The Committee on Small Business Subcommittee on Innovation and Workforce Development will hold a hearing titled, “SBA Programs Spurring Innovation.” The hearing is scheduled to begin at 10:00 A.M. on Thursday, September 19, 2019 in Room 2360 of the Rayburn House Office Building.
The hearing will examine how SBA’s programs, such as the Small Business Innovation Research (SBIR), Small Business Technology Transfer (STTR), and growth accelerators help innovative entrepreneurs, startups, and small businesses grow and create jobs.To view a livestream of the hearing, please click here.
Ms. Alison Brown
President and CEO
Colorado Springs, CO
Mr. Rohit Shukla
Los Angeles, CA
Mr. Javier Saade
Managing Partner & Venture Partner
Impact Master Holdings & Fenway Summer Ventures
Mr. Ron Shroder
CEO and President
Frontier Technology, Inc.
*Witness testimony will be posted within 24 hours after the hearing’s occurrence
- Lisa A. Blatt, Chair, Supreme Court and Appellate practice, Williams & Connolly LLP
- Pratik A. Shah, Co-head, Supreme Court and Appellate practice, Akin Gump Strauss Hauer & Feld LLP
- Jay B. Stephens, Counsel, Kirkland & Ellis LLP and Chair, WLF Legal Policy Advisory Board
The post Upcoming Briefing—The U.S. Supreme Court: October Term 2019 Preview appeared first on Washington Legal Foundation.
Daniel S. Alter is a Shareholder in the New York, NY office of Murphy & McGonigle P.C. and is the WLF Legal Pulse’s Featured Expert Contributor, Legal & Regulatory Challenges for Digital Assets.
Way back in the day—say, between 2016 and 2018—there was a real rush by crypto- enthusiasts to mine (or otherwise create) all manner of coins on the blockchain. The rallying cry of “disrupt or bust” was soon targeted at the global equities markets, with their collective trading volume in 2018 of $68.212 trillion. There was a dewy-eyed expectation among true believers that world financial regulators, wowed by the redundancy, transparency, and incorruptibility of distributed ledger technology, would expedite the displacement of trusted intermediaries (e.g. banks and prime brokers) and their inefficient mechanisms for completing transactions.
As if . . .
In the United States, we have experienced the cautious pace at which the Securities and Exchange Commission (SEC) has prospected for appropriate rules to cover virtual assets and decentralized trading platforms. And neither the Federal Reserve Board (FRB) nor the Office of the Comptroller of the Currency (OCC) has aggressively staked a governance claim covering the dissemination of cryptocurrencies and the myriad payment systems that employ them. In large part, these regulators are panning for nuggets—waiting for smaller yet important marketplace applications to confirm that the transformative innovations on the blockchain are not digital pyrite.
They may have just struck something. On September 5, 2019, the New York State Department of Financial Services (DFS) announced that it had approved the issuance, sale, and trading of a tokenized ownership interest in gold bars by Paxos Trust Company, LLC (Paxos)—a New York State chartered financial institution. The name of this new digital asset is PAX Gold, and DFS superintendent Linda Lacewell assured the public that her agency took adequate care to address “potential risks associated with [its] issuance and offering.”
Full disclosure: earlier in my career, I served as both DFS general counsel and general counsel to Paxos (when Paxos was known as itBit Trust Company). I had nothing whatsoever to do, though, with the approval of PAX Gold, and I have no financial ties to either of them now. I therefore can objectively say that this development is an important regulatory milestone—one worth its weight in tokens.
Founded at the end of the seventeenth century, the London gold market would be an excellent case-study in which to assay the value of using blockchain systems as infrastructure for large financial markets. Each day in London, dealers trade approximately 75% of the world’s gold in over-the-counter transactions (in May 2019, nearly $24 billion per day). Yet historically, the “banks, brokers and dealers” in the trade “have been reluctant to reveal their activity.”
In 1987, the Bank of England formed the London Bullion Market Association (LBMA), which is an international trade association that both represents and supervises its members from at least 24 countries. But it was not until November 2018 that the London gold market—“for the first time in [its] long history”—replaced guesswork with reliable measurements of daily trading volumes. The LBMA hailed this development as “an exciting moment for transparency in the global OTC market.”
Less than one year later, Paxos and DFS have taken what might be an even bigger step towards effective regulatory oversight.
Each PAX Gold token “encapsulat[es] the legal title to a physical bar of gold stored in the Brink’s London vault.” Specifically, each token “represent[s] 1 fine troy ounce of London Good Delivery gold” that is “owned by holders of the token” and for which “access to the serial number, weight and various other attributes of their gold holdings” is available to token holders. Consequently, under appropriate circumstances and careful protocols, such information could be available to regulators, too.
That design is already unfolding. In approving the issuance and trading of PAX Gold, Superintendent Lacewell underscored that DFS “applied New York’s high standards regarding anti-money laundering, anti-fraud, and consumer protection, and cybersecurity measures.” And DFS—along with the rest of the world—can examine the expected independent auditor’s monthly online reports verifying “that the entire supply of PAX Gold tokens is consistent with troy ounces of gold held within the custody of third parties in the United Kingdom.”
As a business strategy, Paxos is searching for treasure buried in market inefficiencies. It believes that blockchain technology can eliminate many of the complications and costs associated with the precious metals trade by making such assets “easily moveable and divisible and not . . . tied to a manual, physical process.” In other words, by increasing their liquidity.
For this venture to grow and succeed on the blockchain, however, both Paxos and DFS will need to address a mountain of issues common to trade in other asset classes. These challenges include establishing well-defined clearing and settlement procedures and securing adequate custody solutions for traded assets, just to name a few. The SEC, FRB, and OCC (along with other market regulators) would do well to pay close attention to the technological and legal answers forged in New York. There might be gold in them there hills.
As Hate Crimes Surge, Cantwell Pushes Facebook, Google, Twitter on Actions to Counter Rise in Extremism
Hearing comes a day after Cantwell joined colleagues on the Senate floor to call for expanded federal background checks, extreme risk protection orders
Between 2013 and 2017, Senator Cantwell’s home state of Washington saw a 78 percent rise in hate crimes; state has third-highest rate of hate crimes per capita in the United States
In 2017, 510 hate crimes were reported statewide – a 32 percent increase
WASHINGTON, DC – As the United States continues to experience a surge in hate crimes and extremism throughout the country, U.S. Senator Maria Cantwell (D-WA), the Ranking Member of the Senate Committee on Commerce, Science, and Transportation, pushed representatives from Facebook, Google, and Twitter on what their companies are doing to push back against hate on their platforms.
