Tuesday, September 08, 2020

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 activate.”

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 harm.

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 entertain.”

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.

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