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Life Sciences
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November 07, 2024
Wuhan Chemical Co. Charged In Latest China Fentanyl Bust
California federal prosecutors announced Thursday that a Wuhan, China-based chemical company has been charged with exporting illegal fentanyl precursors and adulterants to the United States and other countries, the latest in a series of recent criminal actions cracking down on Chinese drug manufacturers' role in the opioid epidemic.
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November 07, 2024
Teva Fails To Convince Judge Inhaler Patents Require Drug
Five patents for an inhaler made by Teva Pharmaceuticals Industries Ltd. don't require an active drug's presence in the device, a New Jersey federal judge has ruled, agreeing with Amneal Pharmaceuticals Inc.'s interpretation of claim language in the brand-name drugmaker's infringement suit against Amneal, a generic pharmaceutical firm.
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November 07, 2024
Masimo Spinoff's Ex-CTO Denies Giving Apple Trade Secrets
Cercacor Laboratories' former chief technology officer testified Thursday that he privately emailed Apple CEO Tim Cook offering to help the tech giant become a top health and wellness device brand, but denied accusations that he gave Apple any of the Masimo spinoff's pulse oximetry trade secrets.
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November 07, 2024
Ex-Natera VP Defends Ad Campaign Against Rival Guardant
A former Natera Inc. marketing vice president defended the company Thursday in a false advertising case launched by Guardant Health Inc., testifying that there was a sales and marketing campaign against Guardant's Reveal colorectal cancer test, but its aim was to address Guardant's "misleading" claims.
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November 07, 2024
3rd Circ. Says Tainted Bayer Antifungals Clearly 'Worth Less'
Four of the nine named plaintiffs in a proposed class action over Bayer's 2021 recall of potentially benzene-tainted antifungal sprays can revive their claims against the company on the grounds that they'd paid for an effectively worthless product, a Third Circuit panel ruled Thursday.
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November 07, 2024
FDA Wants Ineffective Decongestant Removed From Market
The U.S. Food and Drug Administration on Thursday suggested removing the widely used decongestant phenylephrine as an active ingredient in over-the-counter cold and allergy medicines after an agency review determined that the drug is ineffective when taken orally.
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November 07, 2024
Ill. Judge Anticipates 'Massive' Outcome Investor Restitution
An Illinois federal judge signaled Thursday that he anticipates three former Outcome Health executives will pay a "massive" amount in restitution to investors such as Goldman Sachs and CapitalG that were persuaded to give Outcome money in a fraudulent effort to grow the company.
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November 07, 2024
Researcher Sues DEA Over Pot Rescheduling Process
A psychedelic researcher has asked a Washington federal judge to block the Drug Enforcement Administration from proceeding with its plan to hold administrative hearings on a proposal to reclassify marijuana, alleging various breaches of administrative law.
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November 07, 2024
Eye Drop Maker To Pay $3.6M To Settle Class Claims
A maker of homeopathic eye drops has agreed to pay nearly $3.6 million to settle claims its products are being sold as drugs without U.S. Food and Drug Administration approval and don't meet manufacturing safety standards, according to a preliminary settlement agreement filed Wednesday.
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November 07, 2024
Teva Can't End Inhaler Antitrust Suit But Gets Claim Nixed
A Massachusetts federal court refused Teva Pharmaceutical Industries Ltd.'s attempt to end a case accusing it of orchestrating a decade-long scheme to delay generic competition for its QVAR asthma inhalers, but cut allegations that Teva paid Amneal Pharmaceuticals Inc. not to launch its version.
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November 07, 2024
Same PBM Conduct Means Same Insulin Price Trial, FTC Says
Federal Trade Commission staffers want Caremark Rx, Express Scripts and OptumRx kept together in a single in-house case accusing the pharmacy benefit managers of artificially inflating insulin prices through unfair rebate schemes, arguing they are all "accused of violating the same laws by engaging in the same type of conduct."
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November 07, 2024
LeBron Eyes Media Merger, AI Startup IPO, And More Rumors
Basketball star LeBron James wants to merge his TV and film production company with a British studio, while AI-focused startup CoreWeave has selected investment banks to manage an initial public offering planned for 2025, plus a women's clothing retailer and a generic-drug maker are planning a pair of listings that could revive Canada's dormant IPO market.
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November 06, 2024
Masimo Expert Cites LED And Foam As Evidence Apple Stole IP
Apple misappropriated Masimo's pulse oximetry trade secrets and used them to improve its Apple Watch, a Masimo expert witness testified in California federal court Wednesday, pointing to Apple's use of a short circuit LED and a black foam test.
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November 06, 2024
Natera Declared 'War' On Guardant, Jury Told At Trial's Start
Guardant on Wednesday told a California federal jury during opening statements in its false advertising lawsuit that rival Natera saw Guardant's competing colorectal cancer detection test as "an existential threat" and declared "war" while Natera maintained that its ads to doctors comparing the tests were meant "to educate, not deceive."
