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Life Sciences
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March 12, 2025
SEC Says Ex-Allarity Execs Concealed Doomed FDA Approval
The U.S. Securities and Exchange Commission sued three former executives of clinical-stage pharmaceutical company Allarity Therapeutics Inc. in Massachusetts federal court, alleging Wednesday that they schemed to conceal from the public that the company's new drug application for its flagship drug had no chance of gaining regulatory approval.
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March 12, 2025
Caribou Biosciences Brass Face Investor's Clinical Trials Suit
Executives and directors of Caribou Biosciences Inc. have been hit with a shareholder's derivative suit alleging that they overstated the safety and efficacy of Caribou's cell therapy and concealed that the company was at risk of being unable to fund its operations.
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March 12, 2025
COVID Test Device Maker Settles Fed. Circ. Feuds With Rival
A company that makes saliva collection devices used for COVID-19 tests says it will drop out of Federal Circuit appeals fights with Longhorn Vaccines & Diagnostics stemming from the Patent Trial and Appeal Board canceling 183 of Longhorn's patent claims as a punishment for "egregious abuse of the PTAB process."
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March 12, 2025
Publix Policies Don't Cover Opioid Claims, Court Says
Insurers for Publix have no duty to defend or indemnify the supermarket chain in dozens of public nuisance lawsuits related to the opioid crisis, a Florida federal court said Wednesday, following Publix's renewed request that the court enter a final judgment so it could proceed with appeal.
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March 12, 2025
NC Organ Procurer Sues CMS Over Hospital Waiver
A North Carolina-based organ procurement organization told a federal court Wednesday that the Centers for Medicare & Medicaid Services has violated federal law by giving a waiver to a hospital to work with another organ procurement service from a different region.
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March 12, 2025
Cannabis Tech Co. Seeks Over $1M Interest On $4.2M Verdict
A software company that won a $4.2 million judgment last year on claims that it was wrongly pushed out of a state government contract is urging a Pennsylvania federal court to award more than $1 million in pre- and postjudgment interest on the award.
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March 12, 2025
HHS To Eliminate 6 Regional Offices For Legal Staff
The U.S. Department of Health and Human Services said Tuesday it will close six out of 10 regional offices where attorneys for the agency work.
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March 12, 2025
Harvard Docs Say Gov't Censored Articles With Gender Terms
A pair of Harvard Medical School researchers sued the Trump administration in Massachusetts federal court on Wednesday, claiming their work was erased from a government-run patient safety website because their articles contained terms like "LGBTQ" and "transgender."
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March 12, 2025
Mallinckrodt Investors Ask NJ Court To Approve $46M Deal
A group of Mallinckrodt PLC investors has asked a New Jersey federal judge to grant final approval to a $46 million settlement they reached with executives and directors of the pharmaceutical company to resolve claims that they misrepresented the prospects of a drug the company developed.
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March 12, 2025
McCarter & English Wins $3.77M From Ex-Client In Billing Spat
McCarter & English LLP is entitled to nearly $3.77 million from Jarrow Formulas Inc., a nutritional supplement company that refused to pay its legal bills after losing a trade secrets trial and a subsequent malpractice claim against the firm, a Connecticut federal judge has ruled.
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March 11, 2025
Medical Device Co. Seeks Fed. Circ. Redo Over Patent Trial
A medical device manufacturer is asking the full Federal Circuit to reconsider a panel decision reviving a patent infringement case against it, arguing a lower court judge was fine to allow tardy testimony from a witness who took its side.
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March 11, 2025
Kenvue Unit Can't Nix BIPA Suit Over Neutrogena Skin360 App
A Kenvue unit can't escape a proposed class action alleging it unlawfully stores facial scans of people who use its Neutrogena Skin360 tool in violation of Illinois' biometric privacy statute, after a New Jersey federal judge said those users are not "patient[s] in a healthcare setting" under the statute's healthcare exemption.
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March 11, 2025
'Paucity' Of Proof Thwarts NC State Law Claims In Gardasil MDL
A North Carolina federal judge has found that Merck did not violate state law by not including warnings about its Human Papillomavirus vaccine Gardasil, saying there was a "paucity" of evidence that the vaccines cause certain injuries to recipients.
