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Life Sciences
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March 24, 2025
Trump Picks Acting CDC Head After Weldon Nomination Fails
President Donald Trump on Monday nominated acting Centers for Disease Control and Prevention head Susan Monarez to take over as the agency's director, a move that comes after Trump pulled his nomination of Dr. Dave Weldon for the position when it became clear Weldon lacked needed support.
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March 24, 2025
Amgen Wants $50M Leukemia Drug Patent Verdict Thrown Out
Amgen has urged a Delaware federal court to grant it a new trial after a federal jury last year found that it owed Germany's Lindis Biotech $50.3 million in damages for encouraging healthcare providers to infringe immunotherapy patents by administering a leukemia treatment.
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March 24, 2025
Kenvue, J&J Must Face Investor Suit Over FDA Concerns
Consumer health products business Kenvue Inc. and former parent company Johnson & Johnson cannot escape a consolidated lawsuit accusing the companies of failing to warn investors about the potential ineffectiveness of leading products like Tylenol and Sudafed ahead of Kenvue's initial public offering, a New Jersey federal judge ruled on Monday.
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March 24, 2025
Justices Urged To Weigh In On Skinny Label Dispute
A generic-drug industry organization and a group of scholars are urging the U.S. Supreme Court to scrutinize a Federal Circuit decision they say undermines the process for getting generic drugs to market under so-called skinny labels.
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March 24, 2025
Period App Users Get $3.5M In Privacy Deal With Analytics Co.
A defunct mobile analytics company caught up in a proposed class action alleging a menstruation tracking app impermissibly shared health information with Google and others has agreed to a $3.5 million settlement with app users, given its "limited pool of funds," app users informed a California federal court on Friday.
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March 24, 2025
United Healthcare Escapes Some Of Diagnostic Co.'s Claims
A Texas federal judge has wiped away a good portion of a cancer diagnostics company's suit against United Healthcare Services Inc., but left intact the company's claim that United breached an implied contract when it started to take back money it had already paid out.
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March 24, 2025
Investors Blame Electrotherapy Co.'s Practices For Stock Drop
Electrotherapy device maker Zynex Inc. faces a proposed investor class action claiming it harmed shareholders after it was booted from at least one insurer network for U.S. military members, allegedly due to oversupplying its customers.
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March 24, 2025
Seattle Biotech Duped Investors On Drug Progress, Suit Says
Seattle's Sana Biotechnology Inc. is the target of a proposed class action filed on Monday by a shareholder who alleges the company misled investors about its ability to develop genetic therapy treatments for oncology and central nervous system disorders.
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March 24, 2025
Apple, Sony, Others Facing ITC Probes Over Imports
The U.S. International Trade Commission has said it is launching a series of investigations into whether imports of products such as video game consoles, nose cleaning devices and semiconductors have infringed various U.S. patents.
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March 24, 2025
Fla. Judge OKs $19.3M In Spinal Products Noncompete Suit
A Florida federal judge approved a $19.3 million judgment against the owner of a distributor and his affiliated companies, finding that he owes damages for breaching an exclusive sales agreement with a spinal products manufacturer in a case with a "tortured history" that lasted for more than six years.
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March 24, 2025
Norton Rose, Latham Steer Alcon's $430M Lensar Buy
Eye care company Alcon, advised by Norton Rose Fulbright, unveiled on Monday an agreement to purchase medical technology developer Lensar, which is represented by Latham & Watkins LLP, for up to $430 million.
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March 21, 2025
Novartis Urges Court To Make FDA Block Entresto Generic
Novartis says the U.S. Food & Drug Administration has made a drug marketing exclusivity window "meaningless" and wants a D.C. federal judge to block a rival from selling a generic drug that would compete with its blockbuster heart medication Entresto.
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March 21, 2025
Fed. Circ. Revives Blood Pump Patent Suit Against J&J Unit
The Federal Circuit on Friday reinstated a blood pump patent suit by a unit of Swedish medical device company Getinge AB against a Johnson & Johnson MedTech subsidiary, faulting a Massachusetts federal judge's claim construction that led the parties to stipulate that there was no infringement.
