Informed consent and consumer protection: the case of abortion

Acuna v. Turkish, --- A.2d ----, 2007 WL 2609054 (N.J.)

Rosa Acuna filed a malpractice action against Dr. Sheldon Turkish, her obstetrician-gynecologist, alleging that he failed to provide her information necessary to her informed consent to an abortion. She claimed that he should have told her “the scientific and medical fact that [her six- to eight-week-old embryo] was a complete, separate, unique and irreplaceable human being” and that an abortion would result in “killing an existing human being.” The basic theory was that a doctor must, before performing an abortion, “advise the patient in clear and understandable language that ‘the family member [the embryo] is already in existence and that the procedure-indeed the central purpose of the procedure-is intended to kill that family member.’” Otherwise a woman is not making a fully informed decision to abort. (For an overview of this strategy for discouraging abortions, see Reva Siegel, The New Politics of Abortion: An Equality Analysis of Woman-Protective Abortion Restrictions, 2007 U. Ill. Law Rev. 991 (2007).)

In this case, the New Jersey Supreme Court rejected Acuna’s argument and reinstated the dismissal of her suit. A doctor “unquestionably has a common law duty to provide a woman with material information concerning the medical risks of a procedure terminating a pregnancy,” the court was unwilling to extend that to a suggestion that abortion is tantamount to murder. There is no consensus, either among the medical community or the general citizenry, that the statements Acuna wanted are “medical facts” as opposed to ethical beliefs.

The disputed facts shouldn’t matter, but – perhaps unsurprisingly -- the court did recount disagreement between the parties over who brought up the subject of abortion (each identified the other as the culprit), as well as facts about Acuna’s reproductive history and general health that might seem to justify an abortion to those who feel that justifications are required. (The not-so-hidden narrative here is one of the plaintiff’s regret of her voluntary choice.) Acuna said that she asked if “the baby” was “in there,” and that Turkish replied, “don’t be stupid, it’s only blood.” Turkish didn’t recall his specific response, but thought he likely told her that a “seven-week pregnancy is not a living human being,” but rather it “is just tissue at this time.”

In deposition, Acuna stated that she knew she was pregnant, but she wanted to know if there was “a baby” in her, by which she meant a “human being.” She understood that, without some intervening event, a child would be born to her, but she wanted to know whether she was carrying “an existing living human being.” After meeting with Turkish, Acuna consulted with her husband, returned to Turkish’s office three days later, and signed a consent form acknowledging that the “risks and complications” of the procedure had been explained to her. Turkish performed an abortion.

Acuna had continued bleeding, and was ultimately admitted to the hospital, where she was diagnosed with an incomplete abortion. A nurse told her that Turkish “had left parts of the baby inside of you.” (The court noted that the pathology report contradicted this statement.) Upon her release, Acuna began researching early pregnancy, trying to make sense of the nurse’s remarks and Turkish’s statements, and eventually “concluded” – the court’s term – that the abortion killed “a human being.” She suffered as a result, and was later diagnosed with post-traumatic stress disorder.

Acuna sued for malpractice. Her informed consent claims stated that Turkish wrongly failed to inform her that (1) “[Andres] Acuna, although a person unborn, was a complete, separate, unique and irreplaceable human being”; (2) there existed the potential risk that Andres “was capable of experiencing pain” at eight weeks gestation; (3) abortion involved “actually killing an existing human being”; (4) she would be at risk of suffering from “post-abortion syndrome,” a form of a post-traumatic stress disorder; and (5) she would come to realize that she “was responsible for killing her own child” and bear a weight of guilt for the rest of her life. Had she received this information, she alleged, she would not have had the abortion.

After various motions and appeals, the trial court ruled that, though emotional distress claims were available against a doctor who failed to obtain informed consent before performing an abortion, Acuna had failed to demonstrate that Turkish withheld material information that a reasonably prudent woman would need to know. Instead, by asking a doctor to state that an embryo is “a complete, separate, unique and irreplaceable human being” and the like, Acuna was asking for value judgments, not medical facts. The court of appeals, however, found a material factual dispute over whether Turkish accurately answered Acuna’s question, “[I]s the baby already there?” and thus remanded for trial.

The Supreme Court agreed with the trial court. Despite the “don’t-be-stupid-it’s-only-blood” remark, Acuna understood she would, unless something changed, have a child in seven months; she did not interpret Turkish’s statement to mean that there was anything wrong with the embryo. Nor did she rely on Turkish’s alleged claims that her health would be endangered absent an abortion (though she did argue that she would have scrutinized the health risks more closely had she known “her baby was already there”).

Giving Acuna’s proposed warnings, moreover, has disadvantages. Turkish and amici argued that these warnings would force doctors to take sides on highly charged issues, unconstitutionally burden women’s right to choose, and violate the First Amendment’s prohibition on coerced speech.

Despite the contentious subject matter, this is in fact the classic dilemma of consumer protection regulation: information that helps some people hurts others. Even when we discount problems of preference formation (which are foregrounded here by the very content of Acuna’s list and by the possibility that suggesting to women that abortions produce post-abortion syndrome itself helps produce symptoms, or at least attribution of symptoms to the abortion rather than other factors), information that would help some women implement their preferences would hinder others.

Informed consent is medical information “that a reasonably prudent pregnant woman in like circumstances would have considered material before consenting to a termination of pregnancy.” “Like circumstances” provides some possibility for tailoring the duty to the woman, except that there is really no way for doctors to tell in advance who would want to hear that an embryo is an existing human being. Proponents of a duty to disclose Acuna’s list (1)-(5) are really arguing that the risk to every woman of coming to realize that she killed a human being is so great, and the harm to her if she foregoes an abortion she truly desires so minimal, that every woman should hear this cautionary list.