“Across the country, we are seeing and experiencing a surge of hate and as a result we need to think much harder about the tools and resources we need to combat this problem both online and offline,” Senator Cantwell said. “I do want us to think about ways in which we can all work together to address these issues. I feel that working together, these are successful tools that we can deploy in trying to fight extremism that exists online.”
In addition to what more social media platforms can do to counter extremism and hate on their platforms, Cantwell also asked witnesses about incitement happening on the “dark web” and through websites that publish hate, like 8chan.
“What do you think we need to do to monitor incitement on dark websites?” Cantwell asked George Selim, the Senior Vice President of Programs at the Anti-Defamation League.
“A number of measures,” Mr. Selim replied. “The first is having our public policy be starting from a place where we’re victim-focused… We really need to start from a place that prevents and has a better accounting of hate crimes, bias motived crimes, hate-related incidents, etcetera. And when we start from that place, I think we can make better policy and better programs at the federal government and state and local and also in the private industry levels as well.”
In response, Cantwell announced that she will be calling on the U.S. Department of Justice (DOJ) to bolster its efforts against extremism, hatred, and violence on the internet and called on the companies testifying before the committee to join in these efforts, as well as to prevent people supporting hate and terror from moving from social media platforms to the dark web.
“I’m definitely going to be calling on the Department of Justice to ask what more we can do in this coordination,” Cantwell said. “Several years ago, Microsoft worked with [law enforcement] and others on trying to address, on an international basis, child pornography to better skill law enforcement at policing crime scenes online. And I would assume that the representatives today would be supportive, maybe helpful – maybe even financially helpful – in trying to address these crimes as they exist today as hate crimes on the dark side of the web.”
As Congress continues to consider responses to rising hatred and violence, Senator Cantwell joined a group of her colleagues on the Senate floor yesterday to call for a vote on expanded background checks legislation. At today’s hearing, Cantwell also commended a group of 145 companies for a letter last week expressing support for gun safety legislation.
“I do appreciate, just last week representatives from various companies of all sizes in the tech industry sending the Senate a letter, asking for passage of bills requiring extensive background checks,” Senator Cantwell said. “So very much appreciate that and your support of laws to keep guns out of the hands of people who a court has determined are dangerous.”
Senator Cantwell has taken a leadership role in the Senate in countering hate and hate crimes. In April 2017, she led a group of colleagues in sending a letter to President Trump calling for the establishment of a Presidential Task Force to address the alarming rise of hate crimes across many communities in the United States. She continued that push after white supremacist violence in Charlottesville later that year. That letter led the DOJ to form a Hate Crimes Subcommittee as part of the Task Force on Crime Reduction and Public Safety to combat hate crimes, which was later transformed into a freestanding, Department-wide Hate Crimes Enforcement and Prevention Initiative, led by the Civil Rights Division.
Senator Maria Cantwell
Opening Statement at Commerce Committee, Science, & Transportation Hearing on Mass Violence, Extremism, and Digital Responsibility
Witness: Ms. Monika Bickert, Head of Global Policy Management, Facebook;
Mr. Nick Pickles, Public Policy Director, Twitter;
Mr. George Selim, Senior Vice President of Programs, Anti-Defamation League;
Mr. Derek Slater, Global Director of Information Policy, Google
September 18, 2019
CANTWELL: Thank you Mr. Chairman and thank you for holding this important hearing and for our witnesses being here this morning.
Across the country, we are seeing and experiencing a surge of hate and as a result we need to think much harder about the tools and resources we need to combat this problem both online and offline. While the First Amendment to the Constitution protects free speech, speech that incites eminent violence is not protected and Congress should review and strengthen laws that prohibit threats of violence, harassment, stalking, and intimidation to make sure that we stop the online behavior that does incite violence.
In testimony before the Senate Judiciary Committee in July, Federal Bureau of Investigation FBI Director Chris Wray said that the white supremacist violence is on the rise. He said the FBI takes this threat “extremely seriously” and has made over 100 arrests so far this year.
We’re seeing in my state over the last several years. We’ve suffered a shooting at the Jewish community center in Seattle, a shooting of a Sikh in Kent, Washington, a bombing attempt at the MLK Day parade in Spokane, and over the last year, we’ve seen a rise in the desecration of both synagogues and mosques. The rise in hate across the country has also led to multiple mass shootings, including the Tree of Life congregation in Pittsburgh, the Pulse nightclub in Orlando and most recently, the Walmart in El Paso.
Social media is used to amplify that hate and the shooter at one high school in the Parkland posting said the image of himself with guns and knives on Instagram wrote social media posts prior to the attack on his fellow students. In El Paso, the killer published a white supremacist anti-immigration manifesto on 8chan message board, and my colleague just mentioned this streaming of live content related to the Christchurch shooting, the horrific incidents that happened there. In Miramar, the military engaged in a systematic engagement of Facebook, using fake names and sham accounts to promote violence against Muslim Rohingya. These human lives were all cut short by deep hatred and extremism that we have seen has become more common.
This is a particular problem on the dark web, where we see certain websites like 8chan and a host of 24/7, 365 hate rallies. Adding technology tools to mainstream websites to stop the spread of these dark websites is a start, but there needs to be more to be a concentrated and coordinated effort to ensure that people are not directed into these cesspools. I believe calling on the Department of Justice to make sure that we are working across the board on an international basis with companies as well to fight this issue is an important thing to be done. We don’t want to push people off of social media platforms only to then being on the dark web, where we are finding less of them. We need to do more, the Department of Justice, to shut down these dark web sites and social media companies need to work with us to make sure that we are doing this.
