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Life Sciences
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August 20, 2025
Texas AG Threatens Suit Over Orgs. Mailing Abortion Pills
Texas Attorney General Ken Paxton has sent cease-and-desist letters to three organizations he's accused of shipping abortion drugs to women in the state in violation of state and federal laws.
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August 20, 2025
Device Co. Pans FTC's Resistance To $945M Heart Valve Deal
Edwards Lifesciences Corp. is defending its planned $945 million purchase of JenaValve Technology Inc., telling the Federal Trade Commission the deal is the best way to bring a new lifesaving treatment for a heart valve disorder to the market.
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August 20, 2025
Fired Pharma Co. VP Must Arbitrate Sex Bias Claims
A Connecticut federal judge said a former Boehringer Ingelheim Pharmaceuticals LLC vice president must arbitrate his sex bias suit claiming his female boss mistreated him and gave him a low performance rating because he is a man, ruling his case isn't covered by a law barring sex misconduct claims from out-of-court resolutions.
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August 20, 2025
State AGs Sidelined From Sandoz Price-Fixing Deal
A group of over 40 states and territories cannot intervene in a $275 million settlement resolving generic-drug price-fixing claims against Sandoz because they only have a nominal interest in the suit that fails to confer standing, a Pennsylvania federal judge said.
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August 20, 2025
Former J&J Atty Slams Sanctions Bid Over Bias Suit
A former Johnson & Johnson data privacy attorney suing the pharmaceutical giant over alleged racial discrimination told a New Jersey federal court that the company's sanctions motion is an unfair move to "weaponize" the rules of civil procedure.
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August 20, 2025
Biotech Replimune Faces Derivative Suit Over Trial Claims
Executives and directors of biotechnology company Replimune Group Inc. face shareholder derivative claims that they concealed issues affecting a clinical trial of one of the company's lead immunotherapy candidates.
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August 20, 2025
CVS PBM Overbilling Judgment Trebled To $289M
A Pennsylvania federal judge has increased threefold a judgment against CVS Caremark from $95 million to $289 million for overbilling Medicare Part D-sponsored drugs.
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August 19, 2025
NJ Judge Files Corrected Version Of Error-Filled Opinion
A New Jersey federal judge Tuesday filed a new, corrected version of an opinion he withdrew last month in securities litigation against CorMedix Inc. after an attorney for the biopharmaceutical firm pointed out the opinion contained "a series of errors."
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August 19, 2025
3D Systems Brass Sued Over Revenue Projections
Executives and directors of 3D Systems Corp. have been hit with a shareholder derivative suit accusing them of concealing issues that negatively impacted the 3D printer company's revenue prospects, including an update to a partnership agreement with a large customer to develop artificial lungs.
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August 19, 2025
Sotera Urges 6th Circ. To Toss Investors' Toxic Gas Suit
Sotera Health Co. urged the Sixth Circuit to affirm the dismissal of a lawsuit accusing it of concealing the carcinogenic nature of a gas used at its sterilization plants, saying "defending yourself in litigation is not securities fraud."
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August 19, 2025
Lab Owner Gets 3 Years For $40M COVID-19 Test Fraud
A co-founder of a laboratory accused of submitting $40 million in unnecessary COVID-19 and genetic testing claims to healthcare benefit programs was sentenced to three years in prison Tuesday, after a Florida federal judge credited him for the extensive cooperation he provided the government before and during a trial against his co-defendants.
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August 19, 2025
Novo Nordisk Gets Forfeiture Claims Cut From 401(k) Suit
A New Jersey federal judge on Tuesday dismissed workers' allegations that Novo Nordisk unlawfully used forfeited funds in its $2.3 billion 401(k) plan for its own benefit and kept a shoddy fund on its investment roster, leaving an excessive fee claim in play.
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August 19, 2025
21 AGs Push DEA To Schedule 'Designer Xanax'
Kentucky Attorney General Russell Coleman and 20 other state attorneys general are urgently asking the U.S. Drug Enforcement Administration to schedule an unregulated substance known as "designer Xanax" under the Controlled Substances Act, saying it is contributing to overdose deaths and posing a growing threat to public health.
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August 19, 2025
Panel Weighs Ga. High Court Ruling In Sham Donor Suit
Customers who accused a sperm bank of selling sperm without disclosing the true medical and criminal histories of donors urged the Georgia Court of Appeals to revive their lawsuits Tuesday, arguing the dismissals were based on a misreading of a 2020 decision from the state's high court.
