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Court Loss Should Deter Speech Restrictions on Plant-Based Product Names

WLF Legal Pulse - Wed, 01/29/2020 - 12:36pm

In a decision you may have missed during this past holiday season, commercial speech and common sense prevailed when the U.S. District Court for the Eastern District of Arkansas held in Turtle Island Foods SPC d/b/a Tofurky Co. v. Soman that the State could not impose what it thought was the best way to name plant-based meat substitutes. An Arkansas statute would prohibit plant-based-product companies’ use of words on their labels that are “traditionally associated with animal-based meat”—think, “burger,” “chorizo style sausage,” or “deli slices.” Judge Kristine Baker issued a preliminary injunction after determining that the plaintiff, Tofurky, is likely to prevail on the merits of its First Amendment claim.

Tofurky is, as the court put it, a “social purpose corporation” that produces plant-based, vegan or vegetarian meals, often in the form of traditional meat dishes. It labels its products using meat-based terms like “Veggie Burger,” “Slow Roasted Chick’n,” and “Polish-style wheat gluten and tofu sausages.” Each label clearly identified the product as vegan or vegetarian and features the letter “V,” which is widely understood to mean the product is vegan or vegetarian. The Arkansas legislature concluded that such labels mislead consumers, and passed Act 501 to clear up the supposed confusion. It prohibits “[u]tilizing a term that is the same as or similar to a term that has been used or defined historically in reference to a specific agricultural product.” Ark. Code. Ann. § 2-1-305.

Tofurky filed a motion for declaratory and injunctive relief, arguing that Act 501’s labeling provisions infringe upon its First Amendment right to share truthful and non-misleading information about its products and would actually create more consumer confusion than alleviate it.

The District Court considered, among other factors, the likelihood that Tofurky would succeed on the merits of its First Amendment challenge. It applied the Supreme Court’s four-part Central Hudson test. Under Central Hudson, courts consider whether: (1) the commercial speech at issue concerns unlawful activity or is misleading; (2) the government has a substantial interest in regulating the speech; (3) the regulation directly and materially advances the government’s substantial interest; and (4) the regulation is not “more extensive than is necessary to serve” the asserted interest. See Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557, 566 (1980).

The District Court began its analysis by “considering the label as a whole” and determining whether “‘an ordinary consumer would [ ] be deceived’ as to the nature of the product.” Turtle Island Foods SPC d/b/a Tofurky Co. v. Soman, No. 4:19-cv-00514-KGB, 2019 WL 7546141, at *12 (E.D. Ark. Dec. 11, 2019). It stated that, under the first prong of Central Hudson, unless the speech is “inherently misleading” or related to “unlawful activity,” the government has limited power to restrict the speech and the court should conduct a full Central Hudson analysis. Arkansas argued that terms like “Veggie Burger” were inherently misleading and thus deserved no constitutional protection. The court disagreed, concluding that “the simple use of a word frequently used in relation to animal-based meats does not make use of that word in a different context inherently misleading.” Id. at *11.

On the second prong, the court assumed without deciding that the State does have a substantial interest in “protect[ing] consumers from being misled or confused by false or misleading labeling of agricultural products that are edible by humans.”

The third prong requires the regulation to directly advance that interest. Because the court determined that Tofurky’s labels are neither false nor misleading, the Act does not actually alleviate consumer deception and misinformation. The Act also failed the fourth prong as its “blanket restriction is far more extensive than necessary.” Id. at *13. The court noted that Tofurky pointed to several federal and state laws that already prohibit deceptive labeling and marketing of food products, but the State failed to demonstrate why those laws are inadequate. And the court found that less restrictive alternatives did exist, such as requiring “more prominent disclosures of the vegan nature of plant-based products.” Id.

Judge Baker’s decision is just the first step in Tofurky’s legal challenge, but it positively highlights the strength of plant-based-product producers’ constitutional arguments against such labeling restrictions. Unfortunately, one federal court’s preliminary ruling is unlikely to deter other States from attempting to save reasonable consumers from themselves. For instance, a Washington legislator has introduced a bill aimed at “Veggie Burger” and other meat-alternative terms he finds objectionable and misleading.

And paternalistic legislators, often egged on by industry competitors, aren’t stopping at meat alternatives. Plant-based milk alternatives, which prominently use descriptive adjectives such as “almond,” “soy,” and “hemp” in front of the work “milk,” have come under fire. In Oklahoma, a state representative introduced legislation that would limit the use of the word “milk” to only that which is “produced by mammals with hooves.” Our View: Milk-label Bill Better Suited for Compost Bin than Legislative Committee, Muskogee Phoenix (Jan. 19, 2020). A Kentucky State Senator introduced a similar bill, Senate Bill 81, which would also restrict the use of the word “milk” to only refer to that which comes from a hooved animal. See John Cheves, Don’t Call It ‘milk’ If it Doesn’t Come from a Hooved Mammal, KY Senator Says, Lexington Herald Leader (Jan. 16, 2020). These are examples of at least eleven states that have enacted similar laws in recent years targeting plant-based alternatives to meat and dairy. Id. Even a group of federal legislators have joined the chorus, signing a letter to FDA’s Commissioner that urges the agency to “ensure that dairy terms may only be used to describe products that include dairy.” Sylvan Lane, Senators Ask FDA to Crack Down on Non-Dairy Milks, Cheeses, The Hill, Jan. 24, 2020.

Legislators and regulators have the authority to combat speech that is truly misleading, though we’d prefer that unclear labeling be remedied through more speech, not less. And they certainly shouldn’t be embracing cures that are worse than the alleged disease—laws that create confusion where reasonable consumers wouldn’t be confused in the first place. Thankfully we have the First Amendment, and its faithful application by judges like Judge Baker, to help remind our elected officials and unelected regulators of those basic principles of lawmaking and regulation.

