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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.
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
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How Cannabis Rescheduling May Affect Current Operators
The U.S. Drug Enforcement Agency's proposal to reschedule marijuana to Schedule III provides relief in the form of federal policy from the stigma and burdens of Schedule I, but commercial cannabis operations will remain unchanged until the federal-state cannabis policy gap is remedied by Congress, say Meital Manzuri and Alexis Lazzeri at Manzuri Law.
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Series
Skiing And Surfing Make Me A Better Lawyer
The skills I’ve learned while riding waves in the ocean and slopes in the mountains have translated to my legal career — developing strong mentor relationships, remaining calm in difficult situations, and being prepared and able to move to a backup plan when needed, says Brian Claassen at Knobbe Martens.
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Class Actions At The Circuit Courts: June Lessons
In this month's review of class action appeals, Mitchell Engel at Shook Hardy considers two recent decisions from the Third and Tenth Circuits, and identifies practice tips around class action settlements and standing in securities litigation.
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Tracking Implementation Of IRA Programs As Election Nears
As the Biden administration races to cement key regulations implementing the Inflation Reduction Act, a number of the law's programs and incentives are at risk of delay or repeal if Republicans retake control of Congress, the White House or both — so stakeholders should closely watch ongoing IRA implementation and guidance, say attorneys at Squire Patton.
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Unpacking The Circuit Split Over A Federal Atty Fee Rule
Federal circuit courts that have addressed Rule 41(d) of the Federal Rules of Civil Procedure are split as to whether attorney fees are included as part of the costs of a previously dismissed action, so practitioners aiming to recover or avoid fees should tailor arguments to the appropriate court, says Joseph Myles at Finnegan.
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Del. Bankruptcy Ruling Will Give D&O Insureds Nightmares
In Henrich v. XL Specialty Insurance, the Delaware Bankruptcy Court recently found that a never-served qui tam claim had been "brought" before a D&O policy's retroactive date, thereby eliminating coverage, and creating a nightmare scenario for directors and officers policyholders facing whistleblower claims, says David Klein at Pillsbury.
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Opinion
No Matter The Purdue Ruling, Mass Tort Reform Is Needed
The U.S. Supreme Court will soon issue its opinion in the bankruptcy of Purdue Pharma LP, and regardless of the outcome, it’s clear legal and policy reforms are needed to address the next mass tort, says William Organek at Baruch College.
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After A Brief Hiccup, The 'Rocket Docket' Soars Back To No. 1
The Eastern District of Virginia’s precipitous 2022 fall from its storied rocket docket status appears to have been a temporary aberration, as recent statistics reveal that the court is once again back on top as the fastest federal civil trial court in the nation, says Robert Tata at Hunton.
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Protecting Trade Secrets In US, EU Gov't Agency Submissions
Attorneys at Mintz compare U.S. and European Union trade secret laws, and how proprietary information in confidential submissions to the U.S. Food and Drug Administration and the European Medicines Agency is protected in the face of third-party information requests under government transparency laws.
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Recruitment Trends In Emerging Law Firm Frontiers
BigLaw firms are facing local recruitment challenges as they increasingly establish offices in cities outside of the major legal hubs, requiring them to weigh various strategies for attracting talent that present different risks and benefits, says Tom Hanlon at Buchanan Law.
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4 Tips For Drafting Earnouts To Avoid Disputes
Amid slowed merger and acquisition activity, buyers and sellers are increasingly turning to earnout provisions to get deals done, but these must be carefully drafted to avoid interpretative differences that can lead to later disputes, say attorneys at Cooley.
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Series
Glassblowing Makes Me A Better Lawyer
I never expected that glassblowing would strongly influence my work as an attorney, but it has taught me the importance of building a solid foundation for your work, learning from others and committing to a lifetime of practice, says Margaret House at Kalijarvi Chuzi.
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Opinion
Flawed Fintiv Rule Should Be Deemed Overreach In Tech Suit
A pending federal lawsuit over the U.S. Patent and Trademark Office's unilateral changes to key elements of the America Invents Act, Apple v. Vidal, could shift the balance of power between Congress and federal agencies, as it could justify future instances of unelected officials unilaterally changing laws, say Patrick Leahy and Bob Goodlatte.
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How Associates Can Build A Professional Image
As hybrid work arrangements become the norm in the legal industry, early-career attorneys must be proactive in building and maintaining a professional presence in both physical and digital settings, ensuring that their image aligns with their long-term career goals, say Lana Manganiello at Equinox Strategy Partners and Estelle Winsett at Estelle Winsett Professional Image Consulting.
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High Court's Abortion Pill Ruling Shuts Out Future Challenges
The U.S. Supreme Court's unanimous ruling in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine maintains the status quo for mifepristone access and rejects the plaintiffs' standing theories so thoroughly that future challenges from states or other plaintiffs are unlikely to be viable, say Jaime Santos and Annaka Nava at Goodwin.