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Life Sciences
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May 17, 2024
Allergan Says Deserted Drug Rule Weakens $680M Fraud Suit
Allergan drew a Maryland federal court's attention to the Centers for Medicare & Medicaid Services' abandonment of a regulation clarifying drug pricing, arguing the move undermined a whistleblower's claims that it overcharged Medicaid by over $680 million.
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May 17, 2024
Patent Office Gets Another Earful About 'March-In' Plan
Industry groups of all stripes have lined up at the U.S. Patent and Trademark Office to complain yet again about a Biden administration proposal from last year to potentially use "march-in" rights and seize pharmaceutical patents using the Bayh-Dole Act.
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May 17, 2024
Pfizer Unit Wins $107.5M Patent Verdict Against AstraZeneca
A Delaware federal jury on Friday said that AstraZeneca Pharmaceuticals LP should pay $107.5 million in royalty damages for infringing a Pfizer-brand cancer treatment patent, although a final decision won't be issued until after a bench trial on some of AstraZeneca's additional defenses.
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May 17, 2024
FCA Relators Seek Finders Fee For SpineFrontier Doc Deals
Three whistleblowers who tipped off the federal government to a medical device company's multimillion-dollar kickback scheme said Friday the Justice Department is refusing to pay them a cut of the $3 million in False Claims Act settlements paid by surgeons who admitted participating in the sham consulting ploy.
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May 17, 2024
Judge Won't Bar Thermo Fisher Exec's Jump To Repligen
A Massachusetts judge won't block a former Thermo Fisher Scientific executive from jumping to smaller rival Repligen, calling a noncompete agreement signed by the employee overbroad and suggesting that it was really aimed at stifling competition in a ruling released Friday.
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May 17, 2024
EndoStim Emerges From Delaware Insolvency Proceeding
Delaware's Court of Chancery has approved the final accounting for medical device company EndoStim Inc.'s state-administered insolvency proceeding after no creditor or other party raised any objections at a final hearing on Friday.
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May 17, 2024
Industry Emboldened After Justices Galvanize Agency Attacks
In the year since the U.S. Supreme Court said "extraordinary" and "far-reaching" attacks on administrative enforcers can skip agency tribunals and go straight to federal district court, ambitious challenges to regulatory powers are rapidly gaining traction, and the high court is poised to put them on an even firmer footing.
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May 17, 2024
Texas Justices Let Fen-Phen Atty Malpractice Fight Roll On
The Texas Supreme Court ruled Friday that roughly 4,000 former clients of a Houston mass tort lawyer can continue pressing their claims that the lawyer improperly kept millions of dollars in fen-phen diet drug settlement money.
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May 17, 2024
Winston & Strawn Leads Asia-Focused SPAC $100M IPO
Shares of RF Acquisition II, a special-purpose acquisition company targeting the technology sector in Asia, began trading publicly on Friday following the company's $100 million initial public offering.
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May 17, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen a wave of claims filed against Verity Trustees Ltd., Harley-Davidson hit retailer Next with an intellectual property claim, Turkish e-commerce entrepreneur Demet Mutlu sue her ex-husband and Trendyol co-founder Evren Üçok and the Solicitors Regulation Authority file a claim against the former boss of collapsed law firm Axiom. Here, Law360 looks at these and other new claims in the U.K.
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May 16, 2024
Ointment Scheme Conned Gov't Out Of Millions, Fla. Suit Says
Two Florida brothers and one of their former employees are accused of running a years-long fraudulent scheme billing government healthcare programs and receiving millions of dollars after paying kickbacks to generate prescriptions for ointments that were not needed, according to a False Claims Act lawsuit.
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May 16, 2024
3rd Circ. Shuns Teva's 'Novel' Appeal On Israeli Investor Class
The Third Circuit on Thursday turned away an appeal brought by Teva Pharmaceutical Industries Ltd., saying the class certification stage was not the right time to hear arguments over the "novel" question of the applicability of U.S. securities laws to Israeli-listed shares.
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May 16, 2024
FTC Deputy Director Rao On Healthcare Antitrust Agenda
The reason behind the Federal Trade Commission's changed attitude toward antitrust in healthcare in recent years isn't simple, according to Rahul Rao, deputy director of the FTC's Bureau of Competition.
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May 16, 2024
NJ Judge Scrutinizes J&J Unit's Libel Claim Over Talc Study
A bankrupt Johnson & Johnson unit's libel claims over a scientific article linking talcum powder to mesothelioma intrigued a New Jersey federal judge during an oral argument on Thursday, prompting her to muse that the author's consideration of other exposures seemed to bolster the study at issue.