Also published by Forbes.com on WLF’s contributor page.

The post Court Loss Should Deter Speech Restrictions on Plant-Based Product Names appeared first on Washington Legal Foundation.

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SBA Management Review: Office of Field Operations

House Small Business Committee News - Wed, 01/29/2020 - 11:30am

The Committee on Small Business will hold a hearing titled, “SBA Management Review: Office of Field Operations.” The hearing is scheduled to begin at 11:30 A.M. on Wednesday, January 29, 2020 in Room 2360 of the Rayburn House Office Building.

The SBA’s 68 district offices and ten regional offices are the point of delivery for most SBA programs and services. They work to accomplish the SBA mission by providing quality service to the small business community; and work with SBA resources partners, other partners and intermediaries. The Office of Field Operations is responsible for overseeing these offices to ensure the agency meets its mission to serve small businesses and entrepreneurs all over the nation. This hearing will provide Members the opportunity to learn more about the office and review its structure and performance.

To view a livestream of the hearing, please click here. 

Hearing Notice 

Hearing Memo 

Witness List 

Mr. Michael A. Vallante
Associate Administrator
United States Small Business Administration
Washington, DC

*Witness testimony will be posted within 24 hours after the hearing’s occurrence


WLF Urges Fourth Circuit to Vacate Trial Court’s Grab at Agency Rulemaking Power

WLF Legal Pulse - Tue, 01/28/2020 - 12:31pm

“Having concluded that the deadline at issue here was a legislative rule, the trial court was in no position to set a new deadline, thereby assigning the legislative role to itself.”
—Corbin K. Barthold, WLF Senior Litigation Counsel

Click here for WLF’s brief.

(Washington, DC)—Washington Legal Foundation today filed an amicus curiae brief urging the Fourth Circuit to vacate a trial-court order that amounted to a de facto administrative rulemaking.

A 2016 FDA rule ordered e-cigarette companies to apply, by 2018, for permission to continue selling their products. In part to ensure that e-cigarettes remain available to people trying to stop smoking, the FDA in 2017 issued guidance extending the application deadline to 2022. A group of doctors and public-health groups attacked the guidance in court, arguing among other things that the new deadline should have undergone notice and comment. The trial court agreed with this argument and vacated the guidance. But rather than simply remand the matter to the agency, as the law usually requires, the trial court proceeded to set a new deadline—May 2020—itself.

WLF’s brief argues that the trial court had no authority to set a new deadline. A court reviews agency action only as an appellate tribunal. After vacating an agency’s decision, therefore, a court should remand the matter to the agency for further proceedings. The trial court cited deviations from this remand-only rule, but in all of them the agency appeared to be acting in bad faith. That is not this case.

The trial court, WLF’s brief continues, dove headfirst into a policy matter that touches on deep questions of science, economics, statistics, public health, and moral principle. The court co-opted the democratic branches’ policymaking role. The court’s remedy order should be vacated, so that the trial court can remand to the FDA for a notice-and-comment rulemaking that sets a new deadline.

Celebrating its 43rd year as America’s premier public-interest law firm and policy center, WLF advocates for free-market principles, limited government, individual liberty, and the rule of law.


The post WLF Urges Fourth Circuit to Vacate Trial Court’s Grab at Agency Rulemaking Power appeared first on Washington Legal Foundation.

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Teen Vaping Is Bad. So Are Many Ad Campaigns Against Teen Vaping.

WLF Legal Pulse - Mon, 01/27/2020 - 12:50pm

Bright children are often skeptical of authority. They spot early on that many adults are stupid, and that the self-righteous ones are reliably the stupidest of all. The most strenuous posturing, they quickly realize, is usually the most spurious as well.

The young’s awareness that the old don’t know what they’re doing is a central theme of the television show South Park. Take the episode “Butt Out,” in which the show’s protagonists, four fourth-grade boys named Stan, Kyle, Cartman, and Kenny, are made to attend an anti-smoking assembly. Wearing baseball caps at odd angles, the adult speakers inflict on their audience a nauseating medley of obtuse raps and role-plays on the dangers of cigarettes. The effects of smoking are “none to the cool,” one of them declares at the end. “Word!” replies another. “If you don’t smoke, you could grow up to be just like us!” they all then shout. Alarmed at this prospect, the boys hurriedly procure some cigarettes and try to smoke them in a back alley.

Anti-tobacco campaigners try ever so hard to be hip. No one tries harder than the Truth Initiative. They employ outdated internet memes, puppets mimicking the Breakfast Club, and zombies harassing innocent store clerks. Their actors can be awkward and theatrical, their messages ham-handed and overwrought. Their more cringeworthy efforts seem, at least to this captious grown viewer, almost to shout at the Stans and Kyles of the class to give smoking a chance. Badly designed ads can indeed have such a rebound effect. To their credit, however, the Truth campaigners have largely avoided this trap. Their ads revolve around teens having substance-free fun, and the evidence suggests that such ads can work.

South Park’s “Butt Out” assembly isn’t just condescending; it’s hypocritical and illogical. The speakers tell the students not to believe “what those evil tobacco companies tell you,” but they also imply that smoking leads to abortion and AIDS. It’s a slightly exaggerated take on the very real tendency of anti-tobacco activists to flaunt a self-assured fury at the lies of others while peddling deceits of their own. A person is playing fast and loose with causation, for example, if she tells you that “Big Tobacco” sells a product that “created” a 20% “wage gap” between smokers and non-smokers.

