Court Opinion

ID: 9495227
Source: CourtListenerOpinion
Date Created: 2023-08-05 15:57:42.685775+00
Date Added: 2024-06-11T17:56:53.851736
License: Public Domain

FERGUSON, Circuit Judge,
dissenting.
This case should go to a jury and, thus, I respectfully dissent. In this case, the District Court granted summary judgment for Synthes Spine. A grant of summary judgment is reviewed de novo. Delta Sav. Bank v. United States, 265 F.3d 1017, 1021 (9th Cir.2001) (citations omitted). Our review is governed by the same standard used by the trial court under Rule 56(c) of the Federal Rule of Civil Procedure. Id. (citation omitted). Thus, we must determine, viewing the evidence in the light most favorable to Ms. Adams, whether the District Court correctly applied the relevant substantive law and whether there are any genuine issues of material fact. Id. (citation omitted). We must not weight the evidence or determine the truth of the matter, but only determine whether there is a genuine issue of material fact for trial. Meade v. Cedarapids, Inc., 164 F.3d 1218, 1221 (9th Cir.1999) (citation omitted).
The record in this case gives rise to two genuine issues of material fact, which preclude the granting of summary judgment in favor of Synthes Spine: (1) whether the plate manufactured by Synthes Spine was defective under the “reasonable expectation of the consumer” test,1 and (2) whether Synthes Spine was sheltered by the affirmative defense of comment k of the Restatement (Second) of Torts.
A. Reasonable Expectation of the Consumer Test
Under the reasonable expectation of the consumer test, the issue is whether the reasonable expectations of Dr. Leslie Bornfleth, the prescribing physician, were met.2 The District Court held that Dr. Bornfleth’s expectations of the product were met as a matter of law because Dr. Bornfleth knew that screws could break, fracture, and migrate.
However, the District Court incorrectly overlooked other parts of the record that raised a genuine issue as to whether Dr. Bornfleth expected that the plate itself could fracture, thus requiring removal. In his deposition, Dr. Bornfleth stated:
I don’t know the circumstances of the breakage. I mean, if she had a solid fusion and for some reason the plate *1120broke, I would be kind of surprised, number one, but unless she were, say, in some kind of accident or something bad happened. But I am kind of at a loss to explain why the plate would fracture, and if I were faced with that, I don’t know whether I would take the plate out or what I would do.3
Dr. Bornfleth also testified that he remembered hearing of cases in which the screws had backed out or sheered off, but he did not remember hearing of any cases in which the cervical plate itself broke. In fact, during his consultation with Ms. Adams, he did not mention that the plate could break if subjected to stresses. At the time, he did not know why a cervical plate might fracture. Moreover, Dr. Born-fleth testified that, at the time of the implant, he did not understand either that the implant should be removed or that Synthes Spine recommended that it be removed.
In addition, while participating in meetings of the American Associations of Neurological Surgeons and the Congress of Neurological Surgeons, Dr. Bornfleth attended courses and presentations given by representatives of Synthes Spine and other doctors regarding the product. From these courses and presentations, Dr. Born-fleth concluded'that there was “no reason to take the plates out because if the fusion is solid and the plate is there, it’s going to cause no problem.” Both Dr. Bornfleth and Dr. Allan Drapkin, Ms. Adams’ subsequent physician, testified that they did not think that other doctors were removing the plates routinely.
Dr. Bornfleth testified that he did not recall seeing or remember reading the package insert that came with Synthes Spine’s plate products. Even after reading it during the deposition, he concluded that the warnings in the package insert might not apply to cervical plates because of the minimal weight of the head compared to other parts of the body. His conclusion indicates a lack of clarity in the warnings’ language.4
Thus, the record presents a genuine issue of material fact regarding whether Dr. Bornfleth’s reasonable expectations in the use of the plate were met. . He did not expect that the plate could break or that the screws would extrude, as indicated by his statement that he was “surprised” that such would occur. Although Dr. Bornfleth recognized that occasional breakage of plates was theoretically possible, he had not heard of and would not have expected the cervical plate to break in the manner and under the circumstances that occurred here. In addition, his testimony indicates that he did not think removal of Ms. Adams’ plate was necessary because: (1) the presentations of other doctors and Synthes Spine, (2) the practices within the medical profession in using the product, and (3) a lack of clarity in the warning. Thus, there are genuine issues of material fact for a jury to resolve regarding the reasonable expectations of Dr. Bornfleth and whether those expectations were met.
B. Adequacy of Warning
The District Court also erred in determining that the warning provided by Synthes Spine adequately warned of the possibility of breakage. As discussed by the majority, it appears that the reasonable expectation of the consumer test cannot be met if there is no genuine issue of material fact regarding whether the warning was adequate. See Reece v. Good Samaritan Hosp., 90 WasLApp. 574, 953 *1121P.2d 117, 123 (1998) (finding that the consumer expectation test could not be met where the manufacturer had “adequately warned consumers of the risks associated with using a product”). However, if there is a factual dispute regarding the warning’s adequacy, Synthes Spine cannot be sheltered by this affirmative defense.
A product is adequately labeled if it “carries the necessary instructions and warnings to fully apprise the physician of the proper procedures for use and the dangers involved.” Terhune v. A.H. Robins Co., 90 Wash.2d 9, 577 P.2d 975, 978 (1978). In determining that Synthes Spine’s warning was adequate as a matter of law, the District Court relied on both the package insert that accompanied the plate and the testimony by Drs. Bornfleth and Drapkin that they would still use the plate on future patients despite the breakage in this case. In finding that the warning was adequate, the District Court erred because it ignored the ambiguous language of the warning and the confusion that arose from the warning.
The only warnings regarding the necessity for removal was included in a package insert entitled “FOR THE PERSONAL ATTENTION OF THE OPERATING SURGEON” and “SUGGESTIONS CONCERNING ORTHOPAEDIC METALLIC INTERNAL FIXATION DEVICES.”5 Under “Precautions,” the following text appears:
3. Removal after fracture healing. Metallic Implants can loosen, fracture, corrode mitigate, cause pain, or stress shield bone even after a fracture has healed, particularly in young, active patients. While the surgeon must make the final decision on Implant removal, we recommend that whenever possible and practical for the individual patient, fixation devices should be removed . by adequate postoperative management to avoid refracture.
This paragraph regarding removal is not included in the subsection of the insert 'entitled “Warnings,” rather it is in the subsection entitled “Precautions.” This paragraph also uses language, such as “we recommend” and “devices should be removed,” rather than “must,” which is used in other paragraphs in this section. For example, the first paragraph in the “Precautions” subsection states, “Surgical Implants must never be reused.”
In addition to its discretionary nature, the ambiguity in the insert’s meaning raises a triable issue as to whéther the Synthes Spine’s warnings were adequate. Upon reading the package insert during his deposition, Dr. Bornfleth stated:
They imply here that once the need for the fixation device is over, that the implant should be removed. And I don’t think — I don’t think I ündérstood that. In fact I never did take them out except that one case.
* * * * *
I think the other points are pertinent, but as I read this, I get the sense this is more for a lumbar or extremity type thing , because there is not much weight that the neck has to bear, so there is really — applies .-mostly to weight bearing. Although the head weighs 16 pounds, it’s not a tremendous weigh-bearing surface, so a lot of the precautions are I think perhaps not applicable to the cervical plates.
Even after a close read of the warning during his deposition, Dr. Bornfleth was unsure whether the removal recommendation even applied to cervical plates, such as the one at issue in this case.6
*1122Finally, both Dr. Bornfleth and Dr. Drapkin testified that no doctors appeared to know that removal should occur, and no doctors followed such procedures. Thus, the product did not carry “the necessary instructions and warnings to fully apprise the physician of the proper procedures for use and the dangers involved.” Terhune, 577 P.2d at 978. Because the warning was ambiguous in nature and failed to fully apprise doctors that removal was necessary, Synthes Spine’s package insert for its cervical plate does not constitute an adequate warning as a matter of law.
The majority accuses me of wrongdoing, asserting that I am substituting my medical judgment for the medical judgment of a physician.7 This charge demonstrates a myopic view of our legal system and what this lawsuit is all about.8 Every day in courts throughout the nation, judges and layperson juries as finders of fact substitute their judgments for the judgments of physicians in medical malpractice litigation. That’s our legal system. However, this is not a medical malpractice case against a physician. We are not required to determine whether a physician was right or wrong. Rather, this is a products liability case, which is at the summary judgment stage. The questions before the court are whether the product manufactured by Synthes Spine was defective and whether the warnings regarding the dangers of the product were adequate. As shown above, there are disputed issues of fact regarding these questions, which should be determined by a jury, not by a panel of appellate judges. By failing to recognize these genuine issues, the majority usurps the fact-finding role of the jury and substitutes its judgment for that of the jury.
In sum, because the record sets forth specific facts showing that there are genuine issues for trial regarding (1) whether the physician’s reasonable expectations were met, and (2) whether Synthes Spine’s warnings were adequate, I would reverse and remand this case.

