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Life Sciences
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May 03, 2024
6 States Strike $270M Opioid Deal With Amneal
The New York state attorney general on Friday said that a $270 million multistate deal had been reached with opioid manufacturer Amneal Pharmaceuticals for its role in the addiction epidemic over allegations that the company failed to report suspicious orders of the narcotics.
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May 02, 2024
7th Circ. Mostly Backs Ill. Home Health Kickbacks Judgment
The Seventh Circuit on Thursday largely left intact an Illinois federal judge's $6 million ruling that a home health care company broke federal kickback laws, refusing to reverse the lower court's liability finding but directing it to ensure its damages award was calculated correctly.
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May 02, 2024
Endo Judge Hopes Criminal Sentence Warns Opioid Makers
A Michigan federal judge said Thursday she hoped Endo's criminal sentence for falsely advertising a pain medication as "abuse deterrent" would itself be a deterrent for other opioid makers, as she accepted the company's recent $200 million settlement deal with federal prosecutors.
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May 02, 2024
Walgreens Fights $1B Arb. Award Over COVID Test Contract
At-home lab test maker Everly Health urged a Delaware federal judge to affirm its nearly $1 billion arbitration award against Walgreens over claims the pharmacy chain deliberately misused the digital health platform's trademark while secretly diverting COVID-19 tests to its own pharmacists while Walgreens argued the arbitrator overstepped his authority in bestowing such an "egregious" award.
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May 02, 2024
Feds Call Out Gilead's Efforts To Revise HIV Drug IP Judgment
The U.S. Department of Justice has asked a Delaware federal judge to reject Gilead Sciences' motion to modify a judgment finding that two medications in its HIV prevention regimen directly infringe voided patents owned by the government, arguing that the pharmaceutical company's attempt to rewrite the judgment is "unnecessary as well as improper."
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May 02, 2024
Masimo Hit With Derivative Suit Over Audio Co. Acquisition
The top brass at medical device company Masimo Corp. has been hit with a shareholder derivative action claiming they harmed the company and "confused" investors by pushing through a $1 billion acquisition of an audio equipment company, allegedly causing a steep drop in stock prices and a $5.1 billion market capitalization loss.
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May 02, 2024
Latham, Skadden Grab Spotlight As Large IPOs Surge In April
Latham & Watkins LLP guided five initial public offerings in April, while Skadden Arps Slate Meagher & Flom LLP advised the company bringing to market the largest IPO of 2024, concluding the busiest month for new listings year to date.
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May 02, 2024
Email Exchanges Doom Honeywell Bid To Nix $20M GSA Claim
A contract appeals board wouldn't free Honeywell International Inc. from the General Services Administration's efforts to recoup an alleged $20 million overpayment on an energy deal, finding it unclear whether a 2021 agreement related to the contract barred the claim.
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May 02, 2024
Pharma. Co. Wants Ex-Director To Stop Poaching Customers
A pharmaceutical company has doubled down on its bid to stop a former director from soliciting customers for a rival drugmaker, saying he's trying to twist words in his contract and make up excuses for allegedly stealing trade secrets following his termination.
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May 02, 2024
Calif. Justices To Review Gilead's HIV Drug Negligence Fight
The California Supreme Court has granted Gilead Sciences Inc.'s request to review an appellate court's holding that the drugmaker must face claims it held back a safer HIV drug to maximize profits on an older medication.
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May 02, 2024
State Legislators Urge Feds To Change Cannabis' Status
A coalition of state lawmakers on Thursday urged the heads of the U.S. Department of Justice and its drug enforcement agency to prioritize changing cannabis' status as a highly restricted drug.
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May 02, 2024
Recent BigLaw Moves Show Boston Is 'Clearly On The Map'
Three BigLaw firms' recent moves to build out physical footprints in Boston are a testament to the region's thriving technology, healthcare, life sciences and finance industries — a trend that shows no signs of slowing down, experts say.
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May 02, 2024
4th Circ. Revives Workers' Suit Over SC Plant Explosion
The Fourth Circuit on Thursday revived claims from three workers burned in an explosion at a plastic recycling plant, saying the South Carolina Workers' Compensation Law can't deprive the federal courts of diversity jurisdiction in a case where they would otherwise have it.
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May 02, 2024
Schumer Reups Call For His Judge Shopping Bill
U.S. Senate Majority Leader Chuck Schumer, D-N.Y., said Thursday that a suit filed in a controversial Texas court challenging a new firearms policy from the Biden administration underscores the need for his bill to restrict so-called "judge shopping."
