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Life Sciences
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December 03, 2024
J&J's Neosporin Forever Discolored Man's Groin, Suit Says
Johnson & Johnson and its consumer health spinoff were sued in California state court over claims that Neosporin antibiotic ointment badly infected a Los Angeles man's scrotum and permanently discolored his groin.
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December 03, 2024
$1B Sandoz Placeholder Bid Needs More Support, Judge Says
A Connecticut federal judge on Tuesday said he cannot force Novartis spinoff Sandoz Inc. to set aside a $1 billion litigation placeholder in a generic drug pricing lawsuit without hearing whether the state attorney general can enforce possible orders in other states where the pharmaceutical company keeps assets.
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December 03, 2024
USPTO Abandons Polarizing Proposal Over Double Patenting
The U.S. Patent and Trademark Office has withdrawn an extremely controversial proposal tied to double patenting, citing "resource constraints" in a Federal Register notice set to be published Wednesday.
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December 03, 2024
Vidal Aimed To Put USPTO Rulemaking In The Spotlight
Kathi Vidal's tenure as director of the U.S. Patent and Trademark Office has been marked by dedication to making the agency's decisions and processes more transparent, attorneys said ahead of her mid-December departure.
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December 03, 2024
FDA Issues Guidance On Potential Infant Formula Shortages
The U.S. Food and Drug Administration has put forth draft guidance on how the country's infant food manufacturers should tell the agency about permanent or temporary stoppages in the making of infant formula, several years after an outbreak and a national shortage.
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December 03, 2024
4 Mass. State Court Rulings You May Have Missed In Nov.
An age discrimination case was undone by the fine print of an employment agreement, while an "utterly inadequate" document search led to a five-figure sanctions order, among other notable recent decisions in Massachusetts state court.
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December 03, 2024
VA Announces Study On MDMA-Assisted Therapy For Vets
The U.S. Department of Veterans Affairs announced Tuesday it will fund a study on psychedelic-assisted therapy for veterans with post-traumatic stress disorder and alcohol use disorder, alongside researchers from Brown University and Yale University.
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December 02, 2024
House COVID-19 Probe Points to China 'Lab Leak'
The Republican-led House Select Subcommittee on the Coronavirus Pandemic published the results of its two-year investigation into the origins of the COVID-19 pandemic Monday, concluding that COVID-19 "most likely" emerged from a laboratory in Wuhan, China, and heavily criticizing the Biden administration, Anthony Fauci and left-leaning organizations for their responses.
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December 02, 2024
Judge Isn't Seeing 'Good Faith' Compliance In Probiotic Feud
A Maryland federal judge said Monday that a drug company is, yet again, failing to make "good faith substantial compliance" with the terms of an injunction that followed a $15 million jury verdict in a dispute over a proprietary probiotic formula.
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December 02, 2024
Justices Seem Inclined To Back FDA Block Of Flavored Vapes
U.S. Supreme Court justices on Monday seemed skeptical of arguments by an e-cigarette company that the U.S. Food and Drug Administration acted unfairly in rejecting its applications to market its flavored vaping products, with several justices supporting the FDA's position that the company knew it had to counterbalance the risk of its products appealing to kids.
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December 02, 2024
Investor Alleges Medical Device Co. Misled On FDA Clearance
The executives and directors of dialysis equipment company Outset Medical Inc. have been hit with a shareholder derivative suit in California federal court alleging they allowed the company to market its product without proper clearance from the U.S. Food and Drug Administration.
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December 02, 2024
Hagens Berman Sued For Slice Of Atty Fee From Effexor Deal
A pharmaceutical reseller's in-house counsel and founder lodged a breach of contract suit against Hagens Berman in Mississippi federal court, accusing the law firm of refusing to pay him his share of a $13 million attorney fees award stemming from an antitrust class settlement with Pfizer Inc. unit Wyeth.
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December 02, 2024
Chancery OKs $21M Deal To End Gene Co. Class Suit
A $21 million settlement of stockholder challenges to a blank check company's take-public merger with clinical data and genomics company Sema4 Holdings in July 2021 won Delaware Court of Chancery approval Monday, with nearly $4.1 million carved out for attorney fees.
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December 02, 2024
Fla. Tribe Sues Eli Lilly, CVS, Others Over Insulin Price-Fixing
The Miccosukee Tribe in Florida is alleging drugmakers like Eli Lilly & Co. and pharmacy benefit managers like CVS illegally conspired to limit competition and artificially inflate the price of insulin drugs, according to a new lawsuit filed in New Jersey federal court.
