People v. Johnson
& Johnson, 2022 WL 1075421, D077945 (Cal. Ct. App. Apr. 11, 2022)
Long opinion, as you might expect for a big verdict.
Defendants (Ethicon)
appealed their loss at a bench trial, which resulted in nearly $344 million in
civil penalties against Ethicon for willfully circulating misleading medical
device instructions and marketing communications that misstated, minimized,
and/or omitted the health risks of Ethicon’s surgically-implantable
transvaginal pelvic mesh products. The trial court found Ethicon committed
153,351 violations of the Unfair Competition Law (UCL) and 121,844 violations
of the False Advertising Law (FAL) and imposed a $1,250 civil penalty for each
violation. The court of appeals kicked out nearly $42 million in penalties
because there was no evidence of what Ethicon’s employees and agents actually
said in oral marketing communications, which is a good incentive not to leave a
record I guess, but affirmed the rest.
Ethicon sold pelvic
mesh products intended to treat two conditions that can affect women—stress
urinary incontinence (SUI) and pelvic organ prolapse (POP), for which there are
alternative treatments. In 2008, FDA issued a public health notification alerting
health care providers about complications from pelvic mesh implants used to
treat SUI and POP, most frequently “erosion through vaginal epithelium,
infection, pain, urinary problems, and recurrence of prolapse and/or incontinence,”
as well as “bowel, bladder, and blood vessel perforation during insertion.” It
advised that complications were “rare,” but could have “serious consequences.”
A 2011 update found that “surgical mesh for transvaginal repair of POP [was] an
area of continuing serious concern,” and that serious complications in that
context were not rare, including “mesh erosion through the vagina (also
called exposure, extrusion or protrusion), pain, infection, bleeding, pain
during sexual intercourse (dyspareunia), organ perforation, and urinary
problems.” “[M]any of the complications required intervention, some of them
required repair surgeries, and some of them were incapable of being resolved.”
During the relevant
period, Ethicon disseminated: (1) Instructions for Use (IFUs) (information
packets accompanying medical devices); (2) marketing communications directed to
California doctors; and (3) marketing communications directed to California
patients. Alleged falsehoods/misleading omissions: (1) they falsely stated the
pelvic mesh products were approved by the FDA when in fact they were cleared by
the FDA under section 510(k); (2) they omitted known risks and complications
associated with the products; (3) they misrepresented the relative risks
associated with the products compared to non-mesh surgical treatment options;
(4) they misrepresented the severity and frequency of the risks that were
disclosed, including the irreversibility of the effects; and (5) they
overstated the benefits and effectiveness of the products. In short, there was
lots of evidence of this, and the result was a lot of suffering. (If they did this
in writing, what are the chances they didn’t do it orally in “informal”
contacts with doctors?)
The court found all
of the IFUs were deceptive for specific reasons and because they misleadingly stated
the polypropylene mesh composing the products was not subject to degradation or
weakening by the action of tissue enzymes, when mesh can degrade, resulting in
cracking or fragmentation on the mesh surface. So too with its marketing
communications to doctors and patients. The
court also found Ethicon’s sales representatives were trained to convey
deceptive and misleading information to healthcare professionals. Ethicon
actively concealed risks from the public, declining to update risk information
in response to internal suggestions. It instructed its sales representatives to
avoid initiating conversations with doctors about the public health
notification and paid consultants to author an article refuting the FDA’s update.
The court also found
deception: doctors read and rely on IFUs and marketing materials when counseling
and treating patients; they weren’t generally familiar with the risks specific
to pelvic mesh products, and their recent development meant many doctors did
not learn about them during medical school or their residency programs. Ethicon’s
efforts to undercut the FDA’s public health notification and update also
nullified whatever information doctors may otherwise have acquired regarding
the risks associated with pelvic mesh products.
