Axios VItals: Opioid lawsuit shield

Plus, more understandable drug packaging inserts | Wednesday, May 31, 2023

Open in app View in browser   Presented By Kaiser Permanente   Axios Vitals By Adriel Bettelheim · May 31, 2023 It's Adriel, Tina will be back on Friday. Today's newsletter is 853 words or a 3-minute read. Join me today at 12:30pm ET for a virtual event examining ways to eliminate health care deserts and expand access to care. Guests include American Heart Association CEO Nancy Brown and Patient-Centered Outcomes Research Institute executive director Nakela L. Cook. Register here to attend.     1 big thing: Court ruling casts long shadow over opioid lawsuits Illustration: Sarah Grillo/Axios   A federal appeals court on Tuesday potentially laid the groundwork for corporations to avoid legal exposure in future opioid lawsuits, Axios' Sabrina Moreno writes. Driving the news: The New York-based 2nd U.S. Circuit Court of Appeals ruled that, as part of a proposed bankruptcy settlement, members of the Sackler family who own OxyContin maker Purdue Pharma could be shielded from current and future civil claims in exchange for paying up to $6 billion and giving up control of the company. The decision reversed a 2021 lower court ruling against immunity from lawsuits on the grounds the Sackler family members weren't declaring bankruptcy themselves. But it furthered a settlement that would send billions of dollars to states, indigenous tribes and local governments ravaged by the opioid epidemic. What they're saying: Tuesday's decision presses the boundaries of "what we understood commercial bankruptcy to be about" and could inspire more corporations with similar circumstances to limit liability through bankruptcy courts, said Deborah Hensler, a professor at Stanford Law School. This could include mass litigation over toxic chemical exposure or contaminated water, Hensler told Axios. The big picture: Drugmakers have pledged more than $50 billion to settle claims over their role the opioid epidemic, and the money has already begun pouring into states. Purdue's fate, and the money it promised to dispense, has been unsettled over states' refusal to grant the Sacklers' legal protections. What we're watching: The Justice Department could still ask the Supreme Court to review the appeals court decision. Go deeper.     2. FDA proposes easy-to-read drug package inserts The FDA on Tuesday proposed overhauling the paper inserts that come in prescription drug packages so that risks and safety information are summarized on a single page. Why it matters: The agency said existing medication guides, known as patient package inserts, can be confusing and lead people to stop taking their drugs, or not take them as directed. Details: The new guide, called Patient Medication Information, would be required for outpatient prescription drugs, including blood and blood components. Essential information would be summarized on a single page using a standardized format, including the product name, a summary of its uses, safety information, common side effects and directions for use. It would replace two types of FDA-approved written prescription drug patient information and certain biological product information, potentially reducing duplicative information. What they're saying: FDA commissioner Robert Califf said not adhering to medication instructions can contribute to nearly 25% of hospital admissions, 50% of treatment failures, and approximately 125,000 deaths annually. "While medication nonadherence is complex, inconsistency with the existing types of written information for prescription drugs and certain biological products can negatively impact public health, and we are eager to fix it," Califf said. The proposed rule is available for public comment for 180 days.     3. RSV vaccines for older adults under the spotlight Illustration: Brendan Lynch/Axios   After years of failed attempts at finding a vaccine against respiratory syncytial virus, older adults who are especially susceptible to the disease may be close to getting some protection, Axios' Oriana Gonzalez writes. Driving the news: The FDA today is expected to approve Pfizer's RSV vaccine for people 60 and older, potentially making it the second authorized RSV shot in the U.S. Each year, RSV leads to up to 120,000 hospitalizations and as many as 10,000 deaths among people aged 65 and over. The FDA approved GlaxoSmithKline's RSV vaccine for older adults in early May. The CDC still would need to sign off on any shot before it can reach the public. A decision is expected this summer. Details: Pfizer's RSV vaccine was found to be nearly 86% effective at preventing severe illness and around 67% at protecting against milder infection. Yes, but: Researchers have pointed out that even with two options available, it might be difficult to inoculate older patients against the virus, because knowledge about the risk is not widespread. Read the rest.     A message from Kaiser Permanente See all that health care can be     Some health care experiences can be fragmented and impersonal, with the responsibility on the patient to make it work. But at Kaiser Permanente, everything works together to provide equitable, high-quality, affordable care and coverage that support the unique needs of each member. See how.     4. Assault charges hang over elder care startup A $1.4 billion home elder care startup covered by Medicare Advantage and some employer-sponsored health plans has been hit by allegations of sexual harassment, assault and unlawful imprisonment, among a broader range of issues, Bloomberg Businessweek reports. The big picture: Papa Inc. is supposed to serve as a workaround for the nation's shortage of home-care workers, with a network of contractors called "pals" that customers, called "papas," can hire to do household chores, give rides to medical appointments and other tasks. What they found: Businessweek reviewed more than 1,200 complaints logged by Papa over the past four years and found dozens of allegations of sexual harassment and assault, as well as theft and dissatisfaction with the service's quality. The logs show what can happen to elderly clients and its contractors when the company offers little training or oversight, according to the report. What they're saying: A spokesperson for the Centers for Medicare and Medicaid Services told Businessweek the agency has been reviewing complaints and grievances that allegedly involve Papa. The company disputes suggestions its lax on controls and said it closely tracks complaints, with fewer than 1% safety-related.     5. Catch up quick 👀 More U.S. adolescents are getting weight-loss surgery. (Bloomberg). 🧠 Brett Favre reportedly sought Trump White House help to promote concussion drug. (SBNation). 👉 EU committee likely to recommend against approving ALS drug. (Endpoints News)     A message from Kaiser Permanente See all that health care can be     Some health care experiences can be fragmented and impersonal, with the responsibility on the patient to make it work. But at Kaiser Permanente, everything works together to provide equitable, high-quality, affordable care and coverage that support the unique needs of each member. See how.   Thanks for reading Axios Vitals, and to senior copy editor Bryan McBournie. Please ask your friends and colleagues to sign up. Dive deeper into the future of health care Axios Pro is your personal health care industry analyst, here to help you make the news actionable and anticipate future outcomes. Subscribe today.   Axios thanks our partners for supporting our newsletters. Sponsorship has no influence on editorial content. Axios, 3100 Clarendon B‌lvd, Arlington VA 22201   You received this email because you signed up for newsletters from Axios. To stop receiving this newsletter, unsubscribe or manage your email preferences.   Was this email forwarded to you? Sign up now to get Axios in your inbox.   Follow Axios on social media: