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November 15, 2024
Eli Lilly Says HHS Ignores Drug Discount Double-Dipping
Eli Lilly & Co. claims the U.S. Department of Health and Human Services is unlawfully blocking its efforts to crack down on hospitals the company alleges are double-dipping on medication discounts that are meant to benefit low-income patients, according to a lawsuit filed in D.C. federal court.
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November 15, 2024
Natera Exec Calls Guardant's Cancer Test Claims 'Dangerous'
Natera's president of clinical diagnostics testified at trial Friday in a California federal false advertising case that Guardant Health's claims about Guardant's competing colorectal cancer test were "false and misleading" and also "dangerous."
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November 15, 2024
Kroger, Texas Ink $83M Deal Over Opioid Crisis
Texas announced it has agreed to an $83 million settlement with Kroger to resolve the state's claims alleging the groceries and pharmacy chain maintained practices that contributed to the opioid crisis in Texas, apparently as part of a larger $1.37 billion agreement the retailer recently reached with several states.
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November 15, 2024
HHS Likely To Limit Migrant Data After Flores Deal Ends
A California federal judge indicated Friday that she can't force the U.S. Department of Health and Human Services to provide human rights groups with regular data about children in low-security detention facilities now that the long-running Flores settlement has been replaced with a government regulation.
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November 15, 2024
PBMs Denied Breakup Of Combined FTC Insulin Price Trial
The Federal Trade Commission's allegations that pharmacy benefit manager giants Caremark Rx, Express Scripts and OptumRx are artificially inflating insulin prices through unfair rebate schemes will forge ahead as a single case following an in-house agency judge's refusal to break them into separate proceedings.
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November 15, 2024
Despite Vaccine Spotlight, RFK Jr. A Health Policy 'Unknown'
Robert F. Kennedy Jr., President-elect Donald Trump's pick to be the nation's top health official, has made clear his unorthodox and often false views on public health issues like vaccines. But there's still plenty of policy under his potential control where his stance remains opaque, attorneys say, which could stymie their efforts to prepare for the next four years.
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November 15, 2024
Healthcare Co. PACS Made False Claims Before IPO, Suit Says
Healthcare holding company PACS Group Inc. has been hit with a proposed shareholder class action on the heels of a short seller's report that alleged the company engaged in deceptive practices to boost its value ahead of its initial public offering, including Medicare claims fraud.
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November 15, 2024
Ariz. Judge Will Decide Proper Venue For CVS Antitrust Suit
A federal judge concluded Thursday that he must decide whether a proposed class action accusing CVS of exploiting a Medicare loophole to charge independent pharmacies exorbitant fees belongs in arbitration, after scolding CVS's attorneys for failing to adequately develop their arguments defending an underlying delegation clause.
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November 15, 2024
Feds Say 'One' DACA Kid Not Enough To Sue Over Health Reg
The Biden administration slammed North Dakota's attempt to show financial suffering from a federal rule granting health coverage to DACA recipients, saying that the state pointing to "one" unidentified DACA individual isn't enough to establish standing for a lawsuit.
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November 15, 2024
DEA Judge Nixes Vet Group's Bid To Take Part In Pot Hearings
An administrative law judge with the U.S. Drug Enforcement Administration on Friday denied a veterans group's bid to participate in upcoming hearings on a proposal to loosen federal restrictions on marijuana.
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November 15, 2024
Fla. Health Co. Owner Pleads Guilty In $11M Payroll Tax Case
A Florida healthcare business owner who caused a tax loss to the IRS of nearly $11 million pled guilty in a Miami federal court to failing to pay employment taxes and not filing his income tax returns, the U.S. Department of Justice said Friday.
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November 15, 2024
Abbott Inks $8M Deal With Healthcare Fraudster In TM Suit
A New York federal judge on Thursday green-lit a trademark infringement settlement in which Abbott Laboratories will receive $8 million from a Florida businessman who recently pled guilty to healthcare fraud for his role in a sprawling gray market scheme to profit off of Abbott's line of diabetic test strips meant to be sold internationally.
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November 15, 2024
Teva Defends Mifepristone Antitrust Case Against Corcept
Teva Pharmaceuticals has asked a California federal judge to reject a bid to dismiss its lawsuit against the maker of a brand-name drug used to treat a rare cortisol disorder, contending its complaint plausibly alleges an illegal scheme to suppress generic competition.
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November 15, 2024
Attys Get 'Final Warning' In Tepezza Hearing Loss MDL
A magistrate judge has chastised attorneys on both sides of multidistrict litigation involving claims that a thyroid eye disease treatment manufactured by Horizon Pharmaceuticals Inc. causes hearing loss, calling for an end to their "improper" conduct during depositions.
