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Life Sciences
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October 30, 2024
Biopharma Co. Can't Knock Ex-CFO's Bias Suit Out Of Court
A biopharmaceutical development company can't kick a fired executive's bias suit to arbitration, a California federal judge said, ruling that the harassment she said she faced on the job was gendered enough to invoke a federal law curbing out-of-court-resolutions of sex harassment claims.
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October 30, 2024
Ex-Takeda Exec. Gets Nearly 4 Years For Fake Invoice Scam
A former Takeda Pharmaceuticals executive was sentenced Wednesday to 46 months in prison for stealing millions from the drug company through a fake invoice scam that a Boston federal judge characterized as "utterly unnecessary and pointless" and carried out for no other reason than to fund a luxurious lifestyle.
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October 30, 2024
Yale Researcher's Suit Over Loss Of 'Life's Work' Transferred
A Connecticut state court judge in Fairfield is passing on a researcher's lawsuit accusing Yale School of Medicine of destroying two decades of research worth $28 million, transferring the case to the complex litigation docket in Hartford.
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October 30, 2024
Ohio PBM Case Will Wait For High Court Ruling
The Sixth Circuit agreed to pause a case from Ohio state enforcers accusing Express Scripts and Prime Therapeutics of driving up prescription drug prices while the U.S. Supreme Court decides another case dealing with federal versus state jurisdiction.
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October 30, 2024
DLA Piper's FDA Regulation Vice Chair Joins White & Case
The former vice chair of DLA Piper's FDA regulatory practice has joined White & Case LLP's global life sciences and healthcare group and intellectual property practice.
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October 29, 2024
NY Judge Tosses $14B Decongestant MDL
A New York federal judge threw out a streamlined complaint in a multidistrict litigation accusing companies such as Target and Bayer of making and selling ineffective over-the-counter decongestants, finding Tuesday the state claims are expressly preempted, and the proposed class lacks standing on a federal racketeering claim as indirect purchasers.
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October 29, 2024
Y-mAbs Therapeutics Investors Get Final OK For $19.7M Deal
A New York federal judge has granted final approval to a $19.7 million settlement between Y-mAbs Therapeutics and investors who claim the company misrepresented the likelihood that the U.S. Food and Drug Administration would approve the company's signature pediatric nerve cancer treatment, giving class counsel a $6.5 million cut of the deal.
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October 29, 2024
Retired Fed. Circ. Judge Backs Invisalign In Monopoly Cases
Retired Federal Circuit Judge Paul R. Michel warned the Ninth Circuit on Tuesday that reversing a lower court's decision to toss a pair of class actions accusing Invisalign of monopolizing the clear braces and teeth scanners market by illegally refusing to deal with a rival would increase patent owners' legal uncertainties.
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October 29, 2024
Patent Partner Moves From King & Spalding To Steptoe
A former King & Spalding LLP partner has made the jump to Steptoe LLP, filling out the firm's team of California-based litigators who take on patent cases.
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October 29, 2024
4th Circ. Quizzes Drugmaker Challenging W.Va. Abortion Law
An attorney arguing that West Virginia is preempted by federal law from restricting access to an abortion medication faced skeptical questions Tuesday from two judges who suggested it's entirely normal for states to regulate the practice of medicine.
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October 29, 2024
Biopharma Co. Escapes Investor Suit Over Drug Approval Lies
Biopharmaceutical company Spero Therapeutics Inc. has escaped a proposed investor class action accusing it of concealing warning signs that it would not secure regulatory approval of one of its drugs, with the court ruling that Spero's interactions with the U.S. Food and Drug Administration do not indicate Spero should have known its application would be rejected.
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October 29, 2024
Medical Co. Gets No Coverage For Toxic Tort
An insurer for B. Braun Medical Inc. has no duty to defend or indemnify the company against numerous lawsuits accusing B. Braun of exposing residents near one of its medical device manufacturing plants to a carcinogenic gas, a Pennsylvania federal court ruled, finding a pollution exclusion applicable.
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October 29, 2024
Investors Float $21M Deal To End Life Sciences SPAC Suit
Shareholders in special purpose acquisition company CM Life Sciences Holdings have reached a tentative $21 million class settlement in Delaware's Court of Chancery after suing over alleged missing or misleading disclosures in the lead-up to the take-public merger of clinical data and genomics company Sema4 Holdings in July 2021.
