Life Sciences

  • February 15, 2024

    Med Monitoring Claims In Philips MDL Sent Back For Review

    The judge overseeing multidistrict litigation over Koninklijke Philips NV's recalled breathing machines has declined a special master's recommendation to trim claims seeking medical monitoring for some users, instead sending the case back for a deeper look at which states would allow such claims or whether they required proof of physical injury.

  • February 15, 2024

    FTC's Khan Calls Healthcare 'Key' To Fight For Competition

    Federal Trade Commission Chair Lina Khan told a conference of physicians the agency is fighting corporate control at several levels of the healthcare industry, touting the sector as a key battleground in the administration's push for more competition across the economy.

  • February 14, 2024

    Pfizer Reaches $93M Deal With Lipitor Buyers In Antitrust MDL

    Pfizer Inc. has agreed to shell out $93 million to put to rest Lipitor buyers' claims in sprawling antitrust multidistrict litigation over the cholesterol medication that stretches back more than a decade, according to a motion filed Wednesday in New Jersey federal court.

  • February 14, 2024

    Alcon Can't Dodge Suit Over Eye Drops' '30 Day Supply' Claim

    Alcon Laboratories can't escape a proposed class action alleging it falsely claims that its Pataday eye drops have a "30 Day Supply," after a New York federal judge said Wednesday that reasonable consumers could understand the label as assuring that the product, if used as directed, would last 30 days.

  • February 14, 2024

    Karuna Faces Investor Suit Over $14B Bristol Myers Buyout

    A Karuna Therapeutics Inc. shareholder has filed suit against the Boston-based biotechnology company alleging a proxy statement related to a proposed $14 billion buyout deal between Karuna and Bristol Myers Squibb contained false and misleading information and omitted key facts.

  • February 14, 2024

    FTC Seeks Info On 'Powerful Middlemen' Amid Drug Shortages

    The Department of Health and Human Services and the Federal Trade Commission announced Wednesday that they are seeking information on whether legal exemptions for "middlemen" in the generic pharmaceutical market are driving ongoing drug shortages.

  • February 14, 2024

    Adagio Medical Goes Public In $128M SPAC Merger

    Adagio Medical, a catheter ablation tech maker, and Arya Sciences, a special purpose acquisition company, said on Wednesday that they would merge, taking the combined company public at a $128 million value, guided by respective legal adviser Reed Smith and Kirkland.

  • February 14, 2024

    Software Co. Inks $4M Deal In Privacy Suit Over Breached Info

    Patients suing software company Connexin Software for allegedly failing to safeguard the healthcare and personal identifiable information of more than 200,000 people compromised during a data breach, including that of children, asked a Pennsylvania federal judge on Wednesday to approve a $4 million class settlement.

  • February 14, 2024

    Pharma Co. Humanigen Gets OK For Ch. 11 Sale

    Drug researcher Humanigen Inc. can sell nearly all of its assets to a company formed by its CEO, a Delaware bankruptcy judge ruled Wednesday, after the debtor, the buyer and the official committee of unsecured creditors struck a deal resolving objections to the Chapter 11 sale.

  • February 14, 2024

    Breast Implant Co. Wants Ch. 11 Sale Closed In 60 Days

    A Delaware bankruptcy judge granted breast implant manufacturer Sientra preliminary approval Wednesday to tap $22.5 million in Chapter 11 financing and start the process of selling its business within a two-month timetable.

  • February 14, 2024

    Drug Co. Paratek's Officers Sued In Del. Over $462M Sale

    Former stockholders of drug developer Paratek Pharmaceuticals Inc. have sued five directors and officers in Delaware's Court of Chancery, accusing those named of slow-walking company sale efforts and snubbing up to 50% higher offers in favor of a $462 million deal that allegedly assured the directors and officers maximum benefits.

  • February 14, 2024

    Biotech Nabs $200M Via Private Placement, Starts CEO Search

    Public gene therapy company enGene Holdings Inc. announced Wednesday that it will sell 20 million of its common shares, raising an anticipated private placement of around $200 million, to fund the development of its lead compound EG-70.

  • February 14, 2024

    Fox News' Sorrento Report Takes Center Stage At 9th Circ.

    Counsel for Sorrento Therapeutics Inc. investors urged the Ninth Circuit on Wednesday to revive a securities suit alleging executives made misleading statements to Fox News about its COVID-19 research, prompting one judge to ask whether "you have to take things you hear on Fox News with a grain of salt."

  • February 14, 2024

    SmileDirectClub Trustee Wants To Cut Leases To Stop Losses

    The Chapter 7 trustee for dental care company SmileDirectClub Inc. submitted an emergency motion in a Texas court to end more than 100 active leases and discard related assets, aiming to slow the depletion of limited resources during the company's liquidation process.

  • February 14, 2024

    GSK Exec Joins Troutman Pepper's Life Sciences IP Team

    Troutman Pepper Hamilton Sanders LLP continued to expand its health sciences services in the Philadelphia region with the addition this week of a patent practitioner who joined the firm after more than 20 years with GlaxoSmithKline.

  • February 14, 2024

    Dentists Can't Get Class Certification In SmileDirectClub Suit

    A Tennessee federal judge has denied a bid from a group of dentists seeking class certification in their false advertising suit against SmileDirectClub LLC, saying proving an injury and damages would involve too many individualized questions to support class treatment.

