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Life Sciences
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September 20, 2024
J&J Makes Third Try At Handling Talc Claims In Bankruptcy
A Johnson & Johnson talc unit filed for Chapter 11 protection in Texas bankruptcy court Friday, marking the third time the company has tried to deal with liability from alleged asbestos-contaminated talc with a bankruptcy filing.
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September 20, 2024
Cardinal Health Pays $1.12B For Integrated Oncology Network
Ropes & Gray LLP-advised Cardinal Health on Friday announced that it has agreed to buy the physician-led independent community oncology entity Integrated Oncology Network for $1.115 billion in cash, in a deal that Cardinal says builds on its commitment to helping community healthcare providers hold on to their independence.
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September 20, 2024
Womble Bond Hires New Head Of Int'l Disputes From Dechert
Womble Bond Dickinson has hired a former Dechert LLP partner as the head of its international disputes practice, who will be based in the firm's Washington, D.C., office and will double as a partner in its business litigation practice group, Womble Bond recently announced.
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September 20, 2024
Ga. Airport Pat-Down Caused Catastrophic Injuries, Man Says
A man sued the government and several unnamed parties in Georgia federal court Thursday, alleging that he fractured his thoracic vertebrae, spent 52 days in the hospital and had to undergo surgery after an airport screening incident at Hartsfield-Jackson Atlanta International Airport.
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September 20, 2024
UK Litigation Roundup: Here's What You Missed In London
The past week in London has seen crypto exchange Binance face a new claim from the co-founder of SO Legal, a U.S. immersive art company take on a Bristol venue for copyright violations and Blake Morgan LLP hit with a pension schemes claim by The Trust for Welsh Archeology. Here, Law360 looks at these and other new claims in the U.K.
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September 20, 2024
FTC Accuses Drug Middlemen Of Raising Insulin Prices
The Federal Trade Commission on Friday accused the three largest pharmacy benefits managers, Caremark Rx, Express Scripts and OptumRx, of artificially inflating insulin prices by relying on unfair rebate schemes that hurt competition.
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September 19, 2024
Bills On Patent Eligibility, PTAB Limits Near Senate Markup
Legislation aiming to reduce decisions finding inventions ineligible for patenting and restrict invalidity challenges at the Patent Trial and Appeal Board will likely be considered by the Senate Judiciary Committee next week, a sponsor of the measures said Thursday.
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September 19, 2024
AndroGel Antitrust Case On Hold Amid Settlement Talk
A Pennsylvania federal judge has agreed to pause a class action against Abbott and other drugmakers over allegedly sham patent cases, saying a settlement between the two sides may be in the works.
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September 19, 2024
Ga. Appeals Court Says Hospital Must Get Certificate Of Need
The Georgia Court of Appeals for the second time has said that a Georgia hospital must obtain a new certificate of need from the state to convert its long-term care beds to short-stay acute care beds, following guidance issued by the state's justices earlier this year.
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September 19, 2024
Another Ill. Jury Deadlocks Over Zantac Cancer Claims
There was another mistrial declared on Wednesday in a lawsuit over claims that pharmaceutical company Boehringer Ingelheim's over-the-counter-drug for heartburn, Zantac, caused a man's cancer in a case brought by the Illinois man.
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September 19, 2024
Convicted Drexel Professor Won't Get New Tax Evasion Trial
A Drexel University accounting professor was denied a new trial after being convicted on tax evasion charges for failing to report $3.3 million in income from a Trenton pharmacy, a New Jersey federal judge has ruled, reasoning that the professor's case was not prejudiced by keeping accounting records related to his tax returns from the jury.
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September 19, 2024
Outcome Exec Who Flipped Gets 7 Months For $1B Fraud Role
A former Outcome Health sales chief who was charged with helping to carry out a $1 billion fraud, but cooperated early and testified against his co-defendants, received seven months in prison Thursday for his role in the scheme.
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September 19, 2024
Norwich Asks Justices To Allow Sale Of Generic Diarrhea Drug
A New York drugmaker has told the U.S. Supreme Court that the courts have gone too far in preventing the release of a generic version of a blockbuster diarrhea drug, after a lower court found there was a way of using the drug that would infringe certain patents.
