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Life Sciences
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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.
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June 17, 2024
Top Patent Eligibility Rulings In The Decade Since Alice
The U.S. Supreme Court's Alice v. CLS Bank decision 10 years ago this week led to scores of inventions being found ineligible for patenting, and rulings since then have fleshed out the law on the contentious topic. Here's a look at the most notable patent eligibility decisions after Alice.
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June 17, 2024
Ex-Stimwave CEO Gets 6 Years For Dummy Implant Scheme
The founder and former CEO of Stimwave Technologies was sentenced to six years in prison Monday after tearfully proclaiming her innocence to healthcare fraud charges, with a Manhattan federal judge saying it's "sad" the defendant doesn't recognize the harm she inflicted by selling nonfunctional pain management device components.
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June 17, 2024
HUD Freed From Pa. Pot Patients' Suit Over Housing Rebuff
Unless the U.S. Department of Housing and Urban Development fulfills its threat to withhold a Pennsylvania county housing agency's funding for complying with a state court order to admit licensed medical marijuana patients, a lawsuit by the county agency and two potential tenants is premature, a federal judge ruled Monday.
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June 17, 2024
Drugmaker, PE Investor Sued In Del. Over 'Unfair' Deal Terms
Clinical-stage biotechnology firm Omega Therapeutics' board entered into an "unfair" agreement to develop a new drug with the company's controlling private equity stockholder that was heavily tilted in favor of the majority equity holder and Omega insiders, an investor alleged in a lawsuit in Delaware's Chancery Court.
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June 17, 2024
Zantac Suits Must Exit State Court, Conn. Judge Told
A Connecticut state court judge must relinquish jurisdiction over two lawsuits claiming that generic versions of the heartburn drug Zantac caused cancer because state statutes do not subject entities with foreign business registrations to the auspices of Constitution State judges, a pharmaceutical industry attorney argued at a hearing Monday morning.
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June 17, 2024
Fed. Circ. Says Errors Led To Injunction In Trade Secrets Suit
A Federal Circuit panel on Monday overturned a preliminary injunction against a South Korean insulin pump patch manufacturer that allegedly stole trade secrets from a rival, saying a Massachusetts federal court made a series of errors in its determination to grant an injunction.
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June 17, 2024
Catching Up With Delaware's Chancery Court
Proposed amendments to Delaware's General Corporation Law that were prompted by several recent Chancery Court rulings sailed through the state Senate last week despite loud opposition from corporate law professors and other Chancery Court watchers, and Tesla shareholders filed two new suits against CEO Elon Musk.
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June 17, 2024
Talc Claimants Want Documents In Fight Over J&J Unit Venue
Cancer patients with talc damage claims against Johnson & Johnson have urged a New Jersey federal court to give them access to transcripts and exhibits from depositions of top executives at the company's talc unit, saying the information will aid their effort to bar the J&J spinoff from filing a third Chapter 11 outside the Garden State.
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June 14, 2024
Justices Are Asked To Wade Into Blood Pressure Drug IP Fight
United Therapeutics is taking its patent case seeking to stop a rival from selling a drug that competes with its blockbuster treatment for high blood pressure to the U.S. Supreme Court.
Expert Analysis
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Cos. Must Prepare For Calif. Legislation That Would Ban PFAS
Pending California legislation that would ban the sale or distribution of new products containing intentionally added per- and polyfluoroalkyl substances could affect thousands of businesses — and given the bill's expected passage, and its draconian enforcement regime, companies must act now to prepare for it, say attorneys at Alston & Bird.
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FDA Warning Letter Tightens Reins On 'Research Only' Labels
A recent warning letter from the U.S. Food and Drug Administration to Agena Bioscience alleged the company’s diagnostic devices were labeled for research use only, but improperly promoted for human clinical purposes, signifying a reinforcement — and a potential narrowing — of the agency's policy on products labeled “research only,” say attorneys at Sheppard Mullin.
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Practical Pointers After Fed. Circ. Double-Patenting Decision
With the Federal Circuit recently denying a full court review of In re: Cellect, a decision regarding obviousness-type double-patenting, affected patent family holders should evaluate their rights through both patent prosecution and future litigation lenses to minimize risks, say Austin Lorch and Jeff Wolfson at Haynes Boone.
