Life Sciences

  • June 20, 2024

    11th Circ. Upholds $2.5M Pelvic Mesh Verdict, Rules Suit Timely

    The Eleventh Circuit on Thursday refused to throw out a woman's $2.5 million victory against Coloplast Corp. in a suit alleging she was implanted with defective pelvic mesh, saying the evidence does not support a conclusion that her claim was filed too late.

  • June 20, 2024

    No Access To Ethics Docs For Ex-NJ Official Yet, Judge Rules

    A New Jersey judge has rejected a bid by a former Garden State health official asking the court to compel the state and its ethics commission to produce documents related to claims he was fired in 2020 for raising concerns over the earmarking of COVID-19 tests for relatives of a state administration official, according to Wednesday orders.

  • June 20, 2024

    No Atty, No Case: Judge Tosses Attack On Psychedelics Ban

    A federal judge in Washington state threw out a challenge to the U.S. Drug Enforcement Administration's efforts to ban two psychedelic substances in an order Thursday that chided a psychedelic research company for doing "an end run" around requirements that corporations be represented by an attorney.

  • June 20, 2024

    HHS Drug Pricing Program Flouts Constitution, Boehringer Says

    An "unprecedented" new Medicare price negotiation program deprives drugmakers of their constitutional rights and forces them to make declarations on issues of public concern that reflect poorly on them, Boehringer Ingelheim Pharmaceuticals Inc. argued Thursday in Connecticut federal court as it echoed the industry chorus seeking to strike the initiative.

  • June 20, 2024

    11th Circ. Nixes J&J Sunscreen Benzene MDL Settlement

    The Eleventh Circuit on Thursday vacated an order granting approval to a settlement resolving claims that Johnson & Johnson sold sunscreens containing benzene, saying a pair of circuit court decisions since the approval mean the deal needs another look.

  • June 20, 2024

    Theravance, Mylan Say Chinese Co. Copied COPD Drug

    Theravance Biopharma and Mylan Specialty have sued a Chinese drugmaker, alleging it copied Yupelri, one of its chronic obstructive pulmonary disease drugs, and infringed several patents in the process.

  • June 20, 2024

    USPTO's AI-Assisted Inventions Guidance Irks ABA IP Section

    The U.S. Patent and Trademark Office's guidance on when inventions developed using artificial intelligence can be patented generated criticism from the American Bar Association's Section of Intellectual Property Law, expressing concern that it could be detrimental as it "casts doubt on inventorship through general acts of human direction."

  • June 20, 2024

    11th Circ. Backs Stryker's Defeat Of Fired Worker's Leave Suit

    The Eleventh Circuit refused Thursday to revive a suit claiming medical technology company Stryker illegally fired a worker on leave awaiting the birth of his child, ruling that because the leave didn't formally kick in until the child was born, his termination was fair game.

  • June 18, 2024

    High Court Petition Asks Justices: What's A 'Willful' Kickback?

    Does a "willful" act under federal anti-kickback law require a defendant to know that the conduct violates the law? That's the question a whistleblower is asking the U.S. Supreme Court to answer in order to resolve what the petition calls a circuit split on a key question of federal fraud prosecutions.

  • June 18, 2024

    Company, States Battle In Court Over At-Home Rape Kits

    A fight is brewing in federal and state courts between a company that purports to be the nation's only purveyor of self-administered sexual assault DNA collection kits and state attorneys general who believe it is misleading sexual assault victims.

  • June 20, 2024

    CORRECTED: Drug Cos., PBMs Score Win In Calif. AG's Insulin Price Suit

    A Los Angeles judge ruled Tuesday that the statute of limitations bars the California Attorney General's unfair competition law and unjust enrichment claims against drugmakers and pharmacy benefit managers over an alleged conspiracy to spike insulin costs, but granted leave to amend the allegations.

  • June 18, 2024

    Fla. Immune To Contract Suit Over COVID Tests, 4th Circ. Says

    The Fourth Circuit reversed on Tuesday a district court decision denying a motion to dismiss by a Florida state agency in a breach of contract case involving COVID-19 tests, finding the lower court erred in ruling that the state did not have sovereign immunity and remanding the case for further proceedings.

  • June 18, 2024

    11th Circ. Orders New Shrimp Secrets Trial Over Judge's Exit

    The Eleventh Circuit ordered a new trial in a trade secrets dispute involving breeders of disease-resistant shrimp, saying Tuesday that a magistrate judge who oversaw the trial's conclusion so that a federal judge could catch a flight exceeded his authority by answering jury questions and rejecting a defense counsel's request for clarification on damages awarded.

