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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 an argument from the center's managing entity 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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PBM Takeaways From Proposed Telehealth Flexibility Bill
The U.S. House of Representatives' proposal to extend certain telehealth flexibilities signals a robust commitment to expanding telehealth access, though its plan to offset additional expenses through pharmacy benefit manager reform could lead to some industry consolidation, say attorneys at Mintz.
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A Plaintiffs-Side Approach To Cochlear Implant Cases
As the number of cochlear implants in the U.S. continues to grow, some will inevitably fail — especially considering that many recalled implants remain in use — plaintiffs attorneys should proactively prepare for litigation over defective implants, says David Shoop at Shoop.
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Inside Antitrust Agencies' Rollup And Serial Acquisition Moves
The recent request for public comments on serial acquisitions and rollup strategies from the Federal Trade Commission and U.S. Justice Department mark the antitrust agencies' continued focus on actions that fall below premerger reporting thresholds, say attorneys at Paul Weiss.
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Think Like A Lawyer: Always Be Closing
When a lawyer presents their case with the right propulsive structure throughout trial, there is little need for further argument after the close of evidence — and in fact, rehashing it all may test jurors’ patience — so attorneys should consider other strategies for closing arguments, says Luke Andrews at Poole Huffman.
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Series
Playing Chess Makes Me A Better Lawyer
There are many ways that chess skills translate directly into lawyer skills, but for me, the bigger career lessons go beyond the direct parallels — playing chess has shown me the value of seeing gradual improvement in and focusing deep concentration on a nonwork endeavor, says attorney Steven Fink.
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9th Circ. Clarifies ERISA Preemption For Healthcare Industry
The Ninth Circuit's recent ruling in Bristol SL Holdings v. Cigna notably clarifies the broad scope of the Employee Retirement Income Security Act's preemption of certain state law causes of action, standing to benefit payors and health plan administrators, say attorneys at Troutman Pepper.
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Litigation Inspiration: Attys Can Be Heroic Like Olympians
Although litigation won’t earn anyone an Olympic medal in Paris this summer, it can be worthy of the same lasting honor if attorneys exercise focused restraint — seeking both their clients’ interests and those of the court — instead of merely pursuing every advantage short of sanctionable conduct, says Bennett Rawicki at Hilgers Graben.
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Unpacking NY's Revised Hospital Cybersecurity Rule Proposal
The New York State Department of Health's recently revised hospital cybersecurity rule proposal highlights increased expectations and scrutiny around cybersecurity in the healthcare sector, while adapting to both recent industry developments and public comments, say Christine Moundas and Gideon Zvi Palte at Ropes & Gray.
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Short-Term Takeaways From CMS' New Long-Term Care Rules
The Centers for Medicare & Medicaid Services' new final rule on nursing home staffing minimums imposes controversial regulatory challenges that will likely face significant litigation, but for now, stakeholders will need to prepare for increased staffing expectations and more specialized facility assessments without meaningful funding, say attorneys at Morgan Lewis.
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Updated Federal Rules Can Improve Product Liability MDLs
The recent amendment of a federal evidence rule regarding expert testimony and the proposal of a civil rule on managing early discovery in multidistrict legislation hold great promise for promoting the uniform and efficient processes that high-stakes product liability cases particularly need, say Alan Klein and William Heaston at Duane Morris.
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Lean Into The 'Great Restoration' To Retain Legal Talent
As the “great resignation,” in which employees voluntarily left their jobs in droves, has largely dissipated, legal employers should now work toward the idea of a “great restoration,” adopting strategies to effectively hire, onboard and retain top legal talent, says Molly McGrath at Hiring & Empowering Solutions.
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FDA's Data Monitoring Guidance Reveals Future Expectations
As the world of clinical research grows increasingly complex, the U.S. Food and Drug Administration's recent draft guidance on the use of data monitoring committees in clinical trials reveals how the agency expects such committees to develop, say Melissa Markey and Carolina Wirth at Hall Render.
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How Cannabis Rescheduling May Alter Paraphernalia Imports
The Biden administration's recent proposal to loosen federal restrictions on marijuana use raises questions about how U.S. Customs and Border Protection enforcement policies may shift when it comes to enforcing a separate federal ban on marijuana accessory imports, says R. Kevin Williams at Clark Hill.
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FDA Warning Indicates Scrutiny Of Regenerative Health Cos.
The U.S. Food and Drug Administration's recent warning letter to Akan Biosciences is a quintessential example of the agency's enforcement priorities for certain products involving human cells and tissues, and highlights ongoing scrutiny placed on manufacturers, say Dominick DiSabatino and Cortney Inman at Sheppard Mullin.
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New OSHA Memo Helps Clarify Recordkeeping Compliance
Based on recent Occupational Safety and Health Administration guidance on whether musculoskeletal disorders are recordable injuries under the agency's recordkeeping regulation, it appears that OSHA may target active release techniques and stretching programs during its inspections, say attorneys at Morgan Lewis.