FDLI symposium: special topics

Special Topics
FDA Regulation of Genomic Testing and the First Amendment
Barbara Evans, Professor, University of Houston Law Center
 
Of companies in clinical sequencing industry: 10 of 68 do
sequencing only; 21 of 68 annotation and interpretation only. That is speech
only. [Or it’s professional advice and not even protected by Central Hudson, as
Robert Post would say.] Question of FDA scope: when there’s bundling of
interpretation with device/test, FDA jurisdiction is easy, but what if it’s
unbundled and people are merely talking? 
 
Shouldn’t have unintended consequences drive unbundling or
drive it offshore.  Regulator’s task:
protect consumers without causing these effects.
 
Bad consequences aren’t enough to justify speech regulation:
test results that lead people to make stupid medical decisions have to be
regulated by regulating medical decisions, not information.  Could require doctor for interpretation;
could put warnings/disclaimer on interpretation; develop FDA-recognized list of
which claims are proven/legitimate. 
 
State Action in Food and Controlled Substances Regulation
and the Benefits of Friction Between Regulatory Authorities
Diana R. H. Winters, Associate Professor, Indiana University
School of Law
 
Regulatory flexibility can be vertical or horizontal. Can be
productive to fill gaps, address what’s seen as misguided federal policy.  E.g., humane treatment of animal laws in Cal.,
two of which have been invalidated and are on appeal; Vt. GMO labeling law;
concerted AG action to remove allegedly fraudulently labeled dietary
supplements from shelves.  Cal. just past
a law on animal antibiotics—stricter than federal; not yet challenged.  Movement to decriminalize and regulate
marijuana—also brings fed/state interaction into sharp relief.  Challenged & invalidated: ban on sale of
foie gras.  Egg/chicken treatment law now
under challenge as preempted by Egg Inspection Act & as violating dormant
commerce clause.  That case was thrown
out for lack of standing by challenger states; on appeal.  We should enjoy and celebrate the mess as it
fills gaps and spurs national debates.
 
A First Amendment Exception for Flexible FDA Regulation
Sally Wang, Principal, DocFlight
Market arms race: inefficient to keep spending advertising
to keep in the game; costs get passed to payors and consumers.  A lot of blockbusters going off patent: there
should be shrinkage but there is almost doubling of marketing spend.  Regulatory void left by FDA has been filled
to some extent by DOJ actions—over $13 billion in fines for fraudulent
marketing. Less regulation is not beneficial for industry.  Selling drugs is different from selling TVs.  Can use gov’t granted IP rights/monopoly
privileges as a way to continue regulation. 
IP rights for drugs are closely intertwined w/regulatory process.  Analogy to FCC’s rights because it grants
spectrum to broadcasts.
 
Discussant:
Patricia Zettler, Associate Professor, Georgia State
University, College of Law
Genomic testing is high interest in Silicon Valley, with concerns
about FDA regulations stifling innovation. 
Appealing to distinguish between speech about the genomic test itself
and speech about what the test reveals (meaning of particular results).
 
Choice of regulators: if the fed gov’t is not regulating,
states can regulate medical practice. We have seen docs v. Glocks case in
Florida, abortion restrictions—it’s not infeasible that states might regulate.
Who do we want doing the regulating? 
(Though as with abortion, she points out, guns may be special and
therefore not a precedent.)
 
Winters persuasively argues that state-federal friction can
be beneficial for food and perhaps controlled substances. But how far does this
extend? Many examples are from Cal. & NY, which because of size and
politics may be more persuasive to this group than other states’ policy
choices.  Can Vt. be as persuasive on the
national stage?  Also, is this an actual
benefit if GMO status really isn’t that important?
 
Wang’s paper: analogy to FCC and Nat’l Endowment for Arts
may be different—obscenity/profanity restrictions v. info on drugs—some claim
the info is very valuable for the public health. I worry that courts wouldn’t
extend the rationale they’ve used for FCC/NEA to that speech.  Also, consider other areas, such as genomic
testing—how far can this extend into other areas where FDA faces First
Amendment challenges not so tied to regulatory exclusivity? Maybe the answer is
that authorization to market is a gov’t benefit in itself, but wants to know
more.
 
Winters: California does tend to drive national policy.  Humane treatment as related to human health:
connections b/t factory farming and health, as opposed to standalone concerns
about morality—may get more of a patchwork. But we’ll see industry and private
actors (like McDonald’s) moving to creating a uniformity not mandated by
federal law.  We’ll see convergence/informal
agreements.
 
Wang: Art v. IP is an interesting point.  Even profanity could have a benefit, but the
gov’t can still regulate it because of its structural position conferring a
benefit. Step outside of assumptions and think about it from IP perspective.
 
Moderator: Joseph Page, Professor, Georgetown University Law
Center: Consider state right to try laws: statutes giving people with
life-threatening diseases access to drugs w/o full FDA approval.  In order for them to be successful, the fed
gov’t has to stay its hand, as w/marijuana. 
Otherwise all you have is expressive libertarianism: symbolic laws that
make another point. It’s one thing for states to fill in the gaps; it’s another
for states to encourage violation of federal law.
 
Winters: it fits in the theme b/c it’s a conversation, but
agrees it’s different.
 
Zettler: FDA does allow compassionate use, so you could
comply with both treatment regs and right to try laws, though the laws are
intended to circumvent FDA rules.  But
not as direct a conflict.
 
Winters: Controlled Substances Act has mostly been enforced
by states; states are refusing to take action, but historically they were the
ones who locked people up for drugs.  So
that’s another difference.
 
Q: gov’t property allocation doesn’t mean there are no 1A
rights.
 
Wang: there has to be a relationship to the gov’t program.
It’s not a direct mapping, but a looser analogy.

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FDLI symposium: John Coates keynote on deconstitutionalizing corporate speech

John Coates, John F. Cogan, Jr. Professor of Law and
Economics, Research Director, Center on the Legal Profession, Harvard Law
School: Re-de-constitutionalizing Corporate & Commercial Speech
 
What I see as a mess in my space is even more of a mess in
your space.  Struck by practitioners who
were candid about some of the directions—ways in which industry is very
deliberately using 1A attacks to unsettle regulation across the board.  Another perspective w/in many large companies
that don’t view what’s going on with total happiness, though they like
particular wins. Undoing entire regulatory space will not make some big
companies happy.
 
1978: Bellotti/Central Hudson: that was first non-expressive
business victory under 1A; emerged very late. 
US was dominant economic power by 1900. 
Business & corporations didn’t need the constitution to achieve
world economic dominance, despite the existence of extensive regulation of
corporate speech.  Pre-founding, we had
contract law (silence = assent); commercial law—assignability of notes; tort
law (fraud, silence); agency law (apparent authority); waiver, estoppel
(liability from speech); antitrust in common law (price-fixing); corporate law
(charter limits on purposes).  Pre-1931: Sherman
Act (speech about prices); Pure Food and Drug Act; state blue sky securities
laws; professional licensing laws. 
Pre-1952: Securities laws; FDCA; Wheeler-Lea Act; pre 1976: Drug
Industry Act; Truth in Lending Act; state consumer protection laws.
 
Business involvement in 1A SCt cases.  First none, then low level of activity
(media); then giant increase, then stabilized in SCt at about 1/2.  Due to Powell, who was corporate lawyer
before he went to SCt/technical and strategic genius in thinking about clients’
interest.  Memo to Chamber of Commerce,
1972: lays out his plan. “Under our const’l system … the judiciary may be the
most important instrucment for social, economic and policital change.” Didn’t
have this memo when they confirmed Powell. 
At odds w/standard conservative fictions about judiciary.  Business 1A cases ramp up when he’s on SCt.
 
Businesses get much higher win rates in cases.  Appeals court citations to Central Hudson
keep increasing.  Different citation
pattern than for Mapp v. Ohio or Roe v. Wade.  What drives this: people who want to disrupt
existing regulatory system to get advantage. Massive amounts of capital are
ready for any company w/a strategy to exploit the 1A for purposes not w/in
contemplation of Founders or those in 1900 etc. 
Among other cases, consider Safelite Group (2d Cir. 2014)—remarkable
factfinding about what’s important to consumers as a way of avoiding Zauderer and using the incredibly
malleable “fit” requirement of Central
Hudson
.  Invites judicial discretion
to be abused. Asking for what we’ve got on DC Circuit, which is a lottery. 
 
Brilliant strategy: no fit b/c we can find some other sugary
drinks you’re not imposing labeling on. 
Requires regulation to be much tougher to survive scrutiny, which is not
generally something businesses would like if the regulation is adopted.
 
Rent-seeking: stealing/deceiving consumers is rent-seeking,
a form of cost that could be better spent on productive uses.  SCt has essentially said that preventing
rent-seeking isn’t a compelling purpose for 1A principles, in IMS v. Sorrell, preventing economic
regulation that enhances social welfare. 
In other cases, anti-rent-seeking becomes justification for applying
stricter scrutiny: in Safelite, court says “we don’t believe what was
articulated as justification; this was essentially protection for established
industry, so we’re going to apply Central
Hudson
.”  This is worse than ordinary
rent seeking b/c it unsettles old policy, delays convergence on new policy.
What’s the current law on off label promotion? 
No one knows.  Suppresses
resolution of difficult policy tradeoffs. Can’t undo constitutional law through
Congress or rewrite statute through FDA—impose burdens on polity that we’re not
up for.  Forces greater restrictions on
liberty to justify lesser. 
 
For business: Encourages investment in litigation and
deception.  Discourages R&D,
reinforced by uncertainty.  Given
scarcity of time, dilutes strategic focus: C-suite can only focus on one or two
things at once.  Simple strategy is
required. Distorts careers in business. 
For society: more rent seeking = more corruption = less investment =
lower growth.
 
Legal options: Constitutional amendments?  Convention? 
What about the current constitution? 
Courts should ok anti-rent seeking as a compelling interest for
legislative and regulatory action. Defer to judgments, contra Safelite, of
those bodies where there’s a risk how it should be regulated.  Recognize that court-generated rentseeking is
a bad consequence of constitutional method. 
Reverse unworkable precedents that didn’t allow anti-rent-seeking moves
by gov’t, such as Bellotti, Central Hudson, Citizens United, and IMS Health,
all of which reversed previous precedents. 
 
