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Life Sciences
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September 27, 2024
Medical Equipment Co., Founder Settle FCA Suit For $20M
A Florida-based medical equipment company and its founder will pay $20 million to settle claims under the federal False Claims Act that they improperly billed government healthcare plans for duplicated and unnecessary sales of devices meant to offer pain relief through electrical stimulation, Pennsylvania prosecutors said Friday.
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September 26, 2024
SEC Fines Cassava $40M Over Alzheimer's Treatment Claims
Neuroscience-focused biopharmaceutical company Cassava Sciences Inc. and two of its former executives agreed to pay over $40 million to resolve U.S. Securities and Exchange Commission claims related to allegedly misleading statements about clinical trial results for a potential Alzheimer's disease therapeutic, the regulator announced on Thursday.
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September 26, 2024
11th Circ. Affirms Convictions In Fla. Shark Rescue Case
The Eleventh Circuit upheld felony theft convictions for two Florida tour boat divers who were prosecuted for freeing sharks they believed were illegally poached, but turned out to be part of a research project conducted with a permit granted by the National Oceanic and Atmospheric Administration.
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September 26, 2024
2nd Circ. Denies Jury Trial In Abbott Labs Gray Market Case
A man and his wife involved in the sale of gray market diabetes test strips on Tuesday were unable to persuade the Second Circuit to undo the $33.4 million judgment they owe to Abbott Laboratories after a federal judge stripped them of their right to a jury trial.
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September 26, 2024
New Report Urges Feds To Take Larger Role In Pot Policy
The rise of state-sanctioned cannabis markets amid the absence of federal regulation has prioritized policies intended to launch marijuana sales over those focused on public health, according to a government-sponsored report made public Thursday.
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September 26, 2024
Walgreens Struggles To Exit 'Non-Drowsy' Label Suit In Wash.
The Washington State Supreme Court questioned Thursday whether Walgreens could avoid state consumer protection claims over its "non-drowsy" cough medicine label by pointing to a lack of federal labeling requirements for the drug, with one justice calling the argument a non sequitur.
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September 26, 2024
NC Medical Equipment Maker Can't Ditch Unfair Biz Suit
The North Carolina Business Court has denied a medical equipment maker's bid to get a win based on the pleadings in a fraudulent concealment and unfair trade practices lawsuit alleging that it stole the business model and a pregnancy support garment design from a rival.
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September 26, 2024
Obesity Drug Developer Leads 2 Upsized IPOs Totaling $310M
Obesity-focused drug developer BioAge Labs Inc. gained in debut trading Thursday after raising $198 million through an upsized initial public offering, leading one of two new listings that netted a combined $310 million under the guidance of four law firms.
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September 26, 2024
Virtua Discriminates Against Pregnant Patients, NJ Alleges
Virtua Health discriminates against pregnant patients by forcing them to undergo drug testing for inpatient admission to its hospitals — a policy that does not apply universally to other patients, New Jersey Attorney General Matthew J. Platkin alleged in a lawsuit filed Thursday in New Jersey state court.
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September 26, 2024
Senate Patent Bill Markups Delayed Until After Election
Congressional hearings scheduled for Thursday to mark up several bills related to patents, including measures dealing with patent eligibility, validity challenges and drug patents, have been postponed until after Election Day due to the Senate's adjournment.
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September 26, 2024
Nobel Winners Behind Gene Editor Seek To Nix Own Patents
The scientists credited with inventing the gene-editing tool CRISPR have voluntarily requested that two key patents be revoked in Europe, after officials suggested they might get nixed over technical issues.
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September 26, 2024
Quest Diagnostics Escapes 401(k) Mismanagement Suit
A New Jersey federal judge tossed a proposed class action alleging Quest Diagnostics Inc. mismanaged its $5 billion retirement plan by failing to chop under performing investment funds from its lineup, pointing to proof that the company acted to rein in questionable funds.
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September 25, 2024
In-House Counsel To Play Central Role At AI Cos., VCs Say
Venture capital firms expect in-house counsel at artificial intelligence companies to play a bigger role in their businesses due to regulatory uncertainties around AI, while a professor who helped pioneer the technology warned that transparency of commercial AI businesses should be "top of mind," attorneys heard at the seventh annual Berkeley Law AI Institute Wednesday.
