Nadine Menendez urged a New York federal judge Thursday to delay her prison surrender date four months to accommodate breast cancer-related surgeries, to which the judge ordered Menendez explain why her request came “90 minutes” before the Fourth of July long weekend and just days before her surrender date.
Catch up on this past week’s key developments by state from Law360 Real Estate Authority — including attorney insights into recently enacted housing laws in California and Florida, as well as the latest multibillion-dollar data center deals and the law firms guiding them.
Three of the most recent cases to head to the New Jersey Supreme Court will address the admission of evidence in criminal proceedings and civil issues including indemnification.
The Archdiocese of Newark released a report Wednesday by Ropes & Gray LLP concluding that Seton Hall University’s president was not implicated in past sexual misconduct investigations at the university and acted appropriately in a 2012 seminary incident that later became the focus of public scrutiny.
The U.S. Supreme Court’s stark ideological divisions were on full display this term, particularly as it issued long-awaited rulings in the last few days of June. Here, Law360 dives into the numbers behind this court term.
To our Clients and Friends,
The Corporate Transparency Act (signed into law on January 1, 2021) expanded anti-money laundering laws and created new reporting requirements for certain companies doing business in the US Beginning in 2024, many small businesses are required to report information about their beneficial owners to the Financial Crimes Enforcement Network (FinCEN) in an effort to create a national database for use by national security and law enforcement agencies to prevent the use of shell companies for criminal activity.
Both domestic and foreign reporting companies are required to file reports. A company is considered a reporting company if a document was filed with the secretary of state (SOS) or similar office to create or register the entity. Corporations (including S corporations), LLCs, and other entities formed through the SOS are subject to the reporting requirements. But, because sole proprietorships, trusts, and general partnerships do not require the filing of a formal document with the SOS, they generally are not considered a reporting company and will not have a filing requirement. Foreign companies are required to file reports if they are registered with the SOS or similar office under state law.
Some companies are exempt from reporting, but many of the exempted companies are already required to report ownership information to a governmental authority. Of particular interest to you may be the exemption for large operating companies. A large operating company is any entity with (a) more than 20 full-time US employees, (b) an operating presence at a physical office within the US, and (c) more than $5,000,000 of US-sourced gross receipts reported on its prior year federal income tax return. If you meet these qualifications, you are not subject to the new reporting requirements.
Beneficial ownership information (BOI) must be reported for the reporting company’s beneficial owners and (for entities formed or registered after 2023) company applicants. BOI includes an individual’s full legal name, date of birth, street address and a unique ID number. The unique ID number can be from a non-expired US passport, state driver’s license, or other government-issued ID card. If the individual does not have any of those documents, then a non-expired foreign passport can be used. An image of the document showing the unique ID number must also be included with the report.
Two groups of individuals are considered beneficial owners of a reporting company: (1) any individual who directly or indirectly owns or controls at least 25% of the ownership interests of the reporting company; or (2) any individual who exercises substantial control over the reporting company.
Individuals with substantial control are those with substantial influence over important decisions about a reporting company’s business, finances, and structure. Senior officers (president, CFO, general counsel, CEO, COO, and any other officer who performs a similar function) are automatically deemed to have substantial control, as are individuals with the authority to appoint or remove senior officers and board members. There is no requirement that these individuals have actual ownership in the company to be a considered a beneficial owner for reporting purposes.
The company applicant is the person who actually files the document that creates or registers the reporting company (e.g., an attorney). Company applicants must provide the same information that is required of beneficial owners, but only if the reporting company is formed or registered after 2023. Because of the difficulty in tracking down information about company applicants for reporting companies that have been in existence for a number of years, reporting companies formed or registered before 2024 do not have to supply BOI for their company applicants.
Individuals and reporting companies can request a FinCEN Identifier (FinCEN ID) to use in place of supplying detailed information on the report. A FinCEN ID is a unique number assigned by FinCEN which is obtained by submitting the same information as is required of a beneficial owner or reporting company. A FinCEN ID may be useful to individuals that prefer to send their personal information directly to FinCEN rather through a reporting company, or to individuals that may be required to supply information as a beneficial owner or company applicant of several reporting companies.
For existing reporting companies created or registered before 2024, the initial report is due by January 1, 2025. For reporting companies created or registered in 2024, the initial report is due 90 days after the entity’s creation or registration. For reporting companies created or registered after 2024, the initial report is due 30 days after the entity’s creation or registration.
