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Life Sciences
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April 02, 2025
Bidi Vapor Says FDA Denial Of E-Cig Was Unlawful
Vape company Bidi Vapor LLC urged the Eleventh Circuit on Wednesday to reverse a U.S. Food and Drug Administration decision denying its application to market a disposable e-cigarette, saying the agency acted unlawfully and ignored evidence the company presented.
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April 02, 2025
Orthodontic Software Co. Hit With Data Breach Class Action
An orthodontic software company has been hit with a proposed class action in Georgia federal court over a November data breach in which the names, birth dates, medical records, insurance information, payment card data and Social Security numbers of its clients' patients were stolen by hackers.
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April 02, 2025
Justices Broaden RICO Reach To Personal Injuries
The U.S. Supreme Court on Wednesday expanded the type of civil actions that can be brought under a federal racketeering statute, asserting that claims stemming from personal injuries are redressable if they can be shown to have caused economic harm.
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April 02, 2025
Supreme Court Backs FDA Block Of Flavored Vapes
The U.S. Supreme Court on Wednesday overruled a determination that the U.S. Food and Drug Administration acted arbitrarily when it rejected an e-cigarette company's applications to market flavored vape products.
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April 01, 2025
FDA Beats Challenge To Approval Of Elanco's Cattle Gas Drug
The U.S. Food and Drug Administration has defeated an administrative challenge to its approval of Elanco Health's drug meant to reduce ammonia gas emissions from beef cattle and their waste, with a California federal judge ruling Tuesday that the agency reasonably evaluated its safety based on a wide array of studies.
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April 01, 2025
Takeda Antitrust Trial Over Actos Generics Set For July
A New York federal court refused a bid from Takeda Pharmaceuticals Co. to escape a long-running case accusing it of unlawfully delaying generic versions of its diabetes treatment Actos and scheduled a trial to start in July.
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April 01, 2025
Fla. Defends Sandoz Price-Fixing Settlement Terms
Florida defended its deal with Sandoz Inc. on Monday, saying the other states suing the generic-drug maker over price-fixing have no right to object to the settlement, which does not require court approval and does not affect the states objecting to it.
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April 01, 2025
Two More Pharmacies Hit With Eli Lilly Weight Loss Drug Suits
Eli Lilly and Co. filed another round of lawsuits Tuesday accusing compounding pharmacies of selling copycat versions of its weight loss and diabetes medications, saying in New Jersey and Delaware federal courts that two online pharmacies are deceiving consumers about their knockoff products.
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April 01, 2025
No Inequitable Conduct From Fresenius Foe, Judge Says
German medical giant Fresenius has failed to convince a Delaware federal judge that any foul play could be found in the prosecution of a patent involved in a fight over selling IV bags filled with calcium supplements, used to treat hypocalcemia.
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April 01, 2025
Ex-Biotech CEO Wrongly Sentenced To 7 Years, DC Circ. Told
A former biotech executive who pled guilty to misleading investors about a blood-based COVID-19 test urged the D.C. Circuit to order a redo of his seven-year prison sentence on Tuesday, telling an appeals panel that the trial court miscalculated the sentencing guidelines.
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April 01, 2025
IBM And J&J Beat 'Speculative' Data Breach Suit, For Now
A New York federal judge has tossed with leave to amend a proposed class action alleging IBM and Johnson & Johnson's healthcare arm failed to safeguard sensitive health information of thousands of patients before a 2023 data breach, finding the purported harm is "entirely speculative" as currently alleged.
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April 01, 2025
Talc Claimants Tell 3rd Circ. Whittaker Couldn't File Ch. 11
Talc injury claimants on Tuesday asked the Third Circuit to dismiss Whittaker Clark & Daniels' Chapter 11 case, saying a South Carolina state judge had given control of the talc supplier to a receiver six weeks before the company filed for bankruptcy.
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April 01, 2025
FDA Cuts Prompt Biotech Players To Rethink Deal Strategies
Funding cuts at the U.S. Department of Health and Human Services are sending ripples of concern through the biotech industry, as attorneys advise companies to consider a wider breadth of strategic alternatives amid fears of regulatory delays.
