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Life Sciences
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June 06, 2024
$25 Million Flint Water Class Deal Gets Early OK
A Michigan federal judge on Thursday gave initial approval for a $25 million settlement between a class of Flint adults and businesses and a water engineering company accused of prolonging the town's water crisis, calling the deal fair and an opportunity to avoid years of "exhausting" litigation.
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June 06, 2024
Judge OKs $42M Stent IP Verdict, Discards Willfulness Finding
A Delaware federal judge has said Boston Scientific was not entitled to a new trial in a case where it was told to pay $42 million for stent systems patent infringement, but threw out a finding of willful infringement.
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June 06, 2024
FDA Urges High Court To Hear 5th Circ. Flavored E-Cig Case
The U.S. Food and Drug Administration is asking the U.S. Supreme Court to grant its petition for a review of an en banc Fifth Circuit decision overturning its denial of a flavored e-cigarette marketing application, saying this case provides a better vehicle to decide the issues than other petitions at the high court.
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June 06, 2024
Abbott Labs Must Face Bulk Of Glucerna False Ad Suit
A California federal judge won't free Abbott Laboratories from a proposed class action over its Glucerna shakes, saying the complaint plausibly alleges that the labeling would mislead consumers about the health aspects of the drinks.
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June 06, 2024
Biote Investors Sue Cooley, SPAC After Huge Merger Loss
Family trust investors in Biote Corp. have sued Cooley LLP and the "hormone optimization" company's top brass over the $700 million merger Biote completed with a special purpose acquisition company, saying the deal was a "disastrous transaction to divert approximately $70 million of merger consideration to themselves and gain control of an enterprise they did not build."
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June 06, 2024
Law Firm Says Axe 'Draconian' J&J Subpoena In Talc Claim
A Mississippi plaintiffs firm urged a New Jersey federal court on Thursday to quash a subpoena served by Johnson & Johnson requesting that the firm turn over documents related to litigation funding and its communication with media outlets, calling the subpoena "draconian" and improper as the firm is not a party to the pharmaceutical giant's current personal injury litigation surrounding its talcum powder products.
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June 06, 2024
'Brussels Effect' Of EU's AI Act Is Uncertain, Legal Pros Say
BigLaw attorneys advising international clients on the European Union's AI Act tell Law360 there are significant uncertainties over vague terms in the 458-page statute, how its steep eight-figure fines will be enforced, and whether it will set a new standard globally as part of the "Brussels effect."
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June 06, 2024
Pharma Co. Should Get Hungarian Rebate, ECJ Adviser Says
Danish pharmaceutical company Novo Nordisk's mandatory payments into the Hungarian health system should reduce the company's tax base for value-added tax payments, an adviser to the European Union's highest court said Thursday.
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June 05, 2024
USPTO Fee Hike Finds Ally In Google, But Others Have Gripes
The U.S. Patent and Trademark Office's plan to increase many patent-related fees beginning next year has received support from Google, but dozens of other comments came from patent litigators of all stripes who argue that the proposal is a bad idea.
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June 05, 2024
AI Co., Biotech Prep IPOs Worth $602M As Novelis Delays
Healthcare data artificial intelligence platform Tempus AI and Australian biotech Telix Pharmaceuticals on Wednesday unveiled plans for initial public offerings that will aim to raise a combined total of approximately $602 million, while sustainable aluminum solutions provider Novelis, a day prior, postponed IPO plans due to market conditions.
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June 05, 2024
Medtronic Can't Pause FCA Claims For 1st Circ. Detour
A Massachusetts federal judge on Wednesday declined to pause a long-pending False Claims Act and whistleblower retaliation case against medical device maker Medtronic so it can appeal a recent ruling, saying the court and the parties need to "get it moving."
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June 05, 2024
McDermott Lands King & Spalding White Collar Pro In Atlanta
Global law firm McDermott Will & Emery LLP has added a King & Spalding LLP partner in Atlanta, a white-collar defense lawyer and civil litigator who has advised clients in healthcare, life sciences and e-commerce.
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June 05, 2024
Pinsent Mason Guides Lab Services Biz On £11M Fundraise
Angle PLC said Wednesday it has successfully raised gross proceeds of approximately £8.8 million ($11 million) by issuing shares to investors in a targeted £11 million fundraising exercise advised by Pinsent Masons LLP.
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June 05, 2024
AstraZeneca Completes $2.4B Deal To Buy Pharma Co. Fusion
Drugmaker AstraZeneca said on Wednesday that it has bought Fusion Pharmaceuticals Inc., a Canadian company that specializes in oncology, for $2.4 billion in cash to bolster its range of cancer treatments.
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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.
Expert Analysis
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SG's Office Is Case Study To Help Close Legal Gender Gap
As women continue to be underrepresented in the upper echelons of the legal profession, law firms could learn from the example set by the Office of the Solicitor General, where culture and workplace policies have helped foster greater gender equality, say attorneys at Ocean Tomo.
