Strict Products Liability Claims Based On Design Defect Are Inapplicable To Implanted Medical Devices That Are Available Only Through Physicians (With Or Without A Prescription)


A recent California Court of Appeal decision out of the Second District has provided further clarity to the scope of California products liability law by reasserting the general rule that precludes strict liability for design defect for an implantable medical device.  In Garrett v. Howmedica Osteonics Corp. (Nov. 27, 2012, No. B234368) __ Cal.Rptr.3d __ (2012 WL 5911441, the appellate court held that the exclusion of strict products liability design defect claims extends to any implanted medical device that is made available through the services of a physician, regardless of whether or not the implantable device is “prescribed.”

In Garrett, plaintiff Todd Garrett had the middle portion of his left femur replaced with a prosthetic device manufactured by the defendant.  Thereafter, he began experiencing thigh pain and it was subsequently determined there was a fatigue fracture in the prosthesis.  As a result, Garrett underwent surgery  to remove the fractured prosthesis and implant an artificial joint in place of the prosthetic femur.

Shortly thereafter, Plaintiff filed suit against the manufacturer of the prosthetic device, alleging claims of (1) strict products liability design defect; (2) strict products liability manufacturing defect; (3) strict products liability failure to warn; (4) breach of express warranty; and (5) negligence.  The crux of the lawsuit was that the prosthetic device implanted into Plaintiff was defective and fractured while in Plaintiff’s body, causing him significant injury and damages.

The defendant manufacturer successfully moved for summary judgment on the grounds that Plaintiff’s discovery responses showed that he had no evidence to establish the essential elements of his claims, and further arguing that evidence presented in support of their motion showed that the prosthesis was not defective and that they had no duty to warn as a matter of law.

On appeal, Plaintiff argued that triable issues of fact exist concerning the design defect claims under both the risk-benefit test and consumer expectations test, and that the trial court improperly excluded opinions offered by way of declaration from Plaintiff’s metallurgical expert, and as such, triable issues of fact exist as to his claims of design and manufacturing defect, negligence, and causation.

Reviewing the trial court’s ruling de novo, the appellate court affirmed summary judgment with respect to the claim for strict products liability based on design defect. In doing so, the Garrett Court rejected Plaintiff’s argument that the exemption from design defect strict products liability is limited to implanted medical devices that are available only by prescription.  Noting that “it cannot be reasonably disputed that the implant was available only through the services of a physician,” the Garrett Court reiterated that the design defect exemption applies to an implanted medical device regardless of whether it was available only by prescription and regardless of whether it is properly characterized as a “prescription” device.  Because of this exemption, a court need not apply the risk-benefit test or the consumer expectation test that is normally used to evaluate strict liability design defect claims.

The rationale for prohibiting design defect claims for implantable medical devices is derived from the policy arguments to limit claims against pharmaceutical manufacturers, where the general public benefits in having affordable drugs available even though some risks – including serious ones – could accompany their introduction to the market.  See Brown v. Sup. Ct. (1988) 44 Cal.3d 1049 (recognizing that if drug manufacturers were subject to strict liability, they may be reluctant to develop pharmaceuticals that would help benefit society).  This rationale also applies to implantable medical devices, which, like prescription drugs, are only available through the services of a physician and can alleviate pain and suffering, sustain a life or provide other important health benefits.  Accordingly, and as stated by the Court of Appeal in Garrett, “[t]he public interest in the development, availability and affordability of implanted medical devices justifies an exemption from design defect strict products liability for all implanted medical devices.”

With strict liability excluded under this rule, the appropriate test for determining whether a manufacturer is liable for a design defect involves the application of the ordinary negligence standard.  As California has adopted comment k to section 402A of the Restatement Second of Torts for implantable medical device cases, a manufacturer can still be held strictly liable for alleged manufacturing defect or inadequate warnings claims.

The Garrett case joins a line of appellate decisions throughout California excluding strict liability design defect claims for implantable medical devices.  See, e.g., Hufft v. Horowitz (1992) 4 Cal.App.4th 8 (penile prosthesis); Plenger v. Alza (1992) 11 Cal.App.4th 349 (intrauterine device); Artiglio v. Sup. Ct. (1994) 22 Cal.App.4th 1388 (breast implants); and Armstrong v. Optical Radiation Corp. (1996) 50 Cal.App.4th 580 (viscoelastic optical gel).  Medical device manufacturers can rely on Garrett to further strengthen their argument that any strict liability design defect claims involving implantable medical devices should be dismissed.

Greg Jackson, Senior Associate, Morris Polich & Purdy LLP; 619-819-2480

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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