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Life Sciences
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April 02, 2025
CVS Asserts DOJ's Opioid Prescription Suit Lacks Facts
CVS Pharmacy Inc. has told a Rhode Island federal judge that most of the U.S. Department of Justice's claims that it knowingly filed invalid prescriptions for opioids should be tossed, saying the agency failed to adequately allege the company willfully put profits over safety.
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April 02, 2025
Bidi Vapor Says FDA Denial Of E-Cig Was Unlawful
Vape company Bidi Vapor LLC urged the Eleventh Circuit on Wednesday to reverse a U.S. Food and Drug Administration decision denying its application to market a disposable e-cigarette, saying the agency acted unlawfully and ignored evidence the company presented.
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April 02, 2025
Orthodontic Software Co. Hit With Data Breach Class Action
An orthodontic software company has been hit with a proposed class action in Georgia federal court over a November data breach in which the names, birth dates, medical records, insurance information, payment card data and Social Security numbers of its clients' patients were stolen by hackers.
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April 02, 2025
Justices Broaden RICO Reach To Personal Injuries
The U.S. Supreme Court on Wednesday expanded the type of civil actions that can be brought under a federal racketeering statute, asserting that claims stemming from personal injuries are redressable if they can be shown to have caused economic harm.
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April 02, 2025
Supreme Court Backs FDA Block Of Flavored Vapes
The U.S. Supreme Court on Wednesday overruled a determination that the U.S. Food and Drug Administration acted arbitrarily when it rejected an e-cigarette company's applications to market flavored vape products.
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April 01, 2025
FDA Beats Challenge To Approval Of Elanco's Cattle Gas Drug
The U.S. Food and Drug Administration has defeated an administrative challenge to its approval of Elanco Health's drug meant to reduce ammonia gas emissions from beef cattle and their waste, with a California federal judge ruling Tuesday that the agency reasonably evaluated its safety based on a wide array of studies.
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April 01, 2025
Takeda Antitrust Trial Over Actos Generics Set For July
A New York federal court refused a bid from Takeda Pharmaceuticals Co. to escape a long-running case accusing it of unlawfully delaying generic versions of its diabetes treatment Actos and scheduled a trial to start in July.
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April 01, 2025
Fla. Defends Sandoz Price-Fixing Settlement Terms
Florida defended its deal with Sandoz Inc. on Monday, saying the other states suing the generic-drug maker over price-fixing have no right to object to the settlement, which does not require court approval and does not affect the states objecting to it.
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April 01, 2025
Two More Pharmacies Hit With Eli Lilly Weight Loss Drug Suits
Eli Lilly and Co. filed another round of lawsuits Tuesday accusing compounding pharmacies of selling copycat versions of its weight loss and diabetes medications, saying in New Jersey and Delaware federal courts that two online pharmacies are deceiving consumers about their knockoff products.
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April 01, 2025
No Inequitable Conduct From Fresenius Foe, Judge Says
German medical giant Fresenius has failed to convince a Delaware federal judge that any foul play could be found in the prosecution of a patent involved in a fight over selling IV bags filled with calcium supplements, used to treat hypocalcemia.
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April 01, 2025
Ex-Biotech CEO Wrongly Sentenced To 7 Years, DC Circ. Told
A former biotech executive who pled guilty to misleading investors about a blood-based COVID-19 test urged the D.C. Circuit to order a redo of his seven-year prison sentence on Tuesday, telling an appeals panel that the trial court miscalculated the sentencing guidelines.
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April 01, 2025
IBM And J&J Beat 'Speculative' Data Breach Suit, For Now
A New York federal judge has tossed with leave to amend a proposed class action alleging IBM and Johnson & Johnson's healthcare arm failed to safeguard sensitive health information of thousands of patients before a 2023 data breach, finding the purported harm is "entirely speculative" as currently alleged.
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April 01, 2025
Talc Claimants Tell 3rd Circ. Whittaker Couldn't File Ch. 11
Talc injury claimants on Tuesday asked the Third Circuit to dismiss Whittaker Clark & Daniels' Chapter 11 case, saying a South Carolina state judge had given control of the talc supplier to a receiver six weeks before the company filed for bankruptcy.
