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Life Sciences
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June 28, 2024
Chevron's End Is Just The Start For Energized Agency Foes
By knocking down a powerful precedent that has towered over administrative law for 40 years, the U.S. Supreme Court's right wing Friday gave a crowning achievement to anti-agency attorneys. But for those attorneys, the achievement is merely a means to an end, and experts expect a litigation blitzkrieg to materialize quickly in the aftermath.
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June 28, 2024
Will 'Moral Victory' In Purdue Ruling Help Plaintiffs?
The U.S. Supreme Court's decision that the Sackler family members who own Purdue Pharma LP cannot be shielded by the bankruptcy code from lawsuits over the opioid crisis reflects the widespread public outrage over their role in the epidemic, but experts say it remains unclear what will happen next for the individuals and governments that have sued the company.
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June 28, 2024
CUNY Medical Prof Accused Of Fabricating NIH Grant Apps
A medical professor at the City College of New York and paid adviser to Cassava Sciences has been indicted on allegations he falsified scientific data in grant applications submitted to the National Institutes of Health on behalf of himself and Cassava, prosecutors announced Friday.
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June 28, 2024
In Chevron Case, Justices Trade One Unknown For Another
The U.S. Supreme Court's decision to overrule a decades-old judicial deference doctrine may cause the "eternal fog of uncertainty" surrounding federal agency actions to dissipate and level the playing field in challenges of government policies, but lawyers warn it raises new questions over what rules courts must follow and how judges will implement them.
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June 28, 2024
Health Regulators Likely To Tread Carefully Post-Chevron
The demise of Chevron deference at the U.S. Supreme Court on Friday will likely encourage or fortify challenges to agency rulemaking on matters of health policy in the U.S., from Medicare reimbursement decisions to FDA rules on laboratory-developed tests.
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June 28, 2024
Shkreli Asks High Court To Toss $64M Disgorgement Order
Former pharmaceutical executive Martin Shkreli, who gained notoriety for hiking the price of HIV/AIDS medication before serving more than four years in prison for securities fraud, is asking the U.S. Supreme Court to toss a disgorgement order requiring him to pay $64 million for monopolistic price-gouging.
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June 28, 2024
Rite Aid Ch. 11 Plan OK'd With Insurers' Objections Resolved
A New Jersey bankruptcy judge Friday approved pharmacy chain Rite Aid's Chapter 11 restructuring plan after the company said it had resolved objections from its insurance carriers to how the plan treats their policies.
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June 28, 2024
Philips Gets OK For $25M Med Monitoring Deal In CPAP MDL
A Pennsylvania federal judge has given the go-ahead to a $25 million medical monitoring settlement in multidistrict litigation stemming from a recall of ventilator machines by Koninklijke Philips NV and some of its American subsidiaries.
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June 28, 2024
Nationwide Cert. Rejected In Suit Over Stolen Curaleaf Tips
An Illinois federal judge conditionally certified a class of Curaleaf hourly employees in Illinois, Arizona and Massachusetts, but denied a bid to certify a nationwide class of all Curaleaf hourly employees "based on pure speculation," in a suit alleging managers at its cannabis dispensary locations around the country stole the contents of tip jars.
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June 28, 2024
Judge Finalizes $4M Deal In Eye Doc Ransomware Dispute
A North Carolina federal judge has signed off on a $4 million deal to resolve two class actions over an electronic patient recordkeeping and billing company allegedly failing to give truthful, timely notice to ophthalmology practices and their patients about ransomware attacks that damaged its software for months.
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June 28, 2024
4 Things To Know As New SPAC Rules Take Effect
The U.S. Securities and Exchange Commission's new rules governing special-purpose acquisition companies take effect on Monday, marking an expansive attempt to strengthen oversight of SPAC deals. Here, Law360 examines what to expect as the agency's 581-page rule package goes live.
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June 28, 2024
Nixed Purdue Ch. 11 Plan May Leave States Ready For A Fight
State attorneys general across the country could be gearing up for more opioid-related litigation against the Sackler family after the U.S. Supreme Court wiped out a $5.5 billion third-party release for the owners of bankrupt drugmaker Purdue Pharma LP, experts told Law360.
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June 28, 2024
Supreme Court Strikes Down Chevron Deference
The U.S. Supreme Court on Friday overturned a decades-old precedent that instructed judges about when they could defer to federal agencies' interpretations of law in rulemaking, depriving courts of a commonly used analytic tool and leaving lots of questions about what comes next.
