Defense News: The USS Green Bay Arrives in San Diego after a Decade in Japan

Source: United States Navy

“USS Green Bay has been the workhorse of Sasebo and the Seventh Fleet for nearly a decade. We are super proud of our reputation as the most ready well deck in the area of operations, and looking forward to continuing a tradition of excellence in our new home port of San Diego,” said Capt. Aaron DeMyer, commanding officer of Green Bay.

The Green Bay served as part of the America Amphibious Ready Group, operating in the U.S. Seventh Fleet area of operations. With a crew of 400 and the ability to embark 700 Marines, Green Bay’s mission is to transport and launch amphibious craft in support of amphibious warfare and humanitarian operations.

“We have a good crew that understands what needs to be done when it needs to be done. The team has been worked hard in Seventh Fleet and I’m proud of my time serving abroad but I am overjoyed to be heading home to see my wife and kids after a year away,” stated Electronics Technician 1st Class Blake Cross.

Green Bay participated in numerous operations and exercises across the Indo-Pacific to include Exercise Talisman Sabre, a bilateral military exercise between Australia and the United States, with multinational participation, enhancing collective capabilities to respond to a wide array of potential security concerns; Exercise Keen Sword 25, a joint bilateral exercise Japan designed to increase readiness and interoperability while strengthening the U.S.-Japan alliance; Exercise Iron Fist, a bilateral exercise designed to increase interoperability and strengthen the relationships between the U.S. Marine Corps, U.S. Navy, the Japan Ground Self-Defense Force and Japan Maritime Self-Defense Force; Exercise Cobra Gold 2020, a Thailand and United States co-sponsored combined joint task force and joint theater security cooperation exercise in the Kingdom of Thailand; Exercise Garuda Shield 2022, a combined and joint exercise between the Indonesian National Armed Forces and U.S. Indo-Pacific Command designed to strengthen bilateral interoperability, capabilities, trust, and cooperation; Cooperation Afloat Readiness and Training Exercise with ships and aircraft from Thailand for allied training, focused on building interoperability and strengthening relationships. Additionally, the Green Bay conducted several humanitarian assistance missions.

“While in Seventh Fleet, the Green Bay crew became my family while I was away from my own. With multiple forward deployed patrols together, I am thankful for my fellow Sailors. I am excited to go back to the states to see my family and for them to meet my Navy family too,” stated Operations Specialist 2nd Class Juana Cerriteno.

USS Green Bay was commissioned January 24, 2009. The ship is named in honor of Green Bay, Wisconsin, and serves to conduct prompt and sustained amphibious operations to support national defense and theater security cooperation.

Defense News: U.S. Navy Operations in the Information Environment (OIE) Defined

Source: United States Navy

In August of 2023, the U.S. Navy recognized this evolution of the battlespace by establishing a division for Operations in the Information Environment (OIE) within the office of the Deputy Chief of Naval Operations (DCNO) for Information Warfare (OPNAV N2N6). This division serves as the advocate for policy, requirements, and resources for influence-related capabilities and synchronizes OPNAV’s OIE efforts.

In furtherance of the Navy’s OIE division’s efforts, Vice Adm. Karl Thomas, Deputy Chief of Naval Operations for Information Warfare, recently approved a new definition of U.S. Navy Operations in the Information Environment (Navy OIE) that underscores the critical role of cognitive effects in Navy operations and activities.

Navy OIE is now formally defined as “The ability to create cognitive effects to achieve deterrent and warfighting advantages by shaping adversary attitudes, beliefs, and behaviors through influence activities and public messaging paired with Navy, Joint, and combined operations and activities.”

Navy OIE highlights the importance of cognitive effects that are based on influence activities such as deception and operations security. It acknowledges that, to achieve success in the cognitive domain, influence activities must be integrated with the informational power of Navy public affairs and technical capabilities such as electronic warfare and cyberspace operations.

The definition marks the Navy’s adoption of OIE as its preferred term to describe the complex incorporation of influence and information capabilities to carry out the Information Joint Function in support of the Joint Force and national objectives.

“In the face of sophisticated state adversaries that pursue ruthless information campaigns against the United States Navy, the elevation of Navy OIE will make our force more resilient, bolster our ability to shape the information environment, and strengthen vital alliances and partnerships,” according to Rear Admiral Mike Brown, Director for Operations in the Information Environment, Office of the Chief of Naval Operations.