In securities regulation, the DC Circuit judges have no
capacity to evaluate the output of the Federal Reserve Board—they don’t know
how to evaluate a change in the capital reserve rule.  The drug industry seems similar.  The idea of relying on drug companies to help
us—that’s not good enough.  Corporations
have no souls to damn/moral claims on free speech.  Citizens United should be decided as it was
for the nonprofit, but that’s b/c members of the nonprofit all have the same
interests in forming the nonprofit. 
Contrast to Chevron: almost everyone in this room is part owner of
Chevron.  Chevron is speaking on our
behalf?  We have no ability to discover
or respond to that speech.  The corporate
structure is not one in which individuals’ speech interests are typically well
represented or vindicated.  Caronia:
salesperson isn’t speaking out of his own individual interest, but to get paid
by his company. 
 
Current trend: Capitalism will completely prevent
established companies from doing business as usual. They will have to invest in
destroying regulation too or they will go bankrupt.
 
RT: is there any room for judicial factfinding? What if we
think the agency is captured?
 
A: the answer to that we had for the first few hundred years
of the republic is political action. Go to legislature, lobby for change.  There will be pockets that survive for a long
time with rentseeking in place.  The
uncertainty created now deters investment across the board, and creates
rent-seeking opportunities of its own.
 
It’s a cross-regulatory problem. My solution requires a
change in the composition of the bench, or a revelation for those on the bench
now.  In the meantime, you have a big
problem, but a bunch of people share it. 
Agency task forces exist to deal w/the constitution everywhere—could try
to coordinate strategies/share intelligence. The FTC’s problem in the Second
Circuit will become the FDA’s problem. 
 
If federal laws fall because of the constitution,
haphazardly, then all the states get to come in, b/c there will be no more
preemption. If you don’t want tort litigation in every state, if regulation
enhances your ability to sell things effectively—FDA’s success is totally
coincident with pharma’s success—then you should be dramatically worried with
return to state level, w/uneven and sometimes very strict regulation.
 
Q: other areas of 1A are different from off-label uses.  Can be used very paternalistically to block
people’s access to genetic information.
 
A: we already do distinguish between levels of scrutiny
depending on the type of speech. I’d be happy to give robust protection to
individuals. But when business interests capture your data, they have a lot
more money to litigate.  1978 was a
robust time for individual speech. 
 
Q: but regulations can restrict ability of clinical labs to
communicate information to individuals—to deliver results to a patient who wants
to hear them.  Regulator says no.
 
A: consumer protection requires difficult tradeoffs, and
courts using the 1A won’t do it well. There are real interests at stake in
getting some of this info.  But those
same organizations also by design have interests in exploiting the ordinary
person’s inability to understand this information without an intermediary.  Another natural outcome of where we’re going:
patch holes at federal level by starting to regulate doctors, and we’re already
starting to do that with health care costs/payors. If individuals on the ground
don’t pay attention, will find themselves victims of unintended consequences.
 
Q: my daughter had a rare disease for which all the
treatments are off label and off patent, but nobody can talk about it.  A lot of people don’t have the ability to
find that truthful information.  It’s
unconstitutional to keep away truthful information about the standard of
care.  Medical standard for drug induced
abortions is different from what FDA has indicated. To prevent people from
learning about information from the source.
 
A: I’m sorry for your family’s suffering. Others will suffer
if the 1A results in a radical cutback of regulation.
 
Q: we’re talking about truthful.
 
A: no, we’re talking about truthful in the eye of one
particular regulator after the fact.  To
enforce the law, the agency has to bring cases. 
If they don’t then there will be people who aren’t deterred.  Nobody reading Caronia could think that the statement at issue was truthful (this
is a very safe drug = 300 people had died). 
These are hard decisions. The question is who should decide. You don’t
like how the FDA does it. That’s cool.  But I don’t want the courts to rewrite drug
policy. That’s the wrong mechanism and the wrong branch.

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FDLI symposium part 2: First Amendment/Commercial Speech

Session 2: Constraints on Commercial Speech and the First
Amendment
 
Moderator: Richard Cleland, Assistant Director, Federal
Trade Commission, Bureau of Consumer Protection
 
Tracing the FTC’s Line Between Advertising and Free Speech
Katie Bond, Senior Associate, Kelley Drye
 
FTC can only go after commercial speech.  A person who works for a company that makes
super-organic kale chips.  Talking on NPR
about healthy lunches for schools; health benefits of kale.  A person who works at a company that makes
lacrosse helmets; takes to Twitter after seeing a story they think grossly
mischaracterizes the concussion-preventing technology.  Commercial speech?  Current FTC approach seems to say yes and
yes, which is concerning.
 
Law on commercial speech: Three main principles: (1) Va. Bd.
of Pharm.: drug price advertising; didn’t need definition, but said in passing
that it is speech that merely proposes a commercial transaction.  (2) Then you started to see advertorial-type
publications.  Egg trade group published
editorials on eggs and heart disease. 
Seventh Circuit: science was a matter of public debate; but yes, it
proposes a commercial transaction at its core, even if it touches on a matter
of public debate.  (3) SCt looks at
protected speech + commercial speech, but not voluntary mixing—state regulation
of charitable fundraisers that required disclosure from professional
fundraisers.  Inextricably intertwined:
can’t regulate as commercial speech.
 
FTC v. POM: FTC didn’t address inextricably
intertwined.  They’ve taken action
against situations similar to the hypos. Went after a company selling green
coffee diet products, with lots of websites/ads, but also an appearance by
company owner on Dr. Oz show.  Didn’t get
inextricably intertwined standard coming in. 
Proposed a commercial transaction, but didn’t address whether that was
inextricably intertwined.  By contrast:
journalist’s editorial questions about Uber & responses that journalist
decided to print are inextricably intertwined, so it’s fully protected speech.
Companies and company employees have a right to comment in matters of public
debate, but the forum in which they can do so may be shrinking given FTC
guidance—media/social media.  Could be a
person who works for a food company, talking about nutrition; employee of
gunmaker who wants to be part of debate on gun violence; ob-gyn who provides
abortions but wants to be part of the debate. Would they still participate if
they thought their spontaneous comments would be treated like commercial
speech?
 
Rebecca Tushnet, Professor, Georgetown University Law Center
 
First note: abortion is different. The reason ob-gyns don’t
talk on camera is (1) death threats, and (2) regular 1A doesn’t apply even to
their noncommercial speech; maybe more protection for them, both physically and
in 1A terms, is the one thing that we can agree on.
 
When discussing commercial speech, I like to discuss the Stevens
concurrence in Central Hudson: Justice
Stevens proposed a functional definition. 
When protecting the consumer transaction, gov’t has very wide scope for
action; when regulating speech to achieve some other objective, like decreasing
violence, it must satisfy stringent standards. 
So the answer to whether many of these scenarios are commercial speech
is properly: it depends on what the gov’t is trying to regulate. If it’s trying
to decrease the amount of shoe shopping by limiting how many shoe ads can run,
no.  If it’s trying to decrease consumer
deception in the market for shoes, then the answer is yes. 
 
Speech standards are not just a one way ratchet, though it
looks like now.  Speech that isn’t even
commercial speech: warranties, contracts, tort liability for failure to
disclose.  If you expand the 1A too
broadly, you get problems.
 
Speech proposing a commercial transaction: far too narrow,
as Court itself has recognized.  Reason
to believe and buy = enough even if there’s no offer that can be completed by
acceptance.  Not just point of sale.
California Supreme Court’s context-based definition in Nike v. Kasky has some
useful features: Because the messages in question were directed by a commercial
speaker to a commercial audience, and because they made representations of fact
about the speaker’s own business operations for the purpose of promoting sales
of its products, we conclude that these messages are commercial speech for purposes of applying state laws barring
false and misleading commercial messages
. 
 
Very few of the paper’s examples, if any, involve  commercial speech inextricable from political
or fully protected speech.  No law of man
or nature requires you to discuss homemaking with selling plastic bins—that’s
the SUNY
v. Fox case
—and equally true that no law of man or nature requires you to
pitch drugs on morning news shows, which is in general fully protected
speech.  The Supreme Court made a special
rule for charities, and that’s understandable because they have to ask for
money to be charities—a better way to
say it is that asking for money isn’t always proposing a commercial
transaction, as we know from political situations.  The inextricably intertwined argument is not
a good fit for profit-seeking companies that sell goods and services.
 
Why worry: Consumers frequently treat advertising as less
credible than editorial content.  Social
proof—people think that a claim is more credible because it comes from another
person or people like them.  This is why
promoters say that word of mouth is the best way to sell—when advertisers
themselves believe that, maybe we should believe them.
 
Newswashing: if you can make your commercial speech
noncommercial by finding a friendly person to repeat it—in return for free
stuff, even—then that’s how many products will be sold.  Video news releases: produced by companies,
often provided to news stations with space so that the station’s own reporter
can introduce the segment.  False claims
in such presentations can do more damage because the consumer doesn’t know that
they are being sold to as opposed to informed.  Also potential for unfairness/anticompetitiveness
if endorsements are allowed without disclosure because only some businesses
have the ability to get this kind of apparently unsolicited coverage.
 
Consider an FTC action not mentioned in the paper, but worth
discussing:
Consumers who tuned in to programs like the Today Show,
Daybreak USA, and local newscasts may have caught interviews with guests billed
as “The Safety Mom,” a home security expert, or a tech expert.  Among the products they reviewed was ADT’s
Pulse Home Monitoring System.  Describing
it as “amazing” or “incredible,” they offered glowing details about its
capabilities, safety benefits, and cost. 
ADT had paid the three spokespersons a total of more than $300,000 and
provided two of them with free systems valued at $4,000 (not to mention free
monthly monitoring) to tout the ADT Pulse Home Monitoring System.   [clip!]
  This is an ad.
 
Especially since the FTC’s baseline here is just disclosure
when the consumer might find the connection with the advertiser to be material,
I think that’s the minimum necessary constraint.  As for knowing when disclosure is required on
social media and similar areas, I don’t think it’s actually that
difficult.  The FTC’s standard is: when
the connection would be material to consumers. 
There’s a tendency among anti-regulatory types to treat consumers like
incredibly savvy lawyers who scrutinize every claim carefully or discount it
heavily, but then to treat the new wave of social media endorsers as fragile
and easily confused.  But—at least when
the endorsers aren’t savvy as the Kardashians—they’re often just like the other
people in their social circles—they find some things intuitive and some things
confusing; they’re neither robots nor children. 
“I got this for free,” for me, falls on the intuitive side of a statement
required by regulation.
 
