Life Sciences

  • June 11, 2024

    WilmerHale Lands Latham Atty To Help Lead Life Sciences

    WilmerHale has added a partner in Palo Alto, California, who is an expert in complex strategic collaboration and licensing transactions, to co-chair its life sciences practice group, the firm said Tuesday.

  • June 11, 2024

    FDA Urges 11th Circ. To Back E-Cig Ban Over High Nicotine

    The U.S. Food and Drug Administration is urging the Eleventh Circuit to not let Bidi Vapor market an e-cigarette product that the agency claimed would expose users to nearly twice as much nicotine as a typical combustible cigarette.

  • June 10, 2024

    5 Teva Inhaler Patents Kicked Out Of Orange Book

    A New Jersey federal judge said Monday that a handful of patents covering Teva-brand asthma inhalers were "improperly listed in the Orange Book," a legal holding that U.S. Federal Trade Commission Chair Lina Khan quickly took some credit for.

  • June 10, 2024

    Bankrupt UpHealth Warned Of Criminal Charges In India

    A court in India said it has received a criminal charge sheet issued by an investigative governmental agency in Calcutta against bankrupt American healthcare company UpHealth, targeting it and executives over accusations that they conspired to defraud a local healthcare system.

  • June 10, 2024

    DOJ, FDA Form Task Force To Crack Down On Illegal E-Cigs

    The U.S. Department of Justice and the U.S. Food and Drug Administration on Monday said that a federal multi-agency task force has been founded to stop illegal sales of e-cigarettes.

  • June 10, 2024

    Baltimore Lands $45M Deal With Allergan In Opioid Litigation

    Baltimore has put to rest its claims that Allergan played a part in the opioid crisis, reaching a $45 million settlement with the pharmaceutical company, an amount the city called "unprecedented" in an announcement on Monday.

  • June 10, 2024

    9th Circ. Says Choctaw's Dispute With CVS Must Be Arbitrated

    A Ninth Circuit panel forced the Choctaw Nation to arbitrate a dispute over prescription drug reimbursement with CVS Health Corp. subsidiaries, affirming an Arizona federal judge's order in a published opinion Monday.

  • June 10, 2024

    Colo. Justices Say Toxic Tort Plaintiffs Didn't Waive Privilege

    Colorado's justices on Monday said plaintiffs suing a medical sterilization plant over exposure to a carcinogen cannot be forced to turn over communications with their lawyers related to an expert report, rejecting the plant's argument that the disclosure of a spreadsheet to an expert waived attorney-client privilege.

  • June 10, 2024

    Drugmakers Look To Nix Non-Insulin Claims From AG Suit

    Novo Nordisk, Eli Lilly and Sanofi-Aventis asked the federal judge overseeing a diabetes drug price-fixing multidistrict litigation to rule for drugmakers on Mississippi's claims the pricing for GLP-1s is illegal, saying in a brief that the drugs are under patent and too new to be included in the insulin-pricing suit.

  • June 10, 2024

    Parexel Says Staffing Firm Liable For Temp's Alleged Fraud

    Clinical research company Parexel International says a Boston-based staffing agency is liable for damages caused by a rogue temporary employee who engaged in "egregious fraud" involving multiple drug trials, according to a complaint filed in Massachusetts state court.

  • June 10, 2024

    Juul Ends FOIA Suit Over FDA E-Cig Decisions

    Vaping company Juul Labs Inc. has agreed to drop its Freedom of Information Act lawsuit against the U.S. Food and Drug Administration that sought to obtain documents related to the agency's order requiring its e-cigarettes to be pulled off the market.

  • June 10, 2024

    9th Circ. To Hear Args In Psilocybin Right-To-Try Case

    A Ninth Circuit panel will hear oral arguments in August in an appeal brought by a Seattle doctor seeking to administer psilocybin to terminal cancer patients under state and federal right-to-try laws.

  • June 10, 2024

    Catching Up With Delaware's Chancery Court

    Big players and big moves dominated much of the past week in Delaware's Court of Chancery, as Tesla in particular and big corporations in general showed their pique over rulings that went toward stockholders or against conventional expectations.

  • June 10, 2024

    Ventilator Co. Vyaire Hits Ch. 11 As COVID Demand Wanes

    Vyaire Medical Inc., a company that makes breathing ventilators and other respiratory treatment and diagnosis products, filed for Chapter 11 protection in Delaware after demand for its products waned following the COVID-19 pandemic.