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March 31, 2025
Texas Judge Deems Lab-Test Rule Outside FDA Authority
A Texas federal judge on Monday vacated a new U.S. Food and Drug Administration rule that would have brought lab-developed tests under its regulatory authority as "medical devices," finding that the move exceeded the agency's statutory authority and defied "common sense."
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March 31, 2025
Former Stimlabs Exec Must Face Trade Secrets Claims
A former biomedical technology company executive must face claims that she absconded with thousands of internal files containing valuable product information in the days and weeks leading up to her ouster last year, a Georgia federal judge ruled.
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March 31, 2025
Ex-Blood Bank Atty Goes Back To Ballard Spahr In Phoenix
Ballard Spahr LLP has picked up a former in-house intellectual property lawyer from nonprofit blood bank Vitalant who had worked at the law firm a little over a decade ago.
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March 31, 2025
Nasdaq's Tighter IPO Rules Raise Bar For Small Companies
Nasdaq is seeking to weed out volatile stocks by tightening listing standards for small companies conducting initial public offerings or uplistings, although lawyers caution that new rules could prompt capital-hungry companies to pursue other listing strategies, including reverse mergers.
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March 31, 2025
Buyer Class Of Surgical Robots Is Certified In Antitrust Fight
A California federal judge on Monday certified a class of thousands of hospitals alleging Intuitive Surgical monopolized the market for robotic surgical tools by blocking third-party repairs and tying services to robot purchases, finding the case raises common antitrust questions that can be resolved on a classwide basis.
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March 31, 2025
J&J Talc Spinoff's Ch. 11 Case Gets Tossed, Erasing $9B Deal
A Texas bankruptcy judge rejected Johnson & Johnson's third attempt to use Chapter 11 to settle thousands of claims that its products caused cancer, dismissing J&J unit Red River Talc's Chapter 11 case on Monday and throwing out a roughly $9 billion bankruptcy deal over issues with the company's voting procedures and third-party releases.
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March 31, 2025
Despite 'Admirable' Effort, Vertex Kickback Challenge Fails
A D.C. federal judge dealt a loss on Monday to gene therapy drugmaker Vertex Pharmaceuticals, ruling in favor of a U.S. Department of Health and Human Services advisory opinion that found the company's fertility preservation program could potentially violate the Anti-Kickback Statute.
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March 31, 2025
Pierson Ferdinand Adds Taylor English Health Pro In Atlanta
Pierson Ferdinand LLP announced Monday that it has hired a former Taylor English Duma LLP partner who specializes in mergers and acquisitions and also has sleep medicine expertise to strengthen its healthcare practice.
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March 31, 2025
Cleary Gains 5-Atty Latham Team Known For Big IP Wins
Cleary Gottlieb Steen & Hamilton LLP has welcomed a bi-coastal team of five intellectual property litigators from Latham & Watkins LLP, lauding their history leading "many of the most high-profile and complex patent and trade secrets cases of the last decade" in a statement Monday.
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March 28, 2025
Colo. Beats Amgen's Drug Price Cap Challenge, For Now
A Colorado federal judge Friday threw out Amgen's challenge to the Centennial State's drug price cap system, finding that Amgen is not subject to "direct regulation" under the law it's challenging and therefore doesn't have standing to sue.
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March 28, 2025
Janssen Owes Additional $1.5B In HIV Prescription Trial
A New Jersey federal judge on Friday added nearly $1.3 billion in penalties and $240 million in damages to a whistleblower False Claims Act verdict against Janssen over the off-label marketing of two HIV medicines, saying trial evidence laid out "a deliberate and calculated scheme."
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March 28, 2025
PE Firm Hits Back Against Medical Device Coating Challenge
Private equity firm GTCR BC Holdings LLC told a Federal Trade Commission in-house judge Friday the commission has a warped view of the medical device coatings market, as the firm fights a bid to block its $627 million acquisition of Surmodics Inc.
Expert Analysis
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7 Ways 2nd Trump Administration May Affect Partner Hiring
President-elect Donald Trump's return to the White House will likely have a number of downstream effects on partner hiring in the legal industry, from accelerated hiring timelines to increased vetting of prospective employees, say recruiters at Macrae.