The trial court
reasoned that the violation count should include all “quantifiable instances of
[Ethicon’s] circulation or dissemination of deceptive messages”–i.e., it
counted each IFU or marketing communication as a separate violation, at $1,250
per violation—half the amount the Attorney General requested. A big award was warranted
because Ethicon’s misconduct was “grave” and “egregious,” as Ethicon withheld
crucial information about products that were permanently implanted into
patients, caused some patients “debilitating, chronic pain,” and “destroy[ed]
patients’ sexual, urinary and defecatory functions – consequences that go to
the very core of personal identity, dignity, and quality of daily life.” The
court also pointed out that there were likely “far more violations” that were
excluded from the already-large violation count; Ethicon’s misconduct was
persistent and spanned 17 years; Ethicon knowingly misrepresented and concealed
the information at issue; and $344 million civil penalty award was less than
one percent of defendant-parent company Johnson & Johnson’s $70.4 billion
net worth. [Though I can only presume that once Ethicon finishes the Texas
Two-Step its obligations will substantially outstrip its assets, since J&J
knows how to make that work.]
The court did
decline to award injunctive relief because (1) Ethicon amended the IFUs for its
SUI products in 2015 and, in the process, remedied many misleading statements
contained therein; (2) it was already in the process of amending its product
labeling to comply with a 42-state consent order entered as part of a separate
legal proceeding; (3) the current information in the public domain was
sufficient to inform health care providers of the risks; and (4) an injunction
requiring Ethicon to update its labeling without FDA approval could subject
Ethicon to liability under federal law.
Ethicon argued that
the trial court erred by failing to consider whether the IFUs and
doctor-focused marketing communications were misleading from the perspective of
doctors—the target audience—as opposed to members of the public. The court of
appeals disagreed; “even the most cursory review” of the facts found by the
trial court showed that it applied the correct target audience standard. Along
with its discussion of the general level of medical education on pelvic mesh,
the court pointed to several defense witnesses, including surgical
specialists and urogynecologists, who were unaware of complications unique to
pelvic mesh products apart from vaginal erosion and exposure—even though these
complications were “well-known to the company from launch.” It also cited
extensive evidence that doctors rely on IFUs and manufacturer marketing in
making treatment decisions. Nor was there any conflict with the injunctive
relief ruling: there were many rational reasons to find that Ethicon’s marketing
was likely to deceive doctors during the statutory liability period that ended
in 2018, but that there was sufficient current information in the public domain
to warrant the denial of injunctive relief in June 2020.
Ethicon argued that
the court failed to apply the correct standard for omissions, but didn’t
develop what it thought that standard should have been. Regardless, the trial
court did right: A fraudulent or deceptive omission is actionable if it is
“contrary to a representation actually made by the defendant, or an omission of
a fact the defendant was obliged to disclose.”
Courts typically
find omissions actionable: “(1) when the defendant is in a fiduciary
relationship with the plaintiff; (2) when the defendant had exclusive knowledge
of material facts not known to the plaintiff; (3) when the defendant actively
conceals a material fact from the plaintiff; and (4) when the defendant makes
partial representations but also suppresses some material facts.” The court made
extensive findings on (3) and found that Ethicon took “active, willful measures
for nearly twenty years to suppress information and conceal serious risk and
complication information from physicians and patients,” including “marketing
efforts focused on downplaying and rebutting the FDA’s notices” regarding
pelvic mesh products, including paying consultants to author an article to
refute the notices. It also made a number of findings on (4), such as that “[d]efendants’
marketing to both patients and doctors consistently and repeatedly touted
mesh’s benefits while misrepresenting, downplaying, and concealing its
potential for serious, long-term complications.”
Ethicon argued that
the trial court ignored materiality, but materiality doesn’t play the same role
in an action by the People. Materiality can be relevant to a named plaintiff’s
standing in a private class action case, because the class representative must
prove they actually relied on the deceptive advertising to have standing under
the UCL, and “ ‘a presumption, or at
least an inference, of reliance arises wherever there is a showing that a
misrepresentation was material.” Materiality can also be relevant to whether
class treatment is justified in a private FAL/UCL restitution action.
