Johnson & Johnson has recalled certain automated controllers for its Impella heart pumps over a fault linked to five serious injuries, the Food and Drug Administration said Tuesday.
The company’s Abiomed unit told customers to return the affected devices when contacted by its field servicing team because of potentially fatal purge pressure issues. Abiomed will make a design change during device servicing to correct the problem. Hospital inventory can continue to be used, according to the FDA’s alert.
J&J’s recall, which triggered an FDA early alert, follows other recent safety actions to address two problems with Impella that were collectively linked to four deaths.
Abiomed, Inc. Agrees to Pay $3.1 Million to Resolve Kickback Allegations
Thursday, March 8, 2018
excerpt:
BOSTON – Danvers-based Abiomed, Inc. has agreed to pay $3.1 million to resolve allegations that it violated the False Claims Act by purchasing lavish meals for physicians in order to induce them to use Abiomed’s Impella line of heart pumps.
The United States contends that Abiomed sought to induce physicians to use its pumps, which cost more than $20,000 each, by buying meals for them at some of the country’s most expensive restaurants, including Menton in Boston, Nobu in Los Angeles, Spago in Beverly Hills, and Eleven Madison Park in New York City. The government further contends that Abiomed (1) paid for physicians’ meals in instances where attendees ordered alcohol in an amount inconsistent with legitimate scientific discussion; (2) paid for meals at expensive restaurants where employees invited spouses of physicians to attend (and those spouses did attend) even though the spouses had no legitimate business purpose for attending the meal; (3) paid for numerous meals for physicians in which the cost per-attendee well exceeded Abiomed’s own $150 per person guideline (in one instance exceeding $450 per-attendee); and (4) paid for meals for physicians in which their employees misrepresented the number of attendees, listed attendees with generic names (e.g., Mike Anesthesia), or listed fictitious names of individuals who did not attend the meal, which had the effect of making the true per-attendee cost appear lower. Abiomed managers approved the expenses for all of these meals.
National Grid is strengthening its systems and preparing crews for winter weather to help deliver safe, reliable energy communities depend on.
New fromCommonWealth Beacon
HIT THE GAS:Gov. Maura Healey wrote a letterimploringUS Energy Secretary Chris Wright to move with a “sense of urgency” in issuing required permits for a gas expansion project to quickly move forward. Jordan Wolman digs into the unusual politics.
STRIKE FORCE:Nearly 4,000 nurses at Brigham and Women’s Hospital are set to start their open-endedstrikeon October 14 unless a contract deal is reached with hospital leadership. Nurses are seeking cost of living increases, affordable health insurance, limits on the use of temporary travel nurses, and protections around patient care. Alison Kuznitz has more for State House News Service.
OPINION:The Trump administration's proposed changes toHead Startwould threaten the quality, scope, and services of the child care providers that often enroll some of the most vulnerable children in their communities, writes Michelle Haimowitz, executive director of the Massachusetts Head Start Association.
SCRUTINIZE THE BLABBER THAT MIKE MINOGUE PROPOSES! NO SOLUTIONS! HE'S A WEALTHY TRUMPER WHO DOES NOT EVEN COMPREHEND HOW GOVERNMENT WORKS!
Mike Minogue, the Republican mega-donor and candidate for governor, said this week he supports the concept of a legislative push to raise the share of health insurance spending on primary care — but worries that the state could find itself scrambling to funnel more and more money into the health care space unless costs can be controlled.
Minogue, who spent 19 years as CEO ofAbiomed, the Danvers-based heart pump company, joined hosts John McDonough of the Harvard T.H. Chan School of Public Health and Paul Hattis of the Lown Institute on this month's Health or Consequences podcast. (Gov. Maura Healey’s office did not respond to the show's invitation to appear.)
A primary care taskforce and the state Senate have endorsed requiring insurers to raise primary care spending from roughly 7 to 8 percent of premiums today to 15 percent over several years. Minogue questioned whether the mandate would simply shift money from one part of the health care system to another without addressing underlying costs.
“Instead of a problem solved, you take a piece of pie from someone and give it to someone else,” he said. "I haven't seen that work in health care. The way I like it is, let's get rid of some of the waste and fraud."
Minogue, who has rolled out a “Patients First” campaign platform, pointed to pharmacy benefit managers as one target, arguing that PBMs have financial incentives to keep patients on brand-name drugs rather than cheaper generics, costing the state hundreds of millions of dollars.