These days the dubious claims are about vaping. Many ads denounce the Juul pod for containing as much nicotine as 20 cigarettes, even though each pod is meant to provide many cigarettes’ worth of vaping time. Other ads emphasize that people who vape are more likely to try smoking—causation versus correlation be damned. An ad produced by the State of California depicts vaping teens as terrifying rage monkeys, as though nicotine, which the ad calls “brain poison,” were PCP.

Manufacturing a cool image to stop teens from smoking is one thing; broadcasting half-truths to stop them vaping is another. Sadly, the teen vaping rate is rising. But the teen smoking rate is still falling—faster than ever, in fact—and it’s a good, even if not ideal, thing if teens switch from the one vice to the other. “No one knows the long-term effects of Juuling,” warns one ad. True enough, but those long-term effects, whatever they are, will almost certainly be better than the long-term effects of smoking. The Royal College of Physicians has found, for instance, that “the hazard to health arising from long-term vapour inhalation from e‑cigarettes” is “unlikely to exceed 5% of the harm from smoking tobacco.”

According to Pew Research Center, more than two-thirds of Americans believe that the federal government “intentionally withholds important information from the public.” Well, the federal government does not sponsor ads that say vaping is likely safer than smoking, and that urge smokers to switch to e‑cigarettes. No, it sponsors ads that make vapor particulates look worse than the Ebola virus. It’s a wonder the level of distrust is not higher.

A recent study published in the New England Journal of Medicine found that e‑cigarettes were “more effective for smoking cessation than nicotine-replacement therapy.” The advent of e‑cigarettes could save countless lives. Forward-thinking policymakers love “harm reduction” when the drug in question is heroin. Why do these tolerant Bohemians become prohibitionist Victorians when they turn to nicotine? Why does San Francisco distribute free needles but bar the sale of vaping products?

It can’t be that black-market pods filled with THC have recently caused thousands of injuries and dozens of deaths. Although nearly 50,000 people died from opioids in 2017, San Francisco’s leaders are pushing not for stricter bans, but for safe-injection sites. And pushing drugs off the black market was presented as a ground for expanding access to legal marijuana. (So far, by the way, the plan hasn’t worked. It turns out that a well-established black market can outcompete a legal market smothered in red tape and taxes. Who’d have guessed.)

Part of the problem is surely that the vaping industry is dominated by a few large companies, including traditional tobacco companies. The politicians who run our big cities think of themselves as belonging to the party of science. Sometimes it is better described as the party afraid that someone, somewhere, might be turning a profit.

In the end, however, the issue seems cultural. Many societal disputes pit the top and the bottom against the middle. In this instance the top set the drug laws, the bottom shoot heroin, and the middle vape. (All three smoke marijuana.) As in days of old, the nobility looks after the peasantry but hates the bourgeoisie.

Put another way, our professional and political optimates celebrate diversity until they don’t. One exotic creature, the average inhabitant of the American hinterland, they fear and disdain. They want to silence and control him. And when they picture someone vaping, they picture him. South Park captures the pertinent attitude and approach in a satirical exchange between Rob Reiner, the Hollywood director and activist, and an everyman smoking in a rural bar:

Reiner: Oh my God! Excuse me!

Rural man: Yes?

Reiner: Would you mind putting that death stick out?

Rural man: But, uh, this is a bar.

Reiner: Isn’t smoking illegal in bars here?

Rural man: Not in Colorado.

Reiner: Oh my God! What kind of backward hick state is this?!

Rural man: Look man, I work fourteen hours a day at a saw mill. I just got off work and I need to relax.

Reiner: Well when I relax I just go to my vacation house in Hawaii!

Rural man: I ain’t got a vacation house in Hawaii.

Reiner: Your vacation house in Mexico, then; whatever!

Reiner then declares that he will end smoking in Colorado bars. “Isn’t he awesome, you guys?” Cartman, the notorious junior fascist, remarks, awestruck, to his friends. “He just goes around imposing his will on people.”

Everyone takes for granted that teen vaping is bad. No doubt it is—all things being equal. But as Matt Stone, one of South Park’s creators, once said, the young are “not nice, innocent, flower-loving little rainbow children.” Many teens will commit a few offenses precisely because they’ve explicitly been told not to commit them. It is worth asking, therefore, not whether vaping is dangerous, but whether it is dangerous relative to other forbidden fruits. If a defiant teenager is bent on breaking the rules, and his options for doing so are snorting cocaine, smoking weed, binge drinking, smoking tobacco, huffing solvents, or vaping, do we want him convinced that vaping is the most hazardous option?

The alternative to thinking this way is to assume that with the right set of policies and the right educational campaigns, we can suppress risk-seeking behavior among adolescents. Put to one side whether, teens being what they are, we actually could do that. Would we want to? Would we want kids not to question the po-faced adults? It’s hard to know. This much, however, can confidently be said: those who argue for making children safer and more docile will always have the upper hand. Anyone with a puritanical streak can trot out the figures on how many teenagers are engaged in, or hurt by, this or that sin. The consequences of making the young risk-averse and unadventurous, meanwhile, are indirect and diffuse.

A mother whose teenage son gets drunk and falls from a balcony will not agree that his death was the price of maintaining the nation’s daring pioneer spirit. Nor should she. She will probably no longer see a dose of rebellion as a good in itself. Nor need she. But that’s not the end of it. The logic by which safety beats freedom has legs. One can plausibly attack any youth activity that creates modest risks and offers only vague benefits. Children certainly don’t need to wrestle or tackle, to throw dodge balls or head soccer balls, to roll on skateboards or sway on swings, to eat candy or drink soda, or to play violent video games. They don’t even need to keep score or win real prizes. So where is the line?

That’s a fraught question. The parents and communities raising the next generation of citizens must grapple with it. And whatever their elders do, the young, now as ever, will have to figure a lot out for themselves.