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May 16, 2024
IQVIA To Pay $3.5M To Resolve Ex-Workers' 401(k) Suit
Healthcare technology company IQVIA agreed to pay $3.5 million to end a 9,000-member class action accusing it of choosing investments that consistently underperformed and had excessive risk and expense for its $1.13 billion 401(k) plan, a filing in North Carolina federal court said.
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May 16, 2024
Ex-Pharma Exec Cops To Contempt For Barred Finance Work
A Boston federal judge on Thursday accepted a former pharmaceutical company executive's guilty plea to a criminal contempt charge for using an alias to work on a finance venture despite a U.S. Securities and Exchange Commission ban.
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May 16, 2024
Gilead, Teva Want 17 HIV Drug Antitrust Appeals Consolidated
Gilead Sciences Inc. and Teva Pharmaceuticals are asking the Ninth Circuit to consolidate 17 appeals contesting their win in a case alleging they delayed generic versions of HIV medications, saying the three groups of buyers are raising largely the same issues but refuse to commit to combining their briefs.
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May 16, 2024
Pa. Pot Co. Says No Deal To Breach In Growth IP Suit
A Pennsylvania cannabis cultivator is asking a federal court to dismiss a suit claiming it broke an oral agreement with a consulting firm and continued to use the firm's trade secrets, saying no oral contract existed, nor was the firm's information trade secrets.
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May 16, 2024
$5.5M Apotex Generic Drug Price-Fixing Deal Gets Initial OK
A Pennsylvania federal judge gave preliminary approval to yet another settlement in the sweeping generic drug price-fixing multidistrict litigation, this time signing off on pharmaceutical company Apotex's $5.5 million settlement with clinics, hospitals and independent pharmacies.
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May 16, 2024
HUD Calls Pa. Medical Marijuana Housing Suit Premature
A Pennsylvania housing authority and two would-be residents acted hastily in suing the U.S. Department of Housing and Urban Development, since HUD hadn't formally threatened to pull the authority's funding over a state court order to offer assistance to medical marijuana users, a HUD lawyer told a federal judge Thursday.
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May 16, 2024
Biden Admin Proposes To Loosen Restrictions On Marijuana
President Joe Biden on Thursday announced that his administration has formally recommended relaxing restrictions on marijuana, marking the most significant federal policy shift on cannabis since the drug was criminalized more than 50 years ago.
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May 15, 2024
'Excellent' Altria MDL Deal Earns Attys Fees Above Benchmark
A California federal judge on Wednesday awarded $13.65 million in plaintiffs' attorney fees as part of tobacco giant Altria's $45.5 million deal resolving consumer claims in multidistrict litigation alleging the company helped fuel a youth vaping crisis created by e-cigarette maker Juul, saying the "excellent result" merited fees above the normal 25% benchmark.
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May 15, 2024
Lilly Lands Default ITC Order Against Weight Loss Copycats
The U.S. International Trade Commission voted on Wednesday to give Eli Lilly a default win against the remaining companies in the drugmaker's trademark case surrounding its highly popular, billion-dollar weight loss drugs.
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May 15, 2024
Feds, Pesticide Cos. Seek More Time To Find Mediator
The Federal Trade Commission and agricultural chemical companies Syngenta and Corteva are seeking extra time to select a mediator as they litigate claims that the manufacturers leverage loyalty programs to suppress competition from cheaper generic pesticides.
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May 15, 2024
Anthem Blue Cross Owes $3.8M For COVID Tests, Lab Says
Anthem Blue Cross Blue Shield of Connecticut should be forced to pay nearly $3.8 million for medical laboratory work, including COVID-19 tests, that the insurer either denied, underpaid or failed to acknowledge, according to a federal lawsuit by a New Jersey-based company with facilities in Pennsylvania.
Expert Analysis
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Reducing The Risk Of PFAS False Advertising Class Actions
A wave of class actions continues to pummel products that allegedly contain per- or polyfluoroalkyl substances, with plaintiffs challenging advertising that they say misleads consumers by implying an absence of PFAS — but there are steps companies can take to minimize risk, say attorneys at Keller and Heckman.
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Series
Coaching High School Wrestling Makes Me A Better Lawyer
Coaching my son’s high school wrestling team has been great fun, but it’s also demonstrated how a legal career can benefit from certain experiences, such as embracing the unknown, studying the rules and engaging with new people, says Richard Davis at Maynard Nexsen.
