Thursday, March 7, 2024

Generic Pharmaceuticals Manufacturer Pleads Guilty, Agrees to $1.5 Million Criminal Penalty for Distributing Adulterated Drugs and $2 Million to Resolve Civil Liability under the False Claims Act

 

KVK Research Inc., a generic drug manufacturer in Bucks County, Pennsylvania, pleaded guilty to criminal charges that it introduced adulterated drugs into interstate commerce.

A criminal information filed in federal court in Philadelphia charged KVK Research and its corporate affiliate, KVK Tech Inc., with two misdemeanor counts of introducing adulterated drugs into interstate commerce in violation of the Federal Food, Drug and Cosmetic Act (FDCA). Pursuant to a plea agreement, KVK Research pleaded guilty to the information and agreed to a proposed fine and forfeiture amount of $1.5 million.

KVK Tech agreed to a three-year deferred prosecution agreement (DPA) that will allow the company to avoid conviction on the charges in the information if it complies with the terms of the agreement, which include implementation of a compliance program designed to prevent and detect violations of federal regulations regarding current good manufacturing processes. The DPA also requires KVK Tech to engage an independent compliance monitor to evaluate the company’s corporate compliance program to address and reduce the risk of future violations.

U.S. District Judge Harvey Bartle III presided over the KVK Research plea hearing.

“Consumers have a right to expect that the drugs they purchase are safe and manufactured in compliance with the FDCA and FDA regulations,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Justice Department will continue to work with FDA to prosecute companies that put consumers at risk by selling adulterated drugs.”

“Consumers in this District expect that manufacturers will adhere to FDA regulations,” said U.S. Attorney Jacqueline C. Romero for the Eastern District of Pennsylvania. “When adulterated drugs are introduced into interstate commerce, that conduct has the potential to jeopardize patient safety. This case exemplifies my office’s commitment to holding manufacturers responsible for their crimes, as well as refocusing efforts on the company’s compliance to prevent future illegal conduct. In this case, the joint efforts between the office’s criminal and civil divisions to hold defendants accountable also returned money to those federal agencies affected by the defendants’ conduct.”

“The FDA’s requirements for manufacturing generic drugs are designed to ensure that patients receive safe and effective medical treatments. Evading the FDA process and distributing adulterated drugs to U.S. consumers will not be tolerated,” said Special Agent in Charge George Scavdis of the FDA Office of Criminal Investigations, Metro Washington Field Office. “We will continue to investigate and protect the public health of the nation.”

As part of the plea agreement and the DPA, the companies admitted that between January 2011 and October 2013, KVK Tech introduced into interstate commerce at least 62 batches of adulterated hydroxyzine tablets. The tablets were manufactured with an active pharmaceutical ingredient (API) made at a foreign facility. KVK Tech failed to notify FDA or seek FDA authorization to use that facility as a source of API for its hydroxyzine products. The companies also admitted that between Feb. 27, 2019, and April 16, 2019, KVK Tech manufactured prescription drugs while failing to exercise appropriate controls over computer and related systems as required by current good manufacturing practices regulations. Under federal law, such drugs are deemed to be adulterated.

Additionally, KVK Tech agreed to pay $2 million to resolve its civil liability under the False Claims Act arising from the company’s failure to exercise appropriate controls as required by current good manufacturing practice regulations, which caused KVK Tech to introduce into interstate commerce drugs deemed to be adulterated. During the Feb. 27, 2019, through April 16, 2019, time period, KVK Tech sold the adulterated pharmaceuticals, which resulted in alleged false claims submitted to the TRICARE program, Federal Employees Health Benefits Program (FEHBP), Veterans Administration (VA) and Department of Labor, Office of Workers Compensation Programs (DOL-OWCP), in violation of the False Claims Act.

“Protecting the welfare of our nation’s military members and their families is a priority for the Defense Criminal Investigative Service (DCIS), the law enforcement arm of the Department of Defense Office of Inspector General,” said Acting Special Agent in Charge Brian J. Solecki of the DCIS Northeast Field Office. “The introduction of adulterated pharmaceuticals into the TRICARE system endangers the lives of American service members and threatens our military readiness. The DCIS is committed to working with the Justice Department and our law enforcement partners to ensure that companies who engage in fraudulent activity, at the expense of the U.S. military, are investigated and prosecuted.”

