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Life Sciences
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May 09, 2024
Masimo Makes Offer To End Activist Politan's Proxy Contest
Medical technology company Masimo Corp. revealed Thursday that it is willing to appoint one of the director nominees put forth by activist investment firm Politan Capital Management LP in exchange for the company dropping its proxy fight, though Politan signaled distaste with the proposed deal.
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May 09, 2024
Fed. Circ. Skeptical Allergan Illegally Extended Exclusivity
A Federal Circuit panel seemed doubtful Thursday that a patent covering Allergan's bowel treatment drug Viberzi should have its life cut short based on the expiration date of related patents, in oral arguments over obviousness-type double patenting.
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May 09, 2024
Ex-Dental Device CEO Cops To $10.7M Investor Fraud
The former CEO of a dental device company pled guilty Thursday to defrauding investors out of $10.7 million with false claims that his company received the U.S. Food and Drug Administration's approval for a device he promised would take the place of X-rays.
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May 09, 2024
Ex-Official Says NJ, Ethics Board Are 'Stonewalling' Discovery
A former New Jersey health official has asked a state judge to order the state and its ethics commission to provide full discovery around his claims that he was fired in 2020 for raising concerns about the governor's chief of staff earmarking COVID-19 tests for relatives, accusing the Garden State of "stonewalling" his requests for documents and communications.
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May 09, 2024
Body-Sculpting Device Supplier Hit With Fraud Claims
A Massachusetts company that sells body-sculpting equipment tricks buyers into believing their operations will be unrealistically lucrative, and harms them with restraints on pricing and coercion against transferring their devices, according to a lawsuit in Connecticut state court.
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May 09, 2024
11th Circ. Rejects Monsanto's Roundup Suit Redo Request
The full Eleventh Circuit has rejected Monsanto's renewed request for review of a panel's ruling that a Georgia doctor can allege the company failed to warn about cancer risks associated with the use of Roundup weedkiller despite federal pesticide labeling requirements.
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May 09, 2024
Ex-Pharma Exec Asks 1st Circ. To DQ Judge In Contempt Case
U.S. District Judge Mark Wolf cannot be impartial and must be disqualified from presiding over a criminal contempt trial against a former pharmaceutical executive accused of using an alias to flout a civil judgment, the defendant told the First Circuit in a Wednesday filing.
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May 09, 2024
Apnea Device Maker ProSomnus Gets OK For Ch. 11 Loan
A Delaware bankruptcy judge Thursday gave sleep apnea device maker ProSomnus interim permission to tap into $13 million in Chapter 11 financing to fund the company through what it says will be the end of its case in August.
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May 09, 2024
Deals Rumor Mill: Paramount, Peloton, International Paper
Sony and Apollo plan to break up Paramount if their $26 billion bid prevails, private equity firms are eyeing a Peloton buyout, and International Paper gets a $15 billion bid from Brazil's Suzano. Here, Law360 breaks down the notable deal rumors from the past week.
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May 08, 2024
Quinn Emanuel Atty Says Asset Freeze Hurt Outcome Defense
The U.S. government's overreach in restraining millions more than it could reasonably trace back to a $1 billion fraud by Outcome Health prevented the company's former CEO from hiring Quinn Emanuel Urquhart & Sullivan LLP attorneys to defend the charges like he originally wanted, an Illinois federal judge heard Wednesday.
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May 08, 2024
Opioid Maker Beats Investor Suit Over FDA Warning For Good
A California federal judge has permanently dismissed a lawsuit from investors of acute pain drug company AcelRx Pharmaceuticals Inc. accusing it of engaging in misbranding violations that put it at greater risk for regulatory scrutiny.
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May 08, 2024
Shockwave Medical Investor Challenges $13B Deal With J&J
A shareholder of cardiovascular treatment company Shockwave Medical Inc. is attempting to halt the company's "unfair" $13 billion proposed transaction with Johnson & Johnson by filing a securities suit, saying the transaction will only benefit company insiders and damage public shareholders.
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May 08, 2024
Conn. Justices To Hear McCarter & English Damages Demand
The Connecticut Supreme Court has accepted a certified question from a federal district court judge in McCarter & English LLP's yearslong fee feud with a former client, agreeing to decide whether the firm can recover punitive damages after years chasing Jarrow Formulas Inc. and winning a jury verdict last year.
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May 08, 2024
Kirkland Drives Vance Street To $775M Fund IV Closing
Los Angeles-based private equity shop Vance Street Capital, advised by Kirkland & Ellis LLP, on Wednesday announced it held the first and final close for its fourth fund with $775 million in tow.
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May 08, 2024
Sleep Apnea Co. Hits Ch. 11 Over $41.5M In Debt, Cash Woes
California-based ProSomnus, which produces devices to prevent sleep apnea, said a balance sheet heavy with more than $41.5 million in debt and difficulty in funding its continued operations forced it to file for Chapter 11 protections in Delaware.
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May 08, 2024
Simpson Thacher-Led Silver Lake Lands $20.5B For 7th Fund
Technology-focused private equity shop Silver Lake, advised by Simpson Thacher & Bartlett LLP, announced Wednesday the closing of its seventh flagship fund after securing $20.5 billion from investors, beating out the amount raised in its predecessor fund by about half a billion dollars.
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May 07, 2024
GOP Reps. Want IP Enforcers To Get Tougher On Infringers
Republican lawmakers complained at a Tuesday congressional hearing about the Biden administration's move to end the controversial Trump-era "China Initiative" aimed at curbing suspected economic espionage and questioned administration officials over how diligently they have pursued intellectual property cases on behalf of U.S. manufacturers, retailers, movie studios and vape companies.
