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Life Sciences
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November 15, 2024
Pharma Biz To Pay $47M To Settle Feds' Kickback Claims
A Florida pharmaceutical company and its chief executive have agreed to pay $47 million to settle claims that their practice of paying for certain patient tests crossed the line into being an illegal kickback to increase prescriptions of an enzyme replacement therapy, Boston federal prosecutors said on Friday.
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November 15, 2024
Sterilization Co. Cosmed Hits Ch. 11 Amid Cancer Claims
Sterilization company Cosmed Group Inc. filed for Chapter 11 protection in a Texas bankruptcy court Thursday with over $100 million in liabilities, much of it related to cancer claims over the gas that it uses for sterilization.
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November 14, 2024
Trump's RFK Jr. Pick For HHS Draws Its Share Of Critics
The nomination of Robert F. Kennedy Jr. — well-known for his opposition to vaccines — as the secretary of the U.S. Department of Health and Human Services is President-elect Donald Trump's latest controversial pick for his administration, and one that could disrupt the U.S. Food and Drug Administration and its mission.
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November 14, 2024
Senate Panel Delays Votes On Patent Eligibility And PTAB Bills
The Senate Judiciary Committee on Thursday postponed planned votes on legislation aimed at reducing decisions that inventions are ineligible for patents and setting new limits on Patent Trial and Appeal Board challenges, but approved a bill to let the patent office collect demographic data on inventors.
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November 14, 2024
Judge Finds Dexcom Infringed Abbott Patent That Hung Jury
A judge has found that Dexcom Inc. infringed a glucose monitor patent owned by an Abbott Laboratories unit, with the ruling coming after a Delaware federal jury in March said it was hung on the issue.
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November 14, 2024
Takeda Rips Cert. Order's 'Whale Of Assumption' At 9th Circ.
Takeda Pharmaceutical urged the Ninth Circuit on Thursday to reverse a ruling certifying a class of third-party payors who allege Takeda and Eli Lilly & Co. hid their anti-diabetes drug's bladder-cancer risks, arguing the lower court erroneously made a "whale of an assumption" that 56.7% of prescriptions wouldn't have been written with disclosures.
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November 14, 2024
Boehringer Says Inhaler Antitrust Suit 'Fails On Its Face'
Boehringer Ingelheim Pharmaceuticals Inc. and Boehringer Ingelheim International GMBH have urged a Connecticut federal judge to dismiss a proposed class action brought by health funds accusing it of monopolizing the inhaler market with improper patent listings, arguing the suit fails to allege any competitors were actually hindered by those patents.
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November 14, 2024
Boeing Could Sell Navigation Unit For $6B, And More Rumors
Boeing is mulling a sale of its Jeppesen navigation unit at potential $6 billion price tag, Pfizer may be seeking billions for its hospital drug unit, and a U.S. gas station and convenience store business could be sold at a $1.5 billion value. Here, Law360 breaks down these and other notable deal rumors from the past week.
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November 14, 2024
Trump Picks RFK Jr. To Lead Health & Human Services
President-elect Donald Trump announced Thursday that Robert F. Kennedy Jr., a prominent anti-vaccination activist and former presidential candidate, is his nominee to lead the U.S. Department of Health and Human Services.
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November 13, 2024
Guardant Atty Accuses Natera CEO Of Dishonesty At Trial
A Guardant Health lawyer on Wednesday accused Natera's CEO of being disingenuous when he testified at trial that a Natera ad campaign was aimed at correcting misleading information Guardant promoted about its competing colorectal cancer tests, exclaiming, "It was about money, wasn't it? Can't you just be honest about that?"
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November 13, 2024
Damages Limited In AGs' Generic Drug Price-Fixing Case
A Connecticut federal judge has nixed some claims against Sandoz Inc. and other generic-drug makers in a massive antitrust and unfair trade practices case filed by state attorneys general, finding that a handful of the enforcers cannot seek damages on behalf of their allegedly injured citizens.
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November 13, 2024
Honey Pot Greenwashes 'Plant-Derived' Products, Suit Says
The Honey Pot Co. faces a proposed false advertising class action filed Tuesday in California federal court by customers who allege its line of organic feminine care products, which includes foam washes, wipes, pads and liners, contain synthetic ingredients, despite being labeled as "plant-derived."
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November 13, 2024
Ozempic MDL Plaintiffs Say Eli Lilly, Novo Nordisk Hid Risks
Patients accusing Novo Nordisk and Eli Lilly & Co. of failing to warn them about the risks associated with Ozempic and other such medications on Wednesday filed a massive master complaint in the sprawling multidistrict litigation centralized in the Eastern District of Pennsylvania.
