Polsinelli has added trial lawyer Laura B. Angelini as a shareholder in its health care litigation practice in Boston, the firm announced.

Angelini joins the firm’s Boston office with experience defending health care organizations and executives in government investigations and enforcement matters nationwide. Her addition follows the recent hiring of Benjamin Wallfisch in Denver as part of the firm’s expansion of its health care litigation bench.

Angelini represents clients in civil, criminal, and administrative actions involving the False Claims Act, Anti-Kickback Statute, Stark Law, and HIPAA. Her cases often involve alleged Medicare and Medicaid billing violations, off-label promotion, drug diversion, and patient privacy breaches.

She advises pharmaceutical and medical device manufacturers and distributors, hospitals, academic medical centers, behavioral health organizations, physician practice groups, and licensed professionals.

“Polsinelli has long been a leader in health care, and Laura’s arrival further expands that position,” said Chase Simmons, chairman and CEO of Polsinelli.

Sherri T. Alexander, chair of the firm’s health care litigation practice, said Angelini’s trial experience and background in government investigations will strengthen the firm’s ability to guide clients through regulatory scrutiny and complex litigation.

Angelini said the firm’s national health care litigation platform and collaborative approach influenced her decision to join. She said she plans to expand the firm’s white-collar presence in Boston.

Angelini earned her law degree from Boston College Law School and her undergraduate degree, magna cum laude, from Boston College.

Polsinelli’s health care litigation team represents clients in disputes and government investigations in litigation, arbitration, and administrative proceedings. The firm said the group includes former Department of Justice attorneys, former state Medicaid fraud unit attorneys, and former in-house counsel to private and publicly traded health care companies.

ArentFox Schiff has launched a Longevity & Healthspan Industry Group, a cross-sector initiative focused on advising companies involved in longevity, wellness, and preventive health, the firm announced.

The group is designed to support businesses operating across health care, biotechnology, consumer wellness, and technology as interest in anti-aging and healthspan innovation continues to expand. It will provide legal guidance on regulatory compliance, reimbursement strategies, data privacy, intellectual property, corporate transactions, and government relations.

Gayland O. Hethcoat II will lead the group. He said companies in the longevity space face a complex and evolving regulatory environment that requires coordinated legal and strategic support.

The firm said the group will draw on capabilities from its health care, life sciences, regulatory, privacy, patent, corporate, and government relations practices. Areas of focus include biotechnology and life sciences, precision diagnostics, direct-to-consumer testing, imaging centers, wearable health technology, digital health platforms, longevity clinics, nutrition and cosmetic companies, fitness and performance brands, medical travel, senior living operators, and longevity-focused investors.

Anthony V. Lupo, chairman of ArentFox Schiff, said the firm is the first Am Law 100 firm to establish longevity as a dedicated industry group, positioning it to advise clients developing new approaches to health, wellness, and human performance.

In addition to Hethcoat, the group includes Karen Ellis Carr, Abha Kundi, Jo-Ann Marchica, Marc E. Rivera, Michael Scarpati, Jill A. Steinberg, Michelle R. Bowling, and Shoshana Golden, with additional support from Black K. Thelander and Starshine S. Chun.

Tom Sundlof, former senior attorney at the U.S. Food and Drug Administration (FDA), has joined Blank Rome LLP as a partner in its Washington, D.C., office, bolstering the firm’s life sciences practice.

With more than 20 years of experience in government and regulatory affairs, Sundlof brings expertise in FDA compliance, enforcement, and policy. His addition comes as part of Blank Rome’s strategy to expand its life sciences team to serve better clients navigating complex FDA regulations.

Sundlof previously held significant roles at the FDA, including Associate Chief Counsel and Assistant Deputy Chief Counsel (Acting), where he played a key role in regulatory actions involving medical devices and combination products. His extensive background also includes advising on significant FDA rulemakings and enforcement actions.

Blank Rome’s Life Sciences industry team has also recently expanded with the addition of partners Rachael G. Pontikes and Emily L. Hussey, both recognized for their work in healthcare and life sciences sectors.

Grant S. Palmer, Chair and Managing Partner of Blank Rome, expressed confidence that Sundlof’s experience would enhance the firm’s service to clients navigating complex FDA regulations, particularly in the medical device and healthcare sectors.

Sundlof’s role at Blank Rome will involve guiding domestic and international clients through FDA regulations, ensuring compliance post-market, and advocating for their interests in regulatory and legislative matters.