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May 02, 2024
Plaintiff To Share 'Horrific' Story In First Zantac Cancer Trial
The first trial in sprawling state and federal litigation over whether a chemical in Zantac heartburn medication and its generic counterparts causes cancer began Thursday in a packed Chicago courtroom, with counsel for an 89-year-old Illinois woman telling jurors her colorectal cancer diagnosis and the suffering it's caused can be attributed to her 20-year use of the drug.
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May 02, 2024
Skin Care Drug Co. Gets OK For Ch. 11 Wind-Down Plan
A Delaware bankruptcy judge on Thursday said she would approve the unopposed and unanimously approved Chapter 11 wind-down plans of the company previously known as Timber Pharmaceuticals Inc.
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May 02, 2024
Freshfields-Led Novartis Inks $1.75B Cancer Drug Co. Buyout
Novartis AG said Thursday it has agreed to buy U.S. radiopharmaceutical company Mariana Oncology in a transaction worth up to $1.75 billion, as the Swiss pharmaceutical giant moves to bolster its precision nuclear medicine portfolio.
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May 01, 2024
3 Takeaways From The DOJ's Cannabis Recommendation
The marijuana advocacy and business world responded with guarded optimism after the U.S. Department of Justice's announcement this week that it recommended relaxing restrictions on marijuana for the first time in more than 50 years.
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May 01, 2024
Dental Supply Co. Must Face Suit Over COVID-Era Woes
Dental health products supplier Dentsply Sirona Inc. failed to get a suit dismissed accusing it of misleading investors about the extent of its pandemic-era woes, with a New York federal judge finding the suit identifies dozens of actionable misleading statements and plausibly pleads knowledge of wrongdoing by Dentsply's former executives.
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May 01, 2024
Bayer Can't Scratch Off Antitrust Suit Over Flea, Tick Meds
A California federal judge has largely declined Bayer's bid to dismiss generics competitor Tevra's pet medication antitrust suit, saying in an order released Wednesday that there are factual disputes about whether Bayer's exclusivity deals with distributors and retailers significantly foreclosed Tevra's potential sales in the market.
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May 01, 2024
Median Patent Damages Awards Are Shrinking
A New York accounting firm that provides damages experts for intellectual property cases has found in a new study that median damages awards in patent cases have declined over the last 15 years.
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May 01, 2024
Eiger Gets Deal With Merck Over $46M Rare-Disease Drug Sale
Bankrupt Eiger BioPharmaceuticals Inc. told a Texas federal judge Wednesday it had struck a tentative agreement with drug company Merck & Co. over licensing rights to a rare-disease drug that it is selling for $46.1 million.
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May 01, 2024
3rd Circ. Flags Bayer's Knowledge Of Tainted Fungal Spray
A proposed class of consumers who bought tainted Bayer antifungal sprays said they should have standing to sue because they didn't get the "benefit of the bargain" — and a Third Circuit panel questioned Wednesday if Bayer's separate suit blaming a supplier made the consumers' case for them.
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May 01, 2024
'Foul' BioVentrix Cash-Out Gets Extra Scrutiny, Chancery Says
A medical device company's decision to suddenly and without explanation cash out its common stockholders for less than a penny just two months before the company raised $48.5 million in new capital creates such a "foul flavor" that it deserves extra scrutiny, a Delaware Chancery Court judge said Wednesday.
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May 01, 2024
J&J Unit Cuts Deal To End Cancer Drug Trade Secret Fight
A New Jersey federal judge has signed off on a consent judgment that permanently bars Chinese drugmaker Jiangsu Hengrui Pharmaceuticals Co. from misappropriating Johnson and Johnson's pharmaceutical subsidiary Janssen's trade secrets for its popular chemotherapy drug Yondelis.
Expert Analysis
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2 FCPA Settlements Illuminate Self-Disclosure, Disgorgement
Two of last year’s Foreign Corrupt Practices Act settlements — with biomedical company Lifecore and mining company Corsa Coal — suggest that the government will be much more flexible in negotiating disgorgement amounts if an entity voluntarily self-discloses misconduct, say Michael Gilbert and Lucas Amodio at Sheppard Mullin.
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Opinion
Anti-Kickback Statute Does Not Require But-For Causation
A proper interpretation of the Anti-Kickback Statute clearly indicates that but-for causation is not required for False Claims Act Liability, and courts that hold otherwise will make it significantly easier for fraudsters to avoid accountability, says Kenneth Capesius at Baron & Budd.
