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March 22, 2024
Vanda's Obviousness Appeal Isn't Worthwhile, Teva Tells Justices
Teva Pharmaceuticals and Apotex have said the U.S. Supreme Court should reject a petition from Vanda Pharmaceuticals, which said the Federal Circuit "charted its own course" when it invalidated its sleep drug patents as obvious.
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March 22, 2024
FCC Ready To Propose Local Georouting For 988 Calls
The Federal Communications Commission is preparing to take action to make sure that calls coming into the 988 Suicide and Crisis Lifeline are being routed to the nearest call center and not another one states away.
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March 22, 2024
6th Circ. Says Fired Doctor Got Enough Due Process
The Sixth Circuit backed two Ohio healthcare companies and Wright State University's early wins against a former resident doctor's claims that she was improperly fired for unprofessional conduct, stating that all the parties involved engaged in "more than enough due process" before terminating her.
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March 22, 2024
High Court Mifepristone Battle Goes Beyond Abortion
The first major abortion battle to reach the U.S. Supreme Court since the Dobbs decision is about a lot more than abortion.
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March 22, 2024
Ex-Ga. Insurance Head Cops To Healthcare Kickback Scheme
Former Georgia Insurance Commissioner John Oxendine pled guilty Friday to working with an Atlanta-area doctor to run a multimillion-dollar medical testing kickback scheme just weeks before he was set to face trial in federal court.
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March 22, 2024
Congress Spares Employee Benefits From $400M DOL Cut
A commitment from Congress to keep funding level for the U.S. Department of Labor's sub-agency that oversees employee benefits despite a $400 million agency-wide cut was one of the highlights for benefits attorneys in a new fiscal year 2024 spending deal. Here are three takeaways from attorneys on the funding agreement.
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March 22, 2024
Calif. Releases Interim Guidelines On GenAI Use
The state of California on Thursday released interim guidelines for public-sector procurement, uses and training of generative artificial intelligence by state leaders in preparation for all state agencies to consider pilot projects using the technology by July, per Gov. Gavin Newsom's executive order issued last year.
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March 22, 2024
Ex-Drug Rep Won't Serve More Time After 1st Circ. Victory
The second sentencing of a former Aegerion Pharmaceuticals Inc. salesman did not add a day in prison to the roughly seven months he served before the First Circuit wiped away his initial conviction on charges he schemed to fraudulently sell the company's cholesterol treatment.
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March 22, 2024
Del. Courts Examining 'Colonoscopy'-Like Bylaw Rules
Invasive advance-notice bylaws that some observers say make shareholder board nominations as intrusive as a "colonoscopy" are reviving old questions in Delaware courts about how far boards can go to protect themselves against shareholder activism.
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March 22, 2024
LifeCell Cleared Of Liability In NJ Strattice Hernia Mesh Trial
New Jersey state jurors on Friday cleared LifeCell of liability in a Kentucky woman's suit alleging the design of its Strattice surgical mesh is defective and caused a hernia to reoccur and ultimately resulted in "life-altering" surgery, giving the medical device company the first win in a venue with at least 93 pending cases with tort claims over the mesh.
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March 21, 2024
SEC's 'Shadow Trading' Trial To Test Insider Info Boundaries
If the U.S. Securities and Exchange Commission can convince jurors hearing its first-ever "shadow trading" case next week to find a former executive in the wrong for buying up a competitor's securities while having insider information about his own company, the floodgates could open to civil and criminal prosecution of other corporate insiders under the novel legal theory, attorneys told Law360.
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March 21, 2024
5th Circ. Backs FDA's Vivid Warnings Of Cigarette Dangers
Government mandated text warnings and graphic images on cigarette packs to advertise the health risks of smoking do not violate the free speech rights of R.J. Reynolds Tobacco Co. and other cigarette manufacturers, the Fifth Circuit ruled Thursday, saying the warnings are "factual and uncontroversial" and pass constitutional muster.
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March 21, 2024
Schumer Urges Texas District To Adopt Judge-Shopping Rule
Senate Majority Leader Chuck Schumer on Thursday urged the chief judge of the Northern District of Texas to quickly implement the Judicial Conference of the United States' updated policy that looks to prevent litigants from judge shopping, arguing that the district's current practices are "dangerous."
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March 21, 2024
Ill. Judge Leaves Outcome Health Execs' Convictions Intact
An Illinois federal judge said Thursday that he wouldn't disturb three former Outcome Health executives' convictions for carrying out a massive billion-dollar fraud scheme to grow their health advertising business, saying the jury heard enough evidence to support its verdict.
