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Life Sciences
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March 14, 2025
Antigua Clinic Accused Of Lying About 'Miracle' Cancer Cure
A company called ExThera Medical Corp. has been sued in California federal court over a cure, backed by a billionaire investor, marketed for metastatic cancer but was actually a "dangerous medical experiment."
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March 14, 2025
Biotech Wins Dismissal Of Investor Fraud Claims
A Boston federal judge on Friday dismissed a proposed investor class action against biotech Aldeyra Therapeutics Inc., ruling that the lawsuit's facts tend to support innocent explanations for executives' statements about its two drug prospects.
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March 14, 2025
1st Circ. Asked To Look At Takeda Invoice Fraud Conviction
The husband of a former Takeda Pharmaceuticals vice president is appealing his fraud conviction and 2 ½ year prison term over a $2.3 million bogus invoice scheme, according to a Friday notice filed to the First Circuit.
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March 14, 2025
Green Groups Sue Fed. Agencies Over Frozen Funding
Environmental groups are suing five federal government agencies and their leaders, alleging they illegally froze congressionally approved funding and are hampering the organizations' work.
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March 14, 2025
FTC Urges 8th Circ. Not To Pause Insulin Pricing Case
The Federal Trade Commission has urged the Eighth Circuit not to pause its in-house case accusing Caremark Rx, Express Scripts and OptumRx of artificially inflating insulin prices, telling the appeals court the pharmacy benefit managers have no chance of winning on their constitutional claims.
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March 14, 2025
Dr. Oz Pledges 'Upcoding' Crackdown If Confirmed At CMS
Dr. Mehmet Oz told lawmakers he would combat rising healthcare costs by showing there's a "new sheriff in town" opposed to so-called upcoding by Medicare Advantage plans, as he sought support Friday for his nomination to lead the U.S. Centers for Medicare and Medicaid Services.
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March 14, 2025
Colo. Jury Rejects Claims Sterilization Co. Caused Cancer
A Colorado jury Friday morning rejected four women's claims that emissions from a Terumo BCT Inc. medical sterilization plant caused their cancer, finding after a six-week bellwether trial that the company was not negligent in how it handled emissions of a toxic sterilization chemical.
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March 14, 2025
Taxation With Representation: Davis Polk, Paul Weiss
In this week's Taxation With Representation, Mallinckrodt PLC and Endo Inc. combine, Rocket Cos. buys Redfin, and Endo divests its international pharmaceuticals business to Knight Therapeutics Inc.
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March 13, 2025
SEC's Expansion Of Confidential Filings Likely To Spur Deals
The U.S. Securities and Exchange Commission's latest effort to expand companies' ability to confidentially file for more securities offerings during initial stages should accelerate the pace of public issuances, according to capital markets lawyers.
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March 13, 2025
Fed. Circ. Sides With Merck In Reissued Patent Debate
The Federal Circuit isn't buying that a reissued patent was actually "issued" at the time it was originally awarded, dashing generic-drug makers' hopes of breaking pharmaceutical giant Merck's hold on a blockbuster drug that counteracts the effects of anesthesia.
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March 13, 2025
Merck Asks Justices To Block Fosamax Failure-To-Warn Suits
Merck has asked the U.S. Supreme Court to review a Third Circuit ruling that allowed more than 1,000 state-law failure-to-warn claims over its osteoporosis drug Fosamax, arguing that the U.S. Food and Drug Administration's formal rejection of a such a proposed warning label should block such lawsuits under federal law.
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March 13, 2025
Calif. AG Appealing State Limits On Pay-For-Delay Ban
California enforcers are appealing to the Ninth Circuit after a lower court found that a new state law restricting "reverse payment" settlements between brand-name and generic-drug makers cannot be used to regulate deals that were struck outside the state.
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March 13, 2025
Fed. Circ. Dings Antibody Patent App For Lacking Description
The Federal Circuit on Thursday affirmed a decision from top U.S. Patent and Trademark Office officials in a highly watched and technical dispute over an antibody patent application, concluding that preambles for so-called Jepson claims need sufficient written descriptions.
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March 13, 2025
PBMs Tell FTC 5-Month Delay Too Long For In-House Insulin Trial
The nation's "Big Three" pharmacy benefit managers say they want to get to trial in the Federal Trade Commission's administrative suit against them sooner rather than later, arguing that the agency's request for a five-month delay would be too long, but they're open to a three-week postponement.
