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Life Sciences
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June 20, 2025
High Court Urged To Rein In FDA Oversight Of Stem Cells
The Association of American Physicians and Surgeons asked the U.S. Supreme Court Friday to review a Ninth Circuit decision the organization argued would wrongly give the government control over a patient's own stem cells.
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June 20, 2025
Many Foreign Firms Could Face Stricter Access To US Markets
The U.S. Securities and Exchange Commission's reevaluation of the definition of a foreign private issuer could have far-reaching consequences, potentially tightening access to U.S. markets for companies based in China and beyond, lawyers say.
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June 20, 2025
Fed. Circ. Revives MSN Challenge To Bausch IBS Drug Patent
The Federal Circuit has instructed the Patent Trial and Appeal Board to take another crack at evaluating the validity of a drug patent owned by Bausch Health Ireland Ltd., holding that the PTAB's initial decision lacked the detail needed to determine whether it was right or wrong.
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June 20, 2025
DEA Judge Backs Federal Ban On 2 Research Chemicals
A U.S. Drug Enforcement Administration judge determined Friday that two unrestricted psychoactive research chemicals belong in Schedule I, the most stringent tier of prohibited substances under the federal Controlled Substances Act.
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June 20, 2025
2nd Purdue Plan Heading For Creditor Vote, Nov. Hearing
A New York bankruptcy judge Friday set OxyContin maker Purdue Pharma's second try at a bankruptcy plan on course for a November confirmation hearing, clearing the plan disclosure statement to be sent out for a creditor vote.
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June 20, 2025
Investor Can't Get Emergency Injunction In Sinovac Battle
A New York federal judge will not grant an investor an emergency injunction to preserve the status quo as it pursues arbitration in Hong Kong or Beijing stemming from a bitter, yearslong battle for control of Chinese vaccine maker Sinovac, saying the investors have not demonstrated a likelihood of "irreparable harm."
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June 20, 2025
PE Firm Demands FDA Docs For Defense In Deal Challenge
Private equity firm GTCR BC Holdings LLC is seeking a court order for the U.S. Food and Drug Administration to produce over a decade's worth of medical device approval applications, arguing the documents are necessary in its defense against a merger challenge by the federal government.
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June 20, 2025
NJ Court Greenlights Beasley Allen Attys In Talc Litigation
A New Jersey state judge will allow two Beasley Allen Law Firm attorneys to represent a California couple in their suit accusing Johnson & Johnson of selling carcinogenic talc-based baby powder and appear pro hac vice despite the company's vehement opposition.
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June 20, 2025
Nose Spray Co. Sues FTC Over Substantiation Requirement
Nasal spray maker Xlear Inc. is suing the Federal Trade Commission in Utah federal court, seeking a declaration that the agency is going beyond its statutory mandate by requiring scientific substantiation in marketing claims, even if the claims are not false and misleading.
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June 20, 2025
Taxation With Representation: Latham, Paul Weiss, Covington
In this week's Taxation With Representation, Nippon Steel closes its purchase of U.S. Steel, Hunter Point Capital buys a minority stake in Equitix, Eaton acquires Ultra PCS Ltd. from the Cobham Ultra Group, and Eli Lilly and Co. acquires Verve Therapeutics.
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June 20, 2025
Psychedelic Therapy Reform Gets Boost From Conservatives
Former Texas Gov. Rick Perry told attendees at a psychedelics conference this week that he was committed to loosening federal restrictions on a prohibited psychoactive substance that has shown promise in treating mental health conditions like opioid addiction.
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June 20, 2025
Justices Let E-Cig Retailers Join Challenge To FDA Prohibition
The U.S. Supreme Court ruled Friday that e-cigarette retailers can challenge the U.S. Food and Drug Administration's denial of product marketing applications, finding manufacturers aren't the only entities that can be adversely affected by the agency's decisions.
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June 20, 2025
High Court Says FCC Orders Not Above District Court Review
The U.S. Supreme Court on Friday ruled that district courts should be allowed to question the slate of regulations that the Federal Communications Commission has issued under the Telephone Consumer Protection Act, further constricting the power of federal agencies to interpret laws.
