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Life Sciences
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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.
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October 29, 2024
Beyond Abortion, 7 Ballot Questions Set To Shape Care
While reproductive rights have led the healthcare debate this election season, voters across the country will shape state policies on a number of other hot issues, including a Medicaid work requirement and coverage for IVF. Law360 Healthcare Authority looks at seven ballot measures that go beyond abortion.
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October 29, 2024
Allergan, Mankind Settle IP Fight Over Lumigan Generic
Allergan Inc. and Mankind Pharma Ltd. asked a Delaware federal court Tuesday to dismiss infringement litigation over Mankind's proposed generic of Allergan's glaucoma drug Lumigan, stipulating that the patent is valid and has been infringed.
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October 29, 2024
Purdue Creditors Can Sue Sacklers For $11.5B
Creditors of bankrupt OxyContin maker Purdue Pharma LP will get the right to sue the company's owners — certain members of the Sackler family — and others for $11.5 billion, should they choose to do so, a New York judge said on Tuesday.
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October 29, 2024
Pa. DA Says ATF's Pot Patients Ban Doesn't Fit With Bruen
A Pennsylvania district attorney is urging a federal judge not to throw out his suit challenging a Bureau of Alcohol, Tobacco, Firearms and Explosives policy blocking medical cannabis patients from buying or owning firearms, saying the U.S. Supreme Court's recent precedent preempts the restriction.
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October 29, 2024
Senate Panel Targets 'Clever' Pharma Pricing
The Senate Judiciary Committee on Tuesday railed against drugmakers and pharmacy benefit managers for allegedly causing the high cost of prescription drugs, arguing that "Big Pharma" has used anticompetitive tactics through patenting to fleece American patients.
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October 29, 2024
Circuit Judge Rips Atty's 'Unearned Windfall' In Liability Case
Although the Sixth Circuit has affirmed a decision awarding roughly $353,000 to a Texas attorney in a decadelong fee dispute over his representation of a client in a product liability case, one circuit judge expressed "extreme disapproval" over the lawyer's conduct in the matter.
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October 29, 2024
Crescent Inks Oncology Merger With $200M In Private Funding
Crescent Biopharma Inc. has agreed to take fellow cancer-focused biotech GlycoMimetics Inc. private in a deal that includes $200 million of investments from well over a dozen firms to help fund the combined company's operations through 2027, GlycoMimetics revealed Tuesday.
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October 29, 2024
PE-Owned Implant Maker Plagued By Lawsuits Hits Ch. 11
Joint implant maker Exactech Inc. on Tuesday filed for Chapter 11 protection in Delaware bankruptcy court with an offer from its lenders to take over the company, as a wave of lawsuits tied to product recalls weighs on the private equity-owned firm.
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October 28, 2024
Masimo Sues Founder Over Alleged 'Empty Voting' Scheme
Masimo Corp. has sued its founder for allegedly conspiring with an investment firm and company stockholder to manipulate a shareholder vote in order to maintain his seat on the medical technology company's board of directors.
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October 28, 2024
Sterigenics Says Residents Can't Tie Harms To Ethylene Oxide
Medical sterilization company Sterigenics US LLC and its parent, Sotera Health LLC, are asking a Georgia state judge to exclude expert testimony put forward by Peach State residents alleging their ethylene oxide emissions harmed them, and to dismiss the residents' claims against them.
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October 28, 2024
Flint Bellwether Delayed On Eve Of Trial, Again
A Michigan federal judge delayed Monday a bellwether trial set to determine if a water engineering firm was professionally negligent for its role in the Flint water crisis one day before jury selection was scheduled to begin and without explanation.
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October 28, 2024
Judge Leaves Patent Case After Fed. Circ. Undoes Ruling
A Minnesota federal judge has recused himself from a patent dispute between Teleflex and Medtronic he has handled since 2019, saying he was "at a loss" on how to proceed after the Federal Circuit faulted his interpretation of terms in Teleflex's catheter patents.
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October 28, 2024
Judge Tosses Hearing-Loss MDL Bellwether With Voided Law
Horizon Pharmaceuticals Inc. on Monday was able to remove one of the 12 cases selected as bellwethers in multidistrict litigation over claims that its thyroid eye disease treatment causes hearing loss, relying on a repealed Michigan law to create a dismissal-worthy conflict.
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October 28, 2024
Moderna Brass Hit With Investor Suit Over RSV Shot Claims
Officers and directors of Moderna face shareholder derivative allegations that they overstated how effective the company's RSV vaccine candidate was as the pharmaceutical giant sought regulatory permission to expedite its development.
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October 28, 2024
Pfizer Urges Court Not To Ax Delay Defense In Vax IP Fight
Pfizer and BioNTech have urged a Delaware federal judge to reject GlaxoSmithKline's attempt to toss claims that the COVID-19 vaccine technology patents GSK is accusing them of infringing are unenforceable because of an unreasonable delay in obtaining them.
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October 28, 2024
Mass. Court's Wiretap Ruling May Be Bad Omen For Plaintiffs
A ruling by the Massachusetts high court rejecting wiretap claims over website operators' use of tracking software like Meta Pixel and Google Analytics shows the steep climb plaintiffs may continue to face as they try to apply older laws to modern technologies, experts told Law360.
Expert Analysis
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Law Firms Should Move From Reactive To Proactive Marketing
Most law firm marketing and business development teams operate in silos, leading to an ad hoc, reactive approach, but shifting to a culture of proactive planning — beginning with comprehensive campaigns — can help firms effectively execute their broader business strategy, says Paul Manuele at PR Manuele Consulting.
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The Regulatory Headwinds Facing Lab-Developed Tests
Though the U.S. Food and Drug Administration's final rule regarding regulation of laboratory-developed tests outlines a four-year plan for ending enforcement discretion, and though this rule is currently being challenged in courts, manufacturers should heed compliance opportunities immediately as enforcement actions are already on the horizon, say attorneys at Kirkland & Ellis.
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3 High Court Rulings May Shape Health Org. Litigation Tactics
Three separate decisions from the U.S. Supreme Court's most recent term — Loper Bright, Corner Post and Jarkesy — will likely strengthen healthcare organizations' ability to affirmatively sue executive agencies to challenge regulations governing operations and enforcement actions, say attorneys at McDermott.
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Opinion
A New Way Forward For COVID Vaccine Lawsuit Immunity
As Public Readiness and Emergency Preparedness Act protections for COVID-19 vaccines wane, adding those vaccines to coverage by the National Vaccine Injury Compensation Program would bolster defenses for administrators and manufacturers while also providing stronger remedies for those injured by vaccines, says Altom Maglio at MCT Law.
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Opinion
The Big Issues A BigLaw Associates' Union Could Address
A BigLaw associates’ union could address a number of issues that have the potential to meaningfully improve working conditions, diversity and attorney well-being — from restructured billable hour requirements to origination credit allocation, return-to-office mandates and more, says Tara Rhoades at The Sanity Plea.
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Opinion
It's Time For A BigLaw Associates' Union
As BigLaw faces a steady stream of criticism about its employment policies and practices, an associates union could effect real change — and it could start with law students organizing around opposition to recent recruiting trends, says Tara Rhoades at The Sanity Plea.
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How Justices Upended The Administrative Procedure Act
In its recent Loper Bright, Corner Post and Jarkesy decisions, the U.S. Supreme Court fundamentally changed the Administrative Procedure Act in ways that undermine Congress and the executive branch, shift power to the judiciary, curtail public and business input, and create great uncertainty, say Alene Taber and Beth Hummer at Hanson Bridgett.
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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.