I do want to mention, just last week, as there’s much discussion here in Washington, about initiatives. The state of Washington has passed three initiatives, gun initiatives, by the vote of the people, closing background loopholes and also relating to private sales and extreme person laws, all voted on by a majority of people in our state and have successfully passed. So I do appreciate, just last week representatives from various companies of all sizes in the tech industry sending the Senate a letter, asking for passage of bills requiring extensive background checks. So very much appreciate that and your support of extreme person laws to keep guns out of the hands of people who a court has determined are dangerous in the possession of that.
So this morning, we look forward to asking you about ways in which we can better fight these issues. I do want us to think about ways in which we can all work together to address these issues. I feel that working together, these are successful tools that we can deploy in trying to fight extremism that exists online.
Thank you Mr. Chairman for the hearing.
Over the past two decades, the United States has led the world in the development of social media and other services that allow people to connect with one another. Open platform providers like Google, Twitter, and Facebook and products like Instagram and YouTube have dramatically changed the way we communicate and have been used positively in providing spaces for like-minded groups to come together and in shedding light on despotic regimes and abuses of power throughout the world. No matter how great the benefits to society these platforms provide, it is important to consider how they can be used for evil at home and abroad.
On August 3, 2019, twenty people were killed and more than two dozen were injured in a mass shooting at an El Paso shopping center. Police have said that they are “reasonably confident” that the suspect posted a manifesto to a website called “8chan” 27 minutes prior to the shooting. 8chan moderators removed the original post, though users continued sharing copies. Following the shooting, President Trump called on social media companies to work in partnership with local, state, and federal agencies to develop tools that can detect mass shooters before they strike – I certainly hope we talk about that challenge today.
Sadly, the El Paso shooting is not the only recent example of mass violence with an online dimension. On March 15, 2019, 51 people were killed and 49 were injured in shootings at two mosques in Christchurch, New Zealand. The perpetrator filmed the attacks using a body camera and live-streamed the footage to his Facebook followers, who began to re-upload the footage to Facebook and other sites. Access to the footage quickly spread, and Facebook stated that it removed 1.5 million videos of the massacre within 24 hours of the attack. 1.2 million views of the videos were blocked before they could be uploaded. Like the El Paso shooter, the Christchurch shooter also uploaded a manifesto to 8chan.
The 2016 shooting at the Pulse Nightclub in Orlando, Florida, killed 49 and injured 53 more. The Orlando shooter was reportedly radicalized by ISIS and other jihadist propaganda through online sources. Days after the attack, the FBI Director stated that investigators were “highly confident” that the shooter was self-radicalized through the internet. According to an official involved in the investigation, analysis of the shooter’s electronic devices revealed that he had “consumed a hell of a lot of jihadist propaganda,” including ISIS beheading videos. Shooting survivors and family members of victims brought a federal lawsuit against those three social media platforms under the Anti-Terrorism Act. The Sixth Circuit dismissed the lawsuit on the grounds that this was not an “act of international terrorism.”
With over 3.2 billion internet users, this Committee recognizes the challenge facing social media companies and online platforms’ their ability to act and remove content threatening violence from their sites. There are questions about tracking of a user’s online activity, does this invade an individual’s privacy, thwart due process, or violate constitutional rights. The automatic removal of threatening content may also impact an online platform’s ability to detect possible warning signs. Indeed, the First Amendment offers strong protections against restricting certain speech, this undeniably adds to the complexity of our task.
I hope these witnesses will speak to these challenges and how their companies are navigating these challenges.
In today’s internet-connected society, misinformation, fake news, deepfakes, and viral online conspiracy theories have become the norm. This hearing is an opportunity for witnesses to discuss how their platforms go about identifying content and material that threatens violence and poses a real and potentially immediate danger to the public. I hope our witnesses will also discuss how their content moderation processes work. This includes addressing how human review or technological tools are employed to remove or otherwise limit violent content before it is posted, copied, and disseminated across the internet.
Communication with law enforcement officials at the federal, state, and local levels is critical to protecting our neighborhoods and communities. We would like to know how companies are coordinating with law enforcement when violent or extremist content is identified. And finally, I hope witnesses will discuss how Congress can assist ongoing efforts to remove content promoting violence from online platforms and whether best practices or industry codes of conduct in this area would help increase safety both online and offline.
So, I look forward to hearing testimonies from our witnesses, and hope we engage in a constructive discussion about potential solutions to a pressing issue.
The post Facebook Draws Support For 9th Circ. Review Of Privacy Suit appeared first on Washington Legal Foundation.
The Committee on Small Business will meet for a hearing titled, “The Role of the SBA’s 8(a) Program in Enhancing Economic Opportunities.” The hearing is scheduled to begin at 11:30 A.M. on Wednesday, September 18, 2019 in Room 2360 of the Rayburn House Office Building.
The SBA’s 8(a) program was designed as a business development program to help disadvantaged businesses compete in the federal marketplace. The program helps thousands of small businesses start and grow by competing for government contracts and in doing so, assists local communities. Nevertheless, the program has faced several challenges throughout the years. The hearing will examine how the program operates, the benefits to entrepreneurs and communities, and steps Congress can take to improve the effectiveness and oversight of the program.To view a livestream of the hearing, please click here.
Mr. Ralph C. Thomas III
Executive Director Emeritus & Representative of the National Association of Minority Contractors
Law Offices of Ralph C. Thomas III PLLC
Ms. Dottie Li
Founder and CEO
Mr. Clarence McAllister
*Witness testimony will be posted within 24 hours after the hearing’s occurrence
—Cory Andrews, Vice President of Litigation
Click HERE for WLF brief.
(Washington, D.C.)—Washington Legal Foundation (WLF) today filed an amicus curiae brief in the U.S. Court of Appeals for the Ninth Circuit, urging it to grant Facebook, Inc’s petition for rehearing en banc. WLF’s brief is highly critical of the appeals court’s August 8, 2019 decision, which threatens to permit large, no-harm class actions whenever plaintiffs can label the alleged statutory violation an “invasion of privacy.”
The case arises under the Illinois Biometric Privacy Information Act (BIPA), a 2008 law that requires companies to obtain written consent before collecting a person’s biometric information. It provides a private right of action allowing a plaintiff to recover up to $5,000 for a single violation. Seeking to represent a class of six million Illinois Facebook users, the plaintiffs sued Facebook claiming that its Tag Suggestions feature—which uses facial-recognition software to suggest that Facebook users tag their friends in photos they upload to Facebook—violates BIPA.
