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Life Sciences
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June 20, 2024
Spinal Implant Maker Can Liquidate Under Ch. 11 Plan
A Delaware bankruptcy judge agreed Thursday to approve the Chapter 11 liquidation and wind-down plan of biotechnology developer InVivo, which reported it landed a buyer for its spinal cord implant technology following an unsuccessful bankruptcy auction.
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June 20, 2024
11th Circ. Upholds $2.5M Pelvic Mesh Verdict, Rules Suit Timely
The Eleventh Circuit on Thursday refused to throw out a woman's $2.5 million victory against Coloplast Corp. in a suit alleging she was implanted with defective pelvic mesh, saying the evidence does not support a conclusion that her claim was filed too late.
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June 20, 2024
No Access To Ethics Docs For Ex-NJ Official Yet, Judge Rules
A New Jersey judge has rejected a bid by a former Garden State health official asking the court to compel the state and its ethics commission to produce documents related to claims he was fired in 2020 for raising concerns over the earmarking of COVID-19 tests for relatives of a state administration official, according to Wednesday orders.
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June 20, 2024
No Atty, No Case: Judge Tosses Attack On Psychedelics Ban
A federal judge in Washington state threw out a challenge to the U.S. Drug Enforcement Administration's efforts to ban two psychedelic substances in an order Thursday that chided a psychedelic research company for doing "an end run" around requirements that corporations be represented by an attorney.
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June 20, 2024
HHS Drug Pricing Program Flouts Constitution, Boehringer Says
An "unprecedented" new Medicare price negotiation program deprives drugmakers of their constitutional rights and forces them to make declarations on issues of public concern that reflect poorly on them, Boehringer Ingelheim Pharmaceuticals Inc. argued Thursday in Connecticut federal court as it echoed the industry chorus seeking to strike the initiative.
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June 20, 2024
11th Circ. Nixes J&J Sunscreen Benzene MDL Settlement
The Eleventh Circuit on Thursday vacated an order granting approval to a settlement resolving claims that Johnson & Johnson sold sunscreens containing benzene, saying a pair of circuit court decisions since the approval mean the deal needs another look.
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June 20, 2024
Theravance, Mylan Say Chinese Co. Copied COPD Drug
Theravance Biopharma and Mylan Specialty have sued a Chinese drugmaker, alleging it copied Yupelri, one of its chronic obstructive pulmonary disease drugs, and infringed several patents in the process.
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June 20, 2024
USPTO's AI-Assisted Inventions Guidance Irks ABA IP Section
The U.S. Patent and Trademark Office's guidance on when inventions developed using artificial intelligence can be patented generated criticism from the American Bar Association's Section of Intellectual Property Law, expressing concern that it could be detrimental as it "casts doubt on inventorship through general acts of human direction."
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June 20, 2024
11th Circ. Backs Stryker's Defeat Of Fired Worker's Leave Suit
The Eleventh Circuit refused Thursday to revive a suit claiming medical technology company Stryker illegally fired a worker on leave awaiting the birth of his child, ruling that because the leave didn't formally kick in until the child was born, his termination was fair game.
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June 18, 2024
High Court Petition Asks Justices: What's A 'Willful' Kickback?
Does a "willful" act under federal anti-kickback law require a defendant to know that the conduct violates the law? That's the question a whistleblower is asking the U.S. Supreme Court to answer in order to resolve what the petition calls a circuit split on a key question of federal fraud prosecutions.
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June 18, 2024
Company, States Battle In Court Over At-Home Rape Kits
A fight is brewing in federal and state courts between a company that purports to be the nation's only purveyor of self-administered sexual assault DNA collection kits and state attorneys general who believe it is misleading sexual assault victims.
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June 20, 2024
CORRECTED: Drug Cos., PBMs Score Win In Calif. AG's Insulin Price Suit
A Los Angeles judge ruled Tuesday that the statute of limitations bars the California Attorney General's unfair competition law and unjust enrichment claims against drugmakers and pharmacy benefit managers over an alleged conspiracy to spike insulin costs, but granted leave to amend the allegations.
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June 18, 2024
Fla. Immune To Contract Suit Over COVID Tests, 4th Circ. Says
The Fourth Circuit reversed on Tuesday a district court decision denying a motion to dismiss by a Florida state agency in a breach of contract case involving COVID-19 tests, finding the lower court erred in ruling that the state did not have sovereign immunity and remanding the case for further proceedings.
