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Life Sciences
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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.
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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.
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
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Law Firms Should Move From Reactive To Proactive Marketing
Most law firm marketing and business development teams operate in silos, leading to an ad hoc, reactive approach, but shifting to a culture of proactive planning — beginning with comprehensive campaigns — can help firms effectively execute their broader business strategy, says Paul Manuele at PR Manuele Consulting.
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The Regulatory Headwinds Facing Lab-Developed Tests
Though the U.S. Food and Drug Administration's final rule regarding regulation of laboratory-developed tests outlines a four-year plan for ending enforcement discretion, and though this rule is currently being challenged in courts, manufacturers should heed compliance opportunities immediately as enforcement actions are already on the horizon, say attorneys at Kirkland & Ellis.
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3 High Court Rulings May Shape Health Org. Litigation Tactics
Three separate decisions from the U.S. Supreme Court's most recent term — Loper Bright, Corner Post and Jarkesy — will likely strengthen healthcare organizations' ability to affirmatively sue executive agencies to challenge regulations governing operations and enforcement actions, say attorneys at McDermott.
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Opinion
A New Way Forward For COVID Vaccine Lawsuit Immunity
As Public Readiness and Emergency Preparedness Act protections for COVID-19 vaccines wane, adding those vaccines to coverage by the National Vaccine Injury Compensation Program would bolster defenses for administrators and manufacturers while also providing stronger remedies for those injured by vaccines, says Altom Maglio at MCT Law.
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Opinion
The Big Issues A BigLaw Associates' Union Could Address
A BigLaw associates’ union could address a number of issues that have the potential to meaningfully improve working conditions, diversity and attorney well-being — from restructured billable hour requirements to origination credit allocation, return-to-office mandates and more, says Tara Rhoades at The Sanity Plea.
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Opinion
It's Time For A BigLaw Associates' Union
As BigLaw faces a steady stream of criticism about its employment policies and practices, an associates union could effect real change — and it could start with law students organizing around opposition to recent recruiting trends, says Tara Rhoades at The Sanity Plea.
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How Justices Upended The Administrative Procedure Act
In its recent Loper Bright, Corner Post and Jarkesy decisions, the U.S. Supreme Court fundamentally changed the Administrative Procedure Act in ways that undermine Congress and the executive branch, shift power to the judiciary, curtail public and business input, and create great uncertainty, say Alene Taber and Beth Hummer at Hanson Bridgett.
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Parsing FY 2024 DOJ Criminal Healthcare Fraud Enforcement
While the U.S. Department of Justice's Criminal Division's strike force on healthcare fraud enforcement action shows an impressive doubling of criminal indictments, a closer look at the data offers important clues about underlying trends, including the comparably modest, accompanying increase in associated intended loss, say Roderick Thomas and Kathleen Cooperstein at Wiley.
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How Cos. With Chinese Suppliers Should Prep For Biotech Bill
A proposed bill to prohibit government-affiliated life sciences companies from contracting with Chinese biotech companies of concern may necessitate switching to other sources for research and supplies, meaning they should begin evaluating supply chains now due to the long lead times of drug development, say John O'Loughlin and Christina Carone at Weil Gotshal.
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Mirror, Mirror On The Wall, Is My Counterclaim Bound To Fall?
A Pennsylvania federal court’s recent dismissal of the defendants’ counterclaims in Morgan v. Noss should remind attorneys to avoid the temptation to repackage a claim’s facts and law into a mirror-image counterclaim, as this approach will often result in a waste of time and resources, says Matthew Selmasska at Kaufman Dolowich.
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Can Chapter 15 Bankruptcy Help Cannabis Businesses?
Attorneys at Fox Rothschild consider whether Chapter 15 may be used as a tool to liquidate U.S. assets of cannabis companies in foreign bankruptcy proceedings, and look at the statutory provisions that may have a bearing on the successful liquidation of assets under the Bankruptcy Code.
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FTC's Drug Middlemen Probe Highlights Ongoing Scrutiny
The Federal Trade Commission's interim staff report on its inquiry into pharmacy benefit managers suggests that the industry will remain under an enforcement microscope for the foreseeable future due to concerns about how PBMs affect drug costs and accessibility, say attorneys at Arnold & Porter.
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Series
Playing Dungeons & Dragons Makes Me A Better Lawyer
Playing Dungeons & Dragons – a tabletop role-playing game – helped pave the way for my legal career by providing me with foundational skills such as persuasion and team building, says Derrick Carman at Robins Kaplan.
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Del. Dispatch: Director Caremark Claims Need Extreme Facts
The Delaware Court of Chancery recently dismissed Caremark claims against the directors of Centene in Bricklayers Pension Fund of Western Pennsylvania v. Brinkley, indicating a high bar for a finding of the required element of bad faith for Caremark liability, and stressing the need to resist hindsight bias, say attorneys at Fried Frank.
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Parsing NJ Court's Rationale For Denying Lipitor Class Cert.
A New Jersey federal court's recent Lipitor rulings granting summary judgment and denying motions for class certification for two plaintiff classes offer insight into the level of rigorous analysis required by both parties and their experts to satisfy the requirements of class certification, says Catia Twal at Edgeworth Economics.