Without getting into these intractable preference problems, the court looked at general professional norms. Acuna had no evidence that any doctors currently give such warnings, nor that any jurisdictions impose common-law duties to do so. Requiring doctors to say that aborting an embryo is the killing of an existing human being would suggest “that both the doctor and patient would be complicit in committing the equivalent of murder.” This conclusion has been rejected both by New Jersey’s legislature (by enacting a wrongful death act that doesn’t cover fetuses and by refusing to classify fetuses as persons under homicide statutes) and by the Supreme Court in Roe and Casey.

I don’t find the professional norms argument particularly persuasive; absent government regulation, you wouldn’t find many cigarette companies warning about the health consequences of smoking, either, since it’s not in their interest to do so. But the lack of consensus on what the truth of the matter is, as reflected in practice and legislation, is more significant. In general advertising law, as in defamation, this is the fact/opinion divide. Though often spoken of as a subset of puffery, the fact/opinion divide serves to keep advertising law from regulating at least some attempts to affect preference formation. Here, informed consent strives to to target nearly universal preferences (to live, to avoid pain). Disclosures generally imply not only that the disclosed information is material but that it ought to be material to the consumer; in that, disclosures are no different from other explicit ad claims. Mandating a disclosure means taking a side in a debate; here, however, there is no general scientific or social consensus on the right side.

Consensus, of course, is not required for most government-imposed requirements, but it is relevant either if the common law punishes only clear departures from standard practice or if some constitutional right is implicated. After discussing Roe and Casey’s avoidance of the conclusion that a fetus is an “existing human being,” the court noted that Casey indicated that doctors might have some First Amendment rights relevant to compelled disclosures. For a detailed discussion of this last point, see Robert Post, Informed Consent to Abortion: A First Amendment Analysis of Compelled Physician Speech, 2007 U. Ill. Law Rev. 939 (2007).) Moreover, a South Dakota statute requiring similar disclosures has been enjoined (pending review en banc) on First Amendment and due process grounds. That statute, though democratically enacted, “is pushing the doctrine of informed consent to the edge of a new constitutional fault line.” Rather than reaching the constitutional arguments, the court simply declined to stretch the common law so far.

The court didn’t specifically address Acuna’s claims (2) (fetal pain) and (4)-(5) (post-abortion guilt). These appear at first glance to be more capable of scientific resolution, though that apparent falsifiability may quickly dissolve in debates over what it means to feel pain and the difficulty of determining whether abortion differs from childbirth in its effects on the mental health of similarly situated women. The professional consensus against Acuna's position is significant here, though the relevant profession isn’t doctors but people studying the particular subjects at hand.

In general, however, legislatures – and even courts -- can take sides on disputed factual issues. The FDA does so routinely. A physician who didn’t believe that a particular drug posed certain risks considered well-established by the FDA could certainly be held liable for failure to disclose those risks – this is one reason the black-box warnings on antidepressants for teenagers have been so controversial: they deter prescriptions by doctors who disagree with the FDA’s assessment, but fear liability. In many cases, we’ve simply taken it for granted that we can compel speech by doctors, drugmakers, and commercial speakers in general.

If the doctors in South Dakota have a good First Amendment argument, in other words, then the FDA needs to worry. I recommend Post’s article; informed consent and advertising disclosures have a lot in common, especially from a First Amendment perspective, even though they’ve rarely been considered together.

NYT director of advertising acceptability answers your questions

Or at least reads them. Story here.

The hate that dare not speak its name

Oklahoma ex rel. Edmondson v. Pope, -- F.Supp.2d --, 2007 WL 108943 (W.D. Okla.)

In January 2006, Pope hired a company to call thousands of Oklahomans and play a prerecorded message:

Stand by for an important message. Hear County Commissioner Jim Roth speak of his success in advancing the homosexual agenda in Oklahoma County. Including homosexual language into the county personnel handbook and fighting to keep homosexual books in the children's section of the library. Commissioner Jim Roth will discuss his role in advancing the homosexual political agenda on Monday, January 30th at 6:30 p.m. at Epworth United Methodist Church. Stand by for a one question survey. If you think that Commissioner Roth should continue using his position to advance the homosexual agenda press one, if you do not, press two. Thank you.

The message didn’t identify defendant or provide his contact information. (Background, and laughable defense from Pope that he was "promoting" Roth's speech, here. Roth is in charge of things like this parking garage project; I was not previously aware that shovels possessed a sexuality.)

At least nine recipients complained to the state attorney general about the calls. The issues were whether the “technical” standards of the Telephone Consumer Protection Act ("TCPA"), 47 U.S.C.A. § 227 (requiring identifying information to be included in prerecorded calls to residences) applied to political messages, and if so whether the TCPA violated the First Amendment.

The court held that the TCPA did apply. By statute, the FCC is allowed to exempt certain calls from the general prohibition against prerecorded calls made without prior consent, and it has done so for prerecorded calls not made for a commercial purpose. Pope’s calls clearly fit within the exemption. But the court ruled that, based on clear statutory language, even automated calls exempted from the prior consent requirement needed to comply with the technical requirements (which include both identification and a provision that the caller must release the line shortly after a hang-up).

Thus, the court turned to the First Amendment claim: political speech can’t be regulated in this way. I haven’t read the briefs, but it appears from the discussion that the state argued that the proper body of doctrine was public forum doctrine and that, because the telephone system is private but heavily regulated, the lower standard applied to regulation of speech in nonpublic forums should apply, allowing content-based (though not viewpoint-based) discrimination.

