Thursday, March 7, 2024

State Senator Gustavo Rivera - Community Update for Students and Families

 

GOVERNMENT HEADER

COMMUNITY UPDATE FOR STUDENTS AND FAMILIES

NOMINATIONS OPEN FOR NEW YORK STATE SENATE YOUTH LEADERSHIP RECOGNITION AWARDS

Senator Gustavo Rivera is participating in the New York State Senate’s Youth Leadership Recognition Awards program. This program honors outstanding students who will become our future leaders. Eligible students include current sophomores, juniors, and seniors who excel not only academically, but through leadership in extracurricular and volunteer activities. Students selected to receive this award will receive a congratulatory personalized certificate from Senator Rivera. 


All nominations must be submitted by March 22nd, 2024. The nominator must be a school administrator or educator. To learn more about this award and nominate a student, visit the New York State Senate website.

2024 EARTH DAY CELEBRATION - SUBMISSIONS DUE APRIL 12!

The New York State Senate is celebrating Earth Day by encouraging children to develop an awareness of the environment and its resources. We are looking for school children in grades k-12 to submit essays, poetry or artwork, this year's theme is Ways We Can Make Every Day Earth Day! This is to emphasize the importance of recycling and waste reduction among schools, children and adults. 


If you would like to participate, all submissions must be made by teachers or parents of homeschoolers by April 12th to nysenate.gov/earthday.

SENATOR RIVERA VISITS P.S. 96 & P.S. 89

Senator Rivera had the pleasure of visiting two schools in his district last week, P.S 096 & P.S. 89. He toured the schools, met with students and school administrators, and discussed how our office can support the school community. Contact our office to invite Senator Rivera to your school!

SATURDAY 3/16: SENATOR RIVERA HOSTS IMMIGRANT COMMUNITY RESOURCE FAIR

ANNUAL WILLIAMSBRIDGE OVAL SPRING EGG HUNT!

Join us on Saturday March 30th from 11:00am to 2:00pm at the Williamsbridge Oval Recreation Center for games, arts and crafts, entertainment, and community-building. Families and children are invited! 

Former CEO Of Medical Device Company Convicted Of Creating And Selling A Fake Component That Was Implanted Into Patients

 

Damian Williams, the United States Attorney for the Southern District of New York, announced that a jury returned a guilty verdict against LAURA PERRYMAN on two counts of an Indictment charging her with conspiracy to commit health care fraud and wire fraud and substantive health care fraud in connection with her company’s creation and sale of a fake medical device component.  U.S. District Judge Denise L. Cote presided over the 11-day trial. 

U.S. Attorney Damian Williams said: “Laura Perryman brazenly created a dummy medical device component — made entirely out of plastic — to be implanted into patientsShe marketed that dummy component as a means for doctors to bill Medicare and private insurance companies approximately $18,000 for each implantation of the piece of plasticShe did this so that she could entice doctors to buy her device for many thousands of dollarsPerryman recklessly used patients as tools for financial gain, and this jury’s unanimous verdict sends a resounding message that individuals who defraud health care programs will be held criminally accountable.” 

According to the allegations in the Indictment and the evidence at trial:

Stimwave was a medical device company that manufactured and distributed implantable neurostimulation devices.  As the founder and CEO of Stimwave, PERRYMAN oversaw the design of the StimQ PNS System (the “Device”), pictured below, a neurostimulator system designed to treat chronic pain by providing electrical currents to peripheral nerves.  The Device included a component containing electrodes (the “Lead”) and a receiver component that acted as an antenna, transmitting energy from an external power source to the Lead (the “Pink Stylet”).  From at least in or about 2017 up to and including 2020, PERRYMAN, as Stimwave’s CEO, engaged in a multi-year scheme to design, create, manufacture, and market an inert, non-functioning component of the Device — called the “White Stylet.”  The White Stylet was marketed as a receiver of radiofrequency energy, but it was made of plastic and could not function as a receiver.

Photo of the StimQ PNS System (the “Device”)

Stimwave sold the Device to doctors and medical providers for approximately $16,000.  Stimwave instructed health care providers to bill medical insurance providers, including Medicare, for implanting the Device into patients through two separate reimbursement codes.  One code was for implantation of the stimulator portion of the Lead, and a second was for implantation of a receiver.  The billing code for implanting the Lead provided for reimbursement at a rate of between approximately $4,000 and $6,000, while the billing code for implanting a receiver provided for reimbursement at a rate of between approximately $16,000 and $18,000.

Soon after the Device was released, physicians informed Stimwave that they were having trouble implanting the Pink Stylet in certain patients because the Pink Stylet was too long.  Stimwave and PERRYMAN knew that the Pink Stylet could not be cut or trimmed to shorten it without interfering with the functionality of the Pink Stylet as a receiver.  And, without a receiver component for doctors to implant and seek reimbursement for, doctors would incur a substantial financial loss with every purchase of the Device, thereby making it more difficult for Stimwave to sell the Device to doctors and medical providers at the approximately $16,000 price.

However, Stimwave — at the direction of PERRYMAN — did not lower the price of the Device so that its cost to doctors and medical providers could be covered by reimbursement for the implantation of only the Lead.  Nor did PERRYMAN recommend that doctors not implant the Device or its receiver component in cases where the Pink Stylet could not fit comfortably.  Instead, PERRYMAN directed that Stimwave create the White Stylet — a dummy component made entirely of plastic, but which Stimwave misrepresented to doctors as a receiver alternative to the Pink Stylet.  The White Stylet could be cut to size by the doctor for use in smaller anatomical spaces and was created solely so that doctors and medical providers would continue to purchase the Device for use in those scenarios and continue to bill for the implantation of a receiver component.  To perpetuate the lie that the White Stylet was functional, PERRYMAN oversaw training that suggested to doctors that the White Stylet was a “receiver,” when in fact it was made entirely of plastic, contained no copper, and therefore had no conductivity.  In addition, PERRYMAN directed other Stimwave employees to vouch for the efficacy of the White Stylet as a receiver, when she knew that the White Stylet could not function as a receiver.

