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Life Sciences
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April 18, 2024
J&J Notches Win In Fla. Talcum Powder Trial
A Florida state jury returned a verdict for Johnson & Johnson on Thursday, finding the company's talcum-based baby powder had not been shown to cause the ovarian cancer of a longtime user of the product.
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April 18, 2024
Pharma Co. Wants Tribe's Opioid Suit To Stay In Federal Court
A pharmaceuticals distributor has asked an Oklahoma federal court to reject a magistrate judge's recommendation to move to state court a suit accusing it of flooding the Cherokee Nation's communities with opioids, saying the tribe's complaint raises a substantial question of federal law.
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April 18, 2024
Endo Pleads Guilty To Marketing Opioids As 'Crush Proof'
Endo Health Solutions Inc. pled guilty Thursday in Michigan federal court to putting out a drug it falsely advertised as being "crush proof" and "abuse deterrent," part of its larger agreement with the government to resolve nearly $2 billion in civil and criminal claims against the company.
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April 18, 2024
23andMe Taps Dechert To Review CEO Buyout Proposal
A special committee of genetic testing company 23andMe has engaged Dechert LLP as its legal adviser and Wells Fargo as its financial adviser as it looks to review an anticipated buyout offer from its co-founder and CEO Anne Wojcicki, according to a statement Thursday.
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April 18, 2024
FDA Head Gets GOP Rep.'s Rebuke Over Pot Rescheduling
The Republican chair of a U.S. House of Representatives Appropriations subcommittee on Thursday chided the commissioner of the U.S. Food and Drug Administration for the agency's recommendation last year to loosen restrictions on marijuana.
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April 18, 2024
Biotech Co. NanoString Lands $393M Bid At Ch. 11 Auction
Scientific instrument maker Bruker Corp. is set to acquire insolvent biotechnology company NanoString for roughly $393 million in cash that would be used to repay creditors under the debtor's recently proposed Chapter 11 plan, a notice filed in Delaware's bankruptcy court shows.
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April 17, 2024
Trial-Ready Paraquat MDL Cases Tossed After Testimony Axed
An Illinois federal judge on Wednesday threw out the first group of trial-ready cases over the herbicide paraquat, agreeing with Syngenta and Chevron that the plaintiffs' expert testimony must be excluded and finding that the cases fail without that testimony.
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April 17, 2024
Walgreens Investors' $36M Deal In Opioid Suit Gets First OK
An Illinois federal judge on Wednesday granted his initial approval of a $36 million settlement to end a stockholder's derivative suit accusing Walgreens and its leadership of failing to limit retail pharmacies from dispensing unreasonable amounts of opioids.
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April 17, 2024
PTC Therapeutics Settles Shareholder Suit Over Director Pay
PTC Therapeutics Inc. has agreed to corporate governance reforms to settle a derivative shareholder lawsuit challenging its allegedly "lavish" non-employee director compensation awards, according to a stipulation of settlement filed Wednesday in Delaware's Court of Chancery.
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April 17, 2024
United Therapeutics Can't Bar Rival Lung Disease Drug
Repeating himself for the second time in the last several weeks, a federal judge in Delaware on Wednesday said he won't stop a biochemical startup from launching a drug that would compete directly with one of United Therapeutics' biggest pharmaceutical products.
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April 17, 2024
Kraft Sued Over Lead Contamination In Lunchables
Kraft has been slapped with a proposed class action over its popular Lunchables snack kits after independent testing of the kits allegedly found that they contained high, though legally allowable, levels of lead and other harmful substances.
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April 17, 2024
J&J Tells Jurors To Look To Evidence And Science In Talc Trial
Johnson & Johnson's attorney urged a Florida jury Wednesday to look beyond the emotion in the case of a longtime baby powder user who died from cancer and to the science and the evidence, which he said fail to show a causal link between talcum powder and ovarian cancer.
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April 17, 2024
Karuna Investor Ends Suit After Bristol-Myers Seals $14B Deal
A Karuna Therapeutics shareholder has dropped her proposed class action after Bristol-Myers Squibb Co. completed its $14 billion purchase of the biotechology company, a deal the suit alleged was brought about by misrepresentations to investors to gain their support.
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April 17, 2024
Jury To Decide Fault Of Driver In Spray-Huffing DUI Death
A Minnesota federal judge on Wednesday said it's up to a jury to decide whether a driver acted intentionally or negligently when he allegedly huffed a compressed gas spray and killed a woman in a collision, in a trial against the spray's manufacturer over the death.