  • June 10, 2024

    Pharmacy Biz Files Ch. 11 With More Than $235M In Debt

    Illinois-based specialty pharmacy Optio Rx has filed for Chapter 11 protection in Delaware bankruptcy court with more than $235 million in debt and an agreement with creditors for a partial debt-for-equity swap.

  • June 07, 2024

    Motley Rice Allocated Biggest Share Of $2B Opioid Fees

    A panel directed with allocating $2.13 billion in attorney fees stemming from opioid settlements has recommended awarding the largest shares of the pot to Motley Rice LLC, Simmons Hanly Conroy LLC and Napoli Shkolnik PLLC, according to a report filed Friday in Ohio federal court.

  • June 07, 2024

    Talc User With Cancer Had 2nd Exposure Path, Jury Hears

    A pulmonologist helping make the case that a Texas man got mesothelioma from using Johnson & Johnson talcum powder was pressed Friday as to why he failed to tell jurors that medical records reflect the man had a separate type of asbestos exposure.

  • June 07, 2024

    Ozempic MDL Gets New Judge After Judge Pratter's Death

    The U.S. Judicial Panel on Multidistrict Litigation on Thursday reassigned sprawling litigation over Ozempic and similar drugs in the Eastern District of Pennsylvania following the sudden death of U.S. District Judge Gene E.K. Pratter, who'd been overseeing the MDL.

  • June 07, 2024

    Split 9th Circ. Revives LA Schools Vaccine Policy Row

    A split Ninth Circuit panel on Friday reversed a California federal court's dismissal of a proposed class action challenging a recently rescinded Los Angeles Unified School District policy requiring employees to get the COVID-19 vaccine to keep their jobs, ruling that the district still has the potential to reinstate it.

  • June 07, 2024

    Conn. Judge Pushes State For Proof In $11M Kickback Case

    The Connecticut state judge presiding over an $11 million false claims and kickbacks case against a compounding pharmacy appeared unconvinced Friday that the defendants submitted false claims for payment, peppering the government's counsel with requests to support assertions with case law and evidence that was put on at trial.

  • June 07, 2024

    Chicago-Area Man Charged With $60M COVID Test Fraud

    A suburban Chicago man is facing healthcare fraud and money laundering charges over more than $60 million in Medicare reimbursement claims for over-the-counter COVID-19 test kits that were allegedly never provided, including thousands of tests for dead people.

  • June 07, 2024

    DC Circ. Undoes Library Of Congress Win In Fair Use Fight

    The D.C. Circuit on Friday reversed a lower court's decision that had rejected two industry groups' challenge to a final rule that categorized medical device diagnostic procedures and repairs as fair use exemptions to U.S. copyright law.

  • June 07, 2024

    SEC Fines Ex-AstraZeneca Insider $1.4M For Merger Trades

    The U.S. Securities and Exchange Commission has ordered a former AstraZeneca employee to pay $1.4 million to settle claims he used nonpublic information to trade CinCor Pharma shares ahead of the public announcement that the two companies would merge.

  • June 07, 2024

    Ranbaxy Units Overcome Lipitor Antitrust MDL

    Multiple Ranbaxy Inc. entities have defeated multidistrict litigation accusing them of conspiring with Pfizer Inc. to delay releasing a generic alternative to blood pressure drug Lipitor, as a New Jersey federal judge on Thursday criticized the drug purchasers' "speculative" arguments.

  • June 07, 2024

    Goodwin, Cooley Lead J&J-Backed Neurological Firm's IPO

    Johnson & Johnson-backed neurological firm Rapport Therapeutics Inc. rallied in debut trading Friday after it completed a $136 million initial public offering within its price range, guided by Goodwin Procter LLP and underwriters counsel Cooley LLP.

Expert Analysis

  • Opinion

    New Rule 702 Helps Judges Keep Bad Science Out Of Court

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    A court's recent decision to exclude dubious testimony from the plaintiffs' experts in multidistrict litigation over acetaminophen highlights the responsibility that judges have to keep questionable scientific evidence out of courtrooms, particularly under recent amendments to Federal Rule of Evidence 702, says Sherman Joyce at the American Tort Reform Association.

  • SG's Office Is Case Study To Help Close Legal Gender Gap

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    As women continue to be underrepresented in the upper echelons of the legal profession, law firms could learn from the example set by the Office of the Solicitor General, where culture and workplace policies have helped foster greater gender equality, say attorneys at Ocean Tomo.

