Artiglio v. Superior Court

• Decision Date: 24 February 1994
• Docket Number: No. D019805,D019805
• Citation: 27 Cal.Rptr.2d 589,22 Cal.App.4th 1388
• Court: California Court of Appeals Court of Appeals
• Parties: , Prod.Liab.Rep. (CCH) P 13,886 Ed ARTIGLIO, Petitioner, v. The SUPERIOR COURT of San Diego County, Respondent; McGHAN MEDICAL CORP. et al., Real Parties in Interest.

Page 589

27 Cal.Rptr.2d 589

22 Cal.App.4th 1388, Prod.Liab.Rep. (CCH) P 13,886

Ed ARTIGLIO, Petitioner, v. The SUPERIOR COURT of San Diego County, Respondent McGHAN MEDICAL CORP. et al., Real Parties in Interest.

No. D019805.

Court of Appeal, Fourth District, Division 1, California.

Feb. 24, 1994.

Robins, Kaplan, Miller & Ciresi, Joseph L. Dunn, Bruce A. Finzen, Costa Mesa, Gary L. Wilson, Anne Andrews, Tustin, Wilson, Szumowski & Bolton, Daniel C. Bolton, Brown, Monzione, Fabbro, Zakaria & Scarlett, Steve Fabbro, Hersh & Hersh, LeRoy Hersh, San Francisco, Liccardo, Rossi, Sturges & McNeil, Salvador Liccardo, San Jose, Lopez & Hodes, Ramon Lopez, Santa Ana Heights, Ropers, Majeski, Kohn & Bentley, Charles M. Louderback, San Francisco, Robinson & Phillips, Mark P. Robinson, Mission Viejo, Sherman, Dan & Portugal, Arthur Sherman, Beverly Hills, Simke, Chodos, Silberfeld & Anteau and Roman Silberfeld, Los Angeles, for petitioner.

No appearance for respondent.

Haight, Brown & Bonesteel, Thomas M. Moore, Amor Esteban, Jeffrey B. Margulies, Santa Monica, Gordon & Rees, Jack B. McCowan, Jr., San Francisco, Morris, Polich & Purdy, Anthony G. Brazil, Los Angeles, Sedgwick, Detert, Moran & Arnold, Michael F. Healy, San Francisco, Dickson, Carlson & Campillo, Mario Horwitz, Santa Monica McInnis, Fitzgerald, Fees, Sharkey & McIntyre, Cary W. Miller, San Diego, Landels, Ripley & Diamond, James A. Bruen, Derrick K. Watson, Deborah K. Miller, Lynch, Loofbourrow, Helmenstine, Gilardi & Grummer, Robert S. Niemann, San Francisco, Mazzarella, Dunwoody, Wilson & Petty, Regina Petty, San Diego, Palmieri, Tyler, Wiener & Wilhelm and Frank C. Rothrock, Irvine, for real parties in interest.

FROEHLICH, Associate Justice.

This petition seeks reversal of an order of summary adjudication made by the judge in charge of coordinated cases, given the coordination title of "Breast Implant Cases." The court ruled that the plaintiffs could not state a cause of action for strict liability based on design defect. This ruling is challenged on a number of grounds as discussed hereafter. Writ review of the order is authorized by Code of Civil Procedure section 437c, subdivision (l ).

The great number of claims administered in common in this coordinated proceeding were originally based upon individually filed complaints. The coordination process has resulted in an amalgamated standard complaint representative of all interests called the "Master Complaint." The Master Complaint alleges liability on the part of the defendants on a number of bases, including such theories as negligence, breach of warranty, medical malpractice, etc. The only cause of action which is the subject of this order of summary adjudication is the cause of action for strict liability. ¹ The trial court granted the motion for summary adjudication, ruling that "implanted medical devices, such as the mammary prostheses involved in these coordinated cases, are exempt from strict 'design defect' liability as a matter of law...."

The concept of strict liability imposes legal responsibility for injury upon the manufacturer of a product without proof of negligence based upon a determination that the product is: (1) defectively manufactured, (2) defectively designed, or (3) distributed without adequate warnings as to its potential for harm. ² Brown v. Superior Court, supra, 44 Cal.3d 1049, 245 Cal.Rptr. 412, 751 P.2d 470, established an exception to general products strict liability rules for prescription drugs. It was held, for policy reasons set forth at length in the opinion, that drug manufacturers could not be held strictly liable for design defects in prescription drugs. (Id. at p. 1069, 245 Cal.Rptr. 412, 751 P.2d 470.) The trial court held that the rationale of Brown was applicable to breast implant devices. We agree with the trial court and hence deny the writ petition. The explanation for our agreement is best revealed by analysis and rejection of the petitioners' several objections to the ruling.

