Life Sciences

  • May 20, 2024

    McKinsey Can't Nix Pregnant Women's Claims In Opioid MDL

    A California federal judge has cut some claims from multidistrict litigation seeking to hold McKinsey & Co. Inc. liable for infant neonatal abstinence syndrome caused by pregnant women's use of opioids, trimming fraud and nuisance-based claims, but allowing conspiracy and aiding-and-abetting claims to proceed against the consulting firm.

  • May 20, 2024

    Judge Tosses Acuitas' COVID Biotech IP Suit

    A New Jersey federal judge on Monday threw out a lawsuit from a maker of a component of a COVID-19 vaccine relating to patent infringement litigation brought by two other companies against Pfizer and BioNTech.

  • May 20, 2024

    Local Governments Seek Sanctions For PBMs In Opioid MDL

    Four municipalities are asking an Ohio federal court overseeing the national opioid litigation to sanction pharmacy benefit managers Express Scripts Inc. and OptumRX Inc., saying they've willfully defied the court's order to provide complete responses to discovery requests.

  • May 20, 2024

    iRhythm Brass Face Suit Over FDA's Heart Monitor Inquiry

    Several current and former directors and executives of medical technology company iRhythm are named in a shareholder derivative suit alleging they failed to disclose an inquiry by the Food and Drug Administration that found iRhythm's heavily touted and high-cost real-time heart monitoring device failed to meet the company's claims.

  • May 20, 2024

    J&J Says Beasley Allen Looking To 'Bias' Vote On $6.5B Plan

    Johnson & Johnson's bankrupt talc unit accused the Beasley Allen Law Firm of attempting to intentionally "bias" the vote against its recently announced proposal to pay out $6.5 billion in a prepackaged reorganization plan to resolve claims that its talc-based baby powder causes ovarian cancer.

  • May 20, 2024

    Latham Hires 2 Skadden Healthcare Partners In DC

    Latham & Watkins LLP has picked up two healthcare and life sciences partners from Skadden Arps Slate Meagher & Flom LLP in Washington, D.C., the firm announced Monday.

  • May 20, 2024

    Catching Up With Delaware's Chancery Court

    Delaware was full of drama last week, as proposed changes to the state's corporate law statutes raised eyebrows and a professor's friend-of-the-court brief sparked a very unfriendly public exchange. Delaware's court of equity banged the gavel on pipeline and social media disputes, and shareholders filed new suits alleging insider trading, vote bungling, unfair stock buybacks and merger shenanigans. In case you missed any of it, here's the recap of all the top news last week from Delaware's Chancery Court.

  • May 20, 2024

    Ga. Judge OKs $5M Atty Fees In $41M Acella Thyroid Deal

    A Georgia federal judge has signed off on a nearly $41.5 million class action settlement with Acella Pharmaceuticals LLC over faulty thyroid medication, while awarding the class attorneys another $5 million in legal fees courtesy of the pharma company.

  • May 20, 2024

    Moderna Fends Off Pfizer's MRNA Patent Challenge

    Moderna has successfully defended a key patent underpinning its COVID-19 vaccine, after rivals Pfizer and BioNTech attempted to convince the European Patent Office that the IP protections should be nixed.

  • May 20, 2024

    Shah Ends Novavax Proxy Fight Following Sanofi Deal

    Hedge fund Shah Capital Management Inc. told fellow Novavax Inc. shareholders Monday that it is ending its fight to remove certain members of the biotech company's board, citing its favorable view of Novavax's licensing deal with Sanofi earlier this month.

  • May 17, 2024

    VA Deal Winner Says Protest Not Based On Common Sense

    The winner of a U.S. Department of Veterans Affairs mail-order pharmacy deal urged the U.S. Court of Federal Claims to toss a competitor's protest of the award, saying the protester's challenge was based on an incorrect reading of applicable regulations.

  • May 17, 2024

    Allergan Says Deserted Drug Rule Weakens $680M Fraud Suit

    Allergan drew a Maryland federal court's attention to the Centers for Medicare & Medicaid Services' abandonment of a regulation clarifying drug pricing, arguing the move undermined a whistleblower's claims that it overcharged Medicaid by over $680 million.

  • May 17, 2024

    Patent Office Gets Another Earful About 'March-In' Plan

    Industry groups of all stripes have lined up at the U.S. Patent and Trademark Office to complain yet again about a Biden administration proposal from last year to potentially use "march-in" rights and seize pharmaceutical patents using the Bayh-Dole Act.

