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Life Sciences
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August 22, 2024
Mich. Panel Upholds Block Of 24-Hour Abortion Waiting Period
Michigan appellate judges have refused to lift a preliminary injunction blocking the enforcement of a 24-hour waiting period and other abortion regulations, leaving in place a lower court decision that found the laws likely violate the state constitution.
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August 22, 2024
Zantac Cases Must Remain In State Court, Conn. Judge Rules
Two groups of patients can continue their lawsuits in Connecticut state court against GlaxoSmithKline LLC, Pfizer Inc. and Sanofi-Aventis US LLC, a judge has ruled, refusing to immediately truncate novel tort claims that seek to connect generic versions of Zantac with cancer.
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August 22, 2024
Texas Tells High Court It's Not Idaho '2.0' In HHS Abortion Row
Texas and a pair of anti-abortion doctor organizations have urged the U.S. Supreme Court to reject the federal government's appeal of a Fifth Circuit decision blocking the Biden administration's guidance that hospitals must provide emergency stabilizing medical care, including abortions.
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August 22, 2024
Ex-MiMedx Sales Rep Says Fraud Schemes Pushed Her Out
A former employee of controversial biotech firm MiMedx who was sued for joining a competitor earlier this year hit the company back with a counterclaim Tuesday charging that she was forced out for refusing to go along with the company's alleged flouting of U.S. Food and Drug Administration regulations and rampant overbilling schemes.
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August 22, 2024
USPTO Tells High Court To Skip Double-Patenting Fight
The U.S. patent office told the U.S. Supreme Court that fears stoked by a patent licensing outfit complaining about current Federal Circuit jurisprudence surrounding "obviousness-type double patenting" has already been resolved by a different ruling by the same court earlier this month.
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August 22, 2024
Ga. Mineral Co., Insurer Strike Deal In Talc Coverage Suit
Phoenix Insurance Co. reached a contingent settlement with a Georgia-based mineral products company in litigation seeking to force the insurer to defend the company against an underlying suit claiming it supplied asbestos-containing talc products.
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August 22, 2024
Deals Rumor Mill: Saudi Fund, Disney-Reliance, Repligen
Saudi Arabia’s sovereign wealth fund wants to launch a new cargo airline, India’s antitrust regulators worry about power over cricket rights if the $8.5 billion merger of Walt Disney’s Indian business with Reliance Entertainment is allowed, and drug manufacturing provider Repligen is eyeing Maravai LifeSciences. Here, Law360 breaks down these and other notable deal rumors from the past week.
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August 21, 2024
Fed. Circ. Won't Rethink IP Safe Harbor Case
The Federal Circuit on Wednesday declined to review its decision affirming the dismissal of Edwards Lifesciences' infringement suit against Meril Life Sciences after Edwards urged the full court to narrow its interpretation of a U.S. Food and Drug Administration safe harbor that essentially allows patent infringement during drug development.
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August 21, 2024
Spine Implant Caused Patient's TB, Suit Says
A North Carolina couple on Tuesday hit biologic technology company Elutia Inc. with a complaint in federal court alleging that the husband contracted tuberculosis from a bone cell product that was implanted into his spine during surgery.
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August 21, 2024
Cannabinoid Co. Sacked Exec For Flagging Fraud, Suit Says
Psychedelics and cannabinoid company Benuvia Operations has been hit with a wrongful termination lawsuit in Colorado state court filed by a woman who claims management retaliated against her after flagging millions of dollars in misappropriated funds.
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August 21, 2024
Hedge Fund Priest Sues SEC Over Proposed Industry Ban
A Greek Orthodox priest and hedge fund founder who beat most civil claims brought by the U.S. Securities and Exchange Commission at a 2021 trial sued the agency Wednesday, claiming it is unconstitutionally trying to implement a lifetime ban from the securities industry through an administrative case.
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August 21, 2024
9th Circ. Doubts Idaho Trans Health Ban Doesn't Discriminate
The Ninth Circuit appeared reluctant Wednesday to give the state of Idaho a green light for a prohibition on gender dysphoria treatment for minors, with judges vocally skeptical of the state's argument that the policy didn't discriminate based on sex.
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August 21, 2024
Judge Rules Lack Of Expert Dooms Families' Tylenol MDL
Families trying to show that prenatal exposure to acetaminophen causes ADHD cannot rely on the "cherry-picked statements" of a defense expert to keep their claims alive, a New York federal judge ruled, delivering yet another blow to plaintiffs in the sprawling multidistrict litigation.
