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Life Sciences
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July 24, 2024
Clinic Drops Case Against Maker Of Body-Sculpting Devices
BTL Industries Inc., a Massachusetts company that sells body-sculpting equipment, and a Connecticut aesthetic clinic have mutually agreed to dismiss a lawsuit accusing the Bay State company of using misleading profit projections and illegal trade restraints that unfairly penalized equipment buyers and caused hefty investments to wither.
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July 24, 2024
Rite Aid's Elixir Buyer Must Pay Additional $50M In Ch. 11 Sale
Prescription benefits group MedImpact owes an extra $50 million on top of $576 million it paid Rite Aid for its former benefits division Elixir, a New Jersey bankruptcy judge ruled Wednesday, saying his earlier ruling on $200 million in disputed liabilities from the sale didn't fundamentally disrupt a post-closing price adjustment.
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July 24, 2024
Patent Cap In Drug Pricing Bill Seen As Having Muted Effect
The U.S. Senate recently passed a bill aiming to lower drug prices by limiting the number of patents that can be asserted in cases over biosimilars, but attorneys say the measure's numerous exceptions make it unlikely to have a major effect on litigation or consumer costs.
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July 24, 2024
McCarter & English Beats Biotech Malpractice Suit In NJ
McCarter & English LLP defeated a New Jersey biotechnology company's legal malpractice suit this week, following a New Jersey state judge's finding that the malpractice claims should have been brought in an earlier round of litigation over unpaid legal fees.
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July 24, 2024
Ex-Pharma Exec Gets Jail For Insider Trading On Kodak Loan
A Manhattan federal judge sentenced a former pharmaceutical executive from South Carolina to three months in prison Wednesday for taking over $500,000 of illegal trading profit based on his advance knowledge that Kodak would get a massive pandemic-era government loan.
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July 24, 2024
Priest Loses Fee Bid After 'Split Baby' SEC Verdict
A Greek Orthodox priest and hedge fund founder who largely beat a U.S. Securities and Exchange Commission suit is not entitled to recoup $1.7 million in legal fees because the commission was justified in bringing the case, a Boston federal judge ruled Tuesday.
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July 23, 2024
Meet The Lead Ozempic Lawyers
The recently deceased U.S. District Judge Gene E.K. Pratter this past spring appointed plaintiff leadership in litigation over Ozempic and similar drugs over allegations that the medications cause gastrointestinal issues. Here's who's who in the list of plaintiffs' leaders.
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July 23, 2024
Wash. AG Says 'Abortion Reversal' Clinic's Suit Still Deficient
Washington state's attorney general said Monday an anti-abortion clinic group being investigated for marketing an "abortion reversal pill" cannot blame his two-year-old document demands for a recent insurance rate hike, pushing a Tacoma federal judge to reject the group's legal effort to shield itself from future consumer protection enforcement.
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July 23, 2024
$680M Allergan FCA Suit Tossed After High Court Revival
A Maryland federal judge on Tuesday again tossed a False Claims Act suit accusing an Allergan unit of overcharging Medicaid, previously revived by the U.S. Supreme Court, saying a whistleblower still hadn't shown any deliberate wrongdoing by the company.
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July 23, 2024
Invitae's Ch. 11 Plan Needs Tweaking, Judge Says
A New Jersey bankruptcy judge said he would confirm the Chapter 11 liquidation plan for genetic testing company Invitae, if it made changes to how it handled distributions to certain creditors.
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July 23, 2024
4th Circ. Says Bad Jury Instructions Gave J&J Win In Mesh Suit
The Fourth Circuit has vacated a judgment in Ethicon Inc. and Johnson & Johnson's favor in a suit from a woman alleging Ethicon's pelvic mesh was defective, saying a federal judge was wrong to limit her expert's opinion based on the so-called elimination mandate.
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July 23, 2024
Ex-Celgene Exec Off The Hook For Statements To Investors
Celgene Corp.'s former chief operating officer on Tuesday escaped some claims in a class action contending that the biopharmaceutical company artificially inflated its share price, with a New Jersey federal court finding that the ex-executive never made nor could he be linked to the statements that were issued by the company.
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July 23, 2024
Feds Urge 6th Circ. To Affirm Pharma Owner's Fraud Sentence
The Sixth Circuit should affirm a district court's fraud convictions, nearly five-year sentence and $7 million restitution order against an Ohio pharmaceutical salesman who underreported his income to reduce his tax liability in a multimillion-dollar scheme involving bogus insurance billings, the federal government said.
