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Life Sciences
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February 25, 2025
Sterilization Co. Can't Pin Cancer On Genetics, Jury Told
A Colorado woman who alleged toxic emissions from a medical sterilization plant caused her breast cancer testified Tuesday in state court that her family's cancer history was not as extensive as she originally believed, as a lawyer for the company pressed her on genetics and other factors that could increase her cancer risk.
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February 25, 2025
Chancery Likens Claims To Recycling Losing Lottery Ticket
A more than eight-year court battle over a never-triggered dry eye drug development milestone award ended Tuesday with a Delaware vice chancellor's nearly $810,000 fee shifting order against the LLC seeking the payout, while leaving open a potentially unprecedented shift of fees to the nonparty drug's inventor.
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February 25, 2025
Trump Demands Enforcement Of Healthcare Price Disclosures
President Donald Trump on Tuesday ordered federal agencies to step up enforcement of regulations requiring hospitals and health plans to publish price information designed to help patients shop for the best deal.
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February 25, 2025
Kroger Seeks More Sanctions For Prolific Consumer Atty
Kroger is urging an Illinois federal judge to sanction prolific consumer advocate lawyer Spencer Sheehan for filing a meritless suit over the effectiveness of its lidocaine patches, citing his "history of filing frivolous lawsuits across the nation" and a "troubling pattern of recklessness and abuse of the federal judiciary" for which he has been sanctioned three other times.
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February 25, 2025
J&J Says Samsung Is Breaking Deal Over Stelara Biosimilar
Johnson & Johnson and Janssen Biotech have launched a breach of contract suit against Samsung Bioepis over their agreement to let Samsung launch a biosimilar version of J&J's blockbuster biologic Stelara before all patents expire, accusing the company of violating the provision against assigning or sublicensing the patent rights to other parties.
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February 25, 2025
Insulet May Face Choice: $452M Award Or Stifling Rival
A Boston federal judge on Tuesday suggested that a medical device maker could have to choose between portions of its nine-figure trade secrets verdict it won against a rival or its request for a court order to permanently block sales of products based on the stolen technologies.
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February 25, 2025
Couple, Biotech Co. Jointly Drop Lost Embryos Suit
A Charlotte couple and the biotechnology company they accused of making a defective oil used for the in vitro fertilization process came together to drop their dispute from North Carolina federal court, ending the prospective parents' wrongful death claims.
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February 25, 2025
Purdue Gets Time To Document New $7.4B Ch. 11 Settlement
Counsel for bankrupt drugmaker Purdue Pharma received approval Tuesday for an extension of a mediation window during which litigation against nondebtors is paused after telling a New York judge that it has reached definitive terms on a new $7.4 billion settlement of opioid claims and needs time to finalize documentation surrounding the deal.
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February 25, 2025
Masimo Aims To DQ Hueston Hennigan As Ex-CEO's Counsel
Masimo Corp. is urging the Delaware Chancery Court to disqualify Hueston Hennigan LLP from representing its founder and former CEO in a lawsuit over his quest for a $450 million payout from the medical technology company, arguing the firm has a conflict of interest.
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February 25, 2025
Lawyer Who Became Client's 'Punching Bag' Scores Case Exit
A Connecticut attorney who claimed he became his Massachusetts client's "punching bag" can exit her medical negligence lawsuit against two doctors accused of misplacing or destroying her embryos, a Milford judge ruled Tuesday.
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February 25, 2025
WilmerHale, Cleary Steer $4.1B Thermo Fisher-Solventum Deal
WilmerHale and Cleary Gottlieb Steen & Hamilton LLP are the principal advisers on a new agreement for Thermo Fisher Scientific Inc. to purchase the purification and filtration business of Solventum for $4.1 billion in cash, according to statements from the companies on Tuesday.
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February 25, 2025
Dental Co. Biolase Drills Down On Unopposed Ch. 11 Plan
A Delaware bankruptcy judge on Tuesday OK'd the Chapter 11 plan of dental technology maker Biolase Inc., which was fully consensual following changes to gain the approval of the U.S. Trustee and the official committee of unsecured creditors.
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February 24, 2025
Natera's $96M DNA Test Verdict Scrapped, Patents Axed
A Delaware federal judge Monday threw out Natera's $96 million patent infringement verdict against CareDx after determining that the asserted claims in its patents related to DNA tests for organ transplant recipients are invalid.
