Medical device companies are on the defensive after the release of a massive, collaborative investigative report on the medtech industry that suggests that regulation may be failing to keep defective devices from causing harm on a global scale.
The highly critical “Implant Files” report is a collaborative effort overseen by the International Consortium of Investigative Journalists, or ICIJ, and includes work from 252 journalists from 59 media groups across 36 countries.
“Health authorities across the globe have failed to protect millions of patients from poorly tested implants that can puncture organs, deliver errant shocks to the heart, rot bones and poison blood, spew overdoses of opioids and cause other needless harm,” ICIJ investigators wrote in the report. “The Implant Files reporting reveals a fiercely competitive industry that has repeatedly run afoul of global law enforcement, financial and health authorities, and has used its formidable lobbying clout to pressure regulators to speed approvals and lower safety standards.”
In the report, investigators claim that despite the positives that new, innovative medical devices bring, the industry as a whole is “unnecessarily putting millions of patients at risk of serious harm in its quest for profit.”
Investigators collected more than 8 million device-related health records over the course of the investigation, the majority of which came from the more than 5.4 million adverse event reports filed with the FDA over the past 10 years. Over the past decade, more than 1.7 million injuries and approximately 83,000 deaths potentially related to medical devices have been reported. Nearly half a million of those reports mentioned an explant surgery to remove a device in connection with the reported events.
A total of 2,100 Class I recalls have been issued by the FDA – its most extreme classification of recall which indicates a serious risk of injury or death – over the past 10 years, according to the report.
The report goes on to claim that the FDA’s medical oversight is lacking, and that it allows complex devices to be “approved too quickly” while malfunctioning devices are often not pulled from use quickly enough. Less than 5% of devices reviewed by the U.S. federal watchdog go through the more exhaustive and extreme premarket approval process, which “allow major – and sometimes fateful – changes to devices under pathways meant for incremental updates,” according to the report.
Despite these issues, the report suggests that the FDA is looking to further loosen its regulatory grasp to try to compete with the EU, where devices have a much shorter regulatory runway.
Last year, the agency approved three times as many devices than it did in 2010, while safety warnings to device manufacturers fell by approximately 80%, according to the report.
In a request for comments from the ICIJ, the FDA said that patient safety is a cornerstone of its regulatory commitment and acknowledged “limitations” to its ability to “promptly and consistently” identify safety risks of devices that have been released.
Last week, just before publication of the report, the FDA outlined new regulatory goals including becoming “consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices,” which includes efforts to increase post-market oversight.
Today, FDA Commissioner Dr. Scott Gottlieb and FDA Center for Devices and Radiological Health director Dr. Jeff Shuren released plans for modernizing the 510(k) clearance pathway. The plans include the removal of outdated predicate devices, with a specific focus on those more than 10 years old, and the creation of an alternative 510(k) pathway which would rely on objective safety and performance criteria.
Beyond oversight in the U.S., the ICIJ report is also highly critical of the European Union’s CE Mark approval process, suggesting that it acts more as a business than a regulatory body.
In the EU, device manufacturers pay private companies, called notified bodies, to certify any devices that are high or medium-risk, as long as they meet European safety standards, according to the report. Most of these bodies are exempt from laws that would require them to make device approval records public, which the ICIJ report claims is “especially a concern” in relation to implants.
“According to a March 2016 email between top health officials in Germany and Denmark, regulators in the EU have no clinical data on an estimate 90% of highest risk devices because they were assessed as sufficiently similar to existing products,” ICIJ investigators wrote.
Investigators were also critical of the EU’s decision to not publish injury and malfunction reports over claims that such reports would “give away confidential commercial information and unnecessarily scare the public.”
Concerns in the report extended beyond the U.S. and the EU, and included evidence suggesting that in other countries, device event reports were even more scarce and hidden.
“In Chile, health authorities told ICIJ partners that adverse event reporting was voluntary for implanted devices and that in a decade they had received four “relevant” reports, only one for an implanted device. In Mexico, authorities don’t share adverse event data with the public,” ICIJ investigators wrote.
ICIJ investigators said that no global resource existed that complied recalls and safety notices, so the group decided to build their own, dubbing it the International Medical Devices Database.
The system is intended to gather recall, safety alerts and field safety notices, including more than 70,000 from 11 countries, in a single database. The system includes a searchable portal intended to allow individuals to find out if devices have been flagged due to safety or health concerns, according to the report.
The ICIJ said that “because there’s no agreed-upon method for identifying devices” it created tools it believes will give users the “ability to research the safety history of their devices,” whether or not those devices are described differently in different geographies.
Despite oversight issues, the industry is growing at a breakneck speed, haven seen sales double from approximately $118 billion in 2000 to approximately $400 billion in 2018, according to the report.
And while the industry has grown, so has its lobbying force in Washington D.C., according to the report. Over a 10-year period ending in 2017, the ICIJ reports that the medtech industry has spent more than $335 million in lobbying efforts.
Payments from medtech companies to U.S. doctors for research, travel, royalties and consulting fees are also rising, according to the report, with the 10 largest medical device companies paying nearly $600 million last year to doctors or their hospitals.
In 2017, Fridley, Minn.-based medtech giant Medtronic (NYSE:MDT) paid over $150 million in such payments, while Zimmer Biomet (NYSE:ZBH) made over $100 million in related payments. Boston Scientific (NYSE:BSX) and Stryker (NYSE:SYK) reportedly made payments of between $50 million and $100 million while Smith & Nephew (NYSE:SNN), Henry Schein (NSDQ:HSIC), Royal Philips (NYSE:PHG), Becton Dickinson (NYSE:BDX) and Danaher (NYSE:DHR) paid under $50 million.
Outside of lobbying efforts and payments to private physicians, the ICIJ report also suggests that medtech companies are paying large amounts to settle issues related to defective devices.
A total of $1.6 billion has been paid from medical device manufacturers since 2008 to settle corruption, fraud and other charges with U.S. and international regulators. One company – Johnson & Johnson (NYSE:JNJ) – stands out amongst the crowd, the report suggests, having paid $4.3 billion since 2015 to settle injury claims related to defective metal-on-metal hips, mesh implants and surgical staplers, according to the report.
Despite the scathing report, shares in major medtech players have seen a mild day for their shares. Medtronic shares have risen 0.3% so far, at $92.30 as of 11:04 a.m. EDT, while Johnson & Johnson shares have fallen 0.2% to $141.