Life Sciences

  • April 12, 2024

    DEA Unlawfully Pushing Psychedelics Ban, Researcher Says

    A psychedelic research company has asked a Washington federal judge to block the Drug Enforcement Administration from proceeding with its plan to ban two psychedelic substances, saying the agency's process for bringing the matter before an administrative judge has been unlawful.

  • April 12, 2024

    Abbott Labs Gets Price Claims Tossed In Baby Formula MDL

    An Illinois federal judge on Friday threw out a suit from parents alleging that Abbott Laboratories benefited from increased prices during a shortage of baby formula kicked off when one of its facilities was shut down, saying they haven't shown that the company's profits during that time were unjustly retained.

  • April 12, 2024

    Ex-Pfizer Worker's Pal Avoids Prison In Insider Trading Case

    An electrical engineer was sentenced to probation Friday for trading Pfizer Inc.'s stock using confidential tips about the efficacy of its COVID-19 drug, after a Manhattan federal court recognized his decision to voluntarily assist prosecutors with the trial conviction of his friend, a former Pfizer employee who leaked insider information.

  • April 12, 2024

    Trade Groups Urge Senators To Advance Patent Reform Bills

    Groups representing inventors, startups and medical technology companies are putting pressure on U.S. senators to pass bills that would prospectively limit the ability of courts to throw out patent lawsuits, a month after tech industry groups argued the legislation would trigger an onslaught of patent litigation.

  • April 12, 2024

    Woman Pleads Guilty To $1.3M COVID Tax Credit Fraud

    A California woman pled guilty to fraudulently obtaining $2 million in COVID-19 government loans and falsely claiming $1.3 million in tax credits, crimes that could result in a 20-year prison sentence, the U.S. Department of Justice said.

  • April 12, 2024

    Life Sciences Group Of The Year: Latham

    Latham & Watkins LLP marshaled its considerable depth and breadth of experience to score a major Federal Circuit victory and to shepherd biotechnology deals that reached into the 11 figures, earning the firm a nod as one of Law360's 2023 Life Sciences Groups of the Year.

  • April 12, 2024

    US-based MSD Broke Ban On Using 'Merck' In UK, Court Finds

    U.S.-based Merck Sharp & Dohme LLC's use of the "Merck" name on websites and social media breached the terms of a court order barring it from using the name in the U.K. to protect German drugmaker Merck KGaA's rights, a London court ruled Friday.

  • April 12, 2024

    Zoll Says 'Cookie-Cutter' Hack Claims Don't Show Harm

    Zoll Medical Corp. is asking a Boston federal judge to toss a proposed class action brought by medical device customers whose personal information was released during a ransomware attack last year and an earlier data breach in 2019, arguing the consumers weren't actually injured.

  • April 12, 2024

    EU Approves Biotech Co. Illumina's Plan To Divest Grail

    European Union antitrust authorities on Friday approved Illumina's plan to sell off Grail, the latest development in a saga that saw the biotech company reverse course and agree to offload the cancer-screening company after authorities claimed the reacquisition was completed "unlawfully."

  • April 12, 2024

    Asbury Park Escapes Pot Co.'s Zoning Board Conspiracy Suit

    A New Jersey federal court has dismissed a medical cannabis company's suit alleging Asbury Park and its zoning board conspired with a rival to block it from operating a treatment center, saying the complaint fails to support its allegations of the scheme.

  • April 11, 2024

    Sandoz Says Feds Misclassified Generics As 'Innovator Drugs'

    Pharmaceutical company Sandoz Inc. sued the Centers for Medicare & Medicaid Services in Washington, D.C., federal court on Wednesday, alleging the agency ignored the company's objection to classifying two of its generics as "innovator drugs," which could impact Sandoz's rebate obligations under Medicaid.

  • April 11, 2024

    Fed. Circ. Blocks Alvogen Generic Of Bausch Diarrhea Drug

    The Federal Circuit upheld a decision Thursday that prevents Alvogen from releasing a generic version of Bausch Health's blockbuster diarrhea and brain disease drug Xifaxan until 2029, rejecting Alvogen's bid to launch sooner because it was cleared of infringing some patents.

  • April 11, 2024

    FDA Commissioner Says Congress Must Act On Hemp, CBD

    The commissioner of the U.S. Food and Drug Administration said Thursday that the agency did not consider hemp-derived CBD safe enough to be sold lawfully as a dietary supplement, and urged Congress to create a new pathway to regulate the substance.