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February 24, 2025
Fed. Circ. Shouldn't Assume Doctors Read Labels, Profs Say
The Federal Circuit has been reviewing whether generic-drug companies induce infringement of their limited-use drugs based on a misunderstanding of how prescribing physicians do their job, law professors from Illinois and Pennsylvania have argued in a new paper.
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February 24, 2025
Bioanalysis Co. Worker Fired For Flagging FDA Data, Suit Says
A Colorado bioanalysis research contractor is facing claims it unfairly fired an employee who spoke up about allegedly manipulated data and who said he was terminated "because of his protected medical leave of absence," according to a suit recently filed in federal court.
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February 24, 2025
Biotech Minority Investor Sues In Del. To Block Control Moves
A company control and takeover battle between Aurion Biotech Inc. and a large investor made its second landing in Delaware's Court of Chancery on Monday, in a minority stockholder's direct and derivative suit accusing Alcon Research Inc. and its board designates of multiple fiduciary breaches.
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February 24, 2025
Insurer Needn't Cover Hospital's $2.5M Virus Vax Probe Costs
A Chubb unit has no obligation to pay an Illinois hospital for $2.5 million in legal costs associated with responding to federal and state probes into its COVID-19 vaccine distribution program, a federal court ruled, finding that the policy's $1 million regulatory claims sublimit applies.
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February 24, 2025
PBMs To Challenge FTC Case At 8th Circ., But Without Pause
A Missouri federal judge summarily refused, again, on Monday to temporarily block the Federal Trade Commission's in-house case accusing Caremark Rx, Express Scripts and OptumRx of artificially inflating insulin prices, letting the case proceed while the pharmacy benefits managers appeal to the Eighth Circuit.
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February 24, 2025
Purdue's New Ch. 11 Plan Sidesteps Nonconsensual Releases
Mediators helping to craft a new settlement in the case of bankrupt OxyContin maker Purdue Pharma LP said in their latest update in New York bankruptcy court that the company's revised deal does not contain nonconsensual third-party waivers.
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February 24, 2025
Boehringer Ingelheim Wins Illinois Zantac Cancer Retrial
An Illinois state jury swiftly sided with Boehringer Ingelheim on Monday over two men's claims that taking the company's over-the-counter Zantac for decades contributed to their prostate cancer diagnoses, handing each of the men a trial loss after juries in their previous trials had deadlocked.
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February 24, 2025
Skadden, Ropes & Gray Advising On 23andMe Buyout Bid
The CEO of 23andMe has teamed up with private equity firm New Mountain Capital on an offer to purchase and take the genetic testing company private at an equity value of approximately $74.7 million, according to a filing with the U.S. Securities and Exchange Commission.
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February 24, 2025
Elizabeth Holmes Loses 9th Circ. Appeal Over Theranos Fraud
A Ninth Circuit panel on Monday affirmed the criminal fraud convictions of former Theranos CEO Elizabeth Holmes and former Theranos executive Ramesh "Sunny" Balwani along with their respective 11-year and nearly 13-year prison sentences, rejecting arguments that the lower court made multiple evidentiary errors that unfairly swayed jurors.
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February 24, 2025
Justices Nix Whistleblower Suit Over Arbitral Vacatur Limits
The U.S. Supreme Court on Monday declined to review a petition that raised questions about the standards under which courts can vacate or enforce arbitral awards, in a case brought by a whistleblower who sought to challenge an arbitral award favoring his former employer.
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February 24, 2025
Paul Hastings Adds Boston Co-Chair For New Tech Practice
The former global vice chair of Latham & Watkins LLP's data and technology transactions practice has moved to Paul Hastings LLP as co-chair of its newly established technology transactions practice, the latter firm announced Monday.
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February 21, 2025
Colo. Woman Tells Jury Sterilization Plant Caused Cancer
A woman claiming medical sterilization company Terumo caused a cancer cluster in her Colorado community took the stand Friday and told a state jury that her lymphoma gave her debilitating fatigue and self-doubt.
Expert Analysis
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Top 10 Healthcare And Life Sciences Issues To Watch In 2025
Under the new Trump administration, this coming year may benefit some healthcare and life sciences stakeholders, while creating new challenges for others amid an increasingly complex regulatory environment, say attorneys at Debevoise.
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Parsing 3rd Circ. Ruling On Cannabis, Employee Private Suits
The Third Circuit recently upheld a decision that individuals don't have a private right of action for alleged violations of New Jersey's Cannabis Regulatory, Enforcement Assistance and Marketplace Modernization Act, but employers should stay informed as the court encouraged the state Legislature to amend the law, say attorneys at Mandelbaum Barrett.
