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Life Sciences
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October 31, 2024
Flint Water Case Paused For 'Advanced' Settlement Talks
Days after a jury trial meant to decide whether a water firm failed to properly warn of the dangers of the city of Flint's water was delayed a second time, a Michigan federal judge paused two bellwether cases because of "advanced settlement negotiations" between individual plaintiffs and the firm.
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October 31, 2024
Judge Upholds Sanctions Against Ex-Stimwave CEO
A Delaware federal judge has upheld a decision by the bankruptcy judge overseeing the Chapter 11 case of medical device maker Stimwave Technologies to screen the filings of the company's ex-CEO and two of her relatives.
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October 31, 2024
The 2024 Law360 Pulse Leaderboard
Check out the Law360 Pulse Leaderboard to see which firms made the list of leaders in all-around excellence this year.
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October 31, 2024
Firms' Hiring Strategies Are Evolving In Fight For Top Spot
Competition for top talent among elite law firms shows no signs of slowing down, even amid economic uncertainty, with financially strong firms deploying aggressive strategies to attract and retain skilled professionals to solidify their market position.
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October 31, 2024
Teva Fined €463M For Blocking Rival MS Drug Launch
The European Union antitrust enforcer hit pharmaceutical giant Teva with a €463 million ($502 million) fine Thursday for launching a smear campaign against a rival multiple sclerosis drug and misusing the patent system to thwart the competitor's attempt to enter the market.
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October 30, 2024
FDA Didn't Flub Approval In Orphan Drug Case, DC Court Says
The U.S. Food and Drug Administration didn't err in determining that a rival narcolepsy treatment is not the "same drug" as Jazz Pharmaceuticals' exclusive treatment, a D.C. federal judge ruled Wednesday, holding that the FDA's approval of the rival drug didn't run afoul of the Orphan Drug Act.
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October 30, 2024
Alleged Kickback Plotters Can Waive Conflict Over Attorney
A Colorado federal judge on Wednesday concluded that a lab testing company owner charged with participating in a kickback scheme to defraud Medicare and a man who pled guilty to participating in a connected conspiracy could waive any conflicts that might arise from both using the same attorney.
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October 30, 2024
Cigna Wants $16.1M, Florida Labs Seek $5.1M In Benefits Feud
Cigna should pay $5.1 million for harming three Florida laboratories by wrongfully declaring thousands of substance abuse treatment tests medically unnecessary, the labs told a Connecticut jury Wednesday, while Cigna asked to recoup $16.1 million in payouts to the labs for what it called "wasteful" tests.
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October 30, 2024
LA Times Owner Faces Investor Suit Over Drug Co.'s Woes
Officers and directors of biotechnology company ImmunityBio Inc., including L.A. Times owner Patrick Soon-Shiong, face a shareholder's derivative complaint alleging the company concealed issues affecting a path to regulatory approval for one of its key product candidates.
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October 30, 2024
After Exeltis Win, Judge Won't Allow Suits On Dropped Patents
A Delaware federal judge has shot down a request that seven patents Insud Pharma's New Jersey-based division Exeltis USA Inc. dropped in patent litigation against Lupin Pharmaceuticals Inc. be dismissed in a way where they could be refiled later.
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October 30, 2024
Publix Denied Early Win Over Opioid Coverage Defense
A Florida federal court rejected Publix's bid for defense cost coverage for dozens of public nuisance lawsuits related to the opioid crisis, finding that the damages sought are too far removed from particular bodily injuries caused "because of" opioid addiction, as required in Publix's policies.
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October 30, 2024
3rd Circ. Told Medicare Drug Price Talks Not Voluntary
Three pharmaceutical companies told the Third Circuit on Wednesday the Medicare drug price negotiation program is anything but voluntary, arguing the appeals court should revive their challenges to the program because it is unconstitutional.
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October 30, 2024
Biopharma Co. Can't Knock Ex-CFO's Bias Suit Out Of Court
A biopharmaceutical development company can't kick a fired executive's bias suit to arbitration, a California federal judge said, ruling that the harassment she said she faced on the job was gendered enough to invoke a federal law curbing out-of-court-resolutions of sex harassment claims.