Additional Information

Tom Sundlof earned his J.D. from The George Washington University Law School and his B.A. in Economics and Government from the University of Maryland, College Park.

The recent measles outbreak in West Texas has escalated, with cases nearing 230 across Texas and New Mexico. Healthcare professionals like Dr. Ana Montanez from Lubbock are actively working to dispel misinformation and encourage vaccinations. Some parents, influenced by anti-vaccine groups like Children’s Health Defense, have turned to high doses of vitamin A as a preventive measure.

However, experts, including the American Academy of Pediatrics, emphasize that vitamin A does not prevent measles and can be harmful in excessive amounts. The outbreak has resulted in hospitalizations and at least one death, underscoring the critical need for accurate information and immunizations to protect public health.

Former President Donald Trump recently made a striking claim regarding childhood cancer rates, stating they have surged by 40% since 1975. This statement has drawn attention to long-term trends in pediatric cancer cases, prompting discussions about the accuracy of the data and the factors influencing these statistics.

According to figures from the National Cancer Institute (NCI), the incidence of childhood cancer has indeed risen significantly over the past decades. While improvements in medical diagnosis may partially explain the increase, researchers also point to potential environmental and genetic factors. The most common forms of childhood cancer, including leukemia and brain tumors, have seen notable growth in incidence rates.

Experts emphasize that while more children are being diagnosed with cancer, survival rates have also improved dramatically due to advancements in medical treatments. The five-year survival rate for pediatric cancer patients has increased substantially, offering hope amid the rising case numbers.

However, the discussion around this issue remains complex. Scientists continue investigating whether external environmental exposures, lifestyle changes, or unknown risk factors contribute to the rising cancer rates. Meanwhile, public health officials stress the importance of ongoing research and policy measures to protect children’s health and well-being.

As Trump’s statement fuels conversations about childhood cancer trends, the focus remains on addressing the causes behind these numbers and ensuring better prevention and treatment strategies for the future.

A measles outbreak in West Texas has led to the first U.S. measles-related death in a decade, with over 130 reported cases across Texas and New Mexico. The outbreak began in early February in a rural Mennonite community in Gaines County, Texas, and has since spread to about ten counties, including nine cases in eastern New Mexico.

The majority of cases involve unvaccinated children. Patients have exhibited high fever, red, watery eyes, nasal congestion, cough, and a facial rash. Treatments have included supplemental oxygen, fever medications, and IV fluids. According to the Centers for Disease Control and Prevention (CDC), measles has a mortality rate of 1 to 3 deaths per 1,000 cases.

Health officials emphasize the importance of the measles-mumps-rubella (MMR) vaccine, particularly in communities with low vaccination rates. Given measles’ highly contagious nature, additional cases are expected.

Ensuring children receive the MMR vaccine is crucial in preventing further spread. Communities should stay alert for measles symptoms and seek medical attention if needed. Coordinated efforts between state health departments and the CDC remain essential for managing and containing the outbreak.

“A federal appeals court said Wednesday it would not reinstate President Joe Biden‘s Covid-19 vaccine mandate for federal employees while it reviews a lower court’s order putting the requirement on hold — potentially setting the stage for the case to go to the Supreme Court,” reports Tierney Sneed in JD Supra.

“The 5th US Circuit Court of Appeals did not explain its reasoning in the unsigned order that said the court was expediting its review of the case. The court said the Biden administration’s request to put the lower court’s ruling on hold was being “carried with the case,” signaling that the appeals court would not rule on the request until it had conducted a fuller review of the case.”

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“Although there are no federally mandated vaccine-or-testing regulations for employees in any industry other than health care, employers still need to comply with state and local rules aimed at protecting their workers from COVID-19. But rather than tracking vaccination status, tests and other precautions internally, many employers are choosing to outsource those efforts to vendors that have emerged to take the onus off of HR,” reports Kylie Ora Lobell in SHRM.

“For example, Ampirical, a 301-employee construction engineering firm in Covington, La., has enlisted the support of Safe Site Check In to manage all COVID-19 procedures, including contact tracing for employees who test positive. Upon arrival at Ampirical’s office, employees and visitors scan a QR code with their smartphone or tablet, then answer six questions and agree to adhere to COVID-19 protocols while they’re onsite, including all construction sites, said the company’s health, safety and environmental manager Rod Courtney.”