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April 01, 2025
FDA Cuts Prompt Biotech Players To Rethink Deal Strategies
Funding cuts at the U.S. Department of Health and Human Services are sending ripples of concern through the biotech industry, as attorneys advise companies to consider a wider breadth of strategic alternatives amid fears of regulatory delays.
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March 31, 2025
Texas Judge Deems Lab-Test Rule Outside FDA Authority
A Texas federal judge on Monday vacated a new U.S. Food and Drug Administration rule that would have brought lab-developed tests under its regulatory authority as "medical devices," finding that the move exceeded the agency's statutory authority and defied "common sense."
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March 31, 2025
Former Stimlabs Exec Must Face Trade Secrets Claims
A former biomedical technology company executive must face claims that she absconded with thousands of internal files containing valuable product information in the days and weeks leading up to her ouster last year, a Georgia federal judge ruled.
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March 31, 2025
Ex-Blood Bank Atty Goes Back To Ballard Spahr In Phoenix
Ballard Spahr LLP has picked up a former in-house intellectual property lawyer from nonprofit blood bank Vitalant who had worked at the law firm a little over a decade ago.
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March 31, 2025
Nasdaq's Tighter IPO Rules Raise Bar For Small Companies
Nasdaq is seeking to weed out volatile stocks by tightening listing standards for small companies conducting initial public offerings or uplistings, although lawyers caution that new rules could prompt capital-hungry companies to pursue other listing strategies, including reverse mergers.
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March 31, 2025
Buyer Class Of Surgical Robots Is Certified In Antitrust Fight
A California federal judge on Monday certified a class of thousands of hospitals alleging Intuitive Surgical monopolized the market for robotic surgical tools by blocking third-party repairs and tying services to robot purchases, finding the case raises common antitrust questions that can be resolved on a classwide basis.
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March 31, 2025
J&J Talc Spinoff's Ch. 11 Case Gets Tossed, Erasing $9B Deal
A Texas bankruptcy judge rejected Johnson & Johnson's third attempt to use Chapter 11 to settle thousands of claims that its products caused cancer, dismissing J&J unit Red River Talc's Chapter 11 case on Monday and throwing out a roughly $9 billion bankruptcy deal over issues with the company's voting procedures and third-party releases.
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March 31, 2025
Despite 'Admirable' Effort, Vertex Kickback Challenge Fails
A D.C. federal judge dealt a loss on Monday to gene therapy drugmaker Vertex Pharmaceuticals, ruling in favor of a U.S. Department of Health and Human Services advisory opinion that found the company's fertility preservation program could potentially violate the Anti-Kickback Statute.
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March 31, 2025
Pierson Ferdinand Adds Taylor English Health Pro In Atlanta
Pierson Ferdinand LLP announced Monday that it has hired a former Taylor English Duma LLP partner who specializes in mergers and acquisitions and also has sleep medicine expertise to strengthen its healthcare practice.
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March 31, 2025
Cleary Gains 5-Atty Latham Team Known For Big IP Wins
Cleary Gottlieb Steen & Hamilton LLP has welcomed a bi-coastal team of five intellectual property litigators from Latham & Watkins LLP, lauding their history leading "many of the most high-profile and complex patent and trade secrets cases of the last decade" in a statement Monday.
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March 28, 2025
Colo. Beats Amgen's Drug Price Cap Challenge, For Now
A Colorado federal judge Friday threw out Amgen's challenge to the Centennial State's drug price cap system, finding that Amgen is not subject to "direct regulation" under the law it's challenging and therefore doesn't have standing to sue.
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March 28, 2025
Janssen Owes Additional $1.5B In HIV Prescription Trial
A New Jersey federal judge on Friday added nearly $1.3 billion in penalties and $240 million in damages to a whistleblower False Claims Act verdict against Janssen over the off-label marketing of two HIV medicines, saying trial evidence laid out "a deliberate and calculated scheme."
Expert Analysis
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Fed. Circ. Ruling Shows Importance Of Trial Expert Specificity
The Federal Circuit’s recent ruling in NexStep v. Comcast highlights how even a persuasive expert’s failure to fully explain the basis of their opinion at trial can turn a winning patent infringement argument into a losing one, say attorneys at Barnes & Thornburg.
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Think Like A Lawyer: Note 3 Simple Types Of Legal Complexity
Cases can appear complex for several reasons — due to the number of issues, the volume of factual and evidentiary sources, and the sophistication of those sources — but the same basic technique can help lawyers tame their arguments into a simple and persuasive message, says Luke Andrews at Poole Huffman.
