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December 19, 2024
Top Gov't Contracts Cases Of 2024
Courts and the U.S. Government Accountability Office have made several high-profile, consequential decisions for government contractors this year, addressing the constitutionality of the False Claims Act's whistleblower provisions and the limits of the president's authority over federal procurement.
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December 19, 2024
McKesson Urges Justices To Keep Hobbs Act's 'Exclusivity'
McKesson Corp. is urging the U.S. Supreme Court to preserve circuit courts' "exclusive" jurisdiction for Federal Communications Commission orders, warning that regulatory consistency nationwide could be undermined if lower courts are allowed to step in.
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December 19, 2024
Chicago Hospital Network Strikes Deal In 401(k) Fee Suit
A Chicago-area hospital system has agreed to settle a former worker's proposed class action claiming it failed to secure lower recordkeeping fees for its $1.8 billion retirement plan even when its peers were able to land better deals.
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December 19, 2024
Generic-Drug Cos. Get State AGs' Trial Order Flipped
A Connecticut federal court has sided with the generic-drug makers accused of price-fixing by state-level enforcers and will allow a narrower case involving 15 drugs to move ahead prior to a much broader case involving more than 100 medications.
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December 19, 2024
FDA Declaration May Restart Compounders' Shortage Suit
Federal regulators pulled Eli Lilly's lucrative weight-loss and diabetes drug off the national shortage list Thursday and gave compounding pharmacists two months to stop making copycat versions of the injectable medication, a move with the potential to reignite a Texas legal clash.
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December 19, 2024
GAO Says Army Can Stop Solicitation After Multiple Protests
The U.S. Government Accountability Office has rejected a protest over the U.S. Army's decision to cancel a medical instructor support deal, saying the Army reasonably found it had to address changed circumstances after a string of related protests.
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December 19, 2024
Michigan's Biggest Decisions Of 2024
This year, the Michigan Supreme Court instituted sweeping changes to the state's wage and paid leave laws, took some damages off the table for wrongful death plaintiffs, and recognized third-party retaliation claims.
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December 19, 2024
Philips CPAP Suits Against SoClean Tossed From MDLs
A Pennsylvania federal judge has tossed two complaints from Philips RS North America against SoClean Inc. from multidistrict litigation stemming from a CPAP machine recall, saying one would disrupt the wrap-up of the MDL surrounding Philips' products, while the other should not have been filed directly into the SoClean MDL.
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December 19, 2024
5th Circ. Urged To Deny Tax Break For Doc's Captive Insurance
A physician who owns a network of urgent care clinics was correctly denied tax deductions along with his wife for over $1 million in premiums they paid to insurance companies they owned, the government told the Fifth Circuit, saying the captive arrangements didn't qualify as insurance for tax purposes.
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December 19, 2024
Addiction Group Pays $2M In Mass. AG False Billing Probe
An addiction treatment physician group with offices across western Massachusetts will pay $2 million to settle allegations that it overcharged for visits and billed for tests that were not medically necessary, the state's attorney general said Thursday.
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December 18, 2024
Pharma Trial Consultant To Pay SEC $3M Over Insider Trading
An oncologist and clinical professor at the University of California, Irvine agreed to pay the U.S. Securities and Exchange Commission $3 million to resolve allegations he purchased shares in a Massachusetts biotech company based on insider information regarding a clinical trial he was overseeing, the SEC announced Wednesday.
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December 18, 2024
Ex-US Rep. Urges 2nd Circ. To Nix Insider Trading Conviction
Former Indiana Rep. Stephen Buyer on Wednesday urged the Second Circuit to reverse his insider trading conviction or grant him a new trial, saying federal prosecutors violated his Sixth Amendment rights and failed to prove Manhattan was the right place to be tried, which led a pair of circuit judges to voice doubt about the court's standard for establishing venue.
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December 18, 2024
Vaxart Investors Win Class Cert. Over COVID Shot On 2nd Try
A California federal judge has certified a class of Vaxart investors accusing the biotechnology company's onetime controlling shareholder of dumping stock at inflated prices following deceptive headlines about a COVID-19 vaccine, saying the investors' revised motion fixes issues of predominance and the damages model.
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December 18, 2024
Patent Limits For Biosimilar Litigation Lands In Spending Bill
Congress' spending package to keep the government open through March would also limit how many patents a biologics maker can assert when trying to prevent a competitor from getting on the market.
