FOIAengine: As Deaths Mounted, J&J “Promised to Correct” – and Sought FDA Records
Johnson & Johnson (NYSE: JNJ) proudly calls itself “the world’s largest and most diversified healthcare products company.” The company had $85 billion in sales last year, and an appetite to grow even bigger through acquisitions.
J&J’s latest deal, announced just last week, is the $13.1 billion acquisition of Shockwave Medical. Shockwave uses sonic waves to break up calcified plaque in heart vessels. J&J touted the acquisition as a further move into a high-growth market: “Cardiovascular intervention is one of the fastest-growing global med-tech markets, with significant unmet patient need.”
But high growth can also lead to high risk.
Just one week before its acquisition of Shockwave, J&J faced a torrent of negative press about another of its cardiac products, a troubled heart-pump line called Impella that an FDA recall notice linked to at least 49 deaths and 129 serious injuries.
But the FDA’s numbers significantly understated Impella-related deaths.
Data compiled for PoliScio Analytics by regulatory intelligence company Redica Systems placed the number of recent Impella-related deaths at 81 – 65 percent higher than the FDA’s official tabulation. Redica’s count was based on FDA data, and covered a much shorter time span – the most recent 24 months. The FDA told us its count covered February 20, 2018 to October 31, 2023. (The FDA’s original notice did not disclose the time frame.)
J&J’s tiny Impella pumps are threaded through blood vessels to assist patients undergoing complex procedures. There have been three major FDA actions about Impella products in the past year. The FDA’s latest alert – cautioning that “use of these devices may cause serious injuries or death” – was dated March 21. It was first reported by the New York Times on March 29.
J&J MedTech added Impella to its product line in 2022 as one of the crown jewels of J&J’s $16.6 billion acquisition of Abiomed. But controversy, and deaths, have dogged the devices.
Redica Systems, with a custom data-analytics platform derived from FDA records, calculates there has been an 862 percent increase during the past 12 months in reported “adverse events” involving J&J’s Impella line. Based on its analysis of the FDA’s own data, Redica counted 54 Impella-related deaths and 6,941 adverse events during the past year alone, and another 27 deaths during the prior 12 months. The total of 81 deaths in just two years is a statistic that hasn’t been previously reported.
Alison Sathe, Redica’s senior vice president, attributed the FDA’s lower count to an anomaly within the FDA’s database. “We’re certain of our number. There was no double counting. When our analysts took a look, they verified every reported death in the FDA’s database by its [unique] event number.” But some Impella-related deaths hadn’t been coded with product or company names in the FDA’s public-facing database. As a result, the official FDA count came up short.
An FDA spokeswoman said she couldn’t comment on Redica’s methodology but didn’t dispute the result. She added, “It is not yet known whether the deaths associated with the Impella device can be attributed directly to the pump. The FDA is working with the firm to fully investigate the reported deaths and determine if any further correction is needed. We remain committed to evaluating any new information from Abiomed and other sources.”
J&J didn’t respond to requests for comment. In previous statements, the company has promised to implement quality-control improvements and fix the Impella problems.
The chart below, provided by Redica, is based on the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.
In addition to reaching out to Redica, we checked our FOIAengine database, which tracks FOIA requests in as close to real-time as their availability allows, to see whether there were FOIA requests that also might have provided early signals of trouble. We found some things of interest.
An early January FOIA request from Redica to the FDA sought a warning letter, known in industry parlance as a “Form 483,” detailing unsafe practices at a J&J MedTech facility in Vandalia, Ohio. Redica’s FOIA request, one of many it routinely makes, stood out as a possible tip-off to problems at J&J MedTech. The Form 483 in question, although heavily redacted by the FDA before its release under FOIA, listed six broad categories of “objectionable conditions and practices” found by an agency inspector at the J&J MedTech facility in late 2022. (The redactions make it impossible to determine whether the Impella line was then under scrutiny.)
More adverse actions for J&J’s Impella line soon followed.
Three months after the inspector’s findings at the Vandalia facility, another inspector showed up at J&J MedTech’s Abiomed facility in Danvers, Mass. The Form 483 from that inspection, also provided to us by Redica, listed dozens of Impella safety violations found by the FDA.
The violations centered on Abiomed’s failure to directly notify Impella’s users about product risks the company was aware of. Instead of notifying cardiologists and the FDA about the problems, Abiomed told its field reps to pass the word during routine customer visits. During a wrap-up meeting with Abiomed, the FDA inspector noted the company’s response to each violation: “Promised to Correct.”
The FDA followed up with an 11-page warning letter on September 19, 2023 that listed dozens of safety violations. The warning letter cited Abiomed’s failure to report quality problems with the company’s Impella heart pump, and the lack of premarket approval for a monitoring system used with the device.
The FDA finally issued its urgent alert late last month about the Impella line, warning for the first time about serious injuries and deaths. In spite of the alert, the FDA allowed the heart pumps to remain in use.
As the Times reported, “The FDA said the manufacturer of the device, Abiomed, should have notified the agency more than two years ago, when the company first posted an update on its website about the perforation risk. Such a notice, the FDA added, would have led to a much broader official agency warning to hospitals and doctors.”
The Times also said “a series of studies suggested that the Impella heart devices heighten the risk of death in patients with unstable medical conditions. Meanwhile, the device maker has spent millions of dollars promoting the device and awarding consulting payments to cardiologists and grants to hospitals.”
J&J MedTech’s FOIA Requests: Also notable were 20 FOIA requests filed with the FDA during November and December by J&J MedTech – noteworthy because until then J&J MedTech had only shown up in FOIAengine with two prior requests. All 20 of J&J MedTech’s recent requests sought so-called 510(k) submissions – a shortcut for getting FDA approval for a medical device – that were made by seven heart-catheter makers: Penumbra, Stryker, Route 92 Medical, MicroVention, Perfuze, Q’Apel Medical, and Imperative Care.
The FDA’s FOIA summaries don’t indicate why J&J MedTech made those requests.
In the meantime, numerous law firms are gearing up, posting internet solicitations for Impella plaintiffs.
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John A. Jenkins, co-creator of FOIAengine, is a Washington journalist and publisher whose work has appeared in The New York Times Magazine, GQ, and elsewhere. He is a four-time recipient of the American Bar Association’s Gavel Award Certificate of Merit for his legal reporting and analysis. His most recent book is The Partisan: The Life of William Rehnquist. Jenkins founded Law Street Media in 2013. Prior to that, he was President of CQ Press, the textbook and reference publishing enterprise of Congressional Quarterly. FOIAengine is a product of PoliScio Analytics (PoliScio.com), a new venture specializing in U.S. political and governmental research, co-founded by Jenkins and Washington lawyer Randy Miller. Learn more about FOIAengine here. To review FOIA requests mentioned in this article, subscribe to FOIAengine.
Write to John A. Jenkins at [email protected].
