Pacira Biosciences, Inc. v. American Soc’y of
Anesthesiologists, Inc., — F.4th —-, 2023 WL 2621131, No. 22-1411 (3d Cir.
Mar. 24, 2023)
Courts in particular kinds of false advertising cases say
that scientific claims are not falsifiable, even as the majority of workaday false
advertising claims involving scientific fact are (correctly) treated as falsifiable.
The rule seems to be that scientific claims directed at sophisticated
audiences, to whom details of the claims are disclosed, are treated as opinion,
whereas scientific claims in standard consumer advertising are treated as
factual. This may well be justified because of the different ways in which such
claims are perceived, but it also smacks a bit of those old cases that held
that educated men could be allowed access to things that would be obscene as to
their footmen and housemaids.
Anyway, Pacira sued ASA, the editor-in-chief of its medical
journal, and the authors of three articles for statements made about one of
Pacira’s drug products, for trade libel under New Jersey law. The court of
appeals affirmed a finding that the statements were nonactionable opinion.
Pacira makes Exparel, a local anesthetic administered at the
time of surgery to control post-surgical pain; Pacira claims that it offers
longer lasting pain relief than standard local anesthetics. The challenged
statements conveyed defendants’ view that Exparel was not superior or was even
inferior to standard analgesics for pain relief. E.g., the cover of the
February 2021 issue of Anesthesiology stated that “Liposomal Bupivacaine Is Not
Superior to Standard Local Anesthetics.” Pacira challenged three articles: (1)
a meta-analysis of studies of Exparel, which concludes that the drug is “not superior”
to standard anesthetics; (2) a narrative review of clinical trials involving Exparel,
which reaches a similar conclusion; and (3) an editorial based on the
meta-analysis and narrative review.
Pacira had specific complaints about each article, including
that the first one cherry-picked studies; employed a “flawed method” known as
“crude pooling,” in which results from different studies using different
popoulations are grouped together; and violated “the standards of medical
research” by failing to account for the statistical heterogeneity in
population, medication type, outcome definition, and design of the studies on
which it relied. Similarly, the narrative review allegedly failed to discuss
the “most relevant anesthesia procedure,” ignored favorable studies with
minimal explanation, and two of its authors failed to disclose financial
conflicts of interest.
The ASA’s Continuing Medical Education program allowed
participants to answer questions based on the articles and receive credit to
satisfy medical licensure requirements. Pacira alleged that these questions
restated as fact the articles’ conclusions, including that Exparel is
“inferior” to standard anesthetics and that studies favoring it are biased.
In sorting potentially actionable fact statements from
opinion, courts consider the (1) content, (2) verifiability, and (3) context of
the statements.
Content: “Not superior” and “inferior” were the type of “loose” or “figurative”
language that the New Jersey Supreme Court has said is “more likely to be
deemed non-actionable as rhetorical hyperbole.” (This seems like a overgeneralization
of what those terms mean in the abstract, unaccompanied by more specifics—those
types of words are generally opinion on their own, but here the context is one
of analyzing relative efficacy; the court is atomizing the claim in order to reject
it.) In a footnote, the court relied on past precedent: “If a statement could
be construed as either fact or opinion, however, we must construe it as an
opinion. A contrary presumption would ‘tend to impose a chilling effect on
speech.’” Also, that most of the cases it cited were false advertising cases
strengthens, not undermines, our
conclusion that the statements here are nonactionable opinions. Commercial
advertisements are directed at consumers, whereas peer-reviewed academic
journals are generally “directed to the relevant scientific community.” ONY,
Inc. v. Cornerstone Therapeutics, Inc., 720 F.3d 490, 496-97 (2d Cir. 2013). If
New Jersey courts have concluded that statements of relative superiority would
not mislead an average consumer, then similar statements made in an academic
journal will not mislead the experts reading the journal. See Eastman Chem. Co.
v. Plastipure, Inc., 775 F.3d 230, 236 (5th Cir. 2014) (holding disputed
statements made in sales brochures were actionable because “Eastman did not sue
Appellants for publishing an article in a scientific journal. Rather, Eastman
sought to enjoin statements made in commercial advertisements and directed at
customers”).
