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Life Sciences
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September 05, 2025
Casper Can't Escape Innovator-Liability Drug Label Suit
A California federal judge won't let Casper Pharma LLC escape an innovator-liability suit alleging that its failure to provide adequate warnings on its gout treatment led to the death of a man who used its generic version.
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September 05, 2025
Conn. Biotech Hits Ch. 11 With $2.7M Debt After Patent Suit
A Connecticut biotech company has filed a voluntary Chapter 11 petition claiming at least $2.7 million in liabilities, mostly debts to Quinn Emanuel Urquhart & Sullivan LLP and Verrill Dana LLP, after both law firms represented it in a since-settled Massachusetts stem cell patent lawsuit.
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September 05, 2025
Motley Rice Fights OptumRx DQ Bid In Utah Opioid Suit
Pharmacy benefit manager OptumRx cannot disqualify Motley Rice LLC from representing Utah in a lawsuit over the opioid crisis, since any information the firm obtained during its involvement in earlier government investigations is available to all other parties in the multidistrict litigation and so isn't confidential, the state has told a federal court.
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September 04, 2025
Feds Seek Stay On Court Order Releasing Foreign Aid Billions
The Trump administration urged the D.C. Circuit on Thursday to stay a federal judge's order that it release billions in frozen foreign aid pending its appeal, saying the disbursement will likely be "impossible" to recover according to the international aid organization plaintiffs' "own description of their financial condition."
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September 04, 2025
Split 3rd Circ. Rejects Janssen, Bristol Myers Pricing Appeal
A split Third Circuit panel Thursday shot down another challenge to the Medicare drug pricing negotiation, this time rejecting a consolidated appeal from Bristol Myers Squibb and Janssen and upholding a lower court's finding that the program is indeed voluntary and therefore constitutional.
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September 04, 2025
Doc Tells 1st Circ. Acquitted Conduct Marred Drug Sentence
A Massachusetts psychiatrist convicted over an alleged scheme to import and dispense nonapproved forms of addiction medication on Thursday told the First Circuit the trial judge wrongly ran afoul of limitations on the consideration of acquitted conduct in federal sentencings when handing him a three-year prison term.
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September 04, 2025
4th Circ. Affirms Gardasil's Vaccine Table Inclusion
A unanimous Fourth Circuit panel affirmed Thursday that adding the human papillomavirus vaccine Gardasil to the Vaccine Act's injury table did not violate the U.S. Constitution, rejecting three plaintiffs' arguments that the Secretary of Health and Human Services lacks the authority to make additions to the table without an act of Congress.
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September 04, 2025
Generic Drug Org Backs MSN In High Court Entresto Appeal
The Association for Accessible Medicines has thrown its weight behind MSN Pharmaceuticals in the company's U.S. Supreme Court challenge to a Federal Circuit decision blocking its generic version of Novartis' blockbuster cardiovascular drug Entresto, saying Wednesday that the appeals court took the wrong approach to patent validity.
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September 04, 2025
GSK Adds Moderna's New COVID Vaccine To Del. IP Suit
GlaxoSmithKline Biologicals is broadening its patent infringement suit against Moderna Inc. to include the latter's new family of COVID-19 vaccines, mNEXSPIKE.
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September 04, 2025
Why The Harvard Funding Case Is 'Clear As Mud' On Appeal
A sweeping Harvard University victory in a suit challenging President Donald Trump's block on $2.2 billion in grant funding tees up a high-stakes appeal that experts say may turn on a wonky jurisdictional issue on which the U.S. Supreme Court seems to lack any sort of consensus.
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September 04, 2025
Sterne Kessler Adds Ex-Deputy Chief PTAB Judge
The former acting head of the U.S. Patent and Trademark Office's unit that reexamines patents after they have been granted has made the move to Sterne Kessler Goldstein & Fox PLLC, amid a series of personnel changes at the agency.
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September 04, 2025
DOJ Moves To End Challenge To RFK Jr.'s Vaccine Directive
The Justice Department is seeking a quick exit from a suit challenging Robert F. Kennedy Jr.'s directive recommending against the COVID-19 vaccine for pregnant women and children, telling a Massachusetts federal court Thursday that the three women and coalition of medical associations behind the suit can't demonstrate a link between the directive and any potential injuries.