But materiality is
not, as far as precedent discloses, part of the burden in a government
enforcement action filed by the Attorney General or another public prosecutor
to obtain civil penalties on behalf of the People. However, even assuming that
materiality is an implicit requirement, the trial court clearly found materiality.
The trial court found Ethicon misrepresented and concealed “serious risk and
complication information,” including “medically significant” information that
affected medical decision-making. It found that Ethicon’s misconduct “had real
consequences for real people.” It found that, as a result of Ethicon’s
deception, doctors were unable to “factor [the risks] into their patient
counseling and treatment decisions,” or to “provide the information necessary
to inform and counsel their patients,” depriving doctors of the ability to
properly counsel patients and depriving patients of the ability to make
informed choices.
In addition,
substantial evidence supported the findings of likely deception as to written
materials, including professional education and training for doctors as well as
field marketing PR kits and similar materials. However, “there was insufficient
evidence concerning the content of thousands of oral marketing communications
that were penalized by the trial court,” so the finding that those were likely to
deceive was reversed—this covered sales representative detailing; Ethicon-sponsored
meals between sales representatives and doctors; and health fairs. The record
didn’t establish the content of any of them, and “[t]he People’s forensic
accountant—who developed the methodologies underpinning the trial court’s
violations calculation—conceded he did not know whether any particular sales
representative detailing activity was mesh-related; whether mesh was discussed
during Ethicon’s meals with health care providers; or what Ethicon’s employees
and agents even said during health fairs.”
The trial court
relied on evidence that the sales reps “were trained and coached to deliver the
same consistent messages that pervade[d] the company’s print materials and IFUs
....” And there was evidence that Ethicon
trained its sales representatives to convey uniform marketing messages. But
that uniformity did not itself “give rise to a reasonable inference that every
single one of Ethicon’s thousands of oral communications with doctors included
false or misleading statements. The mere fact a sales representative may have
been trained in a particular way—even in a manner that promoted the disclosure
of misleading information—reveals little, if anything, about the content of any
particular conversation that may have occurred many months or years later.”
This strikes me as deeply silly and inconsistent with what we accept about
causation in most contexts—especially, as here, where the deception went to the
heart of the product, overclaiming its benefits and downplaying its risks. Is
it more likely than not that any given interaction with an Ethicon rep did the
same, given Ethicon’s deceptive training and emphasis on uniformity? I would say yes. But there was no
evidence of a specific “script” to be recited, so I guess it’s all good.
So the People only
got $302,037,500.
Nonetheless,
substantial evidence also supported the finding of patient deception, for
similar reasons. E.g., a patient brochure assured “[t]here should be very
little discomfort after the procedure.” At the end, the answer to “What are the
risks?” was: “All medical procedures present risks. As with all procedures of
its type, there’s a risk of injury to the bladder and surrounding organs. For a
complete description of risks, see the attached product information.” But the attached
information was far from complete, omitting “virtually all of the most severe
risks associated with the TVT device—including mesh exposure through the
vagina, mesh erosion, tissue contracture leading to chronic pain, debilitating
and life-changing chronic pain, chronic groin pain, chronic dyspareunia, and
pain to partner.”
Ethicon’s argument
that doctors had a legal duty to disclose all serious risks and to obtain
informed consent, so its materials couldn’t be likely to deceive patients,
failed. “Because doctors themselves were likely to be deceived by Ethicon’s
IFUs and marketing communications, the trial court reasonably found Ethicon’s
marketing communications were likely to deceive patients notwithstanding the
legal duties doctors owe to their patients.”
