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Artiglio v. Superior Court2/24/1994
FROEHLICH, J.:
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 (1).
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. 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. Brown v. Superior Court, supra, 44 Cal. 3d 1049, 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.) 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. 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.) 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.) 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 n
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