If there is a change to previously reported information about the reporting company or its beneficial owners, an updated report must be filed within 30 days of the change. So, it is imperative that your company implement a system to identify reportable changes and file an updated report with FinCEN in a timely manner. The penalties for willfully failing to file both initial and updated reports are steep-$500 per day that the report is late, up to $10,000 and imprisonment for up to two years.
BOI reports must be filed electronically. FinCEN’s e-filing portal, available at https://boiefiling.fincen.gov/, provides two methods to submit a report: (1) by filling out a web-based version of the form and submitting it online, or (2) by uploading a completed PDF version of the BOI report. Some third-party service providers may also offer the ability to file the BOI report through their software. The person who submits the BOI report will need to provide their name and email address to FinCEN. There is no fee for filing the report.
If you have any questions about these new reporting rules and how they affect your business, we would be happy to discuss them with you and provide you with recommendations for legal counsel assistance. FinCEN also has a Small Entity Compliance Guide and frequently asked questions to help guide businesses through the reporting requirements. These are available at https://www.fincen.gov/boi/small-business-resources.
Feeney & Dixon, LLC, Counsellors at Law
David C. Dixon, Esq.
In March 2024, the NAR made headlines by agreeing to a groundbreaking settlement that promises significant changes to the real estate industry. Here are the key points:
1. Compensation Transparency
2. Who’s Covered?
3. Effective Dates
4. Offers of Compensation
So, there you have it! The NAR settlement is like a seismic shift in the real estate tectonic plates. Commissions are out, transparency is in, and the industry is adapting. Whether you’re a seasoned agent or a first-time homebuyer, keep an eye on these changes—they’re reshaping the way we buy and sell homes.
Learn more: NAR Settlement FAQs34.
To explore the many issues surrounding the marketing, sale, and process of residential real estate transactions, please give us a call and make an appointment to speak with our experienced real estate attorneys at Feeney & Dixon, LLC.
The information you obtain on this blog is not, nor is it intended to be, legal advice. You should consult an attorney for advice about your individual situation. The opinions, statements, beliefs and viewpoints expressed by the various authors and blog participants on this web site, do not reflect the opinions, statements, beliefs, or viewpoints of Feeney & Dixon, LLC, or any of their principals, employees, or agents. The authors and blog participants’ opinions are based upon information they consider reliable, but neither Feeney & Dixon, LLC, nor its principals, employees, or agents, warrant its completeness or accuracy, and it should not be relied upon as such.
Living trusts, also known as Inter Vivos trusts, can be a valuable estate planning tool, offering individuals in New Jersey a way to manage their assets and provide for their loved ones. However, like any financial strategy, living trusts come with both advantages and disadvantages. In this article, we’ll explore the pluses and minuses of living trusts in the context of New Jersey.
The Pluses of Living Trusts in New Jersey:
1. Probate Avoidance:
One of the primary advantages of a living trust is the ability to bypass the probate process. Probate can be time-consuming and costly, but a living trust allows assets to pass directly to beneficiaries without court involvement. In New Jersey, where probate can sometimes be a lengthy process, this can be a significant benefit.
2. Privacy Protection:
Unlike a will, which becomes a public record upon death, a living trust provides a greater degree of privacy. The details of the trust remain confidential, shielding your financial affairs from public scrutiny. This can be particularly appealing to individuals who value their privacy or have complex financial situations.
3. Incapacity Planning:
Living trusts allow for the seamless transition of asset management in the event of incapacity. If the grantor becomes unable to handle their affairs, the appointed successor trustee can step in without the need for court intervention. This can provide a sense of security for individuals concerned about potential cognitive decline or unexpected health issues.
4. Flexibility in Distribution:
Living trusts offer flexibility in distributing assets. You can specify conditions for distributions, such as reaching a certain age or achieving a particular milestone. This level of control allows you to tailor the distribution of assets according to your wishes and the unique circumstances of your beneficiaries.
5. Potential Tax Benefits:
While New Jersey does not have its own estate tax, federal estate taxes can still apply. A well-structured living trust may help minimize the impact of federal estate taxes, providing potential tax benefits for individuals with larger estates.
The Minuses of Living Trusts in New Jersey:
1. Upfront Costs:
Establishing a living trust involves upfront costs, including legal fees for drafting the trust document. While this cost may be outweighed by the potential savings in probate expenses later on, it’s essential to consider the initial financial investment.