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July 23, 2024
Chancery Slams 'Squishy' Deal In 'Tagalong' BioMarin Suit
A visibly irritated Delaware Chancery Court judge on Tuesday rejected a settlement with BioMarin Pharmaceuticals Inc. that would have given shareholder attorneys $1.25 million in exchange for broad releases and "squishy" governance reforms, saying he didn't want to encourage "tagalong litigation" that yielded only "ephemeral" benefits.
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July 23, 2024
Split 2nd Circ. Keeps Zantac Suits In Conn. State Court
A split Second Circuit panel on Tuesday allowed nine consolidated suits over carcinogens in heartburn medication Zantac to remain in Connecticut state court, with the majority ruling that the cases' consolidation is not enough to open up federal jurisdiction.
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July 23, 2024
Senate Dems Roll Out Bill To Codify Chevron Deference
Sen. Elizabeth Warren, D-Mass., led a group of Democratic senators Tuesday in introducing a bill to codify the now-defunct doctrine of Chevron deference after it was struck down by the U.S. Supreme Court last month.
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July 23, 2024
4 Firms Guide SPAC Mergers Targeting AI, Cannabis Sectors
An AI-powered startup that vows to combat "disinformation" and a medical cannabis developer have agreed to go public by merging with special purpose acquisition companies through separate deals unveiled this week, guided by four law firms and a law office.
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July 22, 2024
GSK Inks $4.5M Deal Resolving 'Non-Drowsy' Robitussin Suit
GlaxoSmithKline has agreed to pay $4.5 million as well as remove the "non-drowsy" label from its Robitussin cough medicine to put to rest allegations it mislabeled the medicine, which consumers claim does cause drowsiness, according to a motion filed Monday in New York federal court.
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July 22, 2024
AbbVie Challenges Mo. Drug Discount Program Requirements
AbbVie Inc. on Monday asked a Missouri federal court to block a state law that adds requirements to participate in the federal drug discount program, claiming that the measure violates both the federal and Missouri constitutions.
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July 22, 2024
USPTO Wins Dismissal Of Danish Co.'s PTSD Drug Lawsuit
A Virginia federal judge has ruled that the U.S. Patent and Trademark Office appropriately rejected drugmaker Lundbeck's request for three additional months of patent exclusivity for a PTSD drug, saying the agency could dock those days due to the impermissible gray shading of some text in the company's patent application.
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July 22, 2024
Tevra Says Bayer Owes Millions As Antitrust Trial Opens
Tevra Brands LLC told a California federal jury during antitrust trial openings Monday that Bayer owes millions of dollars for allegedly cutting anticompetitive deals with retailers to undermine competition from anti-flea-and-tick treatment generics, while Bayer defended its "reasonable" and optional retailer discounts and criticized Tevra's "astronomical" damages demand.
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July 22, 2024
Allarity Warns Of SEC Suit Over Cancer Drug Statements
Clinical stage pharmaceutical company Allarity Therapeutics informed investors Monday that the U.S. Securities and Exchange Commission is preparing to sue following an investigation into statements the company made as it sought approval for a new cancer treatment.
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July 22, 2024
Michigan's Cases To Watch 2024: A Midyear Report
Michigan's highest court is preparing to take on cases that could restore imperiled PFAS regulations, prevent employers from cutting short employees' window to file civil rights claims and expand the reach of Michigan's consumer protection law. Here are some of Michigan's most important cases to watch for the rest of the year.
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July 22, 2024
Price-Fixing Claims Against Par Pharma On Chopping Block
A Connecticut federal judge has asked a coalition of states to explain why he shouldn't toss two price-fixing lawsuits against Par Pharmaceutical Companies Inc., noting that the defendant and its parent, Endo International PLC, recently filed Chapter 11 reorganization plans shielding them from the cases.
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July 22, 2024
DuPont, NC To Drop Docs Dispute In 'Forever Chemicals' Case
North Carolina and DuPont have come to terms in a dispute over allegedly missing documents as part of the state's lawsuit alleging the predecessor of Chemours and other chemical companies poisoned North Carolina's environment with "forever chemicals."
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
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Opinion
The FTC Needs To Challenge The Novo-Catalent Deal
Novo's acquisition of Catalent threatens to substantially lessen competition in the manufacturing and marketing of GLP-1 diabetes and obesity drugs, and the Federal Trade Commission should challenge it under a vertical theory of harm, as it aligns with last year's merger guidelines and the Fifth Circuit decision in Illumina, says attorney David Balto.
