Life Sciences

  • 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.

  • June 17, 2024

    Ex-Stimwave CEO Gets 6 Years For Dummy Implant Scheme

    The founder and former CEO of Stimwave Technologies was sentenced to six years in prison Monday after tearfully proclaiming her innocence to healthcare fraud charges, with a Manhattan federal judge saying it's "sad" the defendant doesn't recognize the harm she inflicted by selling nonfunctional pain management device components.

  • June 17, 2024

    HUD Freed From Pa. Pot Patients' Suit Over Housing Rebuff

    Unless the U.S. Department of Housing and Urban Development fulfills its threat to withhold a Pennsylvania county housing agency's funding for complying with a state court order to admit licensed medical marijuana patients, a lawsuit by the county agency and two potential tenants is premature, a federal judge ruled Monday.

  • June 17, 2024

    Drugmaker, PE Investor Sued In Del. Over 'Unfair' Deal Terms

    Clinical-stage biotechnology firm Omega Therapeutics' board entered into an "unfair" agreement to develop a new drug with the company's controlling private equity stockholder that was heavily tilted in favor of the majority equity holder and Omega insiders, an investor alleged in a lawsuit in Delaware's Chancery Court.

  • June 17, 2024

    Zantac Suits Must Exit State Court, Conn. Judge Told

    A Connecticut state court judge must relinquish jurisdiction over two lawsuits claiming that generic versions of the heartburn drug Zantac caused cancer because state statutes do not subject entities with foreign business registrations to the auspices of Constitution State judges, a pharmaceutical industry attorney argued at a hearing Monday morning.

  • June 17, 2024

    Fed. Circ. Says Errors Led To Injunction In Trade Secrets Suit

    A Federal Circuit panel on Monday overturned a preliminary injunction against a South Korean insulin pump patch manufacturer that allegedly stole trade secrets from a rival, saying a Massachusetts federal court made a series of errors in its determination to grant an injunction.

  • June 17, 2024

    Catching Up With Delaware's Chancery Court

    Proposed amendments to Delaware's General Corporation Law that were prompted by several recent Chancery Court rulings sailed through the state Senate last week despite loud opposition from corporate law professors and other Chancery Court watchers, and Tesla shareholders filed two new suits against CEO Elon Musk. 

  • June 17, 2024

    Talc Claimants Want Documents In Fight Over J&J Unit Venue

    Cancer patients with talc damage claims against Johnson & Johnson have urged a New Jersey federal court to give them access to transcripts and exhibits from depositions of top executives at the company's talc unit, saying the information will aid their effort to bar the J&J spinoff from filing a third Chapter 11 outside the Garden State.

  • June 14, 2024

    Justices Are Asked To Wade Into Blood Pressure Drug IP Fight

    United Therapeutics is taking its patent case seeking to stop a rival from selling a drug that competes with its blockbuster treatment for high blood pressure to the U.S. Supreme Court.

Expert Analysis

  • DC Circ. Ruling Heightens HHS Contract Pharmacy Challenges

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    The D.C. Circuit's recent ruling that the Section 340B program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies represents a second strike against the U.S. Department of Health and Human Services' current contract pharmacy policy and raises the stakes surrounding an upcoming Seventh Circuit ruling on the same issue, say attorneys at Foley Hoag.

  • 3 Infringement Defenses To Consider 10 Years Post-Nautilus

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    In the 10 years since the U.S. Supreme Court’s influential Nautilus ruling, the spirit of the “amenable to construction” test that the opinion rejected persists with many patent litigators and judges, so patent infringement defense counsel should always consider several key arguments, says John Vandenberg at Klarquist Sparkman.

  • 9th Circ. COVID 'Cure' Case Shows Perks Of Puffery Defense

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    The Ninth Circuit's March decision in a case surrounding a company's statements about a potential COVID-19 cure may encourage defendants to assert puffery defenses in securities fraud cases, particularly in those involving optimistic statements about breakthrough drugs that are still untested, say attorneys at Cahill Gordon.

