Gall v. Smith & Nephew, Inc. ( 2021 )

Filed 10/29/21
CERTIFIED FOR PUBLICATION
IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA
SECOND APPELLATE DISTRICT
DIVISION EIGHT
WAYNE GALL, B296394
Plaintiff and Appellant, (Los Angeles County
Super. Ct. No. BC504268)
v.
SMITH & NEPHEW, INC.,
Defendant and Respondent.
APPEAL from a judgment of the Superior Court of
Los Angeles County, Randolph Rogers, Judge. Affirmed.
Brice E. Bryan & Associates, Brice E. Bryan and
Christopher J. Brantingham for Plaintiff and Appellant.
Shaw Koepke & Satter, John W. Shaw, Jens B. Koepke;
Irwin Fritchie Urquhart & Moore and David W. O’Quinn for
Defendant and Respondent.
____________________
When a hip joint deteriorates, a hip resurfacing implant is
one possible treatment. Smith & Nephew, Inc. (or simply
“Smith”) manufactures hip resurfacing implants. Smith’s
product in this case had two parts: a metal ball that covers the
top of the femur, and a cup that fits inside the hip socket. When
a surgeon puts these ball-and-cup surfaces in the joint, the
polished metal surfaces are supposed to allow smoother
movement than the damaged bone or cartilage they replace.
The patient and plaintiff in this case is Wayne Gall, who
had this kind of hip resurfacing surgery for his left hip. Gall
recovered and became physically active. But years later,
convinced his implant was unsatisfactory, Gall sued Smith.
Gall’s first theory was “failure to warn”: Smith failed
properly to warn Gall’s surgeon, Dr. Jaime Hernandez, about the
risks of using Smith’s product. The trial court granted summary
judgment for Smith because Hernandez independently knew
these risks. Hernandez stayed current by reading scientific
publications. Whether Smith gave Hernandez redundant
warnings did not matter, the court ruled, when Hernandez
already had the necessary information.
Gall’s second theory was that Smith’s product was
defective. The trial court granted summary judgment because
Gall did not show anything was wrong with his implant. Gall did
show Smith’s quality control procedures once failed to satisfy
regulatory authorities, but the trial court concluded this fact did
not imply the parts Gall received were defective.
The trial court also allowed a declarant to revise his
declaration, which Gall protests.
The trial court’s rulings were proper. We affirm.
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I
Gall sought medical help for hip pain. On November 24,
2010, Hernandez described Gall’s treatment options. Hernandez
recommended hip resurfacing surgery. In this procedure, the
surgeon trims the femoral head, caps it with a metal covering,
and puts a cup in the pelvic socket. Both implants are metal.
These are the implants Smith makes.
Hernandez had special training for this kind of surgery.
He traveled to England to study with the surgeon who designed
this implant. Hernandez has performed hundreds or thousands
of these surgeries.
Hernandez routinely stayed abreast of developments in his
field. He learned about this procedure’s risks from scientific
studies. Hernandez’s source was “science that has been
established and researched. And I have equal access to that
information that the people making the labels do. [¶] So before I
look at labels, I have the information that I need. I have the
access to the information that I need. To the science that I need
to educate the patient prior to opening any box [containing
Smith’s product] and looking at any [manufacturer’s] label.”
By reading the scientific studies, Hernandez learned about
the possible risks and side effects “years” before operating on
Gall.
On November 24, 2010, Hernandez advised Gall about his
surgical options and risks. Hernandez and Gall had different
recollections of what Hernandez told Gall that day. They
disagreed about whether Hernandez told Gall the metal implants
could release metal particles that could cause a soft tissue mass
to form. This tissue mass is sometimes called a pseudotumor.
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Gall claimed Hernandez told him no known medical
consequences could arise from the metal ions.
Hernandez had a different account. He testified he did not
recall the particulars of his conversation with Gall. Hernandez
had a custom, however, of discussing major complications with all
surgery patients before he operated on them. Hernandez had a
lengthy list of complications he customarily discussed: metal ion
pseudotumor, tissue damage, soft tissue injury, pain, infection,
bleeding, blood clots, bone fracture, leg length discrepancy,
dislocation, loosening, component fracture and wear, implant
failure, loss of limb, amputation, renal complications, nervous
system complications, mental status changes, and systemic and
local complications.
Hernandez testified about what he knew of the risks on the
date he counseled Gall: November 24, 2010. Hernandez knew
the body’s reaction to metal-on-metal wear debris could produce
an adverse local tissue reaction. He knew this surgery could
cause soft tissue masses called pseudotumors.
After the November 24, 2010 consultation, Gall decided to
go ahead with the procedure. Hernandez performed the surgery
on March 28, 2011.