2. Complexity and Maintenance:
Living trusts can be more complex to set up than a simple will. Ongoing maintenance is also required, such as funding the trust by transferring assets into it. Failure to properly maintain the trust could undermine its effectiveness. Individuals who prefer a straightforward approach to estate planning might find the added complexity challenging.
3. Limited Creditor Protection:
While living trusts provide privacy, they may offer limited protection against creditors. In certain situations, creditors may still have the ability to access trust assets. Individuals with significant creditor concerns may need to explore other asset protection strategies.
4. Not a One-Size-Fits-All Solution:
Living trusts may not be suitable for everyone. For smaller estates or individuals with straightforward financial situations, the benefits of a living trust may not justify the associated costs and complexity. It’s crucial to evaluate whether a living trust aligns with your specific needs and goals.
5. Potential for Overlooking Assets:
In the process of funding a living trust, there is a risk of overlooking certain assets. If an asset is not properly titled in the name of the trust, it may still go through probate. Diligence in funding the trust is essential to ensure the intended probate avoidance benefits are realized.
In conclusion, living trusts can be a valuable estate planning tool for individuals in New Jersey, offering benefits such as probate avoidance, privacy protection, and flexibility in distribution. However, the decision to establish a living trust should be based on careful consideration of individual circumstances, financial goals, and preferences. Consulting with a knowledgeable estate planning attorney in New Jersey can help individuals navigate the complexities and make informed decisions about whether a living trust is the right choice for them.
To explore the many issues surrounding the creation of a living trust, and to determine if this, or other estate planning tools, would be the right fit for you, please give us a call and make an appointment to speak with our experienced estate planning attorney at Feeney & Dixon, LLC.
The information you obtain on this blog is not, nor is it intended to be, legal advice. You should consult an attorney for advice regarding your individual situation. The opinions, statements, beliefs and viewpoints expressed by the various authors and blog participants on this web site, do not reflect the opinions, statements, beliefs, or viewpoints of Feeney & Dixon, LLC, or any of their principals, employees, or agents. The authors and blog participants’ opinions are based upon information they consider reliable, but neither Feeney & Dixon, LLC, nor its principals, employees, or agents, warrant its completeness or accuracy, and it should not be relied upon as such.
In the Garden State, where suburban sprawl and urban development often collide, the land use approval process has become a labyrinthine ordeal. New Jersey’s land use boards, charged with overseeing development projects, have constructed a bureaucratic maze that developers, homeowners, and even seasoned professionals find difficult to navigate. This article aims to shed light on the frustrating complexities and criticisms surrounding the byzantine land use application process in New Jersey.
Among the chief complaints regarding the land use application process in New Jersey is the sheer complexity and convoluted nature of the regulations and procedures involved. The process typically involves a myriad of boards and agencies, each with its own set of rules and requirements. Developers, architects, and property owners must contend with municipal planning boards, zoning boards, environmental commissions, and more, each playing a role in the ultimate decision-making process.
At the heart of the issue is the patchwork quilt of local zoning ordinances that govern land use across New Jersey’s diverse municipalities. Each town has its own set of rules, guidelines, and restrictions, leading to a lack of uniformity and predictability for applicants. What might be permissible in one jurisdiction may be grounds for denial in another, leaving property owners in a perpetual state of uncertainty.
While state guidelines exist, individual towns often adopt additional, and sometimes contradictory, or unnecessarily-burdensome, regulations. This creates a situation where applicants must navigate a patchwork of rules, and requirements, which present a harrowing gauntlet for applicants, rather than a simple review of the merits of a proposal, and making it challenging to predict outcomes or efficiently move through the approval pipeline.
Furthermore, the language used in these regulations is often dense and filled with jargon, making it inaccessible to the average citizen. This lack of clarity contributes to misunderstandings and disputes, further complicating an already intricate process. Critics argue that the opacity of the system serves to exclude community members from meaningful participation in decisions that directly impact their neighborhoods.
New Jersey, like many other states, grapples with the phenomenon known as NIMBYism – Not In My Backyard. This grassroots opposition to new development projects can significantly impact the land use application process. While public input is crucial for a healthy democratic process, the current system in New Jersey often allows vocal minority opinions to unduly influence decisions.