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March 21, 2024
MDL Claims Over Merck's Gardasil Vax Get Trimmed
Pharmaceutical giant Merck need not face many of the claims by patients who allege their autoimmune conditions were caused by its HPV vaccine, a North Carolina federal judge overseeing multidistrict litigation ruled, saying the National Childhood Vaccine Injury Act bars most claims made in the first two bellwethers.
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March 21, 2024
Wash. Judge Says Debt Collector Owes $827K For Violations
A Washington state judge has ordered a medical debt collector to pay more than $827,000 in penalties for failing to include certain debtor's rights information in collection notices sent to tens of thousands of Washingtonians for outstanding balances tied to Providence Health & Services hospitals.
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March 21, 2024
Cigna Slams Suit's Claims Of Algorithm-Led Coverage Denials
Insurance giant Cigna Group wants a Connecticut federal court to toss a proposed class action alleging that an algorithm unlawfully rejected hundreds of thousands of claims en masse and without a proper review, arguing the suit is based on a "misleading" news article and shows a misunderstanding of the health insurer's claim denial process.
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March 21, 2024
UpHealth Claims $110M Win In Glocal Control Fight
Global digital health company UpHealth Inc. says an arbitral panel has awarded it more than $110 million following a dispute that arose out of its subsidiary's acquisition of Glocal Healthcare Systems in 2020 — even as Glocal decried the award as "one-sided and perverse."
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March 21, 2024
Tribe's Opioid Suit Can Head To State Court, Okla. Judge Says
An Oklahoma federal magistrate judge has granted the Cherokee Nation's bid to move to state court its suit accusing pharmaceuticals distributor Morris & Dickson of flooding the tribe's communities with opioids, saying the company only fulfilled one of four prongs necessary for establishing federal jurisdiction.
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March 21, 2024
Va. Court Affirms Doctor's Win, Refuses 'Empty Chair' Appeal
An emergency physician will keep his trial win in a malpractice case involving a patient's fatal aneurysm, a Virginia state appeals court has ruled, rejecting arguments that the trial judge flubbed by refusing to explicitly forbid the jury from considering the possibility that anyone else contributed to her death.
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March 21, 2024
CymaBay Investor Sues For Books On $4.3B Gilead Merger
A shareholder of liver disease-focused biopharmaceutical company CymaBay Therapeutics Inc. sued the company in Delaware Chancery Court to extract more information over a proposed $4.3 billion merger with Gilead Sciences Inc., saying CymaBay has refused to hand over previously requested documents regarding the valuation analyses without a legitimate excuse.
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March 21, 2024
Healthcare Co. Beats Suit Over TDF Funds' Performance
A California federal judge granted a win to a healthcare company and its investment adviser in a class action challenging what former workers claim are shoddy target-date-funds included in the company's 401(k) plan, saying the funds at issue performed better than comparable investments.
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March 21, 2024
VA May Have Acted In Bad Faith On $30M Debt Collection Deal
The U.S. Civilian Board of Contract Appeals refused to toss a $29.6 million appeal accusing the U.S. Department of Veterans Affairs of hampering a contractor's efforts to collect funds from outside insurers, saying the VA may have acted in bad faith.
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March 21, 2024
Gun Rights Org., Pa. DA Seek To Block Pot Patients' Gun Ban
A Pennsylvania prosecutor and a gun rights organization have asked a federal judge to block enforcement of policies that prohibit licensed medical marijuana patients from owning firearms, saying the ban violates the patients' Second Amendment rights.
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March 21, 2024
Business Coalition Rebuffs Biden Plan To Seize Drug Patents
The Biden administration's proposal to exercise so-called march-in rights to seize drug patents would harm innovation in the U.S., according to an assemblage of business-focused groups.
Expert Analysis
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A Look At Successful Bid Protests In FY 2023
Attorneys at Sheppard Mullin look beyond the statistics in the U.S. Government Accountability Office’s recent annual report on bid protests, sharing their insights about nine categories of sustained protests, gained from reading every fiscal year 2023 decision in which the protester had a positive result.
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Rite Aid's Reasons For Ch. 11 Go Beyond Opioid Suits
Despite opioid-related lawsuits being the perceived reason that pushed Rite Aid into bankruptcy, the company's recent Chapter 11 filing reveals its tenuous position in the pharmaceutical retail market, and only time will tell whether bankruptcy will right-size the company, says Daniel Gielchinsky at DGIM Law.
