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Life Sciences
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April 23, 2024
Calif. Fertility Clinic Implanted Dead Embryos, Couples Say
An Orange County, California, fertility clinic accidentally destroyed embryos but still implanted them into patients in an attempt to cover up its mistakes, nine couples said in a suit filed Tuesday in Golden State court.
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April 23, 2024
Medtronic Patent Fight With Axonics Set For September Trial
A California federal judge has lifted a stay in Medtronic's patent infringement suit against Axonics over an electrical stimulation system, while also scheduling a trial for September.
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April 23, 2024
GoodRx Hid Revenue Reliance On Kroger, Suit Claims
GoodRx Holdings Inc. has been hit with a proposed class action alleging it concealed from investors the indispensability of its relationship with Kroger, leading to share declines when GoodRx announced revenue would be severely impacted because the grocery chain would no longer be accepting its discount codes.
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April 23, 2024
Israeli Biotech Files Ch. 15 To Implement Take-Private Deal
Gamida Cell Ltd., an Israeli biotechnology company developing immunotherapy products, filed for Chapter 15 protection Monday in Delaware seeking the American court's approval of its foreign take-private proposal with unsecured lenders.
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April 23, 2024
Ex-Takeda Worker, Boyfriend To Plead Guilty In Invoice Scam
A former Takeda Pharmaceutical Co. employee and her boyfriend plan to plead guilty to a $2.3 million phony invoice scheme, their lawyers told a Massachusetts federal judge on Tuesday.
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April 23, 2024
Drugmakers Hit With RICO Suit Over Insulin Price Hikes
The world's three largest insulin manufacturers engineered an enormous increase in the price of the lifesaving diabetes medication through an "unfair and deceptive conspiracy" with household-name pharmacies, letting all involved reap extraordinary profits for 20 years, according to a lawsuit in Connecticut federal court.
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April 23, 2024
Fenwick, Covington Build $750M Sale Of Pharmaceutical Biz
Global biopharmaceutical company Incyte, advised by Covington & Burling LLP, on Tuesday announced plans to buy clinical-stage drug discovery company Escient Pharmaceuticals, led by Fenwick & West LLP, for $750 million.
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April 23, 2024
Pre-Merger Deal Prompts Pharma Co. Derivative Suit In Del.
An Ayala Pharmaceuticals stockholder has launched a derivative suit against the company's board and controlling investors in Delaware's Court of Chancery, accusing directors of issuing new shares to the controllers at far below market value, timed to take advantage of an asset sale worth up to $85 million.
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April 23, 2024
Colo. Neural Privacy Law Has Attys Scratching Their Heads
Colorado's governor signed the nation's first law specifically protecting neural data last week, but privacy attorneys say key caveats in the legislation leave them unsure how far the measure really goes.
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April 22, 2024
HHS Finalizes Rule Bolstering Abortion Privacy Protections
The U.S. Department of Health and Human Services on Monday issued a finalized version of its new rule that aims to protect the privacy of abortion providers and patients by prohibiting the disclosure of information related to "lawful reproductive health care," according to an announcement made by the agency.
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April 22, 2024
Eli Lilly Tells Fed. Circ. $177M Patent Loss Was Rightly Axed
Eli Lilly & Co. has urged the Federal Circuit to uphold a Massachusetts federal judge's decision that wiped out a $176.5 million verdict against it for infringing Teva migraine drug patents, saying the lower court correctly found the patent claims to be invalid.
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April 22, 2024
9th Circ. Backs Class Cert. In Pet Supplement False Ad Suit
The Ninth Circuit on Monday upheld certification of a consumer class accusing health supplement company Nutramax of falsely marketing Cosequin as promoting healthy joints in dogs, saying an economics expert could use a generic and "otherwise reliable" damages model without applying it specifically to the class at this stage.
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April 22, 2024
J&J Fired Worker For Old Case Against New Boss, Suit Claims
A former senior medical affairs director for Johnson & Johnson's research unit sued the company on Friday in New Jersey state court, alleging she was fired in retaliation for a separate lawsuit filed years earlier in which she named a boss from her prior employer who had recently joined Johnson & Johnson.
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April 22, 2024
J&J Hit With $45M Talc Verdict In Illinois Cancer Trial
An Illinois state jury has awarded $45 million to the estate of a woman who died from mesothelioma after using Johnson & Johnson's talc-based baby powder for years, finding that her exposure to asbestos fibers in the powder led to her cancer.