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June 18, 2024
11th Circ. Orders New Shrimp Secrets Trial Over Judge's Exit
The Eleventh Circuit ordered a new trial in a trade secrets dispute involving breeders of disease-resistant shrimp, saying Tuesday that a magistrate judge who oversaw the trial's conclusion so that a federal judge could catch a flight exceeded his authority by answering jury questions and rejecting a defense counsel's request for clarification on damages awarded.
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June 18, 2024
COVID Test Maker Can't Shake All Of $30M Faulty Kit Suit
A New Jersey federal judge won't let California-based laboratory equipment maker Atila Biosystems Inc. out of a suit alleging it sold faulty COVID-19 testing kits, saying Fusion Diagnostic Laboratories LLC has adequately pled a breach of contract claim.
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June 18, 2024
J&J Fights Law Firm's Bid To Nix Subpoenas In Talc Brawl
Information about the Beasley Allen Law Firm's litigation funding and settlement communications is relevant and necessary to resolving long-running multidistrict litigation over Johnson & Johnson's talcum powder products and so should be turned over, the pharmaceutical giant has told a New Jersey federal court.
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June 18, 2024
Restitution Plan For Lead-Test Defects Leaves Judge Uneasy
A Massachusetts federal judge on Tuesday questioned the legality of a plan to have a claims administrator, rather than the court, oversee victim compensation in a criminal case alleging Magellan Diagnostics hid information about inaccurate results in its lead-testing devices.
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June 18, 2024
Latham Leads Boston Scientific On $1.16B Silk Road Deal
Latham & Watkins-advised Boston Scientific Corp. said Tuesday it has agreed to acquire medical device maker Silk Road Medical Inc., represented by Wilson Sonsini, at an enterprise value of approximately $1.16 billion.
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June 18, 2024
Cancer Test Company DermTech Hits Ch. 11, Seeking Sale
California-based dermatologic test maker DermTech Inc. hit Chapter 11 Tuesday in Delaware and said it would be laying off about 20% of its workforce as it seeks to sell its assets.
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June 18, 2024
Samsung Bioepis Denies Infringing Blood Treatment Patent
Samsung Bioepis has fought back against a bid by Alexion to prevent it from selling a biosimilar version of a patented blood treatment drug by a rival, telling a court that this will not infringe the protections of an AstraZeneca subsidiary over the medicine.
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June 17, 2024
Teva, DOJ Signal Key Kickback Case May Fizzle At 1st Circ.
A U.S. Department of Justice kickback case against Teva Pharmaceuticals — closely watched by False Claims Act lawyers because of its multibillion-dollar stakes and its link to a major circuit split — is poised for settlement, according to a new First Circuit filing ahead of eagerly awaited oral arguments.
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June 17, 2024
NJ Firm Defends Lien On Ex-Client's Patents After Unpaid Bills
A major New Jersey law firm said it has a "common law" right to place a lien on its former client's patents without telling it, after the "failed" biopharmaceutical startup fired the firm and stopped paying its outstanding legal bills.
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June 17, 2024
USC Allegedly Used 'Junk Science' On Black Kidney Patients
The University of Southern California secretly has been using a "junk science" scoring formula that hurts Black patients' eligibility to receive kidney transplants, according to a putative class action in California federal court.
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June 17, 2024
Mifepristone Ruling Means End Of Texas DACA Suit, Feds Say
A Texas-led coalition of states doesn't have standing to challenge the Deferred Action for Childhood Arrivals program after the U.S. Supreme Court's blockbuster decision rejecting a challenge to the abortion drug mifepristone, the Biden administration told the Fifth Circuit on Monday.
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June 17, 2024
DOJ Wants 15 Years For Outcome CEO's $1B Fraud
Federal prosecutors said former Outcome Health CEO Rishi Shah should serve 15 years in prison while Outcome's co-founder and ex-financial chief each serve 10 years following their convictions for running a $1 billion fraud that affected lenders, investors and clients.
Expert Analysis
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Series
The Pop Culture Docket: Judge Djerassi On Super Bowl 52
Philadelphia Court of Common Pleas Judge Ramy Djerassi discusses how Super Bowl 52, in which the Philadelphia Eagles prevailed over the New England Patriots, provides an apt metaphor for alternative dispute resolution processes in commercial business cases.