  • February 14, 2024

    Genetic Testing Co. Invitae Files For Ch. 11 With $1.5B Debt

    California-based genetic testing company Invitae Corp. has filed for Chapter 11 protection in New Jersey with nearly $1.5 billion in debt and what it said is an agreement with senior noteholders to seek a buyer.

  • February 13, 2024

    6th Circ. Backs Drugmakers' Early Win In Diabetes Drug MDL

    The Sixth Circuit on Tuesday affirmed an early victory for AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb Co. and McKesson Corp. in multidistrict litigation alleging the diabetes drugs they manufacture, Onglyza and Kombiglyze, cause heart failure, holding that a lower court had multiple "good reasons" for finding the plaintiffs' expert's testimony unreliable.

  • February 13, 2024

    Indian Pharma Co. Can't Get Fees In $950M COVID Vax Suit

    A Seattle federal judge has nixed an Indian generic-drug maker's bid for about $3 million in attorney fees after it prevailed in a biotherapy company's $950 million lawsuit accusing it of stealing its COVID-19 vaccine, saying the maker didn't convince him it spent extra money litigating the suit.

  • February 13, 2024

    Expert's 11th-Hour Change Blocked In Pet Device IP Retrial

    A New Jersey federal judge refused Tuesday to allow an expert witness to make an 11th-hour addition to his report on the "head start" period in a new damages trial on an inventor's claim that a pet supply company misappropriated her idea for a skin medicine applicator for dogs and cats.

  • February 13, 2024

    Insurers Must Pay Pharma Co. Defense Costs In SEC Probe

    A drug development company formed by a merger is entitled to insurance payments for expenses it paid two of its former officers in connection with federal subpoenas because the insurer failed to show that an exclusion applied, a California federal judge ruled Monday.

  • February 13, 2024

    FDA, Creditors Oppose Drugmaker Humanigen's Ch. 11 Sale

    Biopharmaceutical company Humanigen faced fire on multiple fronts Tuesday after it asked the Delaware bankruptcy court to approve a $2 million stalking horse credit bid from its debtor-in-possession lender, an entity founded by the debtor's chief executive, that is opposed by the FDA and certain creditors.

  • February 13, 2024

    Texas Appeals Court Grants Medical Coding Co.'s Atty Fee Bid

    A Texas appellate panel has ordered a diagnostics business to pay a medical coding company's attorney fees following a contract dispute between the companies, issuing a judgment Tuesday that also affirmed a trial court's decision to grant the coding company summary judgment.

  • February 13, 2024

    Biden Administration Beats Big Pharma Texas Medicare Suit

    A Texas federal judge said he could not entertain Big Pharma's challenge to the Biden administration's prescription drug pricing program since the only Texas-based trade group fighting the lawsuit failed to first bring its constitutional complaint to U.S. healthcare authorities.

  • February 13, 2024

    Ky. Alleges Kroger Had 'Outsized' Role In State's Opioid Crisis

    Kentucky Attorney General Russell Coleman accused the Kroger Co. and two subsidiaries of ignoring red flags and suspicious orders as opioids devastated the state, alleging in a new suit the massive grocery and pharmacy chain violated nuisance and consumer protection laws.

Expert Analysis

  • 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.

  • FTC Rite Aid Order Holds Biometrics And AI Compliance Tips

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    The Federal Trade Commission's recent enforcement action against Rite Aid over its use of facial biometric technology on customers provides lessons that can be leveraged to reduce and manage the risk of regulatory scrutiny of biometrics and artificial intelligence, says David Oberly at Baker Donelson.

  • Bribery Settlement Gives Insight On DOJ Policies

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    Chemical company Albemarle’s recent $218 million settlement with the government to resolve foreign bribery claims provides valuable data points for companies on the U.S. Department of Justice’s voluntary self-disclosure policy and its clawback pilot program, say Michael DeBernardis and Tiauna Mathieu at Hughes Hubbard.

  • SEC Case May Expand Scope Of Insider Trading Liability

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    The U.S. Securities and Exchange Commission's first-of-its-kind enforcement action against an individual in a case involving "shadow trading" demarcates an expansion of insider trading liability to circumstances in which there is a market connection between the source of information and the issuer of the securities traded, say attorneys at Steptoe.

  • Opinion

    Waiving COVID-19 IP Protections Would Harm US Industry

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    President Joe Biden should turn down a World Trade Organization proposal to waive crucial intellectual property protections behind COVID-19 tests and diagnostics — protections that allow U.S. companies to sustain millions of jobs and develop life-saving treatments that benefit patients in every country, says former U.S. Circuit Judge Paul Michel, now at the Council for Innovation Promotion.

  • Fed. Circ. Patent Decisions In 2023: An Empirical Review

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    The Federal Circuit decided 306 patent cases last year, which is still well down from the pre-pandemic norm of around 440, and on the whole the court's decisions were markedly less patentee-friendly in 2023 than in 2022, says Dan Bagatell at Perkins Coie.

  • What The Law Firm Of The Future Will Look Like

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    As the legal landscape shifts, it’s become increasingly clear that the BigLaw business model must adapt in four key ways to remain viable, from fostering workplace flexibility to embracing technology, say Kevin Henderson and Eric Pacifici at SMB Law Group.

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