Wow, that could probably be more wrong, but it’s not clear to me how. The phone system is private property, but the phone system isn’t the speaker and is in fact compelled to offer carriage to everyone who can pay. It’s not like a newspaper or other private intermediary choosing what speech to publish. And in terms of government property, unlike even public parks, the phone system is designed for speech and there aren’t nonspeech activities with which particular calls compete. The idea that the government could decide that speakers uttering nonobscene sexually explicit content can’t use the phone lines, because they’re a nonpublic forum, is a bit surprising. You could, I suppose, analogize prerecorded messages to loudspeaker volume, both technological innovations that allow greater message penetration at the cost of greater annoyance to people at home, but I don’t see that public forum doctrine is relevant to that.

The court modestly declined to reject the state's manifestly silly argument. Rather, it ruled, the key is that the TCPA regulates all prerecorded messages and is content-neutral. The legislative purpose was “to protect consumers from unwarranted and intrusive prerecorded calls,” regardless of the message conveyed. Intermediate scrutiny applied: content-neutral time, place, or manner restrictions are okay if they’re narrowly tailored to serve a significant governmental interest and leave open ample alternative channels for communication. Since everything you can say with a straight face is a significant governmental interest, the keys here are narrow tailoring and alternative channels.

The court found that the technical requirements “allow people receiving those calls to contact someone regarding future calls and to have use of their telephone line after hangup.” These were narrowly tailored measures “to remedy the underlying problems previously experienced with anonymous prerecorded message calls.” And they only incidentally restricted Pope’s ability to spread his message. Pope could have called residences uninvited without providing identifying information, if he’d called himself or used live operators, or he could have provided identifying information. Given the harm inflicted on thousands of Oklahomans – “uninvited calls on their home phones that contained a prerecorded, politically-oriented message with no information about its source or how to avoid subsequent intrusions” – this was a minimal burden.

The court also rejected Pope’s selective enforcement claims.

This all makes sense, except for the bit we rushed over in the beginning: content neutral? A regulation requiring all communications to include a specific piece of information – a name and other contact information – is content neutral with respect to what the speaker wants to say, but content-based with respect to what she doesn’t, if she wishes to remain anonymous. McIntyre v. Ohio Elections Comm’n, 514 U.S. 334 (1995), a case mysteriously absent from the opinion, discusses reasons why governments want to regulate anonymity and why people might want to remain anonymous; those reasons, I submit, make regulation of anonymity content-based. (In a footnote, the court cited Talley v. California, 362 U.S. 60 (1960), another anonymous leafleting case, but distinguished it on the grounds that (1) there was no concern over fears of reprisal from unpopular speech here (wrong, to the extent it was even relevant to this facial challenge), and (2) the privacy interest here is greater.)

I am not arguing that the interest in residential privacy cannot sustain the regulation – it might – nor that other interests, such as those animating campaign finance regulation, cannot justify disclosure requirements for large-scale political speech of the type in which Pope engaged. Those are the things we should be talking about, rather than pretending that the regulation is content-neutral. Indeed, such a discussion might suggest that disclosure of contact information – specifically, a number someone could use to say “never call me again!” – addresses the relevant interests well enough that a ban on anonymity cannot survive. Anonymous unsolicited recorded calls might well be perceived as more intrusive than non-anonymous unsolicited recorded calls, so there’s still some privacy justification for a disclosure requirement. But since a political caller gets one free smear under the TCPA, it’s at least worth considering the extra benefit added by a name disclosure requirement.

Celebrity branding misfires

Article, and related slideshow, here. Note the reference to Tiger Woods; the author makes the same point (does anyone really believe Woods drives a Buick?) as the Hallmark card in Hallmark's line of celebrity "paper dolls." (Also, points to me for predicting the Hallmark/Paris Hilton battle.)

Book chapter: Truth and Advertising

This is my contribution to Trademark Law and Theory: A Handbook of Contemporary Research (Graeme B. Dinwoodie and Mark D. Janis, eds.) (Elgar, forthcoming 2008). It is an overview of my work on the Lanham Act and the First Amendment, with special attention to ways in which dilution law breaks the tradition of regulating the informational content of commercial speech and attempts to regulate its emotional content.

The color purple

A well-known book; not so well-known as a mark for 3M's abrasive products, it seems. The TTABlog reports on the TTAB's ruling, after a hard-fought battle that included a consumer survey by the opposer, denying registration to 3M on the ground that purple had not acquired distinctiveness and was in any case functional.

The well-advised 3M promoted its products with the following slogans: “Ask for it by color, not by name” and “If it’s Purple, it’s from 3M.” The evidence was, however, that numerous producers of abrasive products used purple. So the slogans attempted to create trademark meaning in consumers' minds (though the TTAB found that 3M had failed in this aim), which is ordinarily acceptable, but especially the latter one strikes me as potentially false advertising. A consumer who believed this would either start being confused about the source of other, existing purple abrasives -- which seems counter to the ordinary purpose of trademark, to reduce search costs -- or would regard the other producers as infringers, a sort of reverse confusion situation.

Trademark relies on shaping consumer understanding, of course, but it seems that the preexisting understanding here raises unfair competition questions when 3M tries to appropriate for itself what others have freely used. Precisely because we're used to word marks, we don't usually require instruction to regard them as marks -- even if a particular term is descriptive. But color, like other forms of trade dress, is usually perceived by default as decorative or functional rather than source-indicating. So creating trademark meaning may require aggressive, explicit instruction of consumers in a way that's uncommon with word marks. And that instruction itself may at least start out making false claims about meaning -- but if it succeeds, those claims are no longer false! This is a largely unrecognized problem in regulating false advertising, one I'm exploring in the paper I'm giving at WIPIP later this month.