As a result of these misrepresentations regarding the functionality of the White Stylet, PERRYMAN caused doctors and medical providers to implant the White Stylet into patients and submit reimbursement claims for implantation of the White Stylet to health insurance providers, including Medicare.

PERRYMAN, 55, of Delray Beach, Florida, was convicted of one count of health care fraud and one count of conspiracy to commit health care fraud and wire fraud, which each carry a maximum sentence of 20 years in prison.

The statutory maximum sentences are prescribed by Congress and are provided here for informational purposes only, as any sentencing of the defendant would be determined by the judge.

Mr. Williams praised the outstanding investigative work of the Federal Bureau of Investigation.

Attorney General James Secures $7.8 Million from Ghost Gun Retailer for Illegally Shipping Ghost Guns to New York

 

Indie Guns Also Permanently Banned from Shipping Ghost Gun Components into New York

New York Attorney General Letitia James secured a $7.8 million judgment and permanent injunction against gun retailer Indie Guns, LLC (Indie Guns) for illegally selling ghost gun components in New York. The Florida-based company specializing in selling the parts used to make ghost guns will also be permanently banned from selling unfinished frames and receivers in New York. The judgment is the result of a major lawsuit that Attorney General James filed against Indie Guns and nine other ghost gun retailers in June 2022 for selling tens of thousands of illegal, unfinished frames and receivers to New Yorkers that were assembled into untraceable handguns and assault-style weapons. The judgment resolves the Office of the Attorney General's (OAG) lawsuit against Indie Guns while the lawsuit against the remaining nine defendants is ongoing.

“Ghost guns are one of the greatest threats facing our communities, and the companies that ignore our laws and put our families in danger must be held accountable,” said Attorney General James. “These deadly weapons are designed to be untraceable and can easily end up in the hands of people otherwise barred from owning guns. Indie Guns refused to follow New York and federal law and tried to flood our streets with ghost guns — but now they are paying the price for those bad actions. We will continue to do everything in our power to stop the flow of illegal and dangerous ghost guns into our state and protect our communities from gun violence.”

Indie Guns specializes in selling and shipping the components used to make ghost guns, and explicitly markets itself as a supplier that will allow its customers to evade federal and state gun laws. The company knowingly sells its products directly to consumers without following federal laws requiring background checks, recordkeeping, and serial numbers, and boasts on its website that self-assembling guns allows customers to “put personal firearms beyond the reach of government.” Its “LSB Kit” (short for “lock, stock, and barrel”) is marketed as “everything needed to build a complete pistol in a discounted bundle package.” Indie Guns also sells kits to assemble ghost AR-style assault weapons and promotes its products as being “UNSERIALIZED UNREGISTERED UNTRACEABLE.”

Indie Guns sold tens of thousands of its products to New Yorkers, including those who were seeking to evade state and federal gun laws. As its owner Lawrence Destefano said, the company’s goal was to sell as many “unserialized, untraceable, unregistered gun components” as possible to “flood this damn market.”

Between May and June of 2022, OAG caught Indie Guns and five of the other defendants — Arm or Ally, LLC, Brownells, Inc., Salvo Technologies, Inc. (a/k/a 80 P Builder or 80P Freedom Co.), Rainier Arms, LLC, and Rock Slide USA, LLC — shipping unfinished frames or receivers to undercover investigators in New York. Several defendants advertised ghost gun components for sale and shipped their products to individuals who went on to commit crimes involving ghost guns in New York.

Under New York law, the sale of an unfinished frame or receiver, the core component of a firearm, is a felony. Unfinished frames and receivers do not have serial numbers, and they allow buyers to make ghost guns at home using basic tools. Purchasers of unfinished receivers only have to make a few small changes in order to use them in a fully-assembled, illegal assault weapon. Similarly, a purchaser of an unfinished frame can use commonly available tools to finish the frame, which can then be used in an untraceable handgun.

Indie Guns (1)

An unfinished firearm frame sold by Indie Guns (left) is nearly indistinguishable from the same frame (right) sold by a different retailer as finished, complete with serialization and the required background check

Indie Guns (2)

An unfinished Glock-compatible handgun frame sold and shipped by Indie Guns

In June 2022, Attorney General James filed a lawsuit against 10 national gun manufacturers, including Indie Guns, for selling tens of thousands of unfinished frames and receivers to New Yorkers. In March 2023 Attorney General James sought and secured an order prohibiting the defendants from selling unfinished frames and receivers into New York state. The 10 gun distributors targeted by OAG and banned from shipping ghost gun kits into New York are: Brownells, Inc., Blackhawk Manufacturing Group, Salvo Technologies, Inc., G.S. Performance, LLC, Indie Guns, LLC, Primary Arms, LLC, Arm or Ally, LLC, Rainier Arms, LLC, KM Tactical LLC, and Rock Slide USA, LLC. By one of the retailers’ own admission, the products “make it ridiculously easy for a non-machinist to finish their [handgun frame] in under 1 hour with no drill press required.” This process is designed to work around federal gun serialization, recordkeeping, and background check requirements. 

In February 2024, Judge Furman of the United States District Court for the Southern District of New York denied a motion by the defendants to dismiss this lawsuit with respect to all claims but one, meaning the case could move forward. While the $7,846,400 judgment resolves the case against Indie Guns, OAG will continue to hold the other national gun retailers ignoring New York state laws accountable.  

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.