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July 24, 2024
FTC Chair Wary AI Tools Can Be Used For Corporate Collusion
Federal Trade Commission Chair Lina Khan weighed in on a host of topics during a discussion Wednesday at the Ninth Circuit Judicial Conference, expressing concerns about the agency's high legal bills for expert witnesses and describing AI price-setting tools as a potential loophole for collusion.
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July 24, 2024
Native Hawaiian Midwives Gain Relief From Licensing Law
A Hawaii judge blocked parts of a state law regulating midwives Tuesday, ruling it violates the constitutional rights of Native Hawaiians by denying them a reasonable pathway to securing approval for traditional prenatal care.
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July 24, 2024
DC Circ. Nixes Medicare Hospital Inpatient Payment Rule
The D.C. Circuit has vacated a U.S. Department of Health and Human Services rule that inflated Medicare reimbursements for inpatient care at low-wage hospitals, saying the agency made an "unprecedented, expensive, broad, and possibly never-ending" change to a policy articulated by Congress.
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July 24, 2024
Lab Owner Gets 1 Year In Prison In Medicare Bribe Case
A Florida lab owner who accepted millions in kickbacks for referring Medicare beneficiaries for unneeded genetic tests has been sentenced to a year in federal prison after pleading guilty to conspiracy.
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July 24, 2024
Rite Aid's Elixir Buyer Must Pay Additional $50M In Ch. 11 Sale
Prescription benefits group MedImpact owes an extra $50 million on top of $576 million it paid Rite Aid for its former benefits division Elixir, a New Jersey bankruptcy judge ruled Wednesday, saying his earlier ruling on $200 million in disputed liabilities from the sale didn't fundamentally disrupt a post-closing price adjustment.
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July 24, 2024
6th Circ. Judges Wary Of Dissecting Vaccine Objector's Views
A Sixth Circuit judge said Wednesday he was uncomfortable questioning the legitimacy of a person's religious beliefs, criticizing the American Red Cross' argument that a former worker dressed up her secular anti-vaccine views with religious language to get an exemption from the COVID-19 vaccine.
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July 24, 2024
Patent Cap In Drug Pricing Bill Seen As Having Muted Effect
The U.S. Senate recently passed a bill aiming to lower drug prices by limiting the number of patents that can be asserted in cases over biosimilars, but attorneys say the measure's numerous exceptions make it unlikely to have a major effect on litigation or consumer costs.
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July 24, 2024
GOP States Still Can't Intervene In Wash. Abortion Pill Suit
The Ninth Circuit rejected a bid by Idaho and other Republican-led states to intervene in Washington's lawsuit seeking to expand access to the abortion pill mifepristone, ruling Wednesday the states lacked standing and only speculated about how they were injured.
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July 24, 2024
5th Circ. Says Doctor's Corrective Plan Not A Valid Contract
The Fifth Circuit refused to reinstate a $6.6 million jury verdict in a former medical resident's suit alleging he was fired despite assurances he would have 60 days to rectify professional and interpersonal issues, ruling the residency program's director didn't have the power to offer a binding agreement.
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July 23, 2024
Meet The Lead Ozempic Lawyers
The recently deceased U.S. District Judge Gene E.K. Pratter this past spring appointed plaintiff leadership in litigation over Ozempic and similar drugs over allegations that the medications cause gastrointestinal issues. Here's who's who in the list of plaintiffs' leaders.
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July 23, 2024
Cannabis Industry Stakeholders Weigh In On Rescheduling
As the period for public comment on the Biden administration's proposal to reclassify marijuana came to a close Monday, anti-legalization activists, marijuana industry advocates and state cannabis regulators each submitted their thoughts on the potential policy shift.
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July 23, 2024
Families Seek Class Cert. In Premera Teen Trans Care Case
The families of transgender teens are seeking class certification in a case accusing Premera Blue Cross of age and sex discrimination after denying coverage for gender-affirming chest surgery because the teens are under 18, according to a motion filed in Washington federal court.
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July 23, 2024
Kickback Risk Remains For Gene Therapy Fertility Programs
Federal health officials this week declined to relieve two companies of potential liability under the Anti-Kickback Statute concerning their fertility support programs for patients receiving gene therapies.
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July 23, 2024
NC's $500K Med Mal Damages Cap Faces Fight
A patient who obtained a $7.5 million jury verdict in her case against a North Carolina doctor over the loss of her unborn baby is challenging the constitutionality of the Tar Heel State's cap on compensatory damages in medical negligence suits.