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August 19, 2025
Generic-Drug Makers To Pay $71M To End Price-Fixing Claims
Glenmark Pharmaceuticals Inc. USA has offered to pay approximately $38 million, and Pfizer Inc. and its generic-drug unit Greenstone LLC have promised to pay roughly $33 million, to settle price-fixing claims by the direct purchasers of generic drugs.
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August 19, 2025
Fed. Circ. Backs PTAB Ax Of DexCom Glucose Patent Claims
The Federal Circuit won't disturb a Patent Trial and Appeal Board finding that a DexCom patent on glucose monitoring systems is unpatentable, saying the medical device company misread the board's decision.
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August 18, 2025
HHS Says Layoffs, Reorganization Are Within Its Authority
The Trump administration urged a Rhode Island federal judge to toss claims that massive cuts to the Health and Human Services Department violate the U.S. Constitution and usurp congressional authority, arguing the state plaintiffs don't have the authority to dictate how the executive branch manages its personnel.
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August 18, 2025
'Ketamine Queen' Takes Plea Deal In Matthew Perry Case
The woman known as the "Ketamine Queen" of North Hollywood has agreed to plead guilty to providing the ketamine that led to the 2023 death of "Friends" star Matthew Perry, according to a plea agreement filed in California federal court on Monday.
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August 18, 2025
Pharma Company Beats Investor Suit Over Drug Safety Claims
ChemoCentryx, a California-based pharmaceutical company, has secured summary judgment in shareholder litigation accusing it of overstating the efficacy of its newly developed treatment for an autoimmune disease called ANCA vasculitis, with a California court ruling that the ultimate regulatory approval of the drug may show that the company was not intentionally overhyping it.
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August 18, 2025
Boehringer Long Ignored Zantac's Cancer Risks, Jury Hears
Boehringer Ingelheim ignored years of mounting concerns that the active ingredient in its over-the-counter drug Zantac degraded into a highly toxic compound, and it simply changed the color of its tablets to shield their problems, a colorectal cancer patient told an Illinois state jury Monday.
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August 18, 2025
Catching Up With Delaware's Chancery Court
Executives and board members of Cencora Corp. tentatively settled a stockholder derivative suit for $111.25 million, VectoIQ board members reached a $6.3 million deal on stockholder claims over electric carmaker Nikola's prospects, and class attorneys who secured a $50 million derivative suit settlement saw their proposed 25% attorney fee cut by almost half. Here's the latest from the Delaware Chancery Court.
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August 18, 2025
Akero Investor Suit Over Liver Drug Trials Permanently Tossed
A California federal judge has permanently ended Akero Therapeutics investors' proposed class action alleging they were misled about the patient population in the company's liver disease treatment clinical trial, ruling the investors did not "fill-in the logical gaps" she previously identified when dismissing their earlier pleading for failing to plead scienter.
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August 18, 2025
Life Sciences Data Rivals Settle Trade Secrets Battle
Life sciences data company IQVIA Inc. has settled a suit that alleged data rival Veeva Systems Inc. used "crowdsourcing" to misappropriate trade secrets, the two companies said Monday.
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August 18, 2025
Most Ozempic, Wegovy Claims Survive MDL Dismissal Bid
Eli Lilly & Co. and Novo Nordisk will have to face most of a multidistrict litigation accusing them of misleading consumers over the risks and benefits of popular weight loss drugs like Ozempic and Trulicity, after a Pennsylvania federal judge only trimmed a few of the dozen claims the drugmakers tried to have tossed.
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August 18, 2025
LabMD Fights Dinsmore's Bid To Toss Malpractice Suit
Now-shuttered LabMD Inc. and its CEO are pushing back against a bid from Dinsmore & Shohl LLP and a legal nonprofit to have a malpractice suit in Georgia federal court tossed, saying they haven't abandoned the case but rather were delayed in pursuing arbitration because they were searching for "competent counsel."
Expert Analysis
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2nd Circ. Reinforces Consensus On Vacating Foreign Awards
In Molecular Dynamics v. Spectrum Dynamics Medical, the Second Circuit recently affirmed that federal district courts do not possess subject matter jurisdiction to vacate foreign arbitral awards, strengthening this consensus across the circuits most active in recognition and enforcement actions, says Ed Mullins at Reed Smith.
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E-Discovery Quarterly: Rulings On Relevance Redactions
In recent cases addressing redactions that parties sought to apply based on the relevance of information — as opposed to considerations of privilege — courts have generally limited a party’s ability to withhold nonresponsive or irrelevant material, providing a few lessons for discovery strategy, say attorneys at Sidley.