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“Pfizer Inc wants to intervene in a Texas federal lawsuit seeking information from the U.S. Food and Drug Administration used in licensing the company’s COVID-19 vaccine, a litigation move that plaintiffs who are suing for the data say is premature,” reports Mike Scarcella in Reuters.

“Pfizer’s lawyers at DLA Piper told U.S. District Judge Mark Pittman on Jan. 21 it wanted a role in the proceedings to help the FDA avoid “inappropriately” disclosing trade secret and confidential commercial information.”

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“An appeals court judge on Tuesday granted a stay in an appeal over mask mandates in New York, keeping the rule in effect during the legal process, New York Attorney General Letitia James said,” reports Kanishka Singh in Reuters.

“A day earlier, a judge had struck down the state’s mask mandate, one week before it was due to expire. The state attorney general had filed a motion to stay the ruling in an attempt to put it on hold while the state filed a formal appeal.”

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“The centrality of law as a public health intervention has been undeniable during the Covid-19 pandemic. In just the first half of 2020, more than 1000 laws and orders were issued by federal, state, and local authorities in the United States in an effort to reduce disease transmission,” discuss Scott Burris, J.D., Evan D. Anderson, J.D., Ph.D., and Alexander C. Wagenaar, M.S.W., Ph.D. in The New England Journal of Medicine’s Perspective.

“Legal interventions include stay-at-home orders, mask mandates, and travel restrictions, as well as more particular rules for business operations, alcohol sales, curfews, and health care. Given their heavy use, importance, and obvious socioeconomic side effects, and the social and behavioral complexities of their implementation, one might have expected the National Institutes of Health (NIH), other research funders, and the research community to jump to the work of determining the right mix, intensity, and enforcement approaches of legal restrictions to control transmission with the least and most equitably distributed harms.”

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“Takeda subsidiary Baxalta has spent more than two years pushing back against the $173 million in damages it was ordered to pay as a result of Bayer’s hemophilia patent infringement lawsuit. But after an appeals win for Bayer in March, the companies are putting the case to rest,” reports Noah Higgins-Dunn in Fierce Pharma’s Pharma.

“The two drugmakers, along with Nektar Therapeutics, have entered into a settlement agreement over the patent infringement case, a court filing shows. Bayer will not seek claims for the many millions in damages it was owed under a 2019 verdict and a subsequent appeals ruling.”

“Under the latest settlement, each drugmaker will cover their own legal expenses and Baxalta will give up its right to appeal the 2019 verdict any further. The filings didn’t provide other details on the terms of the settlement.”

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“As vaccine proliferation continues, employers are preparing to welcome their workforces back to offices and job sites across the country,” write Katharine O. Beattie Sara J. Higgins in Foley & Lardner’s Insights.

“While many Americans are eager to return to pre-pandemic life, employers can expect resistance from employees recalled to the office, particularly from those whose medical conditions put them at greater risk for complications from COVID-19. Reviewing best practices under the Americans with Disabilities Act (ADA) and guidance from the Equal Employment Opportunity Commission, this post provides employers with tips for engaging in an effective interactive process with employees seeking disability accommodations for risks associated with COVID-19.”

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“Three large law firms have agreed to reduce fee applications by $1 million in their bankruptcy representation of Purdue Pharma, the maker of the prescription pain medication OxyContin, after the U.S. trustee alleged a failure to disclose a common interest agreement,” reports Debra Cassens Weiss in ABA Journal’s Verdicts & Settlements.

“The three law firms are Skadden, Arps, Slate, Meagher & Flom; Wilmer Cutler Pickering Hale and Dorr; and Dechert.”

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“Cyber threats and cybersecurity controls have evolved significantly over the past two decades since the HIPAA Security Rule were originally promulgated. During this same time, healthcare entities have increasingly become a prime target of hackers seeking to extort payment using ransomware, exfiltrate patient data to commit fraud, or disrupt operations in other nefarious ways,” write Alaap B. Shah and Patricia M. Wagner in The National Law Review.

“Recognizing these challenges, some security professionals have sought further clarity on the HIPAA Security Rule that they deem to be ‘long in the tooth’. Yet, regulators have not made any significant modifications – perhaps driven by the original policy considerations of the HIPAA Security Rule that: ‘the standard should be comprehensive and coordinated to address all aspects of security’; that it be “scalable, so that it can be effectively implemented by covered entities of all types and sizes’; and that it ‘not be linked to specific technologies, allowing covered entities to make use of future technology advancements.’