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June 27, 2024
4 Firms Guide Pair Of IPOs Totaling $457M
Venture-backed drug developer Alumis Inc. and oil-land acquirer LandBridge LLC on Thursday priced initial public offerings, raising a combined $456.5 million, under the guidance of four law firms.
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June 27, 2024
Biden, Trump Spar On Abortion Access In The Wake Of Dobbs
The U.S. Supreme Court's Dobbs decision upending Americans' access to abortion care made an early appearance at Thursday night's presidential debate, with President Joe Biden lamenting the end of Roe v. Wade and former President Donald Trump taking credit for handing the issue of abortion rights "back to the states."
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June 27, 2024
OptumRx Agrees To Pay $20M To Resolve DOJ Opioid Claims
OptumRx Inc. has reached a $20 million deal with the U.S. Department of Justice to end allegations the company improperly filled opioid prescriptions in combination with other drugs, the Justice Department announced Thursday.
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June 27, 2024
State AGs Want Stay Lifted In Generic Drug Pricing Suit
The attorneys general of New York and Connecticut have asked a federal judge to lift a partial discovery stay in three state-led generic drug pricing lawsuits against the pharmaceutical industry, saying it is no longer necessary because sentencing is complete in a parallel U.S. Department of Justice proceeding.
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June 27, 2024
Judge Blasts Prisons Bureau, Sends Exec To Halfway House
An Illinois federal judge said Thursday he felt he needed to protect Outcome Health's co-founder from the Bureau of Prisons' "ridiculous" policy barring her from a low security camp just because she isn't a citizen, sentencing her to time served and three years' supervision in a Chicago halfway house instead.
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June 27, 2024
Insurers Call Rite Aid Ch. 11 Opioid Deal Unfair
Counsel for bankrupt drugstore chain Rite Aid told a New Jersey bankruptcy judge Thursday that it hopes to reach an agreement with at least some of its insurers on payments into an opioid settlement fund before closing arguments in its Chapter 11 plan confirmation Friday.
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June 27, 2024
Rape Kit Co. Wants Wash. Ban Lifted During Free Speech Suit
A company that sells self-administered sexual assault DNA collection kits is urging a Washington federal judge to stop the enforcement of a new state law that it claims stifles its First Amendment rights by barring the marketing of its kits as an alternative to resources offered by law enforcement and the government.
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June 27, 2024
Fed. Circ. Backs Ax Of United Therapeutics' Drug Patent
The Federal Circuit has affirmed a Patent Trial and Appeal Board finding that claims in a United Therapeutics Corp. high blood pressure drug patent challenged by Liquidia Technologies were invalid as obvious, even though Liquidia's petition included an expert declaration that did not have a required oath.
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June 27, 2024
Titanic Purdue Ruling Shifts The Balance Of Power In Ch. 11
The U.S. Supreme Court's decision to strike down the Sackler family's liability shield in the Chapter 11 plan of Purdue Pharma LP not only eliminates a key tool to resolve mass tort liabilities through bankruptcy, it gives claimants more leverage and fundamentally changes the insolvency landscape in future cases, experts tell Law360.
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June 27, 2024
EU High Court Upends Servier Decrease Of Pay-For-Delay Fine
French pharmaceutical giant Servier is back on the hook for all but €2.4 million ($2.57 million) of a more than €300 million European Union antitrust fine after the European Court of Justice upended a lower court decision that had reduced the penalty by over €100 million.
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June 27, 2024
Ex-Exec Fights Sotera's Bid To Toss Del. Stock Vesting Suit
An attorney representing a former Sotera executive said Thursday in Delaware's Court of Chancery that the lab testing and industrial sterilization firm failed to justify its request for dismissal of a lawsuit alleging the company wrongly refused to vest his purported right to 620,000 shares in the business after his departure.
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June 27, 2024
Judge OKs $10M Deal In Generic Price-Fixing MDL
Heritage Pharmaceuticals has secured a Pennsylvania federal court's blessing on the second $10 million deal it has inked this year in hopes of extricating itself from multidistrict litigation accusing the generic-drug maker of working with others to hike up the cost of off-brand drugs.
Expert Analysis
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Reimagining Law Firm Culture To Break The Cycle Of Burnout
While attorney burnout remains a perennial issue in the legal profession, shifting post-pandemic expectations mean that law firms must adapt their office cultures to retain talent, say Kevin Henderson and Eric Pacifici at SMB Law Group.
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Expediting Psychedelics Approvals In The EU, UK, Australia
Accelerated pathways for regulatory approvals for psychedelic drugs in the European Union, U.K. and Australia is indispensable to facilitate a seamless advancement of treatments from the research environment to the consumer, say Kimberly Chew at Husch Blackwell, and Ana Dukic and Sabrina Ramkellawan at AxialBridge.