  • May 17, 2024

    Pfizer Unit Wins $107.5M Patent Verdict Against AstraZeneca

    A Delaware federal jury on Friday said that AstraZeneca Pharmaceuticals LP should pay $107.5 million in royalty damages for infringing a Pfizer-brand cancer treatment patent, although a final decision won't be issued until after a bench trial on some of AstraZeneca's additional defenses. 

  • May 17, 2024

    FCA Relators Seek Finders Fee For SpineFrontier Doc Deals

    Three whistleblowers who tipped off the federal government to a medical device company's multimillion-dollar kickback scheme said Friday the Justice Department is refusing to pay them a cut of the $3 million in False Claims Act settlements paid by surgeons who admitted participating in the sham consulting ploy.

  • May 17, 2024

    Judge Won't Bar Thermo Fisher Exec's Jump To Repligen

    A Massachusetts judge won't block a former Thermo Fisher Scientific executive from jumping to smaller rival Repligen, calling a noncompete agreement signed by the employee overbroad and suggesting that it was really aimed at stifling competition in a ruling released Friday.

  • May 17, 2024

    EndoStim Emerges From Delaware Insolvency Proceeding

    Delaware's Court of Chancery has approved the final accounting for medical device company EndoStim Inc.'s state-administered insolvency proceeding after no creditor or other party raised any objections at a final hearing on Friday.

  • May 17, 2024

    Industry Emboldened After Justices Galvanize Agency Attacks

    In the year since the U.S. Supreme Court said "extraordinary" and "far-reaching" attacks on administrative enforcers can skip agency tribunals and go straight to federal district court, ambitious challenges to regulatory powers are rapidly gaining traction, and the high court is poised to put them on an even firmer footing.

  • May 17, 2024

    Texas Justices Let Fen-Phen Atty Malpractice Fight Roll On

    The Texas Supreme Court ruled Friday that roughly 4,000 former clients of a Houston mass tort lawyer can continue pressing their claims that the lawyer improperly kept millions of dollars in fen-phen diet drug settlement money.

  • May 17, 2024

    Winston & Strawn Leads Asia-Focused SPAC $100M IPO

    Shares of RF Acquisition II, a special-purpose acquisition company targeting the technology sector in Asia, began trading publicly on Friday following the company's $100 million initial public offering.

  • May 17, 2024

    UK Litigation Roundup: Here's What You Missed In London

    This past week in London has seen a wave of claims filed against Verity Trustees Ltd., Harley-Davidson hit retailer Next with an intellectual property claim, Turkish e-commerce entrepreneur Demet Mutlu sue her ex-husband and Trendyol co-founder Evren Üçok and the Solicitors Regulation Authority file a claim against the former boss of collapsed law firm Axiom. Here, Law360 looks at these and other new claims in the U.K.

  • May 16, 2024

    Ointment Scheme Conned Gov't Out Of Millions, Fla. Suit Says

    Two Florida brothers and one of their former employees are accused of running a years-long fraudulent scheme billing government healthcare programs and receiving millions of dollars after paying kickbacks to generate prescriptions for ointments that were not needed, according to a False Claims Act lawsuit.

  • May 16, 2024

    3rd Circ. Shuns Teva's 'Novel' Appeal On Israeli Investor Class

    The Third Circuit on Thursday turned away an appeal brought by Teva Pharmaceutical Industries Ltd., saying the class certification stage was not the right time to hear arguments over the "novel" question of the applicability of U.S. securities laws to Israeli-listed shares.

  • May 16, 2024

    FTC Deputy Director Rao On Healthcare Antitrust Agenda

    The reason behind the Federal Trade Commission's changed attitude toward antitrust in healthcare in recent years isn't simple, according to Rahul Rao, deputy director of the FTC's Bureau of Competition.

  • May 16, 2024

    NJ Judge Scrutinizes J&J Unit's Libel Claim Over Talc Study

    A bankrupt Johnson & Johnson unit's libel claims over a scientific article linking talcum powder to mesothelioma intrigued a New Jersey federal judge during an oral argument on Thursday, prompting her to muse that the author's consideration of other exposures seemed to bolster the study at issue.

Expert Analysis

  • Mid-2024 FCA Enforcement And Litigation Trends To Watch

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    Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.

  • What 100 Federal Cases Suggest About Changes To Chevron

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    With the U.S. Supreme Court poised to overturn or narrow its 40-year-old doctrine of Chevron deference, a review of 100 recent federal district court decisions confirm that changes to the Chevron framework will have broad ramifications — but the magnitude of the impact will depend on the details of the high court's ruling, say Kali Schellenberg and Jon Cochran at LeVan Stapleton.

