Life Sciences

  • 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.

  • 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. 

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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. 

  • August 20, 2024

    A Deep Dive Into Law360 Pulse's 2024 Women In Law Report

    The legal industry continues to see incremental gains for female lawyers in private practice in the U.S., according to a Law360 Pulse analysis, with women now representing 40.6% of all attorneys and 51% of all associates.

  • August 20, 2024

    These Firms Have The Most Women In Equity Partnerships

    The legal industry still has a long way to go before it can achieve gender parity at its upper levels. But these law firms are performing better than others in breaking the proverbial glass ceiling that prevents women from attaining leadership roles.

  • August 20, 2024

    J&J Boosting Cardio Portfolio With Up To $1.7B V-Wave Buy

    Johnson & Johnson said Tuesday it has agreed to acquire V-Wave Ltd., the maker of an implant device that aims to treat heart failure, for up to $1.7 billion as it looks to bolster its cardiovascular disease portfolio.

  • August 19, 2024

    TPG Dumped Opioid Co. On 'Unsuspecting' Endo, Suit Says

    After pushing Par Pharmaceutical to grow its market share in generic opioids and disregard federal requirements to report suspicious orders, TPG Capital saw other opioid manufacturers being inundated with litigation and sold Par to "an unsuspecting" Endo International PLC, according to a lawsuit filed in New York bankruptcy court.

  • August 19, 2024

    Biogen Paid To Help Curb Generic Tecfidera Sales, Says Suit

    Biogen illegally impaired competition for its multiple sclerosis drug Tecfidera by paying major pharmacy benefit managers to prioritize the brand over generics while it worked to shift the market to a different version of the medication, a multi-employer welfare plan alleged Friday.

  • August 19, 2024

    NuVasive Beats Fraudulent Inducement Claim At Trial

    A Delaware federal jury has rejected a physician's claim that NuVasive Inc. fraudulently induced him to enter into a 2014 agreement related to patents he owns for spinal implant system components — but also rejected the medical device manufacturer's claim that the doctor had breached the deal by suing.

  • August 19, 2024

    9th Circ. Told Psilocybin Petition Is Backed By Precedent

    A Ninth Circuit panel on Monday dissected opposing arguments from the U.S. Drug Enforcement Administration and a Seattle doctor over whether there is precedent to allow the dispensing of psilocybin — a psychedelic compound — to treat terminally ill patients.

  • August 19, 2024

    Jadex Sells Temperature-Controlled Packaging Biz For $137M

    Material sciences company Jadex Inc. is selling its temperature-controlled packaging products business Lifoam Industries LLC to Altor Solutions, led by Gibson Dunn & Crutcher LLP, in a $137 million cash deal, the parties announced in separate Monday statements.

  • August 19, 2024

    Second Pharmacist To Avoid Meningitis Murder Trial

    A pharmacist charged with murder in a deadly fungal meningitis outbreak that killed dozens of people is expected to plead no contest to involuntary manslaughter charges this week, averting a Michigan trial that had been set for November.

  • August 19, 2024

    Pennsylvania Litigation Highlights Of 2024: A Midyear Report

    Pennsylvania courts have been the scene of several explosive cases in the first half of 2024, including one that produced an astronomical $2.25 billion verdict against Bayer AG unit Monsanto in the Roundup mass tort unfolding in the Philadelphia County Court of Common Pleas.

  • August 19, 2024

    Israeli Co. Sues NC Packaging Firm For Severing $25M Deal

    An Israeli smart packaging company is suing North Carolina-based Sealed Air Corp. for allegedly backing out of a $25 million contract for smart sensors, saying Sealed Air lied about their progress developing the product and invented defects to tank the deal.

  • August 19, 2024

    Biotech Consultant Sues Ex-Partner To Force $2.5M Share Buy

    Life sciences consulting firm BioPoint is asking a Massachusetts judge to order a former partner to sell back $2.5 million worth of shares in the closely held company following his ouster, according to a lawsuit filed in state court.

  • August 16, 2024

    Fed. Circ. Quells Fears Over Double-Patenting Overreach

    A recent Federal Circuit decision finding patent claims licensed by Allergan were not invalid for obviousness-type double patenting provided relief to attorneys who were concerned the court had made it easier to invalidate patents that had extended expiration dates to make up for regulatory delays.

  • August 16, 2024

    Humana To Pay $90M To End 8-Year Medicare Drug FCA Battle

    Humana Inc. has agreed to pay the federal government $90 million to settle long-running False Claims Act allegations it submitted fraudulent bids for Medicare prescription drug deals, Phillips & Cohen LLP said Friday in announcing the "first case of its kind" to resolve allegations of fraud in the Medicare Part D contracting process.

Expert Analysis

  • The Art Of Asking: Leveraging Your Contacts For Referrals

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    Though attorneys may hesitate to ask for referral recommendations to generate new business, research shows that people want to help others they know, like and trust, so consider who in your network you should approach and how to make the ask, says Rebecca Hnatowski at Edwards Advisory.