In terms of chilling effect, I’m unconvinced that having to
tell your endorsers to disclose their connections and having to possess
substantiation for factual claims causes a chill worth caring about.  This is, after all, the standard that must
already be followed in conventional advertising, so if the advertiser wants to
use a different method to make claims, it has to bring those standards with it
to the new advertising method.  If that’s
costly given the nature of the new method, that’s a cost the advertiser simply
must weigh.  After all, the flip side of
the argument is this: if the First Amendment requires us to allow a person to
make unsubstantiated or even untrue factual claims to tout her employer’s
product because she’s speaking on social media, why doesn’t it also require us
to allow those same claims in a paid ad? 
Does it require us to continue to allow her claims when the post goes
viral and 100,000 people see it?  Or: If
a person belongs to a multilevel marketing scheme and pitches her friends and
family to buy from her, should we not call that commercial speech because it’s
individualized? 
 
Call for ever-more-elaborate standards to deal with ever
more intricate scenarios invites gaming and evasion; FTC FAQs seem pretty
sensible to me, covering common situations and trying to teach advertisers how
to think about the next situation that pops up. 
There might be room for more FAQs as we go on, but the basic approach is
sound.
 
Bond: there is room to do both—loosen up and allow
legitimate public debate and go after fraudsters hawking wares through Dr. Oz.
 
The Promotion of Medical Products in the 21st Century
R. Alta Charo, Warren P. Knowles Professor of Law &
Bioethics School of Law, and Dept of Medical History & Bioethics,
University of Wisconsin
 
A long history of flimflam that did harm.  Overpromising of remedies, sometimes to the
detriment of other things that might have worked better. Sexuality, obesity,
bowel movements; many of the patent medicines contained cocaine, heroin, or
alcohol, so you felt better but didn’t get better. Some were genuinely
dangerous; “snake oil” really did exist. 
That is still with us.  Dietary
supplement industry: homeopathy, constipation remedy that’s 40% alcohol:
problem for alcoholics, teens—not something you necessarily check for on the
label.
 
Fraud: had to prove intent; hard to get a handle on things
before people were injured. 100s of deaths from “elixir of sulfanilamide”—because
victims were children and because this was at the time of the rise of the
regulatory state, had to at least prove safety (which is a relative issue: safe
for what?).  Still fraud-based; there’s
an implicit representation that a product is fit for purpose, and if it’s
unsafe that’s misbranding. 
 
Thalidomide: prescribed offlabel during pregnancy.  US was the only one w/o this scourge b/c
Frances Kelsey, FDA, didn’t feel that the safety data were sufficient.  For a long time, she was celebrated for this—led
to a cautious approach, demanding high levels of proof for clinical trials. We
prided ourselves on not being fast and careless. We now have a whiplash
problem: FDA told that it’s alternately going too slow or too fast.  Laetrile for cancer; HIV treatments for
HIV.  Now there are unexpected problems
in postmarket period: nonsteroidal anti-inflammatories like Vioxx or diabetes/Avandia;
now we’ve forgotten about those and demanded more speed. This is a repeated
pattern. Reactive to latest tragedy; frustrating but real.
 
Against this backdrop, offlabel promotion: we’ve watched
expansion of protections for commercial speech and corporate speech in other
contexts.  Now companies can take
advantage of safe harbors; respond to questions; distribute reprints (including
with risk assessments that differ from FDA’s). 
Previously: had to prove to independent arbitrator, FDA, that
risk/benefit profile was sufficient to justify approval before you could
promote the drug for that purpose.  Otherwise,
could be used but not promoted.  Burden
of proof problem.
 
Which brings us to Amarin:
Amarin had a statement that was really a nonstatement: truthiness: supportive
but not conclusive research shows that consumption may reduce the risk of heart
disease. How could that statement be falsified? 
Its only purpose is to suggest reduction in heart disease even though
the evidence before the FDA suggested the opposite—that there was no reduction.
They do that to get doctors to prescribe offlabel. That’s a statement about intended
use.  Even if there’s a single study,
that doesn’t take account of the other studies that show the opposite.  That’s a misleading omission.

What will be the incentive for anyone to prove safeness & effectiveness for
secondary/tertiary uses? You take away the economic theory behind the way we
regulate drugs to encourage research. 
There’s no logical stopping point: we might end up with postmarket
remedies only/even a requirement of intent to deceive. 
 
Subtle genetic/environmental components to disease are now
being targeted; any component could be targeted by promotion but could still be
highly misleading. It’s time to contextualize 1A against public health
consequences of abandoning what worked well since Kelsey saved us from limbless
children.
 
Discussant: Coleen Klasmeier, Partner, Sidley Austin
Shift of responsibility from FDA to courts seems to be
ongoing; paper argues that this will result in less use of evidence &
corresponding negative impacts on public health.  How confident are we that clinical decisions
are in fact currently based on the evidence that’s permitted by FDA? The way
that clinical decisions occur isn’t the way the reg scheme seems to assume.
Doctors don’t look at the FDA approved labeling and make decision; much
messier, heterogeneous sources.  A lot of
those sources are based on standards of evidence that probably wouldn’t pass
muster if FDA were to evaluate them. What’s our level of confidence/certainty
that current decisions are effective?
 
How confident can we be that outcomes have improved in the
years since FDA/DOJ began aggressively policing drug & medical device
information?  There was a period in the
1990s of more aggressive interpretation of statutory authority; less
comprehensive in 1980s.  Continuing
education moves in 1990s were more ambitious: are we better off?  Given how ubiquitous information is, does it
even make sense to look back at horse and buggy days?  [Um, given that vaccination levels are
dropping to lows not seen in decades, I’ll go with yes.]  Of course we shouldn’t make important policy
decisions in a vacuum, but is that the right context to inform the policy decision?  We have extensive provisions for mandatory
posting of certain details on clinicaltrials.gov; lots of transparency mandates
that are self- or government-enforced. 
Companies have to reveal their clinical data pretty quickly.  [But if the 1A applies fully, that won’t be
true.] Patients and payors also require real-time data; old-school assumption
that info will be scrubbed and censored by the gov’t. Old-fashioned to say that
some sources of information are allowed and others aren’t. Sorrell: that speaker discrimination isn’t ok under current
law.  Public discussion carries a
responsibility to be authentic: a fuzzy concept: better have your facts
straight.  Gov’t shouldn’t need to
preapprove.
 
“FDA doesn’t regulate practice of medicine”: no longer true
b/c of expanded drug safety authority, as well as growth hormone and device
authority.  Pretty clear that FDA has a
big legal problem on its hands b/c off-label use is legal.  If the gov’t continues to permit the conduct,
then how can you ban the speech about that conduct? Doesn’t make sense, amounts
to a constitutional pathology. 
 
Historical article doesn’t wrestle with constitutional
issues—courts are supposed to wrestle with constitutional issues.  Even in Caronia
and Amarin, gov’t conceded that the
statements were truthful and nonmisleading (though that may not have been true
in Caronia)—if true, the case law
would be hard to wrestle with.  Mature
regulatory scheme is on collision course with 1A, and the gov’t is not winning.
 
Options available to the gov’t: should talk about which
option we will use.  What will we do
next? Rather than saying we should maintain the status quo.
 
Charo: How confident we are that doctors use FDA info? As a
matter of policy, the fact they’re using info of varying levels of quality
doesn’t mean we should eliminate the best quality info.  How confident about health claims?  Well, compare health supplement industry—a variety
of things that are useless or affirmatively harmful—and now we’re talking about
going down to that standard for pharmaceuticals! 
 
Are we going to require each doctor to be academic reviewer,
looking for methodologies, hidden conflicts of interest, etc.?  That would further destroy the practice of
information. Nothing stops people from getting realtime information. We want
one really credible, independently verified source of info, so people aren’t
always trying to evaluate the speaker and the source for chemo drugs. 
 
At the center: what is it that constitutes misleading? That’s
a huge gray zone. That nonstatement is viewed as nonmisleading b/c it’s so
empty. But the court in Amarin tried
to rewrite the FDA’s own language.  The
FDA wanted to say “the available evidence doesn’t show …” the court said that
you couldn’t say that b/c it implied that the evidence showed otherwise. Forces
you to rely on the court’s view of the evidence—costly as well as wrong.  That worries me. [Me too!  Innumeracy is a huge problem in courts,
including In re Pearson.]
 
Cleland: Should Amarin finish its trial, if these claims are
currently blessed by the court? What if the trial comes out badly?
 
Klasmeier: Amarin affirmed that it was continuing on with
the study. Broader question of incentives in view of entitlement to make
qualified claims: this concern that research endeavor will be gutted is
overblown; there are lots of reasons other than regulatory approval to do these
studies. Payors drive clinical decisions and payors want data. There’s also
value in demonstrating to regulator your entitlement to make a claim.  [Ah, but which regulator? The court or the
FDA?]  These cases should be troubling to
people who care about FDA regulation, but they don’t represent what the
established players are doing.  [Neither
did the dietary supplement industry; neither did Google represent what
newspapers were doing.]  They want the
FDA to remain relevant.
 
Cleland: I’m not sure the battle will be decided by the core
of the industry. The outliers will want to drive stakes into the heart of the
regulation.
 
Klasmeier: that may be. But you’ll always have that challenge
no matter what improvements you make. [Unless you uphold the scheme.] Would
rather try to improve 1A and 5A treatment [5A!] by FDA.
 
Charo: Hope you’re right, but we already are seeing
disturbing indications in light of the fact that most research isn’t definitive
for a long time. Worlds of opportunities for selective reporting.  Genetic testing: tried to market tests for
indications that were absolutely not proven, but claimed to be relevant to
clinical outcome.  Tempted to use
incomplete indicators; as long as someone can say there’s one study that says
the product might be useful, we’ll have this promotion problem and
consumers/drs are not in a good position to evaluate that.
 
Cleland: Postmarket surveillance as an option?
 
Klasmeier: one of the options, but not the core industry’s
choice.  Industry position is docketed
w/FDA. More finely reticulated regulatory scheme, more responsive to different
stakeholders, w/central role for FDA.  Nobody
that I know is talking about taking FDA approved labeling out of the mix of
info available to doctors.  We’re talking
about data from Phase III clinical studies of a new use of an oncology drug,
where FDA hasn’t yet received the supplemental application but the data results
are published; or where NIH does a study of every atypical antipsychotic.
 
Charo: but those can already be distributed.
 
Klasmeier: you’re lumping everything into the category of
offlabel marketing, though the FDA does distinguish offlabel promotion from
permissible information of offlabel info. 
Standards aren’t clear enough about whether your speeck is on the OK
side of the line. The Justice Dep’t is also running around with FDCA theories
of liability that don’t always accord with what FDA says.  E.g., FDA just proposed a rule saying that
knowledge of offlabel use isn’t enough, but Justice is prosecuting someone
right now on that theory.  Together, a
huge incentive for self-censor. A ton of thoughtfully presented information
w/robust data sources, sometimes important to reinforce FDA labeling, not
getting out there.  We’re not talking
about flimflam.
 
