Life Sciences

  • March 22, 2024

    Del. Courts Examining 'Colonoscopy'-Like Bylaw Rules

    Invasive advance-notice bylaws that some observers say make shareholder board nominations as intrusive as a "colonoscopy" are reviving old questions in Delaware courts about how far boards can go to protect themselves against shareholder activism.

  • March 22, 2024

    LifeCell Cleared Of Liability In NJ Strattice Hernia Mesh Trial

    New Jersey state jurors on Friday cleared LifeCell of liability in a Kentucky woman's suit alleging the design of its Strattice surgical mesh is defective and caused a hernia to reoccur and ultimately resulted in "life-altering" surgery, giving the medical device company the first win in a venue with at least 93 pending cases with tort claims over the mesh.

  • March 21, 2024

    SEC's 'Shadow Trading' Trial To Test Insider Info Boundaries

    If the U.S. Securities and Exchange Commission can convince jurors hearing its first-ever "shadow trading" case next week to find a former executive in the wrong for buying up a competitor's securities while having insider information about his own company, the floodgates could open to civil and criminal prosecution of other corporate insiders under the novel legal theory, attorneys told Law360.

  • March 21, 2024

    Colo. Distributor Seeks $2.3M Sanction For Stryker Spoilation

    A Colorado medical device distributor urged a federal judge to make Stryker and its lawyers pay $2.3 million in attorney fees as sanctions for "pervasive misconduct" throughout discovery and trial, arguing discovery violations will otherwise become the "cost of doing business" for the medical technology giant.

  • March 21, 2024

    Schumer Urges Texas District To Adopt Judge-Shopping Rule

    Senate Majority Leader Chuck Schumer on Thursday urged the chief judge of the Northern District of Texas to quickly implement the Judicial Conference of the United States' updated policy that looks to prevent litigants from judge shopping, arguing that the district's current practices are "dangerous."

  • March 21, 2024

    Ill. Judge Leaves Outcome Health Execs' Convictions Intact

    An Illinois federal judge said Thursday that he wouldn't disturb three former Outcome Health executives' convictions for carrying out a massive billion-dollar fraud scheme to grow their health advertising business, saying the jury heard enough evidence to support its verdict.

  • March 21, 2024

    MDL Claims Over Merck's Gardasil Vax Get Trimmed

    Pharmaceutical giant Merck need not face many of the claims by patients who allege their autoimmune conditions were caused by its HPV vaccine, a North Carolina federal judge overseeing multidistrict litigation ruled, saying the National Childhood Vaccine Injury Act bars most claims made in the first two bellwethers.

  • March 21, 2024

    6th Circ. Revives McKee's Network Plan Fight With Thrifty Med

    The Sixth Circuit reinstated on Thursday McKee Foods Corp.'s suit against Thrifty MedPlus Pharmacy alleging Tennessee law requiring pharmacy benefit managers to let "any willing pharmacies" participate in a network was preempted by the Employee Retirement Income Security Act, finding that amendments made to the statute didn't render McKee's claims moot.

  • March 21, 2024

    Calif. Panel Revives Diner's COVID Sanitization Coverage Bid

    A California state appeals court revived a diner's bid for property insurance coverage of COVID-19 losses after it determined the restaurant credibly alleged direct physical losses and that the policy's language covering losses attributable to a virus applied to COVID-19 sanitization efforts.

  • March 21, 2024

    Tribe's Opioid Suit Can Head To State Court, Okla. Judge Says

    An Oklahoma federal magistrate judge has granted the Cherokee Nation's bid to move to state court its suit accusing pharmaceuticals distributor Morris & Dickson of flooding the tribe's communities with opioids, saying the company only fulfilled one of four prongs necessary for establishing federal jurisdiction.

  • March 21, 2024

    CymaBay Investor Sues For Books On $4.3B Gilead Merger

    A shareholder of liver disease-focused biopharmaceutical company CymaBay Therapeutics Inc. sued the company in Delaware Chancery Court to extract more information over a proposed $4.3 billion merger with Gilead Sciences Inc., saying CymaBay has refused to hand over previously requested documents regarding the valuation analyses without a legitimate excuse.

  • March 21, 2024

    Avoid Major Extension Of Merger Reach, EU High Court Urged

    An important tool for extending European Union antitrust officials' merger scrutiny appears to be in jeopardy after a European Court of Justice advocate general effectively recommended Thursday that the bloc's high court restrict the ability to investigate transactions that don't normally trigger EU thresholds.

  • March 21, 2024

    Business Coalition Rebuffs Biden Plan To Seize Drug Patents

    The Biden administration's proposal to exercise so-called march-in rights to seize drug patents would harm innovation in the U.S., according to an assemblage of business-focused groups.