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October 29, 2024
Beyond Abortion, 7 Ballot Questions Set To Shape Care
While reproductive rights have led the healthcare debate this election season, voters across the country will shape state policies on a number of other hot issues, including a Medicaid work requirement and coverage for IVF. Law360 Healthcare Authority looks at seven ballot measures that go beyond abortion.
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October 29, 2024
Allergan, Mankind Settle IP Fight Over Lumigan Generic
Allergan Inc. and Mankind Pharma Ltd. asked a Delaware federal court Tuesday to dismiss infringement litigation over Mankind's proposed generic of Allergan's glaucoma drug Lumigan, stipulating that the patent is valid and has been infringed.
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October 29, 2024
Purdue Creditors Can Sue Sacklers For $11.5B
Creditors of bankrupt OxyContin maker Purdue Pharma LP will get the right to sue the company's owners — certain members of the Sackler family — and others for $11.5 billion, should they choose to do so, a New York judge said on Tuesday.
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October 29, 2024
Pa. DA Says ATF's Pot Patients Ban Doesn't Fit With Bruen
A Pennsylvania district attorney is urging a federal judge not to throw out his suit challenging a Bureau of Alcohol, Tobacco, Firearms and Explosives policy blocking medical cannabis patients from buying or owning firearms, saying the U.S. Supreme Court's recent precedent preempts the restriction.
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October 29, 2024
Senate Panel Targets 'Clever' Pharma Pricing
The Senate Judiciary Committee on Tuesday railed against drugmakers and pharmacy benefit managers for allegedly causing the high cost of prescription drugs, arguing that "Big Pharma" has used anticompetitive tactics through patenting to fleece American patients.
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October 29, 2024
Circuit Judge Rips Atty's 'Unearned Windfall' In Liability Case
Although the Sixth Circuit has affirmed a decision awarding roughly $353,000 to a Texas attorney in a decadelong fee dispute over his representation of a client in a product liability case, one circuit judge expressed "extreme disapproval" over the lawyer's conduct in the matter.
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October 29, 2024
Crescent Inks Oncology Merger With $200M In Private Funding
Crescent Biopharma Inc. has agreed to take fellow cancer-focused biotech GlycoMimetics Inc. private in a deal that includes $200 million of investments from well over a dozen firms to help fund the combined company's operations through 2027, GlycoMimetics revealed Tuesday.
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October 29, 2024
PE-Owned Implant Maker Plagued By Lawsuits Hits Ch. 11
Joint implant maker Exactech Inc. on Tuesday filed for Chapter 11 protection in Delaware bankruptcy court with an offer from its lenders to take over the company, as a wave of lawsuits tied to product recalls weighs on the private equity-owned firm.
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October 28, 2024
Masimo Sues Founder Over Alleged 'Empty Voting' Scheme
Masimo Corp. has sued its founder for allegedly conspiring with an investment firm and company stockholder to manipulate a shareholder vote in order to maintain his seat on the medical technology company's board of directors.
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October 28, 2024
Sterigenics Says Residents Can't Tie Harms To Ethylene Oxide
Medical sterilization company Sterigenics US LLC and its parent, Sotera Health LLC, are asking a Georgia state judge to exclude expert testimony put forward by Peach State residents alleging their ethylene oxide emissions harmed them, and to dismiss the residents' claims against them.
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October 28, 2024
Flint Bellwether Delayed On Eve Of Trial, Again
A Michigan federal judge delayed Monday a bellwether trial set to determine if a water engineering firm was professionally negligent for its role in the Flint water crisis one day before jury selection was scheduled to begin and without explanation.
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October 28, 2024
Judge Leaves Patent Case After Fed. Circ. Undoes Ruling
A Minnesota federal judge has recused himself from a patent dispute between Teleflex and Medtronic he has handled since 2019, saying he was "at a loss" on how to proceed after the Federal Circuit faulted his interpretation of terms in Teleflex's catheter patents.
Expert Analysis
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FTC Focus: How Scrutiny Of PBMs And Insulin May Play Out
Should Express Scripts' recent judicial challenge to the Federal Trade Commission succeed, any new targets could add litigation and choice of forum to their playbooks, and potential FTC court action on insulin could be forced to parallel venues as the issues between the commission and PBMs evolve, say attorneys at Proskauer.
