Todd Garrett appeals a summary judgment in favor of Howmedica Osteonics Corporation (Howmedica) and Stryker Corporation (Stryker) in a products liability action involving an implanted prosthetic device.
We hold that (1) the doctrine of strict products liability based on a design defect is inapplicable to implanted medical devices available only through the services of a physician and cannot provide a basis for the defendants’ liability, and (2) the exclusion of portions of plaintiffs expert’s declaration was error. In so holding, we reject defendants’ argument that the exclusion of evidence was proper under the principles recently articulated by the California Supreme Court in Sargon Enterprises, Inc. v. University of Southern California (2012)
FACTUAL AND PROCEDURAL BACKGROUND
1. Factual Background
Garrett was treated for cancer in his left femur (thigh bone). Jeffrey Eckardt, an orthopedic surgeon, ordered a prosthetic device to replace the middle portion of the femur. Howmedica and Stryker allegedly participated in some manner in the design or manufacture of the prosthesis. Eckardt implanted the prosthesis in August 2007, attaching it to the two remaining ends of the femur using an adhesive and cross-pins.
Garrett reported pain in his thigh beginning in February 2009. Eckardt investigated and detected a fatigue fracture in the prosthesis. Eckardt replaced the fractured prosthesis with a different type of prosthesis in March 2009. The new prosthesis included an artificial joint, and the second surgery required a considerably longer recovery time than the first.
2. Trial Court Proceedings
Garrett filed a complaint in August 2009 and filed a third amended complaint against Howmedica, Stryker and others in September 2010. He
Howmedica and Stryker filed a motion for summary judgment or summary adjudication in March 2011. They argued that Garrett’s discovery responses showed that he had no evidence to establish the essential elements of his claims. They also argued that the 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. They filed a declaration by Albert H. Burstein, a mechanical engineer, stating his opinion that the prosthesis was not defective in design or manufacture, that the fracture was caused by a cyclical rotational force resulting from normal human activity and that the force simply exceeded the load that the product could bear over time. They also presented Garrett’s discovery responses and other evidence in support of the motion.
Garrett opposed the motion, except that he did not oppose the attack on his count for strict products liability based on failure to warn. Garrett filed a declaration by Lawrence Kashar, a metallurgist, stating that he had determined through destructive testing and other examinations that the portion of the prosthesis that suffered a fracture “was softer tha[n] the minimum required hardness in two of the three ASTM specifications that cover Cobalt-28 % Chromium-6% Molybdenum alloy for use as an implant material, and was less than the expected hardness of the third specification.” Kashar stated that (1) hardness was a direct indication of the strength of the material; (2) a portion of the prosthesis was not made from the cobalt-chromium-molybdenum alloy, but instead was made from a titanium alloy; and (3) he had detected “a layer of polymeric-like material” in holes surrounding the cross-pins and noted that defendants’ deponent had “stated that no polymeric material should be involved with this implant.” Kashar characterized these as “anomalies” and stated his opinion that, based on these purported anomalies, the prosthesis was defective in manufacture and/or design and that there were “strong arguments” that the purported defect had caused the prosthesis to fail.
Howmedica and Stryker filed evidentiary objections to most of the substantive portions of the Kashar declaration on various grounds, including lack of expert qualification, lack of an explanation or reasoning to support an expert opinion, “lacks foundation” (capitalization omitted) and relevance.
The trial court also found that the Kashar declaration failed to satisfy the requirements for admissibility of expert opinion because it lacked a reasoned analysis and an adequate foundation for his opinions.
CONTENTIONS
Garrett contends (1) the evidence that the prosthesis failed less than two years after the surgery creates a triable issue of fact as to the existence of a design defect and causation, and defendants failed to satisfy their burden of presenting evidence that the prosthesis was not defective under the risk-benefit test; (2) a triable issue of fact exists as to the existence of a design defect under the consumer expectations test; (3) Kashar adequately stated the basis for his opinion, and the exclusion of portions of his declaration was error; and (4) the Kashar declaration creates triable issues of fact as to the existence of a design or manufacturing defect, negligence and causation.
