Michelle Himes v. Somatics, LLC

NOT FOR PUBLICATION FILED
UNITED STATES COURT OF APPEALS APR 1 2022
MOLLY C. DWYER, CLERK
U.S. COURT OF APPEALS
FOR THE NINTH CIRCUIT
MICHELLE HIMES; et al., No. 21-55517
Plaintiffs-Appellants, D.C. No.
2:17-cv-06686-RGK-JC
and
JOSE RIERA; et al., MEMORANDUM*
Plaintiffs,
v.
SOMATICS, LLC,
Defendant-Appellee,
and
MECTA CORPORATION,
Defendant.
Appeal from the United States District Court
for the Central District of California
R. Gary Klausner, District Judge, Presiding
Argued and Submitted March 7, 2022
Pasadena, California
Before: IKUTA, LEE, and FORREST, Circuit Judges.
*
This disposition is not appropriate for publication and is not precedent
except as provided by Ninth Circuit Rule 36-3.
Appellants Michelle Himes, Marcia Benjamin, and Daniel Benjamin appeal
the district court’s order granting summary judgment for appellee, Somatics, LLC.
We have jurisdiction under 8 U.S.C. § 1291. We affirm as to the Benjamins’ claims.
For Himes’s claims, we certify a question of law to the Supreme Court of California
in a separate order filed concurrently with this memorandum disposition.
Himes and the Benjamins sued Somatics in diversity for negligence, strict
liability, and loss of consortium arising from injuries that Himes and M. Benjamin
allegedly sustained from Somatics’s electroconvulsive therapy (“ECT”) product,
Thymatron ECT Machine (“Thymatron”). In essence, the appellants claim that
Somatics’s misbranding and failure to warn about certain risks of ECT—
specifically, the risks of permanent memory loss, inability to formulate new
memories, and brain damage—caused Himes and M. Benjamin their injuries. The
appellants relied on the testimony of the prescribing physicians that—had Somatics
given them warnings about these risks—they would have communicated those
warnings to the appellants who, in turn, claim they would not have consented to the
procedures.
The district court granted Somatics’s motion for summary judgment after
concluding that the appellants presented no evidence to create a genuine issue of
material fact as to causation. In particular, the district court held that absent evidence
that the stronger warnings would have affected the physicians’ decision to prescribe
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ECT, the claims fail as a matter of law.
On appeal, the appellants contend that (1) the district court erred in applying
the learned intermediary doctrine to analyze the claims and (2) the district court
applied an incorrect causation standard to the appellants’ claims.
1. To start, we reject the appellants’ argument that the learned intermediary
doctrine does not apply whenever the manufacturer has not provided sufficient
warnings to a physician.
Under California law,1 when drugs or medical devices are supplied in the
context of the physician-patient relationship, the learned intermediary doctrine
applies. See Webb v. Special Elec. Co., Inc., 370 P.3d 1022, 1034 n.10 (Cal. 2016).
Under this doctrine, “manufacturers have a duty to warn physicians of risks that are
known or scientifically knowable at the time of the drug’s distribution.” Wendell v.
GlaxoSmithKline LLC, 858 F.3d 1227, 1238 (9th Cir. 2017) (citing Carlin v.
Superior Court, 920 P.2d 1347, 1349–54 (Cal. 1996)). Thus, “the duty to warn runs
to the physician, not to the patient.” Carlin, 920 P.2d at 1354.
As cases from our court and the Supreme Court of California make plain, even
when warnings are assumed to be deficient, in the context of prescription products,
the analysis always relies on the impact of a hypothetical stronger warning on the
1
Because this is a diversity action, the court applies California substantive law and
federal rules of procedure. See Motus v. Pfizer Inc., 358 F.3d 659, 660 (9th Cir. 2004)
(citing Bank of California v. Opie, 663 F.2d 977, 979 (9th Cir. 1981)).
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physician. See Motus, 358 F.3d at 661; Stevens v. Parke, Davis & Co., 507 P.2d 653,
661–63 (Cal. 1973). After all, because the adequacy of warnings is always
challenged in failure-to-warn claims, “[i]f the learned intermediary doctrine became
inapplicable when a plaintiff alleged that warnings were inadequate, the doctrine
would never operate in California.” Sanchez v. Bos. Sci. Corp., 38 F. Supp. 3d 727,
734 (S.D. W. Va. 2014) (applying California law).
We thus conclude that the district court correctly relied on the learned
intermediary doctrine to analyze the claims. Accordingly, a “product defect claim
based on insufficient warnings cannot survive summary judgment if stronger
warnings would not have altered the conduct of the prescribing physician.” Motus,
358 F.3d at 661.
2. The parties dispute the appropriate causation standard for the learned
intermediary doctrine. The appellants argue that it is enough to show that the
physicians would have passed along to the patients the stronger warnings, which
would have led the patients to refuse the procedure. In contrast, the appellee argues
that there must be evidence to show that the stronger warnings would have altered
the physicians’ decision to prescribe ECT treatment.
The Benjamins’ claims fail, regardless of the causation standard applied,
because a reasonable jury could not find that M. Benjamin’s treating physician, Dr.
Michael Frankel, would have known about any stronger warnings issued by
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Somatics.
