Policy & Compliance
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August 12, 2024
Paragard IUD Makers Gearing Up For Defect Dismissal Bid
Teva Pharmaceuticals and The Cooper Cos. have five days to reach out to plaintiffs who may be included in a motion to dismiss the sprawling litigation over alleged defects in the Paragard IUD, a Georgia federal judge said Monday.
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August 12, 2024
NJ Hospital Ex-Worker's Tactics Doom Class Cert., Court Told
A former employee of a New Jersey healthcare network who seeks to certify a class of employees alleging they were denied proper overtime didn't comply with deposition requests, the company told a federal court, arguing that the certification request should be denied.
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August 12, 2024
Big Tobacco To Pay $600M In 'Historic' Mass. Deal
Philip Morris Inc. and RJ Reynolds Tobacco Co. will pay nine-figure sums as part of a $600 million settlement between Massachusetts and major tobacco companies that resolves yearslong disputes about how much the cigarette makers owe, the state attorney general announced Monday.
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August 09, 2024
Takeda Should Face Certified Antitrust Classes, Judge Says
A New York federal judge on Friday recommended certifying two classes of direct purchasers and end payors in consolidated antitrust actions accusing Takeda Pharmaceuticals Co. of unlawfully inflating the price of its diabetes treatment Actos by delaying entry of generic alternatives.
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August 09, 2024
Valeant's Legal Gripe A Total 'Nothingburger,' Justices Told
A lawyer who assembled a whistleblower lawsuit against a major pharmaceutical company using publicly available patent board filings says the larger legal question of whether he can do that is way too niche for the U.S. Supreme Court to bother thinking about.
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August 09, 2024
Medicare Drug Price Suit Nixed Over 'Forum Shopping' In Ohio
The Department of Health and Human Services has notched yet another win in litigation challenging the constitutionality of the Medicare drug price negotiation program, securing the dismissal of a suit brought by several chambers of commerce.
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August 09, 2024
DC Circ. Pans Suit Claiming HHS Caused Health Aid Shortage
The D.C. Circuit said Friday that a judge properly dismissed a proposed class action blaming the U.S. Department of Health and Human Services for a lack of home health aides willing to assist Medicare beneficiaries with chronic illnesses, saying the private providers aren't required to accept those patients.
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August 09, 2024
FDA Rejects Latest Effort To Treat PTSD With MDMA
The U.S. Food and Drug Administration has rejected a new drug application to treat post-traumatic stress disorder with the psychedelic drug MDMA, an entactogen also known as ecstasy or molly, the company that backed the effort announced Friday.
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August 09, 2024
Aetna Illegally Axed Exec's Disability Benefits, Judge Says
A California federal judge said Aetna was wrong to end an executive's disability benefits after it found he suffered from a mental illness instead of a physical disability, stating the insurer used flawed doctor opinions and may have been motivated by cutting costs.
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August 07, 2024
Feds Let The Wrong Family Bury Hopi Artist's Body, Kids Say
The children of a renowned Hopi artist have sued the United States in Arizona federal court on claims that an Indian Health Service facility gave their deceased mother's body to the wrong family, saying they couldn't give her a proper burial due to the government's negligence.
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August 07, 2024
NC Hospital Can't Avoid Doc's False Report Claims
A North Carolina federal court should only throw out part of a doctor's lawsuit alleging his former employer made a false report to a federal oversight board about an internal investigation, a magistrate judge has recommended, reasoning that the physician plausibly claimed his reputation and business prospects were harmed.
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August 07, 2024
Amgen Waged Lawfare To Overcharge For Drug, Suit Claims
Maryland-based independent licensees of the Blue Cross Blue Shield Association claim pharmaceutical giant Amgen Inc. and its subsidiaries have engaged in unlawful monopolistic practices that have inflated the cost of the blockbuster drug Enbrel.
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August 07, 2024
Okla. Wants Justices To Step Into Title X Funding Cut Fight
Oklahoma has filed an emergency application with the U.S. Supreme Court to stop the U.S. Department of Health and Human Services from withholding millions of dollars of Title X funding from the state because of its refusal to refer family planning patients for abortions.