  • June 18, 2024

    COVID Test Maker Can't Shake All Of $30M Faulty Kit Suit

    A New Jersey federal judge won't let California-based laboratory equipment maker Atila Biosystems Inc. out of a suit alleging it sold faulty COVID-19 testing kits, saying Fusion Diagnostic Laboratories LLC has adequately pled a breach of contract claim.

  • June 18, 2024

    J&J Fights Law Firm's Bid To Nix Subpoenas In Talc Brawl

    Information about the Beasley Allen Law Firm's litigation funding and settlement communications is relevant and necessary to resolving long-running multidistrict litigation over Johnson & Johnson's talcum powder products and so should be turned over, the pharmaceutical giant has told a New Jersey federal court.

  • June 18, 2024

    Restitution Plan For Lead-Test Defects Leaves Judge Uneasy

    A Massachusetts federal judge on Tuesday questioned the legality of a plan to have a claims administrator, rather than the court, oversee victim compensation in a criminal case alleging Magellan Diagnostics hid information about inaccurate results in its lead-testing devices.

  • June 18, 2024

    Latham Leads Boston Scientific On $1.16B Silk Road Deal

    Latham & Watkins-advised Boston Scientific Corp. said Tuesday it has agreed to acquire medical device maker Silk Road Medical Inc., represented by Wilson Sonsini, at an enterprise value of approximately $1.16 billion.

  • June 18, 2024

    Cancer Test Company DermTech Hits Ch. 11, Seeking Sale

    California-based dermatologic test maker DermTech Inc. hit Chapter 11 Tuesday in Delaware and said it would be laying off about 20% of its workforce as it seeks to sell its assets.

  • June 18, 2024

    Samsung Bioepis Denies Infringing Blood Treatment Patent

    Samsung Bioepis has fought back against a bid by Alexion to prevent it from selling a biosimilar version of a patented blood treatment drug by a rival, telling a court that this will not infringe the protections of an AstraZeneca subsidiary over the medicine.

  • June 17, 2024

    Teva, DOJ Signal Key Kickback Case May Fizzle At 1st Circ.

    A U.S. Department of Justice kickback case against Teva Pharmaceuticals — closely watched by False Claims Act lawyers because of its multibillion-dollar stakes and its link to a major circuit split — is poised for settlement, according to a new First Circuit filing ahead of eagerly awaited oral arguments.

  • June 17, 2024

    NJ Firm Defends Lien On Ex-Client's Patents After Unpaid Bills

    A major New Jersey law firm said it has a "common law" right to place a lien on its former client's patents without telling it, after the "failed" biopharmaceutical startup fired the firm and stopped paying its outstanding legal bills.

  • June 17, 2024

    USC Allegedly Used 'Junk Science' On Black Kidney Patients

    The University of Southern California secretly has been using a "junk science" scoring formula that hurts Black patients' eligibility to receive kidney transplants, according to a putative class action in California federal court.

  • June 17, 2024

    Mifepristone Ruling Means End Of Texas DACA Suit, Feds Say

    A Texas-led coalition of states doesn't have standing to challenge the Deferred Action for Childhood Arrivals program after the U.S. Supreme Court's blockbuster decision rejecting a challenge to the abortion drug mifepristone, the Biden administration told the Fifth Circuit on Monday.

  • June 17, 2024

    DOJ Wants 15 Years For Outcome CEO's $1B Fraud

    Federal prosecutors said former Outcome Health CEO Rishi Shah should serve 15 years in prison while Outcome's co-founder and ex-financial chief each serve 10 years following their convictions for running a $1 billion fraud that affected lenders, investors and clients.

  • June 17, 2024

    Top Patent Eligibility Rulings In The Decade Since Alice

    The U.S. Supreme Court's Alice v. CLS Bank decision 10 years ago this week led to scores of inventions being found ineligible for patenting, and rulings since then have fleshed out the law on the contentious topic. Here's a look at the most notable patent eligibility decisions after Alice.

Expert Analysis

  • How AI May Be Used In Fintech Fraud — And Fraud Detection

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    Recent enforcement actions in the fintech and finance industries show that the government is increasingly pursuing fraud enabled by artificial intelligence — at the same time it’s using AI innovations to enforce regulations and investigate fraud, say attorneys at ArentFox Schiff.

  • What Recent Study Shows About AI's Promise For Legal Tasks

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    Amid both skepticism and excitement about the promise of generative artificial intelligence in legal contexts, the first randomized controlled trial studying its impact on basic lawyering tasks shows mixed but promising results, and underscores the need for attorneys to proactively engage with AI, says Daniel Schwarcz at University of Minnesota Law School.

