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Life Sciences
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August 23, 2024
McKinsey Opioid Suits Sent Back To NY, Illinois State Courts
A California federal judge has remanded, to their respective state courts, cases brought by dozens of New York municipalities and two Illinois counties against McKinsey & Co. over its alleged role in the opioid crisis, saying the consulting firm's "tortured interpretations of state law" don't give the Golden State jurisdiction.
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August 23, 2024
9th Circ. Reverses 'Patent Misuse' Ruling Against CR Bard
The Ninth Circuit on Friday reversed a decision that cleared Atrium Medical Corp. in a $52.8 million breach of contract suit by C.R. Bard, concluding that the lower court wrongly held that Bard engaged in patent misuse by seeking royalties after its medical device patent expired.
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August 23, 2024
Ex-Exec Can't Reverse Medtronic Insider Trading Conviction
A Minnesota federal judge on Friday declined to overturn fraud convictions against a former executive of a medical robotics firm, finding the insider tips he provided to a friend ahead of Medtronic's $1.6 billion acquisition of his company were not speculative.
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August 23, 2024
The Biggest Product Liability Cases Of 2024: A Midyear Report
A U.S. Supreme Court ruling that formally ended judges' decades-long deference to federal agencies' understanding of the law, as well as multibillion-dollar settlements over so-called forever chemicals, made Law360's list of top product liability developments so far this year.
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August 23, 2024
Drugmakers' 'Subjective Beliefs' Obscured In Antitrust Case
A Pennsylvania federal judge has denied a request from direct purchasers of pharmaceuticals to compel the leaders of Abbott Laboratories and other companies to express "subjective beliefs" about sham patent litigation they allegedly engaged in, dismissing the purchasers' fears that the companies would change their position on certain issues at the last minute during trial.
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August 23, 2024
Albertsons-Kroger Deal Tests FTC's Stepped-Up Merger Policy
The Federal Trade Commission's highly anticipated hearing to block Albertsons' planned $24.6 billion merger with Kroger kicks off Monday in a Portland, Oregon, courtroom in what attorneys say will be a pivotal test of the Biden administration's newly formalized merger policy.
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August 23, 2024
Covington-Led Getinge Pays $477M For Organ Transplant Biz
Swedish healthcare company Getinge, advised by Covington & Burling LLP, has unveiled plans to buy Sheppard Mullin Richter & Hampton LLP-led Paragonix, a provider of organ transport products and services in the U.S., in a $477 million deal.
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August 23, 2024
Delaware Lets Ventis Move Pacira's False Ad Suit To Calif.
Ventis Pharma Inc., a pharmaceutical company developing nonopioid anesthetics, got a federal court's approval Friday to move a false advertising lawsuit filed by competitor Pacira BioSciences Inc. from Delaware to California, where Ventis is based.
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August 23, 2024
Firms Seek $20M Fee After $58M Deal In Shire Antitrust Suit
A group of nine firms led by Hagens Berman Sobol Shapiro LLP asked a Massachusetts federal judge to sign off on $20 million in fees and expenses after securing a $58 million settlement with drugmaker Shire PLC in a yearslong antitrust class action.
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August 22, 2024
PBMs Can't Yet Duck Municipalities' Claims In Opioid MDL
The Ohio federal judge overseeing multidistrict opioid litigation on Thursday refused, for now, to throw out claims against pharmacy benefit managers Express Scripts Inc. and OptumRX Inc., finding that the PBMs' arguments were brought too early and a more robust record is needed.
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August 22, 2024
Texas Appeals Knocks $1M Hernia Mesh Fee Ask Down To $135K
A Texas appeals court on Wednesday upheld an arbitration award of $135,000 in attorney's fees in a decadeslong hernia mesh litigation dispute while denying the firm's request for $1 million.
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August 22, 2024
2 Biotech Firms File Plans To Go Public As IPO Pipeline Grows
Drug developers Bicara Therapeutics Inc. and Zenas Biopharma Inc. filed plans with regulators on Thursday for initial public offerings that could tap the market as early as September, signaling a potential boost in post-Labor Day IPOs, under the combined guidance of three law firms.
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August 22, 2024
Mich. Panel Upholds Block Of 24-Hour Abortion Waiting Period
Michigan appellate judges have refused to lift a preliminary injunction blocking the enforcement of a 24-hour waiting period and other abortion regulations, leaving in place a lower court decision that found the laws likely violate the state constitution.
