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Life Sciences
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March 22, 2024
Final OK Sought For Economic Loss Deal In CPAP Recall MDL
Users of Philips' recalled CPAP breathing machines have asked a Pennsylvania federal judge to give her final OK to their $467.5 million settlement with the company to cover economic loss claims, arguing only a few objections to the deal remain.
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March 22, 2024
Radiology Co., Trustee Must Face Ex-Worker's ESOP Suit
A Colorado federal judge refused to toss a proposed class action accusing a radiology company and its trustee of overcharging the company's employee stock ownership plan in a $163.7 million sale, saying the former workers' complaint puts forward enough details to back up their allegations.
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March 22, 2024
Vanda's Obviousness Appeal Isn't Worthwhile, Teva Tells Justices
Teva Pharmaceuticals and Apotex have said the U.S. Supreme Court should reject a petition from Vanda Pharmaceuticals, which said the Federal Circuit "charted its own course" when it invalidated its sleep drug patents as obvious.
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March 22, 2024
High Court Mifepristone Battle Goes Beyond Abortion
The first major abortion battle to reach the U.S. Supreme Court since the Dobbs decision is about a lot more than abortion.
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March 22, 2024
Ex-Drug Rep Won't Serve More Time After 1st Circ. Victory
The second sentencing of a former Aegerion Pharmaceuticals Inc. salesman did not add a day in prison to the roughly seven months he served before the First Circuit wiped away his initial conviction on charges he schemed to fraudulently sell the company's cholesterol treatment.
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March 22, 2024
NJ Appeals Court Shuts Down Fired White Worker's Bias Suit
A New Jersey appeals court backed a life sciences company's win in a former manager's suit claiming she was unlawfully fired for posting statistics about police violence on social media following the 2020 murder of George Floyd, ruling she hadn't shown the company discriminated against white workers.
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March 22, 2024
US Greenlights Novartis' $2.9B MorphoSys Takeover
Germany's MorphoSys AG said Friday it has received U.S. antitrust clearance for the biopharmaceutical company's planned $2.9 billion sale to Swiss Pharma giant Novartis AG, a development that clears the final regulatory hurdle needed before closing the deal.
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March 22, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen the BBC and Wall to Wall Media hit with a passing off lawsuit by musician BOSSIIE, Poundland parent company Pepco Group file a commercial fraud claim against several mobile network giants, family law specialists Alexiou Fisher Philipps LLP start proceedings against former oil trader Michael Prest, and a transgender lawyer file a libel claim against a blogger. Here, Law360 looks at these and other new claims in the U.K.
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March 22, 2024
87-Year-Old Billionaire Lewis Seeks No Jail For Insider Trading
Lawyers for British billionaire Joe Lewis have asked a Manhattan federal judge not to impose any prison time after his plea to insider trading, saying a term of probation is appropriate because the 87-year-old is "nearing the end of life in declining health."
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March 22, 2024
Del. Courts Examining 'Colonoscopy'-Like Bylaw Rules
Invasive advance-notice bylaws that some observers say make shareholder board nominations as intrusive as a "colonoscopy" are reviving old questions in Delaware courts about how far boards can go to protect themselves against shareholder activism.
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March 22, 2024
LifeCell Cleared Of Liability In NJ Strattice Hernia Mesh Trial
New Jersey state jurors on Friday cleared LifeCell of liability in a Kentucky woman's suit alleging the design of its Strattice surgical mesh is defective and caused a hernia to reoccur and ultimately resulted in "life-altering" surgery, giving the medical device company the first win in a venue with at least 93 pending cases with tort claims over the mesh.
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March 21, 2024
SEC's 'Shadow Trading' Trial To Test Insider Info Boundaries
If the U.S. Securities and Exchange Commission can convince jurors hearing its first-ever "shadow trading" case next week to find a former executive in the wrong for buying up a competitor's securities while having insider information about his own company, the floodgates could open to civil and criminal prosecution of other corporate insiders under the novel legal theory, attorneys told Law360.
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March 21, 2024
Colo. Distributor Seeks $2.3M Sanction For Stryker Spoilation
A Colorado medical device distributor urged a federal judge to make Stryker and its lawyers pay $2.3 million in attorney fees as sanctions for "pervasive misconduct" throughout discovery and trial, arguing discovery violations will otherwise become the "cost of doing business" for the medical technology giant.
