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Life Sciences
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March 16, 2024
Up Next At High Court: Gov't Jawboning & Retaliatory Arrests
The U.S. Supreme Court has a packed oral arguments calendar this week that includes disputes over the Biden administration's work with social media companies to combat misinformation, the appropriate evidence standard for bringing retaliatory arrest claims and whether the federal government can object to a consent decree entered into by three states.
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March 15, 2024
Judiciary Clarifies Judge Shopping Policy After Senator Letter
The Judicial Conference of the United States said Friday that its updated policy aimed at preventing litigants from shopping for the judge of their choice is not intended to overstep judges' authority or discretion under the law, issuing guidance one day after Republican senators pushed back against the policy.
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March 15, 2024
8th Circ. Nixes Arbitration Bid In $9M Chinese PPE Fight
The Eighth Circuit on Thursday refused to force a Chinese manufacturer of personal protective equipment to arbitrate its $9 million dispute over unpaid invoices with a U.S. distributor, ruling in a published opinion that the underlying pact containing an arbitration clause was never consummated.
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March 15, 2024
'Cobra Venom' Painkiller Co. Inks Deal To Settle SEC Claims
A penny stock company that previously held itself out as a maker of cobra venom-infused pain drugs has agreed to resolve U.S. Securities and Exchange Commission fraud claims, according to court filings that note the company's two principals have also reached a settlement.
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March 15, 2024
Enfamil Maker Hit With $60M Jury Verdict In Infant Death Suit
An Illinois jury has awarded $60 million to the mother of an infant who died after using Mead Johnson's Enfamil formula, a loss for the company in the first of hundreds of suits to go to trial alleging certain cow's milk-based formulas cause a fatal illness in premature infants.
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March 15, 2024
Hospitals Say Constitutional Defenses Valid In FTC Merger Row
Two North Carolina hospital systems shot back at the Federal Trade Commission's contention that constitutional defenses are immaterial to the agency's challenge of a $320 million merger plan, arguing that case law shows that striking the positions would be premature.
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March 15, 2024
Ex-Fugitive Behind Fake Silver COVID Cure Pleads Guilty
A former fugitive who was accused of peddling a phony, silver-based treatment for diseases such as COVID-19 pled guilty Thursday just before opening statements were set to begin at his fraud trial.
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March 15, 2024
Conservative Law Group Asks Justices To Hear FDA Vape Suit
A free-market advocacy group and a vape industry association are urging the U.S. Supreme Court to upend the U.S. Food and Drug Administration's decision denying a manufacturer permission to sell flavored vapes, arguing that the FDA is "moving the goalposts" when it comes to what kind of data is needed when applying.
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March 14, 2024
Pharma Co. Misled Investors On Research Methods, Suit Says
Pharmaceutical company Anavex has been hit with a proposed shareholder class action alleging that it misled the public about research methodologies it was using in its clinical studies for neurological treatments.
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March 14, 2024
Deals Rumor Mill: Trump-Musk, Icahn-Illumina, Paramount
Donald Trump asked Elon Musk to buy Truth Social, Carl Icahn drops latest Illumina board Challenge but presses on with lawsuit, and PE firm Apollo is still eyeing Paramount. Here, Law360 breaks down the notable deal rumors from the past week.
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March 14, 2024
Feds Seek 20 Mos. For Aegerion Fraud 'Puppet Master'
A pharmaceutical sales representative who gloated about being a "puppet master" for false insurance claims for Aegerion's cholesterol drug should serve 20 months in prison, the U.S. government has told a Boston federal judge.
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March 14, 2024
Drug Wholesalers Want Preliminary OK On $265M Sandoz Deal
A group of direct purchasers of generic drugs has asked a Pennsylvania federal court for approval of a $265 million settlement with Swiss drugmaker Sandoz over allegations of federal antitrust violations.
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March 14, 2024
Trial Challenging NC Abortion Restrictions Pushed To July
A July trial date has been set in a closely watched constitutional challenge seeking to dismantle a state law that restricts access to abortions in North Carolina after 12 weeks, marking a pushback from the court's earlier projected spring timetable for the trial.
