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Life Sciences
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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.
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November 27, 2024
Up Next At The High Court: Transgender Care, Holocaust Art
The U.S. Supreme Court will return to the bench Monday for its December arguments session, which will include blockbuster questions about the constitutionality of state laws banning gender-affirming care for transgender minors and whether Hungary can be held liable for property stolen during World War II.
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November 27, 2024
Hospital Sued For Firing Tech Who Reported Lax Drugmaking
A pharmacy technician claims in Illinois state court that she was fired from Lurie Children's Hospital in Chicago for making complaints both internally and to state regulators that the medications for pediatric patients were being compounded in an unsanitary manner and that the facilities weren't being properly cleaned.
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November 27, 2024
Congressional Dems Urge Biden For More Cannabis Reform
Congressional Democrats are urging President Joe Biden to use his executive authority to take further action on marijuana reforms during the waning weeks of his administration.
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November 26, 2024
Trump Taps Bhattacharya For National Institutes Of Health
President-elect Donald Trump announced Tuesday that he has selected Dr. Jay Bhattacharya, a physician who opposed the use of lockdowns and mask mandates to contain the spread of COVID-19, to lead the National Institutes of Health.
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November 26, 2024
NIH Beats 4th Circ. Bid To Unmask COVID Researcher
National Institutes of Health on Tuesday defeated a circuit court appeal by a whistleblower organization which had sought to uncover the identity of a Wuhan University researcher who submitted sequencing data to an open-access NIH archive.
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November 26, 2024
Beasley Allen Escapes Sanctions For J&J Deposition No Show
A Texas bankruptcy judge on Tuesday laid ground rules for documents and communications to be shared in a messy discovery phase of the Chapter 11 of Red River Talc, Johnson & Johnson's latest liability spinoff, while also saying he wouldn't sanction a Beasley Allen attorney who didn't appear at a deposition last week.
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November 26, 2024
Gilead Gets $31.8M In Calif. Case Over Counterfeit HIV Drugs
Gilead Sciences Inc. has won nearly $32 million in a case involving a scheme to wrongfully repackage HIV treatments and sell them off as counterfeit Gilead products, a California federal judge has ruled.
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November 26, 2024
FDA Seeks Fines Against 18 Retailers Over E-Cig Sales
The U.S. Food and Drug Administration said on Tuesday that it is looking to issue fines against two "brick and mortar" stores and 16 online retailers who had been previously warned over sales of unlawful electronic cigarettes.
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November 26, 2024
Court Asked To Halt DEA's Pot Rescheduling Hearing
The Drug Enforcement Administration's plan to hold administrative hearings on a proposal to reclassify marijuana must be stopped, a psychedelics researcher argued, telling a Washington federal judge that the DEA is not giving a voice to small entity researchers and tribal stakeholders.
Expert Analysis
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Justices Must Weigh Reach Of Civil RICO In Cannabis Case
Oral arguments in Medical Marijuana Inc. v. Horn suggest that a majority of the U.S. Supreme Court may agree that a truck driver's losing his job after unknowingly ingesting THC and failing a drug test does not merit a racketeering claim — but the court may not buy the other side's theory of the case either, say attorneys at Lewis Baach.
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Litigation Strategies In View Of New Double Patenting Rulings
Recent Federal Circuit decisions, including in Allergan v. MSN, raise several issues that patent owners should understand and consider addressing proactively regarding obviousness-type double patenting, at least in their prosecution strategies, say attorneys at Dentons.
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Promoting Diversity In The Selection Of ADR Neutrals
Excerpt from Practical Guidance
Choosing neutrals from diverse backgrounds is an important step in promoting inclusion in the legal profession, and it can enhance the legitimacy and public perception of alternative dispute resolution proceedings, say attorneys at Lowenstein Sandler.
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Series
Playing Ultimate Makes Us Better Lawyers
In addition to being fun, ultimate Frisbee has improved our legal careers by emphasizing the importance of professionalism, teamwork, perseverance, enthusiasm and vulnerability, say Arunabha Bhoumik and Adam Bernstein at Regeneron.
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E-Discovery Quarterly: Recent Rulings On Metadata
Several recent rulings reflect the competing considerations that arise when parties dispute the form of production for electronically stored information, underscoring that counsel must carefully consider how to produce and request reasonably usable data, say attorneys at Sidley.
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Opinion
PREVAIL Bill Is Another Misguided Attempt To Restrict PTAB
The decade-long campaign against the U.S. Patent and Trademark Office's Patent Trial and Appeal Board — currently focused on the PREVAIL Act that's slated for markup in the Senate — is not really about procedural issues, and it is not aimed at securing more accurate patentability decisions, says Clear IP's Joseph Matal, former acting director at the USPTO.
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Striking A Balance Between AI Use And Attorney Well-Being
As the legal industry increasingly adopts generative artificial intelligence tools to boost efficiency, leaders must note the hidden costs of increased productivity, and work to protect attorneys’ well-being while unlocking AI’s full potential, says Ed Sohn at Factor.
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Empathy In Mediation Offers A Soft Landing For Disputes
Experiencing a crash-landing on a recent flight underscored to me how much difference empathy makes in times of crisis or stress, including during mediation, says Eydith Kaufman at Alternative Resolution Centers.
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Series
Being An Artist Makes Me A Better Lawyer
My work as an artist has highlighted how using creativity and precision together — qualities that are equally essential in both art and law — not only improves outcomes, but also leads to more innovative and thoughtful work, says Sarah La Pearl at Segal McCambridge.
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How Judiciary Can Minimize AI Risks In Secondary Sources
Because courts’ standing orders on generative artificial intelligence and other safeguards do not address the risk of hallucinations in secondary source materials, the judiciary should consider enlisting legal publishers and database hosts to protect against AI-generated inaccuracies, say attorneys at Lankler Siffert & Wohl.
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Newly Acquired Information Can Be Key In Drug Label Cases
The question of whether federal law preempts state law claims is often central in pharmaceutical labeling cases, like the Fosamax litigation now before the Third Circuit — but parties must also consider whether there is newly acquired information to justify submitting a proposed labeling change in the first place, say attorneys at Arnold & Porter.
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Nvidia Case's Potential Impact On Securities Class Actions
In Nvidia v. Ohman Fonder, the U.S. Supreme Court could strip lower courts of their long-standing ability and obligation to holistically weigh all relevant facts supporting plaintiffs' allegations of securities fraud, which would have a wide-ranging impact on securities fraud class actions in the U.S., say attorneys at Labaton Keller.
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How Attorneys Can Break Free From Career Enmeshment
Ambitious attorneys can sometimes experience career enmeshment — when your sense of self-worth becomes unhealthily tangled up in your legal vocation — but taking the time to discover and realign with your core personal values can help you recover your identity, says Janna Koretz at Azimuth Psychological.
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Key Healthcare Issues That Hinge On The Election Outcome
The 2024 presidential race, while not heavily dominated by healthcare issues compared to past elections, holds significant implications for the direction of healthcare policy in a potential Harris or Trump administration, encompassing issues ranging from Medicare to artificial intelligence, says Miranda Franco at Holland & Knight.
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Patent Lessons From 4 Federal Circuit Reversals In September
Cases that were reversed or vacated by the Federal Circuit last month provide helpful clarity on collateral estoppel, patent eligibility, construction of claim terms that have different boundaries across different claims, and the role of courts as neutral arbiter, say attorneys at Bunsow De Mory.