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July 23, 2024
Wash. AG Says 'Abortion Reversal' Clinic's Suit Still Deficient
Washington state's attorney general said Monday an anti-abortion clinic group being investigated for marketing an "abortion reversal pill" cannot blame his two-year-old document demands for a recent insurance rate hike, pushing a Tacoma federal judge to reject the group's legal effort to shield itself from future consumer protection enforcement.
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July 23, 2024
Optum Can Arbitrate Calif. Healthcare Provider's Antitrust Suit
A California federal judge Tuesday ordered certain Emanate Health entities who signed hospital services and physician agreements with Optum to arbitrate their antitrust suit accusing it of monopolizing a primary care physician market, finding the agreements encompass rules that say issues of arbitrability will be referred to an arbitrator.
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July 23, 2024
$680M Allergan FCA Suit Tossed After High Court Revival
A Maryland federal judge on Tuesday again tossed a False Claims Act suit accusing an Allergan unit of overcharging Medicaid, previously revived by the U.S. Supreme Court, saying a whistleblower still hadn't shown any deliberate wrongdoing by the company.
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July 23, 2024
Mother Urges Sanctions On Nonprofit Over Unpaid $13.4M Win
An 81-year old mother who won a $13.4 million judgment after her son died in a group home run by the Connecticut Institute for the Blind asked a state court judge Tuesday to order swift sanctions against the nonprofit for allegedly dodging depositions and stalling attempts to collect the award.
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July 23, 2024
Feds Urge 6th Circ. To Affirm Pharma Owner's Fraud Sentence
The Sixth Circuit should affirm a district court's fraud convictions, nearly five-year sentence and $7 million restitution order against an Ohio pharmaceutical salesman who underreported his income to reduce his tax liability in a multimillion-dollar scheme involving bogus insurance billings, the federal government said.
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July 23, 2024
6th Circ. Vows Careful Immunity Take In Prof's Retaliation Suit
The Sixth Circuit wrestled Tuesday with whether six University of Louisville officials were each rightly denied immunity from a former professor's suit alleging he was unconstitutionally pushed out because of his views on treating childhood gender dysphoria, with one judge promising meticulous assessments of each defendant.
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July 23, 2024
On Capitol Hill, PBM Execs Deny Role In High Drug Costs
Executives from the nation's three largest pharmacy benefit managers told members of a U.S. House committee on Tuesday that they lower drug costs while pointing the finger at pharmaceutical manufacturers.
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July 23, 2024
Senate Dems Roll Out Bill To Codify Chevron Deference
Sen. Elizabeth Warren, D-Mass., led a group of Democratic senators Tuesday in introducing a bill to codify the now-defunct doctrine of Chevron deference after it was struck down by the U.S. Supreme Court last month.
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July 23, 2024
Ariz. Court OKs Hospital District Tax For Legal Costs
A property tax levied to fund an Arizona hospital district's expenses including legal fees was properly authorized and did not require approval by voters, the Arizona Tax Court said, rejecting a suit by a local taxpayer.
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July 23, 2024
Mich. Justices Urged To Curb Suit-Restricting Job Contracts
A fired caregiver has told the Michigan Supreme Court that employers should not be able to contractually limit employees' time to sue, arguing that job-seekers who sign such contracts are often in a vulnerable position and forced to accept unfair terms.
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July 23, 2024
4 Firms Guide SPAC Mergers Targeting AI, Cannabis Sectors
An AI-powered startup that vows to combat "disinformation" and a medical cannabis developer have agreed to go public by merging with special purpose acquisition companies through separate deals unveiled this week, guided by four law firms and a law office.
Expert Analysis
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Opinion
The FTC Needs To Challenge The Novo-Catalent Deal
Novo's acquisition of Catalent threatens to substantially lessen competition in the manufacturing and marketing of GLP-1 diabetes and obesity drugs, and the Federal Trade Commission should challenge it under a vertical theory of harm, as it aligns with last year's merger guidelines and the Fifth Circuit decision in Illumina, says attorney David Balto.
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Series
Being A Luthier Makes Me A Better Lawyer
When I’m not working as an appellate lawyer, I spend my spare time building guitars — a craft known as luthiery — which has helped to enhance the discipline, patience and resilience needed to write better briefs, says Rob Carty at Nichols Brar.
