Life Sciences

  • July 01, 2024

    Supreme Court Widens Window To Challenge Federal Regs

    Legal challenges to federal regulations can be brought outside the normal statute of limitations if someone isn't adversely affected until after the six-year window of time to file suit, the U.S. Supreme Court ruled Monday.

  • June 28, 2024

    Chevron's End Is Just The Start For Energized Agency Foes

    By knocking down a powerful precedent that has towered over administrative law for 40 years, the U.S. Supreme Court's right wing Friday gave a crowning achievement to anti-agency attorneys. But for those attorneys, the achievement is merely a means to an end, and experts expect a litigation blitzkrieg to materialize quickly in the aftermath.

  • June 28, 2024

    Will 'Moral Victory' In Purdue Ruling Help Plaintiffs?

    The U.S. Supreme Court's decision that the Sackler family members who own Purdue Pharma LP cannot be shielded by the bankruptcy code from lawsuits over the opioid crisis reflects the widespread public outrage over their role in the epidemic, but experts say it remains unclear what will happen next for the individuals and governments that have sued the company.

  • June 28, 2024

    CUNY Medical Prof Accused Of Fabricating NIH Grant Apps

    A medical professor at the City College of New York and paid adviser to Cassava Sciences has been indicted on allegations he falsified scientific data in grant applications submitted to the National Institutes of Health on behalf of himself and Cassava, prosecutors announced Friday.

  • June 28, 2024

    In Chevron Case, Justices Trade One Unknown For Another

    The U.S. Supreme Court's decision to overrule a decades-old judicial deference doctrine may cause the "eternal fog of uncertainty" surrounding federal agency actions to dissipate and level the playing field in challenges of government policies, but lawyers warn it raises new questions over what rules courts must follow and how judges will implement them.

  • June 28, 2024

    Health Regulators Likely To Tread Carefully Post-Chevron

    The demise of Chevron deference at the U.S. Supreme Court on Friday will likely encourage or fortify challenges to agency rulemaking on matters of health policy in the U.S., from Medicare reimbursement decisions to FDA rules on laboratory-developed tests.

  • June 28, 2024

    Shkreli Asks High Court To Toss $64M Disgorgement Order

    Former pharmaceutical executive Martin Shkreli, who gained notoriety for hiking the price of HIV/AIDS medication before serving more than four years in prison for securities fraud, is asking the U.S. Supreme Court to toss a disgorgement order requiring him to pay $64 million for monopolistic price-gouging.

  • June 28, 2024

    Rite Aid Ch. 11 Plan OK'd With Insurers' Objections Resolved

    A New Jersey bankruptcy judge Friday approved pharmacy chain Rite Aid's Chapter 11 restructuring plan after the company said it had resolved objections from its insurance carriers to how the plan treats their policies.

  • June 28, 2024

    Philips Gets OK For $25M Med Monitoring Deal In CPAP MDL

    A Pennsylvania federal judge has given the go-ahead to a $25 million medical monitoring settlement in multidistrict litigation stemming from a recall of ventilator machines by Koninklijke Philips NV and some of its American subsidiaries.

  • June 28, 2024

    Nationwide Cert. Rejected In Suit Over Stolen Curaleaf Tips

    An Illinois federal judge conditionally certified a class of Curaleaf hourly employees in Illinois, Arizona and Massachusetts, but denied a bid to certify a nationwide class of all Curaleaf hourly employees "based on pure speculation," in a suit alleging managers at its cannabis dispensary locations around the country stole the contents of tip jars.

  • June 28, 2024

    Judge Finalizes $4M Deal In Eye Doc Ransomware Dispute

    A North Carolina federal judge has signed off on a $4 million deal to resolve two class actions over an electronic patient recordkeeping and billing company allegedly failing to give truthful, timely notice to ophthalmology practices and their patients about ransomware attacks that damaged its software for months.

  • June 28, 2024

    4 Things To Know As New SPAC Rules Take Effect

    The U.S. Securities and Exchange Commission's new rules governing special-purpose acquisition companies take effect on Monday, marking an expansive attempt to strengthen oversight of SPAC deals. Here, Law360 examines what to expect as the agency's 581-page rule package goes live.

  • June 28, 2024

    Nixed Purdue Ch. 11 Plan May Leave States Ready For A Fight

    State attorneys general across the country could be gearing up for more opioid-related litigation against the Sackler family after the U.S. Supreme Court wiped out a $5.5 billion third-party release for the owners of bankrupt drugmaker Purdue Pharma LP, experts told Law360.

  • June 28, 2024

    Supreme Court Strikes Down Chevron Deference

    The U.S. Supreme Court on Friday overturned a decades-old precedent that instructed judges about when they could defer to federal agencies' interpretations of law in rulemaking, depriving courts of a commonly used analytic tool and leaving lots of questions about what comes next.