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September 04, 2025
Monthly Merger Review Snapshot
The Justice Department settled a challenge to UnitedHealth's $3.3 billion home hospice acquisition while Democrats called for a judge to reject a different government settlement and the Federal Trade Commission moved against medical technologies transactions for heart valves and device coatings.
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September 04, 2025
Robitussin Maker Must Face Woman's Lung Infection Suit
A Pennsylvania judge has refused to dismiss a suit against the maker of Robitussin cough syrup by a woman who alleged she developed a severe lung infection from a contaminated product, saying her allegations are sufficient to plead causation.
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September 04, 2025
PBMs Look To Toss FTC's Insulin Pricing Case
Caremark Rx, Express Scripts and OptumRx have asked to dismiss the Federal Trade Commission's in-house case accusing the pharmacy benefit managers of artificially inflating insulin prices, saying the agency is exceeding its authority to address "unfairness."
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September 04, 2025
RFK Renews Attacks On CDC At Fiery Capitol Hill Appearance
U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. faced intense questioning from lawmakers on Capitol Hill on Thursday, with a handful of Republicans joining Democratic senators in voicing alarm over recent turmoil in vaccine policy and in leadership at the Centers for Disease Control and Prevention.
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September 04, 2025
3rd Circ. Preview: Sept. Features Biosimilars, Gambling Cases
The Third Circuit's September argument lineup is packed with cases centering on the biosimilars segment of the pharmaceutical industry and gambling companies embroiled in disputes originating from New Jersey.
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September 04, 2025
Sanofi Settles Conn. Zantac Suits Alleging Cancer Risks
After more than a year of indicating settlement talks would likely be successful, Sanofi-Aventis US LLC and Sanofi US Services Inc. on Thursday announced accords in two Connecticut state court lawsuits that asserted that generic forms of brand name heartburn and acid reflux drug Zantac degraded into a substance that caused cancer.
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September 04, 2025
Purdue Pharma Approved For $17.5M In Ch. 11 Bonus Plans
Bankrupt pharmaceutical company Purdue Pharma LP received approval from a New York judge Thursday to pay more than $17.5 million in employee bonuses, mirroring the bonus structures of the last few years since the company commenced its Chapter 11 case.
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September 04, 2025
Ohio Cannabis Card Network Sued Over Faulty Cybersecurity
An Ohio man is suing Ohio Medical Alliance LLC in federal court, alleging that its lackluster cybersecurity measures exposed more than 950,000 records containing private health information for its users.
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September 03, 2025
7th Circ. Backs AbbVie's Win Against Ex-Sales Rep's FCA Suit
The Seventh Circuit declined to revive a former AbbVie employee's False Claims Act retaliation suit alleging he faced repercussions for refusing to push Vraylar's off-label use to treat major depressive disorder, ruling Wednesday he didn't put AbbVie on notice that he reasonably believed it was defrauding the government.
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September 03, 2025
9th Circ. Won't Revive Genentech Ex-Worker's 401(k) Suit
The Ninth Circuit will not reconsider whether fiduciaries for the retirement plan of biotechnology company Genentech violated their duty to be prudent by keeping certain target date retirement funds in the company's retirement portfolio.
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September 03, 2025
Fla. Surgeon General Pushes To End State's Vaccine Mandates
Florida's surgeon general on Wednesday said he intends to work toward undoing all of the state's vaccine mandates, including for schoolchildren.
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September 03, 2025
Judge Backs Harvard In Suit Over Trump's $2B Fund Freeze
The Trump administration illegally froze more than $2 billion in grants earmarked for Harvard University when it failed to offer an explanation as to how cutting the funds addressed the government's stated goal of ending antisemitism on campus, a Massachusetts federal judge ruled Wednesday.
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September 03, 2025
Novartis Inks Up To $5.2B Deal With Chinese Cardio Biotech
China's Argo Biopharmaceutical Co., a biotechnology company developing RNA-based medicines, said Wednesday it has struck an up to $5.2 billion deal with Novartis to advance several treatments for heart and blood vessel conditions.
Expert Analysis
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How Big Pharma Has Responded To FTC Delisting Demands
Looking at some statistics concerning how pharmaceutical companies have responded to the Federal Trade Commission's recent challenges to Orange Book listings raises several possible hypotheses about the FTC's strategy and effectiveness, say Ratib Ali and Celia Lu at Competition Dynamics.