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“Area health care providers will finally see millions of dollars in reimbursements tied to a defunct health insurer – but some may be out more than half of the dollars they were owed,” reports Tracey Drury in Business Journal’s Health Care.

“The State Department of Financial Services this week announced a $220.8 million judgment resolving a lawsuit filed in late 2017 against the federal government tied to the collapse of Health Republic Insurance of New York.”

“According to DFS, area hospitals and physicians are expected to recoup the full value of unpaid claims. Here’s what wasn’t in the press release: Providers around the state who didn’t know the settlement was in the works signed offers from Riverdale Capital, a New York-based investment firm for pre-payments of 40 cents on the dollar and are now bound by that agreement.”

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“The anniversary of COVID-19 shutdown orders brought an upturn in both the number of business-interruption lawsuits against insurers and the amount of damages they are claiming,” writes Jim Sams in Claims Journal.

“In the past month:

• A New Jersey hospital system, RWJBarnabas Health, sued Zurich American Insurance Co. seeking $2.5 billion in damages from a virus that sickened 1,000 patients and killed nine staff members.
• Caesers Entertainment filed suit against 60 carriers seeking $2 billion in damages caused by restrictions at its Las Vegas resort casino. The company said it paid $25 million in premiums for $3.4 billion in coverage through a variety of “all-risk” policies, most of which did not include virus exclusions.
• Denison University, Kenyon College, Ohio Wesleyan University and the College of Wooster filed suit against their 16 insurers seeking $1.2 billion in coverage. The consortium of private colleges say their insurers turned their backs on them after the virus made their facilities unsafe and uninhabitable.”

“Also, some of the recent filings were made by groups of businesses against a single or multiple insurers. For example, on March 16, six restaurants and a fitness center in New Jersey filed a class-action suit in Bergen County Superior County against six carriers. On the same day, 26 Ohio dental practices filed suit against Amco Insurance Co. in the U.S. District Court in Toledo.”

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“The information blocking provisions of the 21st Century Cures Act officially went into effect this week, putting into focus the Department of Health and Human Services’ regulatory and compliance effort around HIPAA-required data sharing between applicable healthcare entities,” writes Jessica Davis in Health IT Security.

“Enacted by the 21st Century Cures Act in 2017 and implemented by a final rule in 2020, Congress defined information blocking and established penalties for providers that engage in practices that interfere with the access, exchange, and use of electronic health information.”

“The long-awaited info blocking provision established rules and penalties for non-compliance. The law carves out exclusions for providers if they meet an exception established by the HHS Secretary, or for other applicable reasons.”

“Starting April 5, relevant covered entities and business associates must comply. The Office for the National Coordinator recently released insights on just what the law’s enactment means for those relevant providers, as well as the areas HHS will focus on in the next 18 months.”

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“Purdue Pharma LP has floated a settlement plan calling for members of the billionaire Sackler family to pay more than $4.2 billion to help resolve the thousands of lawsuits that drove the maker of OxyContin opioid painkillers into bankruptcy,” report Jeremy Hill and Jef Feeley in Bloomberg Law’s Bankruptcy Law.

“Court papers filed late Monday by Purdue call for the drugmaker to hand over the company’s assets to trusts for the benefit of states, cities and counties suing to recoup billions spent dealing with the U.S. opioid crisis. Combined with the cash payment by the Sacklers — the company’s current owners — the Chapter 11 reorganization plan may be worth more than $10 billion, according to court filings.”

“In exchange for the company and the cash, slated to be paid out over nine years, Purdue and the Sacklers would be legally insulated from existing and future opioid lawsuits. Some states, cities and counties that sued the drugmaker oppose the proposal, arguing it doesn’t do enough to hold Purdue’s owners accountable.”

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“Novartis AG announced Friday that its global head of litigation, Thomas Kendris, will on an interim basis succeed its outgoing chief legal officer Shannon Thyme Klinger,” reports Brian Baxter in Bloomberg Law’s Business and Practice.

“Novartis said in a statement that Klinger will depart the Swiss drug giant March 15 to return to the U.S. and take a job at ‘a biotechnology company.’ Novartis didn’t identify the company and declined to discuss Klinger’s new role. Klinger didn’t respond to a request for comment on the matter.”

“Her move is the latest in a series of comings-and-goings by law department leaders working for biotechnology startups, drug developers, and medical equipment manufacturers. The health care, life sciences, and pharmaceutical sectors have been busy hiring lawyers within the past year, in part due to the increased demands on some companies stemming from the coronavirus pandemic.”

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