DISCUSSION
1. Standard of Review
A court may grant a summary judgment only if there is no triable issue of material fact and the moving party is entitled to judgment in its favor as a
We review the trial court’s ruling on a summary judgment motion de novo, liberally construe the evidence in favor of the party opposing the motion, and resolve all doubts concerning the evidence in favor of the opponent. (Miller, supra,
We must affirm a summary judgment if it is correct on any of the grounds asserted in the trial court, regardless of the trial court’s stated reasons. (Conte v. Wyeth, Inc. (2008)
2. Design Defect Strict Products Liability Is Inapplicable to Implanted Medical Devices
The doctrine of strict products liability imposes strict liability in tort on the manufacturer of a defective product and others in the product’s chain
Strict products liability has been imposed for defects arising from flaws in the manufacturing process (manufacturing defects), defects in the design rendering a product unsafe (design defects) and inadequate warnings or failure to warn (warning defects). (O’Neil v. Crane Co. (2012)
The California Supreme Court in Brown, supra,
Brown explained that the consumer expectations test is inappropriate for prescription drugs because an ordinary consumer would have no safety expectations with respect to a prescription drug apart from the information provided by his or her physician. (Brown, supra, 44 Cal.3d at pp. 1061-1062.) A prescription drug manufacturer that has provided appropriate warnings to the physician cannot be liable for the physician’s failure to convey those warnings to the patient, and cannot be liable if the patient relies on information provided by others as to the side effects of the drug. (Id. at p. 1062.)
Brown also noted that the risk-benefit test is inappropriate for prescription drugs for public policy reasons. (Brown, supra, 44 Cal.3d at
Brown rejected a case-by-case approach to determining whether a particular drug was exceptionally beneficial and “unavoidably dangerous,” and therefore exempt from strict liability, concluding instead that prescription drugs as a class are exempt from strict liability for design defects regardless of whether the particular drug at issue is found to be “beneficial to the public health.” (Brown, supra,
Hufft v. Horowitz (1992)
Plenger v. Alza Corp. (1992)
Artiglio v. Superior Court (1994)
In this case, Garrett argues that the exemption from design defect strict products liability established in Hufft, supra, 4 Cal.App.4th 8, and its progeny, is limited to implanted medical devices that are available only by prescription. He argues that whether the prosthesis here was available only by prescription was not at issue in the trial court and the evidence in the record is inconclusive on this point, so summary judgment cannot be affirmed on this basis. We hold, however, that the exemption is not so limited. It is undisputed that the prosthesis here was both ordered by a physician and surgically implanted by a physician, and it cannot reasonably be disputed that the implant was available only through the services of a physician. As the court concluded in Artiglio, supra,
3. The Kashar Declaration Creates Triable Issues of Fact as to the Existence of a Manufacturing Defect and Negligence
a. The Exclusion of Portions of the Kashar Declaration Based on Evidence Code Sections 801 and 802 Was Error
The trial court stated that the Kashar declaration “lacks adequate factual foundation” and “is entirely devoid of any reasoned analysis to support his opinion.” Regarding Kashar’s statement that the prosthesis was softer than the “minimum required hardness” in two of the three ASTM specifications covering “Cobalt-28 % Chromium-6% Molybdenum” alloy for use in an implant and was less than the “expected hardness” of the third specification, the court stated that Kashar failed to “describe the testing process he used to arrive at this conclusion or describe the results of the testing.” The court also stated that Kashar failed to describe what the ASTM specifications were and failed to state that the prosthesis should have complied with the ASTM specifications for that particular alloy. The court stated that therefore there was no basis for Kashar’s opinion that the prosthesis was defective. The court also stated that Kashar offered no opinion that the purported defect caused any injury.
