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Life Sciences
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February 26, 2025
CVS Ordered To Comply With FTC's PBM Subpoena
A D.C. federal judge is ordering CVS to turn over new materials in the Federal Trade Commission's investigation into its pharmacy benefit manager Caremark Rx, saying that just because producing updated documents would cost the company more doesn't mean it faces an "undue burden."
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February 25, 2025
Walgreens Inks $595M Deal To End COVID-19 Testing Suit
Walgreens Boots Alliance Inc. has agreed to pay $595 million to a lab testing and diagnostics company to put to rest a dispute over COVID-19 tests, according to a Monday filing with the U.S. Securities and Exchange Commission.
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February 25, 2025
Pa. Biotech Co. Can't Escape $4M Trade Secrets Award
A Delaware vice chancellor declined Monday to nix a nearly $4 million arbitral award issued to Finnish company UPM-Kymmene Corp. in a long-running trade secrets dispute, ruling that a link between the arbitrator and the Finnish company's counsel at DLA Piper was "at most, an attenuated connection."
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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.
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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Opinion
Attorneys Must Act Now To Protect Judicial Independence
Given the Trump administration's recent moves threatening the independence of the judiciary, including efforts to impeach judges who ruled against executive actions, lawyers must protect the rule of law and resist attempts to dilute the judicial branch’s authority, says attorney Bhavleen Sabharwal.
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Rethinking 'No Comment' For Clients Facing Public Crises
“No comment” is no longer a cost-free or even a viable public communications strategy for companies in crisis, and counsel must tailor their guidance based on a variety of competing factors to help clients emerge successfully, says Robert Bowers at Moore & Van Allen.
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As Failure-To-Warn Preemption Wanes, Justices May Weigh In
Federal preemption of state failure-to-warn claims has long been a powerful defense in strict liability tort cases, but is now under attack in litigation over the weedkiller Roundup and other products — so the scope and application of preemption may require clarification by the U.S. Supreme Court, says Michael Sena at Segal McCambridge.
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How Design Thinking Can Help Lawyers Find Purpose In Work
Lawyers everywhere are feeling overwhelmed amid mass government layoffs, increasing political instability and a justice system stretched to its limits — but a design-thinking framework can help attorneys navigate this uncertainty and find meaning in their work, say law professors at the University of Michigan.
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The Fate Of Biden-Era Clinical Study Guidance Under Trump
Draft guidance about the study of sex and gender differences in medical product development issued by the outgoing Biden administration currently faces significant uncertainty and litigation potential due to the Trump administration's executive orders and other actions, say attorneys at Arnold & Porter.
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Trending At The PTAB: Insights From 2024 Fed. Circ. Statistics
Looking at stats from the Federal Circuit's decisions in 219 Patent Trial and Appeal Board appeals last year sheds light on potential trends and strategy considerations that could improve appeals' chances of success, say attorneys at Finnegan.
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Opinion
Weight Drug Suits Highlight Need For Legal Work On Safety
The rapid ascent of glucagon-like peptide-1 receptor agonists like Ozempic has revolutionized diabetes management and weight loss — but legal wrangling over issues including off-label prescriptions, side effects and compounded versions underscores lawyers' roles in protecting patient safety, says attorney Gregg Goldfarb.
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10 Issues To Watch In Aerospace And Defense Contracting
This year, in addition to evergreen developments driven by national security priorities, disruptive new technologies and competition with rival powers, federal contractors will see significant disruptions driven by the new administration’s efforts to reduce government spending, regulation and the size of the federal workforce, say attorneys at Thompson Hine.
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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.