  • Trending At The PTAB: Permissible New Reply Arguments

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    In the time since the Federal Circuit’s Axonics ruling, the Patent Trial and Appeal Board has allowed petitioners to raise new unpatentability grounds in response to unforeseeable claim constructions in petitions, and reiterated that a petition need not anticipate every argument that may be raised in the response, say Joseph Myles and Timothy May at Finnegan.

  • Wave Of Final Rules Reflects Race Against CRA Deadline

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    The flurry of final rules now leaping off the Federal Register press — some of which will affect entire industries and millions of Americans — shows President Joe Biden's determination to protect his regulatory legacy from reversal by the next Congress, given the impending statutory look-back period under the Congressional Review Act, say attorneys at Jenner & Block.

  • 'Beauty From Within' Trend Poses Regulatory Risks For Cos.

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    Companies capitalizing on the current trend in oral supplements touting cosmetic benefits must note that a product claim that would be acceptable for an externally applied cosmetic may draw much stronger scrutiny from the U.S. Food and Drug Administration when applied to a supplement, say Natalie Rainer and Katherine Staba at K&L Gates.

  • McKesson May Change How AKS-Based FCA Claims Are Pled

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    The Second Circuit’s analysis in U.S. v. McKesson, an Anti-Kickback Statute-based False Claims Act case, provides guidance for both relators and defendants parsing scienter-related allegations, say Li Yu at Dicello Levitt, Ellen London at London & Stout, and Erica Hitchings at Whistleblower Law.

  • Series

    Being An Equestrian Makes Me A Better Lawyer

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    Beyond getting experience thinking on my feet and tackling stressful situations, the skills I've gained from horseback riding have considerable overlap with the skills used to practice law, particularly in terms of team building, continuing education, and making an effort to reset and recharge, says Kerry Irwin at Moore & Van Allen.

  • 7th Circ. Mootness Fee Case May Curb Frivolous Merger Suits

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    On April 15, the Seventh Circuit in Jorge Alcarez v. Akorn Inc. mapped out a framework for courts to consider mootness fees paid to individual shareholders after the voluntary dismissal of a challenge to a public company merger, which could encourage objections to mootness fees and reduce the number of frivolous merger challenges filed, say attorneys at Skadden.

  • Fintiv Denials Are On The Rise At PTAB

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    Following last year's CommScope v. Dali decision, the Patent Trial and Appeal Board is increasingly using Fintiv factors to discretionarily deny inter partes review petitions — and attorneys ignore it at their peril, say Josepher Li and Michelle Armond at Armond Wilson.

  • 4 Ways To Refresh Your Law Firm's Marketing Strategy

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    With many BigLaw firms relying on an increasingly obsolete marketing approach that prioritizes stiff professionalism over authentic connection, adopting a few key communications strategies to better connect with today's clients and prospects can make all the difference, say Eric Pacifici and Kevin Henderson at SMB Law.

  • Cos. Must Prepare For Calif. Legislation That Would Ban PFAS

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    Pending California legislation that would ban the sale or distribution of new products containing intentionally added per- and polyfluoroalkyl substances could affect thousands of businesses — and given the bill's expected passage, and its draconian enforcement regime, companies must act now to prepare for it, say attorneys at Alston & Bird.

  • FDA Warning Letter Tightens Reins On 'Research Only' Labels

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    A recent warning letter from the U.S. Food and Drug Administration to Agena Bioscience alleged the company’s diagnostic devices were labeled for research use only, but improperly promoted for human clinical purposes, signifying a reinforcement — and a potential narrowing — of the agency's policy on products labeled “research only,” say attorneys at Sheppard Mullin.

  • Practical Pointers After Fed. Circ. Double-Patenting Decision

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    With the Federal Circuit recently denying a full court review of In re: Cellect, a decision regarding obviousness-type double-patenting, affected patent family holders should evaluate their rights through both patent prosecution and future litigation lenses to minimize risks, say Austin Lorch and Jeff Wolfson at Haynes Boone.

  • Highlights From The 2024 ABA Antitrust Spring Meeting

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    U.S. merger enforcement and cartels figured heavily in this year's American Bar Association spring antitrust meeting, where one key takeaway included news that the Federal Trade Commission's anticipated changes to the Hart-Scott-Rodino form may be less dramatic than many originally feared, say attorneys at Freshfields.

  • Strategies For Challenging A Fla. Grand Jury Report's Release

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    A Florida grand jury’s recent report on potential wrongdoing related to COVID-19 vaccines should serve as a reminder to attorneys to review the myriad legal mechanisms available to challenge the lawfulness of a grand jury report’s publication and expunge the names of their clients, says Cary Aronovitz at Holland & Knight.

  • Patent Lessons From 8 Federal Circuit Reversals In March

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    A number of Federal Circuit patent decisions last month reversed or vacated underlying rulings, providing guidance regarding the definiteness of a claim that include multiple limitations of different scopes, the importance of adequate jury instruction, the proper scope of the precedent, and more, say Denise De Mory and Li Guo at Bunsow De Mory.

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