Monthly Archives: May 2017

Washington has mistakenly joined a handful of other states in what appears to be a coordinated effort to battle the First Amendment.

A proposal to prohibit protesters from wearing masks or hoods during demonstrations is so obviously unconstitutional, its a wonder state Sen. Jim Honeyford, R-Sunnyside, thought it was a good idea.

The Legislature already decided to not even give a hearing to a related proposal from Sen. Doug Ericksen, R-Ferndale, earlier in the session. That one would have made it a crime for protesters to cause economic disruption, such as blocking railroad tracks.

The First Amendment is a powerful protection of the right to free speech and all manner of peaceful protest, masked or unmasked. But the people of Washington state already know that.

Lawmakers have much bigger problems to solve right now, such as passing a state budget and answering the Supreme Courts 2012 McCleary decision on school funding.

So why are these bills popping up in our state this year? According to the National Lawyers Guild, anti-protesting legislation is a national trend, partially tied to protests after the presidential election.

Lawmakers in at least 19 states have proposed bills that would criminalize or penalize protesting in various ways. A handful focus on tampering with infrastructure or trespassing. Missouri also proposed a mask law. Among the most alarming bills is one that would remove liability from drivers who accidentally hit and kill protesters.

Washington is used too often as a proving ground for ideas from out-of-state hyperpartisan groups from protest bills on the right to Democracy vouchers on the left, which were embraced by Seattle but rejected by statewide voters.

The mask bill would make it illegal for someone to stand on a sidewalk, road, alley or any public area with his face covered, but it grants religious and holiday exemptions.

Would the bill exempt people who wear heavy makeup because they are making a choice to alter their appearance? What if someone decides to cover her face for modesty or health reasons, but is not associated with any religion?

Just like Sen. Ericksens bill, Honeyfords bill should not get a hearing in any legislative committee. Lets cut the marionette strings and prevent coordinated attacks on the First Amendment from gaining a foothold in Washington state.

Excerpt from:
Attacking the First Amendment with mask bill is wrong and a waste of legislators' time - The Seattle Times

In a landmark case, lawyers are claiming religious freedom to defend doctors facing charges for performing FGM on seven-year-olds in Michigan.

Two doctors in Detroit, along with one of their wives, are about to take the first religious defense of female genital mutilation to a US Federal court. The case stems from a FBI investigation into Dr. Jumana Nagarwala after the authorities received a tip that the physician was performing the procedure on young girls.

According to the original criminal complaint, the investigation revealed that Nagarwala allegedly performed FGM on two seven-year-old Jane Does, who had travelled from Minnesota with their families. When interviewed by the FBI, one girl said her parents told her she was going Detroit, along with the other child, for a "special girls' trip." After they arrived at the hotel, the girls said their parents took them to the doctor "to get the germs out" of their stomachs. One of the girls described what happened at the clinic, after she took off her pants and underwear, as a "pinch" on "the place [where] she goes pee." The other unnamed girl said that after she took off her pants and underwear she "got a shot," and then could barely walk.

Read more: Female Genital Mutilation and the Women Who Practice It

A winter glove that belonged to one of the girls was recovered at the clinic Nagarwala is said to have operated from. After obtaining a search warrant, an independent medical doctor performed an examination on one of the girls and found that "her clitoral hood has a small incision, and there is a small tear to her labia minor." It was later found that several other girls have allegedly been taken to Nagarwala for genital cutting. Charges have also been brought against the doctor who is accused of allowing Nagarwala to use his clinic, Dr. Fakhruddin Attar, and his wife, who allegedly was present during the procedures, according to the Detroit Free Press.

The publication also reports that Attar's lawyer, Mary Chartier, is planning on arguing that FGM is constitutionally protected under the First Amendment. The defendants are all a part of the Dawoodi Bohra community, which is an Indian Islamic sect. FGM is illegal in the United States, but Chartier says that the law is "unconstitutionally vague and overly broad." She also makes a distinction between FGM and the procedure that the Nagarwala allegedly performed.

"We know there is female genital mutilation. No one is saying it doesn't exist. But what we're saying is this procedure does not qualify as FGM," Chartier told the Detroit Free Press. "And even if it did, it would be exempt because it would violate their First Amendment rights. They believe that if they do not engage in this then they are not actively practicing their religion."

Nicholas Little, the legal director at the Center for Inquiry, doesn't think this argument will hold up. "It is important to note that there's no constitutional right to an exemption from a law of general applicability based on religious belief," he told Broadly. "Under the Religious Freedom Restoration Act, however, a person is entitled to an exemption if they can show that the law substantially burdens their exercise of a sincerely held belief." He adds that an exception can be denied if the government has a compelling interest to do so, which in this case would clearly be "the protection of a seven-year-old child from an abusive procedure."