(Side note: opposer's survey used orange sandpaper as a control against purple; the survey expert contended that, when the percentage of respondents who claimed that orange was a source indicator was subtracted from the percentage who said the same of purple, the net recognition was 6%, "about the same level you’d expect just based on noise or error.” But that quote is deeply misleading, since the control itself is supposed to account for noise and error. Six percent should not suffice to show secondary meaning for color; but neither should double-counting be rewarded.)

Oenofraud

Slate and the New Yorker on the problem of fraud, and the related but distinguishable issue of changing consumer expectations about what a label means, in older wines. If a now-famous vintage was made very differently 50 years ago, including having other grapes added, or if it was "refreshed" with newer wine as was apparently customary until recently, is it really the same wine? You would think, with all the fuss about designations of origin in wine, these practices would be heavily regulated, but they don't seem to have been.

(Medical) food for thought: latest in Lanham Act/FDCA intersection

Midlothian Laboratories, L.L.C. v. Pamlab, L.L.C., --- F.Supp.2d ----, 2007 WL 2458409 (M.D. Ala.)

Time for more fun with the FDA! Plaintiff makes generic versions of prescription drugs and vitamins. Defendant is a competitor and owns a federal registration for FOLTX for a folic acid/B-complex medical food supplement, marketed to physicians for the treatment of B12 deficiency. Plaintiff sued for false advertising and to cancel defendant’s mark. Defendant counterclaimed for false advertising.

Foltx is a “medical food,” defined by law as a food formulated to be used under a doctor’s supervision for dietary management of a disease or condition with distinctive nutritional requirements. Under FDA rules, “[m]edical foods do not have to include nutrition information on their labels, and their claims do not need to meet specific standards.” As a result, medical foods are much less regulated than other foods intended for general consumption. The FDA considered regulating them using drug-type standards, but gave up in 2004 for lack of resources. So medical foods are also much less regulated than prescription drugs.

Plaintiff began marketing a medical food with the same amounts of folic acid, B12, and B6 as Foltx, calling it a “generic equivalent” and “bioequivalent” to Foltx. Rather than marketing to doctors, plaintiff markets to drug wholesalers and retailers including pharmacy chains. They may – and in some cases by law must – substitute a generic product when filling Foltx prescriptions.

The manufacturer of plaintiff’s products analyzed each batch and measured the active ingredients; plaintiff never asked for a report on any batch until after March 2005, more than 14 months after it had begun marketing. At least one test revealed that one of the active ingredients was missing.

In mid-2004, defendant launched a new version of Foltx with twice as much B12, allegedly because the new formulation would better meet patients’ nutritional requirements. It discontinued the old formulation and recalled the remaining stock, replacing it with Foltx labeled “Improved” and “New Strength.” It mailed explanatory letters to 53,000 pharmacists and 57,000 doctors and published ads in industry media such as Pharmacy Times. The letters announced “an important improvement” based on “SAFETY and EFFICACY,” cautioning that all new and refill Foltx prescriptions should be filled with “New Strength Foltx.” After new Foltx was introduced, two major pharmacy chains stopped buying plaintiff’s product.

Meanwhile, a related company, Red River, began advertising itself as the “sole authorized generic licensee” for Foltx, claiming that its products Folbalin and Folbalin Plus (with the same active ingredients as old and new Foltx, respectively) were made by the same company with the same formula and specifications as Foltx – the manufacturer’s own “generics.”

Plaintiff alleged that defendant abandoned the Foltx mark because the reformulation is too different to be sold under the same mark. Abandonment by this route is difficult and usually requires a product so wholly different as to defraud the public. Variation in product composition is “inevitable,” depending on discoveries or changed conditions. Doubling the amount of an active ingredient was not the type of “extreme discontinuity” that could justify an abandonment finding, at least not without evidence that it transformed the product. Plaintiff pointed out that precedents dealing with non-pharmaceutical products might be too broad, because changes in a prescription formulation could have severe consequences for patients. Here, there was no evidence that this change could have severe consequences; plaintiff’s own expert pointed out that B12 doses of this size were not known to have negative effects.

The FDA, plaintiff argued, had never allowed a company to market two prescription products with different amounts of active ingredients under the same name. But the court refused to determine whether the FDA would consider new Foltx misbranded; plaintiff could petition the FDA for such a finding.

Plaintiff also argued that using the same name for new Foltx and telling pharmacists to fill all old Foltx prescriptions with new Foltx was false advertising, causing consumer confusion about whether it was the same product. Product names can be false advertising – Mylanta Night Time Strength antacid and BreathAsure breath freshener are examples from the Third Circuit. The court found that, “if a mark has not been abandoned, then as a logical matter, a company’s rightful continuing use of that mark, alone, cannot constitute false advertising, because no deception is involved in that continuing use.”

Still, plaintiff contended that the letter to pharmacists was misleading because doctors had written existing prescriptions with old Foltx in mind, so there was no reason to think they’d want the prescriptions filled with new Foltx. The court found that such substitutions could cause valid safety concerns, but that plaintiff’s commercial interests were not harmed by those safety concerns and plaintiff couldn’t act as a public avenger. “In other words” defendant’s instructions weren’t misleading about Foltx “as a product” and thus not actionable. Comment: What? Plaintiff’s commercial interests were quite obviously harmed when defendant told pharmacists they could no longer substitute its generic product; the potential safety concerns are one reason the switch is arguably deceptive.

