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Life Sciences
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September 20, 2023
$10M Verdict Against Intuitive Lowered To Just A Dollar
A Delaware federal judge on Wednesday slashed a jury's $10 million jury damages verdict against Intuitive Surgical Inc. to just $1, holding that Rex Medical LP didn't offer up any reasonable evidence for anyone to tie the value of its surgical stapler patent to the $10 million award.
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September 20, 2023
Supplement Co. Wants McCarter & English Win Slashed
A California dietary supplement company is renewing its bid to see a Connecticut federal judge supersede a jury's decision in a breach of contract suit filed against it by its onetime counsel, McCarter & English LLP, arguing the nearly $6.5 million in damages a jury awarded should be reduced to roughly $859,000.
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September 20, 2023
Sutter Health Owes $519M For Double-Billing, Trial Judge Told
Counsel representing a retired Sutter Health orthopedic surgeon told a California state judge during bench trial openings in his whistleblower suit Wednesday that the nonprofit owes $519 million after allegedly double-billing for certain operating-room services without documentation, while Sutter's counsel defended its billing practices as proper.
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September 20, 2023
Stryker Appeals OsteoMed's Surgical Implant Patent Wins
Stryker Corp. filed a pair of appeals Tuesday seeking to undo patent board rulings invalidating its patents for a surgical implant after a Berkshire Hathaway-owned rival challenged multiple claims in patents that are also at issue in an Illinois federal court case.
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September 20, 2023
Mallinckrodt Gets Final OK For $250M Ch. 11 Financing
Drugmaker Mallinckrodt received final approval Wednesday in Delaware bankruptcy court for $250 million of Chapter 11 financing from its prepetition secured lenders, despite one creditor's objection over proposed management bonuses.
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September 20, 2023
Drug Cos. Don't Always Provide Required Discounts To Gov't
A U.S. Department of Veterans Affairs watchdog said Wednesday that drugmakers are failing to provide legally required discounts to federal agencies for hundreds of drugs, potentially resulting in $28.1 million in overcharges to the VA and U.S. Department of Defense.
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September 20, 2023
House Bill Would Shield Psilocybin Legalization From DOJ
A pair of U.S. House of Representatives members on Wednesday pitched a new bill to bar the use of federal funds to enforce federal drug policy against states and jurisdictions that legalize the use and distribution of psilocybin, the active ingredient in so-called magic mushrooms.
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September 20, 2023
Ill. Justices Mull Sending Suit Over Abbott Drug To Jury
Justices of the Illinois Supreme Court pushed counsel for Abbott Laboratories on Wednesday to address why a jury shouldn't weigh in on the credibility of two doctors who testified they would have still prescribed Abbott's anti-convulsant drug Depakote to a woman had they been warned accurately about its risk of birth defects.
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September 20, 2023
Biden Admin Extends Comment Period On Mental Health Regs
The U.S. Department of Labor and two other agencies announced Wednesday that they will give the public more time to weigh in on proposed rules that would require employer health plans to comply with a federal law restricting coverage limitations on mental health and substance use disorder treatments.
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September 20, 2023
Del. Justices Urged To Reverse AmerisourceBergen Dismissal
An attorney for AmerisourceBergen Inc. stockholders urged Delaware's top court Wednesday to reverse a Chancery Court finding that dismissal of federal opioid-related damage claims in West Virginia justified scuttling a multibillion-dollar board liability action.
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September 20, 2023
NJ Judge Tosses Proposed Cannabis REIT Investor Suit
A cannabis-focused real estate investment trust is off the hook in a proposed securities class action from investors who claimed the REIT hid the fact that its major tenant was a Ponzi scheme.
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September 20, 2023
Opiate MDL Special Master Faces DQ Bid Over 'Reply All' Goof
Pharmacy benefit managers OptumRX Inc. and Express Scripts Inc. called for the disqualification of the special master overseeing multidistrict litigation brought against the PBMs over the national opioid epidemic after he allegedly revealed a bias against them in an email they said he inadvertently sent as a "reply all."
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September 20, 2023
Fed. Circ. Hands Win To Roche In Blood Drug Fight
The Federal Circuit on Wednesday relied on the high court's recent Amgen ruling to side with a Delaware federal court decision that let a Roche subsidiary off the hook in an infringement case over its blockbuster hemophilia drug Hemlibra.