With the new Navy OIE definition, OPNAV’s OIE team will next promulgate an OIE Instruction to structure and organize the Navy’s cognitive warfare capabilities and to spur new Navy OIE doctrine and tactics, techniques, and procedures.

Deputy Assistant Attorney General Burden Walker Delivers Remarks at the Food and Drug Law Institute’s Enforcement, Litigation and Compliance Conference

Source: United States Department of Justice Criminal Division

Thank you, Maya, for that introduction and to the Food and Drug Law Institute for inviting me to open the Enforcement, Litigation and Compliance conference today. It’s an honor to be here with colleagues, from both government and industry, to discuss the accomplishments of the Justice Department’s Consumer Protection Branch.  

I am proud to represent the more than 120 attorneys and staff of the branch that work each day to protect Americans’ health, safety, economic security and identity integrity and to obtain justice for those harmed by unlawful products or practices.

We do not do this work alone. The branch works closely with lawyers and investigators from the Food and Drug Administration (FDA), Federal Trade Commission and Offices of Inspectors General from around the federal government, as well as our colleagues at FBI, Drug Enforcement Administration, Bureau of Alcohol, Tobacco, Firearms & Explosives (ATF), U.S. Marshals Service (USMS), U.S. Postal Inspection Service and Homeland Security Investigations (HSI), among others. Working alongside these partners, as well as the Justice Department’s 94 U.S. Attorneys’ Offices, the branch brings civil and criminal enforcement actions to hold accountable those who threaten the safety of Americans.

A large part of this work involves partnering with public health agencies like FDA to enforce laws relating to the regulation of products, including tobacco, food, medical devices, pharmaceuticals and dietary supplements.

Among other actions, the branch pursues civil or criminal actions against:

  • those who fail to maintain sanitary facilities or distribute tainted food products;
  • drug and medical device manufacturers who sell adulterated and misbranded products;
  • fraudsters who sell fake cures or counterfeit drugs; and
  • clinical research personnel who fabricate or falsify clinical trial data in ways that can adversely impact FDA’s drug approval decisions.

Driving this work is the steadfast belief that the medical and scientific judgments of FDA’s experts should be respected. Every day, millions of Americans rely upon FDA’s expertise when consuming food, taking prescription drugs, or using medical devices. The branch is dedicated to ensuring that these consumers can have faith that the products they are using or the medicines they are taking are being marketed and sold to them, and to their medical professionals, consistent with the science and with the law.

I’d like to spend a minute talking about a few recent developments from the past year that highlight this principle. In May of this year, a federal court sentenced Endo Health Solutions for violating the Food, Drug and Cosmetics Act (FDCA) in the distribution of its opioid medication Opana ER with INTAC. The sentence included over $1.5 billion in fines and forfeiture, the second-largest set of criminal financial penalties ever levied against a pharmaceutical company. The sentence followed a guilty plea in which the company admitted that its sales representatives marketed Opana ER by touting its purported drug abuse deterrence and crush resistance despite a lack of clinical data supporting these claims. The truth was that rather than deter opioid abuse, the proliferation of Opana ER and other similar drugs fueled the Nation’s opioid crisis. The consequences were devastating for millions of families across the country. The branch will continue to prioritize investigating and prosecuting drug manufacturers who, like Endo, went beyond the science to boost their profits.

Another area where the branch is committed to ensuring that FDA’s medical judgment is heeded is the sale, distribution, and marketing of electronic nicotine delivery systems, or ENDS — commonly known as e-cigarettes or vapes. According to the most recent National Youth Tobacco Survey, nearly 6% of middle and high school students — about 1.63 million children — report using e-cigarettes. Though this is a significant decline from pre-pandemic numbers, the number of children putting their health at risk with these products remains far too high; of the students who report using, more than one-third reported using e-cigarettes regularly and more than one-fourth did so on a daily basis.

We know that many of these e-cigarette products are specifically designed to attract underage users. The Youth Survey indicated that more than 87% of students who use e-cigarettes, use flavored products such as candy or fruit flavored varieties. And e-cigarettes are now being designed to allow users to play video games, receive text messages or even play music — much like a smartphone — in order to maximize their appeal to youth.

To date, FDA has approved only 34 vaping products, and yet many companies continue to distribute or sell unauthorized products in violation of FDCA requirements. In addition, the Prevent All Cigarette Trafficking (PACT) Act requires tobacco sellers, including e-cigarette sellers, to comport with certain reporting, registration, packaging and delivery requirements, including requiring proof of age at the time of delivery. But many online retailers ignore this requirement and put youth at risk as a result. The branch is currently working with U.S. Attorneys’ Offices across the country to help stop the distribution of illegal e-cigarettes.

