Ony, Inc. v. Cornerstone Therapeutics, Inc., --- F.3d ----,
2013 WL 3198153 (2d Cir.)
This case asks us to decide when a
statement in a scientific article reporting research results can give rise to
claims of false advertising under the Lanham Act, deceptive practices under New
York General Business Law § 349, and the common-law torts of injurious
falsehood and interference with prospective economic advantage. We conclude
that, as a matter of law, statements of scientific conclusions about unsettled
matters of scientific debate cannot give rise to liability for damages sounding
in defamation. We further conclude that the secondary distribution of excerpts
of such an article cannot give rise to liability, so long as the excerpts do
not mislead a reader about the conclusions of the article.
This represents a potentially powerful incursion into the ordinary Lanham
Act standard for establishment claims; many defendants will likely be citing this case at least as often
as they contest standing.
Plaintiff ONY and defendant Chiesi are two of the biggest
producers of surfactants, biological substances that are critical to lung
function. Premature infants often have
inadequate surfactant levels, putting them at higher risk of death. Nonhuman surfactants produced by the parties,
among others, are the primary treatment for this respiratory distress syndrome
(RDS). The FDA has approved three surfactants for treating RDS in
newborns. ONY produces a bovine
surfactant, Infasurf. Chiesi produces a porcine
surfactant, Curosurf. Cornerstone distributes
Curosurf in the US.
The parties “vigorously contest the relative effectiveness
of their products—in the marketplace, in the scientific literature, and in the
instant lawsuit.” They agreed that
mortality rate and length of stay in the hospital for treatment were
particularly relevant variables, though not independent of each other (length
of stay may be shortened by death, or may be shortened because an infant’s case
is less serious).
Chiesi hired defendant Premier to build a database and
conduct a study of the relative effectiveness of the different surfactants. The doctor defendants were hired to present
findings based on Premier’s database at various medical conferences. They presented findings (1) that Curosurf was
associated with a 20% lower mortality rate than either Infasurf or another
competitor, Survanta and (2) that Curosurf was associated with a 15% shorter
length of stay than either Infasurf or Survanta, based on Premier’s
database. They (along with a Premier
employee) eventually decided to publish their findings in a peer-reviewed
journal. The Journal of Perinatology,
the leading journal in the field of neonatology, published
their article after peer review.
ONY argued that the article contained incorrect statements
of fact that Infasurf was “associated with a significantly greater likelihood
of death” than Curosurf, “even after adjusting for patient characteristics such
as gestational age and [birth weight], and after accounting for hospital
characteristics and center effects.” ONY
also argued that the publication was suspect: one of the authors was an
associate editor of the journal, and another was a member of the editorial
board. ONY alleged that one of the two
peer reviewers objected to the publication, but that the editor-in-chief broke
the tie between the reviewers. ONY didn’t
allege, though, that this tiebreaking was a departure from customary or
accepted practice. The article was
published as “open access,” free to the public, and the publication fees were
paid by Chiesi and Cornerstone.
The authors did note that their findings may “most likely
... be due to different surfactant doses administered to the infants included
in the database,” because Curosurf was, on average, prescribed in higher doses
than its competitors. And they disclosed that the study was sponsored by
Chiesi, that one author was an employee of Premier, that Chiesi hired Premier
to conduct the study, and that all three physician defendants had served as
consultants to Chiesi.
ONY’s primary objection to the methodology was that the
authors omitted any mention of length of stay data. This was allegedly done to mask the fact that
Curosurf-treated infants had a greater ex ante chance of survival than those
treated with Infasurf. In addition, the
authors failed to cite articles that concluded differently, though they knew of
such articles, and they used retrospective data, which allegedly rendered the
data subject to selective distortion.
After the article was published, Chiesi and Cornerstone
issued a press release touting its conclusions and distributed promotional
materials that cited the article's findings. ONY’s corporate officers, also
pediatricians, wrote letters to the journal rebutting the article's
conclusions, objecting to its methods, and asking that it be retracted. The
court took judicial notice that several (two?) of the letters
were eventually published,
as were
responses.