As WLF’s brief explains, the panel’s certification ruling throws open the door to class claims threatening draconian liability, creating irresistible pressure to settle even dubious claims. Such hydraulic settlement pressure—leveraging many billions of dollars in potential recovery—raises serious due-process concerns. What’s more, a class action with so many inherent defects is not “superior” under Rule 23(b)(3).
Celebrating its 42nd 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 En Banc Ninth Circuit to Decertify Multi-Billion-Dollar Privacy Class Action appeared first on Washington Legal Foundation.
By James M. Beck, Senior Life Sciences Policy Analyst with Reed Smith LLP in its Philadelphia, PA office, and founder of, and a regular contributor to, the award-winning Drug and Device Law blog.
In 2006 the Food and Drug Administration overhauled drug labeling and created a new section called “Highlights.” See 21 C.F.R. § 201.57(a) (specifying highlights section requirements). Such highlights must include “[a] concise summary of any boxed warning.” §201.57(a)(4). With respect to all other warnings, contraindications, and adverse reactions, the highlights regulation provides:
(9) Contraindications. A concise statement of each of the product’s contraindications, as required under paragraph (c)(5) of this section, with any appropriate subheadings.
(10) Warnings and precautions. A concise summary of the most clinically significant information required under paragraph (c)(6) of this section, with any appropriate subheadings, including information that would affect decisions about whether to prescribe a drug, recommendations for patient monitoring that are critical to safe use of the drug, and measures that can be taken to prevent or mitigate harm.
(11) Adverse reactions.
(i) A list of the most frequently occurring adverse reactions, as described in paragraph (c)(7) of this section, along with the criteria used to determine inclusion (e.g., incidence rate). Adverse reactions important for other reasons . . . must not be repeated under this heading in Highlights if they are included elsewhere in Highlights. . . .
21 C.F.R. § 201.57(a)(9-11) (emphasis added).
The FDA’s final rule adopting the regulation described the Highlights section:
[T]he final rule requires that the labeling for new and more recently approved products include introductory information entitled “Highlights of Prescribing Information” (Highlights) (§§201.56(d)(1) and 201.57(a)).
The final rule requires the same headings for Highlights as proposed, except that, in response to comments, FDA moved “Most Common Adverse Reactions” from “Warnings and Precautions” (proposed §201.57(a)(10)) to a new heading entitled “Adverse Reactions” (§§201.56(d)(1) and 201.57(a)(11)). Like the proposed rule, the final rule requires that Highlights, except for the boxed warning, be limited in length to one-half of the page (§ 201.57(d)(8)) (see comment 104).
The agency is also revising its regulations on supplements and other changes to an approved application in §§314.70 and 601.12 (21 CFR 314.70 and 601.12) to require applicants to obtain prior approval of any labeling changes to Highlights, except for identified minor changes (see comment 5).
Requirements on Content & Format of Labeling for Human Prescription Drug and Biological Products, 71 Fed. Reg. 3299, 3925 (FDA Jan. 24, 2006) (emphasis added).
The creation of this Highlights section directly affects preemption in prescription drug product liability litigation. The U.S. Supreme Court in its October Term 2018 reaffirmed that limits to the preemption of labeling claims for prescription drugs are grounded in the availability of FDA’s changes being effected (“CBE”) regulation, which defeats implied impossibility preemption by allowing certain unilateral label modifications:
[A]n FDA regulation called the ‘changes being effected’ or ‘CBE’ regulation permits drug manufacturers to change a label without prior FDA approval if the change is designed to ‘add or strengthen a . . . warning’ where there is ‘newly acquired information’ about the ‘evidence of a causal association’ between the drug and a risk of harm. 21 C.F.R. §314.70(c)(6)(iii)(A).
Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1673 (2019). The Court also stated:
[F]ederal law − the FDA’s CBE regulation − permits drug manufacturers to change a label to ‘reflect newly acquired information’ if the changes ‘add or strengthen a . . . warning’ for which there is ‘evidence of a causal association,’ without prior approval from the FDA. 21 C.F.R. §314.70(c)(6)(iii)(A). Of course, the FDA . . . can reject label changes even after the manufacturer has made them. See §§ 314.70(c)(6), (7). . . . But in the interim, the CBE regulation permits changes, so a drug manufacturer will not ordinarily be able to show that there is an actual conflict between state and federal law such that it was impossible to comply with both.
Id. at 1679.
This CBE regulation the Court relied on in Albrecht—21 C.F.R. § 314.70—is precisely the same regulation that the FDA stated it was “revising” in 2006 “to require applicants to obtain prior approval of any labeling changes to Highlights.” 71 Fed. Reg. at 3925 (listing “§314.70”). The CBE regulation thus has excepted all aspects of the Highlights section from its scope since 2006.
(6) The agency may designate a category of changes for the purpose of providing that, in the case of a change in such category, the holder of an approved NDA may commence distribution of the drug product involved upon receipt by the agency of a supplement for the change. These changes include. . . .
(iii) Changes in the labeling to reflect newly acquired information, except for changes to the information required in §201.57(a) of this chapter (which must be made under paragraph (b)(2)(v)(C) of this section), to accomplish any of the following:
(A) To add or strengthen a contraindication, warning, precaution, or adverse reaction for which the evidence of a causal association satisfies the standard for inclusion in the labeling under §201.57(c) of this chapter;
21 C.F.R. § 314.70(c)(6)(iii)(A) (emphasis added). This is the Albrecht FDA CBE regulation—down to the last subsection.
The FDA imposed this limitation on changes to Highlights information deliberately—through notice and comment rulemaking. See Albrecht, 139 S. Ct. 1680 (endorsing the preemptive power of “notice-and-comment rulemaking setting forth labeling standards”). This amendment was not some nefarious scheme to benefit manufacturers. To the contrary, as the FDA pointed out, “[m]anufacturers, with some exceptions, were opposed, or strongly opposed, to the inclusion of Highlights.” 71 Fed. Reg. at 3930.