There was also no
safe harbor defense. Under the UCL, “[if]f the Legislature has permitted
certain conduct or considered a situation and concluded no action should lie,
courts may not override that determination. When specific legislation provides
a ‘safe harbor,’ plaintiffs may not use the general unfair competition law to
assault that harbor.” Assuming without deciding that (1) executive action can also
create a safe harbor and (2) the safe harbor applies to the FAL, Ethicon still
lost, because the FDA didn’t create a safe harbor for these communications. The
medical devices here were Class II, for which general controls such as labeling
requirements “are insufficient to provide reasonable assurance of ... safety
and effectiveness” and thus get “‘special controls’ such as “performance
standards, postmarket surveillance, ... recommendations, and other appropriate
actions as the [FDA] deems necessary’ to ensure safety and effectiveness.” During
the 501(k) clearance process for two devices, the FDA informed Ethicon it was
unable to determine whether the devices were substantially equivalent to an
existing legally marketed predicate device due to certain “deficiencies” in
Ethicon’s submissions to the FDA, and their draft IFUs did “not adequately
address issues of usability and potential adverse events.” Ethicon then rewrote
the IFUs to add most of what FDA wanted. Ethicon thus argued that “the FDA
effectively wrote and approved the IFUs” for those devices.
But the FDA’s “limited
review” as part of the section 510(k) clearance process did not create a safe
harbor. “To forestall an action under the unfair competition law, another
provision [or executive action, per our stated assumptions] must actually ‘bar’
the action or clearly permit the conduct.” But “the 510(k) process is focused
on equivalence, not safety.” Former FDA Commissioner Dr. Kessler testified the
FDA’s “clearance [of Ethicon’s] pelvic mesh devices [was] not a finding that
the labeling [was] complete, accurate and not misleading.” So too with the other devices. “At most, the
FDA failed to declare Ethicon’s conduct unlawful.” That’s not the same as
blessing it.
Ethicon argued that
its free speech rights were violated, but false and misleading commercial
speech isn’t entitled to First Amendment protection. Ethicon argued that some
of its statements the court found deceptive “were supported by credible
scientific evidence and subject to legitimate scientific debate; therefore, the
speech was merely potentially misleading—not actually or inherently misleading.”
But the court found literal falsity,
including “false statements about mesh’s properties” and treating incomplete
product information as a complete description of risks. This is unprotected
speech. (Finding that doctors and patients were actually misled also counts as
finding that the speech is more than just potentially misleading—the trial court
found that the risks of misleading speech materialized. To the extent that Ethicon
might be arguing that each marketing communication could only be penalized if
it specifically could be linked to a patient’s harm, that just demonstrates why
First Amendment Lochnerism is not a good idea for commercial deception. And it’s
inconsistent with Zauderer and its progeny. The Court never suggested
that you could only regulate an ad if that particular copy of the ad had
deceived someone; the Court was talking about the message, not the medium.)
And even if the First
Amendment covered this commercial speech, Ethicon didn’t try to explain why Central
Hudson would preclude its regulation and thus waived any argument about
that.
Calculation of the
civil penalty award: The UCL and FAL both say:
The court shall impose a civil penalty for each violation of this
chapter. In assessing the amount of the civil penalty, the court shall consider
any one or more of the relevant circumstances presented by any of the parties
to the case, including, but not limited to, the following: the nature and
seriousness of the misconduct, the number of violations, the persistence of the
misconduct, the length of time over which the misconduct occurred, the
willfulness of the defendant’s misconduct, and the defendant’s assets,
liabilities, and net worth.
But they don’t
specify what constitutes a “violation,” which is decided on a case-by-case
basis. In counting each deceptive IFU and marketing communication as a separate
violation of the UCL and FAL, the court reasoned that each one was “designed to
drive future sales of the product, and thus relate[d] to [Ethicon’s]
opportunity for gain.” The court also noted its calculation was likely an
undercount of the deceptive communications Ethicon circulated during the
liability period.