Q: offlabel marketing to doctors/consumers.  Even more problematic to market to
consumers?  Dr serves as intermediary but
marketing to consumers still has effect.
 
Charo: The rules are different b/c of the absence of dr as
intermediary.  Another avenue of
analysis. Consumer isn’t even arguably in position to act as arbiter.  There is a real distinction in how ads to
consumers are done.   We do know DTC ads work to get consumers to
ask, and the structure of medical services means that doctors, given a choice
of what patient wants and what doctor might have prescribed, is likely to say “sure.”
 
Klasmeier: TV ads are very responsible—tell you to contact
your doctor. Harnessed by the FDA as additional information source to
patients.  Celebrex: when it came back
after the COX-2 scandal, the DTC ad was 2 minutes long, full of contextual
claims. That product still does some people good.
 
Q: would it be legally defensible to have a listener based
restriction?  Amarin: P said it was going to doctor w/its message.
 
Klasmeier: wouldn’t be defensible to go to consumers.
Industry recognizes that “it’s just different” practically and politically if
not legally. I’m personally uncomfortable with that distinction.  Anyone who has a kid knows they have to be a
savvy consumer.  Doesn’t feel right that
I can’t get all the information. 
[Lochner! Smart people will do well, sorry about the rest of you.]
 
Charo: Doctor adds a safety factors to otherwise dangerous
drugs.
 
RT: Strict/heightened scrutiny is not “is this good policy.”  That is one reason why the core industry will
not set the rules if we get Sorrell.  It is very difficult to imagine how the
Amarin standard would allow restrictions on DTC to stand.
 
Klasmeier: No one’s talking about Lochnerizing the First
Amendment.  [Other than some of the
panelists on panel 1, but ok.]

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FDLI symposium on constitutional challenges to FDA

FDLI Symposium: Constitutional Challenges to FDA Law &
Regulation
 
Session 1:  Compelled
Speech
Moderator: Allison Zieve, Director, Public Citizen
Litigation Group, Vice-Chair, FDLI
 
First Amendment Limits on Compulsory Labeling
Nigel Barrella, Sole Practitioner, Washington DC
 
Review of commercial speech doctrine. Product labels are
commercial: propose a transaction.  Other
FDA “labeling”?  Labeling not sold direct
to consumers, such as Rx drugs, vaccines? 
Package inserts?  Medical
literature? (Caronia, Amarin case finding that it was unconstitutional to
regulate off-label promotion by the manufacturer.) 
 
DC Circuit’s rejection of tobacco images trying to promote
an emotional response; 6th Circuit pointed out that facts can
provoke emotions, but that doesn’t make them opinions.
 
Ongoing dispute: what does “uncontroversial” mean?  At a minimum, controversial can’t mean that
someone was willing to sue.
 
Ongoing cases: genetic engineering compulsory labeling for
foods; on appeal in 2d Cir.  Argument:
topic is simply too controversial for labeling. Vt. says the test is whether
the disclosure is factual, not opinion-based, not reasonably disputable.  Abortion regulations provide precedent for
saying that extremely controversial subject matter can’t be subject to
labeling, no matter how true it is.  If
that’s the test, though, then tobacco labeling shouldn’t have been allowed;
total fat etc. labeling shouldn’t be allowed.
 
Some cases suggest you can’t tell consumers what to do: “try
to quit smoking.”  But what about “Surgeon
General’s Warning”?  What about “This
statement hasn’t been evaluated by the FDA”?
 
Future of Zauderer: uncontroversial seems to be gravitating
to being fact-based; can’t tell consumers what to do but can provide them with
consensus.  Substantial interest in
things other than preventing deception as justification for disclosure?
 
Discussant: Bert Rein, Founding Partner, Wiley Rein
 
Zauderer: easy cases make bad law.  Deceptive by omission. If the alternatives
are ban or cure with disclosure, disclosure is what makes sense.  Listerine remedy case: disclosure that it
doesn’t kill germs corrects the falsehood you’ve been disseminating. 
 
Safety warnings: state’s interest is truth in market/health
and safety of consumers. That’s a reasonable interest, and the temptation is to
say “why not”?  Why not poison,
electrical hazard, flammability warning—state has a compelling interest no
matter what standard you apply. 
[Hunh?  Why isn’t public education
a less restrictive alternative?]  But you
can’t use that foundation of health, safety, fairness to go beyond and start
expressing opinions.   Also important to have standardized ways of
defining terms, like “gallons” or the names of foods—fairness/fair choice is an
important interest.  Another interest:
state using compelled speech to carry out a regulatory regime.  Labeling on OTC drugs—comprehensive responsibility
to take care of health and safety in drugs. 
Regulatory interest can be very important, and as part of that it may
need to regulate labeling.  That is a
generally recognized legit interest, but what is the limit on that?  44 Liquormart and compounding cases: you can
use speech regulation as part of a regulatory regime, but only as a last
resort.  Is this essential/can’t be done
another way?  Is it a reasonable advancement
of the interest the gov’t is serving?
 
The AMI case is therefore wrong.  There is no general regime governing safety
[of meat?].  Same with SEC disclosure of
conflict minerals—no relation to the overall regime.  [What counts as a general regime?]  Parsing the conflict minerals disclosure is itself
very difficult.
 
Suppose the gov’t was worried that people were ignoring
Christmas.  Could the gov’t require all
food sold in November to say “remember Xmas is coming on Dec. 25th”?  [No, because of the Establishment Clause, not
b/c of a general restriction on gov’t position-taking.]  That’s inconsistent w/1st
Amendment b/c inconsistent of your right to determine what you want to say,
though it’s truthful and beyond dispute (unless you are Greek Orthodox).  [Wow, where to start.  Okay: let me just say that the “you” is an
important issue here.  Does the
commercial speaker have interests of its own, or just interests in informing
consumers?]  Gov’t shouldn’t instruct
people what to buy.  State has no legit
interest in telling you (food seller) to put that message on food.  If the state can require GMO disclosure, then
it can also require you to disclose that there’s no benefit to GM-free food
that’s been shown.  [Yes, I believe that’s
the teaching of the modern understanding post-Lochner: the legislature in general gets to make these calls.  I’m not clear on why that’s the troublesome
outcome of the slippery slope.]
 
Authors: You Want a Warning with That? Sugar-Sweetened
Beverage Warnings and the Constitution
Sabrina Adler, ChangeLab Solutions, Oakland, CA (co-authored)
 
Increase in obesity; 135% increase in calorie intake from
sugar-sweetened beverage, half of Americans over age 2 drink at least one a
day. 63% of HS students.  Connection
between liquid sugar consumption and greater health problems v. solid
food.  Safety warning issues?  First Amendment, preemption under NLEA, and
dormant commerce clause.
 
Paper argues that the science justifies special treatment
for SSBs, and thus that warnings should be analyzed under Zauderer.  Current agreement
under courts of appeals: Zauderer is
not limited to the potential for consumer deception, but can extend to the
protection of public health.  Even if
substantial interest is required, health is such an interest.  No disclosure has ever been struck down under
Zauderer.
 
However, the evidence that labels decrease consumption (much less improve health outcomes) is weaker
than the evidence that labels increase
awareness
of the risk.  Would be at
risk if strict scrutiny were applied; there are less restrictive means of
conveying the info such as public education.  (Or we could, you know, ban SSBs without
running afoul of the First Amendment.) 
What about the possibility of gov’t speech?  Forcing message on someone else’s label—boundaries
have not been spelled out, but most proposed labels do attribute message to the
gov’t.
 
NLEA has express preemption, no implied preemption.  No definition of what constitutes “nutrition
labeling.”  They argue that it should
mean the quantitative info required on the label, not qualitative info.  Thus shouldn’t be preempted by nutrition
labeling.  Nutrient claim/Health claim:
relationship between ingredient and health conditions. This is technically what
an SSB warning would do. But we argue that “claims” refers to positive
statements made by producers to increase sales—that was what Congress was
concern about.  Regs specify a list of
permissible health claims, and they’re all positive.  Safety warning exception to preemption?  Lactose (not a warning); BPA in baby bottles
(FDA specifically exempted from labeling regulation, and thus warning exception
couldn’t apply); coloring in colas that California added to Prop. 65/potential
carcinogen list (FDA specifically found it to be GRAS/generally recognized it
as safe—court found that unrelated to labeling, but predicate to labeling; thus
this type of warning shouldn’t be preempted and was subject to safety warning
exception to preemption).
 
Stuart Pape, Shareholder, Polsinelli
First Amendment never came up in the 1970s at the FDA—pre Virginia Pharmacy.  Doesn’t envy the task now.  How do you make sense out of current doctrine
combined with regulations that have been around for decades?  How do you advise a client? The principles
aren’t clear enough.
 
If SSB warning has to be on 20% of billboard/other ads, how
does that work?  It’s not scientifically
apparent that two products—12 oz. of 100% organic apple juice, which SF favors
b/c it’s not regulated, and equivalent amount of cola, which does get regulated—are
different; the apple juice even has more calories. So how does the city
conclude there’s clear evidence that one product should get a warning and the
other shouldn’t?  That is part of what
makes the warning constitutional.  FDA is
currently considering an “added sugars” line on the nutrition panel, and
establish a daily reference value.  But
the evidence to support that is weak/unscientifically justified, according to
past FDA heads. If there’s serious controversy over mere disclosure of
amount/reference point that’s subject to the warning, the warning itself is
controversial—singles out one type of beverage and forces them to say “this is
a bad product.”
 
Court rejected disclosure about radiation from cellphones
for similar reasons. 
 
Also hard to demonstrate substantial interest b/c you require
warnings for some things/not other things (the apple juice)—swiss cheese
approach makes it harder to defend. 
Also, it’s just an opinion: we have to do something about obesity; the
scientific evidence about health f/x is compelling (he thinks both of these are
opinions).
 
Discussion among panelists: anti-regulationists say alcohol
label may be ok b/c of the scientific evidence that it is really bad, not like other things, which is an interesting thing to
be assessing under First Amendment standards.
 
Pape: Amarin case: the court observes that the entire
premarket approval system for pharma is at risk under current standards. While
pharma industry would like more freedom to communicate w/doctors, they’re not
looking to have a system in which pharma reg is more like dietary supplement
reg, which is a free for all. Bears watching. 
(Careful what you wish for?  The
First Amendment doesn’t enact Mr. Herbert Spencer’s Social Statics, and neither
does it enact Bayer’s wishlist.  Welcome
to your new competitor, GNC.)
 