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How DOJ's New Data Security Rules Leave HIPAA In The Dust
The U.S. Department of Justice's recently effective data security requirements carry profound implications for how healthcare providers collect, store, share and use data — and approach vendor oversight — that go far beyond the Health Insurance Portability and Accountability Act, say attorneys at Nelson Mullins.
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Opinion
Section 1983 Has Promise After End Of Nationwide Injunctions
After the U.S. Supreme Court recently struck down the practice of nationwide injunctions in Trump v. Casa, Section 1983 civil rights suits can provide a better pathway to hold the government accountable — but this will require reforms to qualified immunity, says Marc Levin at the Council on Criminal Justice.
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Trump's 2nd Term Puts Merger Remedies Back On The Table
In contrast with the Biden administration, the second Trump administration has signaled a renewed willingness to resolve merger enforcement concerns through remedies from the outset, particularly when the proposed fix is structural, clearly addresses the harm and does not require burdensome oversight, say attorneys at Cooley.
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Patent Ambiguity Persists After Justices Nix Eligibility Appeal
The Supreme Court recently declined to revisit the contentious framework governing patent eligibility by denying certiorari in Audio Evolution Diagnostics v. U.S., suggesting a necessary recalibration of both patent application and litigation strategies, say attorneys at Skadden.
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Texas Med Spas Must Prepare For 2 New State Laws
Two new laws in Texas — regulating elective intravenous therapy and reforming healthcare noncompetes — mark a pivotal shift in the regulatory framework for medical spas in the state, which must proactively adapt their operations and contractual practices, says Brad Cook at Munsch Hardt.
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Fed. Circ. In June: Transitional Phrases In Patent Claims
The Federal Circuit's recent decision in Eye Therapies v. Slayback Pharma takes on the rarely addressed topic of transitional phrases in patent claims, providing some useful lessons regarding restating claim language and broadly distinguishing prior art, say attorneys at Knobbe Martens.
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Series
Playing Soccer Makes Me A Better Lawyer
Soccer has become a key contributor to how I approach my work, and the lessons I’ve learned on the pitch about leadership, adaptability, resilience and communication make me better at what I do every day in my legal career, says Whitney O’Byrne at MoFo.
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Strategies For Cos. Navigating US-Indian Pharma Partnerships
Recent policy adjustments implemented by the U.S. government present both new opportunities and heightened regulatory scrutiny for the Indian life sciences industry, amplifying the importance of collaboration between the Indian and U.S. pharmaceutical sectors, say Bryant Godfrey at Foley Hoag and Jashaswi Ghosh at Holon Law Partners.
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DOJ-HHS Collab Crystallizes Focus On Health Enforcement
The recently announced partnership between the U.S. Department of Justice and U.S. Department of Health and Human Services to combat False Claims Act violations, following a multiyear trend of high-dollar DOJ recoveries, signals a long-term enforcement horizon with major implications for healthcare entities and whistleblowers, say attorneys at RJO.
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Series
Law School's Missed Lessons: Learning From Failure
While law school often focuses on the importance of precision, correctness and perfection, mistakes are inevitable in real-world practice — but failure is not the opposite of progress, and real talent comes from the ability to recover, rethink and reshape, says Brooke Pauley at Tucker Ellis.
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23andMe Fine Signals ICO's New GDPR Enforcement Focus
Many of the cybersecurity failures identified by the Information Commissioner’s Office in its investigation of 23andMe, recently resulting in a £2.3 million fine, were basic lapses, but the ICO's focus on several new U.K. General Data Protection Regulation considerations will likely carry into the future, say lawyers at Womble Bond.
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Eye Drop Ruling Clarifies Importance Of Patent Phrasing
The Federal Circuit's recent ruling in Eye Therapies v. Slayback, rejecting the Patent Trial and Appeal Board's interpretation of "consisting essentially of," highlights the importance of using clear and consistent terms throughout a patent's filing history to shield it against future challenges, says Liliana Di Nola-Baron at Panitch Schwarze.
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How The Healthline Privacy Settlement Redefines Ad Tech Use
The Healthline settlement is the first time California has drawn a clear line in the sand around how website tracking must function in practice, so if your site uses tracking technologies, especially around sensitive content like health or finance, regulators are inspecting your website's back end, not just its banner, say attorneys at Baker Donelson.