  • June 27, 2024

    4 Firms Guide Pair Of IPOs Totaling $457M

    Venture-backed drug developer Alumis Inc. and oil-land acquirer LandBridge LLC on Thursday priced initial public offerings, raising a combined $456.5 million, under the guidance of four law firms.

  • June 27, 2024

    Biden, Trump Spar On Abortion Access In The Wake Of Dobbs

    The U.S. Supreme Court's Dobbs decision upending Americans' access to abortion care made an early appearance at Thursday night's presidential debate, with President Joe Biden lamenting the end of Roe v. Wade and former President Donald Trump taking credit for handing the issue of abortion rights "back to the states."

  • June 27, 2024

    OptumRx Agrees To Pay $20M To Resolve DOJ Opioid Claims

    OptumRx Inc. has reached a $20 million deal with the U.S. Department of Justice to end allegations the company improperly filled opioid prescriptions in combination with other drugs, the Justice Department announced Thursday.

  • June 27, 2024

    State AGs Want Stay Lifted In Generic Drug Pricing Suit

    The attorneys general of New York and Connecticut have asked a federal judge to lift a partial discovery stay in three state-led generic drug pricing lawsuits against the pharmaceutical industry, saying it is no longer necessary because sentencing is complete in a parallel U.S. Department of Justice proceeding.

  • June 27, 2024

    Judge Blasts Prisons Bureau, Sends Exec To Halfway House

    An Illinois federal judge said Thursday he felt he needed to protect Outcome Health's co-founder from the Bureau of Prisons' "ridiculous" policy barring her from a low security camp just because she isn't a citizen, sentencing her to time served and three years' supervision in a Chicago halfway house instead. 

  • June 27, 2024

    Insurers Call Rite Aid Ch. 11 Opioid Deal Unfair

    Counsel for bankrupt drugstore chain Rite Aid told a New Jersey bankruptcy judge Thursday that it hopes to reach an agreement with at least some of its insurers on payments into an opioid settlement fund before closing arguments in its Chapter 11 plan confirmation Friday.

  • June 27, 2024

    Rape Kit Co. Wants Wash. Ban Lifted During Free Speech Suit

    A company that sells self-administered sexual assault DNA collection kits is urging a Washington federal judge to stop the enforcement of a new state law that it claims stifles its First Amendment rights by barring the marketing of its kits as an alternative to resources offered by law enforcement and the government.

  • June 27, 2024

    Fed. Circ. Backs Ax Of United Therapeutics' Drug Patent

    The Federal Circuit has affirmed a Patent Trial and Appeal Board finding that claims in a United Therapeutics Corp. high blood pressure drug patent challenged by Liquidia Technologies were invalid as obvious, even though Liquidia's petition included an expert declaration that did not have a required oath.

  • June 27, 2024

    Titanic Purdue Ruling Shifts The Balance Of Power In Ch. 11

    The U.S. Supreme Court's decision to strike down the Sackler family's liability shield in the Chapter 11 plan of Purdue Pharma LP not only eliminates a key tool to resolve mass tort liabilities through bankruptcy, it gives claimants more leverage and fundamentally changes the insolvency landscape in future cases, experts tell Law360.

  • June 27, 2024

    EU High Court Upends Servier Decrease Of Pay-For-Delay Fine

    French pharmaceutical giant Servier is back on the hook for all but €2.4 million ($2.57 million) of a more than €300 million European Union antitrust fine after the European Court of Justice upended a lower court decision that had reduced the penalty by over €100 million.

  • June 27, 2024

    Ex-Exec Fights Sotera's Bid To Toss Del. Stock Vesting Suit

    An attorney representing a former Sotera executive said Thursday in Delaware's Court of Chancery that the lab testing and industrial sterilization firm failed to justify its request for dismissal of a lawsuit alleging the company wrongly refused to vest his purported right to 620,000 shares in the business after his departure.

Expert Analysis

  • Cos. Must Prepare For Calif. Legislation That Would Ban PFAS

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    Pending California legislation that would ban the sale or distribution of new products containing intentionally added per- and polyfluoroalkyl substances could affect thousands of businesses — and given the bill's expected passage, and its draconian enforcement regime, companies must act now to prepare for it, say attorneys at Alston & Bird.

  • FDA Warning Letter Tightens Reins On 'Research Only' Labels

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    A recent warning letter from the U.S. Food and Drug Administration to Agena Bioscience alleged the company’s diagnostic devices were labeled for research use only, but improperly promoted for human clinical purposes, signifying a reinforcement — and a potential narrowing — of the agency's policy on products labeled “research only,” say attorneys at Sheppard Mullin.

