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Life Sciences
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May 24, 2024
Fla. Lab Owner Will Pay $27M To End False Billing Suit
A Florida medical lab owner who pled guilty to charges related to accusations he billed Medicare for $53 million in unnecessary genetic cancer screening tests has agreed to pay more than $27 million to resolve three whistleblower suits over the same conduct, according to an announcement Friday from the U.S. Department of Justice.
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May 24, 2024
Shuttered Paper Mill Flouted $12M Incentive Deal, NC AG Says
The state of North Carolina is suing food and beverage packaging company Pactiv Evergreen to recoup $12 million in economic incentives the company allegedly accepted to keep a local mill up and running after it abruptly shuttered the facility last year.
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May 24, 2024
NY AG Sues Over Illegal Long Island Wetland Construction
New York prosecutors on Friday sued to force a contractor to pay nearly $600,000 and restore a Long Island wetland area the company has been using as a storage site after illegally clearing vegetation and building a parking lot more than a decade ago.
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May 24, 2024
Biden's Judicial Impact And What's Left On The Wish List
President Joe Biden secured confirmation of his 200th federal judge Wednesday and has transformed the judiciary by picking more women and people of color than any other president. But the upcoming election season could derail his hopes of confirming many more judges.
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May 24, 2024
NYSE Companies Could Face Heat If Business Focus Changes
A New York Stock Exchange proposal seeking additional authority to delist companies that enact wholesale business changes after going public could subject certain companies to more scrutiny, attorneys say, though such drastic actions are expected to be rare.
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May 24, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen an IT engineer seek permission to search a landfill hiding a hard drive supposedly storing millions of pounds in bitcoin, Glencore take on legal action by American Century Investments, gold payment app Glint bring a breach of duty claim against FRP Advisory, and an ongoing dispute between a solicitor and the Solicitors Regulation Authority. Here, Law360 looks at these and other new claims in the U.K.
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May 23, 2024
NJ Justices Toss Direct Appeals Over Hospital Contract Bid
The New Jersey Supreme Court ruled Thursday that an independent state-owned teaching hospital's conduct cannot be challenged directly in the state's intermediate appellate court because it isn't considered an administrative agency, affirming the dismissal of two protests over the hospital's selection of a pharmacy vendor.
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May 23, 2024
Fed. Circ. Upends Inventors' Interference Win Over Time-Bar
The Patent Trial and Appeal Board wrongly chose inventors tied to Cook Medical, rather than ones tied to Medtronic, when determining who should prevail in an interference proceeding over catheters, the Federal Circuit held Thursday.
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May 23, 2024
Ex-Judge Pushed False Narrative On Atty Romance, Firm Says
U.S. Bankruptcy Judge David R. Jones of Texas, who resigned last year after his secret relationship with a Jackson Walker LLP partner was revealed, attempted to head off rumors about the relationship by asking the firm to file a false, partial disclosure in 2022, the firm alleged.
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May 23, 2024
Merck To Pay $600M For KKR-Backed Life Sciences Biz
Menlo Park, California-based Gamma Biosciences said Thursday it has agreed to sell its operating company Mirus Bio for $600 million in cash to Merck KGaA, inking the deal under the guidance of Sidley Austin LLP.
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May 23, 2024
Just 57% Of Complex Global Deals Closed Since 2020
About 43% of complex cross-border global deals have failed to close since the start of 2020, while the remaining 57% did close but were highly likely to involve remedies, according to a new report from Weil Gotshal & Manges LLP.
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May 23, 2024
J&J Loses Expedited Bid For Beasley Allen Docs In Talc MDL
Johnson & Johnson has lost its bid in New Jersey federal court to have the Beasley Allen Law Firm quickly produce documents related to what J&J said seems to be an "intentional effort" by the firm to "bias the vote" against a proposed $6.5 billion reorganization plan for its talc subsidiary.
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May 23, 2024
GSK, Boehringer Prevail In 1st Zantac Cancer Trial
A Chicago jury found Thursday that Zantac heartburn medication and its generic counterparts sold by GlaxoSmithKline and Boehringer Ingelheim are not responsible for an Illinois woman's colon cancer and her subsequent, debilitating symptoms, handing the drug companies a decisive victory in the first of hundreds of such cases to go to trial.
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May 22, 2024
Inventor To Take $102M IP Malpractice Row To Ga. High Court
A neurosurgeon pursuing a nearly $102 million legal malpractice case against FisherBroyles LLP and a legal services contractor over a missed patent filing deadline said Wednesday that he is planning to take the dispute to the highest court in the Peach State.
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May 22, 2024
Cancer Patients Target J&J Talc Unit's Asset Shuffles
Cancer patients who have sued Johnson & Johnson alleging that its talcum powder caused their illness alleged Wednesday that the company has tried to intentionally prevent tort victims from getting their day in court through a scheme of fraudulent corporate transactions.
