Expert’s Declaration Contained Sufficient Detail To Make It Admissible And To Raise A Triable Issue Of Material Fact

Garrett v. Howmedica Osteonics Corporation
(Cal. Ct. of App., 2d Dist.), filed November 27, 2012

KEY FACTS

Todd Garrett was treated for cancer in his left thigh bone.  Jeffrey Eckardt, an orthopedic surgeon, ordered and implanted a prosthetic device to replace the middle portion of the thigh bone.  Howmedica Osteonics and Stryker Corporation were involved in the design or manufacture of the prosthesis.

Sometime later, Garrett reported pain in his thigh.  Eckardt investigated and detected a fatigue fracture in the prosthesis.  Eckardt replaced it.

Garrett sued Howmedica and Stryker for (1) strict products liability based on manufacturing and design defects; (2) strict products liability based on failure to warn; (3) breach of express warranty; and (4) negligence.

Howmedica and Stryker moved for summary judgment.  They 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 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.

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 the 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, including lack of expert qualification, lack of an explanation or reasoning to support an expert opinion.  The trial court sustained the objections, found there was no triable issue of material fact and granted the motion.

HOLDING & REASONING

The Court of Appeal reversed the judgment with specific directions to the trial court.  It held:  (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, (2) the exclusion of portions of Garrett’s expert’s declaration was error, and (3) that declaration raised triable issues of fact precluding summary adjudication on the manufacturing and design defects and the negligence claims.

As to the strict products liability claim, the court explained that 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 of distribution to ensure that the loss is borne not by injured consumers but by manufacturers, retailers and others in the chain of distribution who are better able to reduce the risks of injury and can equitably distribute the loss to the consuming public.

A product is defective in design if the benefits of the design do not outweigh the risk of danger inherent in the design or if the product fails to perform as safely as an ordinary consumer would expect when used in an intended or reasonably foreseeable manner.  However, the manufacturer of prescription drugs cannot be strictly liable for a design defect because these considerations are inappropriate for prescription drugs.  First, an ordinary consumer would have no safety expectations with respect to a prescription drug apart from the information provided by his or her physician.  Second, the benefit of making such drugs available outweighs the risks as a matter of public policy.  The same reasoning applies to manufacturers of prosthetic devices that are selected and implanted by a physician.

Thus, Howmedica and Stryker cannot be strictly liable for a design defect.  Nonetheless, they could be liable for a manufacturing defect.

The trial court erred in excluding Garrett’s expert’s declaration.

The expert 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.

The court found that this explanation was sufficient to support his opinion for purposes of opposing the summary judgment motion.  The expert’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 did not indicate that his conclusions are speculative, conjectural or lacked a reasonable basis.

Likewise, his failure to identify the particular ASTM specifications that he considered did not render the declaration conclusory and could not justify the conclusion that there was no reasonable basis for his opinion.

With the declaration in evidence, a trier of fact could have found that the prosthesis was not manufactured according to specifications.  Thus, it was improper to grant a summary adjudication on the manufacturing defect claim.

ANALYSIS

This case provides useful guidance as to a manufacturer’s liability for an allegedly defective prosthesis.  The court’s analysis of the admissibility of the expert’s declaration also shows the importance of fully developing declarations filed in opposition to a summary judgment motion.