. Although not specifically described as the "reasonable expectation of the consumer” test, this is the same test that the majority discusses as arising under the Washington Products Liability Act. Maj. Op. at 1116-17.

. As stated by the majority, the relevant "ordinary consumer” under the consumer expectation test is the prescribing physician in this case. Terhune v. A.H. Robins Co., 90 Wash.2d 9, 577 P.2d 975, 978 (1978).

. Nothing in the record indicates that Ms. Adams was in an accident or had undergone any type of physical trauma.

. The adequacy of the warning and Dr. Born-fleth's testimony regarding the warning is further discussed in the Section B, infra.

. All capitalization and font styles are shown as they were in the warning.

. Iri addition to the possibly inadequate written warning, it appears that Synthes Spine *1122failed to give any oral warnings during their presentations at various meetings. As ■ discussed above, Dr. Bornfleth was given the impression that there would be no complications from leaving the plates in if the fusion was solid.

. Underlying this statement is the majority’s assertion that physicians chose not to remove the plates based on their medical judgment. However, nothing in the record establishes this fact.

. Moreover, the majority ignores the fact that, in this case, the prescribing physician did not testify that he was using his independent judgment when he chose not to remove Ms. Adams' plate. Rather, he relied on what he had heard from Synthes Spine and his colleagues, not on what he learned from any of his own research or doctor-patient consultations regarding Ms. Adams’ medical needs and requirements.