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Life Sciences
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June 07, 2024
Conn. Judge Pushes State For Proof In $11M Kickback Case
The Connecticut state judge presiding over an $11 million false claims and kickbacks case against a compounding pharmacy appeared unconvinced Friday that the defendants submitted false claims for payment, peppering the government's counsel with requests to support assertions with case law and evidence that was put on at trial.
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June 07, 2024
Chicago-Area Man Charged With $60M COVID Test Fraud
A suburban Chicago man is facing healthcare fraud and money laundering charges over more than $60 million in Medicare reimbursement claims for over-the-counter COVID-19 test kits that were allegedly never provided, including thousands of tests for dead people.
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June 07, 2024
DC Circ. Undoes Library Of Congress Win In Fair Use Fight
The D.C. Circuit on Friday reversed a lower court's decision that had rejected two industry groups' challenge to a final rule that categorized medical device diagnostic procedures and repairs as fair use exemptions to U.S. copyright law.
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June 07, 2024
SEC Fines Ex-AstraZeneca Insider $1.4M For Merger Trades
The U.S. Securities and Exchange Commission has ordered a former AstraZeneca employee to pay $1.4 million to settle claims he used nonpublic information to trade CinCor Pharma shares ahead of the public announcement that the two companies would merge.
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June 07, 2024
Ranbaxy Units Overcome Lipitor Antitrust MDL
Multiple Ranbaxy Inc. entities have defeated multidistrict litigation accusing them of conspiring with Pfizer Inc. to delay releasing a generic alternative to blood pressure drug Lipitor, as a New Jersey federal judge on Thursday criticized the drug purchasers' "speculative" arguments.
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June 07, 2024
Goodwin, Cooley Lead J&J-Backed Neurological Firm's IPO
Johnson & Johnson-backed neurological firm Rapport Therapeutics Inc. rallied in debut trading Friday after it completed a $136 million initial public offering within its price range, guided by Goodwin Procter LLP and underwriters counsel Cooley LLP.
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June 07, 2024
COVID Test Supplier Sees $1.4M Default Loss In Gopuff Suit
A Connecticut federal court on Friday handed a medical supply company a default loss in a suit by online retail delivery service Gopuff alleging that the supplier failed to fulfill an order for nearly 106,000 COVID-19 test kits, ordering the company to pay roughly $1.4 million.
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June 07, 2024
Acorda Therapeutics Gets OK On $185M Ch. 11 Sale To Merz
Drugmaker Acorda Therapeutics Inc. received a New York bankruptcy judge's approval Friday to complete a $185 million sale of its assets to a fellow pharmaceutical company, allowing Acorda to move ahead with a Chapter 11 plan to wind down its business.
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June 07, 2024
Fed. Circ. Panel Doubts Bid To Nix Actavis' $12M Deduction
A Federal Circuit panel seemed skeptical of the government's bid to overturn a decision allowing drugmaker Actavis to deduct $12 million it spent fending off lawsuits as it secured approval to sell generics, raising the question during oral arguments Friday whether the company was being uniquely targeted.
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June 06, 2024
White Collar Boutique Sued By Ex-Client Over Representation
White collar boutique Clark Smith Villazor LLP and one of its name partners is facing a lawsuit from a former client, a convicted securities fraud defendant who claims the firm caused him to be arrested by the FBI and face millions of dollars in fines.
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June 06, 2024
USPTO Rejects Apple's Bids To Reexamine Masimo Patents
Apple has failed to convince examiners at the U.S. Patent and Trademark Office that there are any new reasons to cancel claims in a pair of patents cited in a U.S. International Trade Commission ruling that blocks the tech giant from importing Apple Watches with a blood oxygen sensor.
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June 06, 2024
Drugmakers Escape Cancer Drug Antitrust Claims For Now
A New Jersey federal judge granted drugmakers Celgene and Bristol-Myers Squibb an out from consolidated antitrust litigation accusing them of delaying generic competition to their blockbuster cancer treatments, saying the conduct alleged by a group of insurer plaintiffs fails to amount to anti-competitive conduct.
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June 06, 2024
Pharma Co. Misled Investors On Seizure Drug Trial, Suit Says
Marinus Pharmaceuticals has been hit with a proposed shareholder class action alleging that the company understated the risks of an epilepsy drug trial and did not warn investors that trial enrollment would be suspended when it failed to meet certain criteria.
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June 06, 2024
8th Circ. Affirms Cigna Noncompete Applies To CVS Hire
The Eighth Circuit has backed a lower court finding that blocked a healthcare industry executive from making a move to CVS, handing a win to Cigna in a case over trade secrets.
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June 06, 2024
$25 Million Flint Water Class Deal Gets Early OK
A Michigan federal judge on Thursday gave initial approval for a $25 million settlement between a class of Flint adults and businesses and a water engineering company accused of prolonging the town's water crisis, calling the deal fair and an opportunity to avoid years of "exhausting" litigation.
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June 06, 2024
Judge OKs $42M Stent IP Verdict, Discards Willfulness Finding
A Delaware federal judge has said Boston Scientific was not entitled to a new trial in a case where it was told to pay $42 million for stent systems patent infringement, but threw out a finding of willful infringement.
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June 06, 2024
FDA Urges High Court To Hear 5th Circ. Flavored E-Cig Case
The U.S. Food and Drug Administration is asking the U.S. Supreme Court to grant its petition for a review of an en banc Fifth Circuit decision overturning its denial of a flavored e-cigarette marketing application, saying this case provides a better vehicle to decide the issues than other petitions at the high court.
