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Life Sciences
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February 25, 2025
Trump Says Transgender Order Shields Kids From Danger
President Donald Trump's administration said Tuesday that Washington, Colorado and two other states can't block his executive orders targeting transgender people and federal funding for gender-affirming care, because the president has the power to protect children from "potentially dangerous, ineffective" treatments.
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February 25, 2025
Sterilization Co. Can't Pin Cancer On Genetics, Jury Told
A Colorado woman who alleged toxic emissions from a medical sterilization plant caused her breast cancer testified Tuesday in state court that her family's cancer history was not as extensive as she originally believed, as a lawyer for the company pressed her on genetics and other factors that could increase her cancer risk.
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February 25, 2025
Chancery Likens Claims To Recycling Losing Lottery Ticket
A more than eight-year court battle over a never-triggered dry eye drug development milestone award ended Tuesday with a Delaware vice chancellor's nearly $810,000 fee shifting order against the LLC seeking the payout, while leaving open a potentially unprecedented shift of fees to the nonparty drug's inventor.
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February 25, 2025
Trump Demands Enforcement Of Healthcare Price Disclosures
President Donald Trump on Tuesday ordered federal agencies to step up enforcement of regulations requiring hospitals and health plans to publish price information designed to help patients shop for the best deal.
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February 25, 2025
Kroger Seeks More Sanctions For Prolific Consumer Atty
Kroger is urging an Illinois federal judge to sanction prolific consumer advocate lawyer Spencer Sheehan for filing a meritless suit over the effectiveness of its lidocaine patches, citing his "history of filing frivolous lawsuits across the nation" and a "troubling pattern of recklessness and abuse of the federal judiciary" for which he has been sanctioned three other times.
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February 25, 2025
J&J Says Samsung Is Breaking Deal Over Stelara Biosimilar
Johnson & Johnson and Janssen Biotech have launched a breach of contract suit against Samsung Bioepis over their agreement to let Samsung launch a biosimilar version of J&J's blockbuster biologic Stelara before all patents expire, accusing the company of violating the provision against assigning or sublicensing the patent rights to other parties.
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February 25, 2025
Insulet May Face Choice: $452M Award Or Stifling Rival
A Boston federal judge on Tuesday suggested that a medical device maker could have to choose between portions of its nine-figure trade secrets verdict it won against a rival or its request for a court order to permanently block sales of products based on the stolen technologies.
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February 25, 2025
Couple, Biotech Co. Jointly Drop Lost Embryos Suit
A Charlotte couple and the biotechnology company they accused of making a defective oil used for the in vitro fertilization process came together to drop their dispute from North Carolina federal court, ending the prospective parents' wrongful death claims.
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February 25, 2025
Purdue Gets Time To Document New $7.4B Ch. 11 Settlement
Counsel for bankrupt drugmaker Purdue Pharma received approval Tuesday for an extension of a mediation window during which litigation against nondebtors is paused after telling a New York judge that it has reached definitive terms on a new $7.4 billion settlement of opioid claims and needs time to finalize documentation surrounding the deal.
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February 25, 2025
Masimo Aims To DQ Hueston Hennigan As Ex-CEO's Counsel
Masimo Corp. is urging the Delaware Chancery Court to disqualify Hueston Hennigan LLP from representing its founder and former CEO in a lawsuit over his quest for a $450 million payout from the medical technology company, arguing the firm has a conflict of interest.
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February 25, 2025
Lawyer Who Became Client's 'Punching Bag' Scores Case Exit
A Connecticut attorney who claimed he became his Massachusetts client's "punching bag" can exit her medical negligence lawsuit against two doctors accused of misplacing or destroying her embryos, a Milford judge ruled Tuesday.
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February 25, 2025
WilmerHale, Cleary Steer $4.1B Thermo Fisher-Solventum Deal
WilmerHale and Cleary Gottlieb Steen & Hamilton LLP are the principal advisers on a new agreement for Thermo Fisher Scientific Inc. to purchase the purification and filtration business of Solventum for $4.1 billion in cash, according to statements from the companies on Tuesday.
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February 25, 2025
Dental Co. Biolase Drills Down On Unopposed Ch. 11 Plan
A Delaware bankruptcy judge on Tuesday OK'd the Chapter 11 plan of dental technology maker Biolase Inc., which was fully consensual following changes to gain the approval of the U.S. Trustee and the official committee of unsecured creditors.
