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Life Sciences
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August 28, 2025
3rd Circ. Agrees Natera Doesn't Owe $45M In False Ad Fight
The Third Circuit Thursday affirmed a lower court's decision to take genetic testing company Natera off the hook from paying $45 million in damages to rival CareDx, saying in an unpublished opinion that CareDx failed to prove Natera actually deceived consumers through false statements about a Natera test's superiority.
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August 28, 2025
CBP, ITC Say Masimo Suit Over Apple Watch Ruling Misplaced
The U.S. International Trade Commission and U.S. Customs and Border Protection balked at Masimo's request that a D.C. federal court temporarily block a ruling allowing imports of redesigned Apple Watches despite the companies' patent dispute, saying it's seeking relief in the wrong places.
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August 28, 2025
Del. Judge Rejects J&J Unit's $12M Interference Claim
Johnson & Johnson unit DePuy Synthes Sales Inc. could not persuade a Delaware federal judge that it invented the technology behind an RSB Spine LLC spinal fusion surgery patent a jury says it owes $12 million for infringing.
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August 28, 2025
2nd Circ. Affirms Hedge Fund Win In $87M Short-Swing Suit
A unanimous Second Circuit panel on Thursday upheld a summary judgment win for hedge fund Armistice Capital LLC and its managing member in a derivative suit brought by a shareholder of biotechnology company Vaxart Inc., which sought disgorgement of $87 million in short-swing profits that allegedly were wrongfully obtained by the investment adviser.
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August 28, 2025
Kimberly-Clark To Pay $40M Over Adulterated Surgical Gowns
Kimberly-Clark agreed to pay up to $40 million to resolve federal prosecutors' criminal charge that the multinational consumer goods and personal care company sold adulterated surgical gowns and conducted fraudulent testing on the gowns to avoid having to submit a new premarket notification to the FDA.
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August 28, 2025
Local Gov'ts Seek Win In Suit Over HHS-Canceled Grants
Four local governments and a union asked a D.C. federal judge on Wednesday to declare that the U.S. Department of Health and Human Services acted unlawfully when it canceled $11 billion in grants awarded to improve public health systems around the country.
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August 28, 2025
DOJ Seeks Kroger Patient Data In Opioid FCA Probe
The U.S. Department of Justice urged an Ohio federal court to order The Kroger Co. to turn over patient names and other health information the supermarket chain has redacted in responses to the government throughout a False Claims Act investigation into its opioid dispensing practices.
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August 28, 2025
FTC Unpauses Administrative Case Over Insulin Prices
The Federal Trade Commission has restarted its in-house case accusing Caremark Rx, Express Scripts and OptumRx of artificially inflating insulin prices, now that two commissioners are able to consider the claims.
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August 28, 2025
Mylan Must Face Generic Drug Price-Fixing Claims In MDL
A Pennsylvania federal judge shot down most of Mylan's request for an early win in multidistrict litigation claiming price-fixing of the generic antidepressant clomipramine, finding sufficient evidence for the company to have to face direct buyers' claims at trial, but trimming claims that it inflated the drug's price at CVS.
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August 28, 2025
Religion Didn't Drive Ex-CTA Worker's Vax Refusal, Jury Hears
A former Chicago Transit Authority electrician hasn't met his burden of proving religious discrimination was behind his termination when he refused to be vaccinated against COVID-19, and his refusal was based on personal preference and health and safety concerns about the jab, an Illinois federal jury heard Thursday.
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August 28, 2025
AstraZeneca Challenges Colo. Law Over Drug Pricing Rules
Pharmaceutical giant AstraZeneca told a Colorado federal judge Wednesday that a recently passed state law aiming to extend a federal drug discount program to certain pharmacies is preempted by the same law that created the program.
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August 28, 2025
J&J Unit Can't Shake $442M Loss In Catheter Antitrust Suit
A California federal judge has refused to upend the $442 million trial loss of Johnson & Johnson's Biosense Webster health tech unit to Innovative Health, finding the jury was presented with sufficient evidence to fault Biosense for conditioning product support for its cardiac mapping systems on the purchase of cardiac catheters.
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August 28, 2025
1st Circ. OKs Terminating Ex-Pharma VP's Disability Benefits
The First Circuit said Synta Pharmaceuticals' benefits administrator may terminate the benefits of a former executive after deeming that his significant weight loss, six-day-a-week pickleball hobby, and travels to far-flung places like Africa showed he was no longer disabled.