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May 22, 2024
Justices' CFPB Alliance May Save SEC Courts, Not Chevron
A four-justice concurrence to the U.S. Supreme Court's decision upholding the Consumer Financial Protection Bureau's unique funding scheme last week carries implications for other cases pending before the court that challenge the so-called administrative state, or the permanent cadre of regulatory agencies and career government enforcers who hold sway over vast swaths of American economic life.
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May 22, 2024
FDA Must Act On Sexual Side Effects Of SSRIs, Suit Says
The Food and Drug Administration should be forced to warn the public about the serious sexual side effects of a certain class of depression medications after sitting on a petition asking it to do just that for more than six years, a new lawsuit says.
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May 22, 2024
Evidence Shaky In First Zantac Cancer Trial, Drugmakers Say
Attorneys for GlaxoSmithKline and Boehringer Ingelheim told a Chicago jury Wednesday that no one besides a plaintiff's paid witnesses have said publicly that Zantac heartburn medication causes colon cancer, calling on the jurors to reject claims that the companies owe $640 million for a woman's cancer diagnosis.
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May 22, 2024
Doc Gets 3 Mos. For Alexion Trades Despite 'Meaningful Job'
A doctor was sentenced to three months in prison Wednesday for insider trading on an Alexion Pharmaceuticals acquisition, with a Manhattan federal judge saying the defendant's treatment of critically ill, underserved kidney disease patients does not amount to a "get out of jail free card."
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May 22, 2024
DuPont 'Document Dump' Rattles NC In PFAS Suit
North Carolina and DuPont on Wednesday battled over what the state called a roughly 5 million-page "document dump" ahead of a looming June 3 discovery deadline in its contamination lawsuit, irking a business court judge in the process.
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May 22, 2024
Stryker Agrees To Settle Calif. Misclassification Suit
Medical device company Stryker told a California federal court Wednesday it has agreed to settle a proposed class action accusing it of misclassifying workers as overtime-exempt and failing to pay them overtime during their mandatory training.
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May 22, 2024
MilliporeSigma Avoids Charges As DOJ Extols Self-Disclosure
Life sciences firm MilliporeSigma won’t face charges over the illegal exportation of products to China, in what the Justice Department said Wednesday was the first time its National Security Division had declined prosecution under a policy intended to encourage companies to voluntarily disclose wrongdoing,
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May 22, 2024
Teva, Bristol-Myers Cite Bystolic Against Cancer Drug Case
Celgene and parent Bristol-Myers Squibb pointed a New Jersey federal judge to the dismissal, recently upheld by the Second Circuit, of an antitrust suit over delayed generic competition to AbbVie's hypertension treatment Bystolic to argue the same logic applies to their bid to duck antitrust claims over cancer therapies.
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May 22, 2024
Dickinson Adds Ex-Sheppard Mullin IP Pro In Silicon Valley
Dickinson Wright PLLC said Wednesday that it has added a former Sheppard Mullin Richter & Hampton LLP partner as the newest member of its Silicon Valley office.
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May 22, 2024
Lead Blood Test Maker To Plead Guilty, Pay $42M Over Defects
Medical device maker Magellan Diagnostics has agreed to pay at least $42 million and plead guilty to hiding a defect in its blood testing devices for lead that caused inaccurately low results for tens of thousands of children and others, Massachusetts federal prosecutors said.
Expert Analysis
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Assessing HHS' Stance On Rare Disease Patient Assistance
The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.
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Opinion
Feds' Biotech Enforcement Efforts Are Too Heavy-Handed
The U.S. Department of Justice's recent actions against biotech companies untether the Anti-Kickback Statute from its original legislative purpose, and threaten to stifle innovation and undermine patient quality of care, say attorneys at Ropes & Gray.
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Regulating Resurrected Species Under The ESA
As the prospect of extinct species being resurrected from DNA and reintroduced into the wild grows closer, an analysis of the Endangered Species Act suggests that it could provide a thoughtful, flexible governance framework for such scenarios, say Caroline Meadows and Shelby Bobosky at the SMU Dedman School of Law.
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E-Discovery Quarterly: Recent Rulings On Text Message Data
Electronically stored information on cellphones, and in particular text messages, can present unique litigation challenges, and recent court decisions demonstrate that counsel must carefully balance what data should be preserved, collected, reviewed and produced, say attorneys at Sidley.
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What CRA Deadline Means For Biden Admin. Rulemaking
With the 2024 election rapidly approaching, the Biden administration must race to finalize proposed agency actions within the next few weeks, or be exposed to the chance that the following Congress will overturn the rules under the Congressional Review Act, say attorneys at Covington.
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5 Takeaways From FDA's Biosimilars Promotion Guidance
New draft guidance from the U.S. Food and Drug Administration expands upon other recent efforts to clarify expectations for biosimilar and interchangeable labeling, highlighting a number of potential missteps that could draw attention from regulators, say attorneys at Arnold & Porter.
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Dual-Track IPO-M&A Exit Strategies For Life Science Cos.
A dual-track process for life sciences companies offers a proven path to securing favorable deal terms for an exit, and strategic moves can include running a crossover financing round in the lead-up, say attorneys at McDermott.
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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.