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Life Sciences
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October 03, 2024
Flint Water Judge Wishes Public Knew Case Complexity
A Michigan federal judge on Thursday gave the final approval to a $25 million settlement to end claims from a class of Flint adults and businesses accusing a firm of failing to properly alert officials about the dangers of the city's water, noting that the case took years to resolve because it involved complicated legal issues.
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October 03, 2024
NJ Contractors Accused Of $10M Fraud In Lead Removal Work
A New Jersey construction company billed the city of Newark $10.2 million for replacing 1,500 lead water service lines but never did the work, instead concocting false evidence to show new copper pipes had been installed, federal authorities said Thursday in announcing the arrests of the chief executive and a foreperson.
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October 03, 2024
Cos. Want Federal Rule On Litigation Funding Disclosure
The federal courts should adopt a uniform process for the disclosure of third-party litigation funding in federal cases, a host of companies, including Johnson & Johnson and Google, told the judiciary's Rules Committee.
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October 03, 2024
Ex-US House Energy Committee Atty Joins Foley In DC
Foley & Lardner LLP has announced that a former senior counsel to the U.S. House Committee on Energy and Commerce joined the firm's Washington, D.C., office as counsel in its public policy and government relations practice group.
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October 03, 2024
CVS Pushed To Unwind Aetna Megadeal, And Other Rumors
CVS is exploring strategic options that could break up the business, Kleenex's owner explores a sale at a potential $4 billion value, and Ares is in talks to buy 10% of the Miami Dolphins’ parent. Here, Law360 breaks down these and other notable deal rumors from the past week.
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October 02, 2024
Bard Agrees To Individualized Deals In Hernia Mesh Litigation
Tens of thousands of plaintiffs alleging they were injured by hernia mesh implant devices could resolve their claims against C.R. Bard Inc. under a settlement process unveiled Wednesday, a "decisive step" toward addressing the claims in both state and federal courts, counsel for the plaintiffs said in their announcement.
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October 02, 2024
Chancery To Mull Receiver In Drug Co. Consulting Bill Row
Delaware's Supreme Court has appointed a Superior Court judge to sit as a vice chancellor in a suit seeking a receiver for a Dubai-headquartered bio-pharmaceutical company that has run up nearly $600,000 in $3,000-per-day sanctions and counting for failing to comply with an initial $180,000 judgment.
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October 02, 2024
Pfizer Didn't Warn Of Tumor Risks In Depo-Provera, Suit Says
Pfizer Inc. faces a product liability and negligence suit filed Tuesday in California federal court alleging it distributed the hormonal contraceptive drug Depo-Provera without adequately warning patients and doctors about the risk of brain tumors associated with its use, a danger that has been widely published in scientific journals for years.
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October 02, 2024
Avadel Tells Fed. Circ. It Should Be Free To Test Sleep Drug
Specialty-drug maker Avadel Pharmaceuticals says a Delaware federal court went too far in blocking it from testing a narcolepsy drug to treat an uncommon sleep disorder after finding that it infringed a patent covering a rival's narcolepsy drug.
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October 02, 2024
Amarin Says Sky Isn't About To Fall In Skinny Labels Fight
Amarin Pharma Inc., the maker of the cardiovascular drug Vascepa, has defended a Federal Circuit decision reviving its skinny label patent case against a rival U.K. drugmaker, telling the appeals court that the sky is not "going to fall on the generic pharmaceutical industry."
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October 02, 2024
Doctor Cops To Dealing Ketamine That Killed Matthew Perry
A physician pled guilty in California federal court Wednesday to helping supply the ketamine that killed "Friends" star Matthew Perry, including by providing illegally obtained vials of the drug for Perry's personal assistant to administer at home.
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October 02, 2024
Dental Laser Maker Biolase Hits Ch. 11 With $33M In Debt
Biolase, a manufacturer of lasers used in dental procedures, is seeking bankruptcy protection in Delaware, and has disclosed roughly $33 million in debt and a $14 million stalking horse offer for its assets, citing financial challenges that it said stemmed from slow market adoption of new technology and economic headwinds.
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October 02, 2024
Supplement Co. Hits Back At TM Suit, Alleges Fake Reviews
Supplement-maker Nutranext Business LLC failed to disclose that a doctor promoting its products is a paid influence, artificially inflated its positive reviews on Amazon and misrepresented a study that purports to show the benefits of using its products, according to new counterclaims filed by a competitor it sued for trademark infringement.
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October 02, 2024
GNC Wins $45M In Awards Against Asian Franchisees
GNC Holdings LLC has said the International Centre for Dispute Resolution informed the health and wellness company of nearly $45 million it has won in arbitral awards against franchisees located in Singapore and the Philippines.
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October 02, 2024
Fla. Atty Disbarred For Abandoning Pharma Biz Before USPTO
The Florida Supreme Court on Wednesday disbarred an attorney for taking on intellectual property work for a pharmaceutical company only to later cease communications and keep the business in the dark about maintenance fees, causing its patents to expire.
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October 02, 2024
ExecuPharm Agrees To Pay Ransomware Victims $10K Each
U.S. pharmaceutical giant ExecuPharm will pay victims of a data breach up to $10,000 in reimbursements, compensation for lost time, three years of credit monitoring, and $675,000 in attorney fees after a Pennsylvania federal judge gave his final approval to a class action settlement.
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October 02, 2024
Teva Sales Workers Get $2.7M Unpaid OT Deal Approved
A New Jersey federal judge greenlighted a $2.7 million settlement that resolves a suit from a collective of sales specialists who accused pharmaceutical company Teva of unlawfully denying them overtime wages during an extended training program.