The court found that, because defendant recalled original Foltx, the statement might not be misleading in any way, because new Foltx was the only version of the product available. (Except for plaintiff’s product, which was – at least on this analysis, but see below – the generic version of old Foltx. A pharmacist who filled a post-recall prescription – which, not incidentally, would have been written for old Foltx -- with plaintiff’s product would be doing the same thing as a pharmacist who filled a pre-recall prescription with plaintiff’s product.)

Plaintiff challenged two other statements: “(1) pharmacists violate the law when they dispense [plaintiff’s] product in response to prescriptions written for new Foltx and (2) new Foltx is safer and more effective than original Foltx.” The first is certainly an important statement, but there was no evidence that defendant actually said it. The second was an argument in the alternative: if the new product isn’t different enough to cause deception when it’s called by the old name, then claims of improvement are false and misleading. The court thought there was a middle ground: a change might be irrelevant for trademark continuity but relevant in a pharmaceutical context.

So, how to analyze defendant’s claims that new Foltx was put on the market for “SAFETY and EFFICACY” reasons? The court found no need to analyze falsity because there was no evidence of materiality. In many circumstances, the court noted, representations about safety and efficacy automatically satisfy the materiality element of a false advertising claim, especially in the context of drugs and medical foods, where consumers are primarily concerned with safety and efficacy.

Here, however, the court found that defendant’s claims can’t be material to consumers’ purchasing decisions, because new Foltx is the only Foltx on the market, and plaintiff’s product isn’t a market competitor. Because plaintiff only markets to pharmacists, doctors never choose between Foltx and the “generic” version; plaintiff’s product is no longer generic for Foltx. Pharmacies may have stopped doing business with plaintiff, but they would have done so once defendant changed its formula no matter what the advertising explanation for the change was. Comment: This seems more like a proximate cause argument than a materiality argument, but it is certainly an unusual situation.

Defendant counterclaimed for false advertising in plaintiff’s use of “bioequivalent” and “generic equivalent” in its ads. The basic argument: those terms have specific meaning in the industry, derived from their specific meaning established by the FDCA. Any use of those terms necessarily implies that tests have proved such equivalence, but plaintiff never performed tests. Plaintiff’s claims were therefore literally false – or at best misleading, because they induced pharmacists to violate state laws on prescription substitutions.

So we plunge once again into the murky waters dividing the FDA’s jurisdiction from claims actionable under the Lanham Act. A generic prescription drug will only be approved by the FDA if the maker shows therapeutic equivalence – both pharmaceutical equivalence (composition of active ingredients) and bioequivalence (absorption in the body). The FDA publishes approved generic products in the Orange Book; some states only allow pharmacy-based drug substitution when a generic is in the Orange Book, while others require therapeutic equivalence but do not specifically mention the Orange Book. But medical foods are outside the Orange Book regime.

To avoid preemption, a Lanham Act claim must be resolvable without invoking the FDA’s jurisdiction and expertise. A party can use the FDA’s standards to establish falsity as long as no interpretation of those standards is required. So, a claim of bioequivalence is actionable because that claim can be falsified by showing that tests disprove (or fail to prove) it. However, defendant can’t use the mere fact that plaintiff’s product isn’t in the Orange Book to establish falsity.

Defendant argued that a claim of “generic equivalence” requires the same substantiation as listing in the Orange Book: both pharmaceutical and bioequivalence. Here, defendant offered an industry survey showing that pharmacists don’t differentiate prescription dietary foods from prescription drugs. In fact, the parties agreed that pharmacists and doctors are deeply confused about, or altogether ignorant of, the medical foods category – the CEO of plaintiff’s parent company estimated that 95% of them didn’t know Foltx’s category (and he himself misidentified Foltx as a “nutritional supplement,” which is actually a name for a whole different category of products). But the survey didn’t isolate consumers' opinions about the relevant standards for substituting one medical food for another. Plaintiff argued that defendant’s ads led pharmacists to expect that the FDA had approved equivalence – but any claim that FDA approval was required is preempted by the FDCA.

This leaves us with the usual gap between what the FDCA requires and what people believe. People routinely assume that the FDA regulates more, and more vigorously, than it actually does. They are more likely to assume that advertisers wouldn’t be allowed to make untrue or unproved claims when it comes to food and drugs, and thus more vulnerable to deception.

The court pointed out that defendant relied on the FDA’s regulatory gaps in its own business dealings – an ad for Folbalin stated that Red River was the “sole authorized generic licensee” for Foltx, but explicitly stated that there were no FDA requirements for therapeutic equivalence. As a result, the ad continued, plaintiff’s product shouldn’t be considered a generic of Folbalin or Foltx. As the court noted, this fails to explain how Folbalin could be considered generic to Foltx, since there’s no indication it’s been tested for therapeutic equivalence. Red River – “which seemingly is nothing more than [defendant’s] own operation to create a generic” – is using the regulatory loophole for medical foods, “while at the same time--and in the same advertisement--attempting to close that loophole to exclude competitors by suggesting that their products must be rated therapeutically equivalent to be considered generic.”

Okay, so is therapeutic equivalence the proper standard for whether a substance is “generic” for another substance outside the drug regulatory scheme? Yes, at least if defendant can show that pharmacists understand “generic equivalence” to imply therapeutic equivalence. That would mean that the falsity claim was based on market conditions, not violation of FDA regulations. (Though the market is itself responding to expectations created by FDA regulations of pharmaceuticals.)