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June 18, 2025
Texas Judge Vacates Biden-Era HHS Abortion Privacy Rule
A Texas federal judge on Thursday agreed to vacate a U.S. Department of Health and Human Services rule finalized during the Biden administration that aimed to protect the privacy of patients seeking abortions and gender-affirming care, ruling that the HHS didn't have the authority to "fashion special protections" in areas of "great political significance."
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June 18, 2025
J&J Hit With $8M Verdict In Multi-Exposure Talc Case
A jury awarded $8 million on Wednesday to a Massachusetts woman who said Johnson & Johnson's talcum powder caused her mesothelioma, rejecting the company's claims that family members' work around asbestos absolved it of blame.
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June 18, 2025
Anavex Gets Suit Over Rett Syndrome Clinical Trials Nixed
A New York federal judge tossed an Anavex investor's proposed class action alleging she suffered losses from its misleading statements regarding methodologies used in neurological treatment clinical trials, ruling that stock prices rose from the day the statements were made after Anavex made corrective disclosures in a pre-market earnings call.
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June 18, 2025
Sotera Investors Urge 6th Circ. To Reopen Toxic Gas Suit
Sotera Health investors are seeking to revive a lawsuit accusing the company of concealing the carcinogenic nature of a gas used at its sterilization plants, telling the Sixth Circuit that the company knew that its "outrageous and cynical" behavior would cost it hundreds of millions of dollars.
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June 18, 2025
Spectrum Pharma Investors Get First OK For $16M Deal
A Nevada federal judge has given the first green light to a nearly $16 million settlement between a pharmaceutical company and a class of investors who claimed the company and its executives overstated the status of two of its developed drugs and withheld negative data and trial results, leading to a stock drop when the truth was revealed.
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June 18, 2025
Psychedelics And The Law In Focus At Colo. Conference
Colorado Gov. Jared Polis announced a pardon for all state-level convictions for psilocybin and psilocin possession at a psychedelics conference this week, in recognition that these substances are now legal in the state and in another indication that their relationship with the law is in flux.
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June 18, 2025
High Court Concurrences Signal Hard Battle For Trans Rights
U.S. Supreme Court Justice Amy Coney Barrett joined the court's two most conservative members Wednesday to suggest laws that differentiate based on transgender status should be subject to the lowest level of judicial review, providing guidance to lower courts that will likely make it harder for litigants to vindicate trans rights.
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June 18, 2025
23andMe Seeks To Ease Concerns Over Sale To Founder
Several states indicated Wednesday they may no longer oppose the $305 million sale of 23andMe to a nonprofit led by Anne Wojcicki, a co-founder of the company, after the debtor structured the transaction as an equity transfer.
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June 18, 2025
Dealmakers Eye More Crypto-Targeted SPAC Mergers
More special purpose acquisition companies plan to seize upon the revival of cryptocurrencies under a second Trump administration and take cryptocurrency-related ventures public in the coming months, an attorney told a gathering of dealmakers on Wednesday.
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June 18, 2025
Ex-Drug Exec Must Testify, But Keeps 5th Amendment Rights
Sandoz, Teva, Actavis and Taro can again subpoena the deposition testimony of a former Actavis and Teva executive, but a Pennsylvania federal judge is still allowing the witness to invoke his Fifth Amendment rights against self-incrimination, even though the Justice Department dropped the criminal charges against him.
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June 18, 2025
Ga. Court Backs Dismissal Of Hemp Farm's Drug Raid Suit
A Georgia appellate panel has said that state law enforcement cannot be held liable for allegedly damaging tens of thousands of dollars worth of product at a hemp farm, ruling that the Georgia Department of Public Safety was wholly shielded by sovereign immunity.
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June 18, 2025
FDA Dodges Suit Over Ozempic, Wegovy Listing
The U.S. Food and Drug Administration was able to escape allegations that it catered to Big Pharma by nixing cheaper versions of the miracle weight loss drug Ozempic, after a Texas federal judge tossed a lawsuit from two compounding pharmacies.
Expert Analysis
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Series
Power To The Paralegals: The Value Of Unified State Licensing
Texas' proposal to become the latest state to license paraprofessional providers of limited legal services could help firms expand their reach and improve access to justice, but consumers, attorneys and allied legal professionals would benefit even more if similar programs across the country become more uniform, says Michael Houlberg at the University of Denver.