“We expect manufacturers to comply with all federal laws and regulations when they are serving federal health care recipients,” said Deputy Assistant Inspector General for Investigations Conrad J. Quarles of the Office of Personnel Management Office of the Inspector General. “We applaud our investigative staff, and our law enforcement partners for their hard work protecting FEHBP enrollees and their families.”

FDA’s Office of Criminal Investigations investigated the case. 

Additional information about the Consumer Protection Branch and its enforcement efforts can be found at www.justice.gov/civil/consumer-protection-branch.

Except to the extent that the defendants’ admissions are part of its criminal resolution, the claims resolved by the civil settlement are allegations only and there has been no determination of liability.

NYC PUBLIC ADVOCATE'S STATEMENT ON THE GOVERNOR'S 'SUBWAY SAFETY' PLAN

 

"How many surges of law enforcement into the subway will satisfy the political desire of city and state leaders to address the fears incited and fanned by those same leaders? This is the fifth or sixth in recent years, and even in response to real concerns and crimes, it’s as unsustainable as it's been ineffective.

"Militarizing the subway, and suggesting that we can either ethically or practically ban individuals from accessing public transportation, are absurd and dangerous misuses of resources which could be better spent addressing the root causes of crime. It’s one thing to announce police presence on the platforms for political gain, as the governor has in the past. It’s another entirely to further criminalize the public on public transit and neglect the real improvements these resources could be devoted to, like fixing the subway itself.

"Instead of posturing to look ‘tough on crime,’ which is why we’re still having these same conversations, let’s get serious about safety, and what it actually involves."

THE NEW YORK STATE DEPARTMENT OF LABOR CELEBRATES WOMEN IN CONSTRUCTION WEEK


We Are Your DOL - New York State Department of Labor

The New York State Department of Labor (NYSDOL) is proud to participate in Women in Construction Week, taking place March 3-9. Recent census data reveals that over 11,000 women are employed as construction workers within New York State, many of whom have honed their skills through NYSDOL’s Registered Apprenticeship programs. Currently, over 1,100 women are taking proactive steps through these programs to carve out their careers in the construction industry.

New York State Department of Labor Commissioner Roberta Reardon said, “As we celebrate Women in Construction Week, it's vital to recognize and applaud the significant contributions of women in this field. The construction industry thrives on diversity, innovation, and resilience, qualities that women have been demonstrating and enhancing in workplaces across New York State. By breaking barriers and challenging stereotypes, women in construction are not just building structures; they are also constructing a more inclusive and dynamic future for us all.”

President of the Building and Construction Trades Council of Greater New York and the New York State Building and Construction Trades Council Gary LaBarbera said, “During this Women in Construction Week, we not only celebrate the critical role our tradeswomen play in the industry, but also recognize the work yet to be done to provide more women with the middle-class career opportunities available within unionized construction. Through the collaborative efforts of the trades, the NYSDOL and our stakeholders, we remain committed to breaking down barriers for all workers and fostering an environment that allows more women to thrive and lead in the construction sector.”

Since its inception by the National Association of Women in Construction in 1998, Women in Construction Week has played a pivotal role in promoting the essential contributions of women to the construction sector. This year's theme, "Keys to the Future," emphasizes the strength, knowledge, and indispensable role women hold in driving the industry forward.

The NAWIC's initiatives have been instrumental in championing gender diversity, equity, and inclusion within the construction sector. By spotlighting achievements and addressing the systemic barriers women encounter, these efforts have cultivated a more supportive environment that encourages the active participation and leadership of women in construction.

The apprenticeship programs supported by NYSDOL play a pivotal role in this mission, offering women the training, mentorship, and opportunities needed to thrive. These initiatives are vital for not only the personal and professional growth of women in the field but also for ensuring the continued innovation and vitality of New York's construction industry.

As we look to the future, NYSDOL is committed to further breaking down barriers and creating new opportunities for women in construction. Through continued collaboration with organizations like NAWIC, advocacy, and proactive policies, we aim to build an industry that truly reflects the diversity and values of New York State.

Women interested in pursuing a career in construction can get started by learning more about Registered Apprenticeships.