Residents, fearing changes to the character of their neighborhoods or potential impacts on property values, mobilize against proposed developments. This can lead to protracted battles at public hearings, with emotional appeals often taking precedence over evidence-based arguments. The byzantine process, with its multiple layers of approval and opportunities for public input, can inadvertently amplify the influence of NIMBY sentiments, making it challenging for legitimate projects to move forward.
Another critical flaw in the land use application process is the inconsistent decision-making across different boards and municipalities. The interpretation and enforcement of regulations vary widely, leading to disparities in how similar projects are treated. What may be approved in one town could face insurmountable hurdles in a neighboring municipality, creating a sense of arbitrariness that erodes confidence in the system.
This lack of consistency not only creates frustration for applicants but also undermines the principles of fairness and equity. Developers and homeowners should be able to reasonably predict the outcome of their applications based on the merits of the proposal, rather than being subject to the whims of local boards operating within an ambiguous framework.
Another aspect contributing to the complexity is the often protracted nature of the land use application review. The seemingly endless rounds of hearings, appeals, and revisions can turn the approval process into a test of patience for even the most resilient property owners. Delays in decision-making not only escalate costs but also stifle economic development and hinder the realization of community projects.
The labyrinthine land use application process in New Jersey often results in significant delays for development projects. The time it takes to obtain approvals can stretch from months to years, leading to increased costs and financial uncertainty for applicants. The prolonged timelines can be particularly detrimental to developers and investors, who may see their projects become economically unviable due to unforeseen delays.
Furthermore, the slow approval process contributes to a shortage of affordable housing and inhibits economic growth. The difficulty in navigating the bureaucratic maze discourages potential developers, stifling innovation and hindering efforts to address pressing issues such as housing shortages and infrastructure needs.
Given the numerous challenges associated with the land use application process in New Jersey, there is a pressing need for reform. The following recommendations could help streamline the system, improve transparency, and foster more equitable decision-making:
Standardization of Regulations: The state should work towards greater standardization of land use regulations across municipalities. Clear, concise guidelines would reduce confusion and facilitate a more predictable application process.
Enhanced Public Education: Efforts should be made to demystify the land use application process for the general public. This could include educational programs, accessible materials, and community workshops to help residents understand the intricacies of development proposals and their potential impact on neighborhoods.
Community Engagement Reform: While public input is crucial, reforms should aim to balance community engagement with evidence-based decision-making. Boards should be empowered to base their decisions on the merits of a proposal rather than succumbing to the influence of vocal minorities.
Consistency Across Municipalities: Efforts should be made to standardize decision-making processes and ensure consistency in the interpretation and enforcement of regulations. This would reduce disparities between municipalities and promote a fair and predictable system.
Streamlined Review Process: Reducing red tape and unnecessary bureaucracy could expedite the review process, minimizing delays and fostering a more business-friendly environment. This would benefit developers, homeowners, and the overall economic health of the state.
Limit the Economic Incentive for Overly-complex or Dilatory Review: Tighter control over the virtual “blank check” system of escrow deposits, used for the purpose of covering the costs of professional review of applications, in order to lessen both the cost and time it takes to bring an application to the board.
The land use application process in New Jersey is undoubtedly complex and challenging. The labyrinthine nature of the system, influenced by a myriad of factors including NIMBYism, inconsistent decision-making, overly complex requirements, and economic impacts, has created an environment that hinders rather than facilitates development. While the need for careful consideration and community input is recognized, there is a pressing need for reform to create a more transparent, efficient, and equitable process that serves the best interests of the state and its residents.
The information you obtain on this blog is not, nor is it intended to be, legal advice. You should consult an attorney for advice regarding your individual situation. The opinions, statements, beliefs and viewpoints expressed by the various authors and blog participants on this web site, do not reflect the opinions, statements, beliefs, or viewpoints of Feeney & Dixon, LLC, or any of their principals, employees, or agents. The authors and blog participants’ opinions are based upon information they consider reliable, but neither Feeney & Dixon, LLC, nor its principals, employees, or agents, warrant its completeness or accuracy, and it should not be relied upon as such.
by Debbie Cenziper, ProPublica; Michael D. Sallah and Evan Robinson-Johnson, Pittsburgh Post-Gazette; and Margaret Fleming, Medill Investigative Lab
Philips Respironics received thousands of complaints about a dangerous defect in its breathing machines but kept them secret for years as stock prices soared. The devices, including the popular DreamStation for sleep apnea, went to children, the elderly and veterans before the global giant announced a massive recall.
