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Life Sciences
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May 22, 2025
Manufacturer Seeks Over $19M In Beryllium Release Coverage
A medical device manufacturer accused a Zurich unit of breach of contract and bad faith in Massachusetts federal court, seeking at least $19 million in damages after it said storms caused an "unprecedented dispersal" of beryllium at one of its plants in the United Kingdom.
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May 22, 2025
Judge Asks If DEI Is Now 'Homogeneity, Inequity And Exclusion'
A Massachusetts federal judge considering a challenge to the Trump administration's cuts to hundreds of National Institutes of Health grants pressed the U.S. Department of Justice on Thursday for its definition of diversity, equity and inclusion, at one point asking hypothetically whether the government's policy is now "homogeneity, inequity and exclusion."
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May 22, 2025
Conn. AG Targets 'Bootleg' Weight Loss Drug Sellers
Connecticut has launched a consumer protection lawsuit in state court against a Florida-based company and its owner, accusing them of peddling untested and unsafe, research-level, "bootleg" GLP-1 weight loss drugs to customers.
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May 22, 2025
Sanofi To Acquire Goodwin-Led US Biotech Biz For $470M
Drugmaker Sanofi said Thursday that it has agreed to acquire Vigil Neuroscience, a biotechnology company specializing in neurodegenerative diseases, for approximately $470 million to give it a potential new medicine for Alzheimer's disease in a deal guided by Goodwin Procter.
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May 21, 2025
FTC Urges 8th Circ. Not To Pause In-House PBM Case
The Eighth Circuit should once again say no to a request to pause the Federal Trade Commission's in-house case accusing three pharmacy benefit managers of hiking up the price of insulin to line their own pockets, the agency has told the appellate court.
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May 21, 2025
Squires Talks Fortress, PTAB Invalidations In Senate Hearing
The Trump administration's nominee for U.S. Patent and Trademark Office director had his moment before the Senate Judiciary Committee on Wednesday, where he downplayed his controversial connections to litigation finance giant Fortress Investment Group and raised concerns that too many bad patents were being issued.
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May 21, 2025
9th Circ. Judge Asks If Apple's Watch Updates 'Ice Out' Rivals
Two Ninth Circuit judges appeared skeptical Wednesday of Apple Inc.'s arguments against reviving an antitrust suit brought by medical monitoring startup AliveCor Inc. after Apple blocked third-party access to medical data on the Apple Watch, with one judge asking rhetorically whether a "marginal" improvement by Apple could actually be a way to "ice out" competition.
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May 21, 2025
Judge Mulls National Scope Of Bid To Restore COVID Grants
A Washington, D.C., federal judge Wednesday mulled whether it would be appropriate to issue a nationwide injunction blocking the termination of $11 billion public health grants set aside under COVID-era laws in a lawsuit brought by four local governments and a public sector union.
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May 21, 2025
AbbVie Gets Victory In Allergan Shareholder Suit Upheld
An Illinois state appellate panel said Wednesday that a trial court properly dismissed a shareholder class action against biopharmaceutical company AbbVie Inc. that accused the drugmaker of issuing unregistered shares to investors after acquiring Irish pharmaceutical company Allergan.
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May 21, 2025
GOP FTC Renews Calls For Orange Book Patent Delistings
The now-Republican controlled Federal Trade Commission again called on Teva, Novartis, Mylan and other drugmakers to remove patents from a key federal database that partially insulates their drugs from generic competition, arguing Wednesday the patents cover "devices," not drugs, and thus don't warrant such protection.
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May 21, 2025
Kronos Bio Shareholder Says Sale Unfairly Benefits Execs
Kronos Bio is facing a new shareholder suit claiming its plan to be acquired by another biopharmaceutical company will unfairly entitle Kronos executives to "lucrative" benefits unavailable to public shareholders.
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May 21, 2025
Device Maker Who Evaded Tax Gets 2 Years In Prison
A Florida man who sold millions of dollars worth of medical devices that federal prosecutors said were unproven to work was sentenced to two years in prison for evading taxes and ordered to pay $2.3 million in restitution to the Internal Revenue Service.
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May 21, 2025
Walgreens Ducks False Ad Suit Over Mucus Relief Meds
An Illinois federal judge on Tuesday dismissed a potential class action accusing Walgreens of misleading customers by selling them over-the-counter mucus relief medicine containing benzene without warning them of that risk, saying the claims are preempted by a federal drug safety law.
