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Life Sciences
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February 21, 2025
Paul Hastings Seeks To End GenapSys Malpractice Action
Paul Hastings LLP has moved for summary judgment in a malpractice action from GenapSys Inc., saying the case is barred because the company failed to disclose its possible claim until after confirmation of its bankruptcy plan.
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February 21, 2025
NJ High Court Takes Up Pharma Co. Fraud Coverage Row
The New Jersey Supreme Court will review an appeals court's ruling against indemnification in a case of first impression on the applicability of an exclusion barring directors and officers coverage for wrongful acts "in any way involving" an insured's work for an uninsured entity, the high court announced.
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February 21, 2025
WilmerHale Corporate Ace Joins DLA Piper In California
DLA Piper has added a former WilmerHale attorney to strengthen its corporate practice, including bolstering its service to clients in the life sciences and healthcare industries.
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February 21, 2025
NIH Research Cuts Stay On Hold As Judge Mulls Objections
A Boston federal judge on Friday extended her hold on a Trump administration proposal to slash reimbursements from the National Institutes of Health for research grant costs, a move colleges, hospitals and other institutions have said would wreak havoc on scientific research.
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February 20, 2025
DOJ Says Job Protections For ALJs Are Unconstitutional
The U.S. Department of Justice announced Thursday that it no longer backs long-standing job protections for administrative law judges, saying it has determined that the "multiple layers of removal restrictions" shielding ALJs are unconstitutional because they violate the separation of powers doctrine.
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February 20, 2025
Trump Trans Edicts Will Cause More Teen Suicides, States Say
Washington, Colorado, Oregon and Minnesota argued Wednesday for a court order halting President Donald Trump's executive orders targeting federal funding for gender-affirming care for young people, saying the edicts are unconstitutional and have "unleashed unbridled fear and irreparable harms."
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February 20, 2025
Generic-Drug Group Rallies Behind Appeal In Entresto Fight
A generic-drug industry group is weighing in on the Federal Circuit's move last month to revive a patent tied to Entresto, Novartis Pharmaceuticals Corp's blockbuster heart drug, warning that "the pharmaceutical industry is watching this case closely."
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February 20, 2025
Boston, Other Cities And MassBio Back Challenge To NIH Cuts
The city of Boston and 44 other cities, counties and elected officials around the country and, separately, the life sciences industry group Massachusetts Biotechnology Council asked a Massachusetts federal judge on Thursday to extend a temporary restraining order blocking steep cuts to National Institutes of Health reimbursement for research projects.
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February 20, 2025
Green Groups Ask 9th Circ. To Press EPA Again On Atrazine
Environmental groups are urging the Ninth Circuit to reopen a long-running case against the U.S. Environmental Protection Agency over its regulation around the pesticide atrazine, arguing that the agency's yearslong delay in completing a court-ordered review of the chemical has allowed "serious harm to people, plants and wildlife."
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February 20, 2025
Feds Say DC Judge Can't Bar 'Hypothetical' Spending Freezes
A Justice Department attorney argued before a D.C. federal judge Thursday that there is no basis to continue blocking the Trump administration from implementing a blanket suspension on federal spending, saying the court cannot bar "hypothetical" future freezes.
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February 20, 2025
Drug Buyers Get OK On $275M Sandoz Antitrust Settlement
Swiss drugmaker Sandoz and its subsidiaries will pay consumers, insurers and other "end payer plaintiffs" $275 million to settle class action claims that it conspired with other companies to fix the price of certain generic drugs, under a deal that got preliminary approval from a Pennsylvania federal court Wednesday.
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February 20, 2025
Ex-Heritage Pharma CEO Disciplined Over Price-Fixing Case
The New Jersey Supreme Court has retroactively suspended the former chief executive of Heritage Pharmaceuticals Inc. from the state bar for three years over his role in a price-fixing conspiracy.
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February 20, 2025
Ex-Opioid CEO's Billing Spat With Trial Atty Lands In Court
A Manhattan federal judge teed up a briefing schedule Thursday after a fight over expenses erupted between convicted former opioid CEO Laurence Doud and the lawyer who represented him at his criminal trial, who says Doud still owes $150,000.
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February 20, 2025
Research Co. Liable For Bungling $52M COVID-19 Mask Deal
A North Carolina federal judge ruled in favor of an electronics company that made a $52 million deal for masks during the COVID-19 pandemic only to receive no masks and a partial refund, finding the supplier liable for breach of contract.