Wednesday, March 6, 2024

Governor Hochul and Code For America Announce March 12 Launch of Free Program to Help New Yorkers File Tax Returns Online

FileYourStateTaxes, Available to All Eligible New Yorkers Starting Next Week, Will Provide Seamless State Tax Filing Integrated with IRS Direct File

Attorney General James Leads Bipartisan Coalition Calling on Meta to Protect Users’ Accounts From Scammers

 

Coalition of 41 Attorneys General Ask for Data Security Review Following Major Increases in Scammers Taking Over Facebook and Instagram Accounts

New York Attorney General Letitia James led a bipartisan coalition of 41 attorneys general in sending a letter to Meta Platforms, Inc. (Meta) addressing the recent rise of Facebook and Instagram account takeovers by scammers and frauds. Account takeovers are when bad actors break into a user’s account and change passwords, effectively hijacking the account and blocking out the rightful owner. Attorney General James and the bipartisan coalition are calling on Meta to thoroughly review data security practices for protecting its users’ accounts from being unfairly locked out or taken over by scammers. 

“Having your social media account taken over by a scammer can feel like having someone sneak into your home and change all of the locks,” said Attorney General James. “Social media is how millions of Americans connect with family, friends, and people throughout their communities and the world. To have Meta fail to properly protect users from scammers trying to hijack accounts and lock rightful owners out is unacceptable. I thank my fellow attorneys general for joining me to call on Meta to take commonsense user protection measures and dedicate more of their resources to respond to this threat.”

Once scammers hijack a Facebook or Instagram user’s account and change the password, they can steal personal information, read private messages, pose as the user to scam contacts, and even post publicly as the rightful user. All these actions cause undue harm and stress to account owners and their connections. While account takeovers are not a new phenomenon, there has been a dramatic increase in these schemes over the past year. As users have struggled to receive help from Meta, they have turned to their attorneys general seeking assistance and support. Between 2019 and 2023, there has been a 1,000 percent increase in reported account takeover complaints made to the Office of the Attorney General (OAG). In January 2024 alone, 128 complaints were made to OAG about this growing problem. 

To address the account takeover crisis and provide better quality services to the millions of users who rely on Meta platforms daily, the letter from Attorney General James and the bipartisan coalition outlines a series of commonsense steps Meta should take. These include increasing staffing to respond to account takeover complaints and greater investment in account takeover mitigation tactics. The attorneys general also call on Meta to adopt new procedures for users to protect themselves from account takeovers. Additionally, Attorney General James and the bipartisan coalition urge Meta to take this issue more seriously and take stronger enforcement actions against scammers.

Users who experience an account takeover from a scammer or bad actors are encouraged to raise this concern to Meta immediately. Users unable to get in touch with Meta or have the issue resolved can refer to Facebook's help center on how to address an account takeover situation. 

Chinese National Residing in California Arrested for Theft of Artificial Intelligence-Related Trade Secrets from Google

 

Defendant Allegedly Pilfered Technology from Google While Secretly Working for Two PRC-Based Technology Companies

A federal grand jury indicted Linwei Ding, aka Leon Ding, charging him with four counts of theft of trade secrets in connection with an alleged plan to steal from Google LLC (Google) proprietary information related to artificial intelligence (AI) technology. The announcement was made by Attorney General Merrick B. Garland while participating in a “Fireside Chat” at the American Bar Association’s 39th National Institute on White Collar Crime in San Francisco.

According to the indictment, returned on March 5 and unsealed earlier today, Ding, 38, a national of the People’s Republic of China and resident of Newark, California, transferred sensitive Google trade secrets and other confidential information from Google’s network to his personal account while secretly affiliating himself with PRC-based companies in the AI industry. Ding was arrested earlier this morning in Newark.

“The Justice Department will not tolerate the theft of artificial intelligence and other advanced technologies that could put our national security at risk,” said Attorney General Garland. “In this case, we allege the defendant stole artificial intelligence-related trade secrets from Google while secretly working for two companies based in China. We will fiercely protect sensitive technologies developed in America from falling into the hands of those who should not have them.”  

“While we work to responsibly harness the benefits of AI, the Justice Department is on high alert to its risks, including global threats to our national security,” said Deputy Attorney General Lisa Monaco. “As alleged in these charges, the defendant stole from Google over 500 confidential files containing AI trade secrets, while covertly working for China-based companies seeking an edge in the AI technology race. The Justice Department will relentlessly pursue and hold accountable those who would siphon disruptive technologies – especially AI – for unlawful export.”