"While courts have become more willing to grant religious exemptions, I find it very unlikely they will do so to permit this to be done to a child," he explained. "Initially, such exemptions were only sought and granted for self impacting actionssuch as, for example, a Native American using peyote in a religious ceremony. The Supreme Court, in Hobby Lobby, dramatically and wrongly, in my opinion, extended this, allowing a religious corporation to opt out of a law when such an opt out would cause harm to a third party, the women denied access to free contraception. However, this would be a major step further, to allow direct harm to a child."

Rana Elmir, the deputy director of the ACLU of Michigan, agrees that freedom of religion "doesn't allow any of us to ignore laws protecting people from harm," adding that "[this] question before the court is not new."

Read more: How Islamophobia Hurts Muslim Women the Most

She cautions that this case should not be exploited to fuel Islamophobia in the US. "FGM is often erroneously connected to Muslim communities, when in fact it is a cultural practice. It is practiced by a limited number of adherents of the Muslim, Christian, and Jewish faiths, as well as some animists," Elmir said. "However, in the days after these charges came to light, legislators in Michigan introduced an anti-international law bill. While this bill itself may seem innocuous, it was clear by the sponsoring legislator's remarks that the bill was intended to block Sharia law, baselessly connecting sharia to the practice of FGM."

Indeed, many women from the Dawoodi Bohra sect have spoken out against the practice and described the harm it has caused them. Within the community it is referred to as khatna and forced on girls for "religious purity." Sahiyo, an anti-FGM organization which promotes an education-based approach to end the practice, was founded by a Dawoodi Bohra woman who underwent FGM as a resource for other survivors; the organization, too, has expressed concern about the Detroit case being used to expand surveillance of Muslim Americans.

"We have the absolute right to believe whatever we want about God, faith, and religion, and we have the right to act on our beliefs. But there's a distinct line drawn when those actions hurt others," Elmir said. "At the same time, we must also reject those who seek to exploit tragedy for political gain. While legislators may be driven by a desire to protect children, measures such as the anti-international law bill, are misguided, unnecessary and only serve to hurt and divide our communities by scapegoating and discriminating against Muslims, who have widely and vocally rejected this practice."

View post:
Doctors Argue That Female Genital Mutilation Is Protected Under First Amendment - Broadly

Now that Dr. Scott Gottlieb is safely installed as FDA Commissioner, we at DDLaw can end our moratorium on blogposts about First Amendment issues. There was no way we wanted to give his opponents any ammunition by saying nice things about Dr. Gottlieb before his confirmation.

Not so now.

Given what Dr. Gottlieb has said and is saying we doubt that the FDAs absolutist ban on truthful industry speech about off-label uses (pejoratively called promotion) will continue much longer in its current form. For instance, on the FDAs website, Dr. Gottlieb is quoted here as giving a speech saying:

The question we need to ask ourselves is this: Should a patient receive one or even two-year-old care just because the wheels of my government institution and its meticulous work may take longer to turn than the wheels of clinical science? Some people believe that patients should be treated only according to the clinical evidence included in a drugs approved indications. Yet this evidence may be two or maybe three years old, especially in a fast-changing field like cancer, where off label use of medicines provide important opportunities for patients to get access to the latest clinical practice and for doctors to tailor their patients treatment plans based on medical need and personal preferences.

Efforts to limit prescription and scientific exchange to indications only specified on a label could retard the most important advances in 21st century medicine. The development and deployment of drugs is becoming more and more closely linked to understanding of mechanism of action, which means that physicians can use drugs in more sophisticated ways that cannot all be anticipated on a label, or easily or quickly studied in prospective studies. . . . More important, medicine is becoming more personalized as tools like genomics make it possible to tailor treatments on an individual basis. Physicians will not be able to always wait for FDA to approve a new label for every one of their patients, and drug companies will not be able to conduct a trial to explore every possible contingency. In the future, personalization of care could mean that we will have much more off-label use of new medicines, guided by the latest literature, at least until our regulatory approaches are able to fully adapt to a different paradigm where treatment is highly specific to individual patients. Yet policy forces are tugging in exactly the opposite direction by placing restrictions on the exchange of some of the most pertinent information.

(Emphasis added). Defendants in cases involving off-label-use-related allegations should consider having their FDA experts review and, if appropriate, rely upon the current FDA Commissioners positions particularly to rebut contrary views offered by former FDA officials.