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Navigating Discovery Of Generative AI Information
As generative artificial intelligence tools become increasingly ubiquitous, companies must make sure to preserve generative AI data when there is reasonable expectation of litigation, and to include transcripts in litigation hold notices, as they may be relevant to discovery requests, say Nick Peterson and Corey Hauser at Wiley.
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FDA's Lab-Developed Test Rule May Bring Historic Challenges
If finalized, the U.S. Food and Drug Administration's proposed rule for regulating laboratory-developed tests will provoke some of the most interesting legal challenges that the agency has faced in decades, with outcomes that will likely reverberate across the agency's product centers, says Stacy Amin at MoFo.
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Finding Focus: Strategies For Attorneys With ADHD
Given the prevalence of ADHD among attorneys, it is imperative that the legal community gain a better understanding of how ADHD affects well-being, and that resources and strategies exist for attorneys with this disability to manage their symptoms and achieve success, say Casey Dixon at Dixon Life Coaching and Krista Larson at Stinson.
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A Look At DOJ's New Nationwide Investment Fraud Approach
Investment fraud charges are increasingly being brought in unlikely venues across the country, and the rationale behind the U.S. Department of Justice's approach could well be the heightened legal standards in connection with prosecuting investment fraud, says Jonathan Porter at Husch Blackwell.
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AI Use May Trigger False Claims Act's Public Disclosure Bar
The likely use of publicly available artificial intelligence tools to detect government fraud by combing through large data sets will raise complex questions about a False Claims Act provision that prohibits the filing of claims based on previously disclosed information, say Nick Peterson and Spencer Brooks at Wiley Rein.
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Beware Privacy Risks In Training AI Models With Health Data
Because data used to train artificial intelligence models may be protected by the Health Insurance Portability and Accountability Act or other regulations, users of these models should conduct proper diligence to avoid costly compliance failures, say Neha Matta and Barbara Bennett at Frost Brown.
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Unpacking GAO's FY 2023 Bid Protest Report
The U.S. Government Accountability Office's recent bid protest report reflects an increase in sustained protests, illustrating that disappointed offerors may see little reason to refrain from seeking corrective action — but there is more to the story, say Aron Beezley and Patrick Quigley at Bradley Arant.
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How Fla. Bankruptcy Ruling May Affect Equity Owners
A Florida bankruptcy court’s recent ruling in Vital Pharmaceuticals — which rejected the Third Circuit’s Majestic Star decision that determined a bankrupt corporation’s flow-through status was not protected by the automatic stay — may significantly affect how equity owners can mitigate the impact of flow-through structures in bankruptcy, say Eric Behl-Remijan and Natasha Hwangpo at Ropes & Gray.
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Earnout Contract Considerations After NC Good Faith Ruling
The North Carolina Supreme Court's recent Value Health Solutions v. Pharmaceutical Research decision, holding the implied covenant of good faith and fair dealing did not apply in an earnout dispute related to an asset sale, demonstrates the need for practitioners to pay careful attention to milestone concepts in M&A transactions, says Benjamin Hicks at Wagner Hicks.
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FDA's Off-Label Comms Guidance Is A Reluctant Step Forward
The U.S. Food and Drug Administration's latest draft guidance expands its safe harbor for health care providers that communicate information about their products' off-label uses, but does not fully resolve the First Amendment disconnect between federal courts and the agency's regulatory goals, say Jeffrey Shapiro and Lisa Dwyer at King & Spalding.
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White House AI Order Balances Innovation And Regulation
President Joe Biden’s recently issued executive order on artificial intelligence lays out a sprawling list of directives aimed at establishing standards for safety, security and privacy protection, and may help strike the balance between the freedom to innovate and the need to impose regulation in this rapidly evolving space, say Kristen Logan and Martin Zoltick at Rothwell Figg.
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How Biden's AI Order Stacks Up Against Calif. And G7 Activity
Evaluating the federal AI executive order alongside the California AI executive order and the G7's Hiroshima AI Code of Conduct can offer a more robust picture of key risks and concerns companies should proactively work to mitigate as they build or integrate artificial intelligence tools into their products and services, say attorneys at Jenner & Block.
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Reading Between The Lines Of HHS' National Lab Opinion
The U.S. Department of Health and Human Services' Office of Inspector General recently rejected a national laboratory's request to pay a referring lab to process specimens, but the request might have been an attempt to exploit the OIG's advisory opinion process for a competitive advantage, says Mary Kohler at Kohler Health Law.