3d 167, 171-172, 272 Cal.Rptr. 602.)

GENERAL PRINCIPLES REGARDING PREEMPTION

Many of Scott's arguments are grounded on the strong presumption against federal preemption of state police powers which stems from the respect due to federal-state relations. (Cipollone v. Liggett Group, Inc. (1992) 505 U.S. 504, 517-519, 112 S.Ct. 2608, 2618, 120 L.Ed.2d 407. Particularly in the area of public health and safety regulations, she argues, state and local regulations must be allowed to co-exist with federal regulations. (Hillsborough County v. Automated Medical Labs (1985) 471 U.S. 707, 716-717, 105 S.Ct. 2371, 2376-2377, 85 L.Ed.2d 714.) A Congressional intent to preempt all state law, she continues, may be implied only where the scheme of federal regulation is sufficiently comprehensive to infer that Congress "left no room" for supplementary state regulation (Ibid.; Fidelity Federal Sav. & Loan Assn. v. de la Cuesta (1982) 458 U.S. 141, 151-154, 102 S.Ct. 3014, 3022, 73 L.Ed.2d 664), or where state law actually conflicts with federal law, making compliance with both a "physical impossibility." (Florida Avocado Growers v. Paul (1963) 373 U.S. 132, 142-143, 83 S.Ct. 1210, 1217-1218, 10 L.Ed.2d 248; Pac. Gas & Elec. v. St. Energy Resources Conserv. (1983) 461 U.S. 190, 203-205, 103 S.Ct. 1713, 1722, 75 L.Ed.2d 752.)

Scott's reliance on these principles of implied preemption is misplaced, however, since this is a case where Congress's intent to preempt has been " 'explicitly stated in the statute's language....' " (Cipollone v. Liggett Group, Inc. (1992) 505 U.S. 504, 515-516, 112 S.Ct. 2608, 2617, 120 L.Ed.2d 407.) When Congress has considered the issue of preemption and has included in the enacted legislation a provision expressly addressing that issue, there is no need to engage in an analysis of implied preemption principles. (Id. at 517-519, 112 S.Ct. at p. 2618; Greenwood Trust Co. v. Com. of Mass. (1st Cir.1992) 971 F.2d 818, 823.) Cases cited by Scott (Hillsborough County v. Automated Medical Labs, supra, 471 U.S. 707, 105 S.Ct. at 2371; Florida Avocado Growers v. Paul, supra, 373 U.S. at pp. 142-143, 83 S.Ct. at pp. 1217-1218; Michigan Canners and Freezers v. Agricultural Bd. (1984) 467 U.S. 461, 469, 104 S.Ct. 2518, 2522-2523, 81 L.Ed.2d 399; Silkwood v. Kerr-McGee Corp. (1984) 464 U.S. 238, 104 S.Ct. 615, 78 L.Ed.2d 443) which deal with implied preemption are thus inapposite here. Instead we look only to the express preemption provision and consider the scope of its application from the language employed by Congress. (Greenwood Trust Co. v. Com. of Mass., supra, 971 F.2d at p. 823; King v. Collagen Corp. (1st Cir.1993) 983 F.2d 1130, 1134; Stamps v. Collagen Corp., infra, 984 F.2d at p. 1425, fn. 9.)

THE PREEMPTION PROVISION OF THE MDA

Congress enacted the MDA to give the Food and Drug Administration (FDA) comprehensive regulatory authority over medical devices. (Slater v. Optical Radiation Corp.

                (7th Cir.1992) 961 F.2d 1330, 1331;  H.R.Rep. No. 853 94th Cong., 2d Sess. 1, 6-13 (1976) U.S.Code Cong. & Admin.News 1976, pp. 1070, 1075-1083.)   Pursuant to the MDA, medical devices are grouped into three classes, based on the degree of regulation necessary to assure safety and effectiveness.  (Mendes v. Medtronic, Inc.  (1st Cir.1994) 18 F.3d 13, 14;  21 U.S.C. § 360c.)
                

All classes of devices are subject to "general controls," including labeling requirements and good manufacturing practices. (See, e.g., 21 U.S.C. §§ 360i, 360j.) Class III devices pose the greatest risks and thus are the most highly regulated. (21 U.S.C. § 360c, subd. (a)(1)(C); Stamps v. Collagen Corp. (5th Cir.1993) 984 F.2d at p. 1419.) Class III devices require premarket approval (PMA), an extensive evaluation process which permits the FDA to determine whether a proposed product provides "reasonable assurance of its safety and effectiveness." (Ibid.; 21 U.S.C. §§ 360c, subd. (a)(1)(C), 360e.)

Contact lens cleaning products, such as AOSEPT, are Class III devices under the MDA, and thus must comply with the PMA process. (21 C.F.R. § 886.5928.)

The PMA process requires a manufacturer to submit a detailed application to the FDA, including information pertaining to product specifications, intended use, manufacturing methods, and proposed labeling. (21 U.S.C. § 360e, subd. (c).) The FDA refers each application to a panel of qualified experts who prepare a report and recommendation accepting or rejecting the application. (21 U.S.C. § 360e, subd. (d); Stamps v. Collagen Corp., supra, 984 F.2d at p. 1419....