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March 13, 2025
HHS Calls Back Terminated Attys Clearing Medicare Appeals
The U.S. Department of Health and Human Services on Thursday moved to reinstate about 15 attorneys who were cut loose in recent weeks, restoring staff many in the agency saw as critical to clearing a backlog of Medicare appeals.
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March 13, 2025
9th Circ. Ends Idaho Abortion Law Row After Mutual Dismissal
A Ninth Circuit panel has dropped an appeal from Idaho claiming the state's strict abortion ban doesn't conflict with a federal law protecting emergency abortions, after the Trump administration announced its decision to drop the Biden-era legal challenge.
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March 13, 2025
6 Firms Steer $6.7B Mallinckrodt, Endo Pharma Merger
Six law firms are guiding a $6.7 billion merger between Ireland's Mallinckrodt PLC and Pennsylvania-based Endo Inc. on a deal announced Thursday that the companies said will create a global pharmaceutical industry leader with projected 2025 revenues of $3.6 billion.
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March 13, 2025
Full 4th Circ. Urged To Rethink Drug Price-Fixing Class Action
The Fourth Circuit's dismissal of a proposed class action accusing drug companies of conspiring to inflate the price of a drug for Huntington's disease has deepened a circuit split on proving injury under the Racketeer Influenced and Corrupt Organizations Act, a group of reimbursement recovery entities has said in asking the full court to rethink the ruling.
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March 13, 2025
J&J Unit Drops Noncompete Suit Against Ex-Marketing Exec
Johnson & Johnson's vision unit has agreed to drop its claims against a former marketing director after reaching a settlement on allegations that she breached a noncompete agreement, according to a Thursday order in New Jersey federal court.
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March 13, 2025
Days Into New Role, FDA's Top Lawyer Is Out
The top lawyer of the U.S. Food and Drug Administration resigned just two days after she was selected for the role, according to a Thursday announcement by the agency on social media site X.
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March 13, 2025
Lacking Votes, White House Pulls Weldon Nomination At CDC
The White House pulled Dr. Dave Weldon's nomination to lead the Centers for Disease Control and Prevention on Thursday after support among GOP lawmakers wavered, and it became clear he didn't have the votes to clear a Senate committee.
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March 12, 2025
Cancer Cause Or Red Herring? Jury Weighs Plant Bellwether
A medical sterilization company told a Colorado jury Wednesday that four women can't get millions in damages based on the "possibility" that emissions from a sterilization plant caused their cancer, at the close of a six-week trial in which the plaintiffs argued the company should be punished for its negligence.
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March 12, 2025
Del. Justices Told Conflicts Tainted AstraZeneca Co.'s $3B Sale
A stockholder class attorney told Delaware's Supreme Court on Wednesday that a vice chancellor never addressed the undisclosed conflicts cited in a Court of Chancery suit accusing AstraZeneca PLC of lining up a conflicted, underpriced $3 billion sale of clinical stage biopharmaceutical venture Viela Bio Inc.
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March 12, 2025
Labcorp Warns Fed. Circ. Of 'Balkanization' In Prenatal IP Row
Labcorp, one of the world's largest chains of clinical lab providers, told the full Federal Circuit that a loss it incurred there over a patent tied to a $384 million judgment in Texas was the result of the "balkanization" of the court's patent obviousness jurisprudence.
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March 12, 2025
Law360 Cheat Sheet: Novartis' Fight Over Generic Entresto
Novartis has led a wide-ranging litigation campaign to block generic versions of its bestselling cardiovascular drug Entresto that has involved multidistrict litigation, trips to several circuit courts and cases against the federal government. Here, Law360 breaks down how the various cases intersect and what's still playing out.
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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A Judge's Pointers For Adding Spice To Dry Legal Writing
U.S. District Judge Fred Biery shares a few key lessons about how to go against the grain of the legal writing tradition by adding color to bland judicial opinions, such as by telling a human story and injecting literary devices where possible.
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Preparing For Disruptions To Life Sciences Supply Chains
Life sciences companies must assess how new and escalating tariffs — combined with other restrictions on cross-border activity singling out pharmaceutical products and medical devices — will affect supply chains, and they should proactively prepare for antitrust and foreign direct investment regulatory review processes, say attorneys at Weil.