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September 25, 2024
NY Judge Pauses Abortion 'Reversal' Case As AG Files Appeal
A New York federal judge has ruled that two more anti-abortion pregnancy centers are free to promote abortion pill "reversal" while a legal clash continues over whether the First Amendment protects their right to market the treatment, which is doubted by major medical groups.
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September 25, 2024
Ascension Must Face Additional Suit Over Vaccine Mandate
Ascension Health Alliance must face another proposed class action challenging its 2021 COVID-19 vaccination policy, an Indiana federal judge ruled Wednesday, holding that a group of workers who were suspended or fired after refusing the vaccine on religious grounds have a case against the Catholic healthcare system.
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September 25, 2024
Generics Group Names Ex-BIO, PhRMA Exec As New CEO
The generic drug industry group the Association for Accessible Medicines on Wednesday announced it has appointed a new chief executive officer who brings over a decade of experience in the branded drug industry.
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September 25, 2024
3rd Circ. Preserves Monsanto's Win In Cancer Warning Suit
The Third Circuit refused to reconsider its ruling that federal law preempts a more stringent Pennsylvania statute that mandates cancer warnings on chemicals, preserving Monsanto's win against a man who alleged the company's Roundup herbicide caused his illness.
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September 25, 2024
7th Circ. Judge Surprised Key Argument Left In Footnote
A Seventh Circuit judge seemed unsure Wednesday whether an insurer for Sterigenics could avoid a $75 million legal bill for defending the company from pollution suits, noting that the insurer addressed "the biggest issue in the case" in just a single, vague footnote.
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September 25, 2024
NJ Pharmacy Execs Cop To $33M Kickback Scheme
Two men who ran a New Jersey mail-order pharmacy admitted their roles in a $33 million medication kickback scheme, U.S. Attorney Philip R. Sellinger announced Wednesday.
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September 25, 2024
Wyden Pitches New Bill To Regulate Intoxicating Hemp
U.S. Senator Ron Wyden, D-Ore., introduced a new bill on Wednesday to more tightly regulate products with hemp-derived cannabinoids, with an emphasis on age gating, manufacturing standards and labeling requirements.
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September 25, 2024
DC Circ. Judges Ask If It's Too Late To Fast-Track Gastro Drug
A panel of D.C. Circuit judges grilled an attorney for Vanda Pharmaceuticals on Wednesday over claims Vanda's gastroparesis drug was improperly denied fast-track designation by the Food and Drug Administration, questioning why the company declined to complete animal toxicological studies even after the FDA paused the drug's human trials.
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September 25, 2024
Expect More R&D Guidance Before Regs, IRS Atty Says
The Internal Revenue Service plans to release more guidance governing the tax treatment of research and development expenses before it formally issues proposed regulations that implement the 2017 federal tax law's changes to the incentive, an agency attorney said Wednesday.
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September 25, 2024
Cancer Detection Biz To Go Public Via $694M SPAC Merger
Special purpose acquisition company Breeze Holdings Acquisition Corp. on Wednesday announced that it has agreed to merge with and take public clinical-stage biopharmaceutical company YD Biopharma Ltd. in a deal that gives the combined company an estimated enterprise value of $694 million and was built by three firms.
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September 25, 2024
AmerisourceBergen Can't Escape Workers' 401(k) Fee Suit
AmerisourceBergen Corp. can't escape a proposed class action alleging it allowed its employee 401(k) plan to be saddled with excessive recordkeeping costs, a Kentucky federal judge ruled, saying the workers' claims and calculations were detailed enough to move forward.
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September 24, 2024
Google Can't Ditch Privacy Suit Over Period App Data Sharing
A California federal judge has refused to release Google from a proposed class action alleging the company used a data analytics tool to wrongfully retrieve data from menstruation tracking app Flo, rejecting the tech giant's arguments that the plaintiffs lacked standing and had consented to the disclosures.
Expert Analysis
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Opinion
Flawed Fintiv Rule Should Be Deemed Overreach In Tech Suit
A pending federal lawsuit over the U.S. Patent and Trademark Office's unilateral changes to key elements of the America Invents Act, Apple v. Vidal, could shift the balance of power between Congress and federal agencies, as it could justify future instances of unelected officials unilaterally changing laws, say Patrick Leahy and Bob Goodlatte.
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How Associates Can Build A Professional Image
As hybrid work arrangements become the norm in the legal industry, early-career attorneys must be proactive in building and maintaining a professional presence in both physical and digital settings, ensuring that their image aligns with their long-term career goals, say Lana Manganiello at Equinox Strategy Partners and Estelle Winsett at Estelle Winsett Professional Image Consulting.