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Opinion
AI May Limit Key Learning Opportunities For Young Attorneys
The thing that’s so powerful about artificial intelligence is also what’s most scary about it — its ability to detect patterns may curtail young attorneys’ chance to practice the lower-level work of managing cases, preventing them from ever honing the pattern recognition skills that undergird creative lawyering, says Sarah Murray at Trialcraft.
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Series
Round-Canopy Parachuting Makes Me A Better Lawyer
Similar to the practice of law, jumping from an in-flight airplane with nothing but training and a few yards of parachute silk is a demanding and stressful endeavor, and the experience has bolstered my legal practice by enhancing my focus, teamwork skills and sense of perspective, says Thomas Salerno at Stinson.
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And Now A Word From The Panel: The MDL Map
An intriguing yet unpredictable facet of multidistrict litigation practice is venue selection for new MDL proceedings, and the Judicial Panel on Multidistrict Litigation considers many factors when it assigns an MDL venue, says Alan Rothman at Sidley Austin.
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Navigating Restrictions Following Biotech Bill House Passage
Ahead of the BIOSECURE Act’s potential enactment, companies that obtain equipment from certain Chinese biotechnology companies should consider whether the act would restrict their ability to enter into contracts with the U.S. government and what steps they might take in response, say attorneys at Ropes & Gray.
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Why Now Is The Time For Law Firms To Hire Lateral Partners
Partner and associate mobility data from the second quarter of this year suggest that there's never been a better time in recent years for law firms to hire lateral candidates, particularly experienced partners — though this necessitates an understanding of potential red flags, say Julie Henson and Greg Hamman at Decipher Investigative Intelligence.
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A Look At The Economic Impact Of Drug Patent Differentiation
Given the Federal Trade Commission’s recent emphasis on unfair competition based on disputed patent listings, pharmaceutical market participants are likely to require nuanced characterizations of actual and but-for market competition when multiple patents differentiate multiple products, say economists at Competition Dynamics.
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Considering Possible PR Risks Of Certain Legal Tactics
Disney and American Airlines recently abandoned certain litigation tactics in two lawsuits after fierce public backlash, illustrating why corporate counsel should consider the reputational implications of any legal strategy and partner with their communications teams to preempt public relations concerns, says Chris Gidez at G7 Reputation Advisory.
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It's No Longer Enough For Firms To Be Trusted Advisers
Amid fierce competition for business, the transactional “trusted adviser” paradigm from which most firms operate is no longer sufficient — they should instead aim to become trusted partners with their most valuable clients, says Stuart Maister at Strategic Narrative.
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Vertex Suit Highlights Issues For Pharma Fertility Support
Vertex Pharmaceuticals' recent lawsuit challenging the U.S. Department of Health and Human Services' interpretation of the Anti-Kickback Statute is influenced by a number of reproductive rights and health equity issues that the Office of Inspector General should address more concretely, including in vitro fertilization and fertility preservation programs, says Mary Kohler at Kohler Health Law.
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Opinion
CMS' New 'Breakthrough' Device Policy Shows Little Promise
The Centers for Medicare & Medicaid Services’ recent procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices will, at best, be a failed experiment and, at worst, result in Medicare beneficiaries denied access to innovative treatments, say attorneys at King & Spalding.
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New Lessons On Managing Earnout Provision Risks
Earnout provisions can be a useful tool for bridging valuation gaps in M&A, particularly in developmental-stage pharmaceutical transactions, but the Delaware Chancery Court’s recent decision in Shareholder Representative Services v. Alexion sheds new light on the inherent risks and best practices for managing them, say attorneys at Cleary.
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3 Patent Considerations For America's New Quantum Hub
Recent developments signal an incredibly bright future for Chicago as the new home of quantum computing, and it is crucial that these innovators — whose technology has the potential to transform many industries — prioritize intellectual property strategy, says Andrew Velzen at McDonnell Boehnen.
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A Preview Of AI Priorities Under The Next President
For the first time in a presidential election, both of the leading candidates and their parties have been vocal about artificial intelligence policy, offering clues on the future of regulation as AI continues to advance and congressional action continues to stall, say attorneys at Mintz.
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How Companies Are Approaching Insider Trading Policies
An analysis of insider trading policies recently disclosed by 49 S&P 500 companies under a new U.S. Securities and Exchange Commission rule reveals that while specific provisions vary from company to company, certain common themes are emerging, say attorneys at Gibson Dunn.