Relatedly, what kind of claim is “bioequivalent”? The court found that the term was necessarily a “tests prove” claim, inherently implying substantiation. Thus, it could be falsified either by evidence that the products weren’t bioequivalent, or by evidence that plaintiff’s tests didn’t prove bioequivalence. The FDA typically requires in vivo testing for bioequivalence, but of course that doesn’t apply to medical foods because nothing does. Defendant didn’t offer any evidence of the proper testing standards, but plaintiff itself argued that pharmaceutical equivalence could allow pharmacists to presume bioequivalence. And pharmaceutical equivalence was where plaintiff was in big trouble.

As noted above, one of the active ingredients was missing in at least one test of plaintiff's product, thus flunking pharmaceutical equivalence and bringing the whole “bioequivalent”/“generic equivalent” house down, preventing summary judgment.

Plaintiff argued that, regardless, defendant couldn’t show any actual harm, because other distributors of generic versions of Foltx would have captured the lost sales (recall that many states require substitution of a generic where available). But the court refused to grant summary judgment on this point. Unlike products competing through advertising, where harm can often only be circumstantially shown, plaintiff’s product sold because pharmacists substituted it for Foltx, allowing for a very clear picture of damages.

There is a factual dispute about damages if other generic competitors would have filled in the gaps, but that is for a trial to resolve. Given that defendant showed actual injury, it doesn’t have to prove the hypothetical negative about alternative sources of injury.

My blogging policy

As the IP Works in Progress conference approaches, I thought I should say something about my policy on blogging conferences. I treat conferences as open by default, and so I generally plan to share my notes on presentations. Especially when work is in early stages, though, some people are uncomfortable with this. So I won’t post notes if a presenter asks me – or asks everyone, via announcement or word to the organizers – not to do so. I will not publicize any such requests. If I make a mistake, I will edit or delete posts. Because I have a bad memory – which is part of why I take notes – I probably won’t remember that a person opted out by the time the next conference rolls around, so in general I will treat each conference separately.

Works in progress are just that, and should not be judged by the standards applied to finished work. (And people’s relationship to their finished work changes over time, too; there are some things in print I’d never write again.) But we share unfinished works because they’re useful to other people as well as because we can get good suggestions – it's not a one-way street. And if you’re going to the right conferences, a good number of the people whose opinions matter will be able to judge your presentation for themselves.

Regardless, I suspect legal academia is going to have to learn greater formal appreciation for beta versions – the rise of preprint sites like SSRN is a step in that direction. But I have no interest in defying presenters’ preferences.

The law of the goldfish

When I was searching for a good picture to go with the previous post, I came across a commercial photography site offering to license this picture:
From the description: "This is a high definition [picture] of a bunch of generic goldfish crackers laid out on a black background."

Generic? Are you sure?

Review questions: does selling this stock photo infringe Pepperidge Farm's trade dress rights? Dilute them? What about the description of the crackers as "generic" -- does or should a cause of action exist for genericide?

Sample property release form from the Stanford Libraries' fair use site here.

(Post title adapted from The Law of the Horse -- which, by the way, produces an awesome targeted ad result on Google.)

Interview: Larry Weinstein of Proskauer

Larry Weinstein of Proskauer Rose LLP kindly answered my interview questions, which I have edited to add a few links and a picture. Here is his brief biographical statement:

I am a senior intellectual property litigation partner at Proskauer Rose LLP in New York City, and co-chair of Proskauer’s Trademark and False Advertising practice group. I am a 1978 graduate of NYU School of Law, where I was Articles Editor of the NYU Law Review, Order of the Coif and a John Norton Pomeroy scholar. After a judicial clerkship with Judge James Hunter of the U.S. Court of Appeals for the Third Circuit, I began private practice in 1979, and was a partner at two New York City law firms before joining Proskauer Rose in 1999.

Q: How did you get into advertising litigation?

In the late 1980’s, I began doing trademark litigation for SC Johnson & Son, a large consumer products company in Wisconsin. After a few successful cases, they gave me a false advertising case, and then another and another. My work with that client led to false advertising cases with other clients, and by the mid-1990’s, I found myself spending most of my time litigating and counseling clients in the area of false advertising. That has continued to be the case ever since. I find this area of the law fascinating, so much so that I am one of the very few people around who pay close attention to commercials on days other than Super Bowl Sunday.

Q: Tell us about a favorite advertising case (or cases) you litigated.

I don’t really have a favorite case. For whatever reason, my current cases are always my favorites. If I really had to pick one, and this would be a close call, it would be the “Goldfish” false advertising case several years ago in the Southern District of New York and the Second Circuit. In that case, SC Johnson, the manufacturer of ZIPLOC food storage bags, brought a Lanham Act false advertising suit against its archrival Clorox, the maker of GLAD food storage bags, arising out of Clorox advertising featuring a talking Goldfish that portrayed the Ziploc bags as leaking a sieve. SC Johnson did not find the ads the least bit funny. We succeeded in getting the first ad enjoined after trial, and then won summary judgment enjoining a second ad. On appeal, the Second Circuit affirmed. The case ranks high on my list because we defeated a very good adversary, the case involved some fascinating legal issues, including the so-called “necessary implication” doctrine and whether visual images can be literally false, and because the Second Circuit (and other circuit courts) continue to cite that case, which turned out to be an important one in Lanham Act false advertising jurisprudence.

(Picture by colodio.)

Q: What are some hot legal issues in the courts? What emerging trends in advertising law should advertisers be watching?

In the Lanham Act area, there are several. One involves differences among the circuit courts concerning who has standing to sue under the statute. It is clear that consumers do not have standing, but some appellate courts limit standing to direct competitors, and others, including the First and Second Circuits, extend standing to non-competitors that suffered a business injury caused by the false advertising. And recently, the Eleventh Circuit held that a Burger King franchisee that was a direct competitor of McDonald’s lacked standing to sue McDonald’s for false advertising. That decision, which I was not involved in but have written about, was wrongly decided in my view. One of these days, the right case is going to cause the Supreme Court to grant cert. to decide this issue.

