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Life Sciences
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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.
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September 18, 2024
GSK Inks 2 Calif. Zantac Deals
GlaxoSmithKline LLC on Wednesday said that it had reached two settlements in California state court over allegations that its heartburn drug Zantac had caused cancer, although the company did not disclose the deal amounts.
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September 18, 2024
Biotech Co. Escapes Stock-Drop Suit Over COVID-19 Drug
A Massachusetts biotech company won dismissal Wednesday from a proposed class action by investors who say their shares tanked in value after it allegedly came to light that executives had falsely touted an unproven prospective COVID-19 medicine.
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September 18, 2024
Organon To Buy Psoriasis Treatment Biz For Up To $1.2B
Women's healthcare-focused company Organon, advised by Covington & Burling LLP, on Wednesday announced it will purchase Freshfields Bruckhaus Deringer LLP-led Dermavant, a subsidiary of Roivant that develops and commercializes therapies in immuno-dermatology.
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September 17, 2024
Benefit Funds Sue Sandoz Over Alleged Fraudulent Transfers
Several health and welfare funds have filed a class action against Sandoz Inc. and affiliates in Pennsylvania federal court, alleging the drugmaker engaged in fraudulent transfers designed to evade liabilities stemming from drug-pricing antitrust litigation.
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September 17, 2024
GC Base Salaries At Big Companies On The Rise
General counsel base salaries at companies making $5 billion or more in revenue has increased from last year, while their total compensation has decreased, according to a report released Tuesday by the Association of Corporate Counsel and Empsight International LLC.
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September 17, 2024
Philip Morris To Part With Inhaler Maker In Up To £258M Deal
Philip Morris International is spacing itself from the British inhaler maker it purchased in 2021 through an up to £258 million ($339.6 million) sale that preserves a commercial relationship, amid what the tobacco company called "unwarranted opposition" to its role in developing inhaled therapeutics.
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September 17, 2024
Express Scripts Blasts 'Biased' FTC Drug Middlemen Report
The Federal Trade Commission defamed Express Scripts and violated its constitutional rights with an inaccurate report that ripped the role pharmacy benefit managers play as middlemen between drugmakers and insurers, according to a lawsuit lodged Tuesday in Missouri federal court.
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September 17, 2024
Merit Medical To Buy Rival's Heart Implant Biz For $210M
Merit Medical Systems Inc. said Tuesday it has agreed to buy Cook Medical Inc.'s heart device implant portfolio for $210 million, as the U.S. medical product maker looks to capture a slice of the growing global cardiac intervention market.
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September 16, 2024
Teleflex Gets Another Chance In Catheter Patent Feud
The Federal Circuit on Monday held that a Minnesota district court was wrong to invalidate claims in seven catheter patents Teleflex LLC asserted against Medtronic Inc. as indefinite, finding the lower court took an overly narrow view of how claims are construed.
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September 16, 2024
Injectable Analgesic Maker Wants Generic Version Blocked
Mallinckrodt Pharmaceuticals has sued a rival drugmaker in Delaware federal court, alleging the company copied its injectable version of acetaminophen and infringed four patents in the process.
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September 16, 2024
Pot Co. Execs Go To 9th Circ. In Investment Scam Case
A California cannabis company and its co-founders on Monday appealed a federal court decision booting them from the securities industry and holding them liable for roughly $6 million tied to a medical marijuana investment scam, the same day that the U.S. Securities and Exchange Commission asked the court to order a third individual to pay up for his part in the alleged scam.
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September 16, 2024
5th Circ. Judge Chides High Court Calls in Abortion Pill Case
U.S. Circuit Judge James C. Ho on Monday threw shade at the U.S. Supreme Court and the Biden administration over what he described as side-switching on federal conscience laws for doctors.
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September 16, 2024
Pall Corp. Shorts Workers By Rounding OT, Suit Says
A proposed class action filed Sept. 12 alleges that biotech supplier Pall Corp. followed a time-rounding policy that systematically undercompensated employees, and accused the company of improperly deducting 30 minutes from employees' pay for meal breaks, even when employees took shorter breaks.
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September 16, 2024
J&J Cheers Toss Of 'Indefensible' $260M Talc Verdict
An Oregon state judge rejected a jury's $260 million verdict for a woman who blamed Johnson & Johnson's talcum powder for her cancer diagnosis, a company spokesperson said Monday.
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September 16, 2024
Bayer Beats IP Firm's Bid To Nix European MRI Patent
Bayer AG has seen off a challenge by law firm De Simone & Partners to scrap its patent for a type of contrast agent used to improve the quality of MRI scans after European patent officials confirmed that it contained a new compound.
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September 16, 2024
Nebraska Medical Cannabis Initiatives Will Be On Nov. Ballot
Initiatives to legalize medical marijuana in Nebraska will appear on the ballot come November, despite some evidence of fraud in the signature-collecting petition process, according to state election officials.