Evidence Code section 801 states: “If a witness is testifying as an expert, his testimony in the form of an opinion is limited to such an opinion as is: [f] (a) Related to a subject that is sufficiently beyond common experience that the opinion of an expert would assist the trier of fact; and [j[] (b) Based on matter . . . that is of a type that reasonably may be relied upon by an expert in forming an opinion upon the subject to which his testimony relates, unless an expert is precluded by law from using such matter as a basis for his opinion.”
The California Supreme Court in Sargon, supra,
Evidence Code section 802 allows the trial court to inquire into the reasons for an expert’s opinion and to exclude expert opinion testimony if it is “based on reasons unsupported by the material on which the expert relies.” (Sargon, supra,
After discussing the trial court’s gatekeeping responsibility under Evidence Code sections 801 and 802, Sargon also stated that “courts must also be cautious in excluding expert testimony. The trial court’s gatekeeping role does not involve choosing between competing expert opinions. The high court warned that the gatekeeper’s focus ‘must be solely on principles and methodology, not on the conclusions that they generate.’ (Daubert v. Merrell Dow Pharmaceuticals, Inc.[ (1993)] 509 U.S. [579, ]595 [
We review the trial court’s ruling on the admissibility of expert testimony for abuse of discretion, except to the extent that the ruling is based on the court’s conclusion of law, which we review de novo. (Sargon, supra,
In this case, Kashar declared that he “conducted extensive examinations of the portions of the prosthetic device that were removed from Mr. Garrett using visual examination, optical microscopic examination, x-ray radiography, fluorescent dye penetrant examination, scanning electron microscopy, and such destructive testing as hardness testing, micro hardness testing, microstructural analysis, and chemical analysis.” He declared that he had determined, based on his examinations, that the fractured portion of the prosthesis was softer than the “minimum required hardness” in two of the three ASTM specifications covering the alloy for use in an implant and was less than the “expected hardness” of the third specification.
We believe that this explanation is sufficient to support his opinion for purposes of opposing the summary judgment motion. In our view, Kashar’s failure to describe the particular testing processes that he used to arrive at his conclusions regarding the hardness of the prosthesis and his failure to more particularly describe the results of that testing do not in any manner indicate that his conclusions are speculative, conjectural or lack a reasonable basis. Whatever shortcomings that cross-examination may or may not reveal in Kashar’s testing methods and opinion, we believe that the absence of more specific information as to the testing methods used and the results obtained would not provide any grounds for the trial court to conclude that there was no reasonable basis for Kashar’s opinion.
Howmedica and Stryker contend Kashar’s failure to describe the testing methods employed and the test results made it impossible for the trial court to determine whether the material on which he relied supported his opinion. Citing Sargon, supra,
Sargon involved the exclusion of expert testimony at trial. (Sargon, supra,
Sargon discussed the expert’s testimony and the trial court’s ruling at length. (Sargon, supra, 55 Cal.4th at pp. 776-781.) Sargon stated, “To the extent that the expert relied on data that is not relevant to the measure of lost profit damages, the trial court acted within its discretion to exclude the testimony because it was not ‘[bjased on matter . . . that is of a type that reasonably may be relied upon by an expert in forming an opinion upon the subject to which his testimony relates . . . . ’ (Evid.Code, § 801, subd. (b);
Unlike Sargon, supra,
The rule that a trial court must liberally construe the evidence submitted in opposition to a summary judgment motion applies in ruling on both the admissibility of expert testimony and its sufficiency to create a triable issue of fact. (Jennifer C. v. Los Angeles Unified School Dist. (2008)
We therefore hold that the trial court failed to liberally construe the declaration as required, and that the sustaining of the objections to the Kashar declaration based on Evidence Code sections 801, subdivision (b) and 802 was an abuse of discretion.
Howmedica and Stryker also objected to portions of the Kashar declaration on the grounds that he was not qualified to testify as an expert. “A person is qualified to testify as an expert if he has special knowledge, skill, experience, training, or education sufficient to qualify him as an expert on the subject to which his testimony relates.” (Evid. Code, § 720, subd. (a).) Kashar stated in his declaration that he was “a metallurgist with more than 30 years of experience in materials analysis, failure analysis and material trade-off evaluation.” He testified in his declaration on the nature and hardness of the materials used in the prosthesis, a subject for which his experience as a metallurgist undoubtedly qualified him as an expert.
