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Life Sciences
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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.
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August 21, 2024
Calif. AG Secures Rite Aid Deal Ensuring Pharmacy Access
California Attorney General Rob Bonta has announced a settlement with Rite Aid Corp. that will allow his office to oversee any changes in ownership of the company's retail pharmacy outlets across the state.
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August 20, 2024
Mesh Was Implanted After Serious FDA Alert, Jury Hears
A surgery patient went to trial Tuesday against an Oregon hospital and surgeon over an implant of prolapse mesh almost two weeks after the U.S. Food and Drug Administration ordered its maker to stop selling it.
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August 20, 2024
Ala. AG Can't Prosecute Aiding Abortion Travel, DOJ Says
The Alabama attorney general's threats of criminal prosecution against individuals and corporations who assist others in traveling to obtain lawful abortions out of state violates the constitutional right to travel, the U.S. Department of Justice told an Alabama federal judge in a court filing Monday.
Expert Analysis
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Does Expert Testimony Aid Preliminary IPR Responses?
Dechert attorneys analyze six years of patent owners' preliminary responses to inter partes review petitions to determine whether the elimination of the presumption favoring the petitioner as to preinstitution testimonial evidence affected the usefulness of expert testimony in responses.
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Are Concessions In FDA's Lab-Developed Tests Rule Enough?
Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.
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Rebuttal
Double-Patenting Ruling Shows Terminal Disclaimers' Value
While a recent Law360 guest article seems to argue that the Federal Circuit’s Cellect decision last year robs patent owners of lawful patent term, the ruling actually identifies how terminal disclaimers are the solution to the problem of obviousness-type double patenting, say Jane Love and Robert Trenchard at Gibson Dunn.
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Series
Swimming Makes Me A Better Lawyer
Years of participation in swimming events, especially in the open water, have proven to be ideal preparation for appellate arguments in court — just as you must put your trust in the ocean when competing in a swim event, you must do the same with the judicial process, says John Kulewicz at Vorys.
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Mid-2024 FCA Enforcement And Litigation Trends To Watch
Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.
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What 100 Federal Cases Suggest About Changes To Chevron
With the U.S. Supreme Court poised to overturn or narrow its 40-year-old doctrine of Chevron deference, a review of 100 recent federal district court decisions confirm that changes to the Chevron framework will have broad ramifications — but the magnitude of the impact will depend on the details of the high court's ruling, say Kali Schellenberg and Jon Cochran at LeVan Stapleton.
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Why High Court May Have Rejected IP Obviousness Appeal
Attorneys at Womble Bond analyze possible reasons the U.S. Supreme Court rejected Vanda Pharmaceuticals' request to review the Federal Circuit’s reasonable expectation of success standard for determining obviousness, including that the court was unpersuaded by the company's argument that Amgen v. Sanofi places a bind on drug developers.
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Microplastics At The Crossroads Of Regulation And Litigation
Though there are currently not many federal regulations specifically addressing microplastics as pollutants, regulatory scrutiny and lawsuits asserting consumer protection claims are both on the rise, and manufacturers should take proactive steps to implement preventive measures accordingly, say Aliza Karetnick and Franco Corrado at Morgan Lewis.
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The Fed. Circ. In April: Hurdles Remain For Generics
The Federal Circuit’s recent Salix v. Norwich ruling — where Salix's brand-name drug's patents were invalidated — is a reminder to patent practitioners that invalidating a competitor's patents may not guarantee abbreviated new drug application approval, say Sean Murray and Jeremiah Helm at Knobbe Martens.
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Tylenol MDL Highlights Expert Admissibility Headaches
A New York federal court's decision to exclude all plaintiff experts in a multidistrict litigation concerning prenatal exposure to Tylenol highlights a number of expert testimony pitfalls that parties should avoid in product liability and mass tort matters, say Rand Brothers and Courtney Block at Winston & Strawn.
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Don't Use The Same Template For Every Client Alert
As the old marketing adage goes, consistency is key, but law firm style guides need consistency that contemplates variety when it comes to client alert formats, allowing attorneys to tailor alerts to best fit the audience and subject matter, says Jessica Kaplan at Legally Penned.
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Don't Fall On That Hill: Keys To Testifying Before Congress
Because congressional testimony often comes with political, reputational and financial risks in addition to legal pitfalls, witnesses and their attorneys should take a multifaceted approach to preparation, walking a fine line between legal and business considerations, say attorneys at Crowell & Moring.
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Online Portal Helps Fortify Feds' Unfair Health Practices Fight
The Federal Trade Commission, U.S. Justice Department and the U.S. Department of Health and Human Services recently launched an online portal where the public can report potentially unfair healthcare practices, effectively maximizing enforcers' abilities to police anti-competitive actions that can drive up healthcare costs and chill innovation, say attorneys at Seyfarth.
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Series
Walking With My Dog Makes Me A Better Lawyer
Thanks to my dog Birdie, I've learned that carving out an activity different from the practice of law — like daily outdoor walks that allow you to interact with new people — can contribute to professional success by boosting creativity and mental acuity, as well as expanding your social network, says Sarah Petrie at the Massachusetts Attorney General’s Office.
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Think Like A Lawyer: Follow The Iron Rule Of Trial Logic
Many diligent and eager attorneys include every good fact, point and rule in their trial narratives — spurred by the gnawing fear they’ll be second-guessed for leaving something out — but this approach ignores a fundamental principle of successful trial lawyering, says Luke Andrews at Poole Huffman.