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5 Ways Lawyers Can Earn Back The Public's Trust
Amid salacious headlines about lawyers behaving badly and recent polls showing the public’s increasingly unfavorable view of attorneys, we must make meaningful changes to our culture to rebuild trust in the legal system, says Carl Taylor at Carl Taylor Law.
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USPTO's AI Tool Redefines Design Patent Landscape
The U.S. Patent and Trademark Office's newly introduced DesignVision tool for artificial intelligence-powered image searching represents a dramatic shift in how design patent applications are examined, necessitating new strategies for patent practitioners, says Matthew Epstein at Dinsmore.
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Class Actions At The Circuit Courts: August Lessons
In this month's review of class action appeals, Mitchell Engel at Shook Hardy discusses key takeaways from federal appellate decisions involving topics including antitrust, immigration, consumer fraud, birthright citizenship under the Fourteenth Amendment, and product defects.
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Series
Hiking Makes Me A Better Lawyer
On the trail, I have thought often about the parallels between hiking and high-stakes patent litigation, and why strategizing, preparation, perseverance and joy are important skills for success in both endeavors, says Barbara Fiacco at Foley Hoag.
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What US-India Trade Deal Will Mean For Indian Pharma
Complicated by newly imposed tariffs from the U.S., the outcome of the U.S.-India trade talks is poised to reshape not just trade policy, but also the strategic alignment of the two countries' pharmaceutical ecosystems, says Jashaswi Ghosh at Holon Law Partners.
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Opinion
Time For Full Disclosure Of Third-Party Funding In MDLs
It is appropriate that the Federal Advisory Committee on Civil Rules is considering a rule to require disclosure of third-party litigation funding in civil litigation — something that is particularly needed in multidistrict litigation, which now comprises more than half of all civil cases in the federal courts, says Eric Hudson at Butler Snow.
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Series
Law School's Missed Lessons: Negotiation Skills
I took one negotiation course in law school, but most of the techniques I rely on today I learned in practice, where I've discovered that the process is less about tricks or tactics, and more about clarity, preparation and communication, says Grant Schrantz at Haug Barron.
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Conflicting Developments In Homelessness Legal Landscape
Looking at an executive order and Third Circuit opinion from last month highlights the ongoing tension in homelessness-related legal issues facing state and local governments, property owners, and individuals experiencing homelessness, says Josh Collins, an attorney for the City of South Salt Lake.
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AG Watch: Texas Embraces The MAHA Movement
Attorneys at Kelley Drye examine Texas Attorney General Ken Paxton's actions related to the federal Make America Healthy Again movement, and how these actions hinge on representations or omissions by the target companies as opposed to specific analyses of the potential health risks.
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Opinion
Bar Exam Reform Must Expand Beyond A Single Updated Test
Recently released information about the National Conference of Bar Examiners’ new NextGen Uniform Bar Exam highlights why a single test is not ideal for measuring newly licensed lawyers’ competency, demonstrating the need for collaborative development, implementation and reform processes, says Gregory Bordelon at Suffolk University.
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The Patent Eligibility Eras Tour: 11 Years Of Post-Alice Tumult
A survey of recent twists and turns in patent eligibility law highlights the confusion created by the U.S. Supreme Court's 2014 Alice decision and reveals that the continually shifting standards have begun to diverge in fundamental ways between the Federal Circuit and the U.S. Patent and Trademark Office, says Michael Shepherd at Fish & Richardson.
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Location Data And Online Tracking Trends To Watch
Regulators and class action plaintiffs are increasingly targeting companies' use of online tracking technologies and geolocation data in both privacy enforcement and litigation, so organizations should view compliance as a dynamic, cross-functional responsibility as scrutiny becomes increasingly aggressive and multifaceted, say attorneys at Arnold & Porter.
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A Simple Way Courts Can Help Attys Avoid AI Hallucinations
As attorneys increasingly rely on generative artificial intelligence for legal research, courts should consider expanding online quality control programs to flag potential hallucinations — permitting counsel to correct mistakes and sparing judges the burden of imposing sanctions, say attorneys at Lankler Siffert & Wohl and Connors.
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DOJ Consumer Branch's End Leaves FDA Litigation Questions
With the dissolution of the U.S. Department of Justice's Consumer Protection Branch set to occur by Sept. 30, companies must carefully monitor how responsibility is reallocated for civil and criminal enforcement cases related to products regulated by the U.S. Food and Drug Administration, say attorneys at Foley & Lardner.