inhaler marketing is partly deceptive; P not required to resurvey revised material

GlaxoSmithKline LLC v. Boehringer Ingelheim Pharms., Inc., 2020
WL 5258317, No. 19-5321 (E.D. Pa. Sept. 3, 2020)

GSK partially succeeded and partially failed to
preliminarily enjoin some of BI’s marketing in this case involving claims about
different inhalers. Of broader note: when GSK proved that an earlier version of
the marketing campaign included false claims, the court was willing to enjoin
similar statements in the revised campaign, to protect GSK from whack-a-mole.

Chronic Obstructive Pulmonary Disease (COPD) causes
obstructed airflow from the lungs. It’s the third-leading cause of death by
disease in the US, and there’s a huge market for medications to manage its
symptoms is huge ($24.3 billion globally by 2026). Most COPD medications are
delivered by inhalers: (1) Metered dose inhalers (MDIs), which release aerosol
when pressed; since the patient must inhale coordinated with the spray, they
can be difficult to use. (2) Dry powder inhalers (DPIs), which use medication
combined with dry inactive carrier particles; all that is required to use them
is inhalation, which separates the medication from the carrier particles and
delivers the medication to the lungs. Both parties offer DPIs. (3) Slow mist
inhalers (SMIs), which use spring power to generate low velocity mist into the
mouth; they require some coordination, but less than an MDI. BI makes the only
SMI on the market in the US.

To promote its SMI, BI needed to convince doctors to use it
instead of DPIs. Its solution was to focus on COPD patients’ peak inspiratory
flow (PIF or PIFR) which is measured in liters per minute (L/min). The premise of
BI’s current campaign is that a COPD patient’s ability to separate the
medication from the dry powder carriers depends on that patient’s ability to
inhale with sufficient force. BI labeled this the “COPD Paradox”: although DPIs
have an “optimal PIF” of 60 L/min, many COPD patients have “suboptimal PIF” of
less than 60 L/min. By contrast, because SMIs do not require forceful
inhalation, BI’s marketing suggests that doctors should prescribe its SMI for
patients with low PIF.

“At its base, this case comes down to whether BI has
scientific support for its various statements about PIF and DPIs.” Since this
was a “tests prove” case involving claims of empirical proof, GSK could prevail
either by showing that “the tests were not sufficiently reliable to permit a
conclusion that the product is superior” or “that the tests did not establish
the proposition for which they were cited.”

Basically, there was scientific support for the basic idea
that the optimal PIF for most DPIs was >60 L/min, that low PIF is common in
COPD patients, and (more tenuously) that patients who couldn’t achieve that
could benefit from an alternative inhaler (apparently because there was
evidence of a correlation between low PIF and worse clinical outcomes). GSK
argued that there was no clinical evidence establishing a link between low PIF
and clinical efficacy of COPD medication. But BI “consistently” acknowledged
this lack of established correlation in its marketing materials.  So there was no literal falsity here. So too
with related statements; the court noted that they were directed to doctors and
appropriately qualified.

Also, this weird marketing was not false: a box labeled “Dry
Powder Inhaler” that also bore a disclaimer stating “WARNING: Suboptimal
Inhaler Included.” Inside the box was … “a plastic figurine of a COPD patient,
as well as a BI marketing pamphlet.” BI argued that the “suboptimal” reference
was to the patient, not to the DPI, and the court agreed that, while the
outside of the box alone potentially conveyed the false message that DPIs are
suboptimal, the ad as a whole conveyed that many COPD patients are suboptimal
inhalers and was thus not literally false. “Upon opening the box and seeing the
figurine, and as there is no DPI in the box, physicians likely will understand
the intended message. As BI sales representatives were instructed to ‘[p]ut the
box in the customer’s hands,’ it is unlikely that physicians will fail to open
the box.” Referring to a patient, instead of the patient’s breathing, as
suboptimal seems dehumanizing to me, but that’s not the cause of action.

GSK did show a likelihood that “[t]he efficacy of aerosol
deposition in the lungs is dependent upon the peak inspiratory flow rate (PIFR)
of the patient” was false. GSK’s evidence was that “studies have shown that a
lung deposition of as little as 10% of an emitted dose of COPD medication can
effectively treat a patient.” Thus, while BI had support for the claim that patients
with a low PIF would receive less COPD medication from a DPI, BI didn’t
support that they wouldn’t receive enough medication.

Misleadingness: GSK only provided evidence of deception for one
document, a visual aid. While surveys aren’t always required, “[c]onsidering
the complexity of the science, the sophistication of the targeted physicians,
and BI’s efforts to toe the line and only state what its cited studies support,
the Court cannot conclude that BI’s statements are misleading based only on the
marketing materials themselves.”