  • Why High Court May Have Rejected IP Obviousness Appeal

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    Attorneys at Womble Bond analyze possible reasons the U.S. Supreme Court rejected Vanda Pharmaceuticals' request to review the Federal Circuit’s reasonable expectation of success standard for determining obviousness, including that the court was unpersuaded by the company's argument that Amgen v. Sanofi places a bind on drug developers.

  • Microplastics At The Crossroads Of Regulation And Litigation

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    Though there are currently not many federal regulations specifically addressing microplastics as pollutants, regulatory scrutiny and lawsuits asserting consumer protection claims are both on the rise, and manufacturers should take proactive steps to implement preventive measures accordingly, say Aliza Karetnick and Franco Corrado at Morgan Lewis.

  • The Fed. Circ. In April: Hurdles Remain For Generics

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    The Federal Circuit’s recent Salix v. Norwich ruling — where Salix's brand-name drug's patents were invalidated — is a reminder to patent practitioners that invalidating a competitor's patents may not guarantee abbreviated new drug application approval, say Sean Murray and Jeremiah Helm at Knobbe Martens.

  • Tylenol MDL Highlights Expert Admissibility Headaches

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    A New York federal court's decision to exclude all plaintiff experts in a multidistrict litigation concerning prenatal exposure to Tylenol highlights a number of expert testimony pitfalls that parties should avoid in product liability and mass tort matters, say Rand Brothers and Courtney Block at Winston & Strawn.

  • Don't Use The Same Template For Every Client Alert

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    As the old marketing adage goes, consistency is key, but law firm style guides need consistency that contemplates variety when it comes to client alert formats, allowing attorneys to tailor alerts to best fit the audience and subject matter, says Jessica Kaplan at Legally Penned.

  • Don't Fall On That Hill: Keys To Testifying Before Congress

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    Because congressional testimony often comes with political, reputational and financial risks in addition to legal pitfalls, witnesses and their attorneys should take a multifaceted approach to preparation, walking a fine line between legal and business considerations, say attorneys at Crowell & Moring.

  • Online Portal Helps Fortify Feds' Unfair Health Practices Fight

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    The Federal Trade Commission, U.S. Justice Department and the U.S. Department of Health and Human Services recently launched an online portal where the public can report potentially unfair healthcare practices, effectively maximizing enforcers' abilities to police anti-competitive actions that can drive up healthcare costs and chill innovation, say attorneys at Seyfarth.

  • Series

    Walking With My Dog Makes Me A Better Lawyer

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    Thanks to my dog Birdie, I've learned that carving out an activity different from the practice of law — like daily outdoor walks that allow you to interact with new people — can contribute to professional success by boosting creativity and mental acuity, as well as expanding your social network, says Sarah Petrie at the Massachusetts Attorney General’s Office.

  • Think Like A Lawyer: Follow The Iron Rule Of Trial Logic

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    Many diligent and eager attorneys include every good fact, point and rule in their trial narratives — spurred by the gnawing fear they’ll be second-guessed for leaving something out — but this approach ignores a fundamental principle of successful trial lawyering, says Luke Andrews at Poole Huffman.

  • The Art Of Asking: Leveraging Your Contacts For Referrals

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    Though attorneys may hesitate to ask for referral recommendations to generate new business, research shows that people want to help others they know, like and trust, so consider who in your network you should approach and how to make the ask, says Rebecca Hnatowski at Edwards Advisory.

  • Trending At The PTAB: Permissible New Reply Arguments

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    In the time since the Federal Circuit’s Axonics ruling, the Patent Trial and Appeal Board has allowed petitioners to raise new unpatentability grounds in response to unforeseeable claim constructions in petitions, and reiterated that a petition need not anticipate every argument that may be raised in the response, say Joseph Myles and Timothy May at Finnegan.

  • Wave Of Final Rules Reflects Race Against CRA Deadline

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    The flurry of final rules now leaping off the Federal Register press — some of which will affect entire industries and millions of Americans — shows President Joe Biden's determination to protect his regulatory legacy from reversal by the next Congress, given the impending statutory look-back period under the Congressional Review Act, say attorneys at Jenner & Block.

  • 'Beauty From Within' Trend Poses Regulatory Risks For Cos.

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    Companies capitalizing on the current trend in oral supplements touting cosmetic benefits must note that a product claim that would be acceptable for an externally applied cosmetic may draw much stronger scrutiny from the U.S. Food and Drug Administration when applied to a supplement, say Natalie Rainer and Katherine Staba at K&L Gates.

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