Dr. Gottliebs non-FDA writings show similar solicitude for scientific speech whether or not that speech originates with FDA-regulated manufacturers. In an article for the American Enterprise Institute, Dr. Gottlieb criticized FDA policies that prohibited a manufacturer with a drug undergoing supplemental FDA approval for a new use from distributing the findings or educating doctors on the new use through sponsored medical education. [A] more measured approach to the regulation of promotion would allow sharing of useful information that falls within the bounds of appropriate clinical care.

Those who pursue a rigid adherence to restrictions on the exchange of off-label information, and who fail to recognize that the sharing of scientific evidence can sometimes have important public health benefits, are guilty of pursuing a rigid standard that does not take measure of the consequences. . . . [E]stablishing the FDA label as the only determinant for acceptable scientific speech loses sight of the fact that these labels are slow to incorporate important medical results about the effectiveness of medical products. They are not the sole basis for medical practice.

In another AEI article a few years later shortly after the government lost United States v. Caronia, 703 F.3d 149 (2d Cir. 2012) Dr. Gottliebs criticism of the FDAs prohibition of truthful speech about off-label uses was even more pointed.

When this [off-label] speech is truthful, nonmisleading, and promulgated in an educational context, it is quite possible that the speech would be deemed constitutionally protected by the courts under doctrines that recognize commercial speech as being subject to First Amendment considerations.

(Footnote omitted). Basically, Dr. Gottlieb took issue with whether scientific speech concerning off-label uses could ever be considered illegal promotion:

A core principle of Americas constitutional speech protections is that the government should not establish what is orthodox, especially when it comes to politics, the arts, religion, and science. The founders recognized that these matters are by their nature iterative, and that it would be dangerous in a democratic society for the government to use its resources to pick a side in these debates. Matters that are subject to their own evolution a core feature of how new science unfolds are better addressed by adding voices to the debate, not suppressing them.

Dr. Gottlieb even urged FDA regulated manufacturers to stand up and challenge the constitutionality of off-label informational restrictions promulgated by the FDA the agency he now leads:

[T]he drug industry needs to be willing to take the prerogative to challenge the facts in some of these cases and have that day in court. When investigations turn on the sharing of truthful, nonmisleading information about widely accepted uses of drugs, in fast moving fields like cancer, there is a legitimate question about whether public health is being served by suppressing this sort of information. However, until these cases are challenged in court, there will remain ambiguity around where the appropriate lines rest, what speech is constitutionally protected commercial speech or clearly violative, and how public health is best served.

(Emphasis added). Not long after that, a company took up Dr. Gottliebs challenge, and the result was Amarin Pharma, Inc. v. FDA, 119 F. Supp.3d 196 (S.D.N.Y. 2015).

To some extent, where one stands depends upon where one sits, but Dr. Gottlieb has enough of a track record on truthful manufacturer speech about off-label uses of drugs and medical devices, and the constitutional and medical implications of suppressing it, that we are more hopeful now than we have ever been that the FDA will see reason, respect the First Amendment, trust physicians, and change its science-suppressing ways.

With that in mind, we examine the newest First Amendment precedent rejecting governmental prohibition of a manufacturers truthful speech about its product, Ocheesee Creamery LLC v. Putnam, 851 F.3d 1228 (11th Cir. 2017). Ocheesee is a food (skim milk) case, but doesnt involve the FDA it doesnt even involve the federal government. Instead, Ocheesee is a demonstration that, when given the chance, state regulators are still equally capable of behaving just as badly towards the First Amendment as the feds, albeit on a smaller scale.

It may be that Ocheesee doesnt involve interstate commerce, see 851 F.3d at 1231 n.1, or it may be that there is something peculiar about milk regulation that we dont know, but the State of Florida (not the FDA or any other federal entity) came down on the plaintiff, described as a small dairy creamery located on its owners farm that sells all-natural dairy items, like a ton of bricks. Id. Apparently, the process of skimming the cream from whole milk depletes almost all the vitamin A naturally present in whole milk because vitamin A is fat-soluble and is thus removed with the cream. Id. Thus Florida agricultural regulations require vitamin A to be added to skim milk before it can be sold as skim milk. Id.

That was a problem for the plaintiff because, as a matter of philosophy, this business prides itself on selling only all-natural, additive-free products. Id. It therefore refuse[d] to replace the lost vitamin A in its skim milk with a vitamin A additive as Florida law required. Id. The State of Florida thus prevented the plaintiff from calling its product skim milk, even though that product contains no ingredients other than skim milk. Id. Instead (and ironically) the state sought to require the plaintiff to call its product imitation milk. Id. at 1232. Not surprisingly, the plaintiff refused and sued instead.