“These charges are the latest illustration of the lengths affiliates of companies based in the People’s Republic of China are willing to go to steal American innovation,” said FBI Director Christopher Wray. “The theft of innovative technology and trade secrets from American companies can cost jobs and have devastating economic and national security consequences. The FBI will continue its efforts to vigorously pursue those responsible for stealing U.S. companies’ intellectual property and most closely guarded secrets.”  

“Mr. Ding allegedly schemed to siphon off cutting-edge AI technology from Google while secretly trying to go into business with Chinese competitors,” said Assistant Attorney General Matthew G. Olsen of the Justice Department’s National Security Division. “Through the Disruptive Technology Strike Force, we will work relentlessly to find and hold accountable those who would steal advanced American technology and jeopardize our national security and economic prosperity.”

“While Linwei Ding was employed as a software engineer at Google, he was secretly working to enrich himself and two companies based in the People’s Republic of China,” said U.S. Attorney Ismail Ramsey. “By stealing Google’s trade secrets about its artificial intelligence supercomputing systems, Ding gave himself and the companies that he affiliated with in the PRC an unfair competitive advantage.  This office is committed to protecting the innovation of our Silicon Valley companies. To that end, we will aggressively investigate and prosecute the theft of sensitive trade secrets by insiders like Ding, including criminal efforts to jump start illegitimate competition.”

“In the one year since its inception, the Disruptive Technology Strike Force has been relentless in protecting advanced U.S. technologies, like artificial intelligence, from malign actors,” said Assistant Secretary Matthew S. Axelrod of the Commerce Department’s Office for Export Enforcement. “Let today’s announcement serve as further warning – those who would steal sensitive U.S. technology risk finding themselves on the wrong end of a criminal indictment.”

According to court documents, the technology Ding allegedly stole involves the building blocks of Google’s advanced supercomputing data centers, which are designed to support machine learning workloads used to train and host large AI models. According to the indictment, large AI models are AI applications capable of understanding nuanced language and generating intelligent responses to prompts, tasks, or queries. The indictment describes how Google developed both proprietary hardware and software to facilitate the machine learning process powered by its supercomputing data centers. With respect to hardware, Google uses advanced computer chips with the extraordinary processing power required to facilitate machine learning and run AI applications. With respect to software, Google deploys several layers of software, referred to in the indictment as the “software platform,” to orchestrate machine learning workloads efficiently. For example, one component of the software platform is the Cluster Management System (CMS), which functions as the “brain” of Google’s supercomputing data centers. The CMS organizes, prioritizes, and assigns tasks to the hardware infrastructure, allowing the advanced chips to function efficiently when executing machine learning workloads or hosting AI applications.

According to the indictment, Google hired Ding as a software engineer in 2019. Ding’s responsibilities included developing the software deployed in Google’s supercomputing data centers. In connection with his employment, Ding was granted access to Goggle’s confidential information related to the hardware infrastructure, the software platform, and the AI models and applications they supported. The indictment alleges that on May 21, 2022, Ding began secretly uploading trade secrets that were stored in Google’s network by copying the information into a personal Google Cloud account. According to the indictment, Ding continued periodic uploads until May 2, 2023, by which time Ding allegedly uploaded more than 500 unique files containing confidential information.

In addition, the indictment alleges that Ding secretly affiliated himself with two PRC-based technology companies. According to the indictment, on or about June 13, 2022, Ding received several emails from the CEO of an early-stage technology company based in the PRC indicating Ding had been offered the position of Chief Technology Officer for the company. Ding allegedly traveled to the PRC on Oct. 29, 2022, and remained there until March 25, 2023, during which time he participated in investor meetings to raise capital for the new company. The indictment alleges potential investors were told Ding was the new company’s Chief Technology Officer and that Ding owned 20% of the company’s stock.

According to the indictment, unbeknownst to Google, by no later than May 30, 2023, Ding had founded his own technology company in the AI and machine learning industry and was acting as the company’s CEO. Ding’s company touted the development of a software platform designed to accelerate machine learning workloads, including training large AI models. As alleged in the indictment, Ding applied to a PRC-based startup incubation program and traveled to Beijing, to present his company at an investor conference on Nov. 24, 2023. As set forth in the indictment, a document related to Ding’s startup company stated, “we have experience with Google's ten-thousand-card computational power platform; we just need to replicate and upgrade it - and then further develop a computational power platform suited to China's national conditions.” 