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August 21, 2024
Calif. AG Secures Rite Aid Deal Ensuring Pharmacy Access
California Attorney General Rob Bonta has announced a settlement with Rite Aid Corp. that will allow his office to oversee any changes in ownership of the company's retail pharmacy outlets across the state.
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August 20, 2024
Mesh Was Implanted After Serious FDA Alert, Jury Hears
A surgery patient went to trial Tuesday against an Oregon hospital and surgeon over an implant of prolapse mesh almost two weeks after the U.S. Food and Drug Administration ordered its maker to stop selling it.
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August 20, 2024
Ala. AG Can't Prosecute Aiding Abortion Travel, DOJ Says
The Alabama attorney general's threats of criminal prosecution against individuals and corporations who assist others in traveling to obtain lawful abortions out of state violates the constitutional right to travel, the U.S. Department of Justice told an Alabama federal judge in a court filing Monday.
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August 20, 2024
SF Police Can't Sue Navy Over Toxic Shipyard, 9th Circ. Says
A group of San Francisco police officers cannot pursue their suit alleging the U.S. Navy misled the city into leasing a former naval shipyard that was not properly decontaminated following its use during the Cold War, which led to the officers suffering health problems, the Ninth Circuit ruled Tuesday.
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August 20, 2024
Advanced Bionics Sues Med-El At ITC Over Implant Patents
Switzerland's Advanced Bionics has brought claims against Austria's Med-El at the U.S. International Trade Commission, alleging the rival maker of cochlear implants is infringing two patents on hearing aid technology and seeking an exclusion order banning Med-El's products from being imported into the U.S.
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August 20, 2024
Lender's $13M Atty Fee Reserve Bid In Eiger Ch. 11 Plan Nixed
A Texas bankruptcy judge on Tuesday mostly sided with life science company Eiger BioPharmaceuticals in estimating a secured lender's future claims, saying at a hearing that Eiger's Chapter 11 reserve for the claim should include two years worth of interest and agreeing that $1 million should be earmarked for legal fees, not the lender's requested $13 million sum.
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August 20, 2024
Fed Circ. Finds No Fault In Denial Of Flu Vaccine Claim
The Federal Circuit on Tuesday affirmed the denial of a family's petition for compensation alleging their child developed narcolepsy as a result of the FluMist vaccine, saying the special master's determination that the family hasn't properly established the link was not arbitrary.
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August 20, 2024
Insider Trading Won't Impact Pilot's Tax Sentencing Guidelines
A Manhattan federal judge found Tuesday that insider trading allegations won't bump up the guidelines sentencing range for a pilot for U.K. billionaire Joe Lewis who pled guilty to tax evasion.
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August 20, 2024
Vax Patent Battles Heat Up As Attention On Pandemic Wanes
It's been over four years since clinical trials began for COVID-19 vaccines, and while the shots have helped the pandemic recede, the lucrative technology has spurred numerous patent suits, many of which are still in the early stages. Here's a look at some of the key cases in the U.S.
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August 20, 2024
Ex-Client Opposes Amicus In McCarter & English Fee Fight
A dietary supplement maker has asked Connecticut's highest court to reject a bid by the Connecticut Trial Lawyers Association to file a friend-of-court brief in a case questioning whether McCarter & English LLP can obtain punitive damages in a fee dispute, saying no additional input is necessary because no tort occurred.
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August 20, 2024
FTC Endorses Push For Broader Access To Biosimilar Drugs
The Federal Trade Commission is backing a proposal that would make it easier for drugmakers to show biosimilar medicines are safe substitutes for their more expensive counterparts, a move the agency says would boost competition and reduce confusion.
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August 20, 2024
Pathology Trade Group 2nd To Sue FDA Over Lab-Test Rule
A molecular pathology trade group has filed a lawsuit against the U.S. Food and Drug Administration, challenging a recent final rule to regulate laboratory-developed tests as medical devices and arguing the agency has abused its power — the second such case filed in recent months.
Expert Analysis
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Weight-Loss Drugs May Spur Next Major Mass Tort
With lawsuits concerning Ozempic and similar weight-loss drugs potentially becoming the next major mass tort in the U.S., companies should consider key defense strategies ranging from alternate dispute resolution to enhanced drug safety, say Dino Haloulos and Jarif Khan at Foley & Mansfield.
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Opinion
The FTC Needs To Challenge The Novo-Catalent Deal
Novo's acquisition of Catalent threatens to substantially lessen competition in the manufacturing and marketing of GLP-1 diabetes and obesity drugs, and the Federal Trade Commission should challenge it under a vertical theory of harm, as it aligns with last year's merger guidelines and the Fifth Circuit decision in Illumina, says attorney David Balto.