Another interesting issue which the courts have not yet fully dealt with involves statistical significance, particularly what statistical results do and do not enable an advertiser to claim parity.

Third, the necessary implication doctrine is being overextended by some courts to find literally false advertisements that are actually quite ambiguous. That is not a good development in Lanham Act law.

Finally, outside of the Lanham Act, there has been a steady proliferation of state law-based consumer class action false advertising suits. This could turn out to be a revolutionary development, and creates all sorts of different risks and costs for advertisers that has begun to affect how corporate legal advisers assess advertising copy.

Q: Courts have imposed a materiality requirement in Lanham Act false advertising cases, and some have even required specific evidence that a false statement is material – e.g., Pizza Hut Inc. v. Papa John's Int'l, 227 F.3d 489 (5th Cir. 2000). Should trademark law take a cue from false advertising law and require some showing of materiality, for example in source/sponsorship cases?

It’s an interesting question, but I wonder whether the absence of a formal materiality requirement in trademark cases is really a significant problem. Source or sponsorship confusion is typically demonstrated by consumer surveys, and where the confusion is reflected in answers to open ended questions, the importance of the confusion to the survey participant’s assessment of the marks in question is often apparent. It is true, I suppose, that this is not the case where the confusion is demonstrated by close-ended questions. However, the biggest problem with judicial reliance on close ended questions in this context is not materiality, but rather the fact that these questions are so leading. In other words, in my opinion, these questions do not provide an accurate reflection of the extent of consumer confusion at all, much less the extent of confusion likely to affect purchasing decisions.

Q: What is your advice for a law student who wants to practice in the field? Given that most schools don’t teach advertising law, what are the best courses to take?

I can answer the first question easily enough; the second question is tougher. Taking the latter first, a trademark or Lanham Act course would be the best substitute for a course on advertising law. Come to think of it, I wouldn’t mind teaching an advertising course if someone out there wants to offer one. As to the first question, the best advice is to find out through the law firm interviewing process which firms regularly practice in this field, and I emphasize the word regularly here. In fact, surprisingly few firms do. Of those few, New York City has the most, with the remainder primarily in D.C. and Chicago. If a student has the chance to interview with those firms, they should be upfront about their interest, and ask how easy it is to get slotted into this area. If any readers would like more detailed information about how to break into the field, they should email me at lweinstein (at) proskauer.com.

From RT: Thanks again to Larry; I hope to continue this as an occasional series, so reader suggestions are welcome!

Wednesday One-Liners Decry Infringement

Two Overheard in the Office posts on copying in one day!

Sweetener wars reinterpreted as feminist history

From Overheard in New York (ignore the crass headline). Clever, and also up-to-date on the news:

Chick #1: Well, I like to think of Equal as the women's lib of sweetener.
Chick #2: So... What does that make Sweet'N Low? The pre-lib? Feminine mystique?
Chick #1: Yeah... Just look at it -- pink and pretty, sweet, and bowed low. C'mon. It's like, 'Hey, ladies, be sweet and pink for your man -- use Sweet'N Low and stay in shape and he'll love you more!' Then there's Equal -- it's blue, it's bold, it demands attention. It says, 'Yeah, we're an artificial sweetener, marketed towards women, but we're equal!'
Chick #2: Um... Okay, so what does that make Splenda?
Chick #1: I guess post-lib feminism?
Chick #2: Uh, I don't even know what that is...
Chick #1: Well, see, Splenda's in court now because apparently neither does anyone else.
Chick #2: Wow... The history of feminism, as interpreted by Deborah, through artificial sweetener...

color names on the Abercrombie spectrum

Kerr Corp. v. Freeman Manufacturing & Supply Co., 2007 WL 2344752 (N.D. Ohio)

Since the late 1970s, defendant Freeman has developed original formulas for wax products used in molding complicated products. Plaintiff Kerr sold Freeman-made color-coded, flake-form injection waxes for jewelry and optics. In 1984, the parties agreed that Freeman would engage in R&D for wax technology projects proposed in writing by Kerr. Over the next twenty years, Freeman improved seven color-coded injection wax products and developed new waxes, including “NYC Pink” injection wax. Though the term “flake” had been used by Freeman and others throughout the industry prior to these developments, Kerr trademarked “Flakes” in 1999.

Freeman began competing with Kerr; both companies claim to own the underlying formulas for various waxes. Kerr sold the colors at issue as Tuffy Green, NYC Pink, and Flex-Plast, while Freeman began marketing those colors as Tuf Guy Green, Filigree Pink, and Flexible Blue. Freeman refers to its colors as “formerly” Tuffy Green, NYC Pink, and Flex-Plast. Freeman sent letters to customers explaining the changed business relationship between itself and Kerr. Freeman also claimed in those letters that, because it no longer makes waxes for Kerr and hasn’t shared its formulas – which are difficult to reverse engineer – current Kerr waxes may not be chemically identical to Freeman/prior Kerr waxes. Still, some customers at trade fairs have continued to ask about the relationship between the two companies.

Kerr sued Freeman for infringement of Kerr’s color-coding scheme, wax color names, the flake form in which certain wax is sold, and the “Flakes” trademark. There were also claims relating to the technology resulting from the R&D agreement, and Freeman’s alleged false advertising of itself as the owner of that technology. (And here is where I would think there’s an obvious bound on Dastar. No one cares who created the technology; that was Freeman, pursuant to an agreement with Kerr. The parties and their customers care about who owns the technology, which is not the same thing at all. In any event, the court found that Freeman owned the technology and thus was not engaging in false advertising.)