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March 11, 2025
More ITC Patent Cases Expected After Fed. Circ. 'Sea Change'
A recent Federal Circuit decision discarding the U.S. International Trade Commission's limits on what types of domestic expenses qualify a company to bring a patent suit at the agency marks a pronounced shift that will likely spur considerably more ITC cases, attorneys say.
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March 11, 2025
Pharmacies To Appeal In Bid To Keep Making Weight Loss Drug
A group of compounding pharmacies said Monday they would appeal to the Fifth Circuit after a Texas federal judge denied an injunction that would allow compounding pharmacies to produce a lucrative weight loss drug.
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March 11, 2025
J&J Tells 3rd Circ. No Price Impact In Talc Concealment Suit
Johnson & Johnson urged the Third Circuit on Tuesday to undo class certification of investor claims that the company inflated its stock price by failing to disclose cancer risks associated with its talcum powder products, arguing that the investors could not have relied upon its alleged misrepresentations because there was no impact on the stock market's price.
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March 11, 2025
Brazilian 'Drug King' Ran Black Market Pharmacy, Feds Say
Federal prosecutors said a Brazilian national living in the United States without permission falsely portrayed himself as a pharmacist to sell members of a large Portuguese-speaking community west of Boston an array of medications, including painkillers, steroids and other controlled drugs.
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March 11, 2025
Zydus Cuts Deal With States, Tribes In Opioid Nuisance Suit
Zydus Pharmaceuticals Inc. has reached a deal in principle with states and Native American tribes that should quash claims related to the company's alleged role in exasperating the opioid crisis.
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March 11, 2025
Eli Lilly Suit Over Compounded Drugs Survives Dismissal
A Washington federal judge has trimmed Eli Lilly's lawsuit against two Seattle-area clinics and the doctors who run them for allegedly duping consumers into buying copycat versions of its diabetes and weight loss medications Mounjaro and Zepbound, nixing the pharmaceutical giant's consumer protection claim while preserving its trademark infringement and false advertising allegations.
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March 11, 2025
Alaska's RICO Claims Advance Against PBM In Opioid Suit
An Alaska federal judge has allowed most of the state's Racketeer Influenced and Corrupt Organization Act claims to move forward against pharmacy benefits manager Express Scripts for its alleged role in the opioid epidemic.
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March 11, 2025
Post Hit With False Ad Suit Over Rachael Ray Brand Pet Food
Post sells celebrity chef Rachael Ray's Nutrish brand of pet foods that are falsely labeled as being "natural" with "no artificial preservatives" despite containing citric acid, which is derived from heavy chemical processing, according to a proposed class action filed in California federal court Monday.
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March 11, 2025
Endo Sells International Pharma Biz To Knight For Up To $99M
Pharmaceutical company Endo Inc., led by Davis Polk & Wardwell LLP and Torys LLP, on Tuesday announced plans to sell its international pharmaceuticals business to Davies Ward Phillips & Vineberg LLP-advised Canadian pharmaceutical company Knight Therapeutics Inc. for up to $99 million.
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March 11, 2025
Publix's Suit Over Ga. County's Private Attys 'Beyond Reason'
Publix can't sue a metro Atlanta county to force it to drop its private attorneys who filed an opioid suit against the supermarket chain, the Georgia Court of Appeals has said, ruling that the company "fails to show what right the county has violated by its choice of counsel."
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March 11, 2025
Trump Admin Drops Suit Over COVID Nasal Spray Ads Claims
The U.S. Department of Justice quietly moved Monday to drop a Utah federal court lawsuit filed on behalf of the Federal Trade Commission accusing a sinus nasal spray company of falsely claiming its products could help prevent and treat COVID-19.
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March 11, 2025
Sullivan & Cromwell Hires Ex-FTC Deputy Director In Palo Alto
Sullivan & Cromwell LLP announced Tuesday the hiring of a former deputy director of the Federal Trade Commission's Bureau of Competition as a partner in its Palo Alto, California, office.
Expert Analysis
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What's At Stake In High Court's Class Member Standing Case
The U.S. Supreme Court’s eventual decision in Labcorp v. Davis could significantly alter how parties prosecute and defend class actions in federal court, particularly if the court determines some proof of member standing is required before a class may be certified, say attorneys at Reed Smith.