To the groups that run lavishly funded ad campaigns, however, there probably is no line. When such organizations achieve their mission, will they close their doors? Of course not. They will find another dragon to slay. They will go on burlesquing teenage catchphrases and taking liberties with statistics. They will tackle the next cause, and the next, and the next, until the kids are being lectured about the perils of loud music and stairs.

Also published by Forbes.com on WLF’s contributer page.

The post Teen Vaping Is Bad. So Are Many Ad Campaigns Against Teen Vaping. appeared first on Washington Legal Foundation.

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No Redress: Future Generations’ Overheated Climate-Related Suit Doesn’t Stand

WLF Legal Pulse - Mon, 01/27/2020 - 11:57am

Lawrence S. Ebner is founder of Capital Appellate Advocacy PLLC, a boutique law firm in Washington, DC that provides independent appellate advocacy for businesses and industries throughout the United States.*

On January 17, 2020, climate-change activists ran into a man-made constitutional roadblock called the separation of powers. A Ninth Circuit panel composed of three Obama appointees held in a 2 to 1 decision that the plaintiffs in the so-called “Kids’ Climate Suit” lack standing to proceed with their claim that the federal government has violated their supposed constitutional right “to a climate system capable of sustaining human life.” Juliana v. United States, Op. at 11.

Although sympathetic to the plaintiffs, the panel majority concluded that the “redress” they sought—“an order requiring the government to develop a plan to ‘phase out fossil fuel emissions and draw down excess atmospheric CO2’”— is “beyond [the court’s] constitutional power.” Id. The majority indicated that instead, “the plaintiffs’ impressive case for redress must be presented to the political branches of government,” i.e., the elected branches, Congress and the President. Id.

The plaintiffs were “twenty-one young citizens, an environmental organization, and a ‘representative of future generations.’” Id.  They “accuse[d] the government of continuing to ‘permit, authorize, and subsidize’ fossil fuel use despite long being aware of its risks, thereby causing various climate-change related injuries to the plaintiffs.” Id. at 12. Their alleged injuries include psychological and physical harm, recreational impairment, and property damage.

During an earlier phase of the case, the Supreme Court, when denying the government’s request for a stay of proceedings, noted that the “breadth of respondents’ claims is striking . . . and the justiciability of those claims presents substantial grounds for difference of opinion.” Id. at 13.

Plaintiffs’ Broad, Policy-Based Claims Not Redressable By Courts

The legal issue before the court of appeals was whether the plaintiffs have constitutional standing to pursue their claims. It is well established that “[t]o have standing under Article III, a plaintiff must have (1) a concrete and particularized injury that (2) is caused by the challenged conduct and (3) is likely redressable by a favorable judicial decision.” Id. at 18. The panel found that the plaintiffs satisfied these first two prongs: (1) “at least some of the plaintiffs have presented evidence that climate change is affecting them now in concrete ways and will continue to do so unless checked”; and (2) “the causal chain here is sufficiently established.” Id. at 18-19.

As to these findings, it is important to note that the court of appeals reviewed an Oregon federal district court’s interlocutory denial of a summary judgment motion filed by the government. Under the applicable standard of appellate review, the court of appeals was required to  construe the plaintiffs’ “extensive record . . . in the light most favorable to their claims.” Id. at 14.

As to the third requirement for standing, “redressability,” the panel majority “[r]eluctantly” concluded that the plaintiffs lack standing because their claims are not “redressable by an Article III court.” Id. at 11, 21. The plaintiffs had argued that “if their general request for a remedial plan is granted, the political branches can decide what policies will best ‘phase out fossil fuel emissions and draw down excess atmospheric CO2.’” Id. at 26. The majority, however, explained as follows:

“Although the plaintiffs’ invitation to get the ball rolling by simply ordering the promulgation of a plan is beguiling, it ignores that an Article III court will thereafter be required to determine whether the plan is sufficient to remediate the claimed constitutional violation of the plaintiffs’ right to a ‘climate system capable of sustaining human life.’ We doubt that any such plan can be supervised or enforced by an Article III court. And, in the end, any plan is only as good as the court’s power to enforce it.” Id. at 29.

The two-judge panel majority rejected the dissenting judge’s view that “[p]roperly framed, a court order—even one that merely postpones the day when remedial measures become insufficiently effective—would likely have a real impact on preventing the impending cataclysm.” Id. at 46. Instead, the majority correctly held that “[n]ot every problem posing a threat—even a clear and present danger—to the American Experiment can be solved by federal judges.” Id. at 30.

Political Question Doctrine Supports Panel’s Holding

Interestingly, the majority drew a distinction between its “redressability” holding and the political question doctrine.  See id. at 31 n.9. Under the political question doctrine, which reflects the separation of powers, a federal suit is nonjusticiable if a court would have to address questions that the Constitution reserves for the political branches.  Although disavowing that the case involves a political question, the majority acknowledged that the political question doctrine’s “factors often overlap with redressability concerns” since each “stems from the same separation-of-powers principle.” Id. (internal quotation marks omitted).

In my view, the court essentially held that plaintiffs’ suit is barred by the political question doctrine. The majority drew a technical distinction between that doctrine and the redressability prong of the judicial standing test in an effort to make its holding appear as narrow and case-specific as possible.  See id. at 31 n.9. Nonetheless, the appellate court’s broad message to would-be climate-change litigants is unmistakable: A “compelling case that action is needed . . . must  be made to the political branches or to the electorate at large, the latter of which can change the composition of the political branches through the ballot box. That the other branches may have abdicated their responsibility to remediate the problem does not confer on Article III courts, no matter how well-intentioned, the ability to step into their shoes.” Id. at 31-32.

*Originally published as an Insight on Capital Appellate Advocacy’s website. Reprinted with permission.