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February 19, 2025
What To Know About Trump's Likely Pick For USPTO Director
Dilworth Paxson LLP partner John Squires is about to be nominated for director of the U.S. Patent and Trademark Office, about half a dozen sources told Law360 on Tuesday. Here's what you need to know about the attorney who made a name for himself at Goldman Sachs.
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February 19, 2025
Walgreens Says $1B COVID Testing Award Must Be Nixed
Walgreens is urging a Delaware federal judge to rethink his decision enforcing a $987 million arbitral award to a lab testing and diagnostics company in a dispute over COVID-19 tests, arguing Tuesday that he ignored that the arbitrator "invented" language in the contract to arrive at his conclusion.
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February 19, 2025
Colorado Joins Fight Against Trump Trans Health Order
Colorado on Wednesday joined Washington and two other states opposing President Donald Trump's executive order targeting federal funding for gender-affirming care for people younger than 19, in an amended complaint that noted Colorado was the first state to include gender-affirming care among essential health benefits.
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February 19, 2025
Ga. Woman Implanted With Wrong Embryo Sues Fertility Clinic
A Georgia woman who learned that she gave birth to an unknown couple's baby when she saw that the newborn was Black is suing the fertility clinic she claims negligently and recklessly implanted the strangers' embryo, according to a suit filed in state court.
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February 19, 2025
Gilead, Janssen Settle HIV Treatment Suits With Lupin, Apotex
Gilead Sciences Inc. and Johnson & Johnson's Janssen unit settled their patent suits against Lupin and Apotex over generic versions of HIV treatments, according to filings in Delaware federal court on Wednesday.
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February 19, 2025
COVID Fraudsters Get Prison For Trying To 'Make A Buck'
Two Florida men who pled guilty to running a scheme that defrauded businesses of millions during the pandemic by bilking them on orders of face masks and other protective equipment were sentenced to prison by a Georgia federal judge Wednesday.
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February 19, 2025
Judge Won't Halt PBM Case Over Attack On FTC Independence
A Missouri federal judge refused to temporarily block the Federal Trade Commission's in-house case accusing pharmacy benefits managers of artificially inflating insulin prices through unfair rebate schemes, rejecting the PBMs' claims that the Trump administration's attempt to eliminate safeguards protecting FTC members from at-will presidential removal favors their attempt to stop the case.
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February 19, 2025
Fla. Court Won't Revive Property Manager's COVID Claims
A Florida state appeals court on Wednesday said a lower court correctly ruled that a Miami property management company's insurance policy did not cover losses caused by COVID-19 closures because government shutdown orders were not specific to the business.
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February 19, 2025
3rd Circ. Doubts Alleged Cancer Risk Devalued Drug
A Third Circuit panel on Wednesday seemed skeptical that a woman who bought and used a weight loss drug suffered financial harm after she found out it could cause cancer, with the judges aggressively pushing back on her argument that she did not get what she paid for.
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February 19, 2025
LA Gardasil Trial Against Merck Bagged After 3 Weeks
A Los Angeles state court trial over the alleged dangers of Merck & Co. Inc.'s human papillomavirus vaccine Gardasil was abruptly called off after three weeks of testimony, with a new panel of jurors slated to hear the case next fall instead.
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February 19, 2025
BP Must Face Contract Claim In Bayer's $12M Benzene Suit
BP can't escape claims that it breached its contract with a chemical supplier currently defending a $12 million lawsuit from Bayer over alleged benzene contamination in two antifungal sprays, an Illinois federal judge ruled on Tuesday.
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
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Del. Justices' D&O Ruling Clarifies 'Related' Claim Analysis
In its recent decision in the Alexion Pharmaceuticals coverage case, the Delaware Supreme Court adopted a "meaningful linkage" standard for relatedness analysis, providing further guidance to Delaware policyholders on how to navigate those directors and officers insurance disputes, say attorneys at Hunton.
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Compliance Pointers For DOJ's Sweeping Data Security Rule
A new Justice Department rule broadly restricts many common data transactions with the goal of preventing access by countries of concern, and with an effective date of April 8, U.S. companies must quickly assess practices related to employee, customer and vendor data, says Sam Castic at Hintze Law.
