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Life Sciences
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May 09, 2024
First Zantac Trial Plaintiff Says She Can't Live Normal Life
An Illinois woman suing the former manufacturers of Zantac heartburn medication and claiming her long-term use of the drug caused her colon cancer testified Thursday that she has struggled to control her bowels since her 2015 diagnosis and has experienced multiple accidents in public places that left her humiliated and fearful to leave her home.
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May 09, 2024
Judge Halts DEA's Hearing On Proposed Psychedelics Ban
An administrative law judge with the U.S. Drug Enforcement Administration has ordered the agency to cancel a June 10 hearing on its proposal to ban two psychedelic substances while a researcher's federal lawsuit challenging the agency's actions plays out in court, according to an order made public Thursday.
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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.
Expert Analysis
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Think Like A Lawyer: Follow The Iron Rule Of Trial Logic
Many diligent and eager attorneys include every good fact, point and rule in their trial narratives — spurred by the gnawing fear they’ll be second-guessed for leaving something out — but this approach ignores a fundamental principle of successful trial lawyering, says Luke Andrews at Poole Huffman.
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The Art Of Asking: Leveraging Your Contacts For Referrals
Though attorneys may hesitate to ask for referral recommendations to generate new business, research shows that people want to help others they know, like and trust, so consider who in your network you should approach and how to make the ask, says Rebecca Hnatowski at Edwards Advisory.
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Trending At The PTAB: Permissible New Reply Arguments
In the time since the Federal Circuit’s Axonics ruling, the Patent Trial and Appeal Board has allowed petitioners to raise new unpatentability grounds in response to unforeseeable claim constructions in petitions, and reiterated that a petition need not anticipate every argument that may be raised in the response, say Joseph Myles and Timothy May at Finnegan.
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Wave Of Final Rules Reflects Race Against CRA Deadline
The flurry of final rules now leaping off the Federal Register press — some of which will affect entire industries and millions of Americans — shows President Joe Biden's determination to protect his regulatory legacy from reversal by the next Congress, given the impending statutory look-back period under the Congressional Review Act, say attorneys at Jenner & Block.
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'Beauty From Within' Trend Poses Regulatory Risks For Cos.
Companies capitalizing on the current trend in oral supplements touting cosmetic benefits must note that a product claim that would be acceptable for an externally applied cosmetic may draw much stronger scrutiny from the U.S. Food and Drug Administration when applied to a supplement, say Natalie Rainer and Katherine Staba at K&L Gates.
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McKesson May Change How AKS-Based FCA Claims Are Pled
The Second Circuit’s analysis in U.S. v. McKesson, an Anti-Kickback Statute-based False Claims Act case, provides guidance for both relators and defendants parsing scienter-related allegations, say Li Yu at Dicello Levitt, Ellen London at London & Stout, and Erica Hitchings at Whistleblower Law.
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Series
Being An Equestrian Makes Me A Better Lawyer
Beyond getting experience thinking on my feet and tackling stressful situations, the skills I've gained from horseback riding have considerable overlap with the skills used to practice law, particularly in terms of team building, continuing education, and making an effort to reset and recharge, says Kerry Irwin at Moore & Van Allen.
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7th Circ. Mootness Fee Case May Curb Frivolous Merger Suits
On April 15, the Seventh Circuit in Jorge Alcarez v. Akorn Inc. mapped out a framework for courts to consider mootness fees paid to individual shareholders after the voluntary dismissal of a challenge to a public company merger, which could encourage objections to mootness fees and reduce the number of frivolous merger challenges filed, say attorneys at Skadden.
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Fintiv Denials Are On The Rise At PTAB
Following last year's CommScope v. Dali decision, the Patent Trial and Appeal Board is increasingly using Fintiv factors to discretionarily deny inter partes review petitions — and attorneys ignore it at their peril, say Josepher Li and Michelle Armond at Armond Wilson.
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4 Ways To Refresh Your Law Firm's Marketing Strategy
With many BigLaw firms relying on an increasingly obsolete marketing approach that prioritizes stiff professionalism over authentic connection, adopting a few key communications strategies to better connect with today's clients and prospects can make all the difference, say Eric Pacifici and Kevin Henderson at SMB Law.
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Cos. Must Prepare For Calif. Legislation That Would Ban PFAS
Pending California legislation that would ban the sale or distribution of new products containing intentionally added per- and polyfluoroalkyl substances could affect thousands of businesses — and given the bill's expected passage, and its draconian enforcement regime, companies must act now to prepare for it, say attorneys at Alston & Bird.
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FDA Warning Letter Tightens Reins On 'Research Only' Labels
A recent warning letter from the U.S. Food and Drug Administration to Agena Bioscience alleged the company’s diagnostic devices were labeled for research use only, but improperly promoted for human clinical purposes, signifying a reinforcement — and a potential narrowing — of the agency's policy on products labeled “research only,” say attorneys at Sheppard Mullin.
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Practical Pointers After Fed. Circ. Double-Patenting Decision
With the Federal Circuit recently denying a full court review of In re: Cellect, a decision regarding obviousness-type double-patenting, affected patent family holders should evaluate their rights through both patent prosecution and future litigation lenses to minimize risks, say Austin Lorch and Jeff Wolfson at Haynes Boone.
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Highlights From The 2024 ABA Antitrust Spring Meeting
U.S. merger enforcement and cartels figured heavily in this year's American Bar Association spring antitrust meeting, where one key takeaway included news that the Federal Trade Commission's anticipated changes to the Hart-Scott-Rodino form may be less dramatic than many originally feared, say attorneys at Freshfields.
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Strategies For Challenging A Fla. Grand Jury Report's Release
A Florida grand jury’s recent report on potential wrongdoing related to COVID-19 vaccines should serve as a reminder to attorneys to review the myriad legal mechanisms available to challenge the lawfulness of a grand jury report’s publication and expunge the names of their clients, says Cary Aronovitz at Holland & Knight.