On the morning of June 14, 2021, Dr. Radhika Breaden hurried to a computer in her hushed sleep disorders clinic and tried not to panic.
The 52-year-old physician treated patients with heart conditions, cancer and neurological diseases. She cared for veterans with compromised lungs and a woman with Down syndrome. In more than a dozen years of helping people breathe through the night, she had never confronted an emergency that jeopardized nearly all of her patients at once.
Global device maker Philips Respironics was pulling its popular sleep apnea machines and ventilators off the shelves after discovering that an industrial foam built into the devices to reduce noise could release toxic particles and fumes into the masks worn by patients.
Breaden scoured the internet for details, certain that Philips had a plan to quickly ship new, safe machines to the thousands of people under her care at the Portland, Oregon, clinic. “It’s a multibillion-dollar, multinational company,” she recalled telling her staff.
But as Philips publicly pledged to send out replacements, supervisors inside the company’s headquarters near Pittsburgh were quietly racing to manage a new crisis that threatened the massive recall and posed risks to patients all over again.
Tests by independent laboratories retained by Philips had found that a different foam used by the company — material fitted inside the millions of replacement machines — was also emitting dangerous chemicals, including formaldehyde, a known carcinogen.
Though Philips has said the machines are safe, ProPublica and the Pittsburgh Post-Gazette obtained test results and other internal records that reveal for the first time how scientists working for the company grew increasingly alarmed and how infighting broke out as the new threat reached the highest levels of the Pittsburgh operation.
The findings also underscore an unchecked pattern of corporate secrecy that began long before Philips decided to use the new foam.
The company had previously failed to disclose complaints about the original foam in its profitable breathing machines, a polyester-based polyurethane material that was found to degrade in heat and humidity. Former patients and others have described hundreds of deaths and thousands of cases of cancer in government reports.
After the introduction of the new foam in 2021, this one made of silicone, the company again held back details about the problem from the public even as it sent out replacement machines with the new material to customers around the world.
One of the devices was the DreamStation 2, a newly released continuous positive airway pressure, or CPAP, machine promoted as one of the company’s primary replacements.
Federal regulators were alerted to the concern more than two years ago but said in a news release at the time that the company was carrying out additional tests on the foam and that patients should keep using their replacements until more details were available. The Food and Drug Administration has not provided new information on the test results since then, and it is still unclear whether the material is safe.
That leaves millions of people in the United States alone caught in the middle, including those with sleep apnea, which causes breathing to stop and start through the night and can lead to heart attacks, strokes and sudden death.
Philips “let me down all this time and now they’re just doing it again,” said 56-year-old retired nuclear engineer Richard Callender, who recently started using one of the replacement devices in his home near Pittsburgh.
Public health experts interviewed by ProPublica and the Post-Gazette said it’s critical that patients using the machines are told about the potential risks.
“It’s a question of providing the facts,” said Dr. Robert Steinbrook, director of the health research group at the nonprofit Public Citizen and an adjunct professor at the Yale School of Medicine. “The assumption is the new machines and the refitted ones are OK, that the foam issue has been 100% resolved. That’s not the case.”
The new foam isn’t the only problem: An internal investigation at Philips launched in the months after the recall found that water was condensing in the circuitry of the DreamStation 2, creating a new series of safety risks.
“Loss of therapy, thermal events, and shock hazards,” the investigation concluded.
The FDA issued an alert about overheating last month, warning that the devices could produce “fire, smoke, burns, and other signs of overheating” and advising patients to keep the machines away from carpet, fabric and “other flammable materials.”
Philips has said that customers could continue using the devices if they followed safety instructions.
In response to concerns about the silicone foam, the company said the material was tested against safety limits recognized by the FDA and the World Health Organization and did not emit chemicals at unsafe levels. Philips said formaldehyde, found in common household items, only becomes a risk at high exposure.
“The repaired and new replacement devices with the silicone sound abatement foam are safe,” and findings that conclude otherwise are “inaccurate,” the company said in a statement.
Philips said additional test results were submitted last year to the FDA, but the agency has not yet provided a response.
In a statement, the FDA said more tests are needed on the foam before determining if the devices pose “risks to patients.”