The post No Redress: Future Generations’ Overheated Climate-Related Suit Doesn’t Stand appeared first on Washington Legal Foundation.

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Exclusion of Junk Science in “Bair Hugger” MDL Shows Daubert Is Still Breathing

WLF Legal Pulse - Thu, 01/23/2020 - 3:13pm

By Joe G. Hollingsworth and Caroline Barker

Joe G. Hollingsworth is a Partner with Hollingsworth LLP and is the WLF Legal Pulse’s Featured Expert Contributor on Litigation Strategies. Caroline Barker  is an Associate with Hollingsworth LLP.

U.S. District Judge Joan Ericksen extinguished an entire federal multidistrict litigation and breathed life into the Court’s gatekeeping duty to guard against unreliable science when it excluded unfounded expert testimony in In re Bair Hugger Forced Air Warming Devices Products Liability Litigation, MDL No. 15-2666, 2019 WL 4394812 (D. Minn. July 31, 2019).  More than 5,800 plaintiffs sued 3Mthe manufacturer of Bair Hugger—which warms patients during knee surgery through a blanket filled with heated forced air—alleging that the forced air escaped the blanket and created turbulence in the operating room, stirring bacteria-carrying dust and causing periprosthetic joint infection when the dust reached the surgical site.

3M faced a long road and tortuous battle before the court ultimately pulled the plug on the litigation.  Over the course of four years, it became increasingly apparent that there was something dramatically deficient in plaintiffs’ scientific story.  Although the court denied 3M’s initial Daubert challenges and allowed a first bellwether trial to proceed, even in that case the court excluded in its entirety one of plaintiffs’ two theories for how the Bair Hugger caused infections.  That first trial ended with a defense verdict:  the jury found that plaintiffs had failed to prove that the Bair Hugger causes surgical-site infections.  The defense verdict illustrates the weakness of plaintiffs’ claims, but there were even earlier signs of problems for plaintiffs:  The first trial case was actually the sixth in line for trial, but the five earlier plaintiffs dismissed or otherwise avoided going to trial in them.  After that first defense verdict, the plaintiffs in the next two trial cases told the court that they didn’t want to go forward.  It is against this backdrop of repeated plaintiff dismissals and a defense jury verdict that the court revisited the earlier denial of 3M’s Daubert motions.

In its reconsideration, the court systematically tore down plaintiffs’ experts’ opinions using the experts’ own trial testimony against them.  (We commend the full opinion for review if you are interested in a blow-by-blow dismantling of plaintiffs’ experts.)  The Eighth Circuit has long held that “the district court’s gatekeeping role separates expert opinion evidence based on ‘good grounds’ from subjective speculation that masquerades as scientific knowledge.”  Glastetter v. Novartis Pharm. Corp., 252 F.3d 986, 989 (8th Cir. 2001), aff’g, 107 F. Supp. 2d 1015 (E.D. Mo. 2000).1

Judge Ericksen emphasized the hallmarks of unreliable expert testimony when she not only found that the plaintiffs’ expert’s air flow computer model underpinning plaintiffs’ causation theory was designed specifically for the litigation (an alarming fact in itself), but also that the plaintiffs’ air flow model lacked applicability to the real-world—i.e., the expert’s “conclusions have drifted from the factual realities of his test.”  In re Bair Hugger, 2019 WL 4394812, at *9.  Critically, the model failed to account for “key” known causes of air flow disruption that occur in real-world operating suites—such as opening doors, the movement of doctors and nurses, and surgical machinery and equipment.  Without any explanation, the expert ignored these factors as inconsequential, despite relying on a study that found the biggest factor on airborne microorganisms in an operating room is the presence and activity of people in the room.  See id. at *18-19.  He audaciously proffered the untested theory that the movement of personnel in the operating room would exaggerate the findings of his air flow model for the Bair Hugger, claiming that “even reaching a hand in” to test a real-world model would “interrupt the results.”  Id. at *6-7.  But the court rejected the experts’ unfounded extrapolations and conjecture, finding that the expert’s “attempted gap-filling” between his simulation and real-world conditions was “more like a leap of faith than an inferential leap.”  Id. at *8.

Similarly, the court re-examined the observational and epidemiology studies the plaintiffs’ three medical experts referenced, revealing that the Bair Hugger was not the only thing full of hot air.  Plaintiffs’ experts ignored numerous limitations that the authors of the published studies themselves identified, including explicit disclaimers by the authors stating that the studies did not establish causation.  The court rejected plaintiffs’ assertion that observational studies contain “‘pointless’ caveats” that their experts need not address, and held that the plaintiffs’ experts’ unreliably excluded obvious alternative explanations for declining infection rates—such as the introduction of bacterial screening or new antibiotics—when they reached conclusions that the study authors themselves were not willing to draw.  Id. at *18-19.

Without these experts, plaintiffs had no proof that Bair Hugger causes infections, no claim, and no case.  The MDL is now kaput (pending an appeal—which is in its briefing stage).  We applaud the result, and 3M in this case, for sticking to its guns and continuing to challenge what the Court ultimately decided was unreliable science.  Had defendants caved and not held the line after the court rejected the initial Daubert challenges, then they would never have had the opportunity to turn the tide on bad science.  And there is a strong consensus that the science doesn’t back up plaintiffs’ claims:  as the court pointed out, in 2018, at an International Consensus Meeting, 93 percent of scientists agreed “[t]here is no evidence to definitively link [forced-air warming] to an increased risk[.]”  Id. at *20.  Bair Hugger demonstrates that hope is not lost, that Daubert is not dead, and that perseverance has its rewards.


The post Exclusion of Junk Science in “Bair Hugger” MDL Shows <em>Daubert</em> Is Still Breathing appeared first on Washington Legal Foundation.

