Evraets v. Intermedics Intraocular, Inc.

• Decision Date: 26 October 1994
• Docket Number: No. B073283,B073283
• Citation: 34 Cal.Rptr.2d 852,29 Cal.App.4th 779
• Parties: , 25 UCC Rep.Serv.2d 42, Prod.Liab.Rep. (CCH) P 14,054 John C. EVRAETS, Plaintiff and Appellant, v. INTERMEDICS INTRAOCULAR, INC., et al., Defendant and Respondent.
• Court: California Court of Appeals Court of Appeals

Page 852

34 Cal.Rptr.2d 852

29 Cal.App.4th 779, 25 UCC Rep.Serv.2d 42,

Prod.Liab.Rep. (CCH) P 14,054

John C. EVRAETS, Plaintiff and Appellant, v. INTERMEDICS INTRAOCULAR, INC., et al., Defendant and Respondent.

No. B073283.

Court of Appeal, Second District, Division 2, California.

Oct. 26, 1994.

Rehearing Denied Nov. 22, 1994.

Review Denied Feb. 16, 1995.

Rose, Klein & Marias, David A. Rosen and Melissa G. Alvarado, Los Angeles, for plaintiff and appellant.

Ian Herzog, Santa Monica, and Arlyn M. Latin, Studio City, as amicus curiae on behalf of plaintiff and appellant.

Haight, Brown & Bonesteel, Roy G. Weatherup, Kathryn Forgie, Jennifer A. Ellis and Maureen Haight Gee, Santa Monica, for defendants and respondents.

Fred J. Hiestand, Sacramento, as amicus curiae on behalf of defendants and respondents.

BOREN, Presiding Justice.

An individual was injured by an intraocular lens that had been surgically implanted in his eye. He sued the manufacturer and distributor of the device for damages. His suit was dismissed by the trial court.

We conclude that the victim's claims of negligence and strict liability under state tort law are preempted by federal law. His claim for breach of the implied warranty of fitness fails for lack of privity. However, his breach of express warranty and fraud claims, as well as his negligence per se claim that the manufacturer violated numerous federal regulations governing investigative device protocols, are sufficient to withstand a demurrer.

FACTS

Appeal is taken from an order of dismissal after demurrers were sustained without leave to amend. In reviewing a ruling on a demurrer, we assume that the facts properly pleaded in the first amended complaint are true. (Moore v. Regents of University of California (1990) 51 Cal.3d 120, 125, 271 Cal.Rptr. 146, 793 P.2d 479.)

In September of 1983, appellant John Evraets underwent eye surgery at a hospital in Long Beach. At that time, a cataract was extracted, and an artificial lens was implanted. The lens was manufactured, designed, tested, distributed and sold by respondents Intermedics Intraocular, Inc., and Pharmacia Opthalmics Inc.

Following the operation, Evraets suffered pain; irritation; decreased vision; light sensitivity; deterioration of his eye structures, including macular, retinal and corneal damage; edema; and a detached retina and vitreous humor. He was ultimately obliged to undergo another surgery to replace the lens. In addition to his physical suffering, Evraets experienced emotional distress, shock and fright.

In August of 1991, Evraets read a published article in which he learned that defects in respondents' lens implant were the source of his injuries. He alleges that respondents' implant had excessive contact with the interior structures of the eye; caused lacerations; was made of inappropriate materials; and embedded in the eye, making removal difficult.

Evraets claims that respondents failed to perform sufficient studies to determine the safety and efficacy of their product; that they purposefully avoided federal regulations by not following the investigational protocols for intraocular lenses, by failing to obtain informed consent from patients participating in the investigational study, and by failing to report their findings; that they failed to give adequate warning of their product's dangerous characteristics, or reveal that safer alternatives were available; and that they knew or should have known that the lens's inherent design defects tended to cause sight-threatening complications and surgical complications when removal was necessary.

Evraets instituted this action on July 2, 1992. He alleges causes of action against respondents for negligence, breach of implied and express warranty, strict liability, negligence per se, and negligent and fraudulent misrepresentation.