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September 20, 2023
Takeda Settles Gout Drug Antitrust Case Midtrial
Takeda Pharmaceuticals USA Inc. has reached a settlement with drug wholesalers in the middle of an antitrust trial in Pennsylvania federal court over the delayed entry of a generic version of its gout drug Colcrys, according to court filings.
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September 20, 2023
Orrick Adds MoFo Tech And Life Sciences IP Litigator In SF
Orrick Herrington & Sutcliffe LLP is expanding its West Coast team, bringing in a Morrison Foerster LLP intellectual property litigator as a partner in its San Francisco office.
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September 20, 2023
Arnold & Porter Opens Boston Office With Life Science Focus
Arnold & Porter has picked Boston as the site for its 15th office and hired the former co-chair of Foley Hoag LLP's life sciences industry group to head the new outpost.
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September 19, 2023
Humana Tries To Ax Walgreens' Claims Over Crowell & Moring
Humana urged a Washington, D.C., judge Tuesday to throw out Walgreens' claims against the insurer in the ongoing legal battle involving Crowell & Moring LLP's past representation of the companies.
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September 19, 2023
Eli Lilly Launches 10 Suits Over New Diabetes Drug
A little more than a year after releasing a popular billion-dollar drug marketed at people with Type 2 diabetes, Eli Lilly & Co. filed a flurry of lawsuits on Tuesday against spas and other retailers that it says are selling counterfeit or compounded versions of the drug as a weight loss cure.
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September 19, 2023
Merck Chided By AARP, Democrats Over Drug Price Suit
The AARP, along with Democratic lawmakers and physician groups, lambasted Merck & Co. Inc.'s challenge to the Medicare drug price negotiation program on Tuesday, disputing the pharmaceutical company's constitutional arguments and saying it wants to eviscerate a program that will improve drug access and reduce federal spending.
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September 19, 2023
New Jersey Shore Town Wants Pot Co.'s Zoning Suit Tossed
A city in New Jersey wants a federal court to nix a lawsuit alleging a company's application for a medical cannabis facility was unfairly stifled by the local government because the plaintiff did not establish that it has a property stake protected by due process, among other failures of the suit, according to a dismissal bid from the municipality.
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September 19, 2023
Judge OKs Juul's $255M Deal, Bars AI Co.'s 'En Masse' Claims
A California federal judge approved Tuesday Juul's $255 million deal resolving multidistrict litigation over the company's alleged marketing to children, but held off on awarding attorney fees and refused to let the controversial ClaimClam website, which uses AI to identify potential class members, submit thousands of claims "en masse."
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September 19, 2023
J&J Defends Texas Two-Step Talc Gambit To Lawmakers
Johnson & Johnson's litigation head on Tuesday defended the talc unit's use of the "Texas two-step" strategy to handle thousands of talc asbestos claims, as bipartisan lawmakers assailed the tactic as an attempt to reap "all the benefits of bankruptcy without the cost."
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September 19, 2023
Texas Atty Blamed 'Brain Fart' For False Statement, SEC Says
The U.S. Securities and Exchange Commission has sued a Dallas company making CBD inhalers and its attorney CEO, alleging that they raised over $2 million on the strength of "numerous" falsehoods about the company and its operations and citing testimony in which the CEO said one of the alleged lies was due to a "brain fart."
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September 19, 2023
1st Circ. Sides With J&J Subsidiary In Lactaid False Ad Suit
The First Circuit on Monday affirmed the dismissal of a proposed class action alleging that a Johnson & Johnson subsidiary misbrands its Lactaid drug products as dietary supplements, holding that federal labeling laws preempt her claims.
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September 19, 2023
Takeda Wants End To Gout Drug Antitrust Case Midtrial
Takeda Pharmaceuticals is seeking an early end to an ongoing trial in an antitrust case brought by drug wholesalers over the delayed entry of a generic version of its gout drug Colcrys, claiming that underlying patent litigation and that lack of solid evidence pointing to a price-fixing conspiracy torpedo the plaintiffs' case.
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 To Protect Atty-Client Privilege While Using Generative AI
When using generative artificial intelligence tools, attorneys should consider several safeguards to avoid breaches or complications in attorney-client privilege, say Antonious Sadek and Christopher Campbell at DLA Piper.