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April 22, 2024
Opioid Marketer Completes $1.5M Damages Settlement With Del.
Delaware's chancellor signed off Monday on a $1.5 million payment to the state by a company that helped Purdue Pharmaceuticals market its opioid products, the latest step in a $358 million, 50-state damages settlement reached with Publicis Health LLC.
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April 22, 2024
Broker In Penny Stock Scheme Says SEC Is Forum Shopping
A former California securities broker serving a prison term for a $150 million pump and dump scheme said Monday that a companion civil case brought by the Securities and Exchange Commission does not belong in Massachusetts.
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April 22, 2024
DEA Tells 9th Circ. 'Right To Try' Doesn't Rewrite CSA
The U.S. Drug Enforcement Administration is urging the Ninth Circuit to reject an appeal by a doctor who seeks to administer psilocybin to terminal cancer patients to treat depression, saying the Right to Try Act doesn't waive the Controlled Substances Act's prohibitions or authorize the DEA to do so.
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April 22, 2024
J&J Says Worker's Drug Costs Suit Misses Big Picture
Johnson & Johnson asked a New Jersey federal judge to toss a worker's suit claiming employees were overcharged for their prescriptions under a drug benefit program because of a contract with a pharmacy benefits manager, saying employees didn't show they could've gotten a better deal elsewhere.
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April 22, 2024
Catching Up With Delaware's Chancery Court
Last week, Delaware's Chancery Court news included a Tesla announcement about moving to Texas, a midcase appeal of Tripadvisor's move to Nevada, and United Airlines' escape from a stockholder suit. Disputes about board entrenchment, squeeze-out mergers, co-founder fallouts and deadly ice cream moved ahead.
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April 22, 2024
Thermo Fisher Says Rival Is Raiding Its Workforce
Thermo Fisher Scientific Inc. is seeking to block Repligen Corp. from hiring one of its top executives, according to a suit in Massachusetts state court accusing the rival of a "systematic raiding" of its workforce.
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April 22, 2024
Supreme Court Won't Review Vanda's IP Obviousness Appeal
The U.S. Supreme Court on Monday rejected Vanda Pharmaceuticals Inc.'s request for review of how the Federal Circuit is deciding whether patents are invalid as obvious, ending the company's attempt to revive patents covering its sleep disorder drug Hetlioz.
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April 19, 2024
Allergan To Face Kickback Claim In Suit Over Child Botox Use
A Texas federal judge has axed allegations that pharmaceutical company Allergan Inc. defrauded the U.S. government when it promoted the unapproved use of Botox to treat migraines in children but will allow claims that the company bribed doctors to conduct the procedure to move forward.
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April 19, 2024
Judge Mulls Axing Biomedical Cos.' $25M Punitive Damages
Not enough evidence supports Skye Orthobiologics' $25.5 million punitive damages award against an ex-employee found to have breached his fiduciary duties by leveraging Skye's proprietary information, a California federal judge has ruled, asking for briefing on whether the proper remedy is to cut the damages or grant a new trial.
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April 19, 2024
Flint Class Urges Approval Of $25M Water Firm Settlement
A proposed class of 45,000 Flint, Michigan, property owners, businesses and adult residents on Friday urged a Michigan federal court to give the go-ahead to a $25 million settlement with Veolia North America, the last remaining engineering defendant in sprawling litigation over the city's water crisis.
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April 19, 2024
Walgreens Inks $110M Deal To End Philly Opioid Crisis Suit
Walgreens will pay the city of Philadelphia $110 million over the next five years to settle claims that it contributed to the opioid epidemic by ignoring suspicious prescriptions for addictive opioid painkillers, city officials announced Friday.
Expert Analysis
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Series
ESG Around The World: South Africa
While South Africa has yet to mandate the reporting of nonfinancial and environmental, social, and corporate governance issues, policy documents and recent legislative developments are likely to have a material impact in the country's transition to a low-carbon economy and in meeting its international obligations, say Glynn Kent at Eversheds Sutherland.
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FOIA Exemption Questions On Redacted HHS Cannabis Letter
The U.S. Department of Health and Human Services' recent recommendation letter concerning the rescheduling of cannabis was heavily redacted, and based on an analysis on the applicability of Freedom of Information Act Exemption 5 to the letter, it's likely that we will see successful legal challenges to those redactions, say attorneys at Troutman Pepper.