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How Trump 2.0 May Change Business In Latin America
Companies in Latin America should expect to face more trade restrictions, tighter economic sanctions and enhanced corruption risks, as the incoming administration shifts focus to certain non-U.S. actors, most notably China, says Matteson Ellis at Miller & Chevalier.
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Opinion
Courts Must Curb The Drug Price Negotiation Program
The Inflation Reduction Act's drug price negotiation program upends incentive structures that drive medical innovation, and courts must act appropriately to avoid devastating consequences for American healthcare and the pharmaceutical industry, says Jeff Stier at the Consumer Choice Center.
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E-Discovery Quarterly: Rulings On Custodian Selection
Several recent rulings make clear that the proportionality of additional proposed custodians will depend on whether the custodians have unique relevant documents, and producing parties should consider whether information already in the record will show that they have relevant documents that otherwise might not be produced, say attorneys at Sidley.
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Series
Exercising On My Peloton Bike Makes Me A Better Lawyer
While I originally came to the Peloton bike for exercise, one cycling instructor’s teachings have come to serve as a road map for practicing law thoughtfully and mindfully, which has opened opportunities for growth and change in my career, says Andrea Kirshenbaum at Littler.
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5 Drug And Device Developments That Shaped 2024
The last year saw significant legal developments affecting drug and device manufacturers, with landmark decisions and regulatory changes that require vigilance and agility from the industry, say attorneys at Faegre Drinker.
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How To Manage During A Trade Dispute With USMCA Partners
Companies can try to minimize the potential impacts of future tariffs on Mexican and Canadian goods, and uncertainty about future trade relations, by evaluating supply chains, considering how they may be modified, and engaging with the new administration over exemptions and the upcoming review of the U.S.-Mexico-Canada Agreement, say attorneys at Holland & Knight.
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Rejoinder Strategy After Allergan Double-Patenting Case
A closer look at last year's Allergan v. MSN case at the Federal Circuit highlights the importance of rejoinder during patent prosecution in view of the risks associated with obviousness-type double patenting based on later-filed applications in the same patent family, say attorneys at BCLP.
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Takeaways From 2024's Emerging IP Licensing Trends
Themes in intellectual property licensing from the past year – including artificial intelligence; risk management; and name, image and likeness rights – highlight key considerations for navigating an evolving landscape, say attorneys at Ballard Spahr.
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Exploring Venue Strategy For Trump-Era Regulatory Litigation
Litigation will likely play a prominent role in shaping policy outcomes during the second Trump administration, and stakeholders have several tools at their disposal to steer regulatory litigation toward more favorable venues, say attorneys at Covington.
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Consultants Should Be Aware Of DOJ's Potential New Reach
The U.S. Department of Justice's recent first-of-its-kind settlement with McKinsey & Co. indicates not only the DOJ's more aggressive stance toward businesses' potential criminal wrongdoings, but also the benefits of self-disclosure and cooperation when wrongdoing becomes apparent, says Dom Caamano at Kibler Fowler.
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Lessons Learned From 2024's Top FMLA Decisions
Last year's major litigation related to the Family and Medical Leave Act underscores why it is critical for employers to understand the basics of when leave and accommodations are required, say attorneys at Dechert.
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Product Safety Issues In 2024 Highlight Need For Vigilance
A look at some of the medications and foods that led to significant class actions last year demonstrates the need for robust regulatory systems and proactive measures to protect consumers from defective and harmful products, says Jennifer Taylor at the Law Offices of James Scott Farrin.
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Series
Playing Esports Makes Me A Better Lawyer
Competing in a global esports tournament at Wimbledon last year not only fulfilled my childhood dream, but also sharpened skills that are essential to my day job, including strategic thinking, confidence and networking, says AJ Schuyler at Jackson Lewis.
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Health Tech Regulatory Trends To Watch In 2025
With an upcoming change in administration and the release of some long-awaited rules, the healthcare industry should prepare for shifting trends, including a growing focus on health data and interest in technology-enabled delivery of healthcare, say attorneys at Orrick.