But we know this fight is too big to go it alone. So last summer, the department and FDA launched a multi-agency task force to combat the illegal distribution and sale of e-cigarettes. Members of the task force include the ATF, USMS, Postal Inspection Service, HSI and Customs and Border Patrol (CBP), among others. Recently, our colleagues at CBP and FDA announced the result of an operation in which they seized nearly 3 million unauthorized e-cigarette products at the border worth about $76 million. And this fall, the Task Force met with members from offices of 15 different state attorneys general as well as the leadership of the National Association of Attorneys General to discuss ways we could collaborate, and amplify each others’ efforts to stop unauthorized tobacco vaping devices from being sold and distributed.  

Our commitment to ensuring respect for FDA’s medical and scientific expertise extends beyond enforcement to our work defending suits challenging the agency’s actions. One notable example has been a set of cases seeking to displace FDA’s judgment regarding the medical abortion drug mifepristone. In the leading case, Alliance for Hippocratic Medicine vs. FDA, the plaintiffs sought, among other remedies, to set aside FDA’s initial approval of the drug, an approval first granted more than two decades ago. Earlier this year, the Supreme Court held that the plaintiffs in Alliance lacked standing, and the case was remanded back to the District Court. Alliance, and a few other cases also involving mifepristone, remain pending. In each of them, the Consumer Protection Branch — in collaboration with our colleagues in the Federal Programs Branch, Civil Appellate, and the Office of the Solicitor General — has argued that FDA’s decisions are grounded in the relevant medical and scientific data. And we will continue to emphasize that the law and the facts require courts to defer to, and not countermand, FDA’s expert scientific judgment that mifepristone is safe and effective.

The mifepristone cases are not the only examples of the branch’s commitment to defending FDA’s medical and scientific expertise this past year. In October, in Jazz Pharmaceuticals v. Becerra, the branch successfully defended FDA’s judgment that a particular narcolepsy drug was “clinically superior” to another drug and thus qualified for approval under the terms of the Orphan Drug Act. This past summer, in Ipsen Biopharmaceuticals v. Becerra, a unanimous panel of the D.C. Circuit affirmed FDA’s determination that a medicine used to treat certain hormonal disorders was a “drug” regulated under the FDCA, rather than a “biologic” subject to the Public Health Service Act. And in Novartis Pharmaceuticals v. Becerra, the branch persuaded the district court to reject a challenge to FDA’s approval of a so-called “skinny label” for the generic version of Novartis’s heart failure drug Entresto. In its opinion granting the branch’s motion for summary judgment, the district court expressly recognized the common thread that runs through each of these cases: judicial review of FDA’s judgment must be “limited” so that courts are not “unduly second guess[ing]” the agency’s “scientific judgments.”

I want to turn now to another principle that guides our work: the commitment to holding accountable companies and individuals who put particularly vulnerable Americans at risk by not meeting their obligations under our nation’s public health and safety laws. Our recent action against Family Dollar Stores represents perhaps one of the most notable recent examples of our work to hold accountable a company failing to abide by its public health obligations. Family Dollar Stores pleaded guilty last February in the Eastern District of Arkansas to violating the FDCA by holding food, drugs, medical devices, and cosmetics under insanitary conditions. As outlined in the plea, in August 2020, the company began receiving reports of mouse and pest issues with products being shipped from an Arkansas distribution center to 400 different stores across six states. Despite these reports, the company continued to ship from the Arkansas warehouse for another year-and-a-half when an FDA inspection revealed live rodents, dead and decaying rodents, rodent feces, urine, and evidence of gnawing and nesting throughout the facility. As a result of its guilty plea, Family Dollar Stores agreed to pay fines and forfeiture of $41.675 million — the largest ever in a food safety case.

The branch and its agency partners have also recently held accountable companies and executives who fail to ensure the safety of medical devices. In April, we secured a consent decree resolving a complaint against Philips RS and some of its executives for manufacturing and distributing sleep and respiratory devices — including CPAP and BiPAP machines — in violation of FDCA requirements. This resolution followed a 2021 recall due to foam used in many of the devices that could degrade and be inhaled by the machines’ users. Thanks to the consent decree, Philips agreed to cease production of its devices at its three Pennsylvania facilities, with some limited exceptions, until the company has completed a set of specific measures designed to ensure their safety going forward.

