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Life Sciences
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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."
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July 22, 2024
Groups Ask 3rd Circ. To Reverse Medicare Drug Price Rulings
A conservative group was one of several organizations to file amicus curiae briefs with the Third Circuit on Friday urging it to reverse a lower court's finding that Medicare's ability to negotiate drug prices with pharmaceutical companies does not run contrary to the companies' constitutional rights.
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July 22, 2024
Anthem Blue Cross Wants Lab's $3.8M Suit Tossed
Anthem Blue Cross Blue Shield of Connecticut has asked a federal judge to toss a medical lab's lawsuit seeking nearly $3.8 million from it for refusing to pay for or underpaying for lab work and COVID-19 tests, arguing the claims are "baseless."
Expert Analysis
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Navigating FDA Supply Rule Leeway For Small Dispensers
As the November compliance deadline for the U.S. Food and Drug Administration's new pharmaceutical distribution supply chain rules draws closer, small dispensers should understand the narrow flexibilities that are available, and the questions to consider before taking advantage of them, say attorneys at Faegre Drinker.
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Series
Solving Puzzles Makes Me A Better Lawyer
Tackling daily puzzles — like Wordle, KenKen and Connections — has bolstered my intellectual property litigation practice by helping me to exercise different mental skills, acknowledge minor but important details, and build and reinforce good habits, says Roy Wepner at Kaplan Breyer.
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Texas Ethics Opinion Flags Hazards Of Unauthorized Practice
The Texas Professional Ethics Committee's recently issued proposed opinion finding that in-house counsel providing legal services to the company's clients constitutes the unauthorized practice of law is a valuable clarification given that a UPL violation — a misdemeanor in most states — carries high stakes, say Hilary Gerzhoy and Julienne Pasichow at HWG.
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6 Lessons From DOJ's 1st Controlled Drug Case In Telehealth
Following the U.S. Department of Justice’s first-ever criminal prosecution over telehealth-prescribed controlled substances in U.S. v. Ruthia He, healthcare providers should be mindful of the risks associated with restricting the physician-patient relationship when crafting new business models, says Jonathan Porter at Husch Blackwell.
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Series
After Chevron: Scale Tips Favor Away From HHS Agencies
The loss of Chevron deference may indirectly aid parties in challenging the U.S. Department of Health and Human Services' interpretations of regulations and could immediately influence several pending cases challenging HHS on technical questions and agency authority, say attorneys at Ropes & Gray.
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2 Options For Sackler Family After High Court Purdue Ruling
After the U.S. Supreme Court recently blocked Purdue Pharma's plan to shield the family that owns the company from bankruptcy lawsuits, the Sacklers face the choice to either continue litigation, or return to the bargaining table for a settlement that doesn't eliminate creditor claims, says Gregory Germain at Syracuse University.
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In Memoriam: The Modern Administrative State
On June 28, the modern administrative state, where courts deferred to agency interpretations of ambiguous statutes, died when the U.S. Supreme Court overruled its previous decision in Chevron v. Natural Resources Defense Council — but it is survived by many cases decided under the Chevron framework, say Joseph Schaeffer and Jessica Deyoe at Babst Calland.
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Series
After Chevron: Expect Limited Changes In USPTO Rulemaking
The U.S. Supreme Court’s recent ruling overturning Chevron deference will have limited consequences for the U.S. Patent and Trademark Office given the USPTO's unique statutory features, but it is still an important decision for matters of statutory interpretation, especially those involving provisions of the America Invents Act, say Andrei Iancu and Cooper Godfrey at Sullivan & Cromwell.
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How High Court Approached Time Limit On Reg Challenges
The U.S. Supreme Court's decision in Corner Post v. Federal Reserve Board effectively gives new entities their own personal statute of limitations to challenge rules and regulations, and Justice Brett Kavanaugh's concurrence may portend the court's view that those entities do not need to be directly regulated, say attorneys at Snell & Wilmer.
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Fed. Circ. Skinny Label Ruling Guides On Infringement Claims
The Federal Circuit's recent decision in Amarin v. Hikma shows generic drug manufacturers must pay close attention to the statements in their abbreviated new drug application labels to put themselves in the best position in defending against an induced infringement claim, say Luke Shannon and Roshan Shrestha at Taft Stettinius.
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4 Takeaways From Biotech Patent Invalidity Ruling
The recent Patents Court decision in litigation between Advanced Cell Diagnostics and Molecular Instruments offers noteworthy commentary on issues related to experiments done in the ordinary course of business, joint importation, common general knowledge and mindset, and mosaicking for anticipation, say Nessa Khandaker and Darren Jiron at Finnegan.
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How To Clean Up Your Generative AI-Produced Legal Drafts
As law firms increasingly rely on generative artificial intelligence tools to produce legal text, attorneys should be on guard for the overuse of cohesive devices in initial drafts, and consider a few editing pointers to clean up AI’s repetitive and choppy outputs, says Ivy Grey at WordRake.
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Calif. Ruling Heightens Medical Product Maker Liability
The California Supreme Court's decision in Himes v. Somatics last month articulates a new causation standard for medical product manufacturer liability that may lead to stronger product disclosures nationwide and greater friction between manufacturers and physicians, say attorneys at Cooley.
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Constitutional Protections For Cannabis Companies Are Hazy
Cannabis businesses are subject to federal enforcement and tax, but often without the benefit of constitutional protections — and the entanglement of state and federal law and conflicting judicial opinions are creating confusion in the space, says Amber Lengacher at Purple Circle.
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USPTO Disclaimer Rule Would Complicate Patent Prosecution
The U.S. Patent and Trademark Office's proposed changes to terminal disclaimer practice could lead to a patent owner being unable to enforce a valid patent simply because it is indirectly tied to a patent in which a single claim is found anticipated or obvious in view of the prior art, say attorneys at Sterne Kessler.