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Justices Mull Sex-Based Classification In Trans Law Case
After the U.S. Supreme Court heard oral argument in U.S. v. Skrmetti this week, it appears that the fate of the Tennessee law at the center of the case — a law banning gender-affirming healthcare for transgender adolescents — will hinge on whether the majority read the statute as imposing a sex-based classification, says Alexandra Crandall at Dickinson Wright.
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Series
Gardening Makes Me A Better Lawyer
Beyond its practical and therapeutic benefits, gardening has bolstered important attributes that also apply to my litigation practice, including persistence, patience, grit and authenticity, says Christopher Viceconte at Gibbons.
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Litigation Inspiration: Reframing Document Review
For attorneys — new ones especially — there is much fulfillment to find in document review by reflecting on how important, interesting and pleasant it can be, says Bennett Rawicki at Hilgers Graben.
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Key Takeaways From FDA's Latest Social Media Warnings
The U.S. Food and Drug Administration's latest untitled letter concerning a drug company's social media promotion provides lessons for how companies should navigate risk presentation, FDA labeling requirements and superiority claims, say attorneys at Sheppard Mullin.
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Expect More State Scrutiny Of PE In Healthcare M&A
While a California bill that called for increased antitrust scrutiny of many healthcare private equity transactions was recently vetoed by the governor, state legislatures are likely to continue introducing similar laws, particularly if the Trump administration eases federal enforcement, say attorneys at Morgan Lewis.
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Declaring Unexpected Results: Pitfalls For Rule 132 At PTAB
Rule 132 declarations are frequently used in life sciences patent prosecution for rebutting obviousness rejections by establishing that an applicant's invention produces unexpected results, and the Patent Trial and Appeal Board's Eidschun ruling highlights when this important tool may be ineffective, say attorneys at Morrison Foerster.
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IP Ruling Likely To Limit Arguments Against Qualified Experts
The Federal Circuit's recent decision in Osseo v. Planmeca, clarifying when experts may offer testimony from the perspective of a skilled artisan, provides helpful guidance on expert qualifications and could quash future timing arguments regarding declarants' expertise, says Whitney Jenkins at Marshall Gerstein.
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How Boards And Officers Should Prep For New Trump Admin
In anticipation of President-elect Donald Trump's proposed tariffs and mass deportation campaign, company officers and board members should pursue proactive, comprehensive contingency planning to not only advance the best interests of the companies they serve, but to also properly exercise their fiduciary duty of care, say attorneys at Winston & Strawn.
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Dissecting The Obviousness-Type Double Patenting Debate
The Federal Circuit's recent decision in Allergan v. MSN highlights the ongoing evolution of the obviousness-type double patenting doctrine, revealing increasing tension between expiration-based interpretations and procedural flexibility, says Jeremy Lowe at Leydig Voit.
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Service Providers Must Mitigate 'Secondary Target' Risks
A lawsuit recently filed in an Illinois federal court against marketing agency Publicis over its work for opioid manufacturers highlights an uptick in litigation against professional service providers hired by clients that engaged in alleged misconduct — so potential targets of such suits should be sure to conduct proper risk analysis and mitigation, say attorneys at Dechert.
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Health Policy Predictions For Trump's Second Administration
As President-elect Donald Trump's nominations for health policy and enforcement heads work their way through the confirmation process, healthcare organizations can look at nominee backgrounds, campaign statements and actions from Trump's previous presidency to predict incoming priorities, say attorneys at McDermott.
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Series
Flying Makes Me A Better Lawyer
Achieving my childhood dream of flying airplanes made me a better lawyer — and a better person — because it taught me I can conquer difficult goals when I leave my comfort zone, focus on the demands of the moment and commit to honing my skills, says Ivy Cadle at Baker Donelson.
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9th Circ.'s High Bar May Limit Keyword Confusion TM Claims
A recent Ninth Circuit ruling that a law firm did not infringe upon a competitor’s trademarks by paying Google to promote its website when users searched for the rival’s name signals that plaintiffs likely can no longer win infringement suits by claiming competitive keyword advertising confuses internet-savvy consumers, say attorneys at Mitchell Silberberg.