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Life Sciences
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February 27, 2025
Don't Fault Sterilization Co. For What It Didn't Know, Jury Told
A sterilization company's expert told a Colorado state jury Thursday that the company can't be held responsible for not using pollution controls that didn't yet exist, arguing the company has always reasonably controlled emissions of a toxic sterilization chemical based on what was known at the time.
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February 27, 2025
Liquidia Challenge To UTC's Tyvaso Exclusivity Fails
United Therapeutics Corp. is entitled to exclusivity over its blockbuster lung disease treatment Tyvaso through May, and the U.S. Food and Drug Administration was right to hold off approving a competitor until then, a D.C. federal judge said Thursday.
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February 27, 2025
CooperSurgical Says Unique IVF Claims Require Separate Trials
Fertility company CooperSurgical Inc. is pushing back against the suggestion that four lawsuits accusing the company of negligently destroying embryos with its recalled culture media could be consolidated into one trial, saying the couples' varied location and unique IVF situations preclude joining them.
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February 27, 2025
$40M Deal OK'd For Suit Over Emergent Vax Flub
A Maryland federal judge approved a $40 million settlement between Emergent BioSolutions Inc. and a class of investors claiming that it misled them about its ability to meet the demands of two high-profile contracts to produce components of COVID-19 vaccines, leading the stock price to tumble after production deficiencies were discovered.
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February 27, 2025
CVS Freed From Hospital's Suit Over Drug Pricing Program
A Pennsylvania hospital's antitrust lawsuit claiming CVS forced healthcare providers participating in a federal discount drug program to go through the pharmacy chain's administrator has been tossed, with a federal judge ruling the hospital fell short in its allegations of anticompetitive behavior.
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February 27, 2025
OpenEvidence Says Rival's Attack Targeted Its AI 'Blueprint'
Medical artificial intelligence company OpenEvidence accused a Canadian competitor of launching cyberattacks on its system, executing dozens of attempts to trick the platform into handing over some of the technology's most valuable code, according to a Massachusetts federal lawsuit.
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February 27, 2025
Lead Testing Co. Director To Admit False Statements
A former quality assurance director for Magellan Diagnostics will plead guilty to making misleading statements to the government about a malfunction in a device that measures lead levels in blood, according to filings in Massachusetts federal court Thursday.
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February 27, 2025
DOJ Says It Will No Longer Defend DEA Admin Judges
The U.S. Department of Justice told a Rhode Island federal judge Thursday it would no longer defend the federal policy that protects administrative law judges from removal in a lawsuit challenging the Drug Enforcement Administration's internal proceedings.
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February 27, 2025
Ex-Worker Says Manufacturer Fails To Pay For Off-Clock Work
A pharmaceutical manufacturing company requires hourly employees to perform tasks before and after their shifts but fails to compensate them for this extra time, a proposed class and collective action filed in Washington federal court said.
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February 27, 2025
4th Circ. Rips 'Shaky At Best' Drug Price-Fixing Class Action
The Fourth Circuit backed the dismissal of a proposed class action accusing drug companies of conspiring to inflate the price of a drug for Huntington's disease, writing in the opinion that the allegations are "shaky at best," "sparsely pleaded" and "stretch civil RICO liability beyond its limits."
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February 27, 2025
McCarter & English Wants $3.8M, Ex-Client Wants New Trial
Scarcely a month after the Connecticut Supreme Court ruled that McCarter & English LLP is not entitled to $3.6 million in punitive damages from a federal fee feud with ex-client Jarrow Formulas Inc., the firm has requested a nearly $3.8 million judgment against the supplement company, while Jarrow has requested reimbursement and a new trial.
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February 27, 2025
Lenders Can't Claim Ex-Mylan VP's $4M Insider Trade Penalty
Lenders who said they were owed money by a former Mylan vice president can't call dibs on any of the $4.3 million he was ordered to forfeit as part of his guilty plea to insider trading since they hadn't shown that they had a better claim to the money than the defendant or the government, a Pennsylvania federal judge has ruled.
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February 27, 2025
Medical Device Co. Inks €760M Deal, Unveils Separation Plans
Medical device company Teleflex, advised by Simpson Thacher & Bartlett LLP, on Thursday announced that it will split into two separate, publicly traded entities, and that it will acquire Biotronik SE & Co.'s vascular intervention business for €760 million ($791.95 million).
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February 27, 2025
Anthropic Could Hit $62B Valuation, And More Deal Rumors
AI startup Anthropic is close to securing funding at a $61.5 billion valuation, Bain Capital is mulling a sale of Rocket Software at a $10 billion valuation, and various additional private equity players are considering transactions across food, healthcare and finance. Here, Law360 breaks down these and other notable deal rumors from the past week.
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February 26, 2025
Merck, Glenmark Trim United Healthcare's Zetia Antitrust Suit
A Minnesota federal judge has trimmed a United Healthcare unit's antitrust suit claiming that Merck and Glenmark conspired to delay a generic version of the anti-cholesterol drug Zetia, throwing out non-Minnesota state-law claims he called a "bare and conclusory pleading."
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February 26, 2025
Trump Orders Fed Agencies To Plan For Large Layoffs
The White House is telling federal agencies to submit plans for "large-scale" layoffs by mid-March, accusing them of siphoning funding for "unproductive and unnecessary programs" and "not producing results for the American public."
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February 26, 2025
Simpson Thacher Adds Partner From Wilson Sonsini
Simpson Thacher & Bartlett LLP has picked up a trial litigator from Wilson Sonsini Goodrich & Rosati PC who helped a startup defeat a nearly $460 million trade secrets case over expert testimony involving antibody cancer treatments and secured defense victories in patent cases for companies like Google LLC and HTC Corp.
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February 26, 2025
Planned Parenthood Immune From FCA Suit, 5th Circ. Says
Planned Parenthood is entitled to attorney immunity, the Fifth Circuit said Wednesday in a case that had accused the organization of improperly billing Medicaid programs for millions after losing its Medicaid credentials.
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February 26, 2025
GOP-Led House Panel Pushes Easier Rules On Capital Raising
A U.S. House of Representatives subcommittee invited input Wednesday on a slew of deregulatory bills that seek to ease rules governing private and public securities offerings, drawing plaudits from the Republican majority and mixed responses from Democrats.
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February 26, 2025
CBD Co. Sues Rivals Over Topical Treatment Patents
CBD product maker Metronome LLC on Wednesday filed three complaints against competitors in Colorado and Wisconsin, alleging that the other companies' products infringe their patents for topical treatments that use cannabis derivatives.
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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.
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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What Trump Actions Mean For Federal Research Funding
New guidance from the National Institutes of Health represents a massive policy shift regarding federal funding for researchers at institutions of higher education, contributing to a perfect storm of significant resource shortfalls in upcoming years, say attorneys at Arnold & Porter.
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How Courts Can Filter Nonmeritorious Claims In Mass Torts
Nonmeritorious claims have been a key obstacle to settlement in many recent high-profile mass torts, but courts may be able to use tools they already have to solve this problem, says Samir Parikh at Wake Forest University.
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Series
Racing Corvettes Makes Me A Better Lawyer
The skills I use when racing Corvettes have enhanced my legal practice in several ways, because driving, like practicing law, requires precision, awareness and a good set of brakes — complete with the wisdom to know how and when to use them, says Kat Mateo at Olshan Frome.
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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.