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May 20, 2025
Flo Users Get Class Cert. In Google, Meta Data-Sharing Suit
A California federal judge has granted class status to users of the menstrual cycle tracking app developed by Flo Health Inc. in a suit accusing the company of unlawfully sharing their personal health information with Google and Meta, finding that the defendants' opposition to this move lacked clarity and support.
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May 20, 2025
Barclays Officials Beat Shareholder's Suit At NY High Court
New York's highest court on Tuesday rejected arguments that current and former officials of London-based Barclays PLC can be sued under New York law over a series of scandals that have rocked the bank, a decision that sparked rebuke from the court's chief judge.
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May 20, 2025
Novo Fights To Keep Info Bid In $800M Fraud Dispute Alive
Novo Nordisk is urging a North Carolina federal court not to dismiss its order permitting the Danish drugmaker to seek information bolstering its $800 million fraud claims stemming from a hypertension drug deal, saying the testimony is needed to preserve assets as it pursues arbitration of its claims.
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May 20, 2025
Cancer Drug Co. Beats Investor Suit Over FDA Rejection
Cancer drug company Checkpoint Therapeutics Inc. has permanently escaped a shareholder suit alleging it understated the likelihood the U.S. Food and Drug Administration would refuse approving Checkpoint's lead product candidate, with a New York federal judge ruling company statements were not shown to be false or made with scienter.
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May 20, 2025
Medical Organizations Sue Feds For Removing Health Data
The U.S. Department of Health and Human Services and several constituent agencies are accused of violating the Administrative Procedure Act by illegally purging websites containing critical public health information related to trans and HIV care, vaccines and the prevention of outbreaks of communicable diseases, according to a lawsuit filed Tuesday in Washington federal court.
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May 20, 2025
Medical Supply Co. Faces Ga. Suit Over Unwanted Texts
A Florida-based medical supply company has been hit with a proposed Telephone Consumer Protection Act class action in Georgia federal court by a man who says he received several promotional text messages from the company after he added himself to the National Do Not Call Registry.
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May 20, 2025
Moderna Says Order To Narrow Vax IP Case Should Stay
Moderna has said that a federal judge should ignore a rival mRNA developer's request to rethink his decision limiting issues in a patent suit over the company's COVID-19 vaccines, saying the rival is trying to make new arguments too late.
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May 20, 2025
Creditors Win Fight Against Insider Releases In Azzur Ch. 11
A Delaware bankruptcy judge on Tuesday sustained an objection to insider releases in the Chapter 11 liquidation plan of Azzur Group, finding the pharmaceutical services company had not justified the releases for prepetition conduct of current and former officers, directors, and equity holders.
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May 20, 2025
Biotech Stockholders Challenge Director Pay Levels In Del.
Investors in biotech company Intellia Therapeutics Inc. stock opened a derivative suit in Delaware's Court of Chancery on Tuesday seeking recovery of allegedly excessive compensation paid to non-employee directors for multiple years without an approval vote by stockholders.
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May 20, 2025
Sales Exec Admits Role In $70M Brain Scan Kickback Scheme
A former operations and regional sales manager for a mobile medical diagnostic company has agreed to plead guilty to taking part in a $70.6 million conspiracy to pay kickbacks to doctors who ordered unnecessary brain scans, Massachusetts federal prosecutors announced Tuesday.
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May 19, 2025
Former Kite Pharma Exec Alleges Gender Bias, Retaliation
Gilead Sciences and its subsidiary Kite Pharma have been hit with a suit in California state court by a former company executive alleging she was underpaid compared to her male counterparts and fired while out on medical leave after she raised concerns about equal pay.
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May 19, 2025
SEC's 'Shadow Trading' Win Should Be Tossed, 9th Circ. Told
An ex-Medivation Inc. executive found liable in the U.S. Securities and Exchange Commission's first-ever "shadow trading" case has asked the Ninth Circuit to overturn the verdict, arguing that his company's policies should have kept the matter from going to a jury in the first place.
Expert Analysis
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FDA's Red No. 3 Ban Reshapes Food Safety Legal Landscape
The U.S. Food and Drug Administration's recent ban on Red No. 3 represents more than the end of a controversial dye — it signals a shift in regulatory priorities, consumer expectations, intellectual property strategy, compliance considerations and litigation risk, says Dino Haloulos at Foley Mansfield.