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Opinion
Patent Waiver For COVID Meds Would Harm US Biopharma
If the Biden administration backs the World Trade Organization in waiving patent rights on COVID-19 treatments, it would negatively affect the U.S. biopharmaceutical industry and help foreign competitors, without necessarily expanding global access to COVID-19 care, says clinical pathologist Wolfgang Klietmann.
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Skirting Anti-Kickback Causation Standard Amid Circuit Split
Amid the federal circuit court split over the causation standard applicable to False Claims Act cases involving Anti-Kickback Statute violations, which the First Circuit will soon consider in U.S. v. Regeneron, litigators aiming to circumvent the heightened standard should contemplate certain strategies, say Matthew Modafferi and Terence Park at Frier Levitt.
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10 Lessons From A Deep Dive Into IP Damages
Decisions on challenging an intellectual property expert's opinion can benefit from the in-depth study of court rulings on admissibility grounds, where the findings include the fact that patent cases see the most challenges of any IP area, say Deepa Sundararaman and Cleve Tyler at Berkeley Research.
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What Shareholder Approval Rule Changes Mean For Cos.
The U.S. Securities and Exchange Commission recently approved proposed rule changes to shareholder requirements by the New York Stock Exchange, an approval that will benefit listed companies in many ways, including by making it easier to raise capital from passive investors, say attorneys at Baker Botts.
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Reimagining Law Firm Culture To Break The Cycle Of Burnout
While attorney burnout remains a perennial issue in the legal profession, shifting post-pandemic expectations mean that law firms must adapt their office cultures to retain talent, say Kevin Henderson and Eric Pacifici at SMB Law Group.
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Expediting Psychedelics Approvals In The EU, UK, Australia
Accelerated pathways for regulatory approvals for psychedelic drugs in the European Union, U.K. and Australia is indispensable to facilitate a seamless advancement of treatments from the research environment to the consumer, say Kimberly Chew at Husch Blackwell, and Ana Dukic and Sabrina Ramkellawan at AxialBridge.
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Series
ESG Around The World: Brazil
Environmental, social and governance issues have increasingly translated into new legislation in Brazil since 2020, and in the wake of these recently enacted regulations, we are likely to see a growing number of legal disputes in the largest South American country related to ESG issues such as greenwashing if companies are not prepared to adequately adapt and comply, say attorneys at Mattos Filho.
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Opinion
Gilead Ruling Signals That Innovating Can Lead To Liability
A California appeals court's ruling last month in Gilead Life Sciences v. Superior Court of San Francisco that a drug manufacturer can be held liable for delaying the introduction of an improved version of its medication raises concerns about the chilling effects that expansive product liability claims may have on innovation, says Gary Myers at the University of Missouri School of Law.
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Opinion
Vidal Should Amend USPTO Precedent In Automaker Review
U.S. Patent and Trademark Office Director Kathi Vidal's recent decision to review Ford and Honda patent challenges that were rejected by the Patent Trial and Appeal Board provides an opportunity to revisit precedents that have unfairly denied companies a fair review process and align them with commonsense principles of legal equity, says former Sen. Patrick Leahy.
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Grant Compliance Takeaways From Ga. Tech's FCA Settlement
Georgia Tech’s recent False Claims Act settlement over its failure to detect compliance shortcomings in a grant program was unique in that it involved a voluntary repayment of funds prior to the resolution, offering a few key lessons for universities receiving research funding from the government, says Jonathan Porter at Husch Blackwell.
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Series
Competing In Dressage Makes Me A Better Lawyer
My lifelong participation in the sport of dressage — often called ballet on horses — has proven that several skills developed through training and competition are transferable to legal work, especially the ability to harness focus, persistence and versatility when negotiating a deal, says Stephanie Coco at V&E.
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How Poor Governance, Weak Contracts Harm Cannabis Cos.
Decades into cannabis decriminalization and legalization, many companies in the industry still operate on a handshake basis or fail to keep even minimally required records, which can have devastating effects and lead to costly, business-killing litigation, says Griffen Thorne at Harris Bricken.
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Del. Ruling Adds Momentum For Caremark Plaintiffs
The Delaware Supreme Court's recent opinion in Lebanon County Employees' Retirement Fund v. Collis could be viewed as expanding plaintiffs' ability to viably plead a Caremark claim against directors, so Delaware companies should be on heightened alert and focus on creating a record of board oversight, say attorneys at V&E.
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How Biotech Cos. Can Utilize Synthetic Royalty Financing
Synthetic royalty transactions have been on the rise as a funding structure for biotechnology companies, but questions have arisen surrounding how such transactions work, and structuring them correctly requires a nuanced understanding, say Todd Trattner and Ryan Murr at Gibson Dunn.