Zieve: Congress, in response to health tragedies, organized
the regulatory structure: illegal until approved, and then approved only for
conditions it’s safe and effective for according
to FDA
. FDA doesn’t regulate the practice of medicine; FDA’s authority is
only over manufacturers. If you promote it for an unapproved use, that’s
illegal.
 
Rein: asymmetry: unlawful to tout, but lawful to use—that doesn’t
work.
 
Zieve: but the doctor isn’t engaging in off-label promotion.
 
Rein: what bothered ct in Amarin was that the manufacturer was disseminating information
based on well-controlled studies. If studies had been done by independent third
parties, would have been able to disseminate them.  May have promotional effect, but is
scientific speech. Disparity of regulation/intervention.  Nike v.
Kasky
: the same asymmetry.  [No, a different
one.]  Kasky is regulated only by
defamation standard when he says Nike uses child labor; Nike’s speech is
commercial when it denies it does.
 
Zieve: In your remarks before you mentioned a valid warning
as integral to regulatory process—so did you actually mean that?  Vt. did a study showing 90% of consumers
wanted to know whether the food they bought had GMO ingredients—would that
matter?
 
Barrella: the whole reason that we extended protection to
commercial speech was consumers’ interest in getting truthful information.  DC Circuit en banc did say that consumer
interest was substantial interest in itself for country of origin information.
 
Rein: overwhelming support is poor indicator of
constitutionality; NH residents “overwhelmingly supported” putting “Live Free
or Die” on license plates.
 
Zieve: Facts/opinion?
 
Adler: commercial speech also makes a difference from Live
Free or Die.
 
Q: What about the standards of identity?  Hampton Creek’s “Just Mayo”—barred on
standards of identity, which is integral to a regulatory process, but what’s
the compelling interest in saying you can’t label your product “Just Mayo” just
because it isn’t mayo according to the standards of identity. 
 
Barrella: it’s a Central Hudson question. 
 
Zieve: this is false and deceptive advertising. People think
mayo means a certain thing; it’s like calling Coke orange juice.  Standard of identity makes the deception
stronger, but calling it just mayo divorces “mayonnaise” from its meaning.
 
Pape: maybe historically people knew what mayo was; standard
of identity developed b/c producers were making things that people had once
made at home. Congress wanted consumer to be able to go to store and pick up
what he/she would have previously made in the kitchen. The standards of
identity are definitions.  “Cheese food.”  It’s not cheese.  Signal that it’s not cheese. Same thing with
mayo. There is something called “mayonnaise dressing”: like mayo, but not.  Interesting to consider whether standards of
identity are now vulnerable to the First Amendment.  [Yeah, interesting’s one word.]
 
Q: soy milk = milk? 
Industry was laughed out—why isn’t this the same question?  Soy milk has an ingredient list.
 
Zieve: why would you read the ingredient list?  Soy milk isn’t called “just milk.”
 
Rein: State puts up these markers to provide a basis for
comparison in the marketplace. It’s meaningless unless it’s enforced. If std of
identity for mayo is legit exercise of gov’t power, enforcement is ancillary to
that fundamental Q.
 
Q: where in the First Amendment analysis do we deal with
false/misleading speech, trademark, Lanham Act?
 
Barrella: that’s just outside the First Amendment.
 
Adler: there may be affirmative misrepresentations in our
areas, but we’re more worried here about a lack of information.  Slightly different issue.
 
Rien: Zauderer is
a case of fraud by omission.
 
Zieve: Also consider influence of POM v. FTC, where DC Circuit said that a 2 clinical trial standard
was too onerous.  Pom says that if it has
one study, it can make those claims, even if other studies show no effect. Can
drug companies take advantage of this? 
Keep watching—cert petition just filed.

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Transformative work of the day, Pom Wonderful/Halloween edition

Crafty blogger Cat has created an excellent Halloween costume (more pictures at link):

Her purse is a repurposed Pom Wonderful bottle.  Are there possible confusion claims?

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Today’s unauthorized uses

From pictures I have taken around town.

Just Hike It T-shirt

May the Forest Be With You Shenandoah National Park T-shirt

Am I the only one who sees the Amazon smile in this ad?

“Walkens welcome” sign to attract walk-in customers

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Les 1201 exemptions nouvelles sont arrivees: remixers get Blu-Ray

Rulemaking here.  As Jon Band says, people who got organized got much of what they asked for, albeit hemmed in by pointless restrictions, but people who weren’t aggressively represented by groups willing to spend countless hours on this process didn’t.

Edited because it’s been a long time since French class and also I was running from class.

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Annotating competitor’s ad is fair use

Miller UK Ltd. v. Caterpillar Inc., No. 10-cv-03770 (N.D.
Ill. Oct. 21, 2015)
 
Miller sued Caterpillar for breach of a contractual
restriction on the use of Miller’s confidential information, for trade secret misappropriation,
and for fraudulent inducement. Caterpillar counterclaimed for breach of
contract, defamation, disparagement, tortious interference, false advertising,
and copyright infringement. Most interesting: the court granted summary
judgment on the copyright claim because an annotated copy of a Caterpillar ad
was fair use.
 
Miller “made a coupler that allowed earthmover and excavator
vehicles to attach shovels, buckets, and other attachments to their mechanical
arms quickly without requiring the vehicle operator to leave its cab.”  It entered into a supply agreement with Caterpillar
to make couplers that Caterpillar sold under its own name. Caterpillar allegedly
used proprietary information about the coupler to make its own version and then
terminated the supply agreement. After Miller sued, Caterpillar distributed a
brochure to equipment dealers that compared its new coupler favorably to other
couplers.  
 
Miller replied with its own communication package, including
a letter from Miller’s chairman claiming that the Caterpillar coupler was
potentially unsafe because it lacked a mechanical backup.  The accompanying video showed the failure of
a coupler connection, the dropping of a bucket, and the decapitation of a
hard-hat wearing life-sized dummy. There was also a document that purported to
be a third party safety test of the Caterpillar coupler, and an annotated copy
of the Caterpillar coupler brochure, highlighting Miller’s assessment of the
competitive and safety deficiencies of the Caterpillar coupler.
 
Copyright: Market effect is the most important factor. Kienitz
v. Sconnie Nation LLC, 766 F.3d 756, 758 (7th Cir. 2014).  Miller’s annotated version of Caterpillar’s
brochure had no effect on the value of the brochure,
as opposed to the value of the product touted by the brochure.  Plus, negative impact on the value of a work
by convincing the audience that the work is no good is not harm for purposes of
copyright.  Thus, the first factor (?)
weighed in favor of fair use.  “[T]he
commercial value to Miller and any resulting decline in the commercial value of
the original work resulted not from the value of the original, but from the
Miller additions. Such uses are not considered substitutes for the original
work and are encouraged by the fair use doctrine.” The nature of the work—an
ad—didn’t favor Caterpillar, though the wholesale copying did.  Without separately analyzing factor four, the
court found that the annotated brochure was fair use as a matter of law.
 
The disparagement, defamation, consumer fraud, and false
advertising claims against Miller survived because the truth or falsity of
Miller’s statements that Caterpillar’s coupler posed safety risks was not
resolvable on summary judgment. 
Moreover, Caterpillar showed that Miller’s package caused it to take
steps to mitigating the impact on customers, and its expenses were recoupable
as damages.  Therefore, Caterpillar
didn’t need to show lost sales or profits. 
Mitigation expenses also counted as special damage for defamation
purposes.  Miller allegedly said that
Caterpillar made an unsafe product, which would count as incompetence in
business, which could be per se defamatory.

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Registration symposium at William & Mary, part 2

Rebecca Tushnet: And
now for something different!  I’ve been
asked to speak about the implications of the Pro-Football case and decisions
made by the courts with regards to the trademark process and freedom of speech.  Thanks to Fred Schauer and Mark Tushnet for
illuminating discussions, and to William & Mary students for the
opportunity to talk about these important issues. I’ve been trying to work
through them and I caution that my conclusions are necessarily tentative at
this point.
 
All or almost all of
the §2 bars are also reasons that the courts will refuse to protect a claimed
trademark under §43 of the Lanham Act, which provides trademark protection for
unregistered marks.  These reasons
include: the claimed matter is functional, meaning it affects the cost or
quality of the product or service; the claimed matter is merely descriptive, meaning
that consumers don’t understand that it indicates source and instead think that
it just describes some characteristic of the product; the claimed matter is
deceptively misdescriptive, which is like descriptiveness except not true; the
claimed matter is deceptive; the claimed matter is confusingly similar to an
existing registered mark or mark in use in the US; the claimed matter is the
name, photo or signature of a living person and there’s no written consent from
that person to register the mark; the claimed matter is the flag or insignia of
a nation or state or other US political subdivision; the claimed matter creates
a false association with people or institutions; and last but not least, the
claimed matter is scandalous, immoral, or disparaging.
 
The constitutionality
of § 2(a) is now in question because of some high-profile cases.  From the First Amendment side, we have Reed v. Town of Gilbert: last Term’s
sign case in which the Supreme Court struck down a city’s sign regulations on
the theory that they were content-based and didn’t survive strict
scrutiny.  The rule suggested, though
it’s not clear whether it will actually apply this broadly, is that all state
regulations of speech that depend on an evaluation of the content of the speech
to determine whether the regulation has been violated are content-based and
must survive strict scrutiny.  Section 2(a)
is nothing but content-based (with a possible exception to be discussed in a
bit). 
 
Meanwhile, we have
the cases Professor Farley discussed, so the collision with trademark law seems
imminent.  It’s possible to argue that
trademark is a First Amendment-free zone, as copyright basically is except for
the internal restraints of the fact/expression division and fair use, but that
argument seems unlikely to prevail as easily with trademark and trademark
registration, neither of which are mentioned in the Constitution and the latter
of which confers rights unknown at common law.
 
A brief review of
the justifications usually given for the exclusions for marks that are scandalous
or disparaging: (1) the harm done by the government endorsement represented by
a registration; (2) the desire to withhold government resources from
disparaging or scandalous terms; (3) the lack of any effect on a user’s ability or right to use the mark, with (a) possible §43(a) or state common law
protection against confusing uses despite unregistrability, though this is not
at all certain, or (b) even if there’s no protection against confusing uses by
other people, there’s still nothing stopping anyone from using a disparaging
term on a T-shirt (at least if they’re not going to a public school) and thus
there is no government harm inflicted on them. 
 