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Reverse Merger Tips For Biotechs After SEC's Recent Actions
Several recent U.S. Securities and Exchange Commission developments could limit the viability of reverse mergers for biotech companies, and will require additional creativity and analysis for private companies looking to go public, say attorneys at Orrick.
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Opinion
Proposed Rule Misses The Mark On Improving MDLs
The Advisory Committee on Civil Rules' recently proposed rule on multidistrict litigation would provide some guidance for courts on managing MDLs — but without any requirement for the early vetting of claims, it is particularly unhelpful for defendants in pharmaceutical and product liability cases, say attorneys at Crowell & Moring.
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Taking A Closer Look At Fed. Circ. Claim Construction Split
An empirical analysis of a year's worth of claim construction decisions from the Federal Circuit and four key district court jurisdictions shows that these constructions vary in material ways depending on the analysis' source, and this body of case law would benefit from clarification by the Federal Circuit itself, say attorneys at WilmerHale.
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The 7th Circ.'s Top 10 Civil Opinions Of 2023
Attorneys at Jenner & Block examine the most significant decisions issued by the Seventh Circuit in 2023, and explain how they may affect issues related to antitrust, constitutional law, federal jurisdiction and more.
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Employee Experience Strategy Can Boost Law Firm Success
Amid continuing business uncertainty, law firms should consider adopting a holistic employee experience strategy — prioritizing consistency, targeting signature moments and leveraging measurement tools — to maximize productivity and profitability, says Haley Revel at Calibrate Consulting.
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Series
Competing In Triathlons Makes Me A Better Lawyer
While practicing law and competing in long-distance triathlons can make work and life feel unbalanced at times, participating in the sport has revealed important lessons about versatility, self-care and perseverance that apply to the office as much as they do the racecourse, says Laura Heusel at Butler Snow.
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Parsing The USPTO's Guidelines For Assessing Enablement
Ryan Hagglund at Loeb & Loeb details the U.S. Patent and Trademark Office's recent guidelines for assessing enablement principles set forth in the U.S. Supreme Court's 2023 Amgen v. Sanofi decision, including how the guidelines can apply to all fields of technology.
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Notes Of Interest From 5th Circ. Illumina-Grail Merger Ruling
Attorneys at Simpson Thacher consider the Fifth Circuit's recent decision upholding the Federal Trade Commission's challenge of the Illumina merger with Grail, its much-needed boost to the Biden administration's antitrust agenda, and some silver linings the decision offers to merging parties.
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DOJ's Biopharma Settlement Raises Anti-Kickback Questions
In the aftermath of the U.S. Department of Justice's settlement with Ultragenyx over genetic testing programs, it may be prudent to reevaluate genetic tests through the lens of the Anti-Kickback Statute and reconsider whether it is proper for free testing programs to be treated like patient assistance programs, says Mary Kohler at Kohler Health Law.
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Where Justices Stand On Chevron Doctrine Post-Argument
Following recent oral argument at the U.S. Supreme Court, at least four justices appear to be in favor of overturning the long-standing Chevron deference, and three justices seem ready to uphold it, which means the ultimate decision may rest on Chief Justice John Roberts' vote, say Wayne D'Angelo and Zachary Lee at Kelley Drye.
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Precise Advance Notice Bylaws May Help Prevent Disputes
While the Chancery Court's December decision in Kellner v. AIM Immunotech shows that Delaware courts won't always uphold advance notice bylaws, and its willingness to selectively enforce or invalidate individual provisions doesn't create an incentive for companies to be surgical in their drafting, companies should nonetheless be precise when drafting such bylaws to avoid unnecessary disputes, say attorneys at Debevoise.
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Perspectives
6 Practice Pointers For Pro Bono Immigration Practice
An attorney taking on their first pro bono immigration matter may find the law and procedures beguiling, but understanding key deadlines, the significance of individual immigration judges' rules and specialized aspects of the practice can help avoid common missteps, says Steven Malm at Haynes Boone.
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Series
ESG Around The World: Canada
In Canada, multiple statutes, regulations, common law and industry guidance address environmental, social and governance considerations, with debate over ESG in the business realm potentially growing on the horizon, say attorneys at Blakes.
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5 Legal Considerations For Psychedelic Therapy Sector
With multiple developments signaling the rise of psychedelic-assisted psychotherapy, it is imperative that clinicians understand unique legal nuances ranging from corporate formation to specialized insurance coverage, say Kimberly Chew and Natasha Sumner at Husch Blackwell.