The branch also actively pursues medical professionals who betray their patients and the public trust by violating federal public health and safety laws. In April, the branch secured the conviction at trial of a Dallas anesthesiologist for tampering with consumer products and intentional adulteration of a drug. The defendant, Raynaldo Riviera Ortiz Jr., surreptitiously injected the stimulant epinephrine and other drugs into IV bags of saline that he knew were going to be used in his colleagues’ surgeries. In just one summer, numerous patients at the facility where the defendant worked suffered cardiac emergencies as a result of Ortiz’s crimes. Another anesthesiologist died while treating herself for dehydration with an IV bag. Last month, a court sentenced the defendant to 190 years’ imprisonment for his crimes. I am incredibly proud of the lawyers and agents who worked tirelessly to ensure that Ortiz never hurts another patient.

As the Deputy Assistant Attorney General for the Consumer Protection Branch, I have the privilege of working alongside the dedicated career attorneys and staff who commit themselves to protecting Americans from consumer threats.

I am incredibly proud of the work they have done over the past year to tirelessly defend FDA’s medical and scientific judgments, and to hold accountable those who ignore those judgments.

I am fortunate to call them my colleagues, and the American people are fortunate for their continued service.

Nashville Auto Parts Seller Agrees to Settlement for Selling Emissions Defeat Devices

Source: United States Department of Justice Criminal Division

The Justice Department and the Environmental Protection Agency (EPA) today announced that a Nashville automotive aftermarket parts distributor has agreed to pay $320,000 in civil penalties for selling illegal “defeat devices” designed to render automobile emission controls inoperative, in violation of the Clean Air Act (CAA).

Under the terms of the consent decree, Diesel Performance Parts Inc. (DPPI) has also agreed to send notices to dealers and customers notifying them about the settlement. Additionally, DPPI will remove all marketing material related to defeat devices.

“Defeat devices violate the Clean Air Act and cause a vehicle to contribute significantly higher amounts of pollutants into the air,” said Assistant Attorney General Todd Kim of the Justice Department’s Environment and Natural Resources Division (ENRD). “Excess emissions tangibly worsen the air we breathe. We are committed to upholding the rule of law.”

“Defeat devices significantly increase air pollution from motor vehicles and EPA will use all of its enforcement tools to hold sellers of defeat devices like DPPI accountable until these illegal practices stop” said EPA Acting Regional Administrator Jeaneanne Gettle for Region 4. “These illegal practices contribute to harmful air pollution and impede federal, state, and local efforts to implement air quality standards that protect public health. Emissions from mobile sources play an important role in EPA’s Southeastern region, and the use of these defeat devices hampers our ability to maintain compliance with the National Ambient Air Quality Standards.”

Since September 2018, DPPI sold at least 6,858 aftermarket defeat devices that bypassed, defeated or rendered inoperative emissions control systems that were installed in motor vehicles or in motor vehicle engines in compliance with the CAA for motor vehicles equipped with diesel engines.

A vehicle’s emission controls reduce the amount of air pollutants emitted and their harmful effects, but aftermarket defeat devices negate those controls. One EPA study found that known sales of defeat devices for certain diesel trucks between 2009 and 2020 resulted in excess emissions of more than 570,000 tons of nitrogen oxides and 5,000 tons of particulate matter over the lifetime of the trucks. The resulting health conditions include premature mortality, aggravation of respiratory and cardiovascular disease, aggravation of existing asthma, acute respiratory symptoms, chronic bronchitis and decreased lung function. Numerous studies also link diesel exhaust to increased incidence of lung cancer.

Stopping aftermarket defeat devices for vehicles and engines is a top priority for EPA. Visit EPA’s website to learn more about its efforts to stop the sale of illegal defeat devices.

The consent decree was entered in the U.S. District Court for the Middle District of Tennessee. There is a 30-day public comment period. Additional information about the agreement can be found at www.justice.gov/enrd/consent-decrees.

EPA investigated the case.

Attorneys with ENRD’s Environmental Enforcement Section are handling the case.

Two Biotech CEOs Convicted in Securities Fraud Scheme

Source: United States Department of Justice

A federal jury in Maryland convicted two men yesterday for their roles in a scheme to lie to investors in CytoDyn Inc., a publicly traded biotechnology company based in Vancouver, Washington.