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November 13, 2024
Alnylam Says It's Not A 'Patent Troll' In Vax IP Row
Alnylam Pharmaceuticals has shot back at Moderna's request for about $2.8 million in legal costs it incurred defending a patent suit over its coronavirus vaccine, saying Moderna is wrongly trying to paint it as "a pernicious patent troll."
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November 13, 2024
TikTok Asks To Keep NC AG's Addiction Complaint Redacted
TikTok Inc. is asking a North Carolina state court to keep redacted portions of a complaint by the state alleging that it targets youth to make them compulsive and addicted users, saying parts of the complaint include information from confidential documents and trade secrets.
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November 13, 2024
Baltimore Wins $266M In McKesson, Cencora Opioid Case
Baltimore has been awarded more than $266 million in damages from drug distributors McKesson and Cencora, which a jury found responsible for fueling the opioid epidemic in the city, the mayor's office announced Tuesday.
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November 13, 2024
Biotech Brass Misled Investors About Cancer Drugs, Suit Says
Executives and directors of biotechnology company Agenus Inc. have been hit with a shareholder derivative suit in Massachusetts federal court alleging that the company misled investors about the effectiveness of its mainstay cancer treatments.
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November 13, 2024
Trump's Choice Of Matt Gaetz For AG Hints At Cannabis Policy
President-elect Donald Trump's announcement Wednesday that he would nominate Rep. Matt Gaetz, R-Fla., one of the relatively few Republican proponents of cannabis legalization, to be the next U.S. attorney general marks an early sign of how his administration will consider marijuana policy.
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November 12, 2024
Trump Taps Elon Musk To Head New 'Gov't Efficiency' Dept.
President-elect Donald Trump announced Tuesday that billionaire Elon Musk and former presidential candidate Vivek Ramaswamy will lead a newly created "Department in Government Efficiency" for his administration come January.
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November 12, 2024
Masimo Can't Tie Alleged IP Theft To Apple Profits, Expert Says
An Apple expert witness defended the company Tuesday in a California federal bench trial over Masimo's claim that the tech giant stole pulse oximetry trade secrets for its popular smartwatch, testifying Masimo cannot tie any value to the purported secrets and that Apple's profits can't be attributed to the watch's blood oxygen features.
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November 12, 2024
Guardant CEO Says Rival's False Ads Hurt 'Beautiful Baby'
Guardant Health's CEO testified Tuesday in his company's false advertising suit against Natera Inc. that its rival's "misleading" ad campaign hurt Guardant's colorectal cancer test launch, saying he felt like somebody had taken their "beautiful baby" and "slammed its head against the wall."
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November 12, 2024
Justices Told Fed. Circ. Overstep Claims Are 'Simply Incorrect'
A unit of pharmaceutical company Alvogen on Tuesday urged the U.S. Supreme Court to reject a petition from the company whose blockbuster IBS drug it's hoping to copy, saying the "petition's fundamental premise" that the Federal Circuit went beyond its legal boundaries "is simply incorrect."
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November 12, 2024
HIV Drug Buyers Want Gilead Product Switch Claims Revived
Insurers and benefit plans are asking the Ninth Circuit to revive a chunk of their antitrust case against Gilead, arguing their claims that Gilead delayed generic competition to its HIV drugs by monopolizing the market should have new life.
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November 12, 2024
J&J Says HHS Is Thwarting Transparency Of Drug Discounts
Johnson & Johnson claims the U.S. Department of Health and Human Services is thwarting its efforts to crack down on hospitals the company alleges are "reaping immense profits" on reduced-price medications without passing those discounts on to patients, according to a lawsuit filed Tuesday in D.C. federal court.
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November 12, 2024
Elanco Pays $15M SEC Fine To Settle Sales Incentive Claims
Elanco Animal Health Inc. has agreed to pay a $15 million fine to resolve U.S. Securities and Exchange Commission allegations that it deceptively juiced revenues with distributor sales incentives between 2019 and 2020, the regulator announced Tuesday.
Expert Analysis
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How Justices Upended The Administrative Procedure Act
In its recent Loper Bright, Corner Post and Jarkesy decisions, the U.S. Supreme Court fundamentally changed the Administrative Procedure Act in ways that undermine Congress and the executive branch, shift power to the judiciary, curtail public and business input, and create great uncertainty, say Alene Taber and Beth Hummer at Hanson Bridgett.