Dr. Frankel testified that he has not relied on any disclosure from Somatics to
inform him of the risks of ECT. He further testified that he does not “pay terribly
much attention” to literature from manufacturers informing him of updated safety
information associated with their products, and he did not recall ever “specifically
receiving” a “dear physician” letter informing the medical community about new
risks.2 No reasonable juror could conclude from this testimony that Dr. Frankel
would have become aware of any stronger warnings issued by Somatics. And as we
have explained in a similar situation in Motus, when a plaintiff cannot show that the
prescribing physician would have learned about a stronger warning in the first
instance, there cannot be a causal nexus between the allegedly inadequate warning
and the plaintiff’s injury. 358 F.3d at 661.
We thus affirm the district court’s grant of summary judgment for Somatics
with respect to the Benjamins’ claims.
2
At oral argument, appellants’ counsel drew our attention to the part of the
deposition in which Dr. Frankel’s responded affirmatively to the following
questions: “And if you are alerted to new risks concerning . . . a device that you
utilize, you would pay attention to that[] . . .? And if the manufacturer warned of a
new serious risk, you would relay that risk to patients; correct?” (emphasis added).
But that hypothetical assumes that Dr. Frankel would first be alerted to new risks,
which the rest of Dr. Frankel’s testimony showed was implausible since he did not
read disclosures from Somatics, does not pay attention to literature from
manufacturers, and does not remember receiving, let alone reading, a “dear
physician” letter warning about new risks.
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3. For Himes’s claims, we conclude that evidence in the record shows that
Himes’s treating physician, Dr. Raymond Fidaleo, would have learned about
stronger warnings and passed them along to Himes, but there is no evidence that
these warnings would have altered his prescribing conduct.
Dr. Fidaleo testified that he pays attention to “dear physician” letters from
manufacturers alerting him to new safety risks. From this testimony, a reasonable
jury could conclude that if Somatics had issued a stronger warning about the risks
of ECT, Dr. Fidaleo would have become aware of them.
Further, Dr. Fidaleo testified that if he were presented with warnings about
these risks, he would include them in his patient consent forms and discuss them
with his patients. From this testimony, a reasonable jury could conclude that, through
Dr. Fidaleo, Himes would have become aware of the stronger risk warnings. We also
hold that a reasonable jury could conclude that a prudent patient in Himes’s position
would have declined the treatment after receiving warnings about the risk of
permanent memory loss, inability to formulate new memories, and brain damage.3
3
We disagree with the appellants’ contention that in establishing causation through
warnings, the effect of a stronger warning on a patient could be determined through
the patient’s subjective post-hoc declaration. As the Supreme Court of California
has explained in the physician failure-to-inform context,
[s]ince at the time of trial the uncommunicated hazard has materialized,
it would be surprising if the patient-plaintiff did not claim that had he
been informed of the dangers he would have declined treatment.
Subjectively he may believe so, with the 20/20 vision of hindsight, but
6
Dr. Fidaleo’s testimony, however, does not establish that he would have
altered his prescribing conduct. On the contrary: (i) as to the risk of permanent
memory loss, had Dr. Fidaleo been told about the risk, he testified that it “wouldn’t
stop” him from using ECT because “[a]ll drugs and all things have memory loss,”
(ii) as to the risk of inability to formulate new memories, Dr. Fidaleo testified that it
would be a “significant” concern but that he “would have to see it also [him]self”
and that he is “not seeing that with [his] patients,” and (iii) as to the risk of brain
injury, Dr. Fidaleo testified that he would be reluctant to use ECT if that were a risk
but that he does not believe that this is an actual risk “[b]ecause people go back and
function normally after ECT.” (emphasis added). In sum, Dr. Fidaleo’s testimony
demonstrated that warnings about these risks would not have altered his decision to
prescribe ECT either because such risks are not unique to ECT or because he simply
would not credit those warnings based on his own experience with the therapy. No
reasonable jury could conclude from this testimony that warnings about these risks
we doubt that justice will be served by placing the physician in jeopardy
of the patient's bitterness and disillusionment. Thus an objective test is
preferable: i.e., what would a prudent person in the patient's position
have decided if adequately informed of all significant perils.
Cobbs v. Grant, 502 P.2d 1, 11-12 (Cal. 1972). We thus conclude that if it were
possible to establish causation through warnings communicated to the patient by the
physician, the effect on the patient must be determined based on what a prudent
person in the patient’s position would have done with the benefit of stronger
warnings.
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would affect Dr. Fidaleo’s decision to prescribe and use ECT.
The resolution of this appeal turns on the proper causation standard applied to
Himes’s claim. If the district court and Somatics are correct that in failure-to-warn
claims, a plaintiff must show that stronger manufacturer warnings would have
altered the physician’s prescribing conduct, Himes’s claims fail. If, on the other
hand, a plaintiff can establish causation by showing that a physician would have
communicated the stronger warning to the patient and that a prudent person in the
patient’s position would have declined the treatment after receiving the stronger
warning, Himes’s claims survive summary judgment. As further explained in the
accompanying certification order, because there is no controlling state precedent on
this question, and the question implicates important policy concerns, we conclude
that it warrants certification to the California Supreme Court. See Cal. R. Ct.
8.548(a); see also Kremen v. Cohen, 325 F.3d 1035, 1037–38 (9th Cir. 2003).
AFFIRMED IN PART.
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