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On the Trump administration’s so-calledOne Big Beautiful Bill Act's Medicaid cuts—which the Congressional Budget Officeprojectswill cause 326,000 low-income Massachusetts residents to lose coverage and cost the state $2 billion a year in federal revenue— Minogue said he opposes anyone losing health care. His proposed response focused largely on administrative fixes: a 1-800 number and multilingual website to help Medicaid enrollees navigate new work requirements before they lose coverage.
McDonough noted that about 7,500 documented legal immigrants were set to lose MassHealth, the state’s Medicaid coverage, on October 1. Trump administration restrictions on visas could make closing physicians and nurses staffing shortage more difficult, he said.
Minogue did not address the MassHealth population directly, and said the state could “have incentives for people to stay here.”
He mentionedTemporary Protected Statusas a lawful way for people to be in the country. The Trump administration has beenaggressively rollingback TPS status for many of the countries that support the health care workforce.
Minogue noted that mental health needs are a significant strain on the system, touting work by the Michael & Renee Minogue Foundation on homelessness and addiction services.
“We are not ready for the mental health crisis,” he said. “And I look at the mental health crisis as a health care issue, because what a lot of people do for care is they go to that emergency room. That emergency room is the most expensive, least compassionate, and efficient way to treat them.”
On the Health Policy Commission, the independent state agency focused on health care affordability,Minogue declined to propose specific changes.
“Well, I haven't been on the inside,” he said, but “what I would say is that the results are the results. We have the most expensive [commercial] health care in America. We have the longest [emergency room] wait times on record since we've been tracking in the Boston ERs.” Those sorts of realities, he said, mean “we need to do something different.”
He said he would seek a shared savings model agreement with federal health officials, where the state establishes a benchmark budget and works to manage care more efficiently. If the state spends below that agreed-upon baseline, the resulting "savings" are split between the federal government and the state. Minogue said he would push to keep 80 percent of any savings generated.
When Hattis pressed him on hospital market consolidation, which state data has consistently linked to higher prices, Minogue said he would push large systems to expand into communities through surgery centers and clinics, reducing pressure on Boston hospitals.
Minogue also addressed the state's individual health insurance mandate, the mechanism that has helped keep Massachusetts's uninsurance rate at 2 to 3 percent, the lowest in the country, for 20 years. He said he wouldn't commit to supporting or opposing it without more study.
“In concept I agree with it — that people should pay something for health insurance,” he said. “The problem is who pays and makes up the difference. There's a reason we're the most expensive health care in the country.”
Election event: Voting like your life depends on it
Worcester County reported a 67 percent voter turnout rate in 2024. What — if anything — does this tell us about overall health in Central Massachusetts?
Tomorrow,Tuesday, October 6,CommonWealth Beaconreporter Hallie Claflin will be in Worcester to discuss the connection between civic participation and wellbeing with Elana Brochin of the Massachusetts Association of Community Development Corporations, Casey Burns of the Coalition for a Healthy Greater Worcester, and Jerren Chang of Partners in Democracy.
BALLOT QUESTIONS:A dive into the crosstabs of a newCommonWealth Beaconpoll reveals astriking dividebetween voters and party leaders on two of the nine ballot questions, Jennifer Smith reports.
POLITICS:Boston Mayor Michelle WuendorsedGov. Maura Healey in her reelection bid, citing a “partnership to build a Boston and a Massachusetts that works for everyone,” Colin A. Young reports for State House News Service.
OPINION:Recent moves in Massachusetts torestrictinsurance coverage for GLP-1 medication only shifts the costs and limits who in our state has access to the drug, deepening inequities, writes Courtney Desy, an oncology nurse and CPA.
What We're Reading
TRANSPORTATION:Somerville is experimenting with severalstreet makeoversthat intentionally make it harder to drive quickly on roadways, in an effort to prevent deadly crashes. (The Boston Globe– paywall)
LAW ENFORCEMENT:Pittsfield policehave spent$53,449 on equipment and deployed drones nearly 400 times since the start of 2025. (The Berkshire Eagle - paywall)
NEWS:The Coast Guard called off the search for a medicaltransport planethat went missing off the coast of Nantucket after more than a full day of searching. Officials are still unsure of what caused the aircraft to disappear from the Federal Aviation Administration’s radar. (Boston.com)
SPORTS BETTING:Massachusetts will launch an app to support people who areaddicted to gambling. The new tool comes in a peak season for sports betting, and as more people have been turning to online resources for gambling addiction support. (WBUR)
COURTS:The US Supreme Court will allow third-country deportations to resume while legal challenges continue. Two of the four plaintiffsin the caseare Massachusetts residents. (GBH News)
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