In response to “comment 5,” the FDA stated, in 2006:
[B]ecause Highlights is a summary of the most important information for prescribing decisions and some comments expressed concerns about the difficulty involved in summarizing the complex and often lengthy information in the FPI [full prescribing information], the agency believes that it is essential for FDA to review and approve most proposed changes to the information in Highlights. Accordingly, the agency is revising its regulations on supplements and other changes to an approved application. Under §§314.70(b)(2)(v)(C) and (c)(6)(iii) . . ., applicants are required to obtain prior approval of any labeling changes to Highlights, except for editorial or similar minor changes. . . .
71 Fed. Reg. at 3922 (emphasis added). See id. at 3922 (“a sponsor may not use a CBE supplement to make most changes to Highlights.”).
The Federal Register cross-reference for modifications of highlights, 21 C.F.R. § 314.70(b)(2)(v)(C), is to “Changes requiring supplement submission and approval prior to distribution of the product made using the change (major changes).” See also FDA, Guidance for Industry: Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content & Format Requirements (Feb. 2013) (containing detailed information about how changes to Highlights should be made). Thus, any modification of the language of Highlights is a “major change”—and tort actions demanding major changes are preempted. A federal appeals court embraced that principle just last year:
Major changes require approval from the FDA prior to implementation, while moderate and minor changes do not. Controlling case law is clear − and plaintiffs here concede − that if the change they contend state law requires qualifies as ‘major,’ then federal law preempts plaintiffs’ cause of action because defendants cannot lawfully make such a change without prior FDA approval. Our inquiry thus appears, at first glance, straightforward: Does the change urged by plaintiffs qualify as ‘major’? If so, our work is done.
Gustavsen v. Alcon Laboratories, Inc., 903 F.3d 1, 10 (1st Cir. 2018) (citations omitted). See also Yates v. Ortho-McNeil Pharmaceuticals, Inc., 808 F.3d 281, 298 (6th Cir. 2015) (“[Plaintiff’s] post-approval design defect claim is clearly preempted by federal law. FDA regulations provide that once a drug . . ., is approved, the manufacturer is prohibited from making any major changes”); Batoh v. McNeil-PPC, Inc., 167 F. Supp.3d 296, 320-322 (D. Conn. 2016) (“chang[ing] the active ingredient” would have been a “major change” requiring prior FDA approval).
Preemption cases specifically involving demands to modify Highlights have been uncommon, but have uniformly resulted in preemption. In In re Zofran (Ondansetron) Products Liability Litigation, 368 F. Supp. 3d 94, 127 (D. Mass. 2019), plaintiffs conceded preemption of any warning claim involving highlights. The issue was fully litigated in Blackburn v. Shire US, Inc., 2017 WL 1833524, at *5-6 (N.D. Ala. May 8, 2017):
[W]hen sufficient newly acquired information exists in order to support a label change under the CBE process, as has been plausibly pled here, the claim is not preempted. However, the same cannot be said with respect to Plaintiff’s assertion that a change to the Highlights section would be permitted here. Where a private party seeks a label change which requires FDA approval, such as a change to the Highlights section, impossibility preemption exists. . . . The “impossibility” inquiry turns on a private party’s ability to act independently. It is of no consequence that the FDA may have allowed a change to the Highlights section of [the drug]. Because Defendants could not have independently changed the Highlights section of [the drug] in order to conform to state law, any argument that begins with the theory that Defendants could (or should) have changed the Highlights section of [the drug’s] label ends in preemption.
Id. at *5-6 (citations omitted).
The same result was reached in Patton v. Forest Laboratories, LLC, 2018 WL 5270476 (C.D. Cal. May 10, 2018):
[Defendant] also argues that Plaintiffs’ failure-to-warn claim against it is preempted because: (1) [it] could not have ‘unilaterally or independently change[d] the Highlights section; all changes to that section require FDA’s pre-approval’. . . .
In their Opposition, Plaintiffs do not address [defendant’s] arguments concerning the permissible scope of label changes made by a NDA holder under the CBE process. Instead, Plaintiffs argue that their failure-to-warn claim is not preempted because ‘Plaintiffs’ contentions are that the Defendants did not comply with their obligations under Federal law regarding the labeling of [the drug]. . . .’
While it is obvious that the FDA, in approving the relevant [drug’s] labeling, disagreed with Plaintiffs’ contention that the labeling violates ‘federal law’ at the time it approved that labeling, even if the FDA were wrong, only the government (i.e., not Plaintiffs) may bring a lawsuit to enforce the FDCA and the FDA’s regulations. Accordingly, Plaintiffs’ failure-to-warn claim, as presently constituted, is preempted.
Id. at *16-17 (citations omitted). See id. at *4 (“NDA holders may not make any changes to the Highlights section of a drug’s labeling without prior FDA approval”). See also Patton v. Forest Laboratories, Inc., , 2018 WL 5269239, at *11 (C.D. Cal. Sept. 19, 2018) (plaintiffs conceded preemption of claims affecting highlights).
“Highlights summarizes the information from the FPI that is most important for prescribing the drug safely and effectively.” 71 Fed. Reg. at 3922. “[I]t is critical to ensure accuracy and consistency in the information included in Highlights because it contains a summary of the most important information for prescribing the drug safely and effectively.” Id. Thus, it would be impossible to maintain “Highlights [as] a concise extract of the most important information,” id., if plaintiffs could demand different or additional warnings in the full labeling that would diverge from what is contained in unmodified, FDA-approved highlights. Thus, plaintiffs should not be able to evade preemption by ignoring disparities with highlights and demanding only changes to the rest of a drug’s labeling. This need for consistency is analogous to the “sameness” requirement that drives preemption in generic drug cases—for highlights to serve their intended function, they must convey the same information (in abbreviated form) as is found in the rest of a drug’s label.
Preemption exists “when a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency.” PLIVA, Inc. v. Mensing, 564 U.S. 604, 623-34 (2011). Thus, the preemptive effect of this “independence principle” extends to any product liability claim demanding a change to a black box warning, contraindication, warning, adverse event (or anything else) that would require a corresponding modification to the drug’s highlights section. As demonstrated above, the FDA’s current regulatory regime concerning Highlights meets Albrecht’s requirement that “whatever the means the FDA uses to exercise its authority, those means must lie within the scope of the authority Congress has lawfully delegated.” 139 S. Ct. at 1679.
