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Life Sciences
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
Expert Analysis
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Series
Walking With My Dog Makes Me A Better Lawyer
Thanks to my dog Birdie, I've learned that carving out an activity different from the practice of law — like daily outdoor walks that allow you to interact with new people — can contribute to professional success by boosting creativity and mental acuity, as well as expanding your social network, says Sarah Petrie at the Massachusetts Attorney General’s Office.
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Think Like A Lawyer: Follow The Iron Rule Of Trial Logic
Many diligent and eager attorneys include every good fact, point and rule in their trial narratives — spurred by the gnawing fear they’ll be second-guessed for leaving something out — but this approach ignores a fundamental principle of successful trial lawyering, says Luke Andrews at Poole Huffman.
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The Art Of Asking: Leveraging Your Contacts For Referrals
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.
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Trending At The PTAB: Permissible New Reply Arguments
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.
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Wave Of Final Rules Reflects Race Against CRA Deadline
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.
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'Beauty From Within' Trend Poses Regulatory Risks For Cos.
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.
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McKesson May Change How AKS-Based FCA Claims Are Pled
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.
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Series
Being An Equestrian Makes Me A Better Lawyer
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.
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7th Circ. Mootness Fee Case May Curb Frivolous Merger Suits
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.
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Fintiv Denials Are On The Rise At PTAB
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.
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4 Ways To Refresh Your Law Firm's Marketing Strategy
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.
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Cos. Must Prepare For Calif. Legislation That Would Ban PFAS
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.
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FDA Warning Letter Tightens Reins On 'Research Only' Labels
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.
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Practical Pointers After Fed. Circ. Double-Patenting Decision
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.
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Highlights From The 2024 ABA Antitrust Spring Meeting
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.