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February 24, 2025
Natera's $96M DNA Test Verdict Scrapped, Patents Axed
A Delaware federal judge Monday threw out Natera's $96 million patent infringement verdict against CareDx after determining that the asserted claims in its patents related to DNA tests for organ transplant recipients are invalid.
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February 24, 2025
Fed. Circ. Shouldn't Assume Doctors Read Labels, Profs Say
The Federal Circuit has been reviewing whether generic-drug companies induce infringement of their limited-use drugs based on a misunderstanding of how prescribing physicians do their job, law professors from Illinois and Pennsylvania have argued in a new paper.
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February 24, 2025
Bioanalysis Co. Worker Fired For Flagging FDA Data, Suit Says
A Colorado bioanalysis research contractor is facing claims it unfairly fired an employee who spoke up about allegedly manipulated data and who said he was terminated "because of his protected medical leave of absence," according to a suit recently filed in federal court.
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February 24, 2025
Biotech Minority Investor Sues In Del. To Block Control Moves
A company control and takeover battle between Aurion Biotech Inc. and a large investor made its second landing in Delaware's Court of Chancery on Monday, in a minority stockholder's direct and derivative suit accusing Alcon Research Inc. and its board designates of multiple fiduciary breaches.
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February 24, 2025
Insurer Needn't Cover Hospital's $2.5M Virus Vax Probe Costs
A Chubb unit has no obligation to pay an Illinois hospital for $2.5 million in legal costs associated with responding to federal and state probes into its COVID-19 vaccine distribution program, a federal court ruled, finding that the policy's $1 million regulatory claims sublimit applies.
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February 24, 2025
PBMs To Challenge FTC Case At 8th Circ., But Without Pause
A Missouri federal judge summarily refused, again, on Monday to temporarily block the Federal Trade Commission's in-house case accusing Caremark Rx, Express Scripts and OptumRx of artificially inflating insulin prices, letting the case proceed while the pharmacy benefits managers appeal to the Eighth Circuit.
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February 24, 2025
Purdue's New Ch. 11 Plan Sidesteps Nonconsensual Releases
Mediators helping to craft a new settlement in the case of bankrupt OxyContin maker Purdue Pharma LP said in their latest update in New York bankruptcy court that the company's revised deal does not contain nonconsensual third-party waivers.
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February 24, 2025
Boehringer Ingelheim Wins Illinois Zantac Cancer Retrial
An Illinois state jury swiftly sided with Boehringer Ingelheim on Monday over two men's claims that taking the company's over-the-counter Zantac for decades contributed to their prostate cancer diagnoses, handing each of the men a trial loss after juries in their previous trials had deadlocked.
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February 24, 2025
Skadden, Ropes & Gray Advising On 23andMe Buyout Bid
The CEO of 23andMe has teamed up with private equity firm New Mountain Capital on an offer to purchase and take the genetic testing company private at an equity value of approximately $74.7 million, according to a filing with the U.S. Securities and Exchange Commission.
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February 24, 2025
Elizabeth Holmes Loses 9th Circ. Appeal Over Theranos Fraud
A Ninth Circuit panel on Monday affirmed the criminal fraud convictions of former Theranos CEO Elizabeth Holmes and former Theranos executive Ramesh "Sunny" Balwani along with their respective 11-year and nearly 13-year prison sentences, rejecting arguments that the lower court made multiple evidentiary errors that unfairly swayed jurors.
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February 24, 2025
Justices Nix Whistleblower Suit Over Arbitral Vacatur Limits
The U.S. Supreme Court on Monday declined to review a petition that raised questions about the standards under which courts can vacate or enforce arbitral awards, in a case brought by a whistleblower who sought to challenge an arbitral award favoring his former employer.
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February 24, 2025
Paul Hastings Adds Boston Co-Chair For New Tech Practice
The former global vice chair of Latham & Watkins LLP's data and technology transactions practice has moved to Paul Hastings LLP as co-chair of its newly established technology transactions practice, the latter firm announced Monday.
Expert Analysis
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A Look At Drug Price Negotiation Program's Ongoing Impact
More than two years after the passage of the Inflation Reduction Act and the rapid implementation of the drug price negotiation program, attorneys at Ropes & Gray discuss how the IRA has influenced licensing strategies, and how maximum fair prices under the law have economically affected certain drugs.
