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Health
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October 29, 2024
4th Circ. Quizzes Drugmaker Challenging W.Va. Abortion Law
An attorney arguing that West Virginia is preempted by federal law from restricting access to an abortion medication faced skeptical questions Tuesday from two judges who suggested it's entirely normal for states to regulate the practice of medicine.
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October 29, 2024
Biopharma Co. Escapes Investor Suit Over Drug Approval Lies
Biopharmaceutical company Spero Therapeutics Inc. has escaped a proposed investor class action accusing it of concealing warning signs that it would not secure regulatory approval of one of its drugs, with the court ruling that Spero's interactions with the U.S. Food and Drug Administration do not indicate Spero should have known its application would be rejected.
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October 29, 2024
Medical Co. Gets No Coverage For Toxic Tort
An insurer for B. Braun Medical Inc. has no duty to defend or indemnify the company against numerous lawsuits accusing B. Braun of exposing residents near one of its medical device manufacturing plants to a carcinogenic gas, a Pennsylvania federal court ruled, finding a pollution exclusion applicable.
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October 29, 2024
Beyond Abortion, 7 Ballot Questions Set To Shape Care
While reproductive rights have led the healthcare debate this election season, voters across the country will shape state policies on a number of other hot issues, including a Medicaid work requirement and coverage for IVF. Law360 Healthcare Authority looks at seven ballot measures that go beyond abortion.
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October 29, 2024
Pa. DA Says ATF's Pot Patients Ban Doesn't Fit With Bruen
A Pennsylvania district attorney is urging a federal judge not to throw out his suit challenging a Bureau of Alcohol, Tobacco, Firearms and Explosives policy blocking medical cannabis patients from buying or owning firearms, saying the U.S. Supreme Court's recent precedent preempts the restriction.
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October 29, 2024
Warren Pushes FTC Chair To Probe Oncology Acquisitions
Massachusetts Sen. Elizabeth Warren on Tuesday urged the Federal Trade Commission to scrutinize McKesson Corp.'s proposed $2.49 billion acquisition of a controlling stake in Core Ventures, and Cardinal Health's proposed $1.12 billion purchase of a controlling stake in Integrated Oncology, saying the deals would further consolidate the "already highly consolidated" oncology market.
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October 29, 2024
PBM Group Federal Affairs VP Joins Akin In Lobbying Role
A former Capitol Hill health policy advocate who worked in the U.S. Department of Health and Human Services and guided federal and state stakeholders through the implementation of the Affordable Care Act has joined Akin Gump Strauss Hauer & Feld LLP's lobbying team.
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October 29, 2024
Senate Panel Targets 'Clever' Pharma Pricing
The Senate Judiciary Committee on Tuesday railed against drugmakers and pharmacy benefit managers for allegedly causing the high cost of prescription drugs, arguing that "Big Pharma" has used anticompetitive tactics through patenting to fleece American patients.
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October 28, 2024
Masimo Sues Founder Over Alleged 'Empty Voting' Scheme
Masimo Corp. has sued its founder for allegedly conspiring with an investment firm and company stockholder to manipulate a shareholder vote in order to maintain his seat on the medical technology company's board of directors.
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October 28, 2024
Wash. AG Candidates Clash On Consumer Protection, Guns
The candidates vying to replace Washington Attorney General Bob Ferguson, who carved out a national reputation as an antitrust champion, present starkly different visions on whether to build upon his tenure or reverse course, clashing not just on consumer protection, but also gun safety and access to reproductive care.
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October 28, 2024
SEC Sues To Enforce Subpoena On Telehealth Co.
The U.S. Securities and Exchange Commission has asked a New York federal judge to order a weight loss-focused telehealth company to comply with a subpoena issued in connection with the SEC's investigation into whether the company violated federal securities laws.
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October 28, 2024
Ontrak Founder Can't Wipe Novel Insider Trading Verdict
A California federal judge has upheld Ontrak founder Terren Peizer's first-of-its-kind insider trading conviction, holding that jurors had "more than enough evidence" to determine he based a $20 million share sale on nonpublic information that the health tech company was about to lose its biggest client.
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October 28, 2024
Consciousness Not A Factor In $15M Pain And Suffering Verdict
A urological surgeon can't trim a $15 million jury verdict awarded to the wife of an octogenarian patient who died due to the doctor's alleged negligence, a Georgia state appeals court has ruled, rejecting arguments that a patient can't get pain and suffering damages because he was mostly unconscious.
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October 28, 2024
Gov't Says No Duty To Pay $69M In COVID Testing Claims
The Health Resources and Services Administration has urged the Court of Federal Claims to toss a lawsuit alleging the agency owes a laboratory $69 million in unpaid claims under a COVID-19 program for the uninsured, saying there was no contractual duty to pay.
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October 28, 2024
Moderna Brass Hit With Investor Suit Over RSV Shot Claims
Officers and directors of Moderna face shareholder derivative allegations that they overstated how effective the company's RSV vaccine candidate was as the pharmaceutical giant sought regulatory permission to expedite its development.