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March 14, 2024
EPA Slashes Ethylene Oxide Emissions Levels For Sterilizers
The U.S. Environmental Protection Agency on Thursday finalized new Clean Air Act standards that it said will reduce emissions of ethylene oxide from commercial sterilization facilities by 90%, an action the agency said is necessary to help reduce the impact of the carcinogen on communities.
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March 13, 2024
9th Circ. Unsure If Abortion Pill Suit Harms Red States
Two Ninth Circuit judges on Wednesday challenged Idaho and other Republican-led states' bid to intervene in Washington's lawsuit seeking to expand access to the abortion pill mifepristone, asking if the states could back up their claims of economic harm.
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March 13, 2024
Pharma Co. CEO Partly Beats Investor Suit Over Kidney Drug
A California federal judge has tossed for good some claims against Tricida Inc. CEO Gerrit Klaerner in a suit alleging he and the company misled inventors about the ability of Tricida's new kidney disease drug to gain regulatory approval, saying that many of Klaerner's challenged statements are opinions and that he didn't act with knowledge of wrongdoing.
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March 13, 2024
HHS To Investigate Whether Cyberattack Exposed Patient Data
The U.S. Department of Health and Human Services opened an investigation Wednesday into the cyberattack on Change Healthcare to determine whether the hack exposed patients' confidential data or violated other privacy protections.
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March 13, 2024
Planned Parenthood Foe Calls Immunity Claim 'Half-Baked'
Attorneys for a pseudonymous relator who sued Planned Parenthood over allegations that it improperly billed Medicaid programs urged the Fifth Circuit on Wednesday to reject the group's position that it was shielded by attorney immunity, calling the entity's argument "half-baked."
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March 13, 2024
Aetna Can't Avoid Bias Suit Over Fertility Treatment Policy
Aetna must face a proposed class action alleging it readily covers fertility treatments for infertile heterosexual women but forces non-heterosexual women to spend thousands out of pocket before paying for their treatments, with a Connecticut federal judge saying it doesn't matter if the insurer didn't control the health plan's terms.
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March 13, 2024
Jury Must Weigh Willfulness In Secrets Case, Calif. Court Says
A California state appellate court has found a jury will have to decide whether a former director at Applied Medical Distribution Corp. willfully misappropriated trade secrets from his former employer.
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March 13, 2024
BigLaw Paper Poacher Gets 15 Mos. In Merck Insider Case
A Manhattan federal judge hit a former FBI trainee from Pennsylvania with a 15-month prison sentence Wednesday for illegally trading on a Merck & Co. deal using secrets gleaned from legal papers in the possession of his BigLaw ex-girlfriend.
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March 12, 2024
Eli Lilly GC's Pay Jumped To $7M In 2023 Amid Stock Boom
Eli Lilly & Co. legal chief Anat Hakim's total pay package rose to $7 million last year, up 33% from 2022, according to Lilly's latest proxy statement, as the pharmaceutical giant has experienced booming drug sales and positive investor sentiment.
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March 12, 2024
Daiichi Urges Court To OK Arbitrator's Award Against Seagan
Japanese drugmaker Daiichi Sankyo has asked a Seattle federal judge not to toss an arbitral award refusing Seagen Inc.'s claims for billions of dollars in a dispute over cancer drug patents, saying the U.S. biotech company has incorrectly lodged a petition to vacate the award.
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March 12, 2024
Federal Circuit Won't Reconsider Axing Tyvaso Patent
The full Federal Circuit on Tuesday declined to review a panel ruling from late last year that sided with a Patent Trial and Appeal Board decision that there was nothing patentable about a way of administering a blockbuster pulmonary hypertension drug.
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March 12, 2024
Judiciary Touts New Policy To Rein In Judge Shopping
The Judicial Conference of the United States on Tuesday said it has updated a policy on random case assignments to ensure litigants can't shop for the judge of their choice by going to a one-judge division of a district court.
Expert Analysis
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How To Navigate The FTC's New Private Equity Frontier
The Federal Trade Commission's recent district court complaint against an anesthesia firm and its private equity partner tests key bounds of the agency's stand-alone authority, and defense strategies can include challenges to both the geographic and the service market fronts, say attorneys at Baker McKenzie.