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Opinion
New Rule 702 Helps Judges Keep Bad Science Out Of Court
A court's recent decision to exclude dubious testimony from the plaintiffs' experts in multidistrict litigation over acetaminophen highlights the responsibility that judges have to keep questionable scientific evidence out of courtrooms, particularly under recent amendments to Federal Rule of Evidence 702, says Sherman Joyce at the American Tort Reform Association.
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SG's Office Is Case Study To Help Close Legal Gender Gap
As women continue to be underrepresented in the upper echelons of the legal profession, law firms could learn from the example set by the Office of the Solicitor General, where culture and workplace policies have helped foster greater gender equality, say attorneys at Ocean Tomo.
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Opinion
Patent Waiver For COVID Meds Would Harm US Biopharma
If the Biden administration backs the World Trade Organization in waiving patent rights on COVID-19 treatments, it would negatively affect the U.S. biopharmaceutical industry and help foreign competitors, without necessarily expanding global access to COVID-19 care, says clinical pathologist Wolfgang Klietmann.
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Skirting Anti-Kickback Causation Standard Amid Circuit Split
Amid the federal circuit court split over the causation standard applicable to False Claims Act cases involving Anti-Kickback Statute violations, which the First Circuit will soon consider in U.S. v. Regeneron, litigators aiming to circumvent the heightened standard should contemplate certain strategies, say Matthew Modafferi and Terence Park at Frier Levitt.
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10 Lessons From A Deep Dive Into IP Damages
Decisions on challenging an intellectual property expert's opinion can benefit from the in-depth study of court rulings on admissibility grounds, where the findings include the fact that patent cases see the most challenges of any IP area, say Deepa Sundararaman and Cleve Tyler at Berkeley Research.
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What Shareholder Approval Rule Changes Mean For Cos.
The U.S. Securities and Exchange Commission recently approved proposed rule changes to shareholder requirements by the New York Stock Exchange, an approval that will benefit listed companies in many ways, including by making it easier to raise capital from passive investors, say attorneys at Baker Botts.
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Reimagining Law Firm Culture To Break The Cycle Of Burnout
While attorney burnout remains a perennial issue in the legal profession, shifting post-pandemic expectations mean that law firms must adapt their office cultures to retain talent, say Kevin Henderson and Eric Pacifici at SMB Law Group.
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Expediting Psychedelics Approvals In The EU, UK, Australia
Accelerated pathways for regulatory approvals for psychedelic drugs in the European Union, U.K. and Australia is indispensable to facilitate a seamless advancement of treatments from the research environment to the consumer, say Kimberly Chew at Husch Blackwell, and Ana Dukic and Sabrina Ramkellawan at AxialBridge.
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Series
ESG Around The World: Brazil
Environmental, social and governance issues have increasingly translated into new legislation in Brazil since 2020, and in the wake of these recently enacted regulations, we are likely to see a growing number of legal disputes in the largest South American country related to ESG issues such as greenwashing if companies are not prepared to adequately adapt and comply, say attorneys at Mattos Filho.
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Opinion
Gilead Ruling Signals That Innovating Can Lead To Liability
A California appeals court's ruling last month in Gilead Life Sciences v. Superior Court of San Francisco that a drug manufacturer can be held liable for delaying the introduction of an improved version of its medication raises concerns about the chilling effects that expansive product liability claims may have on innovation, says Gary Myers at the University of Missouri School of Law.
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Opinion
Vidal Should Amend USPTO Precedent In Automaker Review
U.S. Patent and Trademark Office Director Kathi Vidal's recent decision to review Ford and Honda patent challenges that were rejected by the Patent Trial and Appeal Board provides an opportunity to revisit precedents that have unfairly denied companies a fair review process and align them with commonsense principles of legal equity, says former Sen. Patrick Leahy.
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Grant Compliance Takeaways From Ga. Tech's FCA Settlement
Georgia Tech’s recent False Claims Act settlement over its failure to detect compliance shortcomings in a grant program was unique in that it involved a voluntary repayment of funds prior to the resolution, offering a few key lessons for universities receiving research funding from the government, says Jonathan Porter at Husch Blackwell.
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Series
Competing In Dressage Makes Me A Better Lawyer
My lifelong participation in the sport of dressage — often called ballet on horses — has proven that several skills developed through training and competition are transferable to legal work, especially the ability to harness focus, persistence and versatility when negotiating a deal, says Stephanie Coco at V&E.