About a month after the operation, Gall reported good
progress. By September 2011, Gall was walking with a normal
gait and was playing baseball. “He has only very occasional
anterior muscle ache with prolonged activity. No fever, chills or
systemic complaints. He is performing all his activities.” This
type of muscle ache, Hernandez testified, is not uncommon after
this type of hip surgery.
After the surgery, Gall began playing full court basketball
in a league.
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Gall eventually became concerned about blood tests
showing somewhat elevated levels of cobalt and chromium. On
February 16, 2014, Hernandez told Gall those test levels were
“not concerning for implant failure.” Hernandez did not
recommend further testing. That was Gall’s last contact with
Hernandez.
After that visit with Hernandez, Gall did not consult with
other doctors about metal ion levels in his blood.
Gall sued Smith and Hernandez. In his deposition, Gall
testified his main concern was the ion level in his blood. After he
filed suit, Gall got a scan showing that he possibly had developed
a pseudotumor. There is no evidence this tissue mass is anything
but benign. No evidence shows the mass was growing or having
adverse or noticeable effects on Gall’s health.
Smith moved for summary judgment, which Gall opposed.
The court issued an eight-page tentative ruling, heard the
motion, and granted it on February 7, 2019. Gall appealed.
II
We independently review the summary judgment ruling
under the usual standard. (See Loomis v. Amazon.com LLC
(2021) 63 Cal.App.5th 466, 475.) There are three issues on
appeal: whether Smith’s failure to warn Hernandez harmed
Gall; whether Smith’s product was defective; and whether the
trial court could permit a witness to revise a declaration.
A
The first issue is whether there was a failure to warn.
Tort law has a special twist when it comes to
manufacturers, physicians, and patients. In the case of
prescription drugs and implants, the physician stands in the
shoes of the product’s ordinary user: a patient learns of the
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properties and proper use of the drug or implant from the
physician. In these cases, the manufacturer’s duty to warn runs
to the physician and not to the patient. (Valentine v. Baxter
Healthcare Corp. (1999) 68 Cal.App.4th 1467, 1483.)
This special twist is called the “learned intermediary”
doctrine. (Bigler-Engler v. Breg, Inc. (2017) 7 Cal.App.5th 276,
318–320.) Its motivating force is that, for prescription drugs and
implants, the doctor interrupts the ordinary commercial chain
from the manufacturer to the final consumer. Patients want to
be able to rely entirely on their doctors’ informed and
independent judgments. The law and medical ethics both
demand that doctors, for their patients’ benefit, evaluate
scientific information about prescription drugs and implants.
Manufacturers thus must warn doctors about product risks. This
duty does not extend to patients, with whom manufacturers have
no cost-effective channel of communication and for whom the
data would be duplicative even if the patient could interpret it.
(Id. at p. 319.)
For Gall’s suit against Smith, then, the decisive issue is,
when Hernandez counseled Gall on November 24, 2010, what
medical risks Hernandez knew. What Hernandez told Gall is a
different matter. That might be pertinent to Gall’s lawsuit
against Hernandez, but that case is not before us.
If Hernandez were fully informed about the implant’s risks
on November 24, Smith wins on this claim, for any failure by
Smith to inform Hernandez could not have caused Gall any harm:
Hernandez already had the needed warning. The parties agree
on this point.
The trial court rightly ruled that Hernandez’s deposition
was unambiguous. Hernandez knew about the metal ion issue
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because he read the underlying scientific studies as they
appeared. Hernandez used primary materials to keep himself
current in his specialty and did not need or use manufacturers’
republications and warnings.
Gall resists this conclusion by seizing on one sentence in
Hernandez’s deposition. Gall claims this sentence creates a
material dispute over whether Hernandez knew about the metal
ion risk from Smith’s product. The trial court properly rejected
this argument. Hernandez was clear and consistent throughout
his deposition: he knew about this risk. No other interpretation
of this deposition is reasonable.
The context is as follows.
Q [by Gall’s counsel]: So since you met with him
before this warning came out, if it had come out sooner,
would you have told him “Hey, there was an FDA warning
that came out and this is the information that was in
it.” Something to that effect?
Mr. Stockalper [Hernandez’s counsel]: Again, you’re
characterizing this as a warning. It’s—and it’s been asked
and answered. He’s already testified that he’s aware of this
information. He talks to the patient about the
information. It’s part of the risk complications. So it’s
asked and answered. So I don’t—
A [by Hernandez]: Yes. I would have—I would
have—I talk to patients about all—all the information that
is relevant to their specific situation and the science that’s
available.
Gall’s argument is that the Food and Drug Administration
published information about metal ion risks between the time of
Hernandez’s November 24, 2010 consultation and the March 28,
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2011 surgery, and in the just-quoted answer Hernandez
demonstrated in effect he did not know of the metal ion risk on
November 24, 2010.