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August 22, 2024
Zantac Cases Must Remain In State Court, Conn. Judge Rules
Two groups of patients can continue their lawsuits in Connecticut state court against GlaxoSmithKline LLC, Pfizer Inc. and Sanofi-Aventis US LLC, a judge has ruled, refusing to immediately truncate novel tort claims that seek to connect generic versions of Zantac with cancer.
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August 22, 2024
Texas Tells High Court It's Not Idaho '2.0' In HHS Abortion Row
Texas and a pair of anti-abortion doctor organizations have urged the U.S. Supreme Court to reject the federal government's appeal of a Fifth Circuit decision blocking the Biden administration's guidance that hospitals must provide emergency stabilizing medical care, including abortions.
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August 22, 2024
Ex-MiMedx Sales Rep Says Fraud Schemes Pushed Her Out
A former employee of controversial biotech firm MiMedx who was sued for joining a competitor earlier this year hit the company back with a counterclaim Tuesday charging that she was forced out for refusing to go along with the company's alleged flouting of U.S. Food and Drug Administration regulations and rampant overbilling schemes.
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August 22, 2024
USPTO Tells High Court To Skip Double-Patenting Fight
The U.S. patent office told the U.S. Supreme Court that fears stoked by a patent licensing outfit complaining about current Federal Circuit jurisprudence surrounding "obviousness-type double patenting" has already been resolved by a different ruling by the same court earlier this month.
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August 22, 2024
Ga. Mineral Co., Insurer Strike Deal In Talc Coverage Suit
Phoenix Insurance Co. reached a contingent settlement with a Georgia-based mineral products company in litigation seeking to force the insurer to defend the company against an underlying suit claiming it supplied asbestos-containing talc products.
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August 22, 2024
Deals Rumor Mill: Saudi Fund, Disney-Reliance, Repligen
Saudi Arabia’s sovereign wealth fund wants to launch a new cargo airline, India’s antitrust regulators worry about power over cricket rights if the $8.5 billion merger of Walt Disney’s Indian business with Reliance Entertainment is allowed, and drug manufacturing provider Repligen is eyeing Maravai LifeSciences. Here, Law360 breaks down these and other notable deal rumors from the past week.
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August 21, 2024
Fed. Circ. Won't Rethink IP Safe Harbor Case
The Federal Circuit on Wednesday declined to review its decision affirming the dismissal of Edwards Lifesciences' infringement suit against Meril Life Sciences after Edwards urged the full court to narrow its interpretation of a U.S. Food and Drug Administration safe harbor that essentially allows patent infringement during drug development.
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August 21, 2024
Spine Implant Caused Patient's TB, Suit Says
A North Carolina couple on Tuesday hit biologic technology company Elutia Inc. with a complaint in federal court alleging that the husband contracted tuberculosis from a bone cell product that was implanted into his spine during surgery.
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August 21, 2024
Cannabinoid Co. Sacked Exec For Flagging Fraud, Suit Says
Psychedelics and cannabinoid company Benuvia Operations has been hit with a wrongful termination lawsuit in Colorado state court filed by a woman who claims management retaliated against her after flagging millions of dollars in misappropriated funds.
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August 21, 2024
Hedge Fund Priest Sues SEC Over Proposed Industry Ban
A Greek Orthodox priest and hedge fund founder who beat most civil claims brought by the U.S. Securities and Exchange Commission at a 2021 trial sued the agency Wednesday, claiming it is unconstitutionally trying to implement a lifetime ban from the securities industry through an administrative case.
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August 21, 2024
9th Circ. Doubts Idaho Trans Health Ban Doesn't Discriminate
The Ninth Circuit appeared reluctant Wednesday to give the state of Idaho a green light for a prohibition on gender dysphoria treatment for minors, with judges vocally skeptical of the state's argument that the policy didn't discriminate based on sex.
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August 21, 2024
Judge Rules Lack Of Expert Dooms Families' Tylenol MDL
Families trying to show that prenatal exposure to acetaminophen causes ADHD cannot rely on the "cherry-picked statements" of a defense expert to keep their claims alive, a New York federal judge ruled, delivering yet another blow to plaintiffs in the sprawling multidistrict litigation.
Expert Analysis
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3 Leadership Practices For A More Supportive Firm Culture
Traditional leadership styles frequently amplify the inherent pressures of legal work, but a few simple, time-neutral strategies can strengthen the skills and confidence of employees and foster a more collaborative culture, while supporting individual growth and contribution to organizational goals, says Benjamin Grimes at BKG Leadership.
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Rebuttal
Cancer Research Org. Is Right To Avoid Corporate Influence
While a previous Law360 guest article criticizes the International Agency for Research on Cancer's processes, its reliance on peer-reviewed literature is proper and its refusal to allow corporate influence is sound science, say Lance Oliver and Ridge Mazingo at Motley Rice.