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What's Next For Lab Test Regulation Without FDA Authority
A recent Texas federal court decision vacating the U.S. Food and Drug Administration's final rule that would apply FDA regulations to laboratory-developed tests signals potential positive impacts in the diagnostic space, and could inspire more healthcare entities to litigate against the government, say attorneys at Hooper Lundy.
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10 Soft Skills Every GC Should Master
As businesses face shifting regulatory and technological uncertainty, general counsel will need to strengthen certain soft skills to succeed, from admitting when they make a mistake to maintaining a healthy dose of dispassion, says Douglas Brown at Manatt.
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6 Criteria Can Help Assess Executive Branch Actions
With new executive policy changes announced seemingly every day, several questions can help courts, policymakers and businesses determine whether such actions are proper, effective and in keeping with our democratic norms, say Marc Levin and Khalil Cumberbatch at the Council on Criminal Justice.
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An Unrestrained, Bright-Eyed View Of Legal AI's Future
Todd Itami at Covington offers a bright-eyed, laughing-all-the-way, skydive look at what the legal industry could look like after an artificial intelligence revolution, which he believes may happen much sooner and more dramatically than we expect.
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Tracking The Evolution In Litigation Finance
Despite continued innovation, litigation finance remains an immature market with borrowers recieving significantly different terms as lenders learn to value cases, which firms need a strong handle on to ensure lending terms do not overwhelm collateral value, says Robert Wilkins at Lightfoot Franklin.
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Keys To Regulatory Diligence In Life Sciences Transactions
Conducting effective regulatory due diligence for life sciences deals requires careful review of a target company's activities, and separate sets of considerations for commercial and pipeline products, says Anna Zhao at GunnerCooke.
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How Courts Weigh Section 1782 Discovery For UPC Cases
A look at cases from six different federal district courts reveals a number of discretionary factors that influence how courts consider Section 1782 discovery applications in connection with Unified Patent Court proceedings, say attorneys at Finnegan.
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Opinion
In Vape Case, Justices Must Focus On Agencies' Results
With the U.S. Supreme Court's ruling in U.S. Food and Drug Administration v. Wages and White Lion Investments having put off the question of whether agency decisions arrived at erroneously are always invalid, the court should give the results of agency actions more weight than the reasoning behind them when it revisits this case, says Jonathan Sheffield at Loyola University Chicago School of Law.
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Series
Volunteer Firefighting Makes Me A Better Lawyer
While practicing corporate law and firefighting may appear incongruous, the latter benefits my legal career by reminding me of the importance of humility, perspective and education, says Nicholas Passaro at Ford.
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E-Discovery Quarterly: The Perils Of Digital Data Protocols
Though stipulated protocols governing the treatment of electronically stored information in litigation are meant to streamline discovery, recent disputes demonstrate that certain missteps in the process can lead to significant inefficiencies, say attorneys at Sidley.
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Defense Strategies After Justices' Personal Injury RICO Ruling
In Medical Marijuana v. Horn, the U.S. Supreme Court recently held that the Racketeer Influenced and Corrupt Organizations Act can be invoked by some plaintiffs with claims arising from personal injuries — but defense counsel can use the limitations on civil RICO claims to seek early dismissal in such cases, say attorneys at Debevoise.
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Series
Law School's Missed Lessons: Preparing For Corporate Work
Law school often doesn't cover the business strategy, financial fluency and negotiation skills needed for a successful corporate or transactional law practice, but there are practical ways to gain relevant experience and achieve the mindset shifts critical to a thriving career in this space, says Dakota Forsyth at Olshan Frome.
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3 Red Flags To Watch For When Valuing Patent Portfolios
As forward-looking intellectual property valuations become increasingly popular, recognizing potential concerns during the due diligence process can help develop a more accurate understanding of a portfolio's true value and potential risk, says Keegan Caldwell at Caldwell Law.
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How Cos. Can Mitigate Increasing Microplastics Liability Risk
Amid rising scrutiny in the U.S. and Europe of microplastics' impact on health and the growing threat of litigation against consumer product and food and beverage manufacturers, companies can limit liability through compliance with labeling laws, careful contract management and other practices, say attorneys at Rogers Joseph.