  • Opinion

    Patent Waiver For COVID Meds Would Harm US Biopharma

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    If the Biden administration backs the World Trade Organization in waiving patent rights on COVID-19 treatments, it would negatively affect the U.S. biopharmaceutical industry and help foreign competitors, without necessarily expanding global access to COVID-19 care, says clinical pathologist Wolfgang Klietmann.

  • Skirting Anti-Kickback Causation Standard Amid Circuit Split

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    Amid the federal circuit court split over the causation standard applicable to False Claims Act cases involving Anti-Kickback Statute violations, which the First Circuit will soon consider in U.S. v. Regeneron, litigators aiming to circumvent the heightened standard should contemplate certain strategies, say Matthew Modafferi and Terence Park at Frier Levitt.

  • 10 Lessons From A Deep Dive Into IP Damages

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    Decisions on challenging an intellectual property expert's opinion can benefit from the in-depth study of court rulings on admissibility grounds, where the findings include the fact that patent cases see the most challenges of any IP area, say Deepa Sundararaman and Cleve Tyler at Berkeley Research.

  • What Shareholder Approval Rule Changes Mean For Cos.

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    The U.S. Securities and Exchange Commission recently approved proposed rule changes to shareholder requirements by the New York Stock Exchange, an approval that will benefit listed companies in many ways, including by making it easier to raise capital from passive investors, say attorneys at Baker Botts.

  • Reimagining Law Firm Culture To Break The Cycle Of Burnout

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    While attorney burnout remains a perennial issue in the legal profession, shifting post-pandemic expectations mean that law firms must adapt their office cultures to retain talent, say Kevin Henderson and Eric Pacifici at SMB Law Group.

  • Expediting Psychedelics Approvals In The EU, UK, Australia

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    Accelerated pathways for regulatory approvals for psychedelic drugs in the European Union, U.K. and Australia is indispensable to facilitate a seamless advancement of treatments from the research environment to the consumer, say Kimberly Chew at Husch Blackwell, and Ana Dukic and Sabrina Ramkellawan at AxialBridge.

  • Series

    ESG Around The World: Brazil

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    Environmental, social and governance issues have increasingly translated into new legislation in Brazil since 2020, and in the wake of these recently enacted regulations, we are likely to see a growing number of legal disputes in the largest South American country related to ESG issues such as greenwashing if companies are not prepared to adequately adapt and comply, say attorneys at Mattos Filho.

  • Opinion

    Gilead Ruling Signals That Innovating Can Lead To Liability

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    A California appeals court's ruling last month in Gilead Life Sciences v. Superior Court of San Francisco that a drug manufacturer can be held liable for delaying the introduction of an improved version of its medication raises concerns about the chilling effects that expansive product liability claims may have on innovation, says Gary Myers at the University of Missouri School of Law.

  • Opinion

    Vidal Should Amend USPTO Precedent In Automaker Review

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    U.S. Patent and Trademark Office Director Kathi Vidal's recent decision to review Ford and Honda patent challenges that were rejected by the Patent Trial and Appeal Board provides an opportunity to revisit precedents that have unfairly denied companies a fair review process and align them with commonsense principles of legal equity, says former Sen. Patrick Leahy.

  • Grant Compliance Takeaways From Ga. Tech's FCA Settlement

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    Georgia Tech’s recent False Claims Act settlement over its failure to detect compliance shortcomings in a grant program was unique in that it involved a voluntary repayment of funds prior to the resolution, offering a few key lessons for universities receiving research funding from the government, says Jonathan Porter at Husch Blackwell.

  • Series

    Competing In Dressage Makes Me A Better Lawyer

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    My lifelong participation in the sport of dressage — often called ballet on horses — has proven that several skills developed through training and competition are transferable to legal work, especially the ability to harness focus, persistence and versatility when negotiating a deal, says Stephanie Coco at V&E.

  • How Poor Governance, Weak Contracts Harm Cannabis Cos.

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    Decades into cannabis decriminalization and legalization, many companies in the industry still operate on a handshake basis or fail to keep even minimally required records, which can have devastating effects and lead to costly, business-killing litigation, says Griffen Thorne at Harris Bricken.

  • Del. Ruling Adds Momentum For Caremark Plaintiffs

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    The Delaware Supreme Court's recent opinion in Lebanon County Employees' Retirement Fund v. Collis could be viewed as expanding plaintiffs' ability to viably plead a Caremark claim against directors, so Delaware companies should be on heightened alert and focus on creating a record of board oversight, say attorneys at V&E.

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