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Health
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August 15, 2024
Matthew Perry's Assistant And 2 Drs. Charged In Actor's Death
The former personal assistant for actor Matthew Perry and two doctors have been criminally charged in connection with the "Friends" star's death last year from an overdose of ketamine, according to a criminal complaint unsealed Thursday in California federal court.
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August 15, 2024
LA Times Owner Sued Over Control Of Biotech Nonprofit
A biotech research institute has sued board member Dr. Patrick Soon-Shiong, the billionaire owner of the Los Angeles Times, in Washington federal court alleging entities controlled by him contractually owe the institute millions, even as Soon-Shiong is demanding the institute reallocate resources to fund pet projects unrelated to its mission.
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August 15, 2024
9th Circ. Judges Seem To Split On Wash. Abortion Coverage
A Ninth Circuit judge asked Thursday how a church could be harmed by a Washington law requiring employee health plans to cover abortions, since none of its workers had ever actually sought one, while another judge asked if tossing the case would slam the door on religious objections.
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August 15, 2024
Pharmacy Can't Dodge Novo Nordisk's Diabetes Drug Suit
A Tennessee federal judge on Thursday declined to throw out a suit by Novo Nordisk Inc. alleging that DCA Pharmacy is selling drugs with the same active ingredient as its Ozempic diabetes medicine without U.S. Food and Drug Administration authorization.
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August 15, 2024
CMS Posts Final Costs For 1st Set Of Drugs After Negotiations
The federal government released on Thursday the final prices of the first 10 drugs negotiated by Medicare under the Inflation Reduction Act, in a long-anticipated move set to shape the future of drug price negotiations.
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August 15, 2024
Price-Fixing Claims Against Par Pharma Tossed After Ch. 11
A Connecticut federal judge on Thursday tossed Par Pharmaceutical Cos. Inc. from two price-fixing lawsuits after the defendant and its parent, Endo International PLC, recently filed the Chapter 11 reorganization plans that they said shielded them from the cases.
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August 15, 2024
Calif. Justices Find Hospital System Exempt From Labor Code
A hospital system a California county created is a public entity that is not required to follow the California Labor Code's meal and rest break requirements, the state's high court ruled Thursday, nixing an appellate panel's ruling against the entity.
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August 15, 2024
Pennsylvania, Agencies Sued Over Child's Death
The half-sisters of a 12-year-old Pennsylvania girl who was allegedly tortured and starved to death by her father and stepmother have filed a lawsuit saying there was "atrocious and reprehensible disregard" shown by those responsible for protecting her.
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August 15, 2024
Fla. Court Wrongly Blocked Health Report Without Evidence
A Florida state appeals court has reversed a state court order blocking the release of an investigative report related to a man's suicide after he was discharged from a mental health center, saying the circuit court shouldn't have denied a request by the man's father for the report based on the center's argument without evidence.
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August 15, 2024
Ill. Health Center Challenges NLRB Constitutionality
An Illinois health center on Wednesday filed the latest constitutional challenge to the National Labor Relations Board, urging an Illinois federal judge to block an NLRB prosecution over its decision to fire employees who allegedly provided fake Social Security numbers when they were hired.
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August 15, 2024
Caterpillar Must Face Illinois Ex-Workers' Genetic Privacy Suit
Caterpillar Inc. can't escape a proposed class action alleging it violated an Illinois genetic information privacy statute by asking job applicants about their family medical history, a federal judge ruled, rejecting the machinery manufacturer's assertion that it didn't intend to collect the data.
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August 15, 2024
Del. Chancery OKs $175M Judgment Against Insys Founder
The convicted founder of drugmaker Insys has told Delaware's Chancery Court he agreed to accept a $175 million judgment as part of a settlement with the company's liquidation trust over his role in an opioid kickback scheme that drove the firm into bankruptcy.
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August 15, 2024
Full 11th Circ. To Weigh Georgia Deputy's Trans Health Win
The Eleventh Circuit agreed Thursday to a full-court rehearing of an appeal from Georgia county officials looking to overturn a deputy's win in her suit alleging a health plan coverage exclusion for gender-affirming surgery violated federal anti-discrimination law.
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August 15, 2024
Fake Prescription Caper Yields $10.2M Fine For Bankrupt Co.
A Manhattan federal judge hit a defunct unit of bankrupt biotechnology concern DMK Pharmaceuticals Corp. with a $10.2 million fine Thursday, after the subsidiary admitted to criminally faking horse-drug prescriptions in a scheme that generated $4.2 million.