The indictment alleges Ding’s conduct violated his employment agreement as well as a separate code of conduct that Ding signed when he became a Google employee. Further, the indictment describes measures that Ding allegedly took to conceal his theft of the trade secrets. For example, he allegedly copied data from Google source files into the Apple Notes application on his Google-issued MacBook laptop. By then converting the Apple Notes into PDF files and uploading them from the Google network into as separate account, Ding allegedly evaded detection by Google’s data loss prevention systems. Likewise, the indictment describes how in December 2023 Ding allegedly permitted another Google employee to use his Google-issued access badge to scan into the entrance of a Google building – making it appear he was working from his U.S. Google office when, in fact, he was in the PRC.

Ding is charged with four counts of theft of trade secrets. If convicted, Ding faces a maximum penalty of 10 years in prison and up to a $250,000 fine for each count. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.

The FBI and Commerce Department are investigating the case.

The U.S. Attorney’s Office for the Northern District of California and Justice Department National Security Division’s Counterintelligence and Export Control Section are prosecuting the case.

Today’s action was coordinated through the Justice and Commerce Departments’ Disruptive Technology Strike Force. The Disruptive Technology Strike Force is an interagency law enforcement strike force co-led by the Departments of Justice and Commerce designed to target illicit actors, protect supply chains, and prevent critical technology from being acquired by authoritarian regimes and hostile nation-states.

An indictment is merely an allegation. All defendants are presumed innocent until proven guilty beyond a reasonable doubt in a court of law.

Three Defendants Arrested For Gunpoint Robberies Of Sex Workers In The Bronx

 

Damian Williams, the United States Attorney for the Southern District of New York; Tommy Kalogiros, Assistant Special Agent in Charge of the New York Field Division of the Bureau of Alcohol, Tobacco, Firearms and Explosives (“ATF”); and Edward A. Caban, the Commissioner of the New York City Police Department (“NYPD”), announced the unsealing of a Complaint charging RAMEL DECKARD, DASHAWN HAMPTON, and TALIEK PAYNE in connection with three armed robberies of women engaged in sex work at hotels in the Bronx.  DECKARD, HAMPTON, and PAYNE were arrested and presented in Manhattan federal court before U.S. Magistrate Judge Ona T. Wang. 

U.S. Attorney Damian Williams said: “These defendants, motivated by greed, allegedly targeted individuals engaged in sex work in the BronxUnder the pretext of setting up appointments with the victims for sexual services, the defendants allegedly met the victims at hotel rooms and proceeded to rob them at gunpointMy Office is committed to doing everything possible to protect the people in this District from violent crime.” 

ATF Assistant Special Agent in Charge Tommy Kalogiros said: “These arrests should send a strong message to those targeting the most vulnerable in our communities.  The ATF/NYPD Strategic Pattern Armed Robbery Technical Apprehension Group will continue working tirelessly to detect, disrupt, and prosecute the most violent offenders.  We hope that these arrests demonstrate to the victims of violent crime that ATF, along with our partners, remain steadfast in our resolve to deliver justice.  Thank you to the New York City Police Department and to the Southern District of New York, two of ATF’s most valued partners.”

NYPD Commissioner Edward A. Caban said: “As alleged, these arrests are another example of our laser-like focus on combating violent crime and holding accountable anyone who endangers people on our streets.  If you carry an illegal gun in New York City, and especially if you use that gun to terrorize our communities, you will be arrested and charged accordingly.  Thanks to the combined efforts of the NYPD and our partners at the ATF and the Office of the U.S. Attorney for the Southern District of New York, the defendants in this case now face the prospect of significant federal prison time.”