Justification (1) very
much depends on public understanding. 
Confederate Veterans license plate case from last Term allowed a state
government to decline to approve a Confederate Veterans logo for personalized
license plates even though it approved a large number of other specialized
license plates.  The Court ruled that the
plate design constituted governmental speech, and thus the government was not
bound to neutrality in its decisions.
 
If registration is
the government’s agreement that a term is appropriate for federal registration,
equivalent to the government’s agreement that a term is appropriate for
placement on a license plate, then there is no problem with refusing the
registration. This is the reasoning recently adopted by the district judge
deciding the Washington football team’s case. 
But do people actually understand the difference between the ® symbol, the
TM symbol, and nothing?  The Supreme
Court didn’t exactly look for empirical evidence in the Confederate Veterans
case!  The dissent argued that, given how
many different license plates are approved, no one could reasonably perceive a
government endorsement; that’s even more true for trademark registrations—the government
couldn’t possibly be both an Apple Mac and a Windows PC, or a UVa alum and a
William & Mary alum.  But that’s
oversimplifying—the government could
express an opinion about what the boundaries of tolerable public discourse are;
allowing a particular plate, or a particular mark, expresses only the opinion
that it’s tolerable, without saying that it’s correct.
 
There’s a related
body of law of some possible relevance: the establishment clause cases, in
which Justice O’Connor developed a line of reasoning that the question of
whether government endorsed religion with some action had to be assessed from
an objective perspective, assuming a person with reasonable levels of
historical knowledge/understanding. 
Anyone to whom the difference between registration and trademark
protection is explained can usually grasp it very easily. Given that fact, by
analogy §2(a) is if anything an easier case than Confederate Veterans.
 
Justification (2) doesn’t
work, because it takes a lot of resources to enforce §2(a).  Also, if §43(a) remains available, then government
resources are still being devoted to protecting such marks, perhaps even more resources, insofar as there is no
more presumption of validity under §43 as there is for a registered mark and
therefore an inquiry into protectability must be made in each case.
 
Justification (3) is
the most interesting to me.  (3)(a) is
unsatisfying to anyone.  There are
significant differences between the benefits of registered and unregistered
marks—nationwide scope, presumption of validity/incontestability after 5 years,
the ability to use a US registration to secure rights under foreign
registration systems, the ability to invoke counterfeiting laws.  If that harm is acceptable, then it should
also be acceptable to impose the further harm of not providing any protection
against confusing uses at all.  So, to
me, this reduces to a question of unconstitutional conditions: does the government
violate the First Amendment by refusing to protect certain marks because of
their content?
 
And asked that way,
it’s clear this challenge opens up numerous cans of worms.  All of the exclusions in §2 are
content-based.  Let’s assume they only
operate on commercial speech (though this is not necessarily true).  Full understanding now requires a brief
excursion into commercial speech doctrine, the centerpiece of which is the Central Hudson rule. Under Central Hudson, false or misleading
commercial speech may be banned. 
Regulations of truthful, nonmisleading commercial speech, however, must actually
serve a substantial government interest and be no more restrictive than
necessary to serve that interest, though this is not a requirement to use the
least restrictive alternative.
 
Assuming that §2
only operates on commercial speech, then, we still face a division between
false/misleading speech and other commercial speech.  Since false and misleading commercial speech
can just be banned, there’s no doubt that the government can refuse to support
it.  Bans on other commercial speech must
survive Central Hudson. But
wait!  There’s also mandatory disclosure
law.  If the government is not suppressing commercial speech, but
rather requiring disclosures, the Zauderer
line of cases becomes relevant.  Zauderer involved attorney advertising
that told laypeople that if the lawyer lost their case, there’d be no fee.  The Supreme Court held that the state could
require an additional disclosure
clarifying that fees and costs were different things and that, if they lost,
they’d still be liable for costs. The Court did not require the mandatory
disclosure to satisfy Central Hudson,
but applied something like rational basis review—as long as the required disclosure
was truthful and noncontroversial, and not unduly burdensome, it was
constitutional.
 
A refusal to provide
trademark protection is arguably much more like requiring disclosures—it may
create an economic burden and thus a possible disincentive for the speech, but
it doesn’t suppress that speech directly—than like a direct ban. However, lower
courts are not in agreement about whether Zauderer
only applies when the government is requiring disclosures to correct
misinformation, versus when it is requiring disclosures to provide useful
information. 
 
Take the broad view
of Zauderer—such burdens on
commercial speech are allowed when the government is requiring disclosure of
truthful, noncontroversial information that isn’t unduly burdensome, even
though it is targeting particular content for the required disclosure.  Do the 2(a) bars look anything like that? 
 
(1) Is the government
determination about being scandalous/disparaging truthful and
noncontroversial?  A weak point—this may
not be an answerable question.  There is
probably some reasonably objective truth about whether a substantial proportion
of the general public, or the targeted group, finds the mark outrageous or
disparaging, respectively.  If we are
confident in the PTO’s factfinding ability, then at least some scandalousness
and disparagement determinations—say, the c-word and the n-word—are probably
truthful and noncontroversial.  Since
failure to protect isn’t itself a disclosure, it might not need to be
noncontroversial—the Court’s concern seems to have been for forcing commercial
speakers to put out ideological messages they didn’t agree with.  That concern would be completely irrelevant
for a refusal to register.  But what it
means for a determination to be noncontroversial is, of course, itself highly
contestable.  The very fact of a
litigated challenge might seem to suggest that a disclosure—or a bar to
registration—is controversial; the Supreme Court has not been very helpful in
identifying what it meant by that term. 
 
(2) Even if we find
a disparagement determination to be truthful and noncontroversial, is it unduly
burdensome to deny TM registration or, in its entirety, TM protection?  I don’t think this Q can be answered except
normatively—this isn’t like a disclosure that takes three minutes to recite
when most ads are only 30 seconds long. 
(3) Suppose we decide that we do need to get rid of scandalousness/disparagement
registration bars because they don’t meet a Zauderer-like
standard.  What of the remaining
exclusions? This question can be fruitfully grouped with the next issue:
 
Take the narrow view
of Zauderer—such burdens are only
allowed when there’s some relationship to preventing deception.  Once we thereby get rid of
scandalousness/disparagement, there are other §2 bars whose constitutionality
remains to be addressed. 
 
(1) Which are at
least arguably related to consumer deception? 
Well, deceptive marks, pretty obviously—though the fact that refusing
registration doesn’t stop the use of
the mark to deceive people might be a problem of insufficient tailoring.  Marks that create a false association with
persons, institutions, etc. Geographically deceptively misdescriptive marks,
ok.  Name, picture, or signature of a
living person (or president whose widow or widower still lives) without written
consent, seems ok as a legislative prediction at the wholesale level about the
risk of false endorsement.  Even the bar
on registering flags and other indicia of states, nations, and other political
units arguably has some relationship to preventing deception in that this is a
subclass of signifiers whose potential for abuse is so great that Congress
could legitimately make a blanket rule without requiring case by case
evaluation.
 
(2) What about those
§2 bars related to consumer understanding, but not so much to deception?  For example, merely descriptive (or
deceptively misdescriptive, or geographically misdescriptive) marks are not deceptive when a TM claimant uses them.
But there are policy reasons we want other
producers to be free to use them as well. 
Claimants could cause harm to the marketplace by gaining monopoly rights
over them.  Is that enough of a
justification to sustain these bars, given that they are content discriminatory
by our excitingly broad definition of content discrimination?  To me, the fact that the acid logic of
current First Amendment protection makes the bar on registering merely
descriptive terms seem even arguably questionable shows that something has gone
seriously wrong with the Supreme Court’s condemnation of content-based
regulation, which has now become detached from the underlying justifications
that one might reasonably give for worrying about content-based
regulation. 
 
Sure, we could say that the bar on registering
descriptive terms survives strict scrutiny, but I don’t see how that can be
true without doing serious damage to the concept of strict scrutiny.  For example, we already have a less restrictive
alternative than barring registration in the very same statute: we could allow
registration of descriptive marks, and give everyone else a descriptive fair
use defense, just as we do now when a descriptive term has secondary meaning
and is registrable.  Of course, having the descriptive fair use
defense is not as good for competitors as full freedom to use a descriptive
term lacking secondary meaning—but is that marginal difference enough to
survive full First Amendment scrutiny?  At
a minimum, the difficulties with this approach indicate that, if Zauderer-like scrutiny should apply to
refusals to register, it should be the broad version of Zauderer, allowing the government to pursue non-deception-related
objectives, though which such objectives are independently constitutional can
still be debated.
 
Side note: another
constitutional jurisprudence could use the fact that a trademark confers some
private right to suppress other people’s speech as a reason that the government
can make balancing decisions about whom to favor—that is, whatever rule the
government makes will affect the speech environment, so saying that each rule
has to survive strict scrutiny doesn’t make much sense.  Unfortunately, that’s a tough argument to
make in our current constitutional order, which tends to assume the existence
of particular baselines, such as that the government will protect trademarks.
 
(3) What about
functionality as a bar to registration/protectability?  This is a fascinating issue because it is a
pure U.S. v. O’Brien situation: by
definition, a symbol that is functioning as a mark, but also possesses
utilitarian or aesthetic functionality, is not barred from
registration/protection because of anything about its communicative status.  It is
barred because of the things that it does that aren’t communicative at all,
just as the government supposedly punished O’Brien for burning his draft card
not because of his anti-war message but because it needed that draft card for
other purposes.  Unlike O’Brien itself, there’s absolutely no
reason to disbelieve the government’s content-indifferent rationale for its
regulation.  With functionality, the government
here is regulating conduct (preserving everyone else’s freedom to use a
functional feature) and not speech. 
Nonetheless the government rule has effects
on speech—it discourages the communicative use of functional features, because
you can’t get protection for them.  Under
O’Brien, a law that burdens
expressive conduct is unconstitutional, even absent any bad state purposes,
unless “it furthers an important or substantial governmental interest; and the
incidental restriction on alleged First Amendment freedoms is no greater than
is essential to the furtherance of that interest.”
 
In some sense the
exclusion for functional matter is motivated by the government’s desire to
shape the universe of communicative devices so that it doesn’t overlap with the
universe of functional features.  The
thing is, there’s just nothing wrong with that desire even if characterized as
speech-related—this is why Justice Breyer and the Justices in agreement with
him are absolutely right that the term “content-based” as recently used in Reed is ridiculously, preposterously,
unsustainably overbroad.  The government
interest is substantial and the restriction is exactly coterminous with the government
interest.  So let’s conclude that at
least functionality would survive Central
Hudson
scrutiny both as a bar to registration and as a total bar to
protection.
 
