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Life Sciences
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August 22, 2024
Texas Appeals Knocks $1M Hernia Mesh Fee Ask Down To $135K
A Texas appeals court on Wednesday upheld an arbitration award of $135,000 in attorney's fees in a decadeslong hernia mesh litigation dispute while denying the firm's request for $1 million.
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August 22, 2024
2 Biotech Firms File Plans To Go Public As IPO Pipeline Grows
Drug developers Bicara Therapeutics Inc. and Zenas Biopharma Inc. filed plans with regulators on Thursday for initial public offerings that could tap the market as early as September, signaling a potential boost in post-Labor Day IPOs, under the combined guidance of three law firms.
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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.
Expert Analysis
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Analyzing Advance Notice Bylaws On 'Clear' Or 'Cloudy' Days
In Kellner v. AIM ImmunoTech, the Delaware Supreme Court recently clarified the framework for judicial review of advance notice bylaws adopted, amended or enforced on "clear" or "cloudy" days, underscoring the responsibility of boards to ensure that their scope does not overreach or prevent the possibility of a contested election, say attorneys at Venable.
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How To Grow Marketing, Biz Dev Teams In A Tight Market
Faced with fierce competition and rising operating costs, firms are feeling the pressure to build a well-oiled marketing and business development team that supports strategic priorities, but they’ll need to be flexible and creative given a tight talent market, says Ben Curle at Ambition.
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Patent Lessons From 5 Federal Circuit Reversals In June
A look at June cases where the Federal Circuit reversed or vacated decisions by the Patent Trial and Appeal Board or a federal district court highlights a potential path for branded drugmakers to sue generic-drug makers for off-label uses, potential downsides of violating a pretrial order offering testimony, and more, say Denise De Mory and Li Guo at Bunsow De Mory.
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Unpacking HHS' Opinion On Cell Therapy Refund Programs
A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.
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Series
Rock Climbing Makes Me A Better Lawyer
Rock climbing requires problem-solving, focus, risk management and resilience, skills that are also invaluable assets in my role as a finance lawyer, says Mei Zhang at Haynes and Boone.
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Think Like A Lawyer: Dance The Legal Standard Two-Step
From rookie brief writers to Chief Justice John Roberts, lawyers should master the legal standard two-step — framing the governing standard at the outset, and clarifying why they meet that standard — which has benefits for both the drafter and reader, says Luke Andrews at Poole Huffman.
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Alice Step 2 Trends Show Courts' Extrinsic Evidence Reliance
A look at recent trends in how district courts are applying Step 2 of the Alice framework shows that courts have increasingly relied on extrinsic evidence to help determine whether a claimed invention is "well-understood, routine, and conventional," says Jonathan Tuminaro at Sterne Kessler.
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Recent Settlement Shows 'China Initiative' Has Life After Death
Though the U.S. Department of Justice shuttered its controversial China Initiative two years ago, its recent False Claims Act settlement with the Cleveland Clinic Foundation demonstrates that prosecutors are more than willing to civilly pursue research institutions whose employees were previously targeted, say attorneys at Benesch.
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DOJ Innovasis Settlement Offers Lessons On Self-Disclosure
The recent $12 million settlement with Innovasis and two of its executives demonstrates the U.S. Department of Justice's continued prioritization of Anti-Kickback Statute enforcement amid the growing circuit split over causation, and illustrates important nuances surrounding self-disclosure, say Denise Barnes and Scott Gallisdorfer at Bass Berry.
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How Orange Book Antitrust Scrutiny Is Intensifying
Pharmaceutical patent holders should be reviewing Orange Book listing practices, as the Federal Trade Commission takes a more aggressive antitrust approach with actions such as the Teva listing probe, and the U.S. Food and Drug Administration calls attention to potentially improper listings, say attorneys at McDermott.
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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.