The court first evaluated claims arising out of the article’s
publication. The Lanham Act “proscribes
conduct that, but for its false or misleading character, would be protected by
the First Amendment,” so “free speech principles inform our interpretation of
the Act.” This is especially so for academic works, because academic freedom is
“a special concern of the First Amendment.”
ONY argued that the article’s scientific claims purported to
be statements of fact, thus falsifiable, thus defamatory/false advertising if
known to be false when made. Scientific
discourse does pose problems for the fact/opinion divide. “Most conclusions contained in a scientific
journal article are, in principle, ‘capable of verification or refutation by
means of objective proof.’” That is, in
fact, what science claims to be for. “At
the same time, however, it is the essence of the scientific method that the
conclusions of empirical research are tentative and subject to revision, because
they represent inferences about the nature of reality based on the results of
experimentation and observation.” The
court emphasized that scientific publications are directed to the “relevant
scientific community, ideally in peer-reviewed academic journals that warrant
that research approved for publication demonstrates at least some degree of
basic scientific competence.” Their
conclusions are then available to other scientists, “who may respond by
attempting to replicate the described experiments, conducting their own
experiments, or analyzing or refuting the soundness of the experimental design
or the validity of the inferences drawn from the results.” When the area is novel, “facts” in the
research “may be highly controversial and subject to rigorous debate by
qualified experts. Needless to say, courts are ill-equipped to undertake to
referee such controversies.”
(As a side note, compare the line of cases about blogs
and hyperbole, where what looks like “factual” claims are dismissed as
nonfactual because of their lowly presentation.
Apparently there is emerging the idea that there is a sweet spot for
things that can be falsifiable; aim above or below and you aren’t making a “factual”
claim for First Amendment purposes.
Whether this is a good idea or not I leave to readers.)
Courts have been reluctant to allow causes of action “grounded
on statements of fact that are best evaluated by an informed reader.” The fact/opinion divide was unhelpful in
evaluating a statement “made as part of an ongoing scientific discourse about
which there is considerable disagreement.”
While in theory scientific assertions are in principle verifiable, “for
purposes of the First Amendment and the laws relating to fair competition and
defamation, they are more closely akin to matters of opinion, and are so
understood by the relevant scientific communities.” (I bet the FDA is going to be super, super
surprised by this. Or are FDA
requirements not about “fair competition”?
As a side note, is it now an unconstitutional condition to approve a new
drug as long as the manufacturer only makes certain claims about it on
labeling?)
Here, it was relevant that ONY didn’t allege that the data
in the article were fabricated or fraudulently created. “If the data were falsified, the fraud would
not be easily detectable by even the most informed members of the relevant
scientific community.” Instead, ONY alleged that the inferences drawn from that
data were wrong, and that competent scientists would have used available
variables that defendant authors didn’t.
“But when the conclusions reached by experiments are presented alongside
an accurate description of the data taken into account and the methods used,
the validity of the authors' conclusions may be assessed on their face by other
members of the relevant discipline or specialty.”
Thus, the rule: “to the extent a speaker or author draws
conclusions from non-fraudulent data, based on accurate descriptions of the
data and methodology underlying those conclusions, on subjects about which
there is legitimate ongoing scientific disagreement, those statements are not
grounds for a claim of false advertising under the Lanham Act.” ONY’s allegations weren’t that the data were
incorrect, but that they were presented in a misleading way. Even if that were actionable, that’s a weak claim
where the authors disclosed the potential shortcomings of their methodology and
their potential conflicts of interest.
Given this result, the article’s contents weren’t actionable
under NY law either.
The court considered Chiesi and Cornerstone’s use of the
article’s findings separately. ONY
alleged that this dissemination tortiously interfered with ONY’s prospective
economic advantage in contracting with hospitals and other health-care
providers. But ONY didn’t allege that the promotional materials misstated the
article’s conclusions. This made the case much easier. On the alleged facts, there was no error in
dismissing the tortious interference claim because (a) the article itself was
not actionable and (b) the tortious interference claim did not separately
allege any additional misleading statements.
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