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WLF Urges Massachusetts Judiciary to Adopt Rule Allowing Both Sides to Address Damages Amount

WLF Legal Pulse - Thu, 01/23/2020 - 2:46pm

“The proposed rule is sensible, fair, and essential for dispensing civil justice.”
—Cory Andrews, WLF Vice President of Litigation

WLF letter available here.

WASHINGTON, DC—Earlier today, Washington Legal Foundation (WLF) joined a coalition of leading business, civil justice, and public-policy groups in urging the Massachusetts Supreme Judicial Court to adopt a proposed rule—Rule 51(a)(2) of the Massachusetts Rules of Civil Procedure—that would help to ensure that civil litigation in the Commonwealth is procedurally fair to all parties.

In 2014, the Massachusetts Legislature amended Mass. Gen. Laws. c. 231, §13B to give plaintiffs in civil actions the statutory right to request a specific amount in damages during closing arguments. WLF’s letter cites studies showing that plaintiffs’ attorneys, by anchoring their closing argument to a specific amount of damages, are more likely to obtain larger jury awards.

But because the plaintiffs’ attorney gives closing argument last in Massachusetts civil trials, defense counsel have no opportunity to rebut the requested amount. In response to this procedural unfairness, the Massachusetts Supreme Judicial Court’s Standing Advisory Committee has proposed an amendment to Rule 51. Under Rule 51(a)(2), if a party who intends to suggest a specific monetary amount fails to notify all parties of that amount before closing argument, the court must structure the closing argument to allow the opposing party an opportunity to respond to the amount requested.

WLF’s letter was drafted with the pro bono assistance of Mark A. Behrens, a partner in the Washington, D.C. office of Shook, Hardy & Bacon L.L.P.

Celebrating its 43rd year, WLF is America’s premier public-interest law firm and policy center advocating for free-market principles, limited government, individual liberty, and the rule of law.

The post WLF Urges Massachusetts Judiciary to Adopt Rule Allowing Both Sides to Address Damages Amount appeared first on Washington Legal Foundation.

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CLOSING THE GATE TO JUNK SCIENCE: How Defendants Can Support Rigorous Judicial Oversight of Expert Testimony

WLF Legal Pulse - Wed, 01/15/2020 - 11:43am

Friday, January 24, 2020, 1:00-2:00 p.m.


Evan M. Tager and Craig A. Woods, Partners, Mayer Brown LLP, and co-authors of WLF’s Monograph Admissibility of Expert Testimony: Manageable Guidance for Judicial Gatekeeping.


Expert testimony not only can decide the outcome of products-liability and toxic-tort lawsuits, but also can impact key rulings such as class-action certification and damages determinations. Judges must act as “gatekeepers,” the U.S. Supreme Court has proclaimed, to shield lay juries from what Justice Antonin Scalia called “expertise that is fausse and science that is junky.” Our speakers are two of a group of attorneys who authored a WLF Monograph, Admissibility of Expert Testimony: Manageable Guidance for Judicial Gatekeeping, released on January 15. The authors wrote this Monograph primarily for a judicial audience. In this Webinar, Tager and Woods will discuss how outside and in-house counsel can encourage judges to apply the Monograph’s principles and will present several of the publication’s case studies from a practitioner’s point of view.

The post CLOSING THE GATE TO JUNK SCIENCE: How Defendants Can Support Rigorous Judicial Oversight of Expert Testimony appeared first on Washington Legal Foundation.

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WLF Monograph Offers Judiciary Guidance for Gatekeeping of Expert Testimony

WLF Legal Pulse - Wed, 01/15/2020 - 11:40am

Click here to visit publication page.

WASHINGTON, DC—Washington Legal Foundation (WLF) today released a Monograph on the key principles federal and state judges should follow when assessing the admissibility of expert testimony in civil litigation. Expert testimony not only can decide the outcome of products-liability and toxic-tort lawsuits, but also can impact key rulings such as class-action certification and damages determinations. Judges must act as “gatekeepers,” the U.S. Supreme Court has proclaimed, to shield lay juries from what Justice Antonin Scalia called “expertise that is fausse and science that is junky.”

A team of Mayer Brown LLP attorneys led by a co-leader of the firm’s Supreme Court and Appellate practice, Evan M. Tager, authored Admissibility of Expert Testimony: Manageable Guidance for Judicial Gatekeeping on a pro bono basis. The Monograph features a foreword by Facebook, Inc. Vice President and Deputy General Counsel Paul S. Grewal, who before joining the company served as a United States Magistrate Judge on the U.S. District Court for the Northern District of California.

The Monograph’s first part discusses four aspects of the judicial gatekeeping function that cut across different substantive areas of law. The authors first explain how the Supreme Court’s  “Daubert trilogy” of decisions established the scope of a judge’s gatekeeping duties. They next illustrate how “hired-gun” experts complicate a juror’s task of deciding liability and how courts can mitigate the confusion. They go on to address how courts must answer a “recurring riddle”—does the expert’s testimony implicate the evidence’s admissibility (a judicial function) or does it go to its weight (a jury’s responsibility). Finally, the authors analyze the tools judges can use to weed out junk science, including holding Daubert hearings and appointing independent technical experts.

The Monograph’s second part delves deeper into these critical aspects of gatekeeping through case studies. The authors explore in detail judicial best-practices for determining relevance and reliability in four areas of law: (1) medical causation; (2) insurance bad faith; (3) class-action certification; and (4) valuation testimony for damage calculations. The medical-causation case study offers especially valuable insights on how judges should manage experts testifying on general and specific causation.

Electronic copies of this Monograph are available online at www.wlf.org. Inquire about additional hard copies with WLF Legal Studies Division Chief Counsel Glenn Lammi (glammi@wlf.org).