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August 06, 2024
Fed. Circ. Told Edwards Filed Safe Harbor Suit With Bad Intent
The Federal Circuit rightfully held Meril Life Sciences was protected by a patent safe harbor when bringing its preapproval transcatheter heart valve system to an industry conference and that Edwards Lifesciences' attempts to prove otherwise are just delay tactics, Meril told the full court.
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August 06, 2024
Ohio Judge Upholds Law Limiting Gender Care, Sports Access
An Ohio judge on Tuesday allowed the state to begin enforcing a law that restricts gender-affirming care for minors and bans transgender girls' participation in female sports, siding with the state and determining that the law is a legitimate attempt to protect children.
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August 06, 2024
A 'Watershed' DOJ Tipster Program Eyes Private Payer Fraud
A U.S. Department of Justice pilot program promising payouts to qualifying whistleblowers who tip off investigators about schemes at private healthcare payers marks a big shift in federal fraud enforcement efforts, and a significant new liability risk for providers.
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August 06, 2024
Cancer Doc In Bitter Firing Dispute Loses At Mont. High Court
A Montana oncologist's firing from his longtime hospital in Helena prompted an outcry among his former patients. A recent ruling by the Montana Supreme Court in favor of his former employer closed a chapter in an ongoing legal saga.
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August 06, 2024
NC Hospital Gets New Shot At Emergency Dept. Plan Approval
A state appellate panel on Tuesday unraveled a decision overturning approval for a freestanding emergency department in rural North Carolina, ruling that an administrative law judge misapplied precedent when deciding whether a state agency's failure to hold a public hearing prejudiced the decision-making process.
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August 07, 2024
Dinsmore Adds 5-Atty Litigation Group From Bricker Graydon
Dinsmore & Shohl LLP announced Tuesday that a five-person litigation team led by a healthcare partner with over 30 years of experience joined the firm's Columbus, Ohio, office from Bricker Graydon LLP.
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August 06, 2024
Alabama Calls Its Gender Care Law A Rational Policy Choice
Alabama lawmakers acted out of a desire to protect children — not discriminatory intent — when they passed legislation that restricted gender-affirming care for minors, easily clearing the legal standard required to uphold the law, the state has told a federal judge.
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August 06, 2024
CMS Signals States Can Dump Medical Debt After NC Consent
After the U.S. Centers for Medicare & Medicaid Services approved North Carolina's plan to offer enhanced Medicaid reimbursements for hospitals that forgive medical debts, other states could follow its lead. Some have questioned whether the state agency implementing the program can legally carry it out.
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August 06, 2024
Ethical, Legal Challenges Await La. Surgical Castration Law
Physicians in Louisiana may be forced to confront unusual ethical questions under a first-in-the-nation state law allowing judges to order the surgical castration of some sex offenders.
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August 06, 2024
5 More Podcasts For Health, Life Sciences Attorneys
As the days get hotter and the start of the school year gets closer, health and life sciences practitioners might need a respite. If you've been there and done that with Law360's first five recommended podcasts, here are five more to take you into the fall and beyond.
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August 05, 2024
Indivior Accused Of Overstating Prospects Of 3 Opioid Drugs
Drugmaker Indivior PLC has been hit with a proposed investor class action in Virginia federal court over claims it overstated the financial prospects of its drugs used to treat opioid use disorders and the company's ability to forecast such financial projections.
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August 05, 2024
Chinese Drug Co. Says Sanctions In Valsartan MDL Too Harsh
Chinese drug firm Zhejiang Huahai Pharmaceutical Co. Ltd. told a New Jersey federal court Friday that sanctions authorizing two adverse jury instructions in multidistrict litigation over generic drugs contaminated with carcinogens should be overturned, arguing the plaintiffs did not allege the bad faith required for such a harsh penalty.