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August 15, 2024
NC Small Biz Challenges VA Bid Process For Prostate Drug
A service-disabled veteran-owned small business in North Carolina is challenging the U.S. Department of Veterans Affairs' bid process for prostate medication, saying the terms unfairly favor foreign manufacturers despite purporting to prioritize American-made products.
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August 15, 2024
Okla. Says 10th Circ. PBM Ruling Defies High Court Precedent
Oklahoma urged the U.S. Supreme Court to review a Tenth Circuit decision nullifying certain parts of a state law regulating pharmacy benefit managers, arguing the appeals court's ruling openly conflicts with sister circuits and previous high court rulings while pushing federal benefits law beyond its limits.
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August 14, 2024
ICE Faces Trimmed Suit Over Detainee's COVID-19 Death
A California federal court on Tuesday again allowed U.S. Immigration and Customs Enforcement to trim a lawsuit alleging it failed to protect a man who died in detention but kept claims alleging ICE failed to oversee its facilities or protect the man from COVID-19.
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August 14, 2024
Doctor Loses Challenge To Nursing Home's Vax Policy
A New Jersey federal judge on Wednesday tossed a CareOne doctor's challenge to the nursing home operator's COVID-19 vaccine mandate, saying she did not pass the Third Circuit's test for an exemption for failing to exhaust her administrative remedies.
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August 14, 2024
J&J Vision Unit Sues Ex-Marketing Exec Over Move To Rival
Johnson & Johnson's vision unit sued a former marketing director on Tuesday, saying her move to a direct competitor is an "imminent threat of immediate, irreparable harm" and asking a New Jersey federal court to enforce her noncompete agreement and other post-employment obligations.
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August 14, 2024
HHS Eyes 2025 For New Medicare Appeal Rule
In response to a Connecticut federal judge's stern demand for quicker progress, the U.S. Department of Health and Human Services has said in a court filing that it should be able to implement a new rule creating an avenue for Medicare beneficiaries to appeal their hospitalization status by Jan. 1.
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August 14, 2024
GSA Hit With Protest Over $985M Migrant Kid Transport Deal
Trailboss Enterprises Inc. is protesting the General Services Administration's decision to award a $985.4 million transportation and logistics contract for unaccompanied children in federal custody to a competitor, saying it lost the contract because of a flawed selection process.
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August 14, 2024
NC Judge OKs $15.2M Deal For Medical Device Investors
A North Carolina federal judge has given the first green light to a $15.25 million settlement that will resolve a securities class action claiming that Bioventus Inc. misled investors about its internal controls and financial health and its readiness to implement new Medicare regulations, leading to inflated stock prices.
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August 14, 2024
Grassley Asks HHS For Clarity On Cannabis Position
Sen. Chuck Grassley has asked federal health officials to clarify their position on marijuana, arguing that a recent U.S. Department of Health and Human Services report is at odds with its recommendation to loosen restrictions on the drug.
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August 14, 2024
Florida AG Can't Nix Hospitals', School Boards' Opioid Claims
A Florida state appeals court on Wednesday reversed a trial court's order allowing the state's attorney general to wipe out a group of suits by hospitals and school boards in opioid litigation, holding that she doesn't have the authority to release their claims without their consent.
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August 14, 2024
Novartis' $45B Biz Can Survive If Generic Debuts, Judge Says
A D.C. federal judge told Novartis to stop acting like it would be destroyed financially by having a generic version of its best-selling drug Entresto enter the market, saying the drugmaker will be fine if it loses $3 billion in U.S. sales out of its $45 billion global revenue.
Expert Analysis
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What Cos. Should Note In DOJ's New Whistleblower Pilot
After the U.S. Department of Justice unveiled a new whistleblower pilot program last week — continuing its efforts to incentivize individual reporting of misconduct — companies should review the eligibility criteria, update their compliance programs and consider the risks and benefits of making their own self-disclosures, say attorneys at Skadden.
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Motion To Transfer Venue Considerations For FCA Cases
Several recent decisions highlight the importance for practitioners of analyzing as early as possible whether a False Claims Act case warrants a change of venue, and understanding how courts weigh certain factors for defendants versus whistleblowers, say Ellen London at London & Stout, and Li Yu and Corey Lipton at DiCello Levitt.