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FDA's Multifaceted Role On Display In MDMA Therapy Scrutiny
Ongoing deliberations at the U.S. Food and Drug Administration regarding MDMA-assisted therapy for post-traumatic stress disorder serves as a window into the intricate balance of scientific innovation and patient safety oversight, and offers crucial insights into regulatory nuances, say Kimberly Chew at Husch Blackwell and Kevin Lanzo at Pharmaka Clinical Consulting.
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Lead Like 'Ted Lasso' By Embracing Cognitive Diversity
The Apple TV+ series “Ted Lasso” aptly illustrates how embracing cognitive diversity can be a winning strategy for teams, providing a useful lesson for law firms, which can benefit significantly from fresh, diverse perspectives and collaborative problem-solving, says Paul Manuele at PR Manuele Consulting.
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Analyzing FDA Draft Guidance On Clinical Trial Diversity
In light of the U.S. Food and Drug Administration's draft guidance on clinical trial diversity action plans, there are several important considerations for sponsors and clinical researchers to keep in mind to prevent delay in a drug or device application, say attorneys at Crowell & Moring.
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What's New In The AI Healthcare Regulatory Space
Attorneys at Hogan Lovells review the current legal and regulatory landscape for artificial intelligence applications in healthcare, touching on policies around safety, transparency, nondiscrimination and reimbursement, and what to expect in the future.
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The Good, The Bad And The Ugly Of Healthcare's PE Boom
While an influx of capital may provide access to new resources and innovative technologies, the private equity model's method of funding may be fundamentally at odds with patient-first healthcare, and in recent years that inherent tension has gotten ugly, say Eva Gunasekera and Jaclyn Tayabji at Tycko & Zavareei.
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3 Policyholder Tips After Calif. Ruling Denying D&O Coverage
A California decision from June, Practice Fusion v. Freedom Specialty Insurance, denying a company's claim seeking reimbursement under a directors and officers insurance policy for its settlement with the Justice Department, highlights the importance of coordinating coverage for all operational risks and the danger of broad exclusionary policy language, says Geoffrey Fehling at Hunton.
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Opinion
Now More Than Ever, Lawyers Must Exhibit Professionalism
As society becomes increasingly fractured and workplace incivility is on the rise, attorneys must champion professionalism and lead by example, demonstrating how lawyers can respectfully disagree without being disagreeable, says Edward Casmere at Norton Rose.
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Opinion
High Court Made Profound Mistake In Tossing Purdue Deal
The U.S. Supreme Court's recent decision to throw out Purdue Pharma's Chapter 11 plan jeopardizes a multistate agreement that would provide approximately $7 billion in much-needed relief to help fight the opioid epidemic, with states now likely doomed to spend years chasing individual defendants across the globe, says Swain Wood at Morningstar.
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How Tech Trackers May Implicate HIPAA After Hospital Ruling
A recent Texas federal court order in American Hospital Association v. Becerra adds a legal protection on key data, clarifying when tracking technologies implicate the Health Insurance Portability and Accountability Act, so organizations should ensure all technology used is known and accounted for, say John Howard and Myriah Jaworski at Clark Hill.
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Series
Serving In The National Guard Makes Me A Better Lawyer
My ongoing military experience as a judge advocate general in the National Guard has shaped me as a person and a lawyer, teaching me the importance of embracing confidence, balance and teamwork in both my Army and civilian roles, says Danielle Aymond at Baker Donelson.
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Big Business May Come To Rue The Post-Administrative State
Many have framed the U.S. Supreme Court’s recent decisions overturning Chevron deference and extending the window to challenge regulations as big wins for big business, but sand in the gears of agency rulemaking may be a double-edged sword, creating prolonged uncertainty that impedes businesses’ ability to plan for the future, says Todd Baker at Columbia University.
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Opinion
Proposed Terminal Disclaimers Rule Harms Colleges, Startups
Universities and startups are ill-suited to follow the U.S. Patent and Trademark Office’s recently proposed rule on terminal disclaimers due to their necessity of filing patent applications early prior to contacting outside entities for funds and resources, say attorneys at Sterne Kessler.
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A Midyear Forecast: Tailwinds Expected For Atty Hourly Rates
Hourly rates for partners, associates and support staff continued to rise in the first half of this year, and this growth shows no signs of slowing for the rest of 2024 and into next year, driven in part by the return of mergers and acquisitions and the widespread adoption of artificial intelligence, says Chuck Chandler at Valeo Partners.