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Series
After Chevron: Slowing Down AI In Medical Research
The U.S. Supreme Court's recent decision overturning the Chevron doctrine may inhibit agencies' regulatory efforts, potentially slowing down the approval and implementation of artificial intelligence-driven methodologies in medical research, as well as regulators' responses to public health emergencies, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.
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Series
Being A Luthier Makes Me A Better Lawyer
When I’m not working as an appellate lawyer, I spend my spare time building guitars — a craft known as luthiery — which has helped to enhance the discipline, patience and resilience needed to write better briefs, says Rob Carty at Nichols Brar.
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FDA's Multifaceted Role On Display In MDMA Therapy Scrutiny
Ongoing deliberations at the U.S. Food and Drug Administration regarding MDMA-assisted therapy for post-traumatic stress disorder serves as a window into the intricate balance of scientific innovation and patient safety oversight, and offers crucial insights into regulatory nuances, say Kimberly Chew at Husch Blackwell and Kevin Lanzo at Pharmaka Clinical Consulting.
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Lead Like 'Ted Lasso' By Embracing Cognitive Diversity
The Apple TV+ series “Ted Lasso” aptly illustrates how embracing cognitive diversity can be a winning strategy for teams, providing a useful lesson for law firms, which can benefit significantly from fresh, diverse perspectives and collaborative problem-solving, says Paul Manuele at PR Manuele Consulting.
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How Cos. Should Handle Research Org.'s Carcinogen Evals
In light of the International Agency of Research for Cancer's list of substances slated for review over the next five years, manufacturers of chemicals, pharmaceuticals and consumer products should monitor for potentially unbalanced determinations, which could stimulate litigation regarding potential exposure from products, say attorneys at Nelson Mullins.
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Analyzing FDA Draft Guidance On Clinical Trial Diversity
In light of the U.S. Food and Drug Administration's draft guidance on clinical trial diversity action plans, there are several important considerations for sponsors and clinical researchers to keep in mind to prevent delay in a drug or device application, say attorneys at Crowell & Moring.
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What's New In The AI Healthcare Regulatory Space
Attorneys at Hogan Lovells review the current legal and regulatory landscape for artificial intelligence applications in healthcare, touching on policies around safety, transparency, nondiscrimination and reimbursement, and what to expect in the future.
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Del. Dispatch: 27.6% Stockholder Not A Controller
The Delaware Court of Chancery's recent decision in Sciannella v. AstraZeneca — which found that the pharma giant, a 26.7% stockholder of Viela Bio Inc., was not a controller of Viela, despite having management control — shows that overall context matters when challenging transactions on breach of fiduciary duty grounds, say attorneys at Fried Frank.
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3 Policyholder Tips After Calif. Ruling Denying D&O Coverage
A California decision from June, Practice Fusion v. Freedom Specialty Insurance, denying a company's claim seeking reimbursement under a directors and officers insurance policy for its settlement with the Justice Department, highlights the importance of coordinating coverage for all operational risks and the danger of broad exclusionary policy language, says Geoffrey Fehling at Hunton.
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1 Year At The UPC: Implications For Transatlantic Disputes
In its first year, the Unified Patent Court has issued important decisions on procedures like provisional measures, but complexities remain when it comes to coordinating proceedings across jurisdictions like the U.S. due to differences in timelines and discovery practices, say attorneys at McDermott.
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Opinion
Now More Than Ever, Lawyers Must Exhibit Professionalism
As society becomes increasingly fractured and workplace incivility is on the rise, attorneys must champion professionalism and lead by example, demonstrating how lawyers can respectfully disagree without being disagreeable, says Edward Casmere at Norton Rose.
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Opinion
High Court Made Profound Mistake In Tossing Purdue Deal
The U.S. Supreme Court's recent decision to throw out Purdue Pharma's Chapter 11 plan jeopardizes a multistate agreement that would provide approximately $7 billion in much-needed relief to help fight the opioid epidemic, with states now likely doomed to spend years chasing individual defendants across the globe, says Swain Wood at Morningstar.
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Series
Serving In The National Guard Makes Me A Better Lawyer
My ongoing military experience as a judge advocate general in the National Guard has shaped me as a person and a lawyer, teaching me the importance of embracing confidence, balance and teamwork in both my Army and civilian roles, says Danielle Aymond at Baker Donelson.