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Highlights From The 2024 ABA Antitrust Spring Meeting
U.S. merger enforcement and cartels figured heavily in this year's American Bar Association spring antitrust meeting, where one key takeaway included news that the Federal Trade Commission's anticipated changes to the Hart-Scott-Rodino form may be less dramatic than many originally feared, say attorneys at Freshfields.
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Strategies For Challenging A Fla. Grand Jury Report's Release
A Florida grand jury’s recent report on potential wrongdoing related to COVID-19 vaccines should serve as a reminder to attorneys to review the myriad legal mechanisms available to challenge the lawfulness of a grand jury report’s publication and expunge the names of their clients, says Cary Aronovitz at Holland & Knight.
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Patent Lessons From 8 Federal Circuit Reversals In March
A number of Federal Circuit patent decisions last month reversed or vacated underlying rulings, providing guidance regarding the definiteness of a claim that include multiple limitations of different scopes, the importance of adequate jury instruction, the proper scope of the precedent, and more, say Denise De Mory and Li Guo at Bunsow De Mory.
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A Look At Ex Parte Seizures 8 Years Post-DTSA
In the eight years since the Defend Trade Secrets Act was enacted, not much has changed for jurisprudence on ex parte seizures, but a few seminal rulings show that there still isn’t a bright line on what qualifies as extraordinary circumstances warranting a seizure, say attorneys at Finnegan.
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Series
Whitewater Kayaking Makes Me A Better Lawyer
Whether it's seeing clients and their issues from a new perspective, or staying nimble in a moment of intense challenge, the lessons learned from whitewater kayaking transcend the rapids of a river and prepare attorneys for the courtroom and beyond, says Matthew Kent at Alston & Bird.
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AI In The Operating Room: Liability Issues For Device Makers
As healthcare providers consider medical devices that use artificial intelligence — including systems to help surgeons make decisions in the operating room — and lobby to shift liability to device manufacturers, companies making these products must review potential product liability risks and important design considerations for such equipment, say attorneys at Troutman Pepper.
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Del. Lessons For Director-Nominees On Sharing With Activists
The Delaware Chancery Court's recent decision in Icahn Partners v. deSouza finding that a director wasn't permitted to share certain privileged information with the activist stockholders that nominated him shows the need for companies to consider imposing appropriate confidentiality requirements on directors, say attorneys at Sullivan & Cromwell.
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10 Years After Alice, Predictability Debate Lingers
A decade after the U.S. Supreme Court’s Alice ruling, critics continue to argue that the subject matter eligibility framework it established yields inconsistent results, but that contention is disproved by affirmance data from the Federal Circuit, district courts and the Patent Trial and Appeal Board, say Dennis Abdelnour and David Thomas at Honigman.
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This Earth Day, Consider How Your Firm Can Go Greener
As Earth Day approaches, law firms and attorneys should consider adopting more sustainable practices to reduce their carbon footprint — from minimizing single-use plastics to purchasing carbon offsets for air travel — which ultimately can also reduce costs for clients, say M’Lynn Phillips and Lisa Walters at IMS Legal Strategies.
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Questions Persist After Ruling Skirts $925M TCPA Award Issue
After an Oregon federal court's recent Wakefield v. ViSalus ruling that the doctrine of constitutional avoidance precluded it from deciding whether a $925 million Telephone Consumer Protection Act damages award was constitutionally sound, further guidance is needed on when statutory damages violate due process, says Michael Klotz at O'Melveny.
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Benzene Contamination Concerns: Drugmakers' Next Steps
After a citizen petition to the U.S. Food and Drug Administration and a flurry of class actions over benzene contamination in benzoyl peroxide acne products, affected manufacturers should consider a thoughtful approach that includes assembling internal data and possibly contacting the FDA for product-specific discussions, say attorneys at Morgan Lewis.
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Opinion
States Should Follow Federal Lead On Expert Evidence Rules
The recently amended Federal Rule of Evidence 702 will help ensure expert testimony in federal courts reflects adequate data and reliable methods properly applied to a given case, and state courts — home to the overwhelming majority of U.S. litigation — should adopt similar changes, says retired attorney Michael Harrington.