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Opinion
HIV Drug Case Against Gilead Threatens Medical Innovation
The California Court of Appeals should dismiss claims alleging that Gilead should be held liable for not bringing an HIV treatment to market sooner, or else the biopharmaceutical industry could be disincentivized from important development and innovation, says James Stansel at Pharmaceutical Research and Manufacturers of America.
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How New Lawyers Can Leverage Feedback For Growth
Embracing constructive criticism as a tool for success can help new lawyers accelerate their professional growth and law firms build a culture of continuous improvement, says Katie Aldrich at Fringe Professional Development.
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RICO Trade Secret Standard Prevails Within 9th Circ. Courts
Federal courts in the Ninth Circuit seem to be requiring a relatively high degree of factual detail — arguably more than is expressly mandated by statute — to plead and maintain Racketeer and Corrupt Organizations Act claims in trade secret disputes, says Cary Sullivan at Jones Day.
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Series
ESG Around The World: Australia
Clive Cachia and Cathy Ma at K&L Gates detail ESG-reporting policies in Australia and explain how the country is starting to introduce mandatory requirements as ESG performance is increasingly seen as a key investment and corporate differentiator in the fight for global capital.
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Concerns For 510(k) Sponsors After FDA Proposes Major Shift
While there may be public health benefits from modernizing the 510(k) process for clearing medical devices, recent draft guidance from the U.S. Food and Drug Administration's Center for Devices and Radiological Health leaves meaningful open questions about the legal and regulatory implications of the new approach, and potential practical challenges, say attorneys at Covington.
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Developers Are Testing Defenses In Generative AI Litigation
In the rapidly growing field of generative artificial intelligence law in the U.S., there are a few possible defenses that have already been effectively asserted by defendants in litigation, including lack of standing, reliance on the fair use doctrine, and the legality of so-called data scraping, say attorneys at K&L Gates.
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Approval Regs Must Change To Keep Up With Biologics Tech
The U.S. Food and Drug Administration’s system for approving biologic therapies, which bans applicants from drawing on previously established safety and efficacy data, may slow innovation in life-saving gene and cell therapies, but policy updates could help the regulatory paradigm keep pace with the scientific cutting edge, say Eva Temkin and Jessica Greenbaum at King & Spalding.
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Opinion
Address The Data Monopoly, Otherwise Tech Giants Control AI
It is likely that we will experience a severe monopoly on artificial intelligence systems and patents by the largest players in the tech industry, so the way we treat data needs to change, whether through the legislature, the courts or tech companies, says Pranav Katti at Barclay Damon.
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Minn. Product Case Highlights Challenges Of Misuse Defense
The recent decision by a Minnesota federal court in McDougall v. CRC Industries illustrates that even where a product that is clearly being misused results in personal injuries, manufacturers cannot necessarily rely on the misuse defense to absolve them of liability exposure, says Timothy Freeman at Tanenbaum Keale.
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The Impact Of A Del. District's Procedural Shift On Disclosures
A Delaware federal judge's standing orders regarding corporate ownership and funding disclosure requirements have had significant impacts even outside of the judge's court, including on how patent assertion entities organize and file cases, and have addressed the ethical implications of litigation control revealed through the disclosures, say attorneys at Finnegan.
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Twitter Legal Fees Suit Offers Crash Course In Billing Ethics
X Corp.'s suit alleging that Wachtell grossly inflated its fees in the final days of Elon Musk’s Twitter acquisition provides a case study in how firms should protect their reputations by hewing to ethical billing practices and the high standards for professional conduct that govern attorney-client relationships, says Lourdes Fuentes at Karta Legal.
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Leveraging The Strategic Pause In Patent Prosecution
Lu Yin at Quarles & Brady examines strategic reasons why slowing down the patent prosecution process can be advantageous, including financial considerations, administrative hurdles and coordination with international filings.
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EU Privacy Framework Bodes Well For US Life Sciences Cos.
U.S.-based life sciences companies could face data transfer challenges since they may be subject to the EU General Data Protection Regulation even without having an EU presence, but a recently approved EU-U.S. Data Privacy Framework may provide helpful protection at least for the near future, says Wim Nauwelaerts at Alston & Bird.
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Opinion
Laws Based On Rapid Drug Tests Are Unscientific And Unfair
Given the widespread legalization of marijuana, states are increasingly implementing laws to penalize drivers under the influence of drugs, but the laws do more harm than good as the rapid tests they rely on do not accurately measure impairment, say Josh Bloom and Henry Miller at the American Council on Science and Health.