The court readily dismissed Kerr’s claim to own its color scheme. Color is functional for investment waxes; some buyers prefer different colors “because they offer greater ‘readability,’ the ability to detect imperfections in wax moldings.” Some customers also prefer darker or lighter waxes, which are associated with color. Kerr’s claims over basic colors like bright red and deep blue would hamper competition. Similarly, use of the flake form of wax is functional as a matter of law. Some buyers prefer flake-form wax for its technical advantages over other waxes.

The color names required different analysis. Interestingly, the court relied on Qualitex, which is about color itself as protectible trade dress, to analyze these color names, starting from the proposition that color is “virtually always descriptive.” Qualitex itself doesn’t say “virtually” but requires secondary meaning all the time – ORANGE brand computers might be arbitrary, but orange-colored computers would still have to show secondary meaning to be protected as a mark. Anyway, the court found the product names “Super Pink,” “Aqua Green,” “Ruby Red,” and “Turquoise” to be merely descriptive and require evidence of “non-functional secondary meaning.”

The court ruled that Kerr’s ads for “Super Pink” and the like aren’t “intended to identify Kerr as the seller, but rather serve the function of identifying the type of wax being sold.” It would be reasonable for both parties to decide to make a new color, say silver, and advertise it as Silver Injection Wax. Buyers would naturally have to ask “whose silver injection wax?” and only other marks – such as “Kerr’s” – could answer that question. Thus, “these color names are prevented from carrying a secondary meaning because they are descriptive, functional elements of the trade dress of the products.”

This is clearly the right result, but the method has a bit of weirdness to it because the ordinary term for what the court is describing is “genericity.” Although genericity (also formerly known as the condition in which a term is the “common descriptive” name of an article) and functionality serve essentially the same purpose, the tests for them differ. When it comes to unregistered trade dress, plaintiffs have the burden of establishing nonfunctionality, whereas a genericity finding usually requires the defendant to submit a substantial amount of evidence. In general, American law fears that plaintiffs overclaim rights in trade dress, often with an anticompetitive result, but sees no such systematic problem with claims to generic terms. A color name is a core generic term for this type of product, but the court didn’t engage in the ordinary steps for evaluating genericity (dictionary definitions, competitors’ uses, etc.).

Kerr had a few color names that weren’t generic. “Tuffy Green” and “NYC Pink” were “partially arbitrary.” The court also said “tuffy” “suggests resiliency,” which makes it suggestive, but also called the terms “fanciful,” so let’s just say it wasn’t all that concerned with the Abercrombie spectrum – the point is, these are inherently distinctive names.

The court thought this case was especially complicated because the underlying green and pink wax products are the same, as opposed to Nike versus Reebok shoes. I think the court meant that the underlying products are commodities, as opposed to items for which tastes might differ, but I’m not sure what makes that a harder case if we don’t care about whether source is material to consumers, as trademark law generally doesn’t. But that consideration, along with Freeman’s use of its house mark on “Tuf Guy Green” and Freeman’s clarifying letters to customers, meant that the issue of likely confusion was for the jury. “NYC Pink” and “Filigree Pink,” however, were too different to cause confusion. (Notes: The court didn’t consider the effect of “formerly” on the analysis, which could lead to confusion about source or sponsorship of the color formerly known as NYC Pink; its general analysis of the effect of Freeman’s clarifications on sophisticated purchasers would apply. Also, Flex-Plast Blue and Flexible Blue dropped out of the analysis somehow; I’m guessing they’re more like the green than the pink and that summary judgment should be denied.)

There was evidence that customers “asked Kerr employees who Freeman was and why it was selling the flake-form and colored waxes Kerr had long sold.” But this was not the type of confusion with which the Lanham Act is concerned. Indeed, this is evidence that consumers recognized a difference between Kerr and Freeman as direct competitors. Freeman used its website and messages to existing customers to explain that its waxes used to be sold under a third party private label (Kerr) but now would be sold exclusively under the Freeman label. This is the kind of explanation that can clarify matters and guard against confusion. Here we face a tradeoff: it may be that some people will be confused by this literally true explanation of the complicated relationship between the parties. But saying nothing, or disclaiming any relationship between the two, would also risk misleadingness, maybe harming a different set of consumers who want the exact wax Kerr used to sell.

Separately, Kerr’s registered trademark “Flakes” was shown to be generic, through industry use and dictionary definitions. The court ordered it cancelled.

It’s pretty clear that the court was not steeped in trademark law. Sometimes this can produce decisions refreshingly free from doctrinal encrustations; sometimes it can produce error. The court’s apparent concern for whether source was material to consumers is probably error, but arguably trademark law would make more sense if it did consider materiality, as false advertising law does.

Cut and paste as literacy

Dan Perkel, Copy and Paste Literacy: Literacy Practices in the Production of a MySpace Profile -- from the abstract:

The expressive power found in the creation of a MySpace profile concerns a technically simple but socially complex practice: the copying and pasting of code as a way to appropriate and reuse other people’s media products. However, the importance of copying and pasting code does not easily fit in the common conventions of reading and writing, consumption and production. By integrating theories of appropriation and reuse of media with theories of literacy, a new way of thinking about this practice emerges, seeing “participation” and “remix” as important concepts to describe the social and technical aspects of these new literacy practices.

I also found danah boyd's essay on MySpace, Facebook, and the class divide to be quite interesting; it is no surprise that I find Facebook much more consistent with my aesthetic and attention patterns than MySpace. (Nor is it particularly surprising that I think danah boyd should capitalize her name.)