  • April 11, 2024

    9th Circ. Nixes 'Super Snap Removals' In Dexcom Suits

    The Ninth Circuit won't let Dexcom Inc. remove three suits alleging its glucose monitoring system is defective to federal court, saying its "super snap removal" motions were premature as they were filed before any of the cases actually commenced.

  • April 11, 2024

    Birth Control Injury Claims Barred From Conn., Court Told

    Connecticut state courts have no basis to exercise jurisdiction over three of the four companies targeted in product liability lawsuits brought by 103 women who claim their Filshie Clip birth control devices migrated within their bodies and caused injuries, counsel for the defendants told a Waterbury judge Thursday.

  • April 11, 2024

    Deals Rumor Mill: US Steel, Germany's Stada, Paramount

    The DOJ opens a probe into Nippon’s proposed $14.9 billion takeover of US Steel, German drugmaker Stada explores a sale, and Paramount and Skydance are hashing out potential deal terms. Here, Law360 breaks down these and other notable deal rumors from the past week.

  • April 11, 2024

    Del. Justices OK Denial Of Icahn-Illumina Midcase Appeal Bid

    Billionaire investor Carl Icahn may not put his Chancery Court litigation against biotechnology company Illumina Inc.'s board on hold for a review of a decision that struck portions of the complaint that were based on confidential information, Delaware's Supreme Court said Thursday, upholding the lower court's rejection of the midcase appeal.

  • April 11, 2024

    Medtronic Can't Ditch Ex-Sales Rep's Retaliation Claim

    Medical device maker Medtronic can't avoid a whistleblower retaliation claim by a former sales rep who says he was pushed out after reporting what he suspected to be a kickback scheme to the U.S. Food and Drug Administration, a federal judge said Wednesday.

  • April 11, 2024

    Kirkland, Jones Day Build $787.5M Sale Of Steris' Dental Unit

    Medical device company Steris, advised by Jones Day, on Thursday announced plans to sell its dental segment to Kirkland & Ellis LLP-advised middle market private equity shop Peak Rock Capital for $787.5 million.

  • April 11, 2024

    Life Sciences Group Of The Year: Sullivan & Cromwell

    Sullivan & Cromwell LLP helped Bayer defeat Merck in litigation over asbestos-containing talc liability and guided mega pharma deals such as Pfizer's $43 billion acquisition of Seagen and Amgen's $27.8 billion acquisition of Horizon Therapeutics, earning the firm a spot among Law360's 2023 Life Sciences Groups of the Year.

  • April 10, 2024

    Pfizer Unit Cuts $39M Deal Ending Effexor Antitrust Claims

    A proposed class of direct buyers asked a New Jersey federal judge on Tuesday to approve a $39 million settlement to end allegations that Pfizer Inc. unit Wyeth engaged in a scheme with Teva Pharmaceuticals to delay generic competition for the antidepressant drug Effexor XR.

  • April 10, 2024

    DOJ Hits Regeneron With False Claims Act Suit Over Eylea

    The federal government has brought a False Claims Act intervenor complaint in Massachusetts against Regeneron, alleging the pharmaceutical giant fraudulently withheld information from its Medicare reports seeking reimbursement for its drug Eylea, the U.S. Department of Justice announced Wednesday. 

  • April 10, 2024

    Del. Justices Probe Validity Of Advance Notice Bylaws

    The appeal of a Delaware Chancery Court decision voiding a biopharmaceutical company's "onerous" advance notice requirements for director nominations while upholding the rejection of an activist shareholder's nominees boiled down to one basic legal question at Delaware's Supreme Court Wednesday: Is this a facial or an as-applied challenge?

  • April 10, 2024

    9th Circ. Mostly Affirms Industry Ban For COVID PPE Delays

    A Ninth Circuit panel on Tuesday largely upheld a district court's ruling requiring personal protective equipment suppliers to pay over $3 million after finding that they misrepresented the shipping times of hand sanitizer products at the start of the COVID-19 pandemic, while reversing the Federal Trade Commission's injunction against one of the companies' owners.

  • April 10, 2024

    Dems Introduce Bill To Codify Policy Barring Judge Shopping

    Senate Majority Leader Chuck Schumer, D-N.Y., along with 37 other Democratic and two independent senators, introduced legislation on Wednesday to codify the new Judicial Conference of the United States policy against judge shopping after pushback from Republicans and a Texas court.

Expert Analysis

  • FTC Rite Aid Order Holds Biometrics And AI Compliance Tips

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    The Federal Trade Commission's recent enforcement action against Rite Aid over its use of facial biometric technology on customers provides lessons that can be leveraged to reduce and manage the risk of regulatory scrutiny of biometrics and artificial intelligence, says David Oberly at Baker Donelson.