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August 28, 2025
Bradley Arant Taps Parker Hudson Healthcare Atty In Atlanta
Bradley Arant Boult Cummings LLP announced Thursday that it continued its Atlanta growth with the addition of a new healthcare practice group partner from Parker Hudson Rainer & Dobbs LLP.
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August 28, 2025
Sycamore Closes $24B Walgreens Deal, Replaces CEO
New York-based private equity firm Sycamore Partners has completed its $24 billion acquisition of Walgreens Boots Alliance Inc., and the pharmacy chain named a new CEO, the companies announced Thursday.
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August 28, 2025
Telehealth Co. Faces Investor Suit Over Revenue Reversal
Telemedicine company LifeMD Inc. and two of its executives face a proposed investor class action alleging they "recklessly" raised revenue expectations for the 2025 fiscal year in May, only to lower their forecast three months later after seeing increased costs affecting the company's men's health and weight management offerings.
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August 28, 2025
SC Ends Sandoz, Novartis Price-Fixing Claims For $2.4M
A Connecticut federal judge on Thursday approved South Carolina's request to dismiss its generic drug price-fixing claims from three multistate lawsuits against Sandoz Inc., Sandoz AG, Novartis AG and Fougera Pharmaceuticals Inc., four months after the parties filed a notice of settlement.
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August 28, 2025
Fed. Circ. Won't Upend Toss Of Flu Vaccine Injury Claim
The Federal Circuit won't revive a man's vaccine injury claim after it was rejected by a special master at the U.S. Court of Federal Claims, finding the decision that his injuries were caused by a separate infection was not arbitrary or capricious.
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August 27, 2025
HHS Says CDC Head Has Been Fired. She Says Otherwise.
Centers for Disease Control and Prevention director Susan Monarez said Wednesday that she's not resigning and also that she cannot be terminated except by the president himself, issuing a statement after CDC parent agency U.S. Department of Health and Human Services said she was "no longer director."
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August 27, 2025
DOJ Throws Lifeline To J&J At 3rd Circ. After $1.6B FCA Loss
A district judge made multiple errors in an opinion and jury instructions underpinning a staggering False Claims Act verdict tied to Johnson & Johnson's drug marketing practices, and a fresh look is needed "under a correct view of the law," the U.S. Department of Justice told the Third Circuit on Wednesday.
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August 27, 2025
Judge Unsure AI Drugmaker Investors Backed Retooled Suit
A Connecticut federal judge seemed open to dismissing a securities suit alleging an artificial intelligence-driven drugmaker's executives misled investors about compliance issues plaguing a dementia drug, suggesting during a hearing Wednesday that the amended complaint may not have enough factual support.
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August 27, 2025
MSN Warns Justices Of 'Double Standard' In Entresto Appeal
MSN Pharmaceuticals is urging the U.S. Supreme Court to step in after the Federal Circuit barred its generic version of Novartis' blockbuster cardiovascular drug Entresto, saying the circuit court used a broad construction of the patent to find infringement and a narrow version to uphold validity.
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August 27, 2025
Splenda Maker Knows It Contains Toxic Chemical, Scientist Says
A scientist accused of falsely stating that Splenda contains cancer-causing chemicals asked a North Carolina federal court to amend her counterclaims, alleging that Splenda-maker TC Heartland LLC has performed tests showing the sweetener contains the very chemical she warned of.
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August 27, 2025
Scholars Tell High Court To Back Conversion Therapy Ban
A group of health law experts told the U.S. Supreme Court that Colorado's conversion therapy ban doesn't violate healthcare providers' First Amendment rights, arguing that the law is consistent with states' and the federal government's ability to regulate healthcare.
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August 27, 2025
Boehringer Wins Another Zantac Cancer Trial In Ill.
An Illinois state court jury sided with Boehringer Ingelheim on Wednesday in a man's lawsuit claiming over-the-counter Zantac use contributed to his colorectal cancer development, adding another tally on the German drugmaker's list of victories over similar accusations.
Expert Analysis
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Texas Med Spas Must Prepare For 2 New State Laws
Two new laws in Texas — regulating elective intravenous therapy and reforming healthcare noncompetes — mark a pivotal shift in the regulatory framework for medical spas in the state, which must proactively adapt their operations and contractual practices, says Brad Cook at Munsch Hardt.
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Fed. Circ. In June: Transitional Phrases In Patent Claims
The Federal Circuit's recent decision in Eye Therapies v. Slayback Pharma takes on the rarely addressed topic of transitional phrases in patent claims, providing some useful lessons regarding restating claim language and broadly distinguishing prior art, say attorneys at Knobbe Martens.