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September 19, 2024
Conn. Justices Wonder How 'Malicious' Firm's Ex-Client Was
The Connecticut Supreme Court on Thursday questioned whether an ex-McCarter & English LLP client was "wanton" and "malicious" enough to justify the firm's novel $3.6 million punitive damages bid in a protracted billing dispute that has already fetched the firm judgments totaling more than $2 million on contract claims.
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September 19, 2024
Airline Sinks Bias Suit From Worker Fired Over Drug Test
A Pennsylvania federal judge tossed a race and disability bias suit from an American Airlines worker who said she was fired over a positive drug test triggered by her ADHD medication, ruling she hadn't presented evidence that bias drove the decision to let her go.
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September 18, 2024
Axonics Didn't Infringe Medtronic Patents, Calif. Jury Says
Axonics did not infringe three of Medtronic's patents related to its bladder and bowel control device, a California federal jury determined Wednesday.
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September 18, 2024
CVS Unit Pays $60M Over Alleged Insurance Kickback Scheme
CVS Health subsidiary Oak Street will pay $60 million to settle allegations it violated the False Claims Act by paying illegal kickbacks to third-party insurers in return for scouting and inducing Medicare and Medicaid beneficiaries to enroll in its primary care clinics, the U.S. Department of Justice announced Wednesday.
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September 18, 2024
7th Circ. Questions Nixing $183M Eli Lilly Drug Rebate Verdict
A Seventh Circuit judge seemed unsure Wednesday whether to disturb a $183 million verdict against Eli Lilly in a false claims case targeting more than a decade of drug rebate miscalculations, questioning whether the company skipped checking legal guidance before calling its price reporting requirements unclear.
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September 18, 2024
Fed. Circ. Revives Astellas Patent Axed As Natural Law
The Federal Circuit on Wednesday vacated a lower court's invalidation of an Astellas Pharma overactive bladder medication patent for claiming only a natural law, saying the holding was improper because the generics makers accused of infringement never made that argument.
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September 18, 2024
Rescheduling Pot Would Not Hasten Research, Report Says
A recently enacted law will continue to make it difficult for medical researchers to conduct studies on marijuana, even if federal restrictions are loosened on the drug, according to a new report published Monday by the Congressional Research Service.
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September 18, 2024
Georgia High Court Won't Hear Missed Patent Deadline Case
The highest court in Georgia has decided not to take up an appeal from a neurosurgeon in his nearly $102 million lawsuit, letting stand a lower court's finding that a patent docketing contractor used by remote law firm FisherBroyles can't be held liable for a missed patent application deadline.
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September 18, 2024
SEC Settles Latest Covington Info Theft Case For $33K
A New Jersey man will pay a $33,000 civil penalty to the U.S. Securities and Exchange Commission for insider trading on confidential merger tips that his cousin stole from a Covington & Burling LLP lawyer, according to a settlement filed in New York federal court on Wednesday.
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September 18, 2024
Ex-Amgen Rep Wasn't Original Whistleblower, Judge Says
A Brooklyn federal judge tossed a former Amgen sales representative's whistleblower suit on Wednesday, saying many elements of his allegations of a kickback scheme had been disclosed in news reports and civil lawsuits prior to his filing.
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September 18, 2024
ITC Looking At Advanced Bionics Implant Patent Claims
The U.S. International Trade Commission said it will look into allegations from Switzerland's Advanced Bionics that Austria's Med-El has been infringing cochlear implant hearing aid technology.
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September 18, 2024
Thermo Fisher Late To Pay Departing Workers, Engineer Says
Thermo Fisher Scientific Inc. and a subsidiary failed to promptly pay all final wages and unused vacation time to departing employees and must now cough up three times the amount of that compensation because of its violation of Massachusetts law, according to a proposed class action filed in state court.
Expert Analysis
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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.
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Del. Dispatch: 27.6% Stockholder Not A Controller
The Delaware Court of Chancery's recent decision in Sciannella v. AstraZeneca — which found that the pharma giant, a 26.7% stockholder of Viela Bio Inc., was not a controller of Viela, despite having management control — shows that overall context matters when challenging transactions on breach of fiduciary duty grounds, say attorneys at Fried Frank.