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October 30, 2024
Ex-Takeda Exec. Gets Nearly 4 Years For Fake Invoice Scam
A former Takeda Pharmaceuticals executive was sentenced Wednesday to 46 months in prison for stealing millions from the drug company through a fake invoice scam that a Boston federal judge characterized as "utterly unnecessary and pointless" and carried out for no other reason than to fund a luxurious lifestyle.
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October 30, 2024
Yale Researcher's Suit Over Loss Of 'Life's Work' Transferred
A Connecticut state court judge in Fairfield is passing on a researcher's lawsuit accusing Yale School of Medicine of destroying two decades of research worth $28 million, transferring the case to the complex litigation docket in Hartford.
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October 30, 2024
Ohio PBM Case Will Wait For High Court Ruling
The Sixth Circuit agreed to pause a case from Ohio state enforcers accusing Express Scripts and Prime Therapeutics of driving up prescription drug prices while the U.S. Supreme Court decides another case dealing with federal versus state jurisdiction.
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October 30, 2024
DLA Piper's FDA Regulation Vice Chair Joins White & Case
The former vice chair of DLA Piper's FDA regulatory practice has joined White & Case LLP's global life sciences and healthcare group and intellectual property practice.
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October 29, 2024
NY Judge Tosses $14B Decongestant MDL
A New York federal judge threw out a streamlined complaint in a multidistrict litigation accusing companies such as Target and Bayer of making and selling ineffective over-the-counter decongestants, finding Tuesday the state claims are expressly preempted, and the proposed class lacks standing on a federal racketeering claim as indirect purchasers.
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October 29, 2024
Y-mAbs Therapeutics Investors Get Final OK For $19.7M Deal
A New York federal judge has granted final approval to a $19.7 million settlement between Y-mAbs Therapeutics and investors who claim the company misrepresented the likelihood that the U.S. Food and Drug Administration would approve the company's signature pediatric nerve cancer treatment, giving class counsel a $6.5 million cut of the deal.
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October 29, 2024
Retired Fed. Circ. Judge Backs Invisalign In Monopoly Cases
Retired Federal Circuit Judge Paul R. Michel warned the Ninth Circuit on Tuesday that reversing a lower court's decision to toss a pair of class actions accusing Invisalign of monopolizing the clear braces and teeth scanners market by illegally refusing to deal with a rival would increase patent owners' legal uncertainties.
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October 29, 2024
Patent Partner Moves From King & Spalding To Steptoe
A former King & Spalding LLP partner has made the jump to Steptoe LLP, filling out the firm's team of California-based litigators who take on patent cases.
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October 29, 2024
4th Circ. Quizzes Drugmaker Challenging W.Va. Abortion Law
An attorney arguing that West Virginia is preempted by federal law from restricting access to an abortion medication faced skeptical questions Tuesday from two judges who suggested it's entirely normal for states to regulate the practice of medicine.
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October 29, 2024
Biopharma Co. Escapes Investor Suit Over Drug Approval Lies
Biopharmaceutical company Spero Therapeutics Inc. has escaped a proposed investor class action accusing it of concealing warning signs that it would not secure regulatory approval of one of its drugs, with the court ruling that Spero's interactions with the U.S. Food and Drug Administration do not indicate Spero should have known its application would be rejected.
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October 29, 2024
Medical Co. Gets No Coverage For Toxic Tort
An insurer for B. Braun Medical Inc. has no duty to defend or indemnify the company against numerous lawsuits accusing B. Braun of exposing residents near one of its medical device manufacturing plants to a carcinogenic gas, a Pennsylvania federal court ruled, finding a pollution exclusion applicable.
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October 29, 2024
Investors Float $21M Deal To End Life Sciences SPAC Suit
Shareholders in special purpose acquisition company CM Life Sciences Holdings have reached a tentative $21 million class settlement in Delaware's Court of Chancery after suing over alleged missing or misleading disclosures in the lead-up to the take-public merger of clinical data and genomics company Sema4 Holdings in July 2021.
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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How Judiciary Can Minimize AI Risks In Secondary Sources
Because courts’ standing orders on generative artificial intelligence and other safeguards do not address the risk of hallucinations in secondary source materials, the judiciary should consider enlisting legal publishers and database hosts to protect against AI-generated inaccuracies, say attorneys at Lankler Siffert & Wohl.