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Opinion
Congress Must Consider Accurate Data About Patent Thickets
If Congress revisits a controversial bill this year aimed at limiting the number of patents pharmaceutical manufacturers could assert, it must make sure to act based on accurate reports — such as a recent U.S. Patent and Trademark Office study that found no evidence of patent thicketing, says David Kappos at the Council for Innovation Promotion.
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Lights, Camera, Ethics? TV Lawyers Tend To Set Bad Example
Though fictional movies and television shows portraying lawyers are fun to watch, Hollywood’s inaccurate depictions of legal ethics can desensitize attorneys to ethics violations and lead real-life clients to believe that good lawyers take a scorched-earth approach, says Nancy Rapoport at the University of Nevada, Las Vegas.
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Will 4th Time Be A Charm For NY's 21st Century Antitrust Act?
New York's recently introduced 21st Century Antitrust Act would change the landscape of antitrust enforcement in the state and probably result in a sharp increase in claims — but first, the bill needs to gain traction after three aborted attempts, says Tyler Ross at Shinder Cantor.
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Perspectives
Accountant-Owned Law Firms Could Blur Ethical Lines
KPMG’s recent application to open a legal practice in Arizona represents the first overture by an accounting firm to take advantage of the state’s relaxed law firm ownership rules, but enforcing and supervising the practice of law by nonattorneys could prove particularly challenging, says Seth Laver at Goldberg Segalla.
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The Post-Macquarie Securities Fraud-By-Omission Landscape
While the U.S. Supreme Court's 2024 opinion in Macquarie v. Moab distinguished inactionable "pure omissions" from actionable "half-truths," the line between the two concepts in practice is still unclear, presenting challenges for lower courts parsing statements that often fall within the gray area of "misleading by omission," say attorneys at Katten.
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AI Will Soon Transform The E-Discovery Industrial Complex
Todd Itami at Covington discusses how generative artificial intelligence will reshape the current e-discovery paradigm, replacing the blunt instrument of data handling with a laser scalpel of fully integrated enterprise solutions — after first making e-discovery processes technically and legally harder.
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IP, Licensing, M&A Trends To Watch In Life Sciences This Year
2025 promises to continue an exciting trajectory for the life sciences industry, with major trends ranging from global harmonization of intellectual property to cross-border licensing activity and an increase of nontraditional financial participants in the mergers and acquisition space, say attorneys at Morgan Lewis.
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When Innovation Overwhelms The Rule Of Law
In an era where technology is rapidly evolving and artificial intelligence is seemingly everywhere, it’s worth asking if the law — both substantive precedent and procedural rules — can keep up with the light speed of innovation, says Reuben Guttman at Guttman Buschner.
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Anticipating Direction Of Cosmetics Regulation Under Trump
It is unclear how cosmetics regulation reform from the last few years will fare under President Donald Trump, but the new administration's emphasis on deregulation and Robert F. Kennedy Jr.'s views on product safety provide some insight, say attorneys at Crowell & Moring.
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Drug Pricing Policy Trends To Expect In 2025 And Beyond
Though 2025 may bring more of the same in the realm of drug pricing policy, business as usual entails a sustained, high level of legal and policy developments across at least six major areas, say attorneys at Ropes & Gray.
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Imagine The Possibilities Of Openly Autistic Lawyering
Andi Mazingo at Lumen Law, who was diagnosed with autism about midway through her career, discusses how the legal profession can create inclusive workplaces that empower openly autistic lawyers and enhance innovation, and how neurodivergent attorneys can navigate the challenges and opportunities that come with disclosing one’s diagnosis.
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Top 10 Healthcare And Life Sciences Issues To Watch In 2025
Under the new Trump administration, this coming year may benefit some healthcare and life sciences stakeholders, while creating new challenges for others amid an increasingly complex regulatory environment, say attorneys at Debevoise.
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Parsing 3rd Circ. Ruling On Cannabis, Employee Private Suits
The Third Circuit recently upheld a decision that individuals don't have a private right of action for alleged violations of New Jersey's Cannabis Regulatory, Enforcement Assistance and Marketplace Modernization Act, but employers should stay informed as the court encouraged the state Legislature to amend the law, say attorneys at Mandelbaum Barrett.
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4 Keys To Litigating In An Active Regulatory Environment
For companies facing litigation influenced by government regulatory action — a recent trend that a politically charged atmosphere will exacerbate — there are a few principles that can help to align litigation strategy with broader public positioning in the regulatory and oversight context, say attorneys at Jenner & Block.