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Opinion
Newman Suspension Shows Need For Judicial Reform
The recent suspension of U.S. Circuit Judge Pauline Newman following her alleged refusal to participate in a disability inquiry reveals the need for judicial misconduct reforms to ensure that judges step down when they can no longer serve effectively, says Aliza Shatzman at The Legal Accountability Project.
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An Overview Of Congress' Proposed Drug Shortage Solutions
Recently, Congress has seen a number of bipartisan bills that seek to prevent and respond to national drug shortages, though disagreements over the right vehicle and timeline have slowed progress, says Miranda Franco at Holland & Knight.
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Considerations And Calculations For DOJ Clawback Program
The U.S. Department of Justice’s clawback pilot program announced earlier this year presents numerous questions for businesses, and both hypothetical and recent real-world examples capture how companies’ cost-benefit analyses about whether to claw back compensation in exchange for penalty reductions may differ, say Yogesh Bahl and Jonathan Hecht at Resolution Economics.
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SEC's Life Sciences Actions Utilize Novel Tools And Theories
Recent enforcement actions show that the U.S. Securities and Exchange Commission is employing new forms of data analytics and noteworthy applications of insider trading laws in its scrutiny of fraud within the life sciences and health industries, say Edward Imperatore and Jina Choi at MoFo.
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What Case Trends Reveal About Life Sciences Results At ITC
A look at recent U.S. International Trade Commission case data shows that pharmaceuticals, medical devices and other life sciences products constitute a growing share of the technologies involved in Section 337 investigations, with overwhelmingly positive results for companies seeking to protect their IP rights from foreign competitors, say Brian Busey and Daniel Muino at MoFo.
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Series
ESG Around The World: Japan
Japan is witnessing rapid developments in environmental, social and corporate governance policies by making efforts to adopt a soft law approach, which has been effective in encouraging companies to embrace ESG practices and address the diversity of boards of directors, say Akira Karasawa and Landry Guesdon at Iwata Godo.
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How And Why Your Firm Should Implement Fixed-Fee Billing
Amid rising burnout in the legal industry and client efforts to curtail spending, pivoting to a fixed-fee billing model may improve client-attorney relationships and offer lawyers financial, logistical and stress relief — while still maintaining profit margins, say Kevin Henderson and Eric Pacifici at SMB Law Group.
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Potential Broader Effects Of FDA's Lab-Developed Test Rule
Though it's unclear whether the U.S. Food and Drug Administration's proposed rule for regulating lab-developed tests will ever go into effect, it nonetheless functions as a threatened hammer that may make legislative efforts to regulate such tests more palatable, say attorneys at King & Spalding.
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Opinion
Judicial Independence Needs Defense Amid Political Threats
Amid recent and historic challenges to the judiciary from political forces, safeguarding judicial independence and maintaining the integrity of the legal system is increasingly urgent, says Robert Peck at the Center for Constitutional Litigation.
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2 New Ways FDA Is Changing Lab-Developed Test Regulation
The U.S. Food and Drug Administration's recently announced rulemaking and voluntary pilot program signal the agency's dedication to ramping up oversight of lab-developed tests, which have been largely unregulated by the FDA until now, say attorneys at Sidley.
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FDI Considerations For UK Venture Capital Transactions
With the U.K. National Security and Investment Act highlighting foreign direct investment matters for venture capital transactions, investors dealing with companies connected to the U.K. should be alive to how the act's requirements can affect deal timelines, structures and terms, say lawyers at Covington.
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How Life Sciences Cos. Can Prevent Securities Class Actions
Though the overall volume of securities fraud class actions has dipped in the last couple of years, life sciences companies remain a particularly popular target for these filings and should employ best practices to minimize risk, say Joni Jacobsen and Angela Liu at Dechert.
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How Law Firms Can Use Account-Based Marketing Strategies
Amid several evolving legal industry trends, account-based marketing can help law firms uncover additional revenue-generating opportunities with existing clients, with key considerations ranging from data analytics to relationship building, say Jennifer Ramsey at stage LLC and consultant Gina Sponzilli.
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11 Ways Senate Bill Would Alter PTAB Practice
Recently proposed legislation, the PREVAIL Act, would change post-grant practice before the U.S. Patent Trial and Appeal Board in several key ways including inter partes review, post-grant review and ex parte reexamination practice, say Jeffrey Shneidman and Jacqueline Tio at Fish & Richardson.