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4 Keys To Litigating In An Active Regulatory Environment
For companies facing litigation influenced by government regulatory action — a recent trend that a politically charged atmosphere will exacerbate — there are a few principles that can help to align litigation strategy with broader public positioning in the regulatory and oversight context, say attorneys at Jenner & Block.
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Kiromic SEC Order Shows Importance Of Self-Reporting
The U.S. Securities and Exchange Commission's recently filed settled charges against Kiromic BioPharma illustrate the critical intersection between U.S. Food and Drug Administration regulatory processes and investor disclosures under the securities laws, and showcase how responding promptly to internal whistleblower reports may reap benefits, say attorneys at Arnold & Porter.
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Series
Documentary Filmmaking Makes Me A Better Lawyer
Becoming a documentary filmmaker has allowed me to merge my legal expertise with my passion for storytelling, and has helped me to hone negotiation, critical thinking and problem-solving skills that are important to both endeavors, says Robert Darwell at Sheppard Mullin.
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Litigation Funding Disclosure Debate: Strategy Considerations
In the ongoing debate over whether courts should require disclosure of litigation funding, funders and plaintiffs tend to argue against such mandates, but voluntarily disclosing limited details about a funding arrangement can actually confer certain benefits to plaintiffs in some scenarios, say Andrew Stulce and Marc Cavan at Longford Capital.
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2025 May Be A Breakout Year For The Cannabis Industry
The cannabis industry faced a slow and frustrating 2024, but consumer trends continue to shift in favor of cannabis, and the new administration may provide the catalyst that the industry needs, says Lynn Gefen at TerrAscend.
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FDA's Red No. 3 Ban Reshapes Food Safety Legal Landscape
The U.S. Food and Drug Administration's recent ban on Red No. 3 represents more than the end of a controversial dye — it signals a shift in regulatory priorities, consumer expectations, intellectual property strategy, compliance considerations and litigation risk, says Dino Haloulos at Foley Mansfield.
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Scope And Nature Of Judicial Relief Will Affect Loper's Impact
The practical result of post-Loper Bright rulings against regulatory actions will depend on the relief courts grant — and there has been controversy in these types of cases over whether the ruling is applied just to the parties or nationwide, and whether the action can be left in place while it's corrected, says Steven Gordon at Holland & Knight.
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The Implications Of E-Cigarette Cos. Taking Suits To 5th Circ.
The U.S. Supreme Court recently heard oral arguments in U.S. Food and Drug Administration v. R.J. Reynolds over the definition of an "adversely affected" person under the Tobacco Control Act, and the justices' ruling will have important and potentially wide-ranging implications for forum shopping claims, says Trillium Chang at Zuckerman Spaeder.
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Series
Adventure Photography Makes Me A Better Lawyer
Photographing nature everywhere from Siberia to Cuba and Iceland to Rwanda provides me with a constant reminder to refresh, refocus and rethink the legal issues that my clients face, says Richard Birmingham at Davis Wright.
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What Vinyl Acetate's Prop 65 Listing Means For Cos.
California's recent move to add vinyl acetate to the Proposition 65 list of carcinogens, with enforcement starting later this year, will have sweeping compliance and risk implications for businesses in the retail, food and beverage, paint, adhesive, industrial manufacturing, and personal care product industries, say attorneys at Alston & Bird.
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Fed. Circ. Inherency Ruling Refines Obviousness Framework
The Federal Circuit's December decision in Cytiva v. JSR has definitively eliminated the requirement of "reasonable expectation of success" analysis for inherent properties in obviousness determinations, while providing some key clarifications for patent practitioners, says Lawrence Kass at Steptoe.
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Navigating The Potential End Of GLP-1 Drug Shortages
The U.S. Food and Drug Administration's determination of whether GLP-1 products are in shortage may affect how compounders provide these products and spur a range of litigation including patent disputes and unfair competition suits, say attorneys at Goodwin.
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High Court Could Further Limit Deference With TCPA Fax Case
The Supreme Court's decision to hear McLaughlin Chiropractic Associates v. McKesson, a case involving alleged junk faxes that centers whether district courts are bound by Federal Communications Commission rules, offers the court a chance to possibly further limit the judicial deference afforded to federal agency interpretations of statutes, says Samantha Duke at Rumberger Kirk.