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Life Sciences
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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.
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February 21, 2025
WebMD Users Secure Class Certification In Video Privacy Suit
WebMD faces a certified class action accusing the health information site of violating federal law by sharing roughly half a million of its users' video-viewing history with Facebook, after a Georgia federal judge rejected some of the website's arguments against certification as "absurd."
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February 21, 2025
MSN Calls Novartis' Entresto Delisting Protest 'Disingenuous'
Novartis' claim that there's no rush to decide whether a patent covering its blockbuster cardiovascular drug Entresto should be removed from a key drug database is "disingenuous and a complete about-face," MSN Pharmaceuticals has told a Delaware federal judge.
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February 21, 2025
Eli Lilly Has Exclusivity Over Weight Loss Drug, FDA Says
The U.S. Food and Drug Administration asked a Texas federal court to reject a request for an injunction that would allow compounding pharmacies to produce a lucrative weight loss drug, saying the agency based its decision on sound facts and it was within its authority.
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February 21, 2025
Harry Manbeck, Former USPTO Head, Dies At 98
Former U.S. Patent and Trademark Office leader and chief patent counsel at General Electric Co., Harry F. Manbeck Jr., died Wednesday. He was 98.
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February 21, 2025
NFL Alums Accused Of Misusing COVID Outreach Funding
The National Football League's largest alumni organization has been accused by a biotechnology company of trying to misuse Georgia taxpayer dollars intended for a COVID-19 vaccine education program before unlawfully breaking their contract last year.
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February 21, 2025
Pharma Co. Investors Get Final OK For $3M Settlement
Investors in Colorado pharmaceutical company Ampio have gotten final approval for their $3 million deal resolving claims that its leadership mishandled a clinical trial for the company's sole drug candidate and distributed the drug outside the trial for unapproved use, leading to an internal investigation in which two executives were fired and a disclosure that there was "no clinical pathway forward" for the treatment.
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February 21, 2025
Manufacturer Not Covered For Pot Grower Claims, Court Told
Cincinnati Insurance Co. said it has no duty to defend or indemnify a manufacturer accused of misrepresenting the capabilities of its indoor marijuana growing systems, telling a Michigan federal court Friday that underlying claims brought by a cannabis company do not trigger coverage.
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February 21, 2025
UChicago Medical Center Can't Duck Wage Suit
An Illinois federal judge largely allowed a proposed class action brought by UChicago Medical Center workers seeking to recover unpaid wages for the time spent undergoing mandatory, pre-shift COVID-19 screenings to move forward, rejecting the center's argument that the screenings weren't "integral and indispensable" to employees' job duties.
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February 21, 2025
Weight Loss Drug Patient Drops Appeal In Cancer Risk Suit
Days after arguing her case before a skeptical Third Circuit panel, a woman who alleges she suffered financial harm by buying a weight loss drug that purportedly causes cancer — which she said she has not been diagnosed with — has voluntarily dismissed the case.
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February 21, 2025
Veolia Ends One Of Few Remaining Flint Water Suits For $53M
A water engineering firm on Friday said it will pay $53 million to settle claims from the state of Michigan and thousands of Flint residents who allege the company failed to properly identify corrosion control treatment issues or alert officials to the dangers of the city's water, prolonging the water crisis.
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February 21, 2025
Paul Hastings Seeks To End GenapSys Malpractice Action
Paul Hastings LLP has moved for summary judgment in a malpractice action from GenapSys Inc., saying the case is barred because the genomic sequencing company failed to disclose its possible claim until after confirmation of its bankruptcy plan.
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February 21, 2025
NJ High Court Takes Up Pharma Co. Fraud Coverage Row
The New Jersey Supreme Court will review an appeals court's ruling against indemnification in a case of first impression on the applicability of an exclusion barring directors and officers coverage for wrongful acts "in any way involving" an insured's work for an uninsured entity, the high court announced.
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February 21, 2025
WilmerHale Corporate Ace Joins DLA Piper In California
DLA Piper has added a former WilmerHale attorney to strengthen its corporate practice, including bolstering its service to clients in the life sciences and healthcare industries.
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February 21, 2025
NIH Research Cuts Stay On Hold As Judge Mulls Objections
A Boston federal judge on Friday extended her hold on a Trump administration proposal to slash reimbursements from the National Institutes of Health for research grant costs, a move colleges, hospitals and other institutions have said would wreak havoc on scientific research.
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.