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Fed. Circ. Ruling Seemingly Offers PTAB Deadline Immunity
The Federal Circuit's recent Purdue Pharma v. Collegium Pharmaceutical Inc. decision that the Patent Trial and Appeal Board had authority to issue a final written decision in a post grant review after the prescribed statutory deadline underscores how courts should consider the overall objective of the statutory scheme when balancing the classic conflict between bright-line rules and flexible standards, says Matthew Dowd at Dowd Sheffel.
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Evaluating Retroactivity Of Mich. Drugmaker Immunity Repeal
In assessing whether a new Michigan law lifting drugmakers' blanket immunity from product liability suits will apply retroactively, there are four key factors that Michigan courts will likely consider, say Sherry Knutson and Brenda Sweet at Tucker Ellis.
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4 Legal Ethics Considerations For The New Year
As attorneys and clients reset for a new year, now is a good time to take a step back and review some core ethical issues that attorneys should keep front of mind in 2024, including approaching generative artificial intelligence with caution and care, and avoiding pitfalls in outside counsel guidelines, say attorneys at HWG.
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FTC Rite Aid Order Holds Biometrics And AI Compliance Tips
The Federal Trade Commission's recent enforcement action against Rite Aid over its use of facial biometric technology on customers provides lessons that can be leveraged to reduce and manage the risk of regulatory scrutiny of biometrics and artificial intelligence, says David Oberly at Baker Donelson.
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Bribery Settlement Gives Insight On DOJ Policies
Chemical company Albemarle’s recent $218 million settlement with the government to resolve foreign bribery claims provides valuable data points for companies on the U.S. Department of Justice’s voluntary self-disclosure policy and its clawback pilot program, say Michael DeBernardis and Tiauna Mathieu at Hughes Hubbard.
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SEC Case May Expand Scope Of Insider Trading Liability
The U.S. Securities and Exchange Commission's first-of-its-kind enforcement action against an individual in a case involving "shadow trading" demarcates an expansion of insider trading liability to circumstances in which there is a market connection between the source of information and the issuer of the securities traded, say attorneys at Steptoe.
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Opinion
Waiving COVID-19 IP Protections Would Harm US Industry
President Joe Biden should turn down a World Trade Organization proposal to waive crucial intellectual property protections behind COVID-19 tests and diagnostics — protections that allow U.S. companies to sustain millions of jobs and develop life-saving treatments that benefit patients in every country, says former U.S. Circuit Judge Paul Michel, now at the Council for Innovation Promotion.
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Fed. Circ. Patent Decisions In 2023: An Empirical Review
The Federal Circuit decided 306 patent cases last year, which is still well down from the pre-pandemic norm of around 440, and on the whole the court's decisions were markedly less patentee-friendly in 2023 than in 2022, says Dan Bagatell at Perkins Coie.
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What The Law Firm Of The Future Will Look Like
As the legal landscape shifts, it’s become increasingly clear that the BigLaw business model must adapt in four key ways to remain viable, from fostering workplace flexibility to embracing technology, say Kevin Henderson and Eric Pacifici at SMB Law Group.
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4 PR Pointers When Your Case Is In The News
Media coverage of new lawsuits exploded last year, demonstrating why defense attorneys should devise a public relations plan that complements their legal strategy, incorporating several objectives to balance ethical obligations and advocacy, say Nathan Burchfiel at Pinkston and Ryan June at Castañeda + Heidelman.
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Digging Into The Debate On FDA's Proposed Lab Test Rule
A proposed 10-word amendment from the U.S. Food and Drug Administration represents a sea change in device regulation as it would summarily end decades of FDA enforcement discretion for laboratory developed tests, and the public comments offer some insight into the future of this long-running saga, say attorneys at Mintz.
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How 2023 Shaped Drug And Medical Device Legal Trends
2023 brought a number of positive developments for the life sciences industry, including great trial and multidistrict litigation outcomes, but also some heavy-handed regulations and other concerning developments that lay the groundwork for significant litigation, say attorneys at Faegre Drinker.
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Opinion
What Insurers Gain When Litigating Coverage Denials
Lately, insurance companies have denied coverage for lawsuits alleging liability relating to the ordinary operations of highly regulated businesses, such as those in the pharmaceutical and energy sectors — demonstrating time and again how litigation can be a vehicle for carriers to mitigate their own costs, say attorneys at Reed Smith.