Expert Analysis
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What An NCAA Drug Test Change Could Mean For Cannabis
If the NCAA follows through with its decision to remove cannabis from its banned list of substances, it will affect college athletes, athletic directors, public relations employees, and marketing departments at universities and colleges, and it will have a significant economic effect on the cannabis industry, say Stanley Jutkowitz and Sydney Jenkins at Seyfarth.
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When Calif. Health Shield Law Reaches Beyond State Borders
In light of California's newly signed shield law to increase protections for reproductive health and gender-affirming care, it's important to understand how the law's covered services and key legal protections could affect patients and providers nationwide, says Natalie Birnbaum at Nelson Hardiman.
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FDA's Lab-Developed Test Rule Faces High Hurdles
The U.S. Food and Drug Administration's recently announced plans to explicitly regulate lab-developed tests will likely face resistance from industry stakeholders and congressional actions, and lead to significant litigation, say attorneys at Hogan Lovells.
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FTC's Health Co. Suit Indicates Agency's Private Equity Focus
The Federal Trade Commission's latest lawsuit against an anesthesia company and its private equity investor highlights the agency's willingness to regulate the health care industry even when relevant acquisitions are relatively dated or when the controlling entity's economic interest is under 50%, say attorneys at Simpson Thacher.
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What Marijuana Status Change Would Mean For Industry
If the Drug Enforcement Administration accepts the U.S. Department of Health and Human Services’ recent recommendation to change marijuana’s classification under federal law, it would be a significant regulatory shift that could foster many industry benefits — but questions, risks and uncertainties at both the state and federal levels would remain, say attorneys at Neal Gerber.
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Top 4 Antitrust Enforcement Issues In Health Care Today
The Federal Trade Commission's recent lawsuit against U.S. Anesthesia Partners exemplifies antitrust enforcement authorities' efforts to aggressively reshape the health care industry, ranging from new proposed rules to withdrawals of previous guidance, say attorneys at Fried Frank.
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Calif. Climate Disclosure Bills Promise Challenges For Cos.
Two novel climate disclosure bills recently passed by the California Legislature will pose challenges for many businesses — especially private companies that are less familiar with climate-related reporting obligations — and will require investments of significant time and effort in processes, procedures and personnel, say John Rousakis and Chris Bowman at O'Melveny.
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Maximizing Law Firm Profitability In Uncertain Times
As threats of an economic downturn loom, firms can boost profits by embracing the power of bottom-line management and creating an ecosystem where strategic financial oversight and robust timekeeping practices meet evolved client relations, says Shireen Hilal at Maior Strategic Consulting.
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5th Circ. Ruling Reminds Attys That CBP Can Search Devices
The Fifth Circuit’s recent Malik v. Department of Homeland Security decision adds to the chorus of federal courts holding that border agents don’t need a warrant to search travelers’ electronic devices, so attorneys should consider certain special precautions to secure privileged information when reentering the U.S., says Jennifer Freel at Jackson Walker.
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ESG Around The World: European Union
As the EU makes ESG regulation a priority, companies — both those based in the EU and others just doing business there — need to keep abreast of myriad new legislation that has either already taken effect or will in the near future, as noncompliance could result in fines, damages and director liability, say attorneys at Steptoe & Johnson.
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Avoiding The Ethical Pitfalls Of Crowdfunded Legal Fees
The crowdfunding of legal fees has become increasingly common, providing a new way for people to afford legal services, but attorneys who accept crowdsourced funds must remember several key ethical obligations to mitigate their risks, say Hilary Gerzhoy and Julienne Pasichow at HWG.
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4 Pharma Industry Arguments Against CMS Drug Pricing Plan
The Centers for Medicare & Medicaid Services is facing significant pushback regarding its plans for implementing the Inflation Reduction Act's Medicare drug price negotiation program, due to a number of potential repercussions for manufacturers, say attorneys at Mintz Levin.
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Issues Ahead As Psychedelic Medicine Faces Pivotal Moment
Recent regulatory changes and decriminalization efforts have opened doors for research and development in psychedelic medicine, but challenges like stigma, access and funding persist, meaning companies will need to address these issues to support the industry’s credibility, say consultants at FTI Consulting.