Verifiability: The statements here weren’t verifiable. (I
suspect the doctors targeted would be surprised to hear that their CME wasn’t
actually telling them verifiable information. Arguably, this line of cases
highlights one way in which the collapse of any kind of consensus reality has
damaged the First Amendment.) First, they were “tentative scientific
conclusions and were expressly disclosed as such.” Adopting the reasoning of ONY,
the court reasoned that the statements, though theoretically provable, were nonetheless
still “tentative and subject to revision, because they represent inferences
about the nature of reality based on the results of experimentation and
observation.”
 |
| [“that’s just, like, your opinion, man” from The Big Lebowski] |
Of possible interest: Cf. to Daubert’s statement: “Scientific
conclusions are subject to perpetual revision.” But in Daubert, that conclusion
is part of the reason that we let factfinders resolve factual disputes. Also,
in a footnote: “One court has recently observed that if there is consensus on a
scientific issue, then a statement about the issue may be deemed verifiable.
Conformis, Inc. v. Aetna, Inc., 58 F. 4th 517, 533 (1st Cir. 2023).” [This is a
product disparagement case that, in some significant tension with ONY
and the case at bar, finds the statement that a treatment is “not clinically
effective and not accepted by doctors and insurance providers as a standard
treatment” is at least potentially factual for purposes of surviving a motion
to dismiss. The court’s references to Plastipure and this case strengthen my conviction that this is a special rule: statements that are in fact verifiable will nonetheless be treated as opinion when made in scholarly format with sufficient detail about their limitations. I don’t think this is wrong as a result, I just wish the rule were stated more clearly.]
However, the broad statements above are probably limited by
the following discussion of the “express[]” qualifications of the challenged
materials. “For example, immediately before concluding that EXPAREL is not
superior to standard analgesics, the Hussain Article enumerates five ‘notable
limitations’ of its study, including ‘variabilities’ that ‘may have played a
confounding effect,’ ‘publication bias’ in selecting studies, and statistical
limitations due ‘to scarcity of data.’” The second article ended, “[h]owever,
medicine is constantly evolving with ongoing research, and the use of [EXPAREL]
for postoperative analgesia will certainly be no different.” It then identifies
several “knowledge gaps for future research,” including improving comparative
data for certain metrics.
Anyway, Pacira’s allegations “boil down to disagreements
about the reliability of the methodology and data underlying the statements,”
which isn’t the same thing as verifiability…. [M]ere disputes about the
reliability of a scientific study’s disclosed methodology cannot create an
actionable falsehood for trade libel, as such disputes do not address whether
the statements themselves are verifiable.” [There were no allegations of faked
data or the like.] Allegedly undisclosed conflicts of interest weren’t relevant
to falsifiability, even if relevant to actual malice.
Another footnote tries to preserve ordinary Lanham Act cases:
“For [establishment] claims, literal falsity may be established by showing that
‘the underlying studies upon which the representations are based are not
sufficiently reliable to permit one to conclude with reasonable certainty that
they established the claim made.’” [Um, the court just said above that
reliability was different from verifiability—why wouldn’t those claims still be
unverifiable even if unreliable? Immediately after this footnote, in text it
says: “It is only after establishing the statements can be proven true or false
that reliability of the underlying data and methodology may become relevant.”
Separately, if the claim isn’t an establishment claim—it doesn’t expressly or
by implication claim scientific backing—it has, historically, been possible to
falsify it by proving the contrary with scientific evidence.]
The real justification for calling these statements opinion,
which the court gets to next, is that these disputes should be kept out of the
legal system in order to avoid chilling scientific research and discourse. [What
happens when plaintiff’s competitors disseminate these articles as part of
their own self-promotion? The commercial/noncommercial speech distinction can
handle this, but defamation/trade libel may be ill-suited to do so.]
Context also pointed in favor of calling these statements
opinion: This was “a peer-reviewed journal for anesthesiology specialists.
While statements are not protected solely because they appear in a
peer-reviewed journal, such journals are often ‘directed to the relevant
scientific community.’ Their readers are specialists in their fields and are
best positioned to identify opinions and ‘choose to accept or reject [them] on
the basis of an independent evaluation of the facts.’” More generally, “statements
directed at readers who are capable of performing an independent evaluation of
the facts upon which an opinion is based support the conclusion that the
opinion is nonactionable.”
The court pointed out that “the readers were provided with
the data and methodology on which the statements were based.” [Note that if no
one is likely to do their own research, that may not matter, just as no one
really reads lots of other disclosures. Also, doctors are actually
not statistics experts, in general, and are just as vulnerable as the rest
of us to being spun.]
from Blogger http://tushnet.blogspot.com/2023/03/third-circuit-follows-second-in.html
Rebecca Tushnet 