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Series
Playing Soccer Makes Me A Better Lawyer
Soccer has become a key contributor to how I approach my work, and the lessons I’ve learned on the pitch about leadership, adaptability, resilience and communication make me better at what I do every day in my legal career, says Whitney O’Byrne at MoFo.
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Strategies For Cos. Navigating US-Indian Pharma Partnerships
Recent policy adjustments implemented by the U.S. government present both new opportunities and heightened regulatory scrutiny for the Indian life sciences industry, amplifying the importance of collaboration between the Indian and U.S. pharmaceutical sectors, say Bryant Godfrey at Foley Hoag and Jashaswi Ghosh at Holon Law Partners.
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DOJ-HHS Collab Crystallizes Focus On Health Enforcement
The recently announced partnership between the U.S. Department of Justice and U.S. Department of Health and Human Services to combat False Claims Act violations, following a multiyear trend of high-dollar DOJ recoveries, signals a long-term enforcement horizon with major implications for healthcare entities and whistleblowers, say attorneys at RJO.
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Series
Law School's Missed Lessons: Learning From Failure
While law school often focuses on the importance of precision, correctness and perfection, mistakes are inevitable in real-world practice — but failure is not the opposite of progress, and real talent comes from the ability to recover, rethink and reshape, says Brooke Pauley at Tucker Ellis.
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23andMe Fine Signals ICO's New GDPR Enforcement Focus
Many of the cybersecurity failures identified by the Information Commissioner’s Office in its investigation of 23andMe, recently resulting in a £2.3 million fine, were basic lapses, but the ICO's focus on several new U.K. General Data Protection Regulation considerations will likely carry into the future, say lawyers at Womble Bond.
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Eye Drop Ruling Clarifies Importance Of Patent Phrasing
The Federal Circuit's recent ruling in Eye Therapies v. Slayback, rejecting the Patent Trial and Appeal Board's interpretation of "consisting essentially of," highlights the importance of using clear and consistent terms throughout a patent's filing history to shield it against future challenges, says Liliana Di Nola-Baron at Panitch Schwarze.
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How The Healthline Privacy Settlement Redefines Ad Tech Use
The Healthline settlement is the first time California has drawn a clear line in the sand around how website tracking must function in practice, so if your site uses tracking technologies, especially around sensitive content like health or finance, regulators are inspecting your website's back end, not just its banner, say attorneys at Baker Donelson.
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How Sweeping Budget Bill Shakes Up Health Industry
With the recently passed One Big Beautiful Bill Act marking one of the most significant overhauls of federal health policy since the passage of the Affordable Care Act, providers, managed care organizations and life sciences companies must now shift focus from policy review to implementation planning, say advisers at Holland & Knight.
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Series
Adapting To Private Practice: From ATF Director To BigLaw
As a two-time boomerang partner, returning to BigLaw after stints as a U.S. attorney and the director of the Bureau of Alcohol, Tobacco, Firearms and Explosives, people ask me how I know when to move on, but there’s no single answer — just clearly set your priorities, says Steven Dettelbach at BakerHostetler.
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A Look At Key 5th Circ. White Collar Rulings So Far This Year
In the first half of 2025, the Fifth Circuit has decided numerous cases of particular import to white collar practitioners, which collectively underscore the critical importance of meticulous recordbuilding, procedural compliance and strategic litigation choices at every stage of a case, says Joe Magliolo at Jackson Walker.
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High Court Cert Spotlights Varying Tests For Federal Removal
A recent decision by the U.S. Supreme Court to review Chevron v. Plaquemines Parish, a case involving the federal officer removal statute, highlights three other recent circuit court decisions raising federal removal questions, and serves as a reminder that defendants are the masters of removal actions, says Varun Aery at Hollingsworth.
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How To Increase 3rd-Party Preissuance Patent Submissions
Attorneys Marian Underweiser and Marc Ehrlich, who helped draft the America Invents Act, discuss changes that the U.S. Patent and Trademark Office could potentially implement to facilitate its hopes for increased participation in front-end patent challenges.
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Trump Air Emissions Carveouts Cloud The Regulatory Picture
President Donald Trump's new proclamations temporarily exempting key U.S. industries from air toxics standards, issued under a narrow, rarely-used provision of the Clean Air Act, will likely lead to legal challenges and tighter standards in some states, contributing to further regulatory uncertainty, say attorneys at GableGotwals.