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March 21, 2025
Bausch & Lomb Says Amcor Must Pay For Botched Bottles
A packaging company evaded quality controls to deliver defective plastic bottles that caused a slowdown in manufacturing at a Bausch & Lomb facility, the eye care company has claimed in a complaint filed in Michigan federal court.
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March 21, 2025
Judge Accused Of Bias Expresses Regret Over MDL Remarks
The chief judge of the Eleventh Circuit has dismissed a judicial ethics complaint alleging that a Florida federal judge had shown impermissible bias in favor of women leading the multidistrict litigation over the hormonal contraceptive drug Depo-Provera, after the judge said she "regrets any misunderstanding" and took steps to address the issue.
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March 21, 2025
New Mexico Lawmakers Approve Medical Psilocybin Bill
New Mexico lawmakers have given final approval to legislation to create a regulated medical psilocybin program, sending the proposal to the governor's desk.
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March 21, 2025
Exactech Strikes $10M Deal With TPG In Ch. 11
Counsel for medical implant maker Exactech Friday told a Delaware bankruptcy judge it has reached a $10 million settlement of potential claims against its equity sponsor a week before it will seek approval to send its Chapter 11 plan out for a vote.
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March 21, 2025
Taxation With Representation: Cravath, Paul Weiss, Cooley
In this week's Taxation With Representation, Google acquires Wiz, QXO Inc. acquires Beacon Roofing Supply, and the Boston Celtics are bought by a group led by private equity firm co-founder William Chisholm.
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March 21, 2025
AstraZeneca To Invest $2.5B In China Research Hub
Pharmaceutical giant AstraZeneca on Friday announced plans to invest $2.5 billion in Beijing over the next five years to establish a new global strategic research and development center, inking agreements with three biotechs to help develop new treatments and advance life sciences in China.
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March 21, 2025
Fed. Circ. Backs Actavis' $12M Patent Suit Cost Deduction
Drugmaker Actavis can take a $12 million tax deduction for money it spent fending off lawsuits while securing approval to sell generic birth control and other drugs, the Federal Circuit ruled Friday, affirming the U.S. Court of Federal Claims' decision that the costs were deductible as ordinary business expenses.
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March 20, 2025
Texas Says Planned Parenthood Can't Get Atty Immunity
Texas has urged the full Fifth Circuit to reconsider a panel's decision concluding that Planned Parenthood is entitled to attorney immunity in a whistleblower suit accusing the organization of improperly billing Medicaid programs, saying state-law attorney immunity doesn't apply.
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March 20, 2025
Class In Bayer 'One A Day' Gummies Lawsuit Gets Judge's OK
A New York federal judge on Wednesday certified a class of consumers who allege that the labeling on Bayer's "One A Day" vitamin gummies is misleading, finding that an expert's survey found that the consumers found that it was so.
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March 20, 2025
8th Circ. Won't Pause FTC's Insulin Pricing Case
The Eighth Circuit refused Thursday to pause the Federal Trade Commission's in-house case accusing Caremark Rx, Express Scripts and OptumRx of artificially inflating insulin prices while the pharmacy benefit managers challenge the constitutionality of the proceedings.
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March 20, 2025
MiMedx Challenges FDA Classification Of Wound Care Powder
Biomedical company MiMedx Group urged a Georgia federal judge on Thursday to overturn the U.S. Food and Drug Administration's classification of a wound care treatment as a biological product, arguing the agency misapplied its own regulations.
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March 20, 2025
6th Circ. Judge Skeptical Of Mich. Newborn Screening Ruling
A Sixth Circuit panel questioned Thursday if Michigan's practice of holding onto blood samples collected through a newborn health screening program violates parents' rights to make medical decisions for their children, with one judge saying he didn't see evidence for that proposition.
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.