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April 17, 2024
3 Takeaways From Revived Obviousness Case On J&J Patent
A Federal Circuit ruling from earlier this month that told a judge to reconsider upholding a Johnson & Johnson schizophrenia drug patent emphasizes that analyzing whether a patent is invalid as obvious requires focusing on what it actually claims and an inventor's creativity, attorneys said.
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April 17, 2024
FDA's Foot-Dragging On Menthol Ban Sparks Frustration
The U.S. Food and Drug Administration's yearslong delay to ban menthol has left public health groups frustrated over why the agency has failed to act on what the groups see as an obvious way to improve public health and prevent needless deaths, prompting a second lawsuit over taking menthol off store shelves.
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April 17, 2024
FDA Denies Marketing For 65 MNGO Disposable E-Cigarettes
The latest action by the U.S. Food and Drug Administration on e-cigarettes was to tell a Chinese company to take its range of 65 e-cigarette products in a variety of flavors from menthol to pink lemonade and watermelon off the market.
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April 17, 2024
FDA Tells Justices It Has A Better Vape Case In Mind
The U.S. Food and Drug Administration has told the U.S. Supreme Court that if it wants to address the agency's decision not to approve applications for flavored e-cigarettes, there is a better case in the pipeline than the appeal lodged by Lotus Vaping Technologies that the justices should choose instead.
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April 17, 2024
SEC Has Careful Eye On Disclosures Amid Israel-Hamas War
Against the backdrop of protracted war, the U.S. securities watchdog is urging U.S.-listed Israeli companies to disclose more details describing how the Israel-Hamas conflict is affecting their operations in order to keep investors apprised of risks, lawyers say.
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April 17, 2024
'Ringleader' Of Black Market HIV Drug Scam Gets 9 Years
A New York federal judge on Wednesday sentenced a pharmacy operator to nine years in prison for spearheading a $13 million scheme to sell black market HIV medication and collect fraudulent reimbursements from Medicaid and Medicare.
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April 17, 2024
Manatt Adds NY Bankruptcy, Financial Regulatory Partners
Manatt Phelps & Phillips LLP announced that it hired a pair of experienced New York-based attorneys who focus their practices on regulatory matters as partners in its bankruptcy and financial regulatory practices.
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April 17, 2024
WashU Medical School Settles Claims Of Asylee Bias, Firing
The Washington University School of Medicine in St. Louis has settled claims that it fired a worker who complained that he was being forced to prove he held asylum, according to the U.S. Department of Justice.
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April 17, 2024
Ex-Pharma Exec's Contempt Plea Rejected By Judge
A Massachusetts federal judge on Wednesday rejected a former pharmaceutical executive's agreement to plead guilty to contempt for using an alias to get around a consent judgment in a U.S. Securities and Exchange Commission fraud case, saying both the former executive and the government knew he'd view the sentence as too low.
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April 17, 2024
Elliott Waives BioMarin Board Deal, Moots Del. Suit
Elliott Investment Management LP has waived an agreement with BioMarin Pharmaceutical Inc. that gave the activist investor three new seats on the biopharmaceutical company's board, mooting a Delaware Chancery Court lawsuit that a BioMarin shareholder filed earlier this month.
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April 16, 2024
House Panel Takes Aim At Change Healthcare, FTC Over Hack
A House subcommittee exploring ways to boost cybersecurity in the healthcare industry on Tuesday blasted Change Healthcare for failing to take appropriate steps to block a damaging cyberattack that echoed another recent strike on critical infrastructure and the Federal Trade Commission for not stopping the provider from controlling such a large market share.
Expert Analysis
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'Patient' Definition Ruling Raises Discount Drug Questions
A South Carolina federal court's recent decision in Genesis Health Care v. Becerra supports a broader definition of a "patient" eligible to receive discounted drugs under the Section 340B program, but raises a host of novel questions regarding how the decision will affect covered entities and enforcement actions, say attorneys at McDermott.
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Breaking Down High Court's New Code Of Conduct
The U.S. Supreme Court recently adopted its first-ever code of conduct, and counsel will need to work closely with clients in navigating its provisions, from gift-giving to recusal bids, say Phillip Gordon and Mateo Forero at Holtzman Vogel.