Ethicon would much
have preferred a per-day violation count, or, better, a figure tied to the rate
of reoperation for women who received pelvic mesh implants. But it was not an
abuse of discretion to do what the trial court did. In previous cases, the
court of appeal held that counting every copy of a newspaper with a violative
ad as a “violation” was not appropriate. In that case, “a reasonable
interpretation of the statute in the context of a newspaper advertisement would
be that a single publication constitutes a minimum of one violation with as
many additional violations as there are persons who read the advertisement or
who responded to the advertisement by purchasing the advertised product or
service or by making inquiries concerning such product or service. Violations
so calculated would be reasonably related to the gain or the opportunity for
gain achieved by the dissemination of the untruthful or deceptive
advertisement.” But in appropriate circumstances, such as when ads are targeted
to consumers who the advertiser deems likely to respond, total circulation can
be a reasonable method to determine the number of statutory violations. It is
important that the People’s burden of proof should not “ ‘be so onerous as to
undermine the effectiveness of the civil monetary penalty as an enforcement
tool.’ ”
Here, “Ethicon’s
deceptive IFUs and marketing communications were substantively targeted to
well-defined groups of people. The IFUs were specifically directed to doctors
who were considering whether to implant Ethicon’s device or were preparing to
do so—often, though not always, to urogynecologists and surgical specialists.
And Ethicon’s marketing communications were explicitly written to appeal to
those same doctors, or to prospective patients who were suffering from SUI or
POP.” Ethicon’s targeting even extended to targeted online ads based on patient
searches. Thus, it was reasonable to find that “each IFU and marketing communication
represented a gain or opportunity to gain for Ethicon.”
Ethicon complained
that the People’s forensic accountant wrongly extrapolated from one salesperson’s
history and failed to account for brochures that were ordered but not
distributed, but Ethicon itself admitted it had no “way to determine how many
such items were actually distributed,” and it had not been able to determine
the “exact number of copies of printed materials that had been sent to
California.” There was no factual finding that Ethicon’s printed materials went
undistributed.
Ethicon argued that $1,250
per violation was inappropriate becuase each IFU and marketing communication
“was different–in what was said, in what context, to whom, etc.–and each had a
different capacity for harm.” Though they may have differed in particulars,
they all (except for the oral communications, the court says) “shared the same
defining features: each contained misstatements, half-truths, and/or omissions
regarding the risks of Ethicon’s pelvic mesh products, and each was likely to
deceive California doctors and/or patients.” Ethicon argued that $1,250 was too
large because Ethicon’s communications—not its pelvic mesh products—were the
focus of the lawsuit, and Ethicon’s communications themselves did not harm
patients. That was “mere semantics,” since the communications misrepresented
the safety and risks associated with Ethicon’s products, which in many cases
caused “medical, physical, and emotional turmoil that lasted years or for the
rest of patients’ lives.” Ethicon’s appeal to its internal vetting practices “tends
to support the trial court’s finding that Ethicon’s deceptive misstatements and
omissions were knowing and intentional, not the product of mere negligence,”
rather than weighing against a big award.
Nor did the award
violate due process just because it was big. Ethicon was not without notice of
the UCL and FAL’s requirements. Even if these civil penalties are the largest
UCL/FAL penalties reported to date, that didn’t deprive Ethicon of notice that
big lies risked big penalties. “Certainly, none of the other appellate
decisions upholding civil penalty awards under the UCL and FAL ‘suggest that
the amounts awarded [in those cases] were somehow in the outer limit of penalties
that may properly be imposed.’” The penalties here are big because Ethicon made
“thousands of deceptive statements for years on end.” And the UCL/FAL expressly
define the maximum per violation at $2500, which provides clear notice, as did
the AG’s investigation long before the statutory liability period ended; they entered
into a tolling agreement effective October 17, 2012. “At that time, Ethicon
could have altered its communications and practices to avoid this outcome or,
at least, to minimize the amount of the potential civil penalty award. It did
not do so.”
For similar reasons,
the penalties did not violate the 8th Amendment/state law prohibitions against
excessive fines. Although a federal law limits the civil penalties available
for violations of federal statutes and regulations governing medical devices to
$1 million, the UCL and FAL authorize more (and the AG requested twice as
much).