DISCUSSION

Overview of Federal Regulatory Scheme

This appeal requires an examination of the Food Drug and Cosmetic Act (FDCA). Medical devices are subject to a classification system under the FDCA. At one end of the classification spectrum, a device which does not present a potential unreasonable risk of illness or injury (appellant offers tongue depressors as an example) is subject only to the most general controls. These are Class I devices. Class II devices are more complex than Class I devices. At the far end of the classification spectrum, a manufacturer must obtain premarket approval for a device which is of substantial importance in preventing impairment of human health or which Intraocular lenses also fall into a special category relating to investigational usage, pursuant to Food and Drug Administration (FDA) regulation. These regulations, which are expressly authorized by statute, are intended to encourage innovation by exempting promising experimental devices from the usual safety and efficacy requirements. (Slater v. Optical Radiation Corp. (7th Cir.1992) 961 F.2d 1330, 1331-1332.)

                presents a potential unreasonable risk of illness or injury.  The purpose of requiring premarket approval of these Class III devices is "to provide reasonable assurance of the safety and effectiveness of the device."  (21 U.S.C. § 360c(a).)   Intraocular lenses are a Class III medical device
                

The investigational device exemption (IDE) expressly exempts intraocular lenses from federal misbranding requirements; from federal registration requirements; from federal performance standard requirements intended to provide reasonable assurance of a device's safe and effective performance; from federal premarket approval requirements; from federal record and reporting requirements obliging a manufacturer to notify federal authorities if it becomes aware that its device causes or contributes to death or serious injury, including damage to a body structure or problems necessitating medical or surgical intervention; from federal restricted device and good manufacturing practice requirements; and from federal color additive listing requirements. (21 U.S.C. § 360j(g); 21 C.F.R. § 813.1.)

Preemptive Effect on State Claims

The FDCA contains an express preemption clause 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.) ¹

An interpretive FDA regulation specifies that the offending state requirement may be one "established by statute, ordinance, regulation, or court decision...." (21 C.F.R. § 808.1(b).) However, state or local requirements are preempted "only when the Food and Drug Administration 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 Food and Drug Administration requirements." (21 C.F.R. § 808.1(d).) ²

The federal regulation does not offend constitutional principles by referring to state court decisions. "State law" includes common law as well as statutes. (Erie R. Co. v. Tompkins (1938) 304 U.S. 64, 78-79, 58 S.Ct. 817, 822-823, 82 L.Ed. 1188.) State regulation "can be as effectively exerted through an award of damages as through some form of preventative relief.... Even the States' salutary effort to redress private wrongs or grant compensation for past harm cannot be exerted to regulate activities that are potentially subject to the exclusive federal regulatory scheme." (San Diego Unions v. Garmon (1959) 359 U.S. 236, 247, 79 S.Ct. 773, 780, 3 L.Ed.2d 775. See plurality opn. of four justices and concurring opn. of Scalia Any reading of the preemption statute must be consistent with Supreme Court pronouncements that the states' police powers are presumed not to be superseded by federal law unless state law actually conflicts with federal law addressing the same subject. (Cipollone v. Liggett Group, Inc., supra, 505 U.S. 504, ----, 112 S.Ct. 2608, 2617.) This is particularly true where the state regulation relates to the primarily local concern of public health and safety rather than the responsibilities of the national government. (Hillsborough County v. Automated Medical Labs. (1985) 471 U.S. 707, 719, 105 S.Ct. 2371, 2378, 85 L.Ed.2d 714.)

and Thomas, JJ., in Cipollone v. Liggett Group, Inc. (1992) 505 U.S. 504, ----, ----, 112 S.Ct. 2608, 2620, 2634, 120 L.Ed.2d 407, concluding that civil suits exert a regulatory effect analogous to that of positive enactments and constitute a state "requirement" for preemption purposes.)

As amicus curiae observes, the Supreme Court instructs us that " ' "[t]he purpose of Congress is the ultimate touchstone" ' of pre-emption analysis." (Cipollone v. Liggett Group, Inc., supra, 505 U.S. 504, ----, 112 S.Ct. 2608, 2617.) Clearly, the purpose of Congress in the area of investigational medical devices was to encourage a high degree of experimentation. Allowing patients to recover for injuries sustained when an experimental device turns out to be neither safe nor effective would deter future investigation and progress, thereby defeating the legislative purpose of exempting investigational devices from the usual FDCA safeguards.

Negligence and Strict Liability

State claims for negligence and strict liability undermine the congressional purpose of allowing lens manufacturers leeway in developing and perfecting their product. These theories are predicated on the notion that a manufacturer has a duty to market a safe product. By definition, experimental medical devices are not known to be safe products, yet society has an interest in encouraging their use, despite the risks involved: "[I]f experimental procedures are subject to hindsight evaluation by juries, so that failed experiments threaten to impose enormous tort liability on the experimenter, there will be fewer experimental treatments, and patients...