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December 18, 2024
Monsanto Protests DNA Damage Argument In PCB Closings
An attorney in a toxic tort against Monsanto drew a sustained objection from the company's defense during closings Wednesday as he attempted to argue that some of the young girls allegedly exposed to PCBs "will give birth to children with altered DNA," as counsel sparred over whether the plaintiffs suffered "generational harm."
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December 18, 2024
FDA's Gastro Drug Fast-Track Denial Survives DC Circ.
A D.C. Circuit panel upheld federal regulators' refusal to streamline approval of a drug to treat nausea in patients with a chronic gastric condition, ruling that the U.S. Food and Drug Administration was right to consider the drug's development plan when deciding whether it qualified for fast tracking.
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December 18, 2024
Pa. Nursing Home Must Face Resident's Slip-And-Fall Suit
A Pennsylvania appeals court on Wednesday reinstated a suit seeking to hold a nursing home liable for a resident's slip-and-fall injuries due to water that allegedly leaked from her room's ceiling, saying there was insufficient evidence that the home performed monthly checks for roof leaks.
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December 18, 2024
State AGs, Generic Cos. Fight Over Price-Fixing Trial Order
A contingent of state-level enforcers told a Connecticut federal court there is no need to reconsider prioritizing a sprawling generic drug price-fixing case that involves more than 100 medications over a narrower case the drugmakers are asking to have tried first.
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December 18, 2024
Morrison Foerster Cites Tariffs As Key M&A Variable For 2025
International law firm Morrison Foerster LLP is among those citing President-elect Donald Trump's tariff plans as a key wild card that could affect mergers and acquisitions deal flow in 2025, a Wednesday report from the firm shows.
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December 18, 2024
Destroyed Docs Merit Harsher Sanctions, Mich. Panel Says
A Michigan appellate panel on Tuesday said fees awarded to the estate of a man who died after choking in an adult foster care facility were likely too low, finding a lower court erred by limiting the scope of available sanctions over the destruction of "copious amounts" of digital evidence.
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December 18, 2024
Philip Morris Sues FDA Over New Cigarette Warning Labels
Tobacco giant Philip Morris and a group of Georgia convenience store interests have sued the U.S. Food and Drug Administration over a rule that would add graphic warnings to cigarette labels, alleging the agency is exceeding its statutory authority in a move that would mark a "sea change" for the industry.
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December 18, 2024
Judge Eyes Limits To Medical Device Co.'s Poaching Verdict
A Boston federal judge on Wednesday considered interpreting twin $5 million jury awards against medical device sales employees as a subset of the $15 million in damages awarded against their employer in a rival company's poaching case.
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December 18, 2024
CVS Fueled Opioid Epidemic In Rush For Profits, Feds Say
The U.S. Department of Justice unveiled a suit Wednesday accusing CVS, the nation's largest pharmacy chain, of knowingly filling invalid prescriptions for powerful opioids and ignoring internal pleas from its pharmacists as it allegedly put profits over safety.
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December 18, 2024
Amgen Hit With $50M Infringement Verdict Over Leukemia Drug
Germany's Lindis Biotech has persuaded a Delaware federal jury that Amgen should pay $50.3 million in damages for encouraging healthcare providers to infringe the Munich company's immunotherapy patents through administering the leukemia drug Blincyto.
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December 18, 2024
Homeless Woman's Residency Unclear In Inter-Insurer Dispute
A Michigan state appeals court has vacated a trial court order finding the insurer for a homeless woman's parents must cover injuries she suffered after being run over by a semitruck, ruling that questions remain over whether the woman had another established residence.
Expert Analysis
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Opinion
Weak Reasoning Underlies Fla. Judge's Bold Qui Tam Ruling
U.S. District Judge Kathryn Mizelle's groundbreaking decision in U.S. ex rel. Zafirov v. Florida Medical Associates LLC, holding that qui tam provisions of the False Claims Act are unconstitutional, relies on weak logic to reach a conclusion that differs from every other court that has ruled on the issue, says Ethan Greenberg at Anderson Kill.
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When Investigating An Adversary, Be Wary Of Forged Records
Warnings against the use of investigators who tout their ability to find an adversary’s private documents generally emphasize the risk of illegal activity and attorney discipline, but a string of recent cases shows an additional danger — investigators might be fabricating records altogether, says Brian Asher at Asher Research.