Go back then to the category
of descriptive terms lacking secondary meaning. 
Can government deny protection to those? 
Denying trademark protection to such terms doesn’t directly protect
consumers from deception, though it may indirectly prevent them from being
fooled by the absence of information
from other producers who also want to use those descriptive terms. 
 
So, may the government
condition the benefit of trademark protection on a claimant’s speech-related choices,
here what kind of word to use? One answer: yes, if the condition is related to
the purpose of the program.  Here, one
core purpose of trademark is to connect nonfunctional terms to particular
producers so consumers can use them as indicators of source.  A descriptive term without secondary meaning
doesn’t do that, so a producer who uses such a term can be excluded from the government
program.
 
But is the only
permissible purpose of the program to improve the quality of truthful or
nondeceptive signals that consumers receive? 
Can our concept of “quality” consider the harm done to significant
segments of the population by having disparaging or scandalous terms
commercialized?
 
I have to admit that
unconstitutional conditions doctrine is a big hairball.[1]  There are huge problems of determining what
counts as coercion, or as the appropriate baseline from which to measure your
entitlement.  Kathleen M. Sullivan,
Unconstitutional Conditions, 102 Harv. L. Rev. 1413 (1989): “[D]eciding under
what circumstances government offers, like private offers, are coercive is an
inevitably normative inquiry.” 
 
Nonetheless I want
to argue that the §2(a) exclusions, all of them, do not represent
unconstitutional conditions.  And the
reason is something peculiar to trademarks: trademarks can communicate (at
least) two different things—but the only thing the government protects as a trademark is the communication
“this symbol stands for a particular producer.” 
Under §2(a), any speaker can continue to use any symbol it wants, but it
can only get a registration for matter
that does not run afoul of any exclusion—for the Redskins, the team colors and
logo. 
 
Friedman v. Rogers,
440 U.S. 1, 12 (1979), says that trademarks have “no intrinsic meaning” and
thus that there’s no First Amendment problem with the government barring
certain marks for fear they might be deceptive. 
From a trademark lawyer’s perspective this might be a puzzling or even
contradictory statement, but one way to read what the Court is saying is that
the source indication function of trademark is not the communication that is
protected in commercial speech.  As
source indicator, a mark is neither truthful nor untruthful in advance of legally
enforceable meaning, and—unlike ordinary communication, where changing the
words can change the meaning, as the “Fuck the Draft” case Cohen v. California
teaches us—a change of mark does not change what is communicated by the
trademark function: this is who I am/this is my source.  Google is
Alphabet.
 
Unlike the clinics
in Rust v. Sullivan, a case in which
the Court found that it wasn’t an
unconstitutional condition to require any health clinic that took federal money
to separate abortion related information and activities from the part of the
clinic funded by the government,[2]
a speaker doesn’t even h ave to separate its activities to take advantage of
the TM registration system. 
 
To analogize
to the Confederate Veterans case, as with the license plate, the speaker’s free
to put a confederate flag bumper sticker on his bumper; he just can’t have it
on the license plate. Washington’s football team can keep its name and continue
to get the government’s help suppressing counterfeits etc. It just can’t get
the government’s help using only this particular disparaging symbol.  If the whole car is our unit of analysis,
like the whole product or service offered by the producer, then the government’s
unwillingness to implicate itself in the disparaging or racist aspects of the message
communicated by the car or the product may be itself a sufficient interest to
justify the exclusion, given that the government is not gaining any leverage
over the message appearing outside the license plate or registered matter.[3]
A number of cases
and commentators have suggested germaneness to the program’s aims as a standard
for determining whether a condition is unconstitutional: you can be denied TANF
because you are making too much money, but not because you protested the government—germaneness
here, though, reduces to the question of whether it’s ok for the government to
have this preference for nondisparaging marks. 
I think there’s no question that denying Washington’s football team any trademark rights in any symbol as long as it also used the
team name would be a penalty for the exercise of First Amendment rights.[4]
 
Moreover, viewpoint
discrimination can be illegitimate in many more instances than content
discrimination—my theory doesn’t license Congress to grant trademarks only to
Republicans.  But: Would my reasoning
license Congress to eliminate any trademarks that were themselves pro-choice?  Viewpoint discrimination can violate the
First Amendment even if the underlying activity isn’t protected by the First
Amendment—RAV v. City of St. Paul teaches that you can’t decide that assaults
against Republicans because they are Republicans will be subject to harsher
punishment, or that only false advertising that degrades men will be banned.[5]
 
Conclusion: Once a
program is exposed to the modern First Amendment in its rawest form, that
program may have difficulty surviving, no matter how sensible it is.  This is either a problem with First Amendment
doctrine—or it’s a problem with the modern rejection of Lochner.  If we are really
that suspicious of government regulation picking winners and losers, then we
shouldn’t even have registration—and maybe not infringement cases!  Or, my preferred response, we should rethink
the corrosiveness of First Amendment doctrine applied to ordinary economic
regulations.  In some ways, whether §2(a)’s
ban on disparaging marks survives constitutional scrutiny is only a small part
of that broader issue.  There remains the
possibility of continued ad hoc-ism, where the Court applies its strict
scrutiny only to the parts of a system that protect less politically powerful
groups, as is its trend with campaign finance and affirmative action.  But that would be the worst result of all.
 
Brooke: Is TM
property?  © and patent are in the
constitution.  It’s not really property,
but represents goodwill. You can pledge TM registrations to a bank and pledge
them as security for a loan; Ford pledged all its TM registrations to
financiers to avoid bankruptcy.  Ambiguity
as to whether it’s property.  The gov’t
is picking winners and losers.  Doesn’t
think Court will hold 2(a) unconstitutional, but we need a working system. 
 
Allen: Personally,
agrees that registration is an affirmation/presumption of validity that there
is some weight behind the mark.  Not just
something that the applicant takes home but can use abroad. 
 
Heymann: is there
any approval of the message in a registration?
 
Allen: Yes, in the
sense that it affirms that it survived §2.
 
Farley: That’s the
question of the day! Going to other gov’ts saying that this gov’t has approved
the mark. Most countries have this kind of prohibition, usually phrased as
public order or morality.  It is the US
saying “this message is ok”—whether it’s “using LEATHER on these products is
nondeceptive” or something else.  Fed.
Cir. was interested in whether CO could bar protection of pornography under
this rationale.
 
RT: Depends on your
theory of the 1A.  I think the answer
could be yes, but there is nonetheless a big distinction between © and TM.  Because TM is about protecting a source link,
the Washington team can have the unregistrable word present on everything that
is protected by its rights in the team colors and logo. By contrast, a work
refused © because it was pornographic would have to change its content to gain
protection.  So you could easily
invalidate such restrictions on © while still sustaining §2.
 
Heymann: questions
of evidence.  If there are a bunch of
actually disparaging marks on the register because the targets don’t have the
resources to challenge, is that a problem?
 
Brooke: we’re
supposed to care about consumers/protecting consumers, not if Ford is trying to
protect its property.  Many of these marks
will fail/be taken care of by the market. 
People can choose to be offended or not.
 
Farley: the market
won’t fix everything; if we trust the market on that, why not trust it on
everything else the TM act is concerned with? 
If the issue is connecting the gov’t w/the ® of a disparaging term
today, then the rule should be that we assess its meaning today.  [That creates some real problems for my
constitutional analysis, since that would mean there are untrademarkable goods
& services, like the Amos & Andy works, or OJ Simpson: any time the
public starts to associate the mark with the underlying offensive
goods/services, then that mark would be disparaging/scandalous too.]
 
Problem with
evidence: PTO relied on blog saying Slants were rejected for their name, but
Slants say that’s not true; blog was mistaken in its facts.  The limited evidence available to the PTO
creates some risks.
 
Brooke: Market
pressure often takes care of this: Sambo’s restaurants have been
abandoned.  If Dan Snyder had been smart,
this would have been taken care of a long time ago.
 
Q: is original
justification just to prevent bad marks from being in the marketplace?
Scandalousness/disparagement doesn’t seem like consumer protection.
 
A: But that’s not
the only justification for TM: ordering producer relations. Incontestability
has nothing to do w/consumer protection, for example.  Also, historically, disparagement was first
before false association—it may well be unconstitutional the way old defamation
law was, but it’s deeply embedded in the existing scheme.
 
Farley: Flag
prohibition could be back-justified as deception based, but legislative history
is about diplomacy; likewise presidential name prohibition is dignity-based in
stated historical justification. 
 
Brooke: would never
say that Lanham Act is other than consumer protection in federal court, as a
practicing attorney.  If you’re
litigating a case, you better be talking about consumers.
 
Heymann: prediction
about In re Tam?
 
Farley: court was
arguing with itself, passionately.  The
fact they’d have to overturn precedent, plus questions about what exactly they’d
be invalidating—disparagement, false association, scandalous, descriptive—is something
they’d have a hard time wrestling with. Fed. Cir. doesn’t want to undo all of
TM law, which might be enough to convince a majority to affirm.
 
Brooke: would
probably have said SCt would find it unconstitutional before Confederate Veterans, but now thinks
they’ll defer to gov’t agency.
 
 


[1]
Mitchell N. Berman, Coercion Without Baselines: Unconstitutional Conditions in
Three Dimensions, 90 Geo. L.J. 1 (2001) (“The Supreme Court’s failure to
provide coherent guidance on the subject is, alas, legendary.”) (footnote
omitted); Cass R. Sunstein, Why the Unconstitutional Conditions Doctrine Is an
Anachronism (With Particular Reference to Religion, Speech, and Abortion), 70
B.U. L. Rev. 593 (1990).
[2]
Rust v. Sullivan (“[A] refusal to fund protected activity, without more, cannot
be equated with the imposition of a ‘penalty’ on that activity.”).
[3]
Cf. Sunstein, supra (“In the spending context, the government may be able to
invoke justifications that are tightly connected to, and become legitimate
because of, the very fact that it is engaging in those activities. In the public
school setting, for example, government can plausibly justify its selectivity
by the need to ensure that public funds are not spent on religious
activities.”).
[4]
Compare Rust v. Sullivan (discussing hypothetical withdrawal of all benefits
from any woman who chose abortion).
[5]
Cf. Sunstein, supra (arguing that government funding choices on aesthetic,
qualitative, and content-based grounds are all acceptable and distinguishable
from viewpoint-based discrimination).