Defendants’ objections to portions of the Kashar declaration on grounds of lack of foundation and relevance, to the extent that they did not merely reiterate the same grounds that we have already rejected, were similarly meritless. No preliminary fact or other foundational matter was lacking, and Kashar’s testimony clearly is relevant and creates triable issues of fact, as we now explain.
c. The Kashar Declaration Creates Triable Issues of Fact
A product has a manufacturing defect if it differs from the manufacturer’s intended result or from other ostensibly identical units of the same product line. (Barker v. Lull Engineering Co., supra,
Defendants’ expert Burstein stated in his declaration filed in support of the summary judgment motion that he “conducted a detailed examination of the subject prosthesis” and reviewed Howmedica’s records with regard to its design and manufacture. Based on his examination of the prosthesis and review of the records, he opined that the prosthesis “entirely met the specifications provided by Dr. Eckardt,” that it “was manufactured by proper means and methods of the proper materials, as also accepted in the industry, for this product and application” and that it “was not defective in design or manufacture.”
Although Kashar did not expressly state that the design specifications for the prosthesis provided for use of the Cobalt-28% Chromium-6% Molybdenum alloy, Garrett presented deposition testimony by Daniel G. Barcenas of Stryker stating that the prosthesis was designed to be made from “cobalt chrome” and not titanium. Eckardt also testified in his deposition that he designed the prosthesis to be constructed of “alloys . . . and of cobalt, chrome molybdenum.”
We must construe the evidence liberally in favor of Garrett as the party opposing summary judgment and must resolve all doubts in the evidence in his favor. (Miller, supra,
The judgment is reversed with directions to the trial court to vacate the order granting summary judgment and enter a new order granting summary adjudication of the counts for failure to warn strict products liability, design defect strict products liability and breach of express warranty and otherwise denying the motion for summary judgment or summary adjudication. Garrett is entitled to recover his costs on appeal.
Klein, P. J., and Kitching, J., concurred.
Respondents’ petition for review by the Supreme Court was denied June 12, 2013, S210018.
Notes
Defendants acknowledge that this action is not preempted by the federal Medical Device Amendments of 1976 (21 U.S.C. § 360c et seq.).
Garrett also alleged a count against Howmedica and Stryker for fraudulent concealment, but he later dismissed that count.
The minute order ruling on defendants’ motion for summary judgment or summary adjudication stated this reason for sustaining the objections to the Kashar declaration and later stated more generally as to each objection “Sustained.”
Garrett does not challenge the granting of summary judgment as to the counts for failure to warn strict products liability and breach of express warranty. He therefore abandons any claim of error with respect to those counts. (Angelotti v. The Walt Disney Co. (2011)
Howmedica and Stryker argue for the first time in their respondents’ brief that design defect strict products liability is inapplicable to implanted medical devices. We will address this argument despite defendants’ failure to raise the issue in the trial court because it is potentially dispositive of part of the appeal and involves a purely legal question. (Fort Bragg Unified School Dist. v. Colonial American Casualty & Surety Co. (2011)
Hufft, supra, 4 Cal.App.4th 8, apparently used the terms “implanted prescription medical devices” (id. at p. 11), “implanted prescription medical product[s]” (id. at pp. 11, 19-20) and “implanted medical devices” (id. at pp. 17-19; see id. at p. 11) interchangeably, and assumed that all implanted medical devices “require a physician’s prescription” (id. at p. 19, fn. 10).
Garrett alleges design defect strict products liability and manufacturing defect strict products liability together in a single count. However, because these are two separate theories of liability that properly could have been alleged as separate counts, we will treat them as such and conclude that summary adjudication is proper as to the count for design defect strict products liability. (Mathieu v. Norrell Corp. (2004)