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November 15, 2024
Orrick Trial Partner Joins Morgan Lewis In Boston
Morgan Lewis & Bockius LLP announced that an experienced litigator from Orrick Herrington & Sutcliffe LLP joined the firm's Boston office as a partner, enhancing its capacity in areas such as life sciences and regulatory compliance.
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November 15, 2024
Pharma Biz To Pay $47M To Settle Feds' Kickback Claims
A Florida pharmaceutical company and its chief executive have agreed to pay $47 million to settle claims that their practice of paying for certain patient tests crossed the line into being an illegal kickback to increase prescriptions of an enzyme replacement therapy, Boston federal prosecutors said on Friday.
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November 15, 2024
Taxation With Representation: Cravath, MoFo, Gibson Dunn
In this week's Taxation With Representation, Cardinal Health takes a majority stake in GI Alliance and acquires Advanced Diabetes Supply Group, Just Eat offloads Grubhub to Wonder Group, Rivian Automotive and Volkswagen Group launch a joint venture, and Ovintiv Inc. buys Montney Basin assets from Paramount Resources Ltd.
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November 15, 2024
Hospital Workers' 2nd Circ. Appeal May Wait For Deloitte Case
Workers for Montefiore Medical Center seeking to revive retirement plan mismanagement allegations may see a delayed ruling in their case until another Second Circuit panel rules on similar claims against Deloitte, a panel judge said Friday during proceedings.
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November 15, 2024
MVP: Ropes & Gray's Tim McCrystal
Tim McCrystal, co-chair of Ropes & Gray LLP's healthcare practice, has guided clients through serious regulatory changes, including advising Vistria Portfolio Co. in its acquisition of Recco Home Care Services Inc. and representing Gentiva in the $350 million sale of its personal care business, earning him a spot as one of the 2024 Law360 Healthcare MVPs.
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November 14, 2024
Trump's RFK Jr. Pick For HHS Draws Its Share Of Critics
The nomination of Robert F. Kennedy Jr. — well-known for his opposition to vaccines — as the secretary of the U.S. Department of Health and Human Services is President-elect Donald Trump's latest controversial pick for his administration, and one that could disrupt the U.S. Food and Drug Administration and its mission.
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November 14, 2024
Ex-Ga. Rep. Doug Collins To Head Trump's Veterans Affairs
President-elect Donald Trump announced Thursday that his administration's U.S. Department of Veterans Affairs will be led by former Rep. Doug Collins, a Republican from Georgia and an attorney who steered Trump's defense during his impeachment by the House.
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November 14, 2024
Patient's Trial Testimony Doomed Med Mal Case, Panel Says
A New Jersey appeals court on Thursday affirmed a doctor's mistrial win in a suit alleging that he failed to diagnose a woman's diabetes, causing serious injuries, saying the woman's own admission on the witness stand made it clear that her claims were untimely.
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November 14, 2024
Maryland Seeks To Undo Litigation Pause In Purdue Appeal
The state of Maryland argued in New York federal court Thursday that it should be allowed to pursue claims against the Sackler family members who own bankrupt OxyContin maker Purdue Pharma LP, and that a temporary injunction currently blocking a flood of litigation should be thrown out.
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November 14, 2024
NY Nursing Homes Ink $45M Deal To End AG's Fraud Suit
Four New York nursing homes have agreed to a $45 million deal that will end a civil lawsuit brought by the state accusing them of neglecting residents and defrauding Medicare and Medicaid, according to a Friday announcement by New York Attorney General Letitia James.
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November 14, 2024
EEOC Says Texas, Think Tank Can't Scrap Bostock Guidance
The U.S. Equal Employment Opportunity Commission urged a federal court to shoot down Texas' challenge to workplace harassment guidance the agency issued based on the U.S. Supreme Court's Bostock decision, arguing the state failed to demonstrate that the guidelines had caused them any harm.
Expert Analysis
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Law Firms Should Move From Reactive To Proactive Marketing
Most law firm marketing and business development teams operate in silos, leading to an ad hoc, reactive approach, but shifting to a culture of proactive planning — beginning with comprehensive campaigns — can help firms effectively execute their broader business strategy, says Paul Manuele at PR Manuele Consulting.
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OSHA Workplace Violence Citation Highlights Mitigation Steps
The Occupational Safety and Health Administration's recent citation against behavioral health company Circles of Care sheds light on the enforcement risks companies may face for failing to prevent workplace violence, and is a reminder of the concrete steps that can help improve workplace safety, say attorneys at Benesch.
