Wednesday, November 28, 2012
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C.A. Declines to Extend Strict Liability to Medical Implants
By KENNETH OFGANG, Staff Writer
Strict products liability based on design defect does not extend to medical devices that have been ordered and implanted by a physician, the Court of Appeal for this district ruled yesterday.
Div. Three, in an opinion by Justice Walter Croskey, upheld a Los Angeles Superior Court judge’s ruling that cancer patient Todd Garrett cannot hold the makers of his femur implant strictly liable for an alleged design defect necessitating a second surgery with a difficult recuperation.
The court did, however, reinstate Garrett’s manufacturing defect and negligence claims, saying Judge Cesar Sarmiento erred in rejecting his expert’s opinion that the device failed because the defendants made it from materials that failed to meet industry standards.
Garrett sued Howmedica Osteonics Corporation and Stryker Corporation in 2009. He alleged that the prosthetic device that was implanted to replace the middle portion of his femur in 2007 fractured two years later.
The complaint alleged causes of action for strict liability based on manufacturing and design defects, strict liability based on failure to warn, breach of express warranty, and negligence.
In moving for summary judgment last year, the defendants argued that Garrett had made no showing of a defect and that they had no duty to warn as a matter of law. They presented a declaration from a mechanical engineer, who opined that the fracture was caused by normal human activity that placed a greater load on the product than it could bear over time.
Expert’s Declaration
In opposition, Garrett offered a declaration by a metallurgist, who said the area in which the fracture occurred failed to meet standards of hardness established by ASTM International, formerly the American Society for Testing and Materials, a leading industry organization.
The expert, Lawrence Kashar, said that destructive testing and other methods revealed that a portion of the prosthesis was made from a titanium alloy, rather than the alloy of cobalt, chromium, and molybdenum called for by ASTM, and that a polymeric material was improperly used.
There were, he said, “strong arguments” that the softness of the material was a manufacture or design defect that had caused the device to fail.
Sarmiento said that the failure of the device did not establish a prima facie case, and that the plaintiff did not present, and could not present, sufficient evidence of defect, breach of warranty, negligence, or causation. Kashar’s declaration, he added, lacked reasoned analysis and adequate foundation.
Croskey, writing for the Court of Appeal, said the trial judge was correct in ruling that there was no triable issue of design defect or breach of warranty. He cited a line of cases beginning with Hufft v. Horowitz (1992) 4 Cal.App.4th 8, holding that “prescription implanted medical devices” are exempt from design defect strict products liability as a matter of the public interest.
He rejected the argument that Hufft did not apply because Garrett’s implant did not require a prescription. Even if that was true, Croskey said, there was no meaningful distinction because the implant in question was ordered and surgically implanted by a physician, and could not have been obtained other than through a physician.
Hufft, he said, “applies to an implanted medical device in these circumstances regardless of whether, strictly speaking, it was available only by prescription and regardless of whether it is properly characterized as a ‘prescription’ implanted medical device” because “[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 that are available only through the services of a physician.”
Sufficient Analysis
He went on to say, however, that Kashar’s declaration contained sufficient analysis and foundation to enable the plaintiff’s claims of manufacturing defect and negligence to go to trial. The expert, he said, provided a reasonable amount of detail as to what kinds of tests he had used, what he had found, and what standards he believed to have been violated.
To the extent there may be shortcomings in Kashar’s work, Croskey explained, the defense can address those on cross-examination, but there was no showing “that his conclusions are speculative, conjectural or lack a reasonable basis.”
Attorneys on appeal were Martin N. Buchanan, along with Thomas V. Girardi and Amanda H. Kent of Girardi | Keese for the plaintiff and Ralph A. Campillo, Steven D. Di Saia and Hall R. Marston of Sedgwick for the defendants.
The case is Garrett v. Howmedica Osteonics Corporation, B234368.
Copyright 2012, Metropolitan News Company