Life Sciences

  • December 03, 2024

    Mich. AG Deal, NIH 4th Circ. Win And X Corp Bid In HIPAA Row

    Michigan's attorney general has agreed not to hold a Christian healthcare provider accountable to certain antidiscrimination protections related to gender and sexuality while the provider challenges them in court. Meanwhile, a New York federal judge decided to keep the largest anesthesiology provider in the U.S. on the hook for antitrust claims over its noncompete agreements with clinicians.

  • December 03, 2024

    Calif. Unveils Reproductive Rights Bills To Prep For Trump

    California lawmakers plan to introduce a pair of bills aimed at protecting access to abortion in the Golden State as Donald Trump returns to office, according to an announcement made Monday, the first day of a special legislative session called by Gov. Gavin Newsom.

  • December 03, 2024

    SEC Says Biopharma's Cooperation Helped It Avoid Penalty

    A Houston biopharmaceutical company accused of misleading investors about the regulatory status of two cancer drugs agreed to settle the U.S. Securities and Exchange Commission's action against it on Tuesday without paying a dime, in recognition of what the SEC said was the company's self-reporting and cooperation with investigators.

  • December 03, 2024

    J&J's Neosporin Forever Discolored Man's Groin, Suit Says

    Johnson & Johnson and its consumer health spinoff were sued in California state court over claims that Neosporin antibiotic ointment badly infected a Los Angeles man's scrotum and permanently discolored his groin.

  • December 03, 2024

    $1B Sandoz Placeholder Bid Needs More Support, Judge Says

    A Connecticut federal judge on Tuesday said he cannot force Novartis spinoff Sandoz Inc. to set aside a $1 billion litigation placeholder in a generic drug pricing lawsuit without hearing whether the state attorney general can enforce possible orders in other states where the pharmaceutical company keeps assets.

  • December 03, 2024

    USPTO Abandons Polarizing Proposal Over Double Patenting

    The U.S. Patent and Trademark Office has withdrawn an extremely controversial proposal tied to double patenting, citing "resource constraints" in a Federal Register notice set to be published Wednesday.

  • December 03, 2024

    Vidal Aimed To Put USPTO Rulemaking In The Spotlight

    Kathi Vidal's tenure as director of the U.S. Patent and Trademark Office has been marked by dedication to making the agency's decisions and processes more transparent, attorneys said ahead of her mid-December departure.

  • December 03, 2024

    FDA Issues Guidance On Potential Infant Formula Shortages

    The U.S. Food and Drug Administration has put forth draft guidance on how the country's infant food manufacturers should tell the agency about permanent or temporary stoppages in the making of infant formula, several years after an outbreak and a national shortage.

  • December 03, 2024

    4 Mass. State Court Rulings You May Have Missed In Nov.

    An age discrimination case was undone by the fine print of an employment agreement, while an "utterly inadequate" document search led to a five-figure sanctions order, among other notable recent decisions in Massachusetts state court.

  • December 03, 2024

    VA Announces Study On MDMA-Assisted Therapy For Vets

    The U.S. Department of Veterans Affairs announced Tuesday it will fund a study on psychedelic-assisted therapy for veterans with post-traumatic stress disorder and alcohol use disorder, alongside researchers from Brown University and Yale University.

  • December 02, 2024

    House COVID-19 Probe Points to China 'Lab Leak'

    The Republican-led House Select Subcommittee on the Coronavirus Pandemic published the results of its two-year investigation into the origins of the COVID-19 pandemic Monday, concluding that COVID-19 "most likely" emerged from a laboratory in Wuhan, China, and heavily criticizing the Biden administration, Anthony Fauci and left-leaning organizations for their responses.

  • December 02, 2024

    Judge Isn't Seeing 'Good Faith' Compliance In Probiotic Feud

    A Maryland federal judge said Monday that a drug company is, yet again, failing to make "good faith substantial compliance" with the terms of an injunction that followed a $15 million jury verdict in a dispute over a proprietary probiotic formula.

  • December 02, 2024

    Justices Seem Inclined To Back FDA Block Of Flavored Vapes

    U.S. Supreme Court justices on Monday seemed skeptical of arguments by an e-cigarette company that the U.S. Food and Drug Administration acted unfairly in rejecting its applications to market its flavored vaping products, with several justices supporting the FDA's position that the company knew it had to counterbalance the risk of its products appealing to kids.

  • December 02, 2024

    Investor Alleges Medical Device Co. Misled On FDA Clearance

    The executives and directors of dialysis equipment company Outset Medical Inc. have been hit with a shareholder derivative suit in California federal court alleging they allowed the company to market its product without proper clearance from the U.S. Food and Drug Administration.

  • December 02, 2024

    Hagens Berman Sued For Slice Of Atty Fee From Effexor Deal

    A pharmaceutical reseller's in-house counsel and founder lodged a breach of contract suit against Hagens Berman in Mississippi federal court, accusing the law firm of refusing to pay him his share of a $13 million attorney fees award stemming from an antitrust class settlement with Pfizer Inc. unit Wyeth.

  • December 02, 2024

    Chancery OKs $21M Deal To End Gene Co. Class Suit

    A $21 million settlement of stockholder challenges to a blank check company's take-public merger with clinical data and genomics company Sema4 Holdings in July 2021 won Delaware Court of Chancery approval Monday, with nearly $4.1 million carved out for attorney fees.