According to court documents and evidence presented at trial, Nader Pourhassan, 61, of Lake Oswego, Oregon, and Kazem Kazempour, 71, of Potomac, Maryland, engaged in a scheme to deceive investors about CytoDyn’s development of an investigational drug to artificially inflate and maintain the price of CytoDyn’s stock and to attract new investors. Between 2018 and 2021, CytoDyn sought approval for the drug from the Food and Drug Administration (FDA) to treat HIV and COVID-19. Pourhassan was the chief executive officer of CytoDyn, and Kazempour was the chief executive officer of Amarex Clinical Research LLC, a Germantown, Maryland-based contract research organization that had been hired to conduct Cytodyn’s clinical trials and was serving as the company’s representative with the FDA. Pourhassan and Kazempour diverted proceeds of the scheme for their own benefit, including by selling personal shares of CytoDyn stock at artificially inflated prices.

“The defendants lied to investors and the public — including during the height of the COVID-19 pandemic — about a drug that purportedly treated HIV and COVID-19 in order to artificially inflate CytoDyn’s stock price,” said Principal Deputy Assistant Attorney General Nicole M. Argentieri, head of the Justice Department’s Criminal Division. “The Justice Department is committed to protecting the investing public from criminals who would exploit public health crises for personal profit. These convictions confirm the department’s commitment, together with our law enforcement partners, to hold corrupt C-suite executives who abuse their positions and engage in securities fraud accountable for their actions.”

“With false promises of FDA approval, the defendants enriched themselves by the millions while investors lost,” said U.S. Attorney Erek L. Barron for the District of Maryland. “White collar criminals cause irreparable harm to the public, and we will continue to bring them to justice without fear or favor.”

Pourhassan and Kazempour made false and misleading statements about the timeline and status of CytoDyn’s regulatory submissions to the FDA. In spring 2020, the pair falsely stated that the drug had been submitted for approval to treat HIV, when they knew that the submitted application was incomplete and that the FDA would therefore refuse to review it. Immediately after the announcement, Pourhassan sold more than 4.8 million shares of Cytodyn. Around the same time, Pourhassan engaged in a scheme to misrepresent the status of CytoDyn’s investigation and development of leronlimab as a potential treatment for COVID-19, including the results of clinical trials and the likelihood of approval from the FDA. Pourhassan knew that leronlimab’s clinical studies had failed and that the FDA had not approved the drug for use as a treatment for COVID-19 and had expressed concerns that the submitted data was misleading. During the scheme, CytoDyn raised approximately $300 million from investors, of which more than $22 million was paid to Kazempour’s company. In addition, Pourhassan received $4.4 million and Kazempour received more than $340,000 from their sales of CytoDyn stock.

“These convictions highlight the serious consequences of defrauding investors and manipulating stock prices,” said Assistant Director Chad Yarbrough of the FBI’s Criminal Investigative Division. “This case reinforces the FBI’s commitment to proving that no scheme, no matter how elaborate, is beyond the reach of the law. We will continue to pursue those who put personal profit above public trust.”

“These convictions demonstrate that those who make misleading statements about clinical trial results to the public — including to healthcare providers and patients — will be held accountable for their actions,” said Special Agent in Charge Robert Iwanicki of the FDA Office of Criminal Investigations (FDA-OCI) Los Angeles Field Office. “The agency will continue to work with other agencies to bring to justice those who place profits above public health.”

“These defendants took advantage of two public health crises when they devised a scheme to swindle investors out of millions of dollars to pad their pockets by lying about the results of clinical trials and approvals from the FDA on an HIV and COVID-19 drug,” said Inspector in Charge Eric Shen of the U.S. Postal Inspection Service (USPIS) Criminal Investigations Group. “Together, with our law enforcement partners, Postal Inspectors will continue the work of keeping financial systems and the investing public safe from fraudsters.”

Pourhassan was convicted of four counts of securities fraud, two counts of wire fraud, and three counts of insider trading. Kazempour was convicted of one count of securities fraud and one count of wire fraud related to his submission of the application for approval from the FDA and attempt to trade Cytodyn shares the following day. They are scheduled to be sentenced at a later date, and they face a maximum penalty of 20 years in prison for each count of securities fraud, wire fraud, and insider trading. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.

The FBI, FDA-OCI, and USPIS investigated the case.

Trial Attorneys Lauren Archer and Matthew Reilly and Senior Litigation Counsel Vasanth Sridharan of the Criminal Division’s Fraud Section and Assistant U.S. Attorney Adeyemi Adenrele for the District of Maryland are prosecuting the case. Law Clerk Kerstin Abolnik and Paralegal Specialists Selam Wehabe and John Lee of the Fraud Section provided assistance.