Readers attuned to the First Amendment no doubt see the problem already. Calling such a product skim milk is truthful. The State of Florida like the FDA with truthful off-label speech sought to suppress the plaintiffs truthful speech in a commercial context, using the public health (vitamin A is not just good for you, but essential to health) as its reason for doing so. Who wins the First Amendment right to engage in truthful commercial speech, or the states public-health-based rationale for suppressing such speech?

In Ocheesee, freedom of speech prevailed. 851 F.3d at 1233 (The sole issue on appeal is whether the States actions prohibiting . . . truthful use of the term skim milk violate the First Amendment. We hold that they do.).

First, the lay of the constitutional land. Ocheesee applied the now-venerable Central Hudson intermediate scrutiny test for constitutionality of governmental restrictions of commercial speech. 851 F.3d at 1233 (citing Central Hudson Gas & Electric Corp. v. Public Service Commn, 447 U.S. 557, 563-64 (1980)). Thus, Ocheesee did not apply the more speech protective tests enunciated in Sorrell v. IMS Health Inc., 564 U.S. 552 (2011) (heightened scrutiny) (see our discussions here, here, here, and here); and Reed v. Town of Gilbert, 135 S.Ct. 2218 (2015) (strict scrutiny) (see our discussion here). That doesnt mean that the Eleventh Circuit was unaware of these cases quite the contrary:

There is some question as to whether under the Supreme Courts decisions in Sorrell and Reed an analysis to determine if the restriction is content based or speaker focused must precede any evaluation of the regulation based on traditional commercial speech jurisprudence, and if so, whether this would alter the Central Hudson framework. In Sorrell, the Supreme Court found the restriction at issue to be content based but nevertheless cited, articulated, and applied the Central Hudson test. And in Reed, the Court arguably broadened the test for determining whether a law is content based. . . . We need not wade into these troubled waters, however, because the State cannot survive Central Hudson scrutiny, and in any event the [plaintiff] does not argue the States restriction was content based or speaker focused.

851 F.3d at 1235 n.7. Thus, the favorable First Amendment decision in Ocheesee sets a floor for the protection of truthful commercial speech in the Eleventh Circuit that parties arguing Sorrell and Reed may exceed.

Under the Central Hudson criteria, as a threshold question, the government (which always has the burden of proof) had to establish that the suppressed speech either concerned unlawful conduct or was false or inherently misleading. 851 F.3d at 1235-36. It failed because selling the plaintiffs product was not unlawful the state would have allowed its sale under the imitation description. Id. at 1237. Note the parallel to off-label speech doctors are free to engage in off-label use, and products so used may be lawfully sold. [T]he only difference between the two courses of conduct is the speech. Id.

Nor could the speech be considered false or misleading. The state could not simply define a product in whatever way it chose, and declare anything not meeting that definition misleading. The court rejected such self-evidently circular reasoning:

Such a per se rule would eviscerate Central Hudson, rendering all but the threshold question superfluous. All a state would need to do in order to regulate speech would be to redefine the pertinent language in accordance with its regulatory goals.

Id. at 1238. Again, any resemblence to the FDAs salami slicing of intended uses is entirely intentional. Consumer unfamiliarity is not synonymous with misinformation. Id. at 1239 (citation and quotation marks omitted).

Next up in Ocheesee was the three-pronged intermediate scrutiny Central Hudson test: (1) was the asserted governmental interest substantial? (2) did the regulation directly advance the that substantial governmental interest? And (3) was the restriction on speech more extensive than is necessary to serve that interest? 851 F.3d at 1235-36.

As in off-label promotion cases, the substantiality of the governments interest in combating deception and in establishing nutritional that is to say product safety and effectiveness standards was concededly substantial. Id. at 1240. Ocheesee jumped over the second prong and went right to the third, because the measure is clearly more extensive than necessary to achieve its goals. Id.

In all commercial speech cases, the preferred remedy is more disclosure, rather than less. Id. (Supreme Court citation omitted). Floridas flat ban on use of the term skim milk failed because a disclaimer would serve the same purpose in a less restrictive and more precise way. Id. [A]llowing skim milk to be called what it is and merely requiring a disclosure that it lacks vitamin A was sufficient to serve [the state] interest in preventing deception and ensuring adequate nutritional standards. Id.

The First Amendment thus prevailed where the speech is truthful without the court going even having to go to the trouble of relying on heightened (Sorrell) or strict (Reed) scrutiny, both of which would be argued in truthful off-label speech cases. Visions of shattered backboards come to mind. We dont think Dr. Gottlieb wants the FDA to end up like Bill Robinzine, so were looking for a more reasonable off-label speech policy to emerge from the FDA, before a court has to do so for the agency.

Read the original:
Speaking of the First Amendment. . . . - Lexology (registration)