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Life Sciences
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June 04, 2024
Judiciary Panel Clears 1st MDL Rule, Eyes 'Mouthpiece' Amici
Top rulemaking gatekeepers for the federal judiciary Tuesday capped off seven years of strife in the defense and plaintiffs bars by backing a milestone measure aimed at optimizing multidistrict litigation, and then promptly greenlighted an entirely different war of words over new efforts to ferret out amicus briefs from "paid mouthpieces" masquerading as independent experts.
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June 04, 2024
Insulin Pens Exposed Patients To Disease, Hospital Says
A Connecticut-based hospital says medical device manufacturer Novo Nordisk should be on the hook for a $1 million settlement the hospital paid to end claims that patients were exposed to blood-borne infections because of the medical staff's use of Novo Nordisk's product.
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June 04, 2024
Biotech RenovaCare Can't Beat Investors' Stock Promo Suit
A New Jersey federal judge has ruled that investors in biotechnology company RenovaCare Inc. failed to prove their case against firms they accused of profiting from a scheme to pump up the company's shares, but otherwise allowed their claims to proceed against the maker of skin burn treatments and a few of its executives.
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June 04, 2024
Chinese Fund Asks To Nix Doc Bid In $830M Transaction Row
A Chinese healthcare investment fund has asked a New York federal court to toss a Hong Kong medical fund's subpoena request seeking information in a foreign case stemming from a stymied $830 million transaction, saying the discovery bid isn't allowed for the private arbitration.
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June 04, 2024
FDA Advisers Rebuff Bid To Treat PTSD With MDMA
A panel of public health experts on Tuesday dealt a blow to a historic effort to regulate MDMA therapy for post-traumatic stress disorder, saying although the positive effects shown in clinical trials are promising, the proposal was hindered by too many confounding factors.
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June 04, 2024
Zantac Suits Belong In Conn. State Court, Cancer Patients Say
Lawsuits claiming Zantac and its generic equivalents caused cancer belong in Connecticut state court, two groups of Constitution State cancer patients and their estates say, arguing against several drugmakers' assertions that they can't be sued in the state on innovator and warning label liability claims.
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June 04, 2024
Pharma Cos. Tell Justices Feds Support Remanding Terror Suit
Pharmaceutical companies urged the U.S. Supreme Court on Tuesday to heed the federal government's suggestion to throw out a D.C. Circuit ruling holding them potentially liable for allegedly financing terror attacks against U.S. servicemembers through contracts with the Iraqi government.
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June 04, 2024
J&J Owes $260M To Ore. Talc Mesothelioma Patient, Jury Says
An Oregon state jury has ruled that Johnson & Johnson owes $260 million to a woman who said she developed mesothelioma from breathing in asbestos during daily talcum powder use.
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June 04, 2024
Honeywell Manager 'Dismissive' Of Black Employee, Suit Says
A Black woman who was a global marketing manager for Honeywell International Inc. has accused the conglomerate of using layoffs as a pretext to get rid of her after she filed an internal complaint calling into question her manager's treatment of women and people of color.
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June 04, 2024
Illumina Board Puts Grail Spinoff In Motion After EU OK
Illumina Inc. said Tuesday that its board had approved a spinoff of its cancer detection company following a push by activist heavyweight Carl Icahn and an ultimate order from European authorities to dispose of the asset.
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June 04, 2024
Research Co. Pays Record $35M Fine In Dog Abuse Case
A clinical research company has agreed to pay a record $35 million fine for violations of the Animal Welfare Act as part of a deal to resolve criminal charges stemming from the abuse of beagles that it bred for medical research.
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June 03, 2024
Ex-Biopharma Co. Prez Accused Of Defecting With Secrets
Biopharmaceutical firm United Therapeutics Corp. has accused a former executive of violating an employment agreement by taking ideas to a rival company to develop a competing lung treatment.
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June 03, 2024
Justices Won't Review Contempt Sanctions Against Drug Co.
The U.S. Supreme Court won't hear Hi-Tech Pharmaceuticals' challenge to the Federal Trade Commission's $40 million judgment against it for misrepresenting weight-loss drugs and violating an injunction.
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June 03, 2024
Glycine Co. Couldn't Compel Cooperation, Trade Court Told
The U.S. Department of Commerce wrongly labeled an Indian glycine company as noncooperative after its unaffiliated suppliers declined to participate in a tariff review, the company said in a motion calling to unwind its penalty duty rate Monday.
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June 03, 2024
Drug Cos. Can Depose DC AG In Drug Price-Fixing Row
A Connecticut federal judge reluctantly ordered the District of Columbia Attorney General's Office to be deposed by the drug companies wrapped up in more than 40 states' claims over an alleged price-fixing conspiracy, noting that he would not have done so but for the case being remanded from a sprawling multidistrict litigation in Pennsylvania.
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June 03, 2024
Group Defends Plan For PED-Fueled Athletic Competitions
The Enhanced Games continues to push for its performance-enhanced events after criticism from the International Federation of Sports Medicine, arguing Monday that its mission is not that different, because it too wants healthy athletes and fair competition.
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June 03, 2024
Ex-SoftBank GC Joins Foley & Lardner As Partner In SF
Foley & Lardner LLP has hired SoftBank Investment Advisers' former general counsel, who has over a decade of experience in private practice and serving as in-house counsel overseeing SoftBank's legal team, which structured and monitored more than 300 portfolio companies worth more than $130 billion.