According to the allegations in the Complaint:[1]

On August 15, 2023, DECKARD met an individual who was engaged in sex work (“Victim-1”) at a hotel room in the Bronx for an appointment to exchange sexual services for payment.  DECKARD subsequently displayed a firearm, demanded that Victim-1 go into the bathroom and sit in the shower, and then proceeded to steal personal possessions and cash from Victim-1.  A still image of DECKARD at the hotel where he robbed Victim-1 is shown below:

Still image of Deckard at the hotel where he robbed Victim-1

On September 19, 2023, DECKARD and PAYNE committed another robbery of two individuals who were engaged in sex work (“Victim-2” and “Victim-3”) at a hotel room in the Bronx.  Victim-2 and Victim-3 were spending time at a hotel room, when Victim-2 was notified by an individual, who advertised Victim-2 and Victim-3’s services online, that someone would meet Victim-2 at the hotel room later that day.  DECKARD and PAYNE then went to the hotel room where Victim-2 and Victim-3 were located.  After entering the hotel room, DECKARD displayed a firearm, and DECKARD and PAYNE stole personal items as well as cash from Victim-2 and Victim-3.  During the robbery, DECKARD struck Victim-2 in the face with his elbow.  Still images of DECKARD (left) and PAYNE (right) at the hotel where they robbed Victim-2 and Victim-3 are shown below:

Still image of Deckard and Payne at the hotel where they robbed Victim-2 and Victim-3

On January 6, 2024, DECKARD and HAMPTON robbed Victim-1 at gunpoint a second time at a hotel room in the Bronx.  At approximately 1:30 pm on January 6, 2024, DECKARD and HAMPTON traveled to the Bronx hotel room where Victim-1 was staying for an appointment to exchange sexual services for payment.  After entering the hotel room, HAMPTON displayed a firearm, and HAMPTON and DECKARD proceeded to rob Victim-1 of her cellphone.  DECKARD also demanded that Victim-1 give him the passcode to her phone, and HAMPTON asked Victim-1, in substance and in part, whether she wanted “to die over a passcode.”  After Victim-1 gave them the passcode to her phone, HAMPTON used Victim-1’s cellphone to send $300 to his account using a payment application.  A still image of HAMPTON (left) and DECKARD (right) at the hotel where they robbed Victim-1 is shown below:

Still image of Hampton and Deckard at the hotel where they robbed Victim-1

The NYPD and ATF Strategic Patterned Armed Robbery Technical Apprehension (“SPARTA”) Task Force believes these defendants may be responsible for the robberies of other women in New York.  Anyone with information about this or any other incident is asked to call the NYPD’s Crime Stoppers hotline at 1-800-577-TIPS (8477) or, for Spanish, 1-888-57-PISTA (74782).  The public can also submit tips on the Crime Stoppers website at https://crimestoppers.nypdonline.org or by sending a direct message to @NYPDTips on X, formerly known as Twitter.  All tips are strictly confidential.

DECKARD, 34, of New York, New York, is charged with one count of conspiracy to commit Hobbs Act robbery and three counts of Hobbs Act robbery, each of which carries a maximum sentence of 20 years in prison, and three counts of using, carrying, and brandishing a firearm during, in relation to, and in furtherance of, a crime of violence, each of which carries a mandatory seven-year consecutive sentence.

HAMPTON, 34, of New York, New York, is charged with one count of conspiracy to commit Hobbs Act robbery and one count of Hobbs Act robbery, each of which carries a maximum sentence of 20 years in prison, and one count of using, carrying, and brandishing a firearm during, in relation to, and in furtherance of, a crime of violence, which carries a mandatory seven-year consecutive sentence.

PAYNE, 34, of East Orange, New Jersey, is charged with one count of conspiracy to commit Hobbs Act robbery and one count of Hobbs Act robbery, each of which carries a maximum sentence of 20 years in prison, and one count of using, carrying, and brandishing a firearm during, in relation to, and in furtherance of, a crime of violence, which carries a mandatory seven-year consecutive sentence.

The mandatory minimum and maximum potential sentences are prescribed by Congress and are provided here for informational purposes only, as any sentencing of the defendants will be determined by a judge. 

Mr. Williams praised the outstanding investigative work of the ATF and NYPD, in particular, the SPARTA Task Force, which is composed of agents and officers of the ATF and the NYPD.

This case is being handled by the Office’s General Crimes Unit.  Assistant U.S. Attorneys Meredith C. Foster and Georgia V. Kostopoulos are in charge of the prosecution.

The charges contained in the Complaint are merely accusations, and the defendants are presumed innocent unless and until proven guilty.

[1] As the introductory phrase signifies, the entirety of the text of the Complaint and the description of the Complaint set forth below constitute only allegations, and every fact described should be treated as an allegation.