Simply put, “to state a claim for failure-to-warn that is not preempted by the FDCA, a plaintiff must plead a labeling deficiency that Defendants could have corrected using the CBE regulation.” Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699, 708 (2d Cir. 2019) (quoting Celexa, 779 F.3d at 41). That regulation explicitly excludes any label change to the substance of the Highlights section. Potentially, this involves considerable preemption, much more than suggested in Wyeth v. Levine, 555 U.S. 555 (2009)—which involved an older drug used in 2000, long before Highlights existed. Such older drugs are not subject to the Highlights requirement at all. 21 C.F.R. § 201.56(b) (new “labeling content and format requirements” apply only to post-2006 drugs). But the amended CBE provision says what it says, and the Supreme Court has put that sort of objection to rest:
We acknowledge the unfortunate hand that federal drug regulation has dealt [these plaintiffs], and others similarly situated. But it is not this Court’s task to decide whether the statutory scheme established by Congress is unusual or even bizarre. . . . But different federal statutes and regulations may, as here, lead to different pre-emption results. We will not distort the Supremacy Clause in order to create similar pre-emption across a dissimilar statutory scheme. As always, Congress and the FDA retain the authority to change the law and regulations if they so desire.
Mensing, 564 U.S. at 625-26 (citation, quotation, and footnote marks omitted).
Preemption of explicit plaintiff demands for changes to the Highlights section of drug labeling is the easy argument to win, and indeed to date it has never lost. However, now that Albrecht has clarified the standards for preemption, the broader argument should also be pursued, extending preemption to any informational claims that demand substantive changes that would necessarily require also modifying the language of the Highlights section. Defendants and their counsel should closely examine all allegations of “inadequate” warnings to determine whether such claims would create inconsistencies with Highlights information, and adjust their preemption strategy accordingly.
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The U.S. Court of Appeals for the Third Circuit has granted interlocutory review of a New Jersey-based federal district court’s certification of a class in In re Lamictal Indirect Purchaser & Antitrust Consumer Litigation. The appeal arises from an antitrust lawsuit brought against manufacturers GlaxoSmithKline (GSK) and Teva by direct purchasers of Lamictal or of its generic version lamotrigine. Plaintiffs allege that GSK and Teva’s settlement of a patent dispute both delayed and suppressed generic competition to Lamictal tablets in violation of the antitrust laws. Because the district court allowed the plaintiffs to improperly use statistical averaging to meet Rule 23’s requirement that common issues must predominate over individual issues, the Third Circuit should reverse class certification.
In conducting its predominance analysis under Rule 23, the district court ignored the complexities of prescription drug pricing and the highly individualized nature of the purchase transactions. The prices consumers pay can vary significantly depending on such individual factors as purchasing power, quantities purchased, and the types of discounts offered to various kinds of purchasers—ranging from large wholesalers and distributors to small specialized pharmacies. A consumer’s price also varies depending on whether she buys generic lamotrigine or brand Lamictal. Although the price paid is an individualized inquiry for each purchaser, the district court allowed the plaintiffs to satisfy predominance by calculating the average price paid and assuming that each class member paid that price. According to the court, such differences in pricing—and the fact that those differences were not reflected in the plaintiffs’ averaging of data—were relevant only to damages and whether “some generic purchasers were injured more or less strongly than others.”1
However, such differences, which were masked by the plaintiffs’ use of averaged prices, affect whether the alleged anti-competitive conduct injured particular purchasers at all. Indeed, the defendants’ experts concluded that a significant portion of generic purchasers paid less for generic lamotrigine as a result of the patent settlement and suffered no injury. The district court’s characterization of the issue as one related to damages, rather than antitrust impact, led it to apply the more lenient predominance standard for individual issues of damages, which do not usually stand in the way of class certification, and to disregard individual issues of antitrust injury, which are subject to a more stringent standard. As the Third Circuit has stated, in antitrust cases, the issue of antitrust injury is “critically important” for the evaluation of the Rule 23(b)(3) predominance requirement because injury “is an element of the claim that may call for individual, as opposed to common proof.”2
In its analysis, the district court declined to conduct a thorough evaluation of the facts relevant to predominance, stating that “a court should not address merits-related issues beyond what is necessary to determine preliminarily whether certain elements will necessitate individual or common proof.”3 Yet, the evaluation appears to have stopped well short of the “rigorous analysis” of factual and legal issues required when determining whether antitrust injury was a common issue that could be resolved on the plaintiffs’ common evidence of average pricing. The court accepted an averaging of discounts from roughly 20% to 60%, a range that meant individual purchasers could well have paid lower prices than they would have paid in the plaintiffs’ “but-for world.”4
Moreover, in an individual lawsuit, an individual purchaser could not show antitrust injury by relying solely on evidence of average prices and discounts, rather than the individual prices actually paid by the purchaser and the discounts actually received. The Rules Enabling Act prevents Rule 23 from being used to enlarge or reduce an individual plaintiff’s burden. That is why, under the Supreme Court’s decision in Tyson Foods, Inc. v. Bouaphakeo, class-action plaintiffs may not rely on averaged, statistical evidence to establish class-wide proof of injury to a hypothetical average plaintiff if there are significant individual differences among class members.5 The district court’s decision in this case contravenes that holding.
The district court inappropriately suggested that the plaintiffs would somehow be able to ensure that uninjured class members did not recover, but did not explain how that could be done in a way that was both administratively feasible and protective of the defendants’ due process and Seventh Amendment rights.6 The court also suggested, without apparent basis, that the issue was not one of uninjured class members, but of class members who received offsetting benefits from the alleged anti-competitive conduct, again attempting to reduce the issue to one of damages.7 In the same vein, the court suggested that class members who “did not switch … to a generic option after it became available” and therefore, as defendants argued, did not suffer injury, could still rely on the common proof provided by plaintiffs’ expert’s “but-for-world” to show what their “purchase patterns would have been” if generics had been introduced earlier.8 Here, the “but-for” world of averaging and statistics is being extended to hypothesize what specific plaintiffs would have done in different circumstances—surely a topic that in the world of individual litigation would require individual proof from the plaintiff.