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Series
ESG Around The World: Brazil
Environmental, social and governance issues have increasingly translated into new legislation in Brazil since 2020, and in the wake of these recently enacted regulations, we are likely to see a growing number of legal disputes in the largest South American country related to ESG issues such as greenwashing if companies are not prepared to adequately adapt and comply, say attorneys at Mattos Filho.
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Opinion
Gilead Ruling Signals That Innovating Can Lead To Liability
A California appeals court's ruling last month in Gilead Life Sciences v. Superior Court of San Francisco that a drug manufacturer can be held liable for delaying the introduction of an improved version of its medication raises concerns about the chilling effects that expansive product liability claims may have on innovation, says Gary Myers at the University of Missouri School of Law.
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Opinion
Vidal Should Amend USPTO Precedent In Automaker Review
U.S. Patent and Trademark Office Director Kathi Vidal's recent decision to review Ford and Honda patent challenges that were rejected by the Patent Trial and Appeal Board provides an opportunity to revisit precedents that have unfairly denied companies a fair review process and align them with commonsense principles of legal equity, says former Sen. Patrick Leahy.
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Grant Compliance Takeaways From Ga. Tech's FCA Settlement
Georgia Tech’s recent False Claims Act settlement over its failure to detect compliance shortcomings in a grant program was unique in that it involved a voluntary repayment of funds prior to the resolution, offering a few key lessons for universities receiving research funding from the government, says Jonathan Porter at Husch Blackwell.
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Series
Competing In Dressage Makes Me A Better Lawyer
My lifelong participation in the sport of dressage — often called ballet on horses — has proven that several skills developed through training and competition are transferable to legal work, especially the ability to harness focus, persistence and versatility when negotiating a deal, says Stephanie Coco at V&E.
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How Poor Governance, Weak Contracts Harm Cannabis Cos.
Decades into cannabis decriminalization and legalization, many companies in the industry still operate on a handshake basis or fail to keep even minimally required records, which can have devastating effects and lead to costly, business-killing litigation, says Griffen Thorne at Harris Bricken.
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Del. Ruling Adds Momentum For Caremark Plaintiffs
The Delaware Supreme Court's recent opinion in Lebanon County Employees' Retirement Fund v. Collis could be viewed as expanding plaintiffs' ability to viably plead a Caremark claim against directors, so Delaware companies should be on heightened alert and focus on creating a record of board oversight, say attorneys at V&E.
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How Biotech Cos. Can Utilize Synthetic Royalty Financing
Synthetic royalty transactions have been on the rise as a funding structure for biotechnology companies, but questions have arisen surrounding how such transactions work, and structuring them correctly requires a nuanced understanding, say Todd Trattner and Ryan Murr at Gibson Dunn.
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The Legal Industry Needs A Cybersecurity Paradigm Shift
As law firms face ever-increasing risks of cyberattacks and ransomware incidents, the legal industry must implement robust cybersecurity measures and privacy-centric practices to preserve attorney-client privilege, safeguard client trust and uphold the profession’s integrity, says Ryan Paterson at Unplugged.
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Fed. Circ. In Jan.: One Word Can Affect Claim Construction
The Federal Circuit's recent Pacific Biosciences v. Personal Genomics decision highlights how even construction of a simple term can be dispositive, and thus disputed, in view of the specific context provided by the surrounding claim language, say Jeremiah Helm and Sean Murray at Knobbe.
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5 Reasons Associates Shouldn't Take A Job Just For Money
As a number of BigLaw firms increase salary scales for early-career attorneys, law students and lateral associates considering new job offers should weigh several key factors that may matter more than financial compensation, say Albert Tawil at Lateral Hub and Ruvin Levavi at Power Forward.
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How Biotech Deals May Help Competition, Despite FTC View
The Federal Trade Commission's complaint against Sanofi's proposed partnership with Maze Therapeutics highlights increasing skepticism of so-called killer acquisitions, but a closer look reveals potentially legitimate reasons behind why entities might decide to delay or abandon the development of acquired products, say consultants at Analysis Group.
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Expediting Psychedelics Approvals In The US And Canada
Accelerated regulatory pathways for psychedelics in the U.S. and Canada play a pivotal role in the progression of drugs, devices and novel therapies toward commercialization, say Kimberly Chew at Husch Blackwell, and Ana Dukic and Sabrina Ramkellawan at AxialBridge.