  • Bribery Settlement Gives Insight On DOJ Policies

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    Chemical company Albemarle’s recent $218 million settlement with the government to resolve foreign bribery claims provides valuable data points for companies on the U.S. Department of Justice’s voluntary self-disclosure policy and its clawback pilot program, say Michael DeBernardis and Tiauna Mathieu at Hughes Hubbard.

  • SEC Case May Expand Scope Of Insider Trading Liability

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    The U.S. Securities and Exchange Commission's first-of-its-kind enforcement action against an individual in a case involving "shadow trading" demarcates an expansion of insider trading liability to circumstances in which there is a market connection between the source of information and the issuer of the securities traded, say attorneys at Steptoe.

  • Opinion

    Waiving COVID-19 IP Protections Would Harm US Industry

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    President Joe Biden should turn down a World Trade Organization proposal to waive crucial intellectual property protections behind COVID-19 tests and diagnostics — protections that allow U.S. companies to sustain millions of jobs and develop life-saving treatments that benefit patients in every country, says former U.S. Circuit Judge Paul Michel, now at the Council for Innovation Promotion.

  • Fed. Circ. Patent Decisions In 2023: An Empirical Review

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    The Federal Circuit decided 306 patent cases last year, which is still well down from the pre-pandemic norm of around 440, and on the whole the court's decisions were markedly less patentee-friendly in 2023 than in 2022, says Dan Bagatell at Perkins Coie.

  • What The Law Firm Of The Future Will Look Like

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    As the legal landscape shifts, it’s become increasingly clear that the BigLaw business model must adapt in four key ways to remain viable, from fostering workplace flexibility to embracing technology, say Kevin Henderson and Eric Pacifici at SMB Law Group.

  • 4 PR Pointers When Your Case Is In The News

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    Media coverage of new lawsuits exploded last year, demonstrating why defense attorneys should devise a public relations plan that complements their legal strategy, incorporating several objectives to balance ethical obligations and advocacy, say Nathan Burchfiel at Pinkston and Ryan June at Castañeda + Heidelman.

  • Digging Into The Debate On FDA's Proposed Lab Test Rule

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    A proposed 10-word amendment from the U.S. Food and Drug Administration represents a sea change in device regulation as it would summarily end decades of FDA enforcement discretion for laboratory developed tests, and the public comments offer some insight into the future of this long-running saga, say attorneys at Mintz.

  • How 2023 Shaped Drug And Medical Device Legal Trends

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    2023 brought a number of positive developments for the life sciences industry, including great trial and multidistrict litigation outcomes, but also some heavy-handed regulations and other concerning developments that lay the groundwork for significant litigation, say attorneys at Faegre Drinker.

  • Opinion

    What Insurers Gain When Litigating Coverage Denials

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    Lately, insurance companies have denied coverage for lawsuits alleging liability relating to the ordinary operations of highly regulated businesses, such as those in the pharmaceutical and energy sectors — demonstrating time and again how litigation can be a vehicle for carriers to mitigate their own costs, say attorneys at Reed Smith.

  • Trending At The PTAB: 6 Areas To Watch In 2024

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    Expect further changes in a half-dozen areas in 2024 following a busy 2023 at the Patent Trial and Appeal Board, including more adjustments to the director review process and the first case to hit the Appeals Review Panel, say attorneys at Finnegan.

  • 5 Trends That Will Affect Food Litigation In 2024

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    In 2024, food and beverage companies are likely to continue to face threats of litigation relating to so-called forever chemicals, citric and malic acid, and ESG claims, but recent developments in case law have created potential avenues for defense, say Abby Meyer and Khirin Bunker at Sheppard Mullin.

  • Law Firm Strategies For Successfully Navigating 2024 Trends

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    Though law firms face the dual challenge of external and internal pressures as they enter 2024, firms willing to pivot will be able to stand out by adapting to stakeholder needs and reimagining their infrastructure, says Shireen Hilal at Maior Consultants.

  • The Most-Read Legal Industry Law360 Guest Articles Of 2023

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    A range of legal industry topics drew readers' attention in Law360's Expert Analysis section this year, from associate retention strategies to ethical billing practices.

  • Inside Higher Education's New FCA Liability Challenges

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    As the educational sector expands its use of government funding, schools are at increased risk under the False Claims Act, but recent settlements offer valuable lessons about new theories of liability they may face and specific procedures to reduce their exposure, say James Zelenay and Jeremy Ochsenbein at Gibson Dunn.

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