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Series
Competitive Weightlifting Makes Me A Better Lawyer
The parallels between the core principles required for competitive weightlifting and practicing law have helped me to excel in both endeavors, with each holding important lessons about discipline, dedication, drive and failure, says Damien Bielli at VF Law.
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The Case For Compliance During The Trump Administration
Given the Trump administration’s shifting white collar enforcement priorities, C-suite executives may have the natural instinct to pare back compliance initiatives, but there are several good reasons for companies to at least stay the course on their compliance programs, if not enhance them, say attorneys at Riley Safer.
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A Look At HHS' New Opinion On Patient Assistance Programs
A recent advisory opinion from the U.S. Department of Health and Human Services' Office of Inspector General follows a recent trend of blessing patient assistance program arrangements that implicate the Anti-Kickback Statute, as long as they are structured with appropriate safeguards to minimize the risk of fraud and abuse, say attorneys at Sheppard Mullin.
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Opinion
Inconsistent Injury-In-Fact Rules Hinder Federal Practice
A recent Third Circuit decision, contradicting a previous ruling about whether consumers of contaminated products have suffered an injury in fact, illustrates the deep confusion this U.S. Supreme Court standard creates among federal judges and practitioners, who deserve a simpler method of determining which cases have federal standing, says Eric Dwoskin at Dwoskin Wasdin.
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2 Anti-Kickback Developments Hold Lessons For Biopharma
The U.S. Department of Justice's Anti-Kickback Statute settlement with QOL Medical and a favorable advisory opinion from the U.S. Department of Health and Human Services provide a study in contrasts, but there are tips for biopharma manufacturers trying to navigate the vast compliance space between them, says Mary Kohler at Kohler Health Law.
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In-House Counsel Pointers For Preserving Atty-Client Privilege
Several recent rulings illustrate the challenges in-house counsel can face when attempting to preserve attorney-client privilege, but a few best practices can help safeguard communications and effectively assert the privilege in an increasingly scrutinized corporate environment, says Daniel Garrie at Law & Forensics.
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How SDNY US Atty Nom May Shape Enforcement Priorities
President Donald Trump’s nominee for U.S. attorney in the Southern District of New York, former U.S. Securities and Exchange Commission Chair Jay Clayton, will likely shift the office’s enforcement priorities, from refining whistleblower policies to deemphasizing novel prosecutorial theories, say attorneys at Cohen & Gresser.
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Improving Comms Between Trial Attys And Tech Witnesses
In major litigation involving complex technology, attorneys should employ certain strategies to collaborate with companies' technical personnel more effectively to enhance both the attorney's understanding of the subject matter and the expert's ability to provide effective testimony in court, say attorneys at Buchalter.
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What's Next For State Regulation Of Hemp Cannabinoids
Based on two recent federal court cases that indisputably fortify broad state authority to regulate intoxicating hemp cannabinoid products, 2025 will feature continued aggressive state regulation of such products as industry stakeholders wait for Congress to release its plans for the next five-year Farm Bill, say attorneys at Foley Hoag.
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Series
Collecting Rare Books Makes Me A Better Lawyer
My collection of rare books includes several written or owned by prominent lawyers from early U.S. history, and immersing myself in their stories helps me feel a deeper connection to my legal practice and its purpose, says Douglas Brown at Manatt Health.
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Opinion
New DOJ Leaders Should Curb Ill-Conceived Prosecutions
First-of-their-kind cases have seemingly led to a string of overly aggressive prosecutions in recent years, so newly sworn-in leaders of the U.S. Department of Justice should consider creating reporting channels to stop unwise prosecutions before they snowball, says Jonathan Porter at Husch Blackwell.
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Tips For Pharma-Biotech Overlap Reporting In New HSR Form
While there’s no secret recipe for reporting overlaps to the Federal Trade Commission in the new Hart-Scott-Rodino Act form, there are several layers of considerations for all pharma-biotech companies and counsel to reflect on internally before reporting on any deal, say attorneys at A&O Shearman.
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Opinion
Judge Should Not Have Been Reprimanded For Alito Essay
Senior U.S. District Judge Michael Ponsor's New York Times essay critiquing Supreme Court Justice Samuel Alito for potential ethical violations absolutely cannot be construed as conduct prejudicial to the administration of the business of the courts, says Ashley London at the Thomas R. Kline School of Law of Duquesne University.