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Scope And Nature Of Judicial Relief Will Affect Loper's Impact
The practical result of post-Loper Bright rulings against regulatory actions will depend on the relief courts grant — and there has been controversy in these types of cases over whether the ruling is applied just to the parties or nationwide, and whether the action can be left in place while it's corrected, says Steven Gordon at Holland & Knight.
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The Implications Of E-Cigarette Cos. Taking Suits To 5th Circ.
The U.S. Supreme Court recently heard oral arguments in U.S. Food and Drug Administration v. R.J. Reynolds over the definition of an "adversely affected" person under the Tobacco Control Act, and the justices' ruling will have important and potentially wide-ranging implications for forum shopping claims, says Trillium Chang at Zuckerman Spaeder.
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Series
Adventure Photography Makes Me A Better Lawyer
Photographing nature everywhere from Siberia to Cuba and Iceland to Rwanda provides me with a constant reminder to refresh, refocus and rethink the legal issues that my clients face, says Richard Birmingham at Davis Wright.
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What Vinyl Acetate's Prop 65 Listing Means For Cos.
California's recent move to add vinyl acetate to the Proposition 65 list of carcinogens, with enforcement starting later this year, will have sweeping compliance and risk implications for businesses in the retail, food and beverage, paint, adhesive, industrial manufacturing, and personal care product industries, say attorneys at Alston & Bird.
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Fed. Circ. Inherency Ruling Refines Obviousness Framework
The Federal Circuit's December decision in Cytiva v. JSR has definitively eliminated the requirement of "reasonable expectation of success" analysis for inherent properties in obviousness determinations, while providing some key clarifications for patent practitioners, says Lawrence Kass at Steptoe.
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Navigating The Potential End Of GLP-1 Drug Shortages
The U.S. Food and Drug Administration's determination of whether GLP-1 products are in shortage may affect how compounders provide these products and spur a range of litigation including patent disputes and unfair competition suits, say attorneys at Goodwin.
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High Court Could Further Limit Deference With TCPA Fax Case
The Supreme Court's decision to hear McLaughlin Chiropractic Associates v. McKesson, a case involving alleged junk faxes that centers whether district courts are bound by Federal Communications Commission rules, offers the court a chance to possibly further limit the judicial deference afforded to federal agency interpretations of statutes, says Samantha Duke at Rumberger Kirk.
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5 Ways To Create Effective Mock Assignments For Associates
In order to effectively develop associates’ critical thinking skills, firms should design mock assignments that contain a few key ingredients, from messy fact patterns to actionable feedback, says Abdi Shayesteh at AltaClaro.
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Calif. Cannabis Decision Deepens Commerce Clause Divide
In Peridot Tree v. Sacramento, the Eastern District of California joined a growing minority of courts that have found the dormant commerce clause inapplicable to state-regulated marijuana, and the Ninth Circuit will soon provide important guidance on this issue, say attorneys at Perkins Coie.
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Opinion
IVF Suits Highlight Need For Better Legal Frameworks
The high number of in vitro fertilization embryo losses underscores the need for more cohesive legal and regulatory guidance related to human errors, property versus personhood, and liability, says Jeff Korek at Gersowitz Libo.
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Recent Suits Show Antitrust Agencies' Focus On HSR Review
The U.S. Department of Justice's suit this month against KKR for inaccurate and incomplete premerger filings, along with other recent cases, highlights the agency's increasing scrutiny of Hart-Scott-Rodino Act compliance for private equity firms, say attorneys at Willkie.
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The 7th Circ.'s Top 10 Civil Opinions Of 2024
Attorneys at Jenner & Block examine the most significant decisions issued by the Seventh Circuit in 2024, and explain how they may affect issues related to mass arbitration, consumer fraud, class certification and more.
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Royal Canin Ruling Won't Transform Removal Jurisdiction
The U.S. Supreme Court's ruling in Royal Canin USA v. Wullschleger means that federal district courts must now remand whenever an amended complaint excises grounds for federal jurisdiction — but given existing litigation strategy and case law trends, this may ultimately preserve, rather than alter, the status quo, say attorneys at Norton Rose.
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Lessons From The Pharma Industry On Patent Cliffs
In the next five years, patents for drugs that have generated billions in global sales are set to expire, and companies that view this imminent patent cliff as an opportunity for strategic renewal rather than a challenge will be best positioned to maintain market leadership, says Keegan Caldwell at Caldwell Law.