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June 06, 2024
Abbott Labs Must Face Bulk Of Glucerna False Ad Suit
A California federal judge won't free Abbott Laboratories from a proposed class action over its Glucerna shakes, saying the complaint plausibly alleges that the labeling would mislead consumers about the health aspects of the drinks.
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June 06, 2024
Biote Investors Sue Cooley, SPAC After Huge Merger Loss
Family trust investors in Biote Corp. have sued Cooley LLP and the "hormone optimization" company's top brass over the $700 million merger Biote completed with a special purpose acquisition company, saying the deal was a "disastrous transaction to divert approximately $70 million of merger consideration to themselves and gain control of an enterprise they did not build."
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June 06, 2024
Law Firm Says Axe 'Draconian' J&J Subpoena In Talc Claim
A Mississippi plaintiffs firm urged a New Jersey federal court on Thursday to quash a subpoena served by Johnson & Johnson requesting that the firm turn over documents related to litigation funding and its communication with media outlets, calling the subpoena "draconian" and improper as the firm is not a party to the pharmaceutical giant's current personal injury litigation surrounding its talcum powder products.
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June 06, 2024
'Brussels Effect' Of EU's AI Act Is Uncertain, Legal Pros Say
BigLaw attorneys advising international clients on the European Union's AI Act tell Law360 there are significant uncertainties over vague terms in the 458-page statute, how its steep eight-figure fines will be enforced, and whether it will set a new standard globally as part of the "Brussels effect."
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June 06, 2024
Pharma Co. Should Get Hungarian Rebate, ECJ Adviser Says
Danish pharmaceutical company Novo Nordisk's mandatory payments into the Hungarian health system should reduce the company's tax base for value-added tax payments, an adviser to the European Union's highest court said Thursday.
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June 05, 2024
USPTO Fee Hike Finds Ally In Google, But Others Have Gripes
The U.S. Patent and Trademark Office's plan to increase many patent-related fees beginning next year has received support from Google, but dozens of other comments came from patent litigators of all stripes who argue that the proposal is a bad idea.
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June 05, 2024
AI Co., Biotech Prep IPOs Worth $602M As Novelis Delays
Healthcare data artificial intelligence platform Tempus AI and Australian biotech Telix Pharmaceuticals on Wednesday unveiled plans for initial public offerings that will aim to raise a combined total of approximately $602 million, while sustainable aluminum solutions provider Novelis, a day prior, postponed IPO plans due to market conditions.
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June 05, 2024
Medtronic Can't Pause FCA Claims For 1st Circ. Detour
A Massachusetts federal judge on Wednesday declined to pause a long-pending False Claims Act and whistleblower retaliation case against medical device maker Medtronic so it can appeal a recent ruling, saying the court and the parties need to "get it moving."
Expert Analysis
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Preparing For DOJ's Data Analytics Push In FCPA Cases
After the U.S. Department of Justice’s recent announcement that it will leverage data analytics in Foreign Corrupt Practice Act investigations and prosecutions, companies will need to develop a compliance strategy that likewise implements data analytics to get ahead of enforcement risks, say attorneys at Cozen O'Connor.
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Reducing The Risk Of PFAS False Advertising Class Actions
A wave of class actions continues to pummel products that allegedly contain per- or polyfluoroalkyl substances, with plaintiffs challenging advertising that they say misleads consumers by implying an absence of PFAS — but there are steps companies can take to minimize risk, say attorneys at Keller and Heckman.
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Series
Coaching High School Wrestling Makes Me A Better Lawyer
Coaching my son’s high school wrestling team has been great fun, but it’s also demonstrated how a legal career can benefit from certain experiences, such as embracing the unknown, studying the rules and engaging with new people, says Richard Davis at Maynard Nexsen.
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Opinion
New Rule 702 Helps Judges Keep Bad Science Out Of Court
A court's recent decision to exclude dubious testimony from the plaintiffs' experts in multidistrict litigation over acetaminophen highlights the responsibility that judges have to keep questionable scientific evidence out of courtrooms, particularly under recent amendments to Federal Rule of Evidence 702, says Sherman Joyce at the American Tort Reform Association.
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SG's Office Is Case Study To Help Close Legal Gender Gap
As women continue to be underrepresented in the upper echelons of the legal profession, law firms could learn from the example set by the Office of the Solicitor General, where culture and workplace policies have helped foster greater gender equality, say attorneys at Ocean Tomo.
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Opinion
Patent Waiver For COVID Meds Would Harm US Biopharma
If the Biden administration backs the World Trade Organization in waiving patent rights on COVID-19 treatments, it would negatively affect the U.S. biopharmaceutical industry and help foreign competitors, without necessarily expanding global access to COVID-19 care, says clinical pathologist Wolfgang Klietmann.
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Skirting Anti-Kickback Causation Standard Amid Circuit Split
Amid the federal circuit court split over the causation standard applicable to False Claims Act cases involving Anti-Kickback Statute violations, which the First Circuit will soon consider in U.S. v. Regeneron, litigators aiming to circumvent the heightened standard should contemplate certain strategies, say Matthew Modafferi and Terence Park at Frier Levitt.
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10 Lessons From A Deep Dive Into IP Damages
Decisions on challenging an intellectual property expert's opinion can benefit from the in-depth study of court rulings on admissibility grounds, where the findings include the fact that patent cases see the most challenges of any IP area, say Deepa Sundararaman and Cleve Tyler at Berkeley Research.
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What Shareholder Approval Rule Changes Mean For Cos.
The U.S. Securities and Exchange Commission recently approved proposed rule changes to shareholder requirements by the New York Stock Exchange, an approval that will benefit listed companies in many ways, including by making it easier to raise capital from passive investors, say attorneys at Baker Botts.
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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.