  • March 21, 2024

    Home Health Cos. Stiffed Workers On OT Pay, Suit Claims

    The operators of several Ohio-based home care staffing agencies have been failing to pay their employees for all the overtime hours they worked, according to a recent proposed class and collective action.

  • March 21, 2024

    Teleflex Catheter Patent Makes It Through Fed. Circ.

    The Federal Circuit on Thursday opted to leave untouched an administrative patent board ruling that rejected a legal effort to invalidate a patent covering a type of catheter that's sold by Teleflex. 

  • March 21, 2024

    Woman Lost Independence Due To Strattice Mesh, Jurors Told

    A Kentucky woman told New Jersey state jurors on Thursday that LifeCell skipped important safety steps while designing its Strattice surgical mesh, and that those skipped steps caused a hernia to reoccur and ultimately resulted in the loss of her independence.

  • March 21, 2024

    3rd Circ. Agrees Investors Have No Case Against Vax Maker

    The Third Circuit on Thursday upheld a Pennsylvania federal judge's ruling that a putative class of investors alleging biopharmaceutical company Ocugen Inc. made misleading statements about its ability to quickly produce a COVID-19 vaccine failed to state a claim against the company.

  • March 21, 2024

    6th Circ. Doubtful Of Hospital Workers' Vax Exemption Claim

    A Sixth Circuit panel appeared skeptical Thursday of an argument from a class of former employees of Ohio Children's Hospital that their First Amendment rights to freedom of religion were violated under the hospital's COVID-19 employee vaccination policy.

  • March 21, 2024

    Fed. Circ. Upholds Edwards' PTAB Win On Heart Valve Patent

    The Federal Circuit has affirmed a Patent Trial and Appeal Board finding that various parts of medical technology maker Cardiovalve's patent on an artificial heart valve implant were invalid as obvious.

  • March 21, 2024

    6th Circ. Zeroes In On CBA In Vax Bias Preemption Battle

    A Sixth Circuit panel pressed on Thursday a cargo airline and pilots who say they were unlawfully fired for refusing COVID-19 vaccinations about the pilots' union contract, with one judge asking whether the open questions about their collective bargaining agreement meant the discrimination case was preempted.

  • March 21, 2024

    Chancery Denies Icahn Midcase Appeal In Illumina Board Suit

    Carl Icahn can't interrupt his Chancery Court lawsuit against biotech Illumina Inc.'s board to appeal a decision about redactions to the Delaware Supreme Court, a vice chancellor ruled Wednesday, saying there are no "exceptional circumstances" that call for a midcase review.

  • March 21, 2024

    Greenberg Traurig Adds Jackson Walker FDA Pro In Houston

    Greenberg Traurig LLP's most recent Houston addition is a shareholder who came aboard from Jackson Walker LLP, where he established and led its U.S. Food and Drug Administration practice.

  • March 20, 2024

    4th Circ. Backs Rockefeller Group in Guatemalans' Syphilis Suit

    A group of Guatemalans who sued The Rockefeller Foundation over venereal disease experiments conducted on prisoners and psychiatric patients in the 1940s did not show an American doctor involved in the gruesome activities acted on behalf of the organization, a Fourth Circuit panel ruled Wednesday.

  • March 20, 2024

    Endo Plan To Trim $5B In Debt Confirmed By NY Judge

    Drugmaker Endo International got a New York bankruptcy judge's approval for its Chapter 11 plan that aims to cut more than $5 billion in debt and hand over ownership to its lenders, roughly a month after it finalized a $465 million deal to resolve criminal and civil opioid claims.

  • March 20, 2024

    PTAB To Analyze Moderna COVID Vaccine Patents

    The Patent Trial and Appeal Board has agreed to review two Moderna COVID-19 vaccine patents challenged by rivals Pfizer and BioNTech as having "unimaginably broad claims directed to a basic idea that was known long before."

Expert Analysis

  • Series

    Baking Bread Makes Me A Better Lawyer

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    After many years practicing law, and a few years baking bread, I have learned that there are a few keys to success in both endeavors, including the assembly of a nourishing and resilient culture, and the ability to learn from failure and exercise patience, says Rick Robinson at Reed Smith.

  • Supreme Court Amgen Ruling's Major Effect On Enablement

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    The U.S. Supreme Court's Amgen v. Sanofi invalidity holding continues to significantly affect technologies and all aspects of the patent system by providing confidence in the Federal Circuit's approach and a clearer understanding on enforceability and the disclosure needed for compliance, say Irena Royzman and Daniel Williams at Kramer Levin.