  • Fed. Circ. Patent Lesson: No Contradiction, No Indefiniteness

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    The Federal Circuit’s recent ruling in Maxwell v. Amperex Technology highlights the complexities of construing patent claims when seemingly contradictory limitations are present, and that when a narrowing limitation overrides a broader one, they do not necessarily contradict each other, says Roy Wepner at Kaplan Breyer.

  • 11th Circ. FMLA Ruling Deepens Divide Over Causation

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    The Eleventh Circuit's recent ruling in Lapham v. Walgreen distinguishes the circuit as the loudest advocate for the but-for causation standard for assessing Family and Medical Leave Act retaliation claims, though employers in other jurisdictions may encounter less favorable standards and the U.S. Supreme Court will likely have to address the circuit split eventually, say attorneys at Benesch.

  • Decline In Same-Industry M&A Tells A Nuanced Policy Story

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    In light of newly available Hart-Scott-Rodino Act data suggesting that intraindustry mergers are down overall and pharmaceutical and hospital intraindustry transactions tend to face greater antitrust scrutiny than in the past, attorneys at Morgan Lewis explore whether Biden administration enforcement policies may be curbing pro-competitive strategic M&A.

  • What's At Play In Rising Lanham Act Cases At The ITC

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    Amid an uptick in Lanham Act claims involving false advertising related to medical devices at the U.S. International Trade Commission, Brian Busey and Maryrose McLaughlin at MoFo discuss recent ITC complaints from Eli Lilly and R.J. Reynolds, Lanham Act claim limits under the Federal Food, Drug, and Cosmetic Act, and the issues practitioners face in this realm.

  • BIPA's Statutory Exemptions Post-Healthcare Ruling

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    The Illinois Supreme Court's November opinion in Mosby v. Ingalls Memorial Hospital, which held that the Biometric Information Privacy Act's healthcare exemption also applies when information is collected from healthcare workers, is a major win for healthcare defendants that resolves an important question of statutory interpretation, say attorneys at Quinn Emanuel.

  • Key Factors In Establishing Compelling Merits At The PTAB

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    A look at over 450 Patent Trial and Appeal Board decisions between June 2022 and now provides insights into strategies for petitioners and patent owners in establishing compelling merits arguments in post-grant proceedings, say David Holman and Tyler Liu at Sterne Kessler.

  • Litigation Inspiration: A Source Of Untapped Fulfillment

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    As increasing numbers of attorneys struggle with stress and mental health issues, business litigators can find protection against burnout by remembering their important role in society — because fulfillment in one’s work isn’t just reserved for public interest lawyers, say Bennett Rawicki and Peter Bigelow at Hilgers Graben.

  • What FTC's 'Killer Acquisition' Theory Means For Pharma Cos.

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    The Federal Trade Commission's recent lawsuit to block Sanofi's acquisition of a pharmaceutical treatment developed by Maze Therapeutics builds on previous enforcement actions and could indicate the agency's growing willingness to use its so-called killer acquisition theory against perceived attempts to eliminate nascent competition, say attorneys at Morgan Lewis.

  • Series

    Skiing Makes Me A Better Lawyer

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    A lifetime of skiing has helped me develop important professional skills, and taught me that embracing challenges with a spirit of adventure can allow lawyers to push boundaries, expand their capabilities and ultimately excel in their careers, says Andrea Przybysz at Tucker Ellis.

  • The Road Ahead For Florida's Drug Importation Program

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    Though the U.S. Food and Drug Administration approved Florida's drug importation program in January, a series of hurdles — including requisite buy-in from Canada — and potential legal challenges must be addressed before importation can begin, say attorneys at Ropes & Gray.

  • Assessing CDC's Revised Guideline On Opioid Prescriptions

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    Kenneth Weinstein, Nicholas Van Niel and Kate Uthe at Analysis Group look at newly available data to evaluate the impact that the Centers for Disease Control and Prevention's revised opioid monitoring guideline have had on prescription trends in recent years, highlighting both specific and overall decreases.

  • Think Like A Lawyer: Forget Everything You Know About IRAC

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    The mode of legal reasoning most students learn in law school, often called “Issue, Rule, Application, Conclusion,” or IRAC, erroneously frames analysis as a separate, discrete step, resulting in disorganized briefs and untold obfuscation — but the fix is pretty simple, says Luke Andrews at Poole Huffman.

  • Valeant Ruling May Pave Way For Patent-Based FCA Suits

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    The Ninth Circuit’s recent ruling in Silbersher v. Valeant marks a significant development in False Claims Act jurisprudence, opens new avenues for litigation and potentially raises the stakes for patent applicants who intend to do business with the government, say Joshua Robbins and Rick Taché at Buchalter.

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