Washington Legal Foundation preserves and defends America’s free-enterprise system by litigating, educating, and advocating for free-market principles, a limited and accountable government, individual and business civil liberties, and the rule of law

The post WLF Monograph Offers Judiciary Guidance for Gatekeeping of Expert Testimony appeared first on Washington Legal Foundation.

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Admissibility of Expert Testimony: Manageable Guidance for Judicial Gatekeeping

WLF Legal Pulse - Wed, 01/15/2020 - 11:36am

By Evan M. Tager, Craig A. WoodsReginald R. Goeke, and Daniel E. Jones, Partners with Mayer Brown LLP; Carl J. Summers and Matthew C. Sostrin, Counsel with Mayer Brown LLP; and Jonathan S. Klein, an Associate with the firm.

Featuring a foreword by The Honorable Paul S. Grewal, United States Magistrate Judge (ret.), who serves as Vice President and Deputy General Counsel of Facebook, Inc.

Click here for this publication’s press release.

Summary: This 90-page Monograph explores the key principles federal and state judges should follow when assessing the admissibility of expert testimony in civil litigation. Expert testimony not only can decide the outcome of products-liability and toxic-tort lawsuits, but also can impact key rulings such as class-action certification and damages determinations. Judges must act as “gatekeepers,” the U.S. Supreme Court has proclaimed, to shield lay juries from what Justice Antonin Scalia called “expertise that is fausse and science that is junky.”

To inquire about printed copies, email glammi@wlf.org.

The post Admissibility of Expert Testimony: Manageable Guidance for Judicial Gatekeeping appeared first on Washington Legal Foundation.

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Enhancing Patent Diversity for America’s Innovators

House Small Business Committee News - Wed, 01/15/2020 - 11:30am

The Committee on Small Business will hold a hearing titled, “Enhancing Patent Diversity for America’s Innovators.” The hearing is scheduled to begin at 11:30 A.M. on Wednesday, January 15, 2020 in Room 2360 of the Rayburn House Office Building.

The American economy is reliant on its ability to innovate and retain its status as a global leader. To continue the nation’s leadership in innovation, it’s important to ensure every person and idea has equal opportunity to intellectual property protections. The Study of Underrepresented Classes Chasing Engineering and Science Success (SUCCESS) Act, enacted last Congress, required the United States Patent and Trademark Office (USPTO) Director to consult with the Small Business Administration to identify publicly available data on the number of patents women, minorities, and veterans apply for and obtain. The hearing will examine the findings of the report and discuss the legislative options for increasing the ability and opportunity for a diverse population of innovators to gain patent protection.

To view a livestream of the hearing, please click here. 

Hearing Notice 

Hearing Memo 

Witness List 

Ms. Andrea Ippolito
Program Director of W.E. Cormell
Cornell University
Ithaca, NY

Dr. Rashawn Ray
David M. Rubenstein Fellow
The Brookings Institution
Washington, DC

Ms. Janeya Griffin
Managing Member and Principal Consultant
The Commercializer, LLC
Lancaster, CA

*Witness testimony will be posted within 24 hours after the hearing’s occurrence


Second Circuit Paves Way for Future Insider Trading Prosecutions

WLF Legal Pulse - Mon, 01/13/2020 - 12:56pm

By Gregory A. Brower and Thomas J. Krysa

Gregory A. Brower is a Shareholder with Brownstein Hyatt Farber Schreck, LLP in Las Vegas, NV and Washington, DC. Mr. Brower also serves on WLF Legal Policy Advisory Board and is the WLF Legal Pulse’s Featured Expert Contributor, White Collar Crime and Corporate Compliance.  Thomas J. Krysa is a Shareholder with the firm in its Denver, CO office.

In a recent Second Circuit decision, a divided three-judge panel drew a stark distinction between two federal securities fraud statutes likely providing a blueprint for future criminal prosecutions for insider trading.  In United States v. Blaszczak, a Second Circuit panel held that the Dirks “personal benefit” test, which applies to certain civil and criminal insider trading charges, did not apply to criminal insider trading charges brought under Title 18 of the federal criminal code. 1  This decision could have significant implications for future insider trading prosecutions.

The Tipping Scheme

In Blaszczak, the government charged several individuals with securities fraud for a tipping scheme involving confidential information from the Centers for Medicare and Medicaid Services (CMS).  Blaszczak, a former CMS employee, was employed as a paid “political-intelligence” consultant for various hedge funds.  He used former CMS colleagues as inside sources at the agency to obtain key information involving future agency rule changes that would move the stock market when publicly disclosed.  He tipped this material, nonpublic information to his hedge fund contacts who traded on the information reaping millions in profits.  Although Blaszczak received consulting fees from the hedge funds for his services, his friend and inside source at CMS (the lone-charged CMS tipper) did not receive any monetary benefit for his tips.  The government alleged that the CMS source received a benefit in exchange for the tips by virtue of his close friendship with Blaszczak who provided him with private sector employment advice and professional introductions. 

The Federal Securities Fraud Statutes

The government charged the tipping scheme under both Section 10(b) of the Securities Exchange Act of 1934 (Title 15) and Section 1348 of Title 18 of the federal criminal code.2  Section 10(b) and its related Rule 10b-5 are the traditional securities fraud provisions that are charged by both the SEC and DOJ in civil and criminal cases, respectively.  In the insider trading context, Section 10(b) and Rule 10b-5 have been analyzed extensively at the circuit court and Supreme Court levels.  Section 1348, a criminal statute enacted in 2002 and charged solely by the DOJ, has received much less attention.  Section 1348 was patterned after the federal mail and wire fraud statutes.  Generally speaking, when charging Section 1348 securities fraud the government must prove that an individual knowingly and willfully participated in a fraudulent scheme to defraud a person in connection with a securities transaction.