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Series
After Chevron: Slowing Down AI In Medical Research
The U.S. Supreme Court's recent decision overturning the Chevron doctrine may inhibit agencies' regulatory efforts, potentially slowing down the approval and implementation of artificial intelligence-driven methodologies in medical research, as well as regulators' responses to public health emergencies, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.
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Series
Being A Luthier Makes Me A Better Lawyer
When I’m not working as an appellate lawyer, I spend my spare time building guitars — a craft known as luthiery — which has helped to enhance the discipline, patience and resilience needed to write better briefs, says Rob Carty at Nichols Brar.
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FDA's Multifaceted Role On Display In MDMA Therapy Scrutiny
Ongoing deliberations at the U.S. Food and Drug Administration regarding MDMA-assisted therapy for post-traumatic stress disorder serves as a window into the intricate balance of scientific innovation and patient safety oversight, and offers crucial insights into regulatory nuances, say Kimberly Chew at Husch Blackwell and Kevin Lanzo at Pharmaka Clinical Consulting.
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Lead Like 'Ted Lasso' By Embracing Cognitive Diversity
The Apple TV+ series “Ted Lasso” aptly illustrates how embracing cognitive diversity can be a winning strategy for teams, providing a useful lesson for law firms, which can benefit significantly from fresh, diverse perspectives and collaborative problem-solving, says Paul Manuele at PR Manuele Consulting.
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How Cos. Should Handle Research Org.'s Carcinogen Evals
In light of the International Agency of Research for Cancer's list of substances slated for review over the next five years, manufacturers of chemicals, pharmaceuticals and consumer products should monitor for potentially unbalanced determinations, which could stimulate litigation regarding potential exposure from products, say attorneys at Nelson Mullins.
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Analyzing FDA Draft Guidance On Clinical Trial Diversity
In light of the U.S. Food and Drug Administration's draft guidance on clinical trial diversity action plans, there are several important considerations for sponsors and clinical researchers to keep in mind to prevent delay in a drug or device application, say attorneys at Crowell & Moring.
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What's New In The AI Healthcare Regulatory Space
Attorneys at Hogan Lovells review the current legal and regulatory landscape for artificial intelligence applications in healthcare, touching on policies around safety, transparency, nondiscrimination and reimbursement, and what to expect in the future.
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Del. Dispatch: 27.6% Stockholder Not A Controller
The Delaware Court of Chancery's recent decision in Sciannella v. AstraZeneca — which found that the pharma giant, a 26.7% stockholder of Viela Bio Inc., was not a controller of Viela, despite having management control — shows that overall context matters when challenging transactions on breach of fiduciary duty grounds, say attorneys at Fried Frank.
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3 Policyholder Tips After Calif. Ruling Denying D&O Coverage
A California decision from June, Practice Fusion v. Freedom Specialty Insurance, denying a company's claim seeking reimbursement under a directors and officers insurance policy for its settlement with the Justice Department, highlights the importance of coordinating coverage for all operational risks and the danger of broad exclusionary policy language, says Geoffrey Fehling at Hunton.
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1 Year At The UPC: Implications For Transatlantic Disputes
In its first year, the Unified Patent Court has issued important decisions on procedures like provisional measures, but complexities remain when it comes to coordinating proceedings across jurisdictions like the U.S. due to differences in timelines and discovery practices, say attorneys at McDermott.
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Opinion
Now More Than Ever, Lawyers Must Exhibit Professionalism
As society becomes increasingly fractured and workplace incivility is on the rise, attorneys must champion professionalism and lead by example, demonstrating how lawyers can respectfully disagree without being disagreeable, says Edward Casmere at Norton Rose.
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Opinion
High Court Made Profound Mistake In Tossing Purdue Deal
The U.S. Supreme Court's recent decision to throw out Purdue Pharma's Chapter 11 plan jeopardizes a multistate agreement that would provide approximately $7 billion in much-needed relief to help fight the opioid epidemic, with states now likely doomed to spend years chasing individual defendants across the globe, says Swain Wood at Morningstar.
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Series
Serving In The National Guard Makes Me A Better Lawyer
My ongoing military experience as a judge advocate general in the National Guard has shaped me as a person and a lawyer, teaching me the importance of embracing confidence, balance and teamwork in both my Army and civilian roles, says Danielle Aymond at Baker Donelson.
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Big Business May Come To Rue The Post-Administrative State
Many have framed the U.S. Supreme Court’s recent decisions overturning Chevron deference and extending the window to challenge regulations as big wins for big business, but sand in the gears of agency rulemaking may be a double-edged sword, creating prolonged uncertainty that impedes businesses’ ability to plan for the future, says Todd Baker at Columbia University.