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)

by CMCP - California Minority Counsel Program

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

Written by:

CMCP - California Minority Counsel Program

CMCP - California Minority Counsel Program on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at:

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.