Expert Analysis
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Updated Federal Rules Can Improve Product Liability MDLs
The recent amendment of a federal evidence rule regarding expert testimony and the proposal of a civil rule on managing early discovery in multidistrict legislation hold great promise for promoting the uniform and efficient processes that high-stakes product liability cases particularly need, say Alan Klein and William Heaston at Duane Morris.
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Lean Into The 'Great Restoration' To Retain Legal Talent
As the “great resignation,” in which employees voluntarily left their jobs in droves, has largely dissipated, legal employers should now work toward the idea of a “great restoration,” adopting strategies to effectively hire, onboard and retain top legal talent, says Molly McGrath at Hiring & Empowering Solutions.
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How Cannabis Rescheduling May Alter Paraphernalia Imports
The Biden administration's recent proposal to loosen federal restrictions on marijuana use raises questions about how U.S. Customs and Border Protection enforcement policies may shift when it comes to enforcing a separate federal ban on marijuana accessory imports, says R. Kevin Williams at Clark Hill.
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What The NYSE Proposed Delisting Rule Could Mean For Cos.
The New York Stock Exchange's recently proposed rule would provide the exchange with discretionary authority to commence delisting proceedings for a company substantially shifting its primary business focus, raising concerns for NYSE-listed companies over the exact definition of the exchange's proposed "substantially different" standard, say attorneys at Winston & Strawn.
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FDA Warning Indicates Scrutiny Of Regenerative Health Cos.
The U.S. Food and Drug Administration's recent warning letter to Akan Biosciences is a quintessential example of the agency's enforcement priorities for certain products involving human cells and tissues, and highlights ongoing scrutiny placed on manufacturers, say Dominick DiSabatino and Cortney Inman at Sheppard Mullin.
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2 Regulatory Approaches To Psychedelic Clinical Trials
Comparing the U.S. and Canada's regulatory frameworks for clinical trials of psychedelic drugs can be useful for designing trial protocols that meet both countries' requirements, which can in turn help diversify patient populations, bolster data robustness and expedite market access, say Kimberly Chew at Husch Blackwell and Sabrina Ramkellawan at AxialBridge.
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Opinion
Bankruptcy Judges Can Justly Resolve Mass Tort Cases
Johnson & Johnson’s recent announcement of a prepackaged reorganization plan for its talc unit highlights that Chapter 11 is a continually evolving living statute that can address new types of problems with reorganization, value and job preservation, and just treatment for creditors, says Kenneth Rosen at Ken Rosen Advisors PC.
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Series
Fishing Makes Me A Better Lawyer
Atop the list of ways fishing makes me a better lawyer is the relief it offers from the chronic stress of a demanding caseload, but it has also improved my listening skills and patience, and has served as an exceptional setting for building earnest relationships, says Steven DeGeorge at Robinson Bradshaw.
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A Healthier Legal Industry Starts With Emotional Intelligence
The legal profession has long been plagued by high rates of mental health issues, in part due to attorneys’ early training and broader societal stereotypes — but developing one’s emotional intelligence is one way to foster positive change, collectively and individually, says attorney Esperanza Franco.
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To Make Your Legal Writing Clear, Emulate A Master Chef
To deliver clear and effective written advocacy, lawyers should follow the model of a fine dining chef — seasoning a foundation of pure facts with punchy descriptors, spicing it up with analogies, refining the recipe and trimming the fat — thus catering to a sophisticated audience of decision-makers, says Reuben Guttman at Guttman Buschner.
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Circuit Judge Writes An Opinion, AI Helps: What Now?
Last week's Eleventh Circuit opinion in Snell v. United Specialty Insurance, notable for a concurrence outlining the use of artificial intelligence to evaluate a term's common meaning, is hopefully the first step toward developing a coherent basis for the judiciary's generative AI use, says David Zaslowsky at Baker McKenzie.
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Fed. Circ. Rulings Crystallize Polymorph Patent 'Obviousness'
A comparison of two recent Federal Circuit obviousness challenge decisions regarding polymorph patents provides helpful insight into the assessment of screening arguments, particularly the issue of reasonable expectation of success, say Michael Green and John Molenda at Steptoe.
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DC Circ. Ruling Heightens HHS Contract Pharmacy Challenges
The D.C. Circuit's recent ruling that the Section 340B program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies represents a second strike against the U.S. Department of Health and Human Services' current contract pharmacy policy and raises the stakes surrounding an upcoming Seventh Circuit ruling on the same issue, say attorneys at Foley Hoag.
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3 Infringement Defenses To Consider 10 Years Post-Nautilus
In the 10 years since the U.S. Supreme Court’s influential Nautilus ruling, the spirit of the “amenable to construction” test that the opinion rejected persists with many patent litigators and judges, so patent infringement defense counsel should always consider several key arguments, says John Vandenberg at Klarquist Sparkman.
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9th Circ. COVID 'Cure' Case Shows Perks Of Puffery Defense
The Ninth Circuit's March decision in a case surrounding a company's statements about a potential COVID-19 cure may encourage defendants to assert puffery defenses in securities fraud cases, particularly in those involving optimistic statements about breakthrough drugs that are still untested, say attorneys at Cahill Gordon.