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3 Ways To Train Junior Lawyers In 30 Minutes Or Less
Today’s junior lawyers are experiencing a skills gap due to pandemic-era disruptions, but firms can help bring them up to speed by offering high-impact skill building content in bite-sized, interactive training sessions, say Stacey Schwartz at Katten, Diane Costigan at Winston & Strawn and Lauren Tierney at Freshfields.
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Medicare Overpayment Rules Are A Mixed Bag For Providers
The Centers for Medicare & Medicaid Services' updated rules for handling agency overpayments adopt a more reasonable definition of what it means to have "identified" an overpayment, which is a win for providers, but their new time frame for investigating related overpayments is unrealistic, says Susan Banks at Holland & Knight.
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Navigating Decentralized Clinical Trials With FDA's Guidance
The U.S. Food and Drug Administration's recently finalized guidance on conducting decentralized clinical trials, while not legally binding, can serve as a road map for sponsors, investigators and others to ensure trial integrity and participant safety, say attorneys at Phillips Lytle.
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The Bar Needs More Clarity On The Discovery Objection Rule
Almost 10 years after Federal Rule of Civil Procedure 34 was amended, attorneys still seem confused about what they should include in objections to discovery requests, and until the rules committee provides additional clarity, practitioners must beware the steep costs of noncompliance, says Tristan Ellis at Shanies Law Office.
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Expect More State-Level Scrutiny Of Noncompetes Ahead
Despite the nationwide injunction against the Federal Trade Commission’s noncompete ban, and the incoming Republican administration, employers should anticipate that state legislatures will continue to focus on laws that limit or ban noncompetes, including those that target certain salary thresholds or industries, says Benjamin Fryer at FordHarrison.
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Series
Being A Navy Reservist Makes Me A Better Lawyer
Serving this country in uniform has not only been one of the greatest honors of my life, but it has also provided me with opportunities to broaden my legal acumen and interpersonal skills in ways that have indelibly contributed to my civilian practice, says Phillip Smith at Weinberg Wheeler.
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Cos. Should Inventory Issues To Prep For New Congress
As the legislative and oversight agendas of the 119th Congress come into sharper focus, corporate counsel should assess and plan for areas of potential oversight risk — from tax policy changes to supply chain integrity — even as much uncertainty remains, say attorneys at WilmerHale.
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Incoming Admin May Shake Up Life Sciences Regulation
Though President-elect Donald Trump has not yet articulated policy priorities regarding the life sciences industry, the sector is positioned to see significant changes that could affect everything from drug exclusivity and generic drug approvals, to the availability of over-the-counter drugs, to laboratory-developed tests and digital health, say attorneys at Morgan Lewis.
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Next Steps In The $2.8B Blue Cross Payout To Providers
Healthcare providers deciding whether to participate in Blue Cross Blue Shield network's recent $2.8 billion antitrust class action settlement must weigh key recovery factors, including provider type and litigation cost, say attorneys at Hall Render.
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Navigating DOJ's Patchwork Whistleblower Regime
In the past few months, the U.S. Department of Justice and several individual U.S. attorney’s offices have issued different pilot programs aimed at incentivizing individuals to blow the whistle on misconduct, but this piecemeal approach may create confusion and suboptimal outcomes, say attorneys at BakerHostetler.
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What To Expect From State AGs As Federal Control Changes
Under the next Trump administration, Democratic attorneys general are poised to strengthen enforcement in certain areas as Republican attorneys general continue their efforts with stronger federal support — resulting in a confusing patchwork of policies that create unintended liabilities for businesses operating in multiple jurisdictions, say attorneys at Morgan Lewis.
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So You Want To Move Your Law Practice To Canada, Eh?
Google searches for how to move to Canada have surged in the wake of the U.S. presidential election, and if you’re an attorney considering a move to the Great White North, you’ll need to understand how the practice of law differs across the border, says David Postel at Henein Hutchison.
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What To Expect Next From Federal Health Tech Regulation
Healthcare organizations should pay close attention to federal health information technology regulators' recent guidance concerning barriers to accessing electronic health information, which signals that more enforcement in this area is likely forthcoming, say attorneys at Ropes & Gray.