Gall’s proposed interpretation is not reasonable.
Hernandez testified he did know of the ion risk on November 24,
2010. Hernandez’s testimony was straightforward: steadfast,
unequivocal, and with no backtracking.
When evaluating the record of a summary judgment
motion, the trial court must consider all inferences reasonably
deducible from the evidence in the opposing party’s favor. (Code
Civ. Proc., § 437c, subd. (c); Aguilar v. Atlantic Richfield Co.
(2001) 25 Cal.4th 826, 843, 850–851.) The court may not weigh
the plaintiff’s evidence or inferences against the defendants’ as
though it were sitting as the trier of fact. The court nevertheless
must determine what the evidence or inference could imply to a
reasonable trier of fact. (Aguilar, at p. 856.)
The fact that Hernandez knew of the ion risk when
counseling Gall deflates many of Gall’s other arguments. These
arguments involve an agency alert in the United Kingdom,
Smith’s delay in getting data to the Food and Drug
Administration, and an allegedly deficient brochure. The
pertinence of these arguments evaporates once Hernandez
explained he learned of the ion risk from scientific studies. The
agency alerts and the brochure merely repeated what Hernandez
already knew. The secondhand reports were superfluous.
Hernandez testified that nothing about the Food and Drug
Administration’s warning changed his “thinking or decision
making for Mr. Gall.” He said, “this information was already
known by me.” The contents of this agency alert was “no news to
anybody like me.” Gall does not suggest or offer authority for the
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notion that an agency imprimatur changes the quality or
significance of the science the agency relayed.
The trial court properly rejected Gall’s argument on the
failure-to-warn issue.
B
The second issue is whether there was a manufacturing
defect in the product Smith supplied to Gall.
A defective product differs either from what the
manufacturer intended or from the standard items in the
manufacturer’s same product line. (Barker v. Lull Engineering
Co. (1978) 20 Cal.3d 413, 429.) A classic manufacturing defect is
when a product leaves the assembly line in substandard
condition, as when a crane maker means to use strong cable but
mistakenly installs weak cable in its crane. (Ibid., citing Lewis v.
American Hoist & Derrick Co. (1971) 20 Cal.App.3d 570, 580.)
Gall did not show his implant came from the factory in
substandard condition. The evidence was to the contrary. His
implant had been checked for defects twice: once at the factory
and again by Hernandez before he used it in Gall’s operation.
Both inspections showed Gall’s implant was free of defects.
Gall points to a 2010 inspection report by the Food and
Drug Administration that criticized Smith for lacking validation
of supplier processes. The trial court accurately characterized
this report as showing merely that Smith’s quality control process
did not satisfy the regulatory authorities. No evidence shows any
defective product entered the stream of commerce.
Gall cites no product defect precedent for substituting a
process defect for a product defect. Gall’s opening brief cites only
two decisions in this argument. Both decisions concern
employment law, not defective products. (See McDonald v.
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Antelope Valley Community College Dist. (2008) 45 Cal.4th 88;
Reeves v. Safeway Stores, Inc. (2004) 121 Cal.App.4th 95.) Nor
does Gall attempt an analysis of the strengths and weaknesses of
his proposed doctrinal innovation. We will not embark on this
journey without some kind of map.
To the extent Gall attempts to argue the alleged
pseudotumor itself is evidence of a defect, the trial court correctly
noted this fact does not support Gall’s belief his implant was
defective. Pseudotumors are risks of nondefective implants. This
result is consistent with a perfect implant and is not probative of
a defect.
C
Gall’s negligence claim falls with his claims about the
failure to warn and the manufacturing defect. These claims
share the same causation element. Gall concedes this point. We
affirm the trial court’s rulings on the failure-to-warn and
manufacturing defect claims. We thus likewise affirm the trial
court’s ruling on Gall’s negligence claim.
D
Gall argues in his opening brief that the trial court erred by
considering evidence attached to the declaration of attorney
David O’Quinn in support of Smith’s motion. Gall bases this
argument on O’Quinn’s technical violation of Code of Civil
Procedure section 2015.5: O’Quinn executed the declaration
outside California but did not include language stating he made
the declaration under penalty of perjury “under the laws of the
State of California.” O’Quinn fixed this mistake before the
hearing. Gall’s argument is meritless. (See Hearn v. Howard
(2009) 177 Cal.App.4th 1193, 1203–1204 [courts can properly find
errors under section 2015.5 harmless].)
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DISPOSITION
We affirm the judgment and award costs to Smith &
Nephew.
WILEY, J.
We concur:
STRATTON, Acting P. J.
OHTA, J. *
* Judge of the Los Angeles Superior Court, assigned by the
Chief Justice pursuant to article VI, section 6 of the California
Constitution.
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