GSK provided a survey that showed a since-changed “COPD
Paradox” visual aid. Its expert coded 51% of the respondents’ answers as
stating that BI’s messaging conveyed that “COPD patients with suboptimal PIF
don’t get sufficient benefit from their inhalers.” In response to the question:
“What, if anything, does material convey or suggest about use of certain dry
DPIs for COPD patients with suboptimal peak inspiratory flow (PIF)?” 34% of the
responses were coded as stating that “[e]fficacy of DPI medications may be
compromised/insufficient for some patients with low/reduced PIF.” Thus, a
substantial number of physicians were deceived into believing that DPIs do not
work for COPD patients with suboptimal PIF. BI quibbled with the coding but
even excluding the disputed responses gave a deception rate of well over 15%.

BI argued that the survey was irrelevant because it used a
now-expired ad, not the current visual aid. But the old visual aid was “substantially
similar” to the current one. As BI’s Director of Respiratory Marketing stated
in a memo sent to the sales team, “[d]on’t worry, the new assets are very
similar to the old assets in terms of the overall story content and message
flow. You will see immediately that the changes are relatively minor…[w]e are
very confident that these new assets will help you continue to tell the core
story….” The court credited the conclusion of GSK’s expert, “the only
marketing expert whose opinion has been presented to the Court,” that “[o]ne
would not need to survey each and every iteration to reach the conclusion that
the message was communicated in prior pieces, and that it continues to be
communicated now.” The court pointed out, for example, that “MORE THAN HALF of
COPD patients can have suboptimal peak inspiratory flow (PIF)” evolved to “MANY
COPD patients can have suboptimal peak inspiratory flow (PIF).” The first
visual aid stated that “[y]our patients live with damaged lungs and many cannot
forcefully inhale…yet…[m]any COPD inhalers may require your patients to
forcefully inhale,” while the current one says “[m]any patients with COPD
cannot forcefully inhale because they live with damaged lungs…yet…[a]ll dry
powder inhalers (DPIs) require patients to forcefully inhale to optimally

Takeaway: the survey was “comprehensive and compelling. BI
cannot dodge the legal consequences of that survey by making superficial tweaks
to its marketing materials, turning Lanham Act litigation into a never-ending
shell game.”

BI didn’t contest materiality (or interstate commerce or
likely injury to GSK).

Irreparable harm: Harm to reputation or goodwill can
constitute irreparable injury because it is “virtually impossible to quantify
in terms of monetary damages.” BI argued that GSK’s claim was belied by its
17-month delay in seeking injunctive relief and by data showing no competitive

Delay “may be excused where the party seeking a preliminary
injunction delays only in the reasonable belief that negotiations may resolve
the dispute.” GSK learned about BI’s marketing campaign in the summer of 2018. It
then convened an internal team to assess BI’s campaign. In September 2018, it
sent an objection letter to BI, which led to an exchange of letters that lasted
through June 2019. “Significantly, in response to GSK’s complaints, BI revised
some of its marketing materials.” In November 2019, GSK’s survey expert
submitted her report, and GSK sued and requested injunctive relief.  GSK’s conduct, “which entailed an initial
resort to a consensual resolution of the controversy” and then waiting to
obtain evidence necessary to support its claim, “did not constitute
unreasonable delay.”

Harm: It was undisputed that GSK’s market share hadn’t
shrunk. But the irreparable harm was “long-term goodwill and reputation.”  GSK’s expert explained:  “[p]harmaceutical marketing is given structure
by campaigns that unfold over a period of years to advance a particular
strategy…[i]t takes time to make a case.” Here, because “virtually none of
the physicians in practice today have been trained in their medical education
to rely on PIF (or to think about PIF at all), it will take time, repetition,
and iteration to prime the marketplace for behavior change.” She further declared:
“[w]ith repeated exposure over time [to BI’s marketing campaign], innuendo and
suggestion are likely to take firm shape in physicians’ minds” and “physicians
can often be persuaded to act on speculation so long as they don’t feel they
are putting patients are risk.” This was especially likely here because COPD is
a “leading cause of death, but there have been no dramatic advances in
treatment therapy for years.” The survey also showed that, even though GSK’s
market share had yet to erode, the campaign was damaging GSK’s DPIs’ reputation
and goodwill. GSK sales representatives also reported that multiple hospitals
are now “testing PIF and if below 60, they are switching patients off of [GSK]
products.” GSK’s expert stated that “[t]he equity drained away through brand
reputation risk may never be recovered. It will be hard for physicians to
‘unhear’ these ideas once heard because the burden of definitively disproving
(or proving) them is too onerous for any company with a stake in this market to

GSK wasn’t required to wait until it lost market share,
which would be too late.

The public interest favored enjoining false or misleading
health-related statements, as BI was allowed to continue to truthfully
advertise the state of the evidence. (I wonder how easy that will be, given
that the problem is misleadingness; disclaimers alone won’t necessarily fix
that even if they avoid falsity.)

The court also ordered a $5 million bond.

from Blogger

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