Petitioners first contend that a condition to avoidance of strict liability is that the product has been marketed with adequate warnings of its potential risks. It is true that pre-Brown authorities lumped together the concepts of proper manufacture, lack of design defect and adequate warning. ³ Brown, however, very clearly distinguished among the three concepts of fault. Liability for defective design could not be premised on strict liability, but would require proof of negligence. (Brown v. Superior Court, supra, 44 Cal.3d at p. 1061, 245 Cal.Rptr. 412, 751 P.2d 470.) Strict liability would continue applicable for manufacturing defects; and liability for failure to warn of known or reasonably knowable risks in the use of the product remains viable "under general principles of negligence." (Id. at p. 1069, fn. 12, 245 Cal.Rptr. 412, 751 P.2d 470.) Therefore, in reaching the question of strict liability based solely on design defect the court was not required to, and it did not, consider or rule upon either manufacturing fault or failure to give adequate warnings. The summary adjudication leaves these issues unresolved and available for future adjudication.

A second contention of the petitioners is that exemption from exposure to strict liability for design defects is available only for drug products which have been tested and approved by the United States Food and Drug Administration (hereafter FDA). Petitioners assert that breast implants not only have not been so tested and approved, but in fact in recent years have been disapproved by the FDA. Petitioners base their argument upon a portion of footnote 12 on page 1069, page 412 of 245 Cal.Rptr., page 470 of 751 P.2d of Brown, which states:

"It should also be noted that the consumers of prescription drugs are afforded greater protection against defects than consumers of other products, since 'the drug industry is closely regulated by the Food and Drug Administration, which actively controls the testing and manufacture of drugs and the method by which they are marketed, including the contents of warning labels.' " (Quoting from Sindell v. Abbott Laboratories (1980) 26 Cal.3d 588, 609, 163 Cal.Rptr. 132, 607 P.2d 924.)

The weakness of petitioners' position is that nowhere in the Brown opinion proper is there any suggestion that FDA testing or approval is a requisite to exemption from design defect strict liability. The footnote reference is little more than a makeweight afterthought to the opinion's policy argument. Further, in its footnote the Brown court did not state that FDA "approval" was a condition to exemption, but merely that the drug industry in general is closely regulated. Through appellate briefing we have been educated as to the various levels of FDA testing, regulation and approval, and the years at which such came into effect. This dissection and examination of the federal regulation of the drug industry was in the main not available to the trial court, however, and the court's order granting summary adjudication does not refer to this aspect of petitioners' argument. Also, there is no suggestion in Brown or any other California authority that FDA approval or regulation is relevant to the determination of prescription drug exemption from design defect strict liability. On the contrary, the Brown court consistently speaks simply of "drug manufacturers," "drugs," and occasionally of "prescription drugs." We note, also, that Comment k to the cited Restatement provision, which is the genesis of the special treatment of prescription drugs, pertains broadly to products for which FDA review and approval could not have occurred at the time of initial distribution, as it covers "many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients...." We therefore conclude that there is no authority for the proposition that FDA control or approval of a product has anything to do with its exemption from design defect products strict liability.

Conceivably the most potentially persuasive of petitioners' arguments is that based on the definitional holding of Brown. Brown establishes a rule for prescription drugs; this rule does not control the issue of strict liability for breast implants, it is contended, because the breast implant is a medical device and not a "drug." Related to this argument is the corollary contention that the exemption from strict liability should be available only for worthy prescriptions which save lives or promote health, and should be denied for medical applications which are merely cosmetic.

We are able to deal with these contentions summarily, since they have been completely addressed in Hufft v. Horowitz (1992) 4 Cal.App.4th 8, 5 Cal.Rptr.2d 377. ⁴ That case, from a sister division of our Fourth District, dealt with the potential of strict liability for design defects in penile prostheses. After ample exploration of the subject, the Hufft court concluded that "the rule of Brown ... immunizing manufacturers of prescription drugs from strict liability for design defects, should be extended to manufacturers of implanted prescription medical devices." (Id. at p. 11, 5 Cal.Rptr.2d 377.) While there are obvious differences in the devices, we apprehend that the reasoning leading the Hufft court to exempt penile prostheses from strict liability applies equally to breast implants. Just as drugs are injected or ingested into the body, a breast implant, as a penile prosthesis, is "plugged in" to the individual. The implant, in each case, poses the potential of harm and the possibility of required removal. (Id. at p. 18, 5 Cal.Rptr.2d 377.) Just as with typical prescription drugs, the public interest is served by the development of effective and affordable medical implants, such as each of these devices illustrates.

We also reject, as did the Hufft court,...