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Cannabis Biz Real Estate Loan Considerations For Lenders
Now that cannabis sales are legal in some states, real estate lenders are interested in financing the land used by cannabis companies, but because cannabis sales are still illegal under federal law, lenders must make adjustments for cannabis-adjacent transactions, say Mark Levenson and Jeffrey Wendler at Sills Cummis.
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E-Discovery Quarterly: Rulings On Hyperlinked Documents
Recent rulings show that counsel should engage in early discussions with clients regarding the potential of hyperlinked documents in electronically stored information, which will allow for more deliberate negotiation of any agreements regarding the scope of discovery, say attorneys at Sidley.
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Loper Bright Limits Federal Agencies' Ability To Alter Course
The U.S. Supreme Court's recent decision to dismantle Chevron deference also effectively overrules its 2005 decision in National Cable & Telecommunications Association v. Brand X, greatly diminishing agencies' ability to change regulatory course from one administration to the next, says Steven Gordon at Holland & Knight.
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A Primer On EU's Updated Human Substance Regulations
The European Union's updated standards regarding quality and safety of substances of human origin meant for human application carry significant implications for companies that work with cells and tissues, and U.S. companies active in the EU market should pay particular attention to the import and export rules, say Geneviève Michaux and Georgios Symeonidis at King & Spalding.
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Series
Teaching Scuba Diving Makes Me A Better Lawyer
As a master scuba instructor, I’ve learned how to prepare for the unexpected, overcome fears and practice patience, and each of these skills – among the many others I’ve developed – has profoundly enhanced my work as a lawyer, says Ron Raether at Troutman Pepper.
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The Road Ahead For Regulation Of Digital Twins In Healthcare
Digital replicas of cells, organs and people — known as digital twins — can facilitate clinical trials for new drugs by reducing the number of patients required, but data limitations can create logistical hurdles and regulatory efforts addressing digital twins are still in early stages, say consultants at Keystone Strategy.
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Lawyers Can Take Action To Honor The Voting Rights Act
As the Voting Rights Act reaches its 59th anniversary Tuesday, it must urgently be reinforced against recent efforts to dismantle voter protections, and lawyers can pitch in immediately by volunteering and taking on pro bono work to directly help safeguard the right to vote, says Anna Chu at We The Action.
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3rd Circ. Ruling Shows Benefits Of IP Licenses In Bankruptcy
The Third Circuit’s recent ruling in Mallinckrodt’s Chapter 11 filing, which held that Mallinckrodt could sever its obligations to pay Sanofi royalties on sales of an autoimmune disease drug, highlights the advantages of structuring transactions as nonexclusive licenses for developers of intellectual property, say Gregory Hesse and Kaleb Bailey at Hunton.
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Opinion
Unclear Intellectual Property Laws Are Stifling US Innovation
U.S. intellectual property law’s lack of predictability means far less job-creating investments for companies that need patent protection to compete, and Congress must step in with legislation like the Patent Eligibility Restoration Act to help address the problem, says Michael Gulliford at Soryn IP Capital Management.
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The Fed. Circ. In June: More Liability For Generic-Drug Makers
The Federal Circuit’s June ruling in Amarin v. Hikma will likely result in more allegations of induced infringement by generic drugs postapproval, with more of those cases proceeding to at least the summary judgment stage instead of being cut off at the outset, say Jeremiah Helm and Sean Murray at Knobbe Martens.
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Opinion
Expert Witness Standards Must Consider Peer Review Crisis
For nearly two decades, the so-called replication crisis has upended how the scientific community views the reliability of peer-reviewed studies, and it’s time for courts to reevaluate whether peer review is a trustworthy proxy for expert witness reliability, say Jeffrey Gross and Robert LaCroix at Reid Collins.
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Analyzing Advance Notice Bylaws On 'Clear' Or 'Cloudy' Days
In Kellner v. AIM ImmunoTech, the Delaware Supreme Court recently clarified the framework for judicial review of advance notice bylaws adopted, amended or enforced on "clear" or "cloudy" days, underscoring the responsibility of boards to ensure that their scope does not overreach or prevent the possibility of a contested election, say attorneys at Venable.
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How To Grow Marketing, Biz Dev Teams In A Tight Market
Faced with fierce competition and rising operating costs, firms are feeling the pressure to build a well-oiled marketing and business development team that supports strategic priorities, but they’ll need to be flexible and creative given a tight talent market, says Ben Curle at Ambition.