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5 Litigation Funding Trends To Note In 2024
Over the next year and beyond, litigation funding will continue to evolve in ways that affect attorneys and the larger litigation landscape, from the growth of a secondary market for funded claims, to rising interest rates restricting the availability of capital, says Jeffery Lula at GLS Capital.
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Medtronic's Cautionary Tale Of Fed. Circ. Word Limits
The Federal Circuit's ruling in Medtronic v. Teleflex that Medtronic waived an argument that it had sought to incorporate by reference illustrates the pitfalls facing parties in complex patent cases involving numerous issues that cannot all be addressed within the strict word limits for appellate briefs, say Sean Murray and Jeremiah Helm at Knobbe Martens.
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Key Legal Trends For Healthcare And Life Sciences In 2024
Due to the impact of contentious legal battles over drug pricing negotiations, the growing integration of artificial intelligence into drug development and manufacturing, and the publication of industry segment-specific guidance, the year ahead promises to be a dynamic period of changes and challenges, say Xin Tao and Lois Liu at Baker McKenzie.
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Series
ESG Around The World: South Africa
While South Africa has yet to mandate the reporting of nonfinancial and environmental, social, and corporate governance issues, policy documents and recent legislative developments are likely to have a material impact in the country's transition to a low-carbon economy and in meeting its international obligations, say Glynn Kent at Eversheds Sutherland.
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FOIA Exemption Questions On Redacted HHS Cannabis Letter
The U.S. Department of Health and Human Services' recent recommendation letter concerning the rescheduling of cannabis was heavily redacted, and based on an analysis on the applicability of Freedom of Information Act Exemption 5 to the letter, it's likely that we will see successful legal challenges to those redactions, say attorneys at Troutman Pepper.
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Fed. Circ. Ruling Seemingly Offers PTAB Deadline Immunity
The Federal Circuit's recent Purdue Pharma v. Collegium Pharmaceutical Inc. decision that the Patent Trial and Appeal Board had authority to issue a final written decision in a post grant review after the prescribed statutory deadline underscores how courts should consider the overall objective of the statutory scheme when balancing the classic conflict between bright-line rules and flexible standards, says Matthew Dowd at Dowd Sheffel.
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Evaluating Retroactivity Of Mich. Drugmaker Immunity Repeal
In assessing whether a new Michigan law lifting drugmakers' blanket immunity from product liability suits will apply retroactively, there are four key factors that Michigan courts will likely consider, say Sherry Knutson and Brenda Sweet at Tucker Ellis.
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4 Legal Ethics Considerations For The New Year
As attorneys and clients reset for a new year, now is a good time to take a step back and review some core ethical issues that attorneys should keep front of mind in 2024, including approaching generative artificial intelligence with caution and care, and avoiding pitfalls in outside counsel guidelines, say attorneys at HWG.
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FTC Rite Aid Order Holds Biometrics And AI Compliance Tips
The Federal Trade Commission's recent enforcement action against Rite Aid over its use of facial biometric technology on customers provides lessons that can be leveraged to reduce and manage the risk of regulatory scrutiny of biometrics and artificial intelligence, says David Oberly at Baker Donelson.
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Bribery Settlement Gives Insight On DOJ Policies
Chemical company Albemarle’s recent $218 million settlement with the government to resolve foreign bribery claims provides valuable data points for companies on the U.S. Department of Justice’s voluntary self-disclosure policy and its clawback pilot program, say Michael DeBernardis and Tiauna Mathieu at Hughes Hubbard.
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SEC Case May Expand Scope Of Insider Trading Liability
The U.S. Securities and Exchange Commission's first-of-its-kind enforcement action against an individual in a case involving "shadow trading" demarcates an expansion of insider trading liability to circumstances in which there is a market connection between the source of information and the issuer of the securities traded, say attorneys at Steptoe.
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Opinion
Waiving COVID-19 IP Protections Would Harm US Industry
President Joe Biden should turn down a World Trade Organization proposal to waive crucial intellectual property protections behind COVID-19 tests and diagnostics — protections that allow U.S. companies to sustain millions of jobs and develop life-saving treatments that benefit patients in every country, says former U.S. Circuit Judge Paul Michel, now at the Council for Innovation Promotion.
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Fed. Circ. Patent Decisions In 2023: An Empirical Review
The Federal Circuit decided 306 patent cases last year, which is still well down from the pre-pandemic norm of around 440, and on the whole the court's decisions were markedly less patentee-friendly in 2023 than in 2022, says Dan Bagatell at Perkins Coie.