Can product-design-defect strict liability apply to implanted medical devices? When can expert declaration be excluded on MSJ?

Posted in: Evidence, Summary Judgment, Tort Liability by Steven Vartabedian on

The above two questions are presented in Garrett v. Howmedica Osteonics Corp. (filed 3/6/2013) B238304. Plaintiff Garrett was treated for cancer in his left femur by an orthopedic surgeon who implanted a prosthetic device, designed and manufactured by defendants, the surgeon had selected to replace the middle portion of the femur. When plaintiff complained about the pain in his thigh approximately 1½ years after the surgery, the surgeon discovered a fatigue fracture in the prosthesis, which had to be replaced in a second surgery.

Plaintiff sued the device-providing defendants for strict product liability (manufacturing defect, design defect, and failure to warn), breach of express warranty, and negligence. These defendants filed a motion for summary judgment claiming no defect factually, and no duty to warn as a mater of law. The motion was accompanied by a declaration of their expert mechanical engineer who said the prosthesis was not defective and the fracture was caused by an excessive load that the product could not bear over time.

Conceding the failure-to-warn claim could not be established, plaintiff otherwise opposed the motion with its own expert metallurgist’s declaration which stated that he tested the prosthesis material and found it failed to meet certain minimum requirements for hardness, making the product defective in manufacture and design in his opinion. Defendants objected to most of the substantive portions of this declaration. The trial court sustained the objections and granted the motion, which caused judgment to be entered in favor of these defendants.

Plaintiff appealed, contending exclusion of major portions of its expert’s declaration was error, and that triable issues of fact remained. The Court of Appeal, Second Appellate District, Division Three, reversed, vacating that portion of the summary adjudication concerning manufacturing defect and negligence, but directing summary adjudication of the remaining causes of action. In particular, it held that the trial court failed to liberally construe the plaintiff’s expert’s declaration, causing the sustaining of the objections to be an abuse of discretion.

Concerning the question of design defect, the appellate court adopted the approach taken by the California Supreme Court in Brown v. Superior Court (1988) 44 Cal.3d 1049, 1061, 1069, as applied to prescription drugs: a manufacturer of prescription drugs cannot be held strictly liable for a design defect, but is still legally accountable under ordinary negligence standards and for defective manufacture. As to design, the Brown court rejected the case-by case approach to benefits versus the risks of a drug’s design because the choice and advice to the patient comes from patient’s physician. Hufft v. Horowitz (1992) 4 Cal.App.4th 8 applied Brown to “implanted prescription medical devices” (penile implants), as did Plenger v. Alza Corp. (1992) 11 Cal.App.4th 349 (intrauterine devices).

Plaintiff here tried to distinguish the above cases as requiring a “prescription.” But the appellate court found this distinction to be without a difference as here the implanted device is available only through the services of a physician.

Regarding the exclusion of substantive portions of plaintiff’s declaration, the defendant’s relied upon the Supreme Court authority of Sargon v. University of Southern California (2012) 55 Cal.4th 747 (see this blog of November 30, 2012) to argue that the trial court had discretion to exclude expert conclusions that are “speculative, conjectural or lacking a reasonable basis.” But the appellate court here distinguished a judge’s discretion to exclude testimony at trial versus to exclude portions of a declaration submitted in opposition to a motion for summary judgment. In this latter instance, the declaration need not be as detailed and extensive as that required of expert testimony at trial or of an expert declaration in support ofsummary judgment. The exclusion here was thus an abuse of discretion. And the inclusion of the plaintiff expert’s previously excluded analysis leaves demonstrates triable issues of fact on the defective manufacturing and negligence causes of action.

This opinion should serve as a reminder to trial judges and attorneys that determinations at a motion for summary judgment stage of a case follow different rules and burdens. Even admissibility can be different when it comes to evidence in opposition to such motions. As a matter of policy, the opposing side is entitled to the benefit of the doubt on minimal foundation when giving a necessarily summary glimpse of its evidence to establish a triable issue of fact, facing the death knell of its case that would deprive it of a full trial on the merits. As to potential deficiencies of the expert, the moving party has the remedy of full cross-examination of that witness at trial.

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