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Parsing FY 2024 DOJ Criminal Healthcare Fraud Enforcement
While the U.S. Department of Justice's Criminal Division's strike force on healthcare fraud enforcement action shows an impressive doubling of criminal indictments, a closer look at the data offers important clues about underlying trends, including the comparably modest, accompanying increase in associated intended loss, say Roderick Thomas and Kathleen Cooperstein at Wiley.
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How Cos. With Chinese Suppliers Should Prep For Biotech Bill
A proposed bill to prohibit government-affiliated life sciences companies from contracting with Chinese biotech companies of concern may necessitate switching to other sources for research and supplies, meaning they should begin evaluating supply chains now due to the long lead times of drug development, say John O'Loughlin and Christina Carone at Weil Gotshal.
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Mirror, Mirror On The Wall, Is My Counterclaim Bound To Fall?
A Pennsylvania federal court’s recent dismissal of the defendants’ counterclaims in Morgan v. Noss should remind attorneys to avoid the temptation to repackage a claim’s facts and law into a mirror-image counterclaim, as this approach will often result in a waste of time and resources, says Matthew Selmasska at Kaufman Dolowich.
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Can Chapter 15 Bankruptcy Help Cannabis Businesses?
Attorneys at Fox Rothschild consider whether Chapter 15 may be used as a tool to liquidate U.S. assets of cannabis companies in foreign bankruptcy proceedings, and look at the statutory provisions that may have a bearing on the successful liquidation of assets under the Bankruptcy Code.
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FTC's Drug Middlemen Probe Highlights Ongoing Scrutiny
The Federal Trade Commission's interim staff report on its inquiry into pharmacy benefit managers suggests that the industry will remain under an enforcement microscope for the foreseeable future due to concerns about how PBMs affect drug costs and accessibility, say attorneys at Arnold & Porter.
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Series
Playing Dungeons & Dragons Makes Me A Better Lawyer
Playing Dungeons & Dragons – a tabletop role-playing game – helped pave the way for my legal career by providing me with foundational skills such as persuasion and team building, says Derrick Carman at Robins Kaplan.
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Del. Dispatch: Director Caremark Claims Need Extreme Facts
The Delaware Court of Chancery recently dismissed Caremark claims against the directors of Centene in Bricklayers Pension Fund of Western Pennsylvania v. Brinkley, indicating a high bar for a finding of the required element of bad faith for Caremark liability, and stressing the need to resist hindsight bias, say attorneys at Fried Frank.
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Parsing NJ Court's Rationale For Denying Lipitor Class Cert.
A New Jersey federal court's recent Lipitor rulings granting summary judgment and denying motions for class certification for two plaintiff classes offer insight into the level of rigorous analysis required by both parties and their experts to satisfy the requirements of class certification, says Catia Twal at Edgeworth Economics.
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Gilead Drug Ruling Creates Corporate Governance Dilemma
If upheld, a California state appellate court's decision — finding that Gilead is liable for delaying commercialization of a safer HIV drug to maximize profits on another drug — threatens to undermine long-standing rules of corporate law and exposes companies to liability for decisions based on sound business judgment, says Shireen Barday at Pallas.
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3 Leadership Practices For A More Supportive Firm Culture
Traditional leadership styles frequently amplify the inherent pressures of legal work, but a few simple, time-neutral strategies can strengthen the skills and confidence of employees and foster a more collaborative culture, while supporting individual growth and contribution to organizational goals, says Benjamin Grimes at BKG Leadership.
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Rebuttal
Cancer Research Org. Is Right To Avoid Corporate Influence
While a previous Law360 guest article criticizes the International Agency for Research on Cancer's processes, its reliance on peer-reviewed literature is proper and its refusal to allow corporate influence is sound science, say Lance Oliver and Ridge Mazingo at Motley Rice.
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Cannabis Biz Real Estate Loan Considerations For Lenders
Now that cannabis sales are legal in some states, real estate lenders are interested in financing the land used by cannabis companies, but because cannabis sales are still illegal under federal law, lenders must make adjustments for cannabis-adjacent transactions, say Mark Levenson and Jeffrey Wendler at Sills Cummis.
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E-Discovery Quarterly: Rulings On Hyperlinked Documents
Recent rulings show that counsel should engage in early discussions with clients regarding the potential of hyperlinked documents in electronically stored information, which will allow for more deliberate negotiation of any agreements regarding the scope of discovery, say attorneys at Sidley.
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Loper Bright Limits Federal Agencies' Ability To Alter Course
The U.S. Supreme Court's recent decision to dismantle Chevron deference also effectively overrules its 2005 decision in National Cable & Telecommunications Association v. Brand X, greatly diminishing agencies' ability to change regulatory course from one administration to the next, says Steven Gordon at Holland & Knight.