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Mastering The Fundamentals Of Life Sciences Due Diligence
As life sciences transactions continue to gain tremendous momentum, companies participating in these transactions must conduct effective and strategic regulatory due diligence, which involves extensive amounts of information and varies by manifold factors, says Anna Zhao at GunnerCooke.
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Beware Risks Of Arguing Multiple Constructions In IP Cases
Defendants accused of patent infringement often argue for different, potentially contradictory, claim constructions before district courts and the Patent Trial and Appeal Board, but the board may be clamping down on this strategy, say attorneys at Dechert.
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What's At Stake In High Court Transgender Care Suit
The outcome of U.S. v. Skrmetti will have critical implications for the rights of transgender youth and their access to gender-affirming care, and will likely affect other areas of law and policy involving transgender individuals, including education, employment, healthcare and civil rights, say attorneys at ArentFox Schiff.
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6th Circ. Ruling Paves Path Out Of Loper Bright 'Twilight Zone'
The U.S. Supreme Court’s Loper Bright ruling created a twilight zone between express statutory delegations that trigger agency deference and implicit ones that do not, but the Sixth Circuit’s recent ruling in Moctezuma-Reyes v. Garland crafted a two-part test for resolving cases within this gray area, say attorneys at Wiley.
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A Reminder On Avoiding Improper Venues In Patent Cases
A Texas federal court's recent decision in the Symbology and Quantum cases shows that baseless patent venue allegations may be subject to serious Rule 11 sanctions, providing venue-vetting takeaways for plaintiffs and defendants.
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NIH Cuts To Indirect Costs May Stifle IP Generation
Although currently blocked by a preliminary injunction, the National Institutes of Health's new policy to cut down on indirect cost funding creates challenges for university research projects, and may hamper the development of intellectual property — which is considered an indirect cost — for years to come, say attorneys at Snell & Wilmer.
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Recent Cases Clarify FCA Kickback Pleading Standards
Two recently resolved cases involving pharmaceutical manufacturers may make it more difficult for False Claims Act defendants facing kickback scheme allegations to get claims dismissed for lack of evidence, say Li Yu at Bernstein Litowitz, Ellen London at London & Noar, and Gregg Shapiro at Gregg Shapiro Law.
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Opinion
Antitrust Analysis In Iowa Pathologist Case Misses The Mark
An Iowa federal court erred in its recent decision in Goldfinch Laboratory v. Iowa Pathology Associates by focusing exclusively on market impacts and sidestepping key questions that should be central to antitrust standing analysis, says Daniel Graulich at Baker McKenzie.
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Opinion
State FCAs Should Cover Local Fund Misuse, State Tax Fraud
New Jersey and other states with similar False Claims Acts should amend them to cover misappropriated municipal funding, and state and local tax fraud, which would encourage more whistleblowers to come forward and increase their recoveries, says Kenneth Levine at Stone & Magnanini.
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7 Tips For Associates To Thrive In Hybrid Work Environments
Excerpt from Practical Guidance
As the vast majority of law firms have embraced some type of hybrid work policy, associates should consider a few strategies to get the most out of both their in-person and remote workdays, says James Argionis at Cozen O’Connor.
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Series
Playing Beach Volleyball Makes Me A Better Lawyer
My commitment to beach volleyball has become integral to my performance as an attorney, with the sport continually reminding me that teamwork, perseverance, professionalism and stress management are essential to both undertakings, says Amy Drushal at Trenam.
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What To Expect From 'Make America Healthy Again' Actions
The Make America Healthy Again Commission recently established by President Donald Trump and chaired by Robert F. Kennedy Jr. will potentially bring energy and attention to important public health topics, and stakeholders should be aware of pathways for sharing their input and proactively informing proceedings, says Nicholas Manetto at Faegre Drinker.
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How Law Firms Can Counteract The Loneliness Epidemic
The legal industry is facing an urgent epidemic of loneliness, affecting lawyer well-being, productivity, retention and profitability, and law firm leaders should take concrete steps to encourage the development of genuine workplace connections, says Michelle Gomez at Littler and Gwen Mellor Romans at Herald Talent.