  • Federal Courts And AI Standing Orders: Safety Or Overkill?

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    Several district court judges have issued standing orders regulating the use of artificial intelligence in their courts, but courts should consider following ordinary notice and comment procedures before implementing sweeping mandates that could be unnecessarily burdensome and counterproductive, say attorneys at Curtis.

  • 7 E-Discovery Predictions For 2024 And Beyond

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    The legal and technical issues of e-discovery now affect virtually every lawsuit, and in the year to come, practitioners can expect practices and policies to evolve in a number of ways, from the expanded use of relevancy redactions to mandated information security provisions in protective orders, say attorneys at Littler.

  • Top Considerations For Retailers Using AI To Combat Theft

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    The Federal Trade Commission's recent enforcement action against Rite Aid indicates a significant evolution in the landscape surrounding biometric information and artificial intelligence data collection by retailers, meaning retailers should take reasonable measures to prevent harm to customers, say attorneys at Dentons.

  • 2 FCPA Settlements Illuminate Self-Disclosure, Disgorgement

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    Two of last year’s Foreign Corrupt Practices Act settlements — with biomedical company Lifecore and mining company Corsa Coal — suggest that the government will be much more flexible in negotiating disgorgement amounts if an entity voluntarily self-discloses misconduct, say Michael Gilbert and Lucas Amodio at Sheppard Mullin.

  • Opinion

    Anti-Kickback Statute Does Not Require But-For Causation

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    A proper interpretation of the Anti-Kickback Statute clearly indicates that but-for causation is not required for False Claims Act Liability, and courts that hold otherwise will make it significantly easier for fraudsters to avoid accountability, says Kenneth Capesius at Baron & Budd.

  • 5 Litigation Funding Trends To Note In 2024

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    Over the next year and beyond, litigation funding will continue to evolve in ways that affect attorneys and the larger litigation landscape, from the growth of a secondary market for funded claims, to rising interest rates restricting the availability of capital, says Jeffery Lula at GLS Capital.

  • Medtronic's Cautionary Tale Of Fed. Circ. Word Limits

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    The Federal Circuit's ruling in Medtronic v. Teleflex that Medtronic waived an argument that it had sought to incorporate by reference illustrates the pitfalls facing parties in complex patent cases involving numerous issues that cannot all be addressed within the strict word limits for appellate briefs, say Sean Murray and Jeremiah Helm at Knobbe Martens.

  • Key Legal Trends For Healthcare And Life Sciences In 2024

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    Due to the impact of contentious legal battles over drug pricing negotiations, the growing integration of artificial intelligence into drug development and manufacturing, and the publication of industry segment-specific guidance, the year ahead promises to be a dynamic period of changes and challenges, say Xin Tao and Lois Liu at Baker McKenzie.

  • Series

    ESG Around The World: South Africa

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    While South Africa has yet to mandate the reporting of nonfinancial and environmental, social, and corporate governance issues, policy documents and recent legislative developments are likely to have a material impact in the country's transition to a low-carbon economy and in meeting its international obligations, say Glynn Kent at Eversheds Sutherland.

  • FOIA Exemption Questions On Redacted HHS Cannabis Letter

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    The U.S. Department of Health and Human Services' recent recommendation letter concerning the rescheduling of cannabis was heavily redacted, and based on an analysis on the applicability of Freedom of Information Act Exemption 5 to the letter, it's likely that we will see successful legal challenges to those redactions, say attorneys at Troutman Pepper.

  • Fed. Circ. Ruling Seemingly Offers PTAB Deadline Immunity

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    The Federal Circuit's recent Purdue Pharma v. Collegium Pharmaceutical Inc. decision that the Patent Trial and Appeal Board had authority to issue a final written decision in a post grant review after the prescribed statutory deadline underscores how courts should consider the overall objective of the statutory scheme when balancing the classic conflict between bright-line rules and flexible standards, says Matthew Dowd at Dowd Sheffel.

  • Evaluating Retroactivity Of Mich. Drugmaker Immunity Repeal

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    In assessing whether a new Michigan law lifting drugmakers' blanket immunity from product liability suits will apply retroactively, there are four key factors that Michigan courts will likely consider, say Sherry Knutson and Brenda Sweet at Tucker Ellis.

  • 4 Legal Ethics Considerations For The New Year

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    As attorneys and clients reset for a new year, now is a good time to take a step back and review some core ethical issues that attorneys should keep front of mind in 2024, including approaching generative artificial intelligence with caution and care, and avoiding pitfalls in outside counsel guidelines, say attorneys at HWG.

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