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June 03, 2024
Biotech Firm, Mobile App Prepare To Enter IPO Fray
Biotechnology firm Rapport Therapeutics Inc. and Australian-listed mobile-sharing app Life360 Inc. unveiled plans on Monday for initial public offerings that are estimated to raise about $311 million combined this week, under guidance from three law firms.
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June 03, 2024
House COVID Panel Questions Fauci Over Pandemic Origins
Anthony Fauci, the former director of the National Institute of Allergy and Infectious Disease responsible for overseeing the pandemic response, was pressed by a U.S. House COVID-19 panel Monday about recent allegations that a senior official tried to evade open records laws regarding the origins of the pandemic.
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June 03, 2024
Ropes & Gray Guides Becton On $4.2B Edwards Unit Buy
Ropes & Gray LLP is guiding Becton Dickinson and Co. on a deal that will see the medical technology company pay $4.2 billion for Edwards Lifesciences' critical care product group, which focuses on patient monitoring using artificial intelligence, the companies said Monday.
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June 01, 2024
Blockbuster Summer: 10 Big Issues Justices Still Must Decide
As the calendar flips over to June, the U.S. Supreme Court still has heaps of cases to decide on issues ranging from trademark registration rules to judicial deference and presidential immunity. Here, Law360 looks at 10 of the most important topics the court has yet to decide.
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May 31, 2024
Caremark Cut Loose From CVS Price-Gouging Case
A Rhode Island federal judge on Thursday dismissed Caremark from long-running litigation alleging CVS schemed with pharmacy benefit managers to overcharge insured health plans for generic drugs, finding Caremark's contracts with the funds have enforceable arbitration clauses.
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May 31, 2024
Samsung Strikes First With Smart Ring IP Suit Against Oura
Samsung has yet to announce a release date for its new Galaxy Ring brand of wearable, health-tracking devices, but it has filed an intellectual property suit in California federal court Thursday targeting a Finnish startup that makes its own line of smart rings.
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May 31, 2024
PTAB Upholds Medtronic Bladder Control Patents On Remand
The Patent Trial and Appeal Board affirmed Medtronic patents covering a sacral stimulation system after Federal Circuit judges ordered the board last year to give the maker of a rival bladder and bowel control device another shot at knocking those patents out.
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May 31, 2024
COVID Test Contract Suit 'Cries Out' For Jury, NC Judge Says
A fight between two companies over a doomed distribution deal for COVID-19 tests has gone from "ships passing in the night" to not even "sailing in the same ocean," a North Carolina Business Court judge said, paring the case for trial.
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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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.
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FTC Focus: Exploring The Meaning Of Orange Book Letters
The Federal Trade Commission recently announced an expansion of its campaign to promote competition by targeting pharmaceutical manufacturers' improper Orange Book patent listings, but there is a question of whether and how this helps generic entrants, say Colin Kass and David Munkittrick at Proskauer.
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Investors Can Aid In The Acceptance Of Psychedelic Medicine
Psychedelic medicine is ready to have its breakthrough moment, and although it still faces political, legal and communications challenges, private equity investors can play a significant role in changing the public perception on psychedelics from taboo to acceptance, say Kimberly Chew at Husch Blackwell, Charlie Panfil at the Daschle Group and Ethan Lutz at FTI Consulting.
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Class Actions At The Circuit Courts: May Lessons
In this month's review of class action appeals, Mitchell Engel at Shook Hardy discusses four notable circuit court decisions on topics from automobile insurance to securities — and provides key takeaways for counsel on issues including circuit-specific ascertainability requirements and how to conduct a Daubert analysis prior to class certification.
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Perspectives
Trauma-Informed Legal Approaches For Pro Bono Attorneys
As National Trauma Awareness Month ends, pro bono attorneys should nevertheless continue to acknowledge the mental and physical effects of trauma, allowing them to better represent clients, and protect themselves from compassion fatigue and burnout, say Katherine Cronin at Stinson and Katharine Manning at Blackbird.
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Series
Playing Music Makes Me A Better Lawyer
My deep and passionate involvement in playing, writing and producing music equipped me with skills — like creativity, improvisation and problem-solving — that contribute to the success of my legal career, says attorney Kenneth Greene.
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Proposed Cannabis Reschedule Sidesteps State Law Effects
The U.S. Department of Justice's recent proposal to move cannabis to Schedule III of the Controlled Substances Act provides certain benefits, but its failure to address how the rescheduling would interact with existing state cannabis laws disappointed industry participants hoping for clarity on this crucial question, says Ian Stewart at Wilson Elser.
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How Attys Can Avoid Pitfalls When Withdrawing From A Case
The Trump campaign's recent scuffle over its bid to replace its counsel in a pregnancy retaliation suit offers a chance to remind attorneys that many troubles inherent in withdrawing from a case can be mitigated or entirely avoided by communicating with clients openly and frequently, says Christopher Konneker at Orsinger Nelson.
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Using A Children's Book Approach In Firm Marketing Content
From “The Giving Tree” to “Where the Wild Things Are,” most children’s books are easy to remember because they use simple words and numbers to tell stories with a human impact — a formula law firms should emulate in their marketing content to stay front of mind for potential clients, says Seema Desai Maglio at The Found Word.
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A Changing Regulatory Landscape For Weight Loss Drugs
As drugs originally approved to treat diabetes become increasingly popular for weight loss purposes, federal and state regulators and payors are increasing their focus on how these drugs are prescribed, and industry participants should pay close attention to rapidly evolving compliance requirements, say attorneys at Goodwin.