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March 21, 2024
Schumer Urges Texas District To Adopt Judge-Shopping Rule
Senate Majority Leader Chuck Schumer on Thursday urged the chief judge of the Northern District of Texas to quickly implement the Judicial Conference of the United States' updated policy that looks to prevent litigants from judge shopping, arguing that the district's current practices are "dangerous."
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March 21, 2024
Ill. Judge Leaves Outcome Health Execs' Convictions Intact
An Illinois federal judge said Thursday that he wouldn't disturb three former Outcome Health executives' convictions for carrying out a massive billion-dollar fraud scheme to grow their health advertising business, saying the jury heard enough evidence to support its verdict.
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March 21, 2024
MDL Claims Over Merck's Gardasil Vax Get Trimmed
Pharmaceutical giant Merck need not face many of the claims by patients who allege their autoimmune conditions were caused by its HPV vaccine, a North Carolina federal judge overseeing multidistrict litigation ruled, saying the National Childhood Vaccine Injury Act bars most claims made in the first two bellwethers.
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March 21, 2024
6th Circ. Revives McKee's Network Plan Fight With Thrifty Med
The Sixth Circuit reinstated on Thursday McKee Foods Corp.'s suit against Thrifty MedPlus Pharmacy alleging Tennessee law requiring pharmacy benefit managers to let "any willing pharmacies" participate in a network was preempted by the Employee Retirement Income Security Act, finding that amendments made to the statute didn't render McKee's claims moot.
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March 21, 2024
Calif. Panel Revives Diner's COVID Sanitization Coverage Bid
A California state appeals court revived a diner's bid for property insurance coverage of COVID-19 losses after it determined the restaurant credibly alleged direct physical losses and that the policy's language covering losses attributable to a virus applied to COVID-19 sanitization efforts.
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March 21, 2024
Tribe's Opioid Suit Can Head To State Court, Okla. Judge Says
An Oklahoma federal magistrate judge has granted the Cherokee Nation's bid to move to state court its suit accusing pharmaceuticals distributor Morris & Dickson of flooding the tribe's communities with opioids, saying the company only fulfilled one of four prongs necessary for establishing federal jurisdiction.
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March 21, 2024
CymaBay Investor Sues For Books On $4.3B Gilead Merger
A shareholder of liver disease-focused biopharmaceutical company CymaBay Therapeutics Inc. sued the company in Delaware Chancery Court to extract more information over a proposed $4.3 billion merger with Gilead Sciences Inc., saying CymaBay has refused to hand over previously requested documents regarding the valuation analyses without a legitimate excuse.
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March 21, 2024
Avoid Major Extension Of Merger Reach, EU High Court Urged
An important tool for extending European Union antitrust officials' merger scrutiny appears to be in jeopardy after a European Court of Justice advocate general effectively recommended Thursday that the bloc's high court restrict the ability to investigate transactions that don't normally trigger EU thresholds.
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March 21, 2024
Business Coalition Rebuffs Biden Plan To Seize Drug Patents
The Biden administration's proposal to exercise so-called march-in rights to seize drug patents would harm innovation in the U.S., according to an assemblage of business-focused groups.
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March 21, 2024
Home Health Cos. Stiffed Workers On OT Pay, Suit Claims
The operators of several Ohio-based home care staffing agencies have been failing to pay their employees for all the overtime hours they worked, according to a recent proposed class and collective action.
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March 21, 2024
Teleflex Catheter Patent Makes It Through Fed. Circ.
The Federal Circuit on Thursday opted to leave untouched an administrative patent board ruling that rejected a legal effort to invalidate a patent covering a type of catheter that's sold by Teleflex.
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March 21, 2024
Woman Lost Independence Due To Strattice Mesh, Jurors Told
A Kentucky woman told New Jersey state jurors on Thursday that LifeCell skipped important safety steps while designing its Strattice surgical mesh, and that those skipped steps caused a hernia to reoccur and ultimately resulted in the loss of her independence.
Expert Analysis
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AI Can Help Lawyers Overcome The Programming Barrier
Legal professionals without programming expertise can use generative artificial intelligence to harness the power of automation and other technology solutions to streamline their work, without the steep learning curve traditionally associated with coding, says George Zalepa at Greenberg Traurig.
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How Legal Teams Can Prep For Life Sciences' Tech Revolution
The life sciences and health care industries are uniquely positioned to take advantage of new efficiencies created by cloud computing and generative artificial intelligence, but the sensitivity of their data also demands careful navigation of an expanding legislative and regulatory landscape, say Kristi Gedid, Zack Laplante and Lisa LaMotta at Ernst & Young.