Experts who reviewed the test results for the news organizations said the findings revealed troubling markers, including the presence of formaldehyde at levels that exceed safety thresholds established by multiple organizations. Thresholds vary, they said, and those cited by Philips allow for far higher formaldehyde levels than others.
Safety thresholds also do not take into account patients who are already suffering from chronic illnesses and breathing from devices that emit fumes directly into the lungs.
The experts said that one of the most vexing concerns is that formaldehyde — linked to respiratory problems and certain cancers — showed up in multiple tests and at varying levels, at times low and at others higher.
“Who knows what a patient could be exposed to?” said an engineer familiar with the testing who still works in the industry and did not want to be identified for fear of reprisals. “If you had grenades and you’re not sure where they’re going to go off, that’s a problem.”
After questions from ProPublica and the Post-Gazette — and more than two years after the problem surfaced — the company put out a more detailed explanation about the issue late last week.
Documents related to the company’s testing have been turned over to the Department of Justice, which launched an investigation of the recall last year, according to sources familiar with the probe.
Philips has said that it is cooperating with investigators and that the company initially did not believe that complaints dating back more than a decade about the recalled machines needed to be reported. The company said it took action as soon as it learned of the significance of the problem.
Breaden, the Portland physician, said she had no idea that new problems have emerged and now worries that doctors and patients have been once again left to fend for themselves.
“There’s just a lot of things that we’re all being kept in the dark about,” she said.
The trouble with the replacement machines surfaced shortly after the June 2021 recall, which sent the company’s stock prices tumbling and led to hundreds of lawsuits by Philips customers.
An FDA inspection of the firm’s manufacturing plant near Pittsburgh turned up a surprise discovery: a copy of a test that an independent lab conducted on a CPAP machine with the new foam showing results that the agency had not previously seen, public records show.
An inspector later noted in a report that the machine failed emissions testing because it produced “compounds of concern” with carcinogenic properties and that pediatric patients who use the machines could be especially vulnerable.
At the time, the FDA said it carried out a “benefit-risk assessment” and decided that until more information became available, not using the devices at all “may be more harmful to a patient’s health.”
One of the chemicals that turned up in the testing was formaldehyde, which also showed up on a second set of test results from another lab in August, records and interviews show.
That fall, the company opened an internal investigation after receiving complaints about the DreamStation 2. Engineers evaluated 97 devices and found that about 1 in 5 showed evidence of moisture and that nine had experienced “thermal events,” according to the company’s report.
Though the investigation concluded the problem could cause the machines to stop working or shock patients while in use, Philips deemed the risk “acceptable” and said “containment activities” were unnecessary, the records show.
In the months that followed, Philips forged ahead. With pressure mounting to meet the needs of customers, the company promised that everyone affected by the recall would get a replacement machine or a repaired one within a year.
At the time, hospitals and medical practices were waiting on the devices. So was the Department of Veterans Affairs, where an urgent alert in late 2021 warned that the supply of CPAPs was “critically low.”
“Warehouses are currently out,” the agency said in an internal email. “Level red.”
The wait forced some sleep apnea patients to place a dangerous bet. In suburban Pittsburgh, Callender continued to use his recalled CPAP for months. He said he couldn’t get a new one from Philips even though he had a double lung transplant in 2015 and a kidney transplant in 2021.
“I told them I was in dire need,” said Callender, a former mayor of Lower Burrell, Pennsylvania, who eventually started using an old machine that he had stashed in a bedroom closet. “Never heard back from Philips.”
Callender said he had no idea he was waiting on a machine that was fitted with a foam still under review by federal regulators.
“They failed me on so many levels,” said Callender, who received a replacement machine from Philips several weeks ago.
In the spring of 2022, as Philips continued to ship out replacements filled with the new foam, the company had a series of meetings with the FDA to discuss the ongoing testing.
Jeff Shuren, the agency’s chief regulator of medical devices, was directly involved, writing to Philips in May about test results that the company had promised but not yet delivered to the agency, according to emails obtained through a public records lawsuit filed against the FDA by ProPublica and the Post-Gazette.
“This is especially important,” Shuren emailed the company.
The records do not make clear what transpired in those meetings, but more than a year later, the FDA has continued to advise patients that the agency will provide information on the testing when it becomes available.
While the FDA was meeting with Philips, tensions flared among the company’s scientists and managers responsible for handling the crisis, interviews and internal communications show.
Philips “didn’t believe the results,” said the engineer familiar with the testing. “The Philips folks gnashed their teeth at it and they went to test more devices.”