The Third Circuit’s resolution of these issues will have important ramifications for antitrust litigation, especially for those involving pharmaceuticals. If allowed to stand, the district court’s decision will furnish a precedent for class-action trials that permits class certification and trials in antitrust cases on a hypothetical level that ignores real-world variations among individual class members, while also eroding the stringent requirements for proof of antitrust injury. The Third Circuit should reverse the district court’s flawed class certification in In re Lamictal and reaffirm the principles set forth in decisions such as In re Hydrogen Peroxide, Newton, and Gates.
The policymaking power routinely exercised by unelected officials in federal agencies is under pressure from both sides of the ideological spectrum. On the right, libertarians and regulated businesses rail against the “deep state.” On the left, there is concern about a deregulatory Executive Branch’s new and revised statutory interpretations by. Both sides turn to the courts for relief.
A majority of the U.S. Supreme Court under Chief Justice John Roberts has shown some sympathy for the Trump Administration’s revisions of prior regulatory policies but continues to express discomfort with an administrative state that “wields vast power and touches almost every aspect of daily life.” See Free Enter. Fund v. Pub. Co. Accounting Oversight Bd., 561 U.S. 477, 499 (2010). While the Court’s reining in of regulation has so far been limited, an important dissent from Justice Gorsuch in Gundy v. United States, 139 S. Ct. 2116 (2019), may foretell a broader effort. There, Justices Gorsuch, Roberts, and Thomas articulated a vision for restoring congressional accountability for administrative regimes by revitalizing the long-dormant nondelegation doctrine. Although their view did not command a majority in Gundy, the dissent may presage a coming sea change in judicial review of agency rules implementing broad Congressional directives.
The Status Quo
For 35 years, Justice Stevens’ opinion in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), has provided a deferential framework for judicial review of agency actions. Under Chevron, if a statute is silent or ambiguous on the legal basis of the agency’s action, the reviewing court must defer to an agency’s permissible construction.
The most common application of Chevron is in the rulemaking context. There, Chevron is premised on a theory of implied delegation: when Congress leaves a statute ambiguous, Congress intends the agency, rather than the courts, to exercise whatever interpretive discretion that ambiguity allows. Accordingly, under Chevron, a reviewing court must determine whether the statute contains an ambiguity. If so, the Court will uphold an agency’s “reasonable” interpretation of that ambiguity even if it is not the “best” interpretation.
Litigants challenging agency rulemaking have chafed under Chevron. And the doctrine has allowed the power of unelected government to expand. Nevertheless, the Supreme Court has been unwilling to reconsider Chevron. Moreover, the Court’s refusal last term to overturn Bowles v. Seminole Rock & Sand Co., 325 U.S. 410 (1945)—a case establishing Chevron-like deference for agency interpretations of their own rules (rather than statutes)—has led many to conclude that Chevron is now more entrenched than ever.
A Potential Limit
Gundy may open a new path for curbing Chevron deference without transferring interpretive authority from agencies to the courts. In Gundy, the Attorney General promulgated rules implementing the Sex Offender Registration and Notification Act (SORNA) under a broad and vague statutory mandate to deal with sex offenders who had completed serving their sentences before its enactment. Petitioner Herman Gundy, a convicted sex offender in that category who failed to register under the Attorney General’s rules, argued that the rules were void because SORNA unconstitutionally delegated legislative power to the Attorney General.
The Court, led by Justice Kagan, rejected Gundy’s petition in a 5-3 vote, holding that SORNA provided the Attorney General’s with enough policy guidance to draft reasonable rules. Justice Alito concurred in the result but declined to join Justice Kagan’s opinion. He expressed sympathy for the dissent and indicated his willingness to change his position in a future case. Justice Kavanaugh did not participate in Gundy.
Justice Gorsuch authored the dissent. Relying on two New Deal-era nondelegation decisions long thought consigned to the dustbin of history, Justice Gorsuch argued that SORNA was unconstitutional because it gave the Attorney General too much interpretive discretion on a central policy issue. He also noted that, even under Chevron, the Court has sometimes refused to defer to agency interpretations of statutes affecting “major questions” of policy: “Although it is nominally a canon of statutory construction, we apply the major questions doctrine in service of the constitutional rule that Congress may not divest itself of its legislative power by transferring that power to an executive agency.” Justice Gorsuch laid a doctrinal foundation for the test the Court has employed when rejecting deference to agencies in “big” cases. At the same time, however, Justice Gorsuch would ensure that the judiciary’s role is a limited one so courts are not tempted to supply the “most reasonable answer” to major policy questions Congress had not resolved. In his view, the constitutionally correct remedy was to return the responsibility for policy decisions to Congress by voiding the vague statute itself.
In attempting to delineate the contours of a revived nondelegation doctrine, Justice Gorsuch articulated what he deemed the three categories of permissible congressional delegations to the other branches: (1) delegations of authority to “fill up the details” of defined congressional programs; (2) delegations of authority to make factual determinations that trigger statutorily defined consequences; and (3) delegations of authority to carry out “non-legislative responsibilities” within the scope of functions assigned to the Executive Branch to the courts by Articles II or III of the Constitution.
Were Justice Gorsuch’s dissent to command a future majority with Justices Alito and Kavanaugh, the non-delegation doctrine would reset administrative litigation strategy for both challengers and defenders of agency rules. Under current law, challengers argue that an agency has departed from a specific congressional directive. They argue, in other words, that the statute cabins the agency’s discretion and that the agency transcended the limit. Regulators, on the other hand, typically argue that the statute is ambiguous, because Congress wanted the agency to make an expert, reasonable choice between alternative policy resolutions within a broad area of discretion. Most challenges are won or lost on this basis; if the analysis turns on the reasonableness of the agency’s decision, the agency almost always prevails.
A revived nondelegation doctrine would force both sides to rethink current strategies. Challengers unable to establish that Congress mandated a particular legal interpretation may argue that if Congress left interpretation to agency discretion, it evaded its legislative responsibility. Conversely, agencies may have to contend initially that their regulations merely implement specific congressional directives, thus avoiding nondelegation challenges. Alternatively, agencies may argue that if Congress delegated discretionary authority to the agency, the delegation fell within the areas Justice Gorsuch recognized as permissible. Defining the boundaries of those areas will require a case-by-case development of wholly new principles of nondelegation law. But agencies regulating within those boundaries would have a strong argument that Chevron deference should then apply to support their decisions.