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May 07, 2024
Iceberg Image Closes Pacira Drug Patent Infringement Trial
A generic drugmaker on Tuesday used imagery to argue that the information in a Pacira Biosciences Inc. painkiller patent is just the proverbial tip of the iceberg, positing that regulators would have rejected the application if all the data on the medicine had been revealed.
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May 07, 2024
Pharma Co. Falsely Touted Obesity Drug Results, Suit Claims
Biopharmaceutical company Altimmune Inc. and three of its executives were hit with a proposed class action alleging they overstated the clinical trial results and prospects of its obesity drug and its ability to compete with other weight loss medications like Ozempic.
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May 07, 2024
Fed. Circ. Seems Wary Of Broad's CRISPR Inventorship Win
Federal Circuit Judge Todd Hughes on Tuesday suggested that the Patent Trial and Appeal Board cited the correct standard when reviewing who first invented a particular use of the gene-editing technology CRISPR-Cas9, but then applied an improper standard when ruling in favor of a Massachusetts research team.
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May 07, 2024
Colo. Judge Tells Cos. Their Warring Briefs Aren't Helping
A Colorado federal judge has warned a medical device distributor and a Stryker subsidiary warring over a $2.3 million sanctions request that neither of their briefs appeared to provide "meaningful assistance" to help him determine what to award.
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May 07, 2024
Fla. Schools And Hospitals Fight To Save Opioid Claims
Five public hospital districts and two school districts told a Florida appeals court Tuesday that their claims for damages from the opioid crisis should not be eclipsed by the attorney general's settlements with opioid makers and distributors, arguing that she did not have the authority to bring claims on their behalf.
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May 07, 2024
Gov't Seeks Early Win In Ga. Medicaid Expansion Suit
The Biden administration is urging a federal judge to take its side in a lawsuit in which Georgia is attempting to keep its Medicaid program for low-income residents running until 2028, arguing that the state never properly asked for a program extension and that the court lacks jurisdiction to extend its end date.
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May 07, 2024
NJ Law Firm Scores Exit In Benicar MDL Fees Suit
A New Jersey federal judge on Tuesday granted Mazie Slater Katz & Freeman LLC attorneys a quick win in a proposed class action claiming they took excessive fees from plaintiffs' settlements in multidistrict litigation over the blood pressure drug Benicar, ruling the suit alleges identical claims to another suit that has been dismissed.
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May 07, 2024
Prepetition Waivers Sway Invitae Judge On Kirkland Hire
A New Jersey bankruptcy judge approved the retention of Kirkland & Ellis LLP as bankruptcy counsel for debtor Invitae Corp. Tuesday, the same day he approved a $239 million sale of its assets to Labcorp.
Expert Analysis
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Global Cartel Enforcement Looks Set To Intensify In 2024
The cartel enforcement winds may strengthen this year, with the U.S. Department of Justice, as well as regulators in other countries, placing a renewed focus on pursuing international cartels and more traditional, hard-core cartel conduct, say attorneys at Simpson Thacher.
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Series
Baking Bread Makes Me A Better Lawyer
After many years practicing law, and a few years baking bread, I have learned that there are a few keys to success in both endeavors, including the assembly of a nourishing and resilient culture, and the ability to learn from failure and exercise patience, says Rick Robinson at Reed Smith.
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Supreme Court Amgen Ruling's Major Effect On Enablement
The U.S. Supreme Court's Amgen v. Sanofi invalidity holding continues to significantly affect technologies and all aspects of the patent system by providing confidence in the Federal Circuit's approach and a clearer understanding on enforceability and the disclosure needed for compliance, say Irena Royzman and Daniel Williams at Kramer Levin.
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Federal Courts And AI Standing Orders: Safety Or Overkill?
Several district court judges have issued standing orders regulating the use of artificial intelligence in their courts, but courts should consider following ordinary notice and comment procedures before implementing sweeping mandates that could be unnecessarily burdensome and counterproductive, say attorneys at Curtis.
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7 E-Discovery Predictions For 2024 And Beyond
The legal and technical issues of e-discovery now affect virtually every lawsuit, and in the year to come, practitioners can expect practices and policies to evolve in a number of ways, from the expanded use of relevancy redactions to mandated information security provisions in protective orders, say attorneys at Littler.
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Top Considerations For Retailers Using AI To Combat Theft
The Federal Trade Commission's recent enforcement action against Rite Aid indicates a significant evolution in the landscape surrounding biometric information and artificial intelligence data collection by retailers, meaning retailers should take reasonable measures to prevent harm to customers, say attorneys at Dentons.
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2 FCPA Settlements Illuminate Self-Disclosure, Disgorgement
Two of last year’s Foreign Corrupt Practices Act settlements — with biomedical company Lifecore and mining company Corsa Coal — suggest that the government will be much more flexible in negotiating disgorgement amounts if an entity voluntarily self-discloses misconduct, say Michael Gilbert and Lucas Amodio at Sheppard Mullin.
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Opinion
Anti-Kickback Statute Does Not Require But-For Causation
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.
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5 Litigation Funding Trends To Note In 2024
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.
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Medtronic's Cautionary Tale Of Fed. Circ. Word Limits
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.
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Key Legal Trends For Healthcare And Life Sciences In 2024
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.
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Series
ESG Around The World: South Africa
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.
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FOIA Exemption Questions On Redacted HHS Cannabis Letter
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.
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Fed. Circ. Ruling Seemingly Offers PTAB Deadline Immunity
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.
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Evaluating Retroactivity Of Mich. Drugmaker Immunity Repeal
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.