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December 02, 2024
Heritage's $10M Generic Drugs Deal With AGs Gets 1st OK
A Connecticut federal judge gave his initial approval on Monday to Heritage Pharmaceuticals Inc.'s $10 million settlement agreement with state attorneys general to resolve allegations it took part in an anticompetitive, price-fixing scheme focused on generic drugs.
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December 02, 2024
DEA Asserts Its Role As Proponent Of Pot Rescheduling Plan
The Drug Enforcement Administration on Monday affirmed it was acting as the proponent of a proposal to loosen federal restrictions on marijuana, and the administrative law judge said supporters of rescheduling would not get an opportunity to cross-examine DEA witnesses.
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December 02, 2024
Ex-Parexel Worker Says Vax Rule Lacked 'Informed Consent'
A former employee of clinical research firm Parexel International says the company's COVID-19 vaccine requirement was a breach of contract because she and other workers did not have the option of giving informed consent for what she calls an "experimental medical treatment," according to a lawsuit filed in Massachusetts state court.
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December 02, 2024
Shipping Industry Braces For Waves Of New Trump Tariffs
After a holiday weekend marked by a fresh round of tariff threats from President-elect Donald Trump, the shipping and logistics industry is beginning to feel the heat, warning companies to prepare for massive upheaval if Trump follows through.
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December 02, 2024
Co-Worker's Affair Isn't Harassment, Research Co. Tells Court
A clinical research company urged a Georgia federal judge to toss a former employee's suit claiming the business failed to take action when a co-worker made sexual comments about her father and began an affair with him, arguing the conduct isn't protected by federal civil rights law.
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November 27, 2024
A Look Back At Years Of Zantac Litigation: Timeline
After the U.S. Food and Drug Administration raised a red flag five years ago that heartburn drug Zantac and its generics contained levels of a chemical that could cause cancer, litigation kicked off in federal and state courts. Here, Law360 presents a timeline of the lawsuits, trials and settlements that ensued.
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November 27, 2024
PTAB Finds Hormone Treatment Patent Claims Invalid
The Patent Trial and Appeal Board has found Neurocrine Biosciences Inc. was able to show that all the claims in a patent owned by biotechnology company Spruce Biosciences Inc. relating to the treatment of a hormonal disorder were invalid.
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November 27, 2024
Deloitte Posed As Consultant To Steal Vax Software, Suit Says
An inventor has accused Deloitte Consulting LLP in New York federal court of stealing her proprietary vaccination management system and securing a multimillion-dollar government contract for rolling out COVID-19 vaccines, saying the firm colluded with the Centers for Disease Control and Prevention to pilfer the technology.
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November 27, 2024
PBM Says Opioid Ruling Ignored High Court's Privilege Stance
A special master's ruling that internal audit records from Express Scripts Inc. are not protected by attorney-client privilege should be overturned because it contradicts nearly 40 years of U.S. Supreme Court precedent, the pharmacy benefit manager told an Ohio federal court overseeing multidistrict opioid litigation.
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November 27, 2024
Nonprofit Warns 3rd Circ. Against 'Abuse' In Merck Vax Case
The anti-monopoly think tank Open Markets Institute urged the full Third Circuit to rethink a panel's immunization of Merck & Co. Inc. from antitrust claims over its mumps vaccine, arguing in an amicus brief that the doctrine cementing the right to petition the government doesn't justify the use of courts and administration as a "competitive weapon."
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November 27, 2024
Amid Claims Of Bias, DEA To Kick Off Historic Pot Hearing
The Drug Enforcement Administration's administrative law tribunal will hold a preliminary hearing Monday on the U.S. Department of Justice's proposal to relax restrictions on marijuana, kicking off a historic process that has already been marked by allegations of agency bias.
Expert Analysis
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Use The Right Kind Of Feedback To Help Gen Z Attorneys
Generation Z associates bring unique perspectives and expectations to the workplace, so it’s imperative that supervising attorneys adapt their feedback approach in order to help young lawyers learn and grow — which is good for law firms, too, says Rachael Bosch at Fringe Professional Development.
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Opinion
Congress Can And Must Enact A Supreme Court Ethics Code
As public confidence in the U.S. Supreme Court dips to historic lows following reports raising conflict of interest concerns, Congress must exercise its constitutional power to enact a mandatory and enforceable code of ethics for the high court, says Muhammad Faridi, president of the New York City Bar Association.
