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Life Sciences
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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.
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April 16, 2024
Eli Lilly's Insulin Price Cap Deal Collapses After Cert. Denial
Eli Lilly & Co. and insulin buyers have called off a proposed nationwide settlement that would've capped insulin prices and been worth up to $500 million over several years, a decision that was made after the buyers lost a class certification bid early this year, according to the buyers' counsel.
Expert Analysis
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What's On The Horizon In Attorney General Enforcement
A look at recent attorney general actions, especially in the areas of antitrust and artificial intelligence, can help inform businesses on what they should expect in terms of enforcement trends as 10 attorney general races play out in 2024, say attorneys at Cozen O'Connor.
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Preparing For DOJ's Data Analytics Push In FCPA Cases
After the U.S. Department of Justice’s recent announcement that it will leverage data analytics in Foreign Corrupt Practice Act investigations and prosecutions, companies will need to develop a compliance strategy that likewise implements data analytics to get ahead of enforcement risks, say attorneys at Cozen O'Connor.
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Reducing The Risk Of PFAS False Advertising Class Actions
A wave of class actions continues to pummel products that allegedly contain per- or polyfluoroalkyl substances, with plaintiffs challenging advertising that they say misleads consumers by implying an absence of PFAS — but there are steps companies can take to minimize risk, say attorneys at Keller and Heckman.
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Series
Coaching High School Wrestling Makes Me A Better Lawyer
Coaching my son’s high school wrestling team has been great fun, but it’s also demonstrated how a legal career can benefit from certain experiences, such as embracing the unknown, studying the rules and engaging with new people, says Richard Davis at Maynard Nexsen.
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Opinion
New Rule 702 Helps Judges Keep Bad Science Out Of Court
A court's recent decision to exclude dubious testimony from the plaintiffs' experts in multidistrict litigation over acetaminophen highlights the responsibility that judges have to keep questionable scientific evidence out of courtrooms, particularly under recent amendments to Federal Rule of Evidence 702, says Sherman Joyce at the American Tort Reform Association.
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SG's Office Is Case Study To Help Close Legal Gender Gap
As women continue to be underrepresented in the upper echelons of the legal profession, law firms could learn from the example set by the Office of the Solicitor General, where culture and workplace policies have helped foster greater gender equality, say attorneys at Ocean Tomo.
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Opinion
Patent Waiver For COVID Meds Would Harm US Biopharma
If the Biden administration backs the World Trade Organization in waiving patent rights on COVID-19 treatments, it would negatively affect the U.S. biopharmaceutical industry and help foreign competitors, without necessarily expanding global access to COVID-19 care, says clinical pathologist Wolfgang Klietmann.
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Skirting Anti-Kickback Causation Standard Amid Circuit Split
Amid the federal circuit court split over the causation standard applicable to False Claims Act cases involving Anti-Kickback Statute violations, which the First Circuit will soon consider in U.S. v. Regeneron, litigators aiming to circumvent the heightened standard should contemplate certain strategies, say Matthew Modafferi and Terence Park at Frier Levitt.
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10 Lessons From A Deep Dive Into IP Damages
Decisions on challenging an intellectual property expert's opinion can benefit from the in-depth study of court rulings on admissibility grounds, where the findings include the fact that patent cases see the most challenges of any IP area, say Deepa Sundararaman and Cleve Tyler at Berkeley Research.
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What Shareholder Approval Rule Changes Mean For Cos.
The U.S. Securities and Exchange Commission recently approved proposed rule changes to shareholder requirements by the New York Stock Exchange, an approval that will benefit listed companies in many ways, including by making it easier to raise capital from passive investors, say attorneys at Baker Botts.
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Reimagining Law Firm Culture To Break The Cycle Of Burnout
While attorney burnout remains a perennial issue in the legal profession, shifting post-pandemic expectations mean that law firms must adapt their office cultures to retain talent, say Kevin Henderson and Eric Pacifici at SMB Law Group.
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Expediting Psychedelics Approvals In The EU, UK, Australia
Accelerated pathways for regulatory approvals for psychedelic drugs in the European Union, U.K. and Australia is indispensable to facilitate a seamless advancement of treatments from the research environment to the consumer, say Kimberly Chew at Husch Blackwell, and Ana Dukic and Sabrina Ramkellawan at AxialBridge.
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Series
ESG Around The World: Brazil
Environmental, social and governance issues have increasingly translated into new legislation in Brazil since 2020, and in the wake of these recently enacted regulations, we are likely to see a growing number of legal disputes in the largest South American country related to ESG issues such as greenwashing if companies are not prepared to adequately adapt and comply, say attorneys at Mattos Filho.
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Opinion
Gilead Ruling Signals That Innovating Can Lead To Liability
A California appeals court's ruling last month in Gilead Life Sciences v. Superior Court of San Francisco that a drug manufacturer can be held liable for delaying the introduction of an improved version of its medication raises concerns about the chilling effects that expansive product liability claims may have on innovation, says Gary Myers at the University of Missouri School of Law.
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Opinion
Vidal Should Amend USPTO Precedent In Automaker Review
U.S. Patent and Trademark Office Director Kathi Vidal's recent decision to review Ford and Honda patent challenges that were rejected by the Patent Trial and Appeal Board provides an opportunity to revisit precedents that have unfairly denied companies a fair review process and align them with commonsense principles of legal equity, says former Sen. Patrick Leahy.