  • Practical Pointers After Fed. Circ. Double-Patenting Decision

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    With the Federal Circuit recently denying a full court review of In re: Cellect, a decision regarding obviousness-type double-patenting, affected patent family holders should evaluate their rights through both patent prosecution and future litigation lenses to minimize risks, say Austin Lorch and Jeff Wolfson at Haynes Boone.

  • Highlights From The 2024 ABA Antitrust Spring Meeting

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    U.S. merger enforcement and cartels figured heavily in this year's American Bar Association spring antitrust meeting, where one key takeaway included news that the Federal Trade Commission's anticipated changes to the Hart-Scott-Rodino form may be less dramatic than many originally feared, say attorneys at Freshfields.

  • Strategies For Challenging A Fla. Grand Jury Report's Release

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    A Florida grand jury’s recent report on potential wrongdoing related to COVID-19 vaccines should serve as a reminder to attorneys to review the myriad legal mechanisms available to challenge the lawfulness of a grand jury report’s publication and expunge the names of their clients, says Cary Aronovitz at Holland & Knight.

  • Patent Lessons From 8 Federal Circuit Reversals In March

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    A number of Federal Circuit patent decisions last month reversed or vacated underlying rulings, providing guidance regarding the definiteness of a claim that include multiple limitations of different scopes, the importance of adequate jury instruction, the proper scope of the precedent, and more, say Denise De Mory and Li Guo at Bunsow De Mory.

  • A Look At Ex Parte Seizures 8 Years Post-DTSA

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    In the eight years since the Defend Trade Secrets Act was enacted, not much has changed for jurisprudence on ex parte seizures, but a few seminal rulings show that there still isn’t a bright line on what qualifies as extraordinary circumstances warranting a seizure, say attorneys at Finnegan.

  • Series

    Whitewater Kayaking Makes Me A Better Lawyer

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    Whether it's seeing clients and their issues from a new perspective, or staying nimble in a moment of intense challenge, the lessons learned from whitewater kayaking transcend the rapids of a river and prepare attorneys for the courtroom and beyond, says Matthew Kent at Alston & Bird.

  • AI In The Operating Room: Liability Issues For Device Makers

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    As healthcare providers consider medical devices that use artificial intelligence — including systems to help surgeons make decisions in the operating room — and lobby to shift liability to device manufacturers, companies making these products must review potential product liability risks and important design considerations for such equipment, say attorneys at Troutman Pepper.

  • Del. Lessons For Director-Nominees On Sharing With Activists

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    The Delaware Chancery Court's recent decision in Icahn Partners v. deSouza finding that a director wasn't permitted to share certain privileged information with the activist stockholders that nominated him shows the need for companies to consider imposing appropriate confidentiality requirements on directors, say attorneys at Sullivan & Cromwell.

  • 10 Years After Alice, Predictability Debate Lingers

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    A decade after the U.S. Supreme Court’s Alice ruling, critics continue to argue that the subject matter eligibility framework it established yields inconsistent results, but that contention is disproved by affirmance data from the Federal Circuit, district courts and the Patent Trial and Appeal Board, say Dennis Abdelnour and David Thomas at Honigman.

  • This Earth Day, Consider How Your Firm Can Go Greener

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    As Earth Day approaches, law firms and attorneys should consider adopting more sustainable practices to reduce their carbon footprint — from minimizing single-use plastics to purchasing carbon offsets for air travel — which ultimately can also reduce costs for clients, say M’Lynn Phillips and Lisa Walters at IMS Legal Strategies.

  • Questions Persist After Ruling Skirts $925M TCPA Award Issue

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    After an Oregon federal court's recent Wakefield v. ViSalus ruling that the doctrine of constitutional avoidance precluded it from deciding whether a $925 million Telephone Consumer Protection Act damages award was constitutionally sound, further guidance is needed on when statutory damages violate due process, says Michael Klotz at O'Melveny.

  • Benzene Contamination Concerns: Drugmakers' Next Steps

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    After a citizen petition to the U.S. Food and Drug Administration and a flurry of class actions over benzene contamination in benzoyl peroxide acne products, affected manufacturers should consider a thoughtful approach that includes assembling internal data and possibly contacting the FDA for product-specific discussions, say attorneys at Morgan Lewis.

  • Opinion

    States Should Follow Federal Lead On Expert Evidence Rules

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    The recently amended Federal Rule of Evidence 702 will help ensure expert testimony in federal courts reflects adequate data and reliable methods properly applied to a given case, and state courts — home to the overwhelming majority of U.S. litigation — should adopt similar changes, says retired attorney Michael Harrington.

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