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Series
The Pop Culture Docket: Justice Lebovits On Gilbert And Sullivan
Characters in the 19th century comic operas of Gilbert and Sullivan break the rules of good lawyering by shamelessly throwing responsible critical thought to the wind, providing hilarious lessons for lawyers and judges on how to avoid a surfeit of traps and tribulations, say acting New York Supreme Court Justice Gerald Lebovits and law student Tara Scown.
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New HHS Research Misconduct Rules Bring Seismic Changes
The U.S. Department of Health and Human Services' new rule regarding research misconduct investigations brings significant changes that focus on remediation, appeals and confidentiality, while other changes could result in institutions causing undue harm to scientists accused of such misconduct, say attorneys at Cohen Seglias.
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State Of The States' AI Legal Ethics Landscape
Over the past year, several state bar associations, as well as the American Bar Association, have released guidance on the ethical use of artificial intelligence in legal practice, all of which share overarching themes and some nuanced differences, say Eric Pacifici and Kevin Henderson at SMB Law Group.
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How Biden Admin Has Used Antitrust Tools, And What's Next
The last four years have been marked by an aggressive whole-of-government approach to antitrust enforcement using a broad range of tools, and may result in lasting change regardless of the upcoming presidential election result, say attorneys at Norton Rose.
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Defining All-Risk: Despite $30M Loss, Loose Bolt Not 'Damage'
A Massachusetts federal court’s recent ruling in AMAG Pharmaceuticals v. American Guarantee and Liability Insurance Co., denying coverage for $30 million in damages claimed when a loose bolt caused an air leak, highlights an ongoing debate over the definition of “direct physical loss or damage,” say Josh Tumen and Paul Ferland at Cozen O'Connor.
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The Shifting Role Of Patent Attorneys In The Age Of AI
The integration of artificial intelligence into patent drafting represents a significant change in how legal work is performed, and patent attorneys must shift from manual drafting to a strategy-oriented approach, says Ian Schick at Draft Builders.
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8 Childhood Lessons That Can Help You Be A Better Attorney
A new school year is underway, marking a fitting time for attorneys to reflect on some fundamental life lessons from early childhood that offer a framework for problems that no legal textbook can solve, say Chris Gismondi and Chris Campbell at DLA Piper.
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Opinion
This Election, We Need To Talk About Court Process
In recent decades, the U.S. Supreme Court has markedly transformed judicial processes — from summary judgment standards to notice pleadings — which has, in turn, affected individuals’ substantive rights, and we need to consider how the upcoming presidential election may continue this pattern, says Reuben Guttman at Guttman Buschner.
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A Look At The PTAB's Assessment Of Prior Art Exceptions
The Patent Trial and Appeal Board's approach over the last 10 years to assessing Section 102(b) prior art exceptions reveals a few trends, including that evidence of common ownership may have a higher likelihood of successfully disqualifying prior art under Section 102(b)(2)(C) at the institution stage, say Louis Panzica and David Holman at Sterne Kessler.
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Series
Playing Diplomacy Makes Us Better Lawyers
Similar to the practice of law, the rules of Diplomacy — a strategic board game set in pre-World War I Europe — are neither concise nor without ambiguity, and weekly gameplay with our colleagues has revealed the game's practical applications to our work as attorneys, say Jason Osborn and Ben Bevilacqua at Winston & Strawn.
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How Patent Litigation Is Changing Amid Decline In Filings
Marked by a notable decline in case filings and preferred venue shifts, patent litigation has undergone significant changes over the last decade and litigation hot spots have shifted, encouraging a more strategic approach to patent disputes, says Saishruti Mutneja at Winston & Strawn.
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Mental Health First Aid: A Brief Primer For Attorneys
Amid a growing body of research finding that attorneys face higher rates of mental illness than the general population, firms should consider setting up mental health first aid training programs to help lawyers assess mental health challenges in their colleagues and intervene with compassion, say psychologists Shawn Healy and Tracey Meyers.
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Opinion
FTC's Report Criticizing Drug Middlemen Is Flawed
The Federal Trade Commission's July report, which claims that pharmacy benefit managers are inflating drug costs, does not offer a credible analysis of PBMs, and its methodology lacks rigor, says Jay Ezrielev at Elevecon.