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When Banks Unknowingly Become HIPAA Biz Associates
There appears to be significant confusion regarding the application of the Health Insurance Portability and Accountability Act to financial institutions when serving healthcare-related clients, so these institutions should consider undertaking several steps as a starting point in the effort to achieve compliance, say attorneys at Vorys.
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The Regulatory Headwinds Facing Lab-Developed Tests
Though the U.S. Food and Drug Administration's final rule regarding regulation of laboratory-developed tests outlines a four-year plan for ending enforcement discretion, and though this rule is currently being challenged in courts, manufacturers should heed compliance opportunities immediately as enforcement actions are already on the horizon, say attorneys at Kirkland & Ellis.
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3 High Court Rulings May Shape Health Org. Litigation Tactics
Three separate decisions from the U.S. Supreme Court's most recent term — Loper Bright, Corner Post and Jarkesy — will likely strengthen healthcare organizations' ability to affirmatively sue executive agencies to challenge regulations governing operations and enforcement actions, say attorneys at McDermott.
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Opinion
A New Way Forward For COVID Vaccine Lawsuit Immunity
As Public Readiness and Emergency Preparedness Act protections for COVID-19 vaccines wane, adding those vaccines to coverage by the National Vaccine Injury Compensation Program would bolster defenses for administrators and manufacturers while also providing stronger remedies for those injured by vaccines, says Altom Maglio at MCT Law.
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Opinion
The Big Issues A BigLaw Associates' Union Could Address
A BigLaw associates’ union could address a number of issues that have the potential to meaningfully improve working conditions, diversity and attorney well-being — from restructured billable hour requirements to origination credit allocation, return-to-office mandates and more, says Tara Rhoades at The Sanity Plea.
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Opinion
It's Time For A BigLaw Associates' Union
As BigLaw faces a steady stream of criticism about its employment policies and practices, an associates union could effect real change — and it could start with law students organizing around opposition to recent recruiting trends, says Tara Rhoades at The Sanity Plea.
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Why DOJ's Whistleblower Program May Have Limited Impact
The U.S. Department of Justice’s new whistleblower pilot program aims to incentivize individuals to report corporate misconduct, but the program's effectiveness may be undercut by its differences from other federal agencies’ whistleblower programs and its interplay with other DOJ policies, say attorneys at Milbank.
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How Justices Upended The Administrative Procedure Act
In its recent Loper Bright, Corner Post and Jarkesy decisions, the U.S. Supreme Court fundamentally changed the Administrative Procedure Act in ways that undermine Congress and the executive branch, shift power to the judiciary, curtail public and business input, and create great uncertainty, say Alene Taber and Beth Hummer at Hanson Bridgett.
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Opinion
DOL's Impending Mental Health Act Regs Should Be Simplified
The U.S. Department of Labor should consider revising these six issues in its forthcoming Mental Health Parity and Addiction Equity Act regulations to ease the significant compliance hurdles for group health plan sponsors, says Alden Bianchi at McDermott.
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Parsing FY 2024 DOJ Criminal Healthcare Fraud Enforcement
While the U.S. Department of Justice's Criminal Division's strike force on healthcare fraud enforcement action shows an impressive doubling of criminal indictments, a closer look at the data offers important clues about underlying trends, including the comparably modest, accompanying increase in associated intended loss, say Roderick Thomas and Kathleen Cooperstein at Wiley.
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9th Circ. Ruling Flags Work Harassment Risks Of Social Media
The recent Ninth Circuit ruling in Okonowsky v. Garland, holding an employer could be liable for a co-worker's harassing social media posts, highlights new challenges in technology-centered and remote workplaces, and underscores an employer's obligation to prevent hostile environments wherever their employees clock in, say Jennifer Lada and Phillip Schreiber at Holland & Knight.
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Vendor Rights Lessons From 2 Chapter 11 Cases
A Texas federal court’s recent critical vendor order in the Zachry Holdings Chapter 11 filing, as well as a settlement between Rite Aid and McKesson in New Jersey federal court last year, shows why suppliers must object to critical vendor motions that do not recognize creditors' legal rights, says David Conaway at Shumaker.
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How Cos. With Chinese Suppliers Should Prep For Biotech Bill
A proposed bill to prohibit government-affiliated life sciences companies from contracting with Chinese biotech companies of concern may necessitate switching to other sources for research and supplies, meaning they should begin evaluating supply chains now due to the long lead times of drug development, say John O'Loughlin and Christina Carone at Weil Gotshal.