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October 01, 2024
From AI To Enviro: The Top Biz Bills Calif. Gov. Inked Into Law
California Gov. Gavin Newsom signed hundreds of bills into law ahead of an Oct. 1 deadline, meaning major changes are on the horizon for employers, tech companies, healthcare providers and others doing business in the Golden State.
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October 01, 2024
9th Circ. Cites 'Sunscreen' Song In Reviving Banana Boat Suit
The Ninth Circuit on Tuesday revived a proposed class action claiming Banana Boat sunscreen contains unsafe levels of benzene, citing a one-hit wonder from an Academy Award nominated director and saying a lower court judge erred by prematurely resolving disputed issues of fact and the merits of the consumer case.
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October 01, 2024
Judge Backs Louisiana 340B Law In Loss For Pharma Lobby
A Louisiana federal court has issued a sweeping loss to Big Pharma's top lobbying group and two pharmaceutical companies that argued a state law improperly expands the scope of the federal drug discount program.
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October 01, 2024
Activists Sue Ark. Officials Over Medical Pot Ballot Measure
Activists attempting to put a measure that would expand medical marijuana access in Arkansas on the ballot brought a lawsuit against John Thurston, the state's secretary of state, on Tuesday, one day after he said that the campaign did not have enough signatures to qualify for the ballot.
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October 01, 2024
Ex-CBD Exec Must Face SEC Fraud Suit Over $13M Deal
The U.S. Securities and Exchange Commission sufficiently backed its claims that a former cannabidiol products executive misled investors, including by making false statements in press releases, a Connecticut federal judge has ruled.
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October 01, 2024
DOJ Says It Is Constitutional To Disarm Pot Patients
The U.S. Department of Justice told a Pennsylvania federal judge Tuesday that a federal policy barring medical marijuana patients from lawfully possessing firearms is constitutional, and it urged the court to dismiss a legal challenge to the statute.
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October 01, 2024
Amgen Must Face Suit It Misled Investors On $10.7B Tax Bill
Amgen lost an attempt to escape a potential class action claiming the pharmaceutical giant hid a $10.7 billion tax bill from investors after a New York federal court ruled there was sufficient evidence for the action to proceed.
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October 01, 2024
Biotech Investors Reach $32.5M Deal Over Failed COVID Test
A class of Talis Biomedical Corp. investors accusing the company of inflating their stock price in the run-up to its IPO and then failing to launch a COVID-19 diagnostic test asked a California federal judge on Monday to preliminarily approve their $32.5 million settlement, citing Talis' shrinking cash reserves and imminent plans to file for bankruptcy.
Expert Analysis
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Alice Step 2 Trends Show Courts' Extrinsic Evidence Reliance
A look at recent trends in how district courts are applying Step 2 of the Alice framework shows that courts have increasingly relied on extrinsic evidence to help determine whether a claimed invention is "well-understood, routine, and conventional," says Jonathan Tuminaro at Sterne Kessler.
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Recent Settlement Shows 'China Initiative' Has Life After Death
Though the U.S. Department of Justice shuttered its controversial China Initiative two years ago, its recent False Claims Act settlement with the Cleveland Clinic Foundation demonstrates that prosecutors are more than willing to civilly pursue research institutions whose employees were previously targeted, say attorneys at Benesch.
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DOJ Innovasis Settlement Offers Lessons On Self-Disclosure
The recent $12 million settlement with Innovasis and two of its executives demonstrates the U.S. Department of Justice's continued prioritization of Anti-Kickback Statute enforcement amid the growing circuit split over causation, and illustrates important nuances surrounding self-disclosure, say Denise Barnes and Scott Gallisdorfer at Bass Berry.
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How Orange Book Antitrust Scrutiny Is Intensifying
Pharmaceutical patent holders should be reviewing Orange Book listing practices, as the Federal Trade Commission takes a more aggressive antitrust approach with actions such as the Teva listing probe, and the U.S. Food and Drug Administration calls attention to potentially improper listings, say attorneys at McDermott.
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Weight-Loss Drugs May Spur Next Major Mass Tort
With lawsuits concerning Ozempic and similar weight-loss drugs potentially becoming the next major mass tort in the U.S., companies should consider key defense strategies ranging from alternate dispute resolution to enhanced drug safety, say Dino Haloulos and Jarif Khan at Foley & Mansfield.
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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
After Chevron: Slowing Down AI In Medical Research
The U.S. Supreme Court's recent decision overturning the Chevron doctrine may inhibit agencies' regulatory efforts, potentially slowing down the approval and implementation of artificial intelligence-driven methodologies in medical research, as well as regulators' responses to public health emergencies, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.
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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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How Cos. Should Handle Research Org.'s Carcinogen Evals
In light of the International Agency of Research for Cancer's list of substances slated for review over the next five years, manufacturers of chemicals, pharmaceuticals and consumer products should monitor for potentially unbalanced determinations, which could stimulate litigation regarding potential exposure from products, say attorneys at Nelson Mullins.
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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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Del. Dispatch: 27.6% Stockholder Not A Controller
The Delaware Court of Chancery's recent decision in Sciannella v. AstraZeneca — which found that the pharma giant, a 26.7% stockholder of Viela Bio Inc., was not a controller of Viela, despite having management control — shows that overall context matters when challenging transactions on breach of fiduciary duty grounds, say attorneys at Fried Frank.
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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.