Section 10(b) and Rule 10b-5 tipping cases have their own unique judicially-created requirements.  In Dirks, the Supreme Court held that in order to prove tipping liability under Section 10(b) and Rule 10b-5 the government must prove that the insider breached a duty of trust and confidence by tipping material, nonpublic information to others in exchange for a “personal benefit.” 3  During the last six years, the definition of a personal benefit has been vigorously litigated in the courts. 4  The results have varied.  Currently, a personal benefit is broadly defined for the most part and can range from a clear monetary benefit such as kickback, to a mere quid pro quo between friends or relatives.  Under Dirks, a tippee, or recipient of inside information, is not liable under Section 10(b)/Rule 10b-5 unless the government proves he or she traded on, or tipped the inside information, while knowing that the original tipper received a personal benefit in exchange for the information. 

The Jury Instructions                    

In Blaszczak, the trial judge gave differing instructions to the jury with respect to the Section 10(b)/Rule 10b-5 and Section 1348 securities fraud charges.  For the Section 10(b)/Rule 10b-5 charges, the trial judge instructed the jury that the government had to prove the Dirks personal benefit test; that is that the CMS tipper received a personal benefit in exchange for providing the material, nonpublic information to Blaszczak and that the downstream tippees knew this.  Conversely, for the Section 1348 charges, the trial judge declined the defendants’ request to provide a Dirks-like instruction, and instead instructed the jury that the government must prove the defendants “participated in a scheme to embezzle or convert confidential information from CMS by wrongfully taking that information and transferring it to his own use or the use of someone else.”    

After four days of deliberations, the jury returned a split verdict on the securities fraud charges.  Of note, the jury acquitted all defendants on the Section 10(b)/Rule 10b-5 charges while at the same time convicting all but one defendant (the CMS tipper) on the Section 1348 charges.  One can infer from this result that the government likely failed to prove the Dirks personal benefit test for the Section 10(b)/Rule 10b-5 charges.

The Second Circuit Decision            

On appeal, the defendants argued that the trial judge erred by not including a Dirks-like instruction to the jury for the Section 1348 charges.  The defendants argued that the term “defraud” should be construed consistently and have the same meaning in insider trading cases across the securities fraud statutes whether charged under Title 15 or Title 18.  The Second Circuit panel disagreed.  The panel noted that the personal benefit test was a judge-made doctrine that arose from the Exchange Act’s statutory purpose (i.e., to eliminate the use of inside information for personal advantage).  The panel drew a distinction between this statutory purpose and Section 1348 which it said was rooted in the embezzlement or misappropriation theory of fraud, where the Dirks test could find no footing.  The panel further noted that Congress enacted Section 1348 as part of the Sarbanes-Oxley Act of 2002 in large part to overcome the technical impediments of the existing Title 15 securities-fraud regime, and to provide a broader enforcement mechanism for federal prosecutors to pursue securities fraud claims.

Future Implications             

Certainly this decision will provide a blueprint for future criminal insider trading prosecutions by the DOJ under Section 1348, perhaps even in cases that are not prosecuted by the SEC due to questionable evidence supporting the Dirks personal benefit test.  However, in this potentially narrow band of cases, the DOJ still would be required to prove beyond a reasonable doubt that the defendants knowingly and willfully participated in a scheme to defraud, which always requires significant, probative evidence.  That being said, an anomalous outcome could be possible where the SEC loses a civil case that the DOJ wins criminally on the same facts.   

In addition, going forward, the Dirks personal benefit test will continue to come under scrutiny by the courts and advocates alike.  In the absence of a clear monetary benefit, the test is difficult to apply in practice particularly in a jury trial setting, and it will continue to create issues on appeal.

Finally, the Blaszczak decision could amplify the call for insider trading legislation to bring some clarity and harmony to the federal securities fraud statutes.  Until that time comes, however, the government and charged defendants will continue the ongoing tug-of-war over the boundaries of the current insider trading laws.    


The post Second Circuit Paves Way for Future Insider Trading Prosecutions appeared first on Washington Legal Foundation.

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Farming in the 21st Century: The Impacts of Agriculture Technology in Rural America

House Small Business Committee News - Thu, 01/09/2020 - 10:00am

The Committee on Small Business Subcommittee on Innovation and Workforce Development will hold a hearing titled, “Farming in the 21st Century: The Impacts of Agriculture Technology in Rural America.” The hearing is scheduled to begin at 10:00 A.M. on Thursday, January 9, 2020 in Room 2360 of the Rayburn House Office Building.

In recent decades technology has disrupted many industries including manufacturing, media, banking, and retail shopping. The same technological innovation is happening in agriculture. New advances in agricultural software, computer hardware and durable farm equipment are building towards comprehensive solutions that significantly improve farming conservation, plant growth and processing, yield and input mapping, and even autonomous self-driving tractor capabilities. Technology and data can help farmers in many ways. The hearing will highlight many advances made in the agriculture technology industry and how federal policy can be utilized for even greater success.

To view a livestream of the hearing, please click here. 

Hearing Notice 

Hearing Memo 

Witness List 


Mr. Kevin M. France
President and CEO
SWIIM System, Ltd.
Denver, CO

Dr. David Potere
Head of GeoInnovation
Indigo Agriculture
Boston, MA

Mr. Robert Meza 
Co-Founder and Farmer 
Emerald Gardens 
Bennett, CO
* Testifying on behalf of the Rocky Mountain Farmers Union 

Dr. Douglas Jackson-Smith
Professor and Assistant Director
School of Environment and Natural Resources
The Ohio State University
Wooster, OH

*Witness testimony will be posted within 24 hours after the hearing’s occurrence



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