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Life Sciences
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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.
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June 27, 2024
AbbVie Buys Bowel Disease Biotech Celsius For $250M
Chicago-based pharmaceutical company AbbVie said Thursday it has acquired Celsius Therapeutics Inc., a privately held clinical-stage biotechnology company developing therapies for patients with inflammatory disease, for $250 million.
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June 27, 2024
Calif. Justices Say Patient's Choice A Factor In Product Cases
The California Supreme Court has sided with a woman alleging that a shock therapy device made by Somatics LLC caused her permanent injuries, saying she can establish that her injuries were caused by a lack of warning as long as she shows that a prudent patient would have declined treatment upon hearing a warning.
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June 27, 2024
Poor Governance Tanked Genomic Co.'s Stock, Investor Says
Poor corporate governance led to Sema4 Holdings Corp., now named GeneDx Holdings Corp., nixing hundreds of jobs and failing the Nasdaq requirement for common stock to close above $1 per share for 30 consecutive trading days, a derivative shareholder suit filed Tuesday against the genomics company's top brass alleges.
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June 27, 2024
Honeywell Says Sourcing Co. Backpedaled On Supply Deal
Honeywell has accused a sourcing company of trying to claw its way out of a contract to buy medical-grade gloves by fabricating quality concerns and launching a bogus recall in an allegedly underhanded way to make itself more appealing to potential buyers.
Expert Analysis
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5 Takeaways From FDA's Biosimilars Promotion Guidance
New draft guidance from the U.S. Food and Drug Administration expands upon other recent efforts to clarify expectations for biosimilar and interchangeable labeling, highlighting a number of potential missteps that could draw attention from regulators, say attorneys at Arnold & Porter.
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Dual-Track IPO-M&A Exit Strategies For Life Science Cos.
A dual-track process for life sciences companies offers a proven path to securing favorable deal terms for an exit, and strategic moves can include running a crossover financing round in the lead-up, say attorneys at McDermott.
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Does Expert Testimony Aid Preliminary IPR Responses?
Dechert attorneys analyze six years of patent owners' preliminary responses to inter partes review petitions to determine whether the elimination of the presumption favoring the petitioner as to preinstitution testimonial evidence affected the usefulness of expert testimony in responses.
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Are Concessions In FDA's Lab-Developed Tests Rule Enough?
Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.
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Rebuttal
Double-Patenting Ruling Shows Terminal Disclaimers' Value
While a recent Law360 guest article seems to argue that the Federal Circuit’s Cellect decision last year robs patent owners of lawful patent term, the ruling actually identifies how terminal disclaimers are the solution to the problem of obviousness-type double patenting, say Jane Love and Robert Trenchard at Gibson Dunn.
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Series
Swimming Makes Me A Better Lawyer
Years of participation in swimming events, especially in the open water, have proven to be ideal preparation for appellate arguments in court — just as you must put your trust in the ocean when competing in a swim event, you must do the same with the judicial process, says John Kulewicz at Vorys.
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Mid-2024 FCA Enforcement And Litigation Trends To Watch
Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.
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What 100 Federal Cases Suggest About Changes To Chevron
With the U.S. Supreme Court poised to overturn or narrow its 40-year-old doctrine of Chevron deference, a review of 100 recent federal district court decisions confirm that changes to the Chevron framework will have broad ramifications — but the magnitude of the impact will depend on the details of the high court's ruling, say Kali Schellenberg and Jon Cochran at LeVan Stapleton.
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Why High Court May Have Rejected IP Obviousness Appeal
Attorneys at Womble Bond analyze possible reasons the U.S. Supreme Court rejected Vanda Pharmaceuticals' request to review the Federal Circuit’s reasonable expectation of success standard for determining obviousness, including that the court was unpersuaded by the company's argument that Amgen v. Sanofi places a bind on drug developers.
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Microplastics At The Crossroads Of Regulation And Litigation
Though there are currently not many federal regulations specifically addressing microplastics as pollutants, regulatory scrutiny and lawsuits asserting consumer protection claims are both on the rise, and manufacturers should take proactive steps to implement preventive measures accordingly, say Aliza Karetnick and Franco Corrado at Morgan Lewis.
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The Fed. Circ. In April: Hurdles Remain For Generics
The Federal Circuit’s recent Salix v. Norwich ruling — where Salix's brand-name drug's patents were invalidated — is a reminder to patent practitioners that invalidating a competitor's patents may not guarantee abbreviated new drug application approval, say Sean Murray and Jeremiah Helm at Knobbe Martens.
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Tylenol MDL Highlights Expert Admissibility Headaches
A New York federal court's decision to exclude all plaintiff experts in a multidistrict litigation concerning prenatal exposure to Tylenol highlights a number of expert testimony pitfalls that parties should avoid in product liability and mass tort matters, say Rand Brothers and Courtney Block at Winston & Strawn.
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Don't Use The Same Template For Every Client Alert
As the old marketing adage goes, consistency is key, but law firm style guides need consistency that contemplates variety when it comes to client alert formats, allowing attorneys to tailor alerts to best fit the audience and subject matter, says Jessica Kaplan at Legally Penned.
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Don't Fall On That Hill: Keys To Testifying Before Congress
Because congressional testimony often comes with political, reputational and financial risks in addition to legal pitfalls, witnesses and their attorneys should take a multifaceted approach to preparation, walking a fine line between legal and business considerations, say attorneys at Crowell & Moring.
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Online Portal Helps Fortify Feds' Unfair Health Practices Fight
The Federal Trade Commission, U.S. Justice Department and the U.S. Department of Health and Human Services recently launched an online portal where the public can report potentially unfair healthcare practices, effectively maximizing enforcers' abilities to police anti-competitive actions that can drive up healthcare costs and chill innovation, say attorneys at Seyfarth.