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Registration symposium at William & Mary, part 1

William & Mary Student Intellectual Property Society
Symposium
A Right  to Register:
A discussion of First Amendment Implications of the Trademark Registration
Process
 
Overview: Dean Laura Heymann, W&M Law: TMs reduce
consumer search costs.  TMs don’t exist
in the abstract—have to be associated w/ a good or service.  Apple = TM for computers, not fruit.  In the US, right to use doesn’t depend on
registration, but on qualifying use in commerce.  ® has many benefits, but you don’t have to
register in order to claim rights. 
 
Susan Allen, USPTO: Not official views.  Examiner’s perspective on an
application.  Application usually takes
2.8 months to be examined—about 480 examiners now.  Allowed = publication; denied = appeal to
TTAB or abandoned.  Opposition also
possible to TTAB after publication.  From
the TTAB, can appeal to the district court or Federal Circuit.
 
Outside perspective: you’re taking lots of issues from all
over and trying to figure out what bucket to put them in: a shoe design—©, TM,
design patent.  Examiner is target of
these issues and your job is to figure out which submissions qualify, over and
over, like grading papers.
 
Example: DYKES ON BIKES. 
Examine all the record, including dictionaries and internet.  Office Action attached dictionary definitions
that said “dyke” was disparaging for lesbians. Note that Office is very busy
and inter partes record will be very different—mostly looking at internet and
making best judgment possible.  Is it
completely subjective?  No.  Evidence is required, and examiners are
trained to determine what’s refusal-worthy. 
TMEP says senior or managing atty must consult on scandalousness
refusal: always a review process for those.
 
Applicant responded with evidence of reclaiming the
term.  Examining att’y issued a final
rejection and applicant requested reconsideration/filed notice of appeal to
TTAB.  The refusal was withdrawn.  Opposition occurred with publication; TTAB
rejected the opposition on standing grounds; court of appeals agreed w/TTAB, so
registration issued.
 
Examiners review 8-10 applications/day on average.  About 60% of TM employees do examining, and
6% of PTO as a whole.
 
Between Apr. 2008-Dec. 2013, 185 first actions for
disparagement refusals, 42 final actions; 902 first actions for
immoral/scandalous, 158 final actions. 
2012 alone: 2071 first actions for deceptiveness; 224 final actions
(though now we issue more warnings instead of first action refusals).  Most common 2(a) refusal is deceptiveness.  Most common issue is ID of goods making the
mark deception.
 
Used to do a lot of refusals for definition of goods: if it
says leather in the mark but the goods listed are all clothes, we now ask for
amendment; if they don’t amend they are refused.
 
Immoral/scandalous: shocking to substantial component of
general public.  PTO looks at the overall
context, not just the applied-for mark.  TITMOUSE
as mark for clothing with birds on it = ok; TITMOUSE as mark for computer mouse
in the shape of a human breast = not ok. 
THE SLANTS = material submitted with the application had all sorts of
Asian references.
 
Commercial/noncommercial refusals: what’s the meaning of the
matter, and is it likely to be disparaging/offensive to a substantial composite
of the reference group, except with corporations because corporations can’t
take offense.  KHORAN for wines:
association of alcohol with Muslim religion. 
SQUAW and SQUAW VALLEY = disparaging for clothes but not ski
equipment.  Disparaging/scandalous:
assessed by the views of the relevant group (general public or targeted group,
depending) at the time of the application. 
 
Thomas Brooks, Holland & Knight: IP is more than patents—often
a misconception that people have. 
Washington team’s marks—long time registered, compared to In re Tam
where the examiner denied registrations. 
Can be challenges at any stage on several grounds.  Vast majority of applications fly right
through.  Clients don’t like paying extra
money for holdups with examination—many think it should be like going down to
the courthouse to get a marriage license or dog license; since they’re using
the mark, why aren’t they entitled to a registration?  Even big firms that understand the issues don’t
want to pay extra.
 
Current cases: client trying to register VERSA for duct tape
and other construction equipment.  VERSA
TRACTION w/tagline cited against it, but it’s for surfboards; we argue that no
one will confuse duct tape w/tape used by surfers.  Client wants CHUCS for clothing, and CHUCK
TAYLOR from Converse is an issue. Another wants to move a Middle East chain
using a surname, but surnames require secondary meaning.  Luchese cowboy boots: no problem w/new
registrations b/c known, but every time we need a disclaimer that it’s a
surname but has so much secondary meaning that it’s a mark.
 
Whether something brings a group into contempt or disrepute
is subjective, and you have to make a judgment call. You can’t say no to your
client forever. 
 
Words can be common in England/offensive here (fag for
cigarette); offensive in UK/not so bad here (bloody for bad).  What about remaining Native American symbols
on the register?  Land O’Lakes Native
American; Sue Bee honey; Mutual of Omaha; etc. 
It’s all contextual.  RED MAN
chewing tobacco?  Famous in the field/big
seller.  Not sure it would get through
today, but registered.  A number of other
registrations that may be offensive: NWA for the rap group (but its full name,
no; never tried, as far as he can tell and many n-word attempts have failed,
except for very old registrations that have been abandoned); DAGO RED for
clothing; POLOCK JOHNNY’s restaurant; PUSSY POWER REVOLUTION for clothing. These
might be gone in a few decades (actually my searches suggest DAGO RED and PUSSY
POWER REVOLUTION are already gone).
 
Practical perspective: do you have the time and money for a
fight on this?  Typical client doesn’t
want this fight, and will generally turn away. 
Many sports teams have moved away from Native American images,
especially caricatures.  Even the
Washington team has a plan for change if it has any sense. 
 
Domain names: no policing of those, even though there are a
number of offensive ones out there.
 
Christine Haight Farley, American: COCKSUCKER denied
registration, but GAMECOCK SUCKER allowed, as was BIG COQ, and COCK RUB.  A lot of criticism of the subjective nature
of the determinations/inconsistent outcomes. 
 
What questions do we ask for scandalousness/immorality?  We ask in the context of contemporary attitudes.
What was scandalous 50 years ago may no longer be scandalous—BUBBY TRAP for
bras.  Judge in context of marketplace in
context of goods described in application, from perspective of substantial
composite of general public.

Disparaging marks: Fed. Cir. adopted TTAB test in STOP THE ISLAMIZATION OF
AMERICA.  First determine the meaning of
the mark: a religious or political meaning; either way it was disparaging to a
substantial composite of Muslim-Americans. 
Look at dictionary definitions; relation of matter to other elements of
the mark; nature of goods/services; manner in which mark is used in the marketplace.  If that meaning is found to refer to
identifiable persons, institutions, beliefs, or national symbols, whether that
meaning may be disparaging to a substantial composite of the referenced group.
Context includes entirety of mark’s impression, expected commercial use,
whether the secondary meaning supports primary meaning, time of application,
views of population targeted.  Don’t
consider identity of the applicant or intent of applicant.  Don’t consider audience/relevant consumers.
 
Context:

 Sometimes context can
provide offense or remove it. 

KHORAN:
not disparaging in the abstract, but in context of alcohol.  JESUS JEANS? 
The ads for the company are highly sexualized, but also play up the
religious meaning in a deliberately provocative way.  JESUS JEANS registered in the US, then opposed
an application for JESUS SURFED.  JESUS
SURFED is an evangelical Christian clothing company, so it sought to cancel
JESUS JEANS on disparagement grounds. 
Tried to bring in the ads to provide context.  PTO doesn’t want to decide who really
represents Christians.

 
SQUAW: disparaging term/version of a term that means vagina,
according to Harjo; dispute over who gets to determine what the term means.
Should it be reclaimed? Opposed?  Loretta
Lynn dressed as an “Indian” for her album “Your Squaw is on the Warpath.”  “Squaw Bread”—said they didn’t mean to offend
b/c it was just called “squaw bread”/they wanted to give credit to Native
American origin.  Squaw Valley: ski
location/sought marks.  Split decision
because of the context of the goods. 
Similar case: HEEB—magazine had a registration for the magazine, but
applied for clothing, unhinged from the particular context of the magazine, it
was found to be disparaging.  TTAB found
it irrelevant that the applicant was Jewish or well-intentioned.  Relevant community was important.
 
DYKES ON BIKES is now the model for reclaiming terms. They
submitted 400 pages of evidence proving that it wasn’t just intent to reclaim or
good intent, but that the reclaiming had happened and now had positive
connotations.
 
THE SLANTS: (No similar history of “Slants to Watch Out For”)  Context was the reason: it was Asian in
context and the attempt to “own” the stereotype proved irrelevant good
intentions and relevant connection to Asianness.  Their first specimens of use had Asian
symbols, fonts.  The second application,
after abandoning the first, included only specimens that didn’t have obvious “Asian”
indicators—they were posters for concerts the Slants played at though not
designed by the Slants.  Examiner looked
at the older specimens too and still refused the registration.  Recent album: “The Yellow Album.”  Fed. Cir. recently reheard en banc. 
 
REDSKINS: First action against TMs brought in 1992; still
ongoing.  Team wanted EDVa. because the
trend in the Fed. Cir. didn’t look good. 
NFL is footing the bill, so the team has limited incentive to stop just
because it’s expensive.  Initial
evidentiary problems: much the evidence didn’t go to the reference group, but
to Americans generally.  Is less than ½ of
the group finding it disparaging sufficient? 
Her answer: yes, given what percentages are accepted in TM infringement
cases.  Also, the evidence didn’t go to
what Native Americans thought at the time the registrations issued.  Survey would have required a time machine!  Also, asked about offense instead of
disparagement.
 
Dictionary definitions: again, they’re not from the right
times. After 1966, “redskins” is a slur any time it’s used.  Suggests that over time, understanding of
majority groups about how awful it was changed. 
Actions that Native Americans took during the relevant time period—meetings
w/team, organized protests, had a resolution, formal objections: that’s the
most relevant.  Is it substantial?  Team said: just the leaders thought this, not
the general population—can’t prove leaders represent the whole of the
group.  That’s an impossible task.
 
Native American leaders met with the team president.  He knew as of 1972.  The Washington papers even ran a political
cartoon about the meeting and protest. 
Wasn’t unhinged from racial references also used w/ the team names. Team
suggests now that the name change from Boston Braves honored a Native American
head coach, but at the time they said that wasn’t the reason for changing the
name and also he was not a Native American.
 
Owner George Preston Marshall was an unabashed racist; last
team to integrate by far; set up a foundation for DC children, but said couldn’t
be used for any support of racial integration. His wife came up with the theme
song, which was the first team theme song; it is awful.
 
All REDSKINS applications not dealing with peanuts or
potatoes have been refused since 1992.

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