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High Court's Abortion Pill Ruling Shuts Out Future Challenges
The U.S. Supreme Court's unanimous ruling in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine maintains the status quo for mifepristone access and rejects the plaintiffs' standing theories so thoroughly that future challenges from states or other plaintiffs are unlikely to be viable, say Jaime Santos and Annaka Nava at Goodwin.
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Emerging Trends In ESG-Focused Securities Litigation
Based on a combination of shareholder pressure, increasing regulatory scrutiny and proposed rulemaking, there has been a proliferation of litigation over public company disclosures and actions regarding environmental, social, and governance factors — and the overall volume of such class actions will likely increase in the coming years, say attorneys at Mintz.
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Orange Book Warnings Highlight FTC's Drug Price Focus
In light of heightened regulatory scrutiny surrounding drug pricing and the Federal Trade Commission's activity in the recent Teva v. Amneal case, branded drug manufacturers should expect the FTC's campaign against allegedly improper Orange Book listings to continue, say attorneys at Ropes & Gray.
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Firms Must Rethink How They Train New Lawyers In AI Age
As law firms begin to use generative artificial intelligence to complete lower-level legal tasks, they’ll need to consider new ways to train summer associates and early-career attorneys, keeping in mind the five stages of skill acquisition, says Liisa Thomas at Sheppard Mullin.
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A Plaintiffs-Side Approach To Cochlear Implant Cases
As the number of cochlear implants in the U.S. continues to grow, some will inevitably fail — especially considering that many recalled implants remain in use — plaintiffs attorneys should proactively prepare for litigation over defective implants, says David Shoop at Shoop.
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Think Like A Lawyer: Always Be Closing
When a lawyer presents their case with the right propulsive structure throughout trial, there is little need for further argument after the close of evidence — and in fact, rehashing it all may test jurors’ patience — so attorneys should consider other strategies for closing arguments, says Luke Andrews at Poole Huffman.
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Tracking China's Push To Invalidate Foreign Patents
China’s increasing use of courts and administrative panels to nullify patents in strategically important industries, such as technology, pharmaceuticals and rare-earth minerals, raises serious concerns about the intellectual property rights of foreign businesses operating there, say Rajat Rana and Manuel Valderrama at Selendy Gay.
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Takeaways From Nat'l Security Division's Historic Declination
The Justice Department National Security Division's recent decision not to prosecute a biochemical company for an employee's export control violation marks its first declination under a new corporate enforcement policy, sending a clear message to companies that self-disclosure of misconduct may confer material benefits, say attorneys at Perkins Coie.
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Series
Playing Chess Makes Me A Better Lawyer
There are many ways that chess skills translate directly into lawyer skills, but for me, the bigger career lessons go beyond the direct parallels — playing chess has shown me the value of seeing gradual improvement in and focusing deep concentration on a nonwork endeavor, says attorney Steven Fink.
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Litigation Inspiration: Attys Can Be Heroic Like Olympians
Although litigation won’t earn anyone an Olympic medal in Paris this summer, it can be worthy of the same lasting honor if attorneys exercise focused restraint — seeking both their clients’ interests and those of the court — instead of merely pursuing every advantage short of sanctionable conduct, says Bennett Rawicki at Hilgers Graben.
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Updated Federal Rules Can Improve Product Liability MDLs
The recent amendment of a federal evidence rule regarding expert testimony and the proposal of a civil rule on managing early discovery in multidistrict legislation hold great promise for promoting the uniform and efficient processes that high-stakes product liability cases particularly need, say Alan Klein and William Heaston at Duane Morris.
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Lean Into The 'Great Restoration' To Retain Legal Talent
As the “great resignation,” in which employees voluntarily left their jobs in droves, has largely dissipated, legal employers should now work toward the idea of a “great restoration,” adopting strategies to effectively hire, onboard and retain top legal talent, says Molly McGrath at Hiring & Empowering Solutions.
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How Cannabis Rescheduling May Alter Paraphernalia Imports
The Biden administration's recent proposal to loosen federal restrictions on marijuana use raises questions about how U.S. Customs and Border Protection enforcement policies may shift when it comes to enforcing a separate federal ban on marijuana accessory imports, says R. Kevin Williams at Clark Hill.