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A Primer On EU's Updated Human Substance Regulations
The European Union's updated standards regarding quality and safety of substances of human origin meant for human application carry significant implications for companies that work with cells and tissues, and U.S. companies active in the EU market should pay particular attention to the import and export rules, say Geneviève Michaux and Georgios Symeonidis at King & Spalding.
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Series
After Chevron: New Lines Of Attack For FCA Defense Bar
Loper Bright has given defense counsel new avenues to overcome the False Claims Act elements of falsity and scienter, as any FCA claim based upon ambiguous statutory terms can no longer stand solely on agency regulations to establish the statute's meaning, which is itself necessary to satisfy the FCA's basic requirements, says Elisha Kobre at Bradley Arant.
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CFPB's Medical Debt Proposal May Have Side Effects
The Consumer Financial Protection Bureau’s recent proposal to prevent medical debt information from appearing on consumer reports and creditors from basing lending decisions on such information may have initial benefits for some consumers, but there are potential negative consequences that should also be considered, say attorneys at Cooley.
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Series
Teaching Scuba Diving Makes Me A Better Lawyer
As a master scuba instructor, I’ve learned how to prepare for the unexpected, overcome fears and practice patience, and each of these skills – among the many others I’ve developed – has profoundly enhanced my work as a lawyer, says Ron Raether at Troutman Pepper.
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15 Areas That Would Change Under Health Data Rule Proposal
If finalized, the Office of the National Coordinator for Health Information Technology's proposed rule will significantly progress its efforts to advance interoperability, respond to stakeholder concerns and clarify compliance with the health IT certification program, say attorneys at Ropes & Gray.
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The Road Ahead For Regulation Of Digital Twins In Healthcare
Digital replicas of cells, organs and people — known as digital twins — can facilitate clinical trials for new drugs by reducing the number of patients required, but data limitations can create logistical hurdles and regulatory efforts addressing digital twins are still in early stages, say consultants at Keystone Strategy.
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3 Ways To Lower Insider Trading Risk After First 10b5-1 Case
In light of the U.S. Department of Justice's insider trading prosecution against the former CEO of Ontrack based on alleged abuse of a Rule 10b5-1 safe harbor plan — designed to allow executives to sell their companies' securities without liability — companies and individuals should take steps to avoid enacting similar plans in bad faith, say attorneys at Jenner & Block.
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Lawyers Can Take Action To Honor The Voting Rights Act
As the Voting Rights Act reaches its 59th anniversary Tuesday, it must urgently be reinforced against recent efforts to dismantle voter protections, and lawyers can pitch in immediately by volunteering and taking on pro bono work to directly help safeguard the right to vote, says Anna Chu at We The Action.
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PE Firms Should Prepare For Increased False Claims Scrutiny
The impact private equity firms may have over medical decisions and care is increasingly attracting potential liability under the False Claims Act and attention from states and the federal government, so investors should follow best practices including conducting due diligence both before and after acquisitions, say attorneys at K&L Gates.
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3 Healthcare FCA Deals Provide Self-Disclosure Takeaways
Several civil False Claims Act settlements of alleged healthcare fraud violations over the past year demonstrate that healthcare providers may benefit substantially from voluntarily disclosing potential misconduct to both the U.S. Department of Justice and the U.S. Department of Health and Human Services, say Brian Albritton and Raquel Ramirez Jefferson at Phelps Dunbar.
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Series
After Chevron: ERISA Challenges To Watch
The end of Chevron deference makes the outcome of Employee Retirement Income Security Act regulatory challenges more uncertain as courts become final arbiters of pending lawsuits about ESG investments, the definition of a fiduciary, unallocated pension forfeitures and discrimination in healthcare plans, says Evelyn Haralampu at Burns & Levinson.
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Opinion
Expert Witness Standards Must Consider Peer Review Crisis
For nearly two decades, the so-called replication crisis has upended how the scientific community views the reliability of peer-reviewed studies, and it’s time for courts to reevaluate whether peer review is a trustworthy proxy for expert witness reliability, say Jeffrey Gross and Robert LaCroix at Reid Collins.
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Takeaways From High Court's Tribal Health Admin Cost Ruling
The U.S. Supreme Court's recent determination that the government must reimburse two Native American tribes for administrative healthcare costs will help tribes maintain equal footing with the Indian Health Service when administering programs, and continues a pattern of how the current court aligns on tribal concerns, say attorneys at Lewis Roca.