ProPublica and the Post-Gazette obtained communications sent by a scientist at Philips who was alarmed about test results showing formaldehyde over the “threshold for safe exposure.” “FDA has the data. Are they just waiting for the final report from Philips? How is this sustainable?”
Though the chemical tends to quickly dissipate, experts say that even brief exposure at high levels can pose serious risk to patients who are already vulnerable, including infants, the elderly and others with chronic illnesses.
In June 2022, then-Philips biological safety engineer Adam Majka sent an email to several colleagues, writing, “We need to start finalizing reports where we have acceptable results and we do not expect further changes.”
One of the recipients was Denver Faulk, a senior safety engineer at Philips who was charged with helping to lead the company’s response, according to interviews and emails.
That same month, Philips put out an update saying that draft test reports on the foam had “not identified any safety issues.”
Around that time, Faulk sent an internal message about a safety threshold for formaldehyde proposed by Philips to one of the independent labs brought on by the company.
Toxicologists can assess the level of cancer risk against different thresholds used by scientists, governments and others; the same device can pass one test but fail another depending on the threshold. In his message, Faulk said the lab had accepted the benchmark proposed by Philips.
“Great news. … They are updating all of their reports accordingly,” Faulk wrote. “A big win for the team!”
In its statement, Philips said it proposed a limit used by the World Health Organization to provide a “harmonized” threshold at the company’s testing labs.
That threshold allows for far higher formaldehyde emissions than benchmarks used by other organizations, including the Environmental Protection Agency.
Neither Faulk nor Majka responded to requests for comment.
As lawmakers call on federal investigators to hold Philips accountable, Connecticut Attorney General William Tong said he wants the FDA, not the company, to oversee the testing.
“People are suffering,” said Tong, who, along with Sen. Richard Blumenthal, D-Conn., wrote to the agency last year urging aggressive enforcement against Philips. “We don’t know enough about what’s happening with the silicone to make a judgment about it and so we’re still very concerned.”
Patients say they have received little or no information about the issue. Hundreds have reported other concerns to the government, including the delivery of refurbished devices that were missing parts or had foul odors.
“Completely unusable,” one customer wrote last year. “It emitted an extremely … nauseating smell. I was so sick I got up and did not sleep the rest of the night.”
Others described long waits for their replacements. Hundreds of thousands of people were still waiting on their machines in April, nearly two years after the recall, according to the company’s website.
“I wanted to go there and throw the machine right through the window,” said David Campano, 71, a former steelworker who continued to use his recalled CPAP for months while he waited on a replacement from the sprawling Philips factory only miles from his home near Pittsburgh.
In the suburbs of Atlanta, retired elementary school teacher Debra Miller emailed Philips last year after endless rounds of automated responses as she tried to figure out when she would get a new machine.
A few days later, she said, a package arrived at her home containing the motor of a new machine, but no electrical cord, explanation or instructions for use.
“Dumped in a box,” said Miller, 70, who taught for 30 years. “I literally got … half of an old machine.”
Miller said she had no idea that the machine she was waiting on came with its own risks.
Philips said the recall required the company to reach millions of patients and was complicated by supply chain challenges. In some cases, CPAP motors were delivered without other parts to “enable the easiest and most familiar replacement option,” the company said, adding that the replacement plan for sleep apnea machines is nearly complete in the United States.
In the early days of the recall, Breaden and her team at the sleep clinic in Portland were focused only on getting new machines to the thousands of patients who used them night after night.
Just beyond a waiting room with a framed message, “Healthy people get their sleep,” Breaden said she now worries about an entirely new set of problems.
After learning about the test results on the new foam from ProPublica and the Post-Gazette, the sleep medicine doctor who had been personally using a DreamStation 2 said she needs more information from the company and the government.
“I’m prescribing air. It’s wonderful to prescribe something that has no side effects and can help with your sleep,” she said. “It’s sad not to be able to say that anymore.”
The opinions, statements, beliefs and viewpoints expressed by the various authors and blog participants on this web site, do not reflect the opinions, statements, beliefs, or viewpoints of Feeney & Dixon, LLC, or any of their principals, employees, or agents. The authors and blog participants’ opinions are based upon information they consider reliable, but neither Feeney & Dixon, LLC, nor its principals, employees, or agents, warrant its completeness or accuracy, and it should not be relied upon as such.
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