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How Citizen Petitions Have Affected Drug Competition
In light of recent citizen petitions and proposed legislation regulating such petitions, Omar Robles at Managing Health analyzes the statistics of the extent to which citizen petitions have been filed, and to what extent they have delayed competition in prescription pharmaceuticals.
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5 Keys To Building Stronger Attorney-Client Relationships
Attorneys are often focused on being seen as the expert, but bonding with clients and prospects by sharing a few key personal details provides the basis for a caring, trusted and profoundly deeper business relationship, says Deb Feder at Feder Development.
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Drug Kickback Ruling Will Make FCA Liability Harder To Prove
The First Circuit's ruling in U.S. v. Regeneron Pharmaceuticals, requiring the government to prove but-for causation to establish False Claims Act liability based on violations of the Anti-Kickback Statute, raises the bar for FCA enforcement and deepens a circuit split that the U.S. Supreme Court may need to resolve, say attorneys at Baker Donelson.
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Assessing PE Risk After Mass. False Claims Act Amendments
A law recently passed in Massachusetts amends the commonwealth's False Claims Act by dramatically expanding potential liability for private equity firms and investors, underscoring the importance of robust diligence and risk assessments for private equity firms conducting transactions in the commonwealth, say attorneys at Gibson Dunn.
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What Trump Actions Mean For Federal Research Funding
New guidance from the National Institutes of Health represents a massive policy shift regarding federal funding for researchers at institutions of higher education, contributing to a perfect storm of significant resource shortfalls in upcoming years, say attorneys at Arnold & Porter.
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How Courts Can Filter Nonmeritorious Claims In Mass Torts
Nonmeritorious claims have been a key obstacle to settlement in many recent high-profile mass torts, but courts may be able to use tools they already have to solve this problem, says Samir Parikh at Wake Forest University.
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Series
Racing Corvettes Makes Me A Better Lawyer
The skills I use when racing Corvettes have enhanced my legal practice in several ways, because driving, like practicing law, requires precision, awareness and a good set of brakes — complete with the wisdom to know how and when to use them, says Kat Mateo at Olshan Frome.
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Opinion
Attorneys Must Act Now To Protect Judicial Independence
Given the Trump administration's recent moves threatening the independence of the judiciary, including efforts to impeach judges who ruled against executive actions, lawyers must protect the rule of law and resist attempts to dilute the judicial branch’s authority, says attorney Bhavleen Sabharwal.
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Rethinking 'No Comment' For Clients Facing Public Crises
“No comment” is no longer a cost-free or even a viable public communications strategy for companies in crisis, and counsel must tailor their guidance based on a variety of competing factors to help clients emerge successfully, says Robert Bowers at Moore & Van Allen.
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As Failure-To-Warn Preemption Wanes, Justices May Weigh In
Federal preemption of state failure-to-warn claims has long been a powerful defense in strict liability tort cases, but is now under attack in litigation over the weedkiller Roundup and other products — so the scope and application of preemption may require clarification by the U.S. Supreme Court, says Michael Sena at Segal McCambridge.
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How Design Thinking Can Help Lawyers Find Purpose In Work
Lawyers everywhere are feeling overwhelmed amid mass government layoffs, increasing political instability and a justice system stretched to its limits — but a design-thinking framework can help attorneys navigate this uncertainty and find meaning in their work, say law professors at the University of Michigan.
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The Fate Of Biden-Era Clinical Study Guidance Under Trump
Draft guidance about the study of sex and gender differences in medical product development issued by the outgoing Biden administration currently faces significant uncertainty and litigation potential due to the Trump administration's executive orders and other actions, say attorneys at Arnold & Porter.
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Trending At The PTAB: Insights From 2024 Fed. Circ. Statistics
Looking at stats from the Federal Circuit's decisions in 219 Patent Trial and Appeal Board appeals last year sheds light on potential trends and strategy considerations that could improve appeals' chances of success, say attorneys at Finnegan.
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Opinion
Weight Drug Suits Highlight Need For Legal Work On Safety
The rapid ascent of glucagon-like peptide-1 receptor agonists like Ozempic has revolutionized diabetes management and weight loss — but legal wrangling over issues including off-label prescriptions, side effects and compounded versions underscores lawyers' roles in protecting patient safety, says attorney Gregg Goldfarb.