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Life Sciences
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October 15, 2024
Ill. Home Health Kickbacks Ruling Intact After Justices Pass
The nation's top court said Tuesday it won't review a Seventh Circuit decision largely affirming that a home health care company broke federal kickback laws, leaving intact its holding that the company must pay millions in damages.
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October 14, 2024
Baker McKenzie Leads Lundbeck's $2.6B Deal For US Pharma
Lundbeck said Monday that it has agreed to buy Longboard, a U.S. biopharmaceutical business, for $2.6 billion in cash as the Danish drug giant aims to capture a drug with "blockbuster potential" to treat a rare form of epilepsy.
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October 11, 2024
Pharmacist Gets Up To 15 Years In Mich. For Fatal Outbreak
A pharmacist charged for the deaths in a 2012 fatal fungal meningitis outbreak was sentenced Friday afternoon in Michigan state court to 7½ to 15 years in prison, concluding the state's case that had been pending for six years, the pharmacist's attorney has announced.
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October 11, 2024
High Court's TCPA Grant Set To Broaden Loper Bright's Blow
On the heels of the U.S. Supreme Court dealing a major blow to the power of federal agencies to interpret laws, the justices are poised to again boost judicial authority and potentially release a torrent of litigation challenging the established tome of regulations crafted under the Telephone Consumer Protection Act.
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October 11, 2024
Apotex Accused Of Infringing Novo Nordisk Diabetes Drug
The largest producer of generic drugs in Canada is infringing U.S. patents for Rybelsus, a medication for people with Type 2 diabetes that also is used for weight loss, drugmaker Novo Nordisk Inc. claimed in a federal lawsuit.
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October 11, 2024
Up Next At High Court: CBD Injuries & The Clean Water Act
The U.S. Supreme Court will be closed Monday, but the justices will return to the bench Tuesday to hear arguments over whether the federal Racketeering Influenced and Corrupt Organizations Act allows litigants to pursue claims of economic harm tied to personal injuries, and how specific pollutant discharge limits have to be under the Clean Water Act.
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October 11, 2024
Apple Watch Patents Dodge Ax As Masimo Jury Trial Nears
A Delaware federal judge has refused to invalidate Apple Inc.'s smartwatch patents being challenged by health technology company Masimo Corp. ahead of this month's jury trial over whether the tech behemoth infringed Masimo's pulse oximetry technology patents.
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October 11, 2024
Medytox Loses ITC Fight Over Antiwrinkle Trade Secrets Use
The U.S. International Trade Commission has backed a finding that medical aesthetic provider Medytox Inc. failed to prove that two other companies wrongly used its antiwrinkle biotechnology to create another product.
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October 11, 2024
Texan Who Sued Ex's Colleagues Over Abortion Drops Suit
A Texas man who filed a wrongful-death suit against his ex-wife's co-workers that alleged that they helped her obtain pills to terminate her pregnancy has dropped the suit on the eve of trial, saying in a notice Friday that the parties have settled.
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October 11, 2024
J&J Should Pay $30M For Developer's Cancer, Conn. Jury Told
Attorneys for a western Massachusetts real estate developer on Friday urged a Connecticut jury to award $30 million for past and future suffering to a lifelong Johnson & Johnson baby powder user diagnosed with mesothelioma, but the company's attorneys suggested $4 million was a more reasonable figure while contesting liability whatsoever.
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October 11, 2024
Justices Will Evaluate RICO Scope In Trucker's CBD Case
The U.S. Supreme Court on Tuesday will hear a case brought by a trio of CBD companies asking the justices to establish whether a trucker can bring a personal injury claim under the Racketeer Influenced and Corrupt Organizations Act, or RICO.
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October 11, 2024
Swiss Officials Clear Novartis IP Suits As 'Common Practice'
Swiss authorities have dropped their antitrust probe into patent suits Novartis lodged against rival Eli Lilly and others over psoriasis treatment Cosentyx, saying Novartis' actions were aboveboard.
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October 11, 2024
9th Circ. Backs Planned Parenthood's $14M Atty Fee Win
The Ninth Circuit upheld a nearly $14 million attorney fee award to Planned Parenthood after the reproductive health service provider won its suit claiming the Center for Medical Progress unlawfully recorded abortion service providers, saying Friday the award was not unreasonably disproportionate to the jury's $2.4 million damages award.