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October 28, 2024
Surge In Nicotine Fee Suits Shows Wellness Program Risks
A recent crop of suits accusing large employers of violating nondiscrimination provisions in federal benefits law by making workers who use nicotine pay more for health insurance underscore the risk of using fees to offset healthcare costs, attorneys say. Here are five nicotine surcharge suits to keep an eye on.
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October 28, 2024
HHS Says In-Home Evals Raised Insurers' Medicare Payments
Private Medicare insurers collected an estimated $4.2 billion in extra federal payments last year from in-home health assessments they conducted, even though the evaluations led to no treatment, according to a report by the U.S. Department of Health and Human Services' internal watchdog.
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October 28, 2024
Conn. Healthcare Co.'s $1.5M Data Breach Deal Gets Final OK
A Connecticut federal judge has given his final approval to a class action settlement that requires Merritt Healthcare Advisors to pay thousands of people whose personal information was exposed in a data breach.
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October 28, 2024
Mass. Court's Wiretap Ruling May Be Bad Omen For Plaintiffs
A ruling by the Massachusetts high court rejecting wiretap claims over website operators' use of tracking software like Meta Pixel and Google Analytics shows the steep climb plaintiffs may continue to face as they try to apply older laws to modern technologies, experts told Law360.
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October 28, 2024
5th Circ. Affirms Texas Health Coordinator Is Not Tax-Exempt
A Texas nonprofit corporation that coordinates healthcare mostly for privately insured patients does not qualify for tax-exempt status because its business fails to help the larger community, the Fifth Circuit ruled Monday in affirming a U.S. Tax Court decision.
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October 28, 2024
Hospital Wants NC County's 'Monopoly' Suit Tossed
Owners of an Asheville, North Carolina, hospital accused of understaffing its emergency room and driving up wait times say the county suing them for unjust enrichment is actually trying to get paid twice for healthcare its emergency responders have already provided.
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October 28, 2024
Crown Settles Customer Dispute To Close $924M Revance Buy
Revance Therapeutics has settled a distribution-related dispute with customer Teoxane SA, potentially clearing the path for its planned $924 million acquisition by skincare company Crown Laboratories.
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October 25, 2024
NLRB Wins Injunction, Defeats Constitutional Claims In Mich.
A Michigan federal judge handed the National Labor Relations Board two victories Friday in the agency's dispute with a hospital, ordering the hospital to resume recognizing the Service Employees International Union affiliate it ousted last year and rejecting the hospital's argument that the agency's structure is unconstitutional.
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October 25, 2024
Jury In Formula Trial Told Baby's Condition Likely Genetic
An expert witness for Abbott and Mead Johnson in the first joint trial against the baby formula makers told a St. Louis jury Friday he believes the child at the center of the case has a genetic condition that's responsible for most of his intellectual impairment.
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October 25, 2024
NJ Ethics Board Faces Contempt Bid In Retaliation Fight
Counsel for a New Jersey health official who claimed his firing during the COVID-19 pandemic was retaliatory asked a court to hold the State Ethics Commission in contempt for stalling discovery under the guise that the state health regulator initiated the termination, despite "well documented" evidence that it was the commission and Gov. Phil Murphy.
Expert Analysis
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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.
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Justices' Intent Witness Ruling May Be Useful For Defense Bar
At first glance, the U.S. Supreme Court’s recent Diaz v. U.S. decision, allowing experts to testify to the mental state of criminal defendants in federal court, gives prosecutors a new tool, but creative white collar defense counsel may be able to use the same tool to their own advantage, say Jack Sharman and Rachel Bragg at Lightfoot Franklin.
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Eye On Compliance: New Pregnancy And Nursing Protections
With New York rolling out paid lactation breaks and extra leave for prenatal care, and recent federal legislative developments enhancing protection for pregnant and nursing workers, employers required to offer these complex new accommodations should take several steps to mitigate their compliance risks, says Madjeen Garcon-Bonneau at Wilson Elser.
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How To Grow Marketing, Biz Dev Teams In A Tight Market
Faced with fierce competition and rising operating costs, firms are feeling the pressure to build a well-oiled marketing and business development team that supports strategic priorities, but they’ll need to be flexible and creative given a tight talent market, says Ben Curle at Ambition.
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FTC Focus: Private Equity Investments In Healthcare
As the Federal Trade Commission is tightening its scrutiny of private equity investment in healthcare, the agency is finding novel grounds to challenge key focus areas, including rollup acquisitions, the flip-and-strip approach and minority investments in rival providers, say attorneys at Proskauer.
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High Court's Expert Ruling May Help Health Fraud Defendants
The U.S. Supreme Court's decision in Diaz v. U.S. appears to give the government a powerful new tool in calling its own agents as expert witnesses, but it could also benefit defense counsel in criminal healthcare fraud and other white collar criminal cases that arise in complex legal or regulatory environments, say attorneys at Holland & Knight.