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Newly Acquired Information Can Be Key In Drug Label Cases
The question of whether federal law preempts state law claims is often central in pharmaceutical labeling cases, like the Fosamax litigation now before the Third Circuit — but parties must also consider whether there is newly acquired information to justify submitting a proposed labeling change in the first place, say attorneys at Arnold & Porter.
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Nvidia Case's Potential Impact On Securities Class Actions
In Nvidia v. Ohman Fonder, the U.S. Supreme Court could strip lower courts of their long-standing ability and obligation to holistically weigh all relevant facts supporting plaintiffs' allegations of securities fraud, which would have a wide-ranging impact on securities fraud class actions in the U.S., say attorneys at Labaton Keller.
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How Attorneys Can Break Free From Career Enmeshment
Ambitious attorneys can sometimes experience career enmeshment — when your sense of self-worth becomes unhealthily tangled up in your legal vocation — but taking the time to discover and realign with your core personal values can help you recover your identity, says Janna Koretz at Azimuth Psychological.
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Key Healthcare Issues That Hinge On The Election Outcome
The 2024 presidential race, while not heavily dominated by healthcare issues compared to past elections, holds significant implications for the direction of healthcare policy in a potential Harris or Trump administration, encompassing issues ranging from Medicare to artificial intelligence, says Miranda Franco at Holland & Knight.
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Patent Lessons From 4 Federal Circuit Reversals In September
Cases that were reversed or vacated by the Federal Circuit last month provide helpful clarity on collateral estoppel, patent eligibility, construction of claim terms that have different boundaries across different claims, and the role of courts as neutral arbiter, say attorneys at Bunsow De Mory.
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Lawyers With Disabilities Are Seeking Equity, Not Pity
Attorneys living with disabilities face extra challenges — including the need for special accommodations, the fear of stigmatization and the risk of being tokenized — but if given equitable opportunities, they can still rise to the top of their field, says Kate Reder Sheikh, a former attorney and legal recruiter at Major Lindsey & Africa.
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Opinion
Judicial Committee Best Venue For Litigation Funding Rules
The Advisory Committee on Civil Rules' recent decision to consider developing a rule for litigation funding disclosure is a welcome development, ensuring that the result will be the product of a thorough, inclusive and deliberative process that appropriately balances all interests, says Stewart Ackerly at Statera Capital.
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The Strategic Advantages Of Appointing A Law Firm CEO
The impact on law firms of the recent CrowdStrike outage underscores that the business of law is no longer merely about providing supplemental support for legal practice — and helps explain why some law firms are appointing dedicated, full-time CEOs to navigate the challenges of the modern legal landscape, says Jennifer Johnson at Calibrate Strategies.
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How 2 Proposed Bills Could Transform Patent Law
The Patent Eligibility Restoration Act and the Prevail Act may come up for vote by the Senate Judiciary Committee after the election, and both offer benefits and challenges for inventors and companies seeking to obtain patents, says Philip Nelson at Knobbe Martens.
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Series
Beekeeping Makes Me A Better Lawyer
The practice of patent law and beekeeping are not typically associated, but taking care of honeybees has enriched my legal practice by highlighting the importance of hands-on experience, continuous learning, mentorship and more, says David Longo at Oblon McClelland.
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Budding Lessons From Landmark Plant Seed Patent Battle
The Corteva v. Inari case involving intellectual property rights in genetically modified plants is now proceeding through discovery and potentially to trial, and will raise critical questions that could have a major impact on the agriculture technology industry, say Tate Tischner and Andrew Zappia at Troutman Pepper.
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The Key To Solving High Drug Costs Is Understanding Causes
One-sided views on who or what contributes to the high cost of pharmaceuticals render possible solutions much harder to discover and implement, and a better approach would be to examine history and learn why costs have increased and what legislation has and hasn't helped, says Nancy Linck at NJ Linck Consulting.
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Opinion
Legal Institutions Must Warn Against Phony Election Suits
With two weeks until the election, bar associations and courts have an urgent responsibility to warn lawyers about the consequences of filing unsubstantiated lawsuits claiming election fraud, says Elise Bean at the Carl Levin Center for Oversight and Democracy.
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Opinion
Bring Back Patent Models To Shut Down The Patent Trolls
By reintroducing the requirement that inventors submit a miniature working model of their inventions along with their patent, legislators could help to deter patent trolls, reduce frivolous litigation and support legitimate inventors in protecting their innovations, says Darin Gibby at Kilpatrick.