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October 11, 2024
'Bloodsport' Poaching Case To Mediate After Disputed Verdict
An exasperated Boston federal judge on Friday talked two rival medical aesthetic device companies into a round of mediation with a magistrate judge to see if they could wrap up the fiercely litigated poaching case that's already resulted in a contested eight-figure verdict.
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October 11, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen billionaire Lakshmi Mittal sue steel magnate Sanjeev Gupta in a long-running clash to claw back €140 million ($153 million) of debt, a high-profile AI researcher take action against the Intellectual Property Office to register his software as a listed patent inventor and troubled housing trust Home Reit face a claim by a real estate developer. Here, Law360 looks at these and other new claims in the U.K.
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October 10, 2024
Animal Medication Co. Sued Over Dog Arthritis Treatment Risks
New Jersey-based animal medication company Zoetis Inc. was hit with a proposed class action Wednesday alleging that a drug used to treat osteoarthritis in dogs has harmful effects such as seizures, inability to walk, organ damage and even death, which the company has failed to warn about.
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October 10, 2024
Federal Policy Can't Kill Psilocybin Access Suit, Court Told
A group of psilocybin facilitators suing Oregon health officials to expand access to homebound clients told a federal judge on Wednesday that the state should not be able to use the federal ban on the psychoactive compound to kill their suit.
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October 10, 2024
Biotech Co. Gritstone Hits Ch. 11 With Over $100M Debt
Vaccine developer Gritstone bio Inc. filed for Chapter 11 protection in Delaware bankruptcy court Thursday with at least $100 million of debt, saying it was in discussions with a potential bidder for a sale of the business to ensure it can continue researching cancer and other disease treatments.
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October 10, 2024
Target Made Inflated Claims About Gas Pills, Shoppers Allege
Target customers hit the retailer with a putative class action lawsuit in New York federal court Wednesday alleging its line of Up & Up gas relief pills is not "maximum strength" as the label contends, and other similar medications have higher concentrations of key ingredients.
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October 10, 2024
Teva To Pay $450M To Settle Kickback Cases
Pharmaceutical giant Teva will pay $450 million to settle allegations it violated the False Claims Act by fixing the prices of several generic drugs and by raising the price of a multiple sclerosis treatment while covering Medicare recipients' copays, civil prosecutors said Thursday.
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October 10, 2024
Sen. Warren, Novo At Odds On Merits Of $16.5B Deal
Sen. Elizabeth Warren on Thursday raised the alarm on Novo Holdings' planned $16.5 billion purchase of Catalent, arguing the transaction could give Novo "unprecedented" control over the production of certain obesity drugs by Eli Lilly and other top competitors, but Novo insists the deal would give it no such edge.
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October 10, 2024
Pfizer Threatened To Sue Former Execs, Starboard Says
Activist investment firm Starboard Value has set its sights on pharmaceutical giant Pfizer, issuing a letter Thursday that alleges Pfizer has threatened to sue former executives that Starboard is working with and expresses "concerns about the trajectory of the business."
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October 10, 2024
Hyundai Plans IPO For Indian Biz, Plus More Rumors
Hyundai's Indian unit is eyeing a massive $3.3 billion initial public offering, rumors are swirling regarding ownership stakes of major European soccer clubs, and Saudi Arabia’s Public Investment Fund may buy a $1 billion minority stake in sports-streaming giant DAZN. Here, Law360 breaks down these and other notable rumors from the past week.
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October 09, 2024
CVS, United Health Seek Removal Of FTC's Khan In PBM Case
Major pharmacy benefit manager owners are calling on a Federal Trade Commission administrative judge to disqualify three Democratic FTC commissioners from the agency's in-house lawsuit accusing them of artificially inflating insulin prices, arguing that the commissioners have repeatedly vilified PBMs and prejudged the proceeding.
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October 09, 2024
Philips Preserves Lanham Act Counterclaim In CPAP Cleaner MDL
A Pennsylvania federal judge has trimmed some counterclaims by Koninklijke Philips NV and its American affiliates against SoClean Inc., whose cleaning products they say are responsible for damage to Philips' CPAP machines.
Expert Analysis
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Series
Rock Climbing Makes Me A Better Lawyer
Rock climbing requires problem-solving, focus, risk management and resilience, skills that are also invaluable assets in my role as a finance lawyer, says Mei Zhang at Haynes and Boone.
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Think Like A Lawyer: Dance The Legal Standard Two-Step
From rookie brief writers to Chief Justice John Roberts, lawyers should master the legal standard two-step — framing the governing standard at the outset, and clarifying why they meet that standard — which has benefits for both the drafter and reader, says Luke Andrews at Poole Huffman.