  • FTC Focus: Exploring The Meaning Of Orange Book Letters

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    The Federal Trade Commission recently announced an expansion of its campaign to promote competition by targeting pharmaceutical manufacturers' improper Orange Book patent listings, but there is a question of whether and how this helps generic entrants, say Colin Kass and David Munkittrick at Proskauer.

  • Investors Can Aid In The Acceptance Of Psychedelic Medicine

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    Psychedelic medicine is ready to have its breakthrough moment, and although it still faces political, legal and communications challenges, private equity investors can play a significant role in changing the public perception on psychedelics from taboo to acceptance, say Kimberly Chew at Husch Blackwell, Charlie Panfil at the Daschle Group and Ethan Lutz at FTI Consulting.

  • Class Actions At The Circuit Courts: May Lessons

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    In this month's review of class action appeals, Mitchell Engel at Shook Hardy discusses four notable circuit court decisions on topics from automobile insurance to securities — and provides key takeaways for counsel on issues including circuit-specific ascertainability requirements and how to conduct a Daubert analysis prior to class certification.

  • Perspectives

    Trauma-Informed Legal Approaches For Pro Bono Attorneys

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    As National Trauma Awareness Month ends, pro bono attorneys should nevertheless continue to acknowledge the mental and physical effects of trauma, allowing them to better represent clients, and protect themselves from compassion fatigue and burnout, say Katherine Cronin at Stinson and Katharine Manning at Blackbird.

  • Series

    Playing Music Makes Me A Better Lawyer

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    My deep and passionate involvement in playing, writing and producing music equipped me with skills — like creativity, improvisation and problem-solving — that contribute to the success of my legal career, says attorney Kenneth Greene.

  • Proposed Cannabis Reschedule Sidesteps State Law Effects

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    The U.S. Department of Justice's recent proposal to move cannabis to Schedule III of the Controlled Substances Act provides certain benefits, but its failure to address how the rescheduling would interact with existing state cannabis laws disappointed industry participants hoping for clarity on this crucial question, says Ian Stewart at Wilson Elser.

  • How Attys Can Avoid Pitfalls When Withdrawing From A Case

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    The Trump campaign's recent scuffle over its bid to replace its counsel in a pregnancy retaliation suit offers a chance to remind attorneys that many troubles inherent in withdrawing from a case can be mitigated or entirely avoided by communicating with clients openly and frequently, says Christopher Konneker at Orsinger Nelson.

  • Using A Children's Book Approach In Firm Marketing Content

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    From “The Giving Tree” to “Where the Wild Things Are,” most children’s books are easy to remember because they use simple words and numbers to tell stories with a human impact — a formula law firms should emulate in their marketing content to stay front of mind for potential clients, says Seema Desai Maglio at The Found Word.

  • A Changing Regulatory Landscape For Weight Loss Drugs

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    As drugs originally approved to treat diabetes become increasingly popular for weight loss purposes, federal and state regulators and payors are increasing their focus on how these drugs are prescribed, and industry participants should pay close attention to rapidly evolving compliance requirements, say attorneys at Goodwin.

  • Opioid Suits Offer Case Study In Abatement Expert Testimony

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    Settlements in the opioid multidistrict litigation provide useful insight into leveraging expert discovery on abatement in public nuisance cases, and would not have been successful without testimony on the costs necessary to lessen the harms of the opioid crisis, says David Burnett at DiCello Levitt.

  • Patent Lessons From 4 Federal Circuit Reversals In April

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    Four Federal Circuit decisions in April that reversed or vacated underlying rulings provide a number of takeaways, including that obviousness analysis requires a flexible approach, that an invalidity issue of an expired patent can be moot, and more, say Denise De Mory and Li Guo at Bunsow De Mory.

  • Opinion

    USPTO's Proposed Disclaimer Rule Would Harm Inventors

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    The U.S. Patent and Trademark Office’s recently proposed rule on terminal disclaimers will make the patent system less available to inventors and will unfairly favor defendants in litigation, say Stephen Schreiner at Carmichael IP and Sarah Tsou at Omni Bridgeway.

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