  • December 02, 2024

    Fla. Tribe Sues Eli Lilly, CVS, Others Over Insulin Price-Fixing

    The Miccosukee Tribe in Florida is alleging drugmakers like Eli Lilly & Co. and pharmacy benefit managers like CVS illegally conspired to limit competition and artificially inflate the price of insulin drugs, according to a new lawsuit filed in New Jersey federal court.

  • December 02, 2024

    Heritage's $10M Generic Drugs Deal With AGs Gets 1st OK

    A Connecticut federal judge gave his initial approval on Monday to Heritage Pharmaceuticals Inc.'s $10 million settlement agreement with state attorneys general to resolve allegations it took part in an anticompetitive, price-fixing scheme focused on generic drugs.

  • December 02, 2024

    DEA Asserts Its Role As Proponent Of Pot Rescheduling Plan

    The Drug Enforcement Administration on Monday affirmed it was acting as the proponent of a proposal to loosen federal restrictions on marijuana, and the administrative law judge said supporters of rescheduling would not get an opportunity to cross-examine DEA witnesses.

  • December 02, 2024

    Ex-Parexel Worker Says Vax Rule Lacked 'Informed Consent'

    A former employee of clinical research firm Parexel International says the company's COVID-19 vaccine requirement was a breach of contract because she and other workers did not have the option of giving informed consent for what she calls an "experimental medical treatment," according to a lawsuit filed in Massachusetts state court.

  • December 02, 2024

    Shipping Industry Braces For Waves Of New Trump Tariffs

    After a holiday weekend marked by a fresh round of tariff threats from President-elect Donald Trump, the shipping and logistics industry is beginning to feel the heat, warning companies to prepare for massive upheaval if Trump follows through.

  • December 02, 2024

    Co-Worker's Affair Isn't Harassment, Research Co. Tells Court

    A clinical research company urged a Georgia federal judge to toss a former employee's suit claiming the business failed to take action when a co-worker made sexual comments about her father and began an affair with him, arguing the conduct isn't protected by federal civil rights law.

  • November 27, 2024

    A Look Back At Years Of Zantac Litigation: Timeline

    After the U.S. Food and Drug Administration raised a red flag five years ago that heartburn drug Zantac and its generics contained levels of a chemical that could cause cancer, litigation kicked off in federal and state courts. Here, Law360 presents a timeline of the lawsuits, trials and settlements that ensued.

  • November 27, 2024

    PTAB Finds Hormone Treatment Patent Claims Invalid

    The Patent Trial and Appeal Board has found Neurocrine Biosciences Inc. was able to show that all the claims in a patent owned by biotechnology company Spruce Biosciences Inc. relating to the treatment of a hormonal disorder were invalid.

  • November 27, 2024

    Deloitte Posed As Consultant To Steal Vax Software, Suit Says

    An inventor has accused Deloitte Consulting LLP in New York federal court of stealing her proprietary vaccination management system and securing a multimillion-dollar government contract for rolling out COVID-19 vaccines, saying the firm colluded with the Centers for Disease Control and Prevention to pilfer the technology.

Expert Analysis

  • Class Actions At The Circuit Courts: August Lessons

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    In this month's review of class action appeals, Mitchell Engel at Shook Hardy considers certification cases touching on classwide evidence of injury from debt collection practices, defining coupon settlements under the Class Action Fairness Act, proper approaches for evaluating attorney fee awards in class action settlements, and more.

  • Leveraging Policy Changes To Achieve AI Patent Eligibility

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    With the latest U.S. Patent and Trademark Office guidance in hand and legislation looming in Congress, innovators should file their artificial intelligence patent applications now — and five strategies can maximize their chances of success, says Nicholas Gallo at Troutman Pepper.

  • Planning Law Firm Content Calendars: What, When, Where

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    During the slower month of August, law firms should begin working on their 2025 content calendars, planning out a content creation and distribution framework that aligns with the firm’s objectives and maintains audience engagement throughout the year, says Jessica Kaplan at Legally Penned.

  • Series

    Playing Golf Makes Me A Better Lawyer

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    Golf can positively affect your personal and professional life well beyond the final putt, and it’s helped enrich my legal practice by improving my ability to build lasting relationships, study and apply the rules, face adversity with grace, and maintain my mental and physical well-being, says Adam Kelly at Venable.

  • Law Firms Should Move From Reactive To Proactive Marketing

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    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.

  • The Regulatory Headwinds Facing Lab-Developed Tests

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    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.

  • 3 High Court Rulings May Shape Health Org. Litigation Tactics

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    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.

  • Opinion

    A New Way Forward For COVID Vaccine Lawsuit Immunity

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    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.

  • Opinion

    The Big Issues A BigLaw Associates' Union Could Address

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    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.

  • Opinion

    It's Time For A BigLaw Associates' Union

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    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.

  • How Justices Upended The Administrative Procedure Act

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    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.

  • Parsing FY 2024 DOJ Criminal Healthcare Fraud Enforcement

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    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.

  • How Cos. With Chinese Suppliers Should Prep For Biotech Bill

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    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.

  • Mirror, Mirror On The Wall, Is My Counterclaim Bound To Fall?

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    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.

  • Can Chapter 15 Bankruptcy Help Cannabis Businesses?

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    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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