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November 06, 2024
Trump's Win Likely To Spur Deals For Capital Markets Attys
Former President Donald Trump's decisive win in Tuesday's presidential election will enable deals to proceed on a more certain basis, capital markets advisers said Wednesday, citing pent-up demand to restart capital raising after a long period of subdued activity.
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November 06, 2024
After Electoral Defeats, Cannabis Advocates Eye Next Steps
Cannabis industry advocates and reform activists struck a note of cautious optimism Wednesday following an expected Republican electoral sweep of the federal government, while opponents of legalization touted the defeat of multiple statewide ballot measures as proof of their position that marijuana reform efforts were losing support.
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November 06, 2024
Sanctioned Supplier, Abbott Strike Deal Over TM Judgment
Abbott Laboratories has resolved a dispute with a diabetes test-strip wholesaler that was ordered to pay Abbott $33.4 million after committing discovery misconduct, with the parties saying they've agreed to a settlement after a federal appeals court upheld Abbott's default win in September.
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November 06, 2024
Medtronic Says Axonics Misled Jury To Beat Patent Case
Medtronic is seeking a new trial after a California federal jury two months ago found that Axonics did not infringe three of its patents related to its bladder and bowel control device, while Axonics wants the court to find that one of those patents wasn't valid to begin with.
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November 06, 2024
Feds Fight Philly Injection Site Group's 3rd Circ. Appeal
The U.S. Department of Justice has urged the Third Circuit to preserve its win in preventing an overdose prevention organization from opening a supervised safe-injection site in Philadelphia, arguing that a lower court correctly ruled that the group is not a religious organization eligible for federal protection.
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November 06, 2024
Insurers Urge Del. Justices To Reverse Drug Co. Policy Ruling
Attorneys for three insurers battling Alexion Pharmaceuticals Inc. over potential director and officer insurance payouts in a securities action launched before Alexion received a separate federal regulator penalty told Delaware's Supreme Court on Wednesday that a lower court decision wrongly sided with the company on coverage worth an additional $20 million.
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November 06, 2024
Feds Look To Halt Vitamin Co. Payouts Amid $1.4M Tax Fight
A couple who bought a vitamin supplement company shouldn't continue to get payments from the business amid a suit claiming they're liable for a previous owner's $1.4 million tax lien, the U.S. Department of Justice told a Connecticut federal court Wednesday.
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November 06, 2024
Business Groups Urge Calif. Justices To Nix HIV Drug Ruling
Business groups led by the U.S. Chamber of Commerce are asking the California Supreme Court to throw out a suit alleging Gilead Sciences Inc. deprived customers of a safer form of its HIV drug for profits, saying the current ruling creates an untenable duty and liability even when there's no harmful defect in a product.
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November 06, 2024
What A Second Trump Term Could Mean For FDA And CPSC
The historic reelection of former President Donald Trump could lead to shake-ups at the U.S. Food and Drug Administration and the U.S. Consumer Product Safety Commission, while questions remain about what policies he will enact.
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November 06, 2024
Tobacco Cos. Side With FDA In Menthol Cigarette Ban Fight
Tobacco giants R.J. Reynolds and Philip Morris have come to the aid of the U.S. Food and Drug Administration in a pair of friend-of-the-court briefs, urging a federal court to toss a suit against the agency over its purported delays in implementing a ban on menthol cigarettes.
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November 05, 2024
How The Patent System May Look After Trump's Return
The U.S. Patent and Trademark Office during Donald Trump's first term as president focused on making the invalidation of patents more difficult, and attorneys say his second administration is likely to do the same following his projected reelection.
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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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.
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Lawyers With Disabilities Are Seeking Equity, Not Pity
Attorneys living with disabilities face extra challenges — including the need for special accommodations, the fear of stigmatization and the risk of being tokenized — but if given equitable opportunities, they can still rise to the top of their field, says Kate Reder Sheikh, a former attorney and legal recruiter at Major Lindsey & Africa.
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Opinion
Judicial Committee Best Venue For Litigation Funding Rules
The Advisory Committee on Civil Rules' recent decision to consider developing a rule for litigation funding disclosure is a welcome development, ensuring that the result will be the product of a thorough, inclusive and deliberative process that appropriately balances all interests, says Stewart Ackerly at Statera Capital.
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The Strategic Advantages Of Appointing A Law Firm CEO
The impact on law firms of the recent CrowdStrike outage underscores that the business of law is no longer merely about providing supplemental support for legal practice — and helps explain why some law firms are appointing dedicated, full-time CEOs to navigate the challenges of the modern legal landscape, says Jennifer Johnson at Calibrate Strategies.