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Preparing Law Students For A New, AI-Assisted Legal World
As artificial intelligence rapidly transforms the legal landscape, law schools must integrate technology and curricula that address AI’s innate challenges — from ethics to data security — to help students stay ahead of the curve, say Daniel Garrie at Law & Forensics, Ryan Abbott at JAMS and Karen Silverman at Cantellus Group.
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Series
ESG Around The World: South Korea
Numerous ESG trends have materialized in South Korea in the past three years, with impacts ranging from greenwashing prevention and carbon neutrality measures to workplace harassment and board diversity initiatives, say Chang Wook Min and Hyun Chan Jung at Jipyong.
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General Counsel Need Data Literacy To Keep Up With AI
With the rise of accessible and powerful generative artificial intelligence solutions, it is imperative for general counsel to understand the use and application of data for myriad important activities, from evaluating the e-discovery process to monitoring compliance analytics and more, says Colin Levy at Malbek.
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Trending At The PTAB: Administrative Procedure
A pair of recent Federal Circuit rulings on Patent Trial and Appeal Board inter partes review shed light on applications of the Administrative Procedure Act, adding to an ever-growing body of case law showing the board's final written decision must be based on arguments clearly put forth by the parties, say Robert High and Benjamin Saidman at Finnegan.
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Rite Aid's Reasons For Ch. 11 Go Beyond Opioid Suits
Despite opioid-related lawsuits being the perceived reason that pushed Rite Aid into bankruptcy, the company's recent Chapter 11 filing reveals its tenuous position in the pharmaceutical retail market, and only time will tell whether bankruptcy will right-size the company, says Daniel Gielchinsky at DGIM Law.
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Navigating Discovery Of Generative AI Information
As generative artificial intelligence tools become increasingly ubiquitous, companies must make sure to preserve generative AI data when there is reasonable expectation of litigation, and to include transcripts in litigation hold notices, as they may be relevant to discovery requests, say Nick Peterson and Corey Hauser at Wiley.
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FDA's Lab-Developed Test Rule May Bring Historic Challenges
If finalized, the U.S. Food and Drug Administration's proposed rule for regulating laboratory-developed tests will provoke some of the most interesting legal challenges that the agency has faced in decades, with outcomes that will likely reverberate across the agency's product centers, says Stacy Amin at MoFo.
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Finding Focus: Strategies For Attorneys With ADHD
Given the prevalence of ADHD among attorneys, it is imperative that the legal community gain a better understanding of how ADHD affects well-being, and that resources and strategies exist for attorneys with this disability to manage their symptoms and achieve success, say Casey Dixon at Dixon Life Coaching and Krista Larson at Stinson.
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A Look At DOJ's New Nationwide Investment Fraud Approach
Investment fraud charges are increasingly being brought in unlikely venues across the country, and the rationale behind the U.S. Department of Justice's approach could well be the heightened legal standards in connection with prosecuting investment fraud, says Jonathan Porter at Husch Blackwell.
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Earnout Contract Considerations After NC Good Faith Ruling
The North Carolina Supreme Court's recent Value Health Solutions v. Pharmaceutical Research decision, holding the implied covenant of good faith and fair dealing did not apply in an earnout dispute related to an asset sale, demonstrates the need for practitioners to pay careful attention to milestone concepts in M&A transactions, says Benjamin Hicks at Wagner Hicks.
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FDA's Off-Label Comms Guidance Is A Reluctant Step Forward
The U.S. Food and Drug Administration's latest draft guidance expands its safe harbor for health care providers that communicate information about their products' off-label uses, but does not fully resolve the First Amendment disconnect between federal courts and the agency's regulatory goals, say Jeffrey Shapiro and Lisa Dwyer at King & Spalding.
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How Biden's AI Order Stacks Up Against Calif. And G7 Activity
Evaluating the federal AI executive order alongside the California AI executive order and the G7's Hiroshima AI Code of Conduct can offer a more robust picture of key risks and concerns companies should proactively work to mitigate as they build or integrate artificial intelligence tools into their products and services, say attorneys at Jenner & Block.
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Reading Between The Lines Of HHS' National Lab Opinion
The U.S. Department of Health and Human Services' Office of Inspector General recently rejected a national laboratory's request to pay a referring lab to process specimens, but the request might have been an attempt to exploit the OIG's advisory opinion process for a competitive advantage, says Mary Kohler at Kohler Health Law.