Of course, litigants can have no assurance that Justice Gorsuch’s dissent will become a majority view. But Justice Alito’s expression of sympathy for the dissent, and similar concerns articulated by then-Judge Kavanaugh at the court of appeals and in his academic writing, strongly suggest that possibility. Accordingly, where challengers face limited prospects of establishing an express congressional directive, it might even be wise to acknowledge a congressional delegation of authority and then attack the legitimacy of that delegation.
Faced with the prospect of a revitalized nondelegation doctrine, the administrative state would likely seek to expand the categories of permissible delegations with the hope that exceptions will swallow the rule and thus reinter the doctrine. Agencies could find sympathy in lower courts that want to preserve the full scope of federal government activity and may be sensitive to the potential for paralysis in forcing Congress to make hard decisions. But Justice Gorsuch’s dissent relies on far more than a technical analysis. Harking back to the Founders’ philosophy and the importance of making legislation run the gauntlet of checks and balances, Justice Gorsuch sees the separation of powers as an assurance that the federal government would limit the scope of its activity and its intrusions into individual liberty. Justice Gorsuch clearly seems willing, if not eager, to curb not only agency policy discretion but the scope of federal activity fostered by the ease of delegating authority to a host of “expert” agencies.
The administrative state, having long expanded under the protection of Chevron, may soon be in for a rougher ride.
WASHINGTON, D.C. – Today, U.S. Senator Maria Cantwell (D-WA), the Ranking Member of the Senate Committee on Commerce, Science, and Transportation, pressed Patricia Cogswell, the Acting Deputy Administrator of the Transportation Security Administration (TSA), on staffing levels and security measures at Sea-Tac Airport.
“As one of the fastest growing airports, if not the fastest growing airport in the nation, the challenges of moving people and making sure that we’re all secure is a very, very important daily task,” Senator Cantwell said.
In her questions for Acting Deputy Administrator Cogswell, Cantwell asked about ongoing efforts to train additional teams to handle the growth in passenger traffic at Sea-Tac.
“I mentioned Sea-Tac and its rapid growth – I think we’re at 135,000 people a day and almost 50 million a year. I noticed that the site for Sea-Tac says it was built in 1949 to accommodate a million people, so the fact that we’re accommodating annually 50 million people shows the stress and strain on the system,” Senator Cantwell said.
“These security measures are of the utmost importance to us in continuing to do a good job at the security layer, as well as moving in a cost-effective fashion,” Cantwell continued. “I wanted to ask you about the new rules for developing third party canine units for explosive detection. When will we see those, and what other initiatives are we pursuing to have fully-trained teams available for deployment?”
Cogswell answered that TSA is continuing its work to address passenger and cargo screening needs.
“We expect to see continued growth and volume in that space; we’ve had a lot of interest in it,” Cogswell said. “In addition to the aspect around the third-party canine, we are also looking at the next round, next review, next enhancement, of technology that could be available for use in screening of cargo.”
“So, it’s safe to say that Sea-Tac will be seeing aggressive use of canines and that TSA will be continuing its own efforts as well as whatever Sea-Tac does on its own,” Cantwell concluded.
Senator Cantwell has long been a leader on aviation security issues in Congress. She authored legislation to help bring more bomb-sniffing dogs, which improve security and decrease passenger wait times, to airports across the country. Cantwell has also worked with TSA to deploy new dogs to Sea-Tac Airport to improve security checkpoint wait times at the airport. She has also worked with her colleagues to oppose cuts proposed by the Trump administration for Visible Intermodal Prevention and Response (VIPR) teams, a critical mass transit security program.
Senator Maria Cantwell
Opening Statement at Commerce Committee, Science, & Transportation Hearing on Oversight of the Transportation Security Administration
Witness: Patricia Cogswell, Acting Deputy Administrator, Transportation Security Administration
September 11, 2019
CANTWELL: Thank you, Mr. Chairman, and let me also welcome Acting Deputy Administrator Cogswell for joining us this morning. And thank you for all the work that TSA does in keeping us safe every day.
On this somber date, we remember the tragic and devastating events of 18 years ago. An adversary motivated by nothing short of an evil attack on our nation and the horrifying grief and loss of life was unimaginable. Establishing the Transportation Security Administration was among several steps that Congress took to ensure the attack would never be repeated. In the last Congress, this committee worked hard to complete the work on the FAA Reauthorization Act of 2018, also including the first comprehensive reauthorization of TSA since the agency was created shortly after the September 11 attacks. Our focus today is on oversight of the agency as it continues its critical mission and seeks to implement the mandates included in last year’s TSA authorization, formerly known as the TSA Modernization Act.
As you know, last year’s TSA Modernization Act focused on improving transportation security by addressing such issues as training and deployment of canines for screening of passengers and cargo, reinforcing efforts the intercept insider threats, and expediting testing and deployment of new screening technologies in various organizations to ensure the effective leadership at the agency. I also want to note here I appreciate the good work of the Pacific Northwest Laboratories in Richland, Washington, who, at airports with the Millimeter Wave Scan, have worked through security and developing, we call it the TSA salute, but nonetheless, this overhead has given us quite the security layer, and yesterday had the chance to talk with Acting Director Cogswell about the next generation of technology we will be deploying at airports. But both at our airports with individual travelers and our cargo containers, the Pacific Northwest Laboratory continues to stay ahead on cutting-edge technology, and we appreciate the work of our R&D labs in helping us maintain security.
I also appreciate your candor regarding a recent diversion of TSA resources to the southern border. I spoke to you about a letter that was sent by my colleague Senator Wicker and I about the diversion of those resources. My guess is we’ll have a chance to ask you in this morning’s hearing about that. Reports indicated at the time that there could be an additional FAMs deployed, with an ultimate goal of sending 175 to support the CBP operations, so I look forward to asking you about those questions this morning.
So, as my colleague said, we’re here to review what we can do to make sure that the TSA remains a strong and viable force. I remain very interested in the canine units’ success and the further deployment of that as one of the fastest growing airports, if not the fastest growing airport in the nation, Sea-Tac, the challenges of moving people and making sure that we’re all secure is a very very important daily task. So thank you for being here to address these issues.