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How Purdue High Court Case Will Shape Ch. 11 Mass Injury
The U.S. Supreme Court's recent arguments in Harrington v. Purdue Pharma, addressing the authority of bankruptcy courts to approve nonconsensual third-party releases in Chapter 11 settlement plans, highlight the case's wide-ranging implications for how mass injury cases get resolved in bankruptcy proceedings, says George Singer at Holland & Hart.
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Opinion
Legal Profession Gender Parity Requires Equal Parental Leave
To truly foster equity in the legal profession and to promote attorney retention, workplaces need to better support all parents, regardless of gender — starting by offering equal and robust parental leave to both birthing and non-birthing parents, says Ali Spindler at Irwin Fritchie.
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Managing ANDA Venue Issues As Del. And NJ Filings Rise
Delaware and New Jersey have prevailed as the primary forum for pharmaceutical litigation as more generic companies file abbreviated new drug applications, but this venue scheme presents traps for the unwary, and legislation may still be necessary to ensure fairness and predictability, say Timothy Cook and Kevin Yurkerwich at WilmerHale.
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Series
Writing Thriller Novels Makes Me A Better Lawyer
Authoring several thriller novels has enriched my work by providing a fresh perspective on my privacy practice, expanding my knowledge, and keeping me alert to the next wave of issues in an increasingly complex space — a reminder to all lawyers that extracurricular activities can help sharpen professional instincts, says Reece Hirsch at Morgan Lewis.
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What Lawyers Must Know About Calif. State Bar's AI Guidance
Initial recommendations from the State Bar of California regarding use of generative artificial intelligence by lawyers have the potential to become a useful set of guidelines in the industry, covering confidentiality, supervision and training, communications, discrimination and more, say attorneys at Debevoise.
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Industry Must Elevate Native American Women Attys' Stories
The American Bar Association's recent research study into Native American women attorneys' experiences in the legal industry reveals the glacial pace of progress, and should inform efforts to amplify Native voices in the field, says Mary Smith, president of the ABA.
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The Fed. Circ. In Nov.: Factual Support And Appellate Standing
The Federal Circuit's recent Allgenesis Biotherapeutics v. Cloud Break Therapeutics decision shows that appellate standing requires specific factual support, underscoring the necessary requirements for a patent challenger in an appeal from an inter partes review at the U.S. Patent and Trademark Office, say Jeremiah Helm and Sean Murray at Knobbe Martens.
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White House Activity Is A Band-Aid For Regulating AI In Health
In the medium term, recent White House actions will have a greater impact on AI in the health care industry than Congress' sluggish efforts to regulate it, but ultimately legislation of AI's development and use in the health space will fall to Congress, say Wendell Bartnick and Vanessa Perumal at Reed Smith.
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Understanding Discovery Obligations In Era Of Generative AI
Excerpt from Practical Guidance
Attorneys and businesses must adapt to the unique discovery challenges presented by generative artificial intelligence, such as chatbot content and prompts, while upholding the principles of fairness, transparency and compliance with legal obligations in federal civil litigation, say attorneys at King & Spalding.
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Kochava Ruling May Hint At Next Privacy Class Action Wave
The Southern District of California's recent ruling in Greenley v. Kochava and increasing complaints alleging that a consumer website is an illegal “pen register” due to the use of third-party marketing software tools foreshadow a new theory of liability for plaintiffs in privacy litigation, say attorneys at Crowell & Moring.
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Forecasting The Impact Of High Court Debit Card Rule Case
John Delionado and Aidan Gross at Hunton consider how the U.S. Supreme Court's forthcoming ruling in a retailer's suit challenging a Federal Reserve rule on debit card swipe fees could affect agency regulations both new and old, as well as the businesses that might seek to challenge them.
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Series
ESG Around The World: Mexico
ESG has yet to become part of the DNA of the Mexican business model, but huge strides are being made in that direction, as more stakeholders demand that companies adopt, at the least, a modicum of sustainability commitments and demonstrate how they will meet them, says Carlos Escoto at Galicia Abogados.
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Opinion
FDA And Companies Must Move Quickly On Drug Recalls
When a drug doesn't work as promised — whether it causes harm, like eyedrops recalled last month by the U.S. Food and Drug Administration, or is merely useless, like a widely used decongestant ingredient recently acknowledged by the agency to be ineffective — the public must be notified in a timely manner, says Vineet Dubey at Custodio & Dubey.