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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.
Expert Analysis
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Parsing FY 2024 DOJ Criminal Healthcare Fraud Enforcement
While the U.S. Department of Justice's Criminal Division's strike force on healthcare fraud enforcement action shows an impressive doubling of criminal indictments, a closer look at the data offers important clues about underlying trends, including the comparably modest, accompanying increase in associated intended loss, say Roderick Thomas and Kathleen Cooperstein at Wiley.
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How Cos. With Chinese Suppliers Should Prep For Biotech Bill
A proposed bill to prohibit government-affiliated life sciences companies from contracting with Chinese biotech companies of concern may necessitate switching to other sources for research and supplies, meaning they should begin evaluating supply chains now due to the long lead times of drug development, say John O'Loughlin and Christina Carone at Weil Gotshal.
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Mirror, Mirror On The Wall, Is My Counterclaim Bound To Fall?
A Pennsylvania federal court’s recent dismissal of the defendants’ counterclaims in Morgan v. Noss should remind attorneys to avoid the temptation to repackage a claim’s facts and law into a mirror-image counterclaim, as this approach will often result in a waste of time and resources, says Matthew Selmasska at Kaufman Dolowich.
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Can Chapter 15 Bankruptcy Help Cannabis Businesses?
Attorneys at Fox Rothschild consider whether Chapter 15 may be used as a tool to liquidate U.S. assets of cannabis companies in foreign bankruptcy proceedings, and look at the statutory provisions that may have a bearing on the successful liquidation of assets under the Bankruptcy Code.
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FTC's Drug Middlemen Probe Highlights Ongoing Scrutiny
The Federal Trade Commission's interim staff report on its inquiry into pharmacy benefit managers suggests that the industry will remain under an enforcement microscope for the foreseeable future due to concerns about how PBMs affect drug costs and accessibility, say attorneys at Arnold & Porter.
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Series
Playing Dungeons & Dragons Makes Me A Better Lawyer
Playing Dungeons & Dragons – a tabletop role-playing game – helped pave the way for my legal career by providing me with foundational skills such as persuasion and team building, says Derrick Carman at Robins Kaplan.
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Del. Dispatch: Director Caremark Claims Need Extreme Facts
The Delaware Court of Chancery recently dismissed Caremark claims against the directors of Centene in Bricklayers Pension Fund of Western Pennsylvania v. Brinkley, indicating a high bar for a finding of the required element of bad faith for Caremark liability, and stressing the need to resist hindsight bias, say attorneys at Fried Frank.
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Parsing NJ Court's Rationale For Denying Lipitor Class Cert.
A New Jersey federal court's recent Lipitor rulings granting summary judgment and denying motions for class certification for two plaintiff classes offer insight into the level of rigorous analysis required by both parties and their experts to satisfy the requirements of class certification, says Catia Twal at Edgeworth Economics.
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Gilead Drug Ruling Creates Corporate Governance Dilemma
If upheld, a California state appellate court's decision — finding that Gilead is liable for delaying commercialization of a safer HIV drug to maximize profits on another drug — threatens to undermine long-standing rules of corporate law and exposes companies to liability for decisions based on sound business judgment, says Shireen Barday at Pallas.
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3 Leadership Practices For A More Supportive Firm Culture
Traditional leadership styles frequently amplify the inherent pressures of legal work, but a few simple, time-neutral strategies can strengthen the skills and confidence of employees and foster a more collaborative culture, while supporting individual growth and contribution to organizational goals, says Benjamin Grimes at BKG Leadership.
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Rebuttal
Cancer Research Org. Is Right To Avoid Corporate Influence
While a previous Law360 guest article criticizes the International Agency for Research on Cancer's processes, its reliance on peer-reviewed literature is proper and its refusal to allow corporate influence is sound science, say Lance Oliver and Ridge Mazingo at Motley Rice.
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Cannabis Biz Real Estate Loan Considerations For Lenders
Now that cannabis sales are legal in some states, real estate lenders are interested in financing the land used by cannabis companies, but because cannabis sales are still illegal under federal law, lenders must make adjustments for cannabis-adjacent transactions, say Mark Levenson and Jeffrey Wendler at Sills Cummis.
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E-Discovery Quarterly: Rulings On Hyperlinked Documents
Recent rulings show that counsel should engage in early discussions with clients regarding the potential of hyperlinked documents in electronically stored information, which will allow for more deliberate negotiation of any agreements regarding the scope of discovery, say attorneys at Sidley.
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Loper Bright Limits Federal Agencies' Ability To Alter Course
The U.S. Supreme Court's recent decision to dismantle Chevron deference also effectively overrules its 2005 decision in National Cable & Telecommunications Association v. Brand X, greatly diminishing agencies' ability to change regulatory course from one administration to the next, says Steven Gordon at Holland & Knight.
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A Primer On EU's Updated Human Substance Regulations
The European Union's updated standards regarding quality and safety of substances of human origin meant for human application carry significant implications for companies that work with cells and tissues, and U.S. companies active in the EU market should pay particular attention to the import and export rules, say Geneviève Michaux and Georgios Symeonidis at King & Spalding.