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Alice Step 2 Trends Show Courts' Extrinsic Evidence Reliance
A look at recent trends in how district courts are applying Step 2 of the Alice framework shows that courts have increasingly relied on extrinsic evidence to help determine whether a claimed invention is "well-understood, routine, and conventional," says Jonathan Tuminaro at Sterne Kessler.
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Recent Settlement Shows 'China Initiative' Has Life After Death
Though the U.S. Department of Justice shuttered its controversial China Initiative two years ago, its recent False Claims Act settlement with the Cleveland Clinic Foundation demonstrates that prosecutors are more than willing to civilly pursue research institutions whose employees were previously targeted, say attorneys at Benesch.
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DOJ Innovasis Settlement Offers Lessons On Self-Disclosure
The recent $12 million settlement with Innovasis and two of its executives demonstrates the U.S. Department of Justice's continued prioritization of Anti-Kickback Statute enforcement amid the growing circuit split over causation, and illustrates important nuances surrounding self-disclosure, say Denise Barnes and Scott Gallisdorfer at Bass Berry.
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How Orange Book Antitrust Scrutiny Is Intensifying
Pharmaceutical patent holders should be reviewing Orange Book listing practices, as the Federal Trade Commission takes a more aggressive antitrust approach with actions such as the Teva listing probe, and the U.S. Food and Drug Administration calls attention to potentially improper listings, say attorneys at McDermott.
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Weight-Loss Drugs May Spur Next Major Mass Tort
With lawsuits concerning Ozempic and similar weight-loss drugs potentially becoming the next major mass tort in the U.S., companies should consider key defense strategies ranging from alternate dispute resolution to enhanced drug safety, say Dino Haloulos and Jarif Khan at Foley & Mansfield.
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Opinion
The FTC Needs To Challenge The Novo-Catalent Deal
Novo's acquisition of Catalent threatens to substantially lessen competition in the manufacturing and marketing of GLP-1 diabetes and obesity drugs, and the Federal Trade Commission should challenge it under a vertical theory of harm, as it aligns with last year's merger guidelines and the Fifth Circuit decision in Illumina, says attorney David Balto.
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Series
After Chevron: Slowing Down AI In Medical Research
The U.S. Supreme Court's recent decision overturning the Chevron doctrine may inhibit agencies' regulatory efforts, potentially slowing down the approval and implementation of artificial intelligence-driven methodologies in medical research, as well as regulators' responses to public health emergencies, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.
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Series
Being A Luthier Makes Me A Better Lawyer
When I’m not working as an appellate lawyer, I spend my spare time building guitars — a craft known as luthiery — which has helped to enhance the discipline, patience and resilience needed to write better briefs, says Rob Carty at Nichols Brar.
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FDA's Multifaceted Role On Display In MDMA Therapy Scrutiny
Ongoing deliberations at the U.S. Food and Drug Administration regarding MDMA-assisted therapy for post-traumatic stress disorder serves as a window into the intricate balance of scientific innovation and patient safety oversight, and offers crucial insights into regulatory nuances, say Kimberly Chew at Husch Blackwell and Kevin Lanzo at Pharmaka Clinical Consulting.
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Lead Like 'Ted Lasso' By Embracing Cognitive Diversity
The Apple TV+ series “Ted Lasso” aptly illustrates how embracing cognitive diversity can be a winning strategy for teams, providing a useful lesson for law firms, which can benefit significantly from fresh, diverse perspectives and collaborative problem-solving, says Paul Manuele at PR Manuele Consulting.
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How Cos. Should Handle Research Org.'s Carcinogen Evals
In light of the International Agency of Research for Cancer's list of substances slated for review over the next five years, manufacturers of chemicals, pharmaceuticals and consumer products should monitor for potentially unbalanced determinations, which could stimulate litigation regarding potential exposure from products, say attorneys at Nelson Mullins.
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Analyzing FDA Draft Guidance On Clinical Trial Diversity
In light of the U.S. Food and Drug Administration's draft guidance on clinical trial diversity action plans, there are several important considerations for sponsors and clinical researchers to keep in mind to prevent delay in a drug or device application, say attorneys at Crowell & Moring.
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What's New In The AI Healthcare Regulatory Space
Attorneys at Hogan Lovells review the current legal and regulatory landscape for artificial intelligence applications in healthcare, touching on policies around safety, transparency, nondiscrimination and reimbursement, and what to expect in the future.