Recalls Archives - Medical Design Sourcing

These devices are the top targets of lawsuit-related advertisements

Surgical mesh products continue to drive medical device lawsuit spending. [Photo via Adobe Stock]

Spending on advertisements related to medical device lawsuits this year is on track to exceed last year’s tally.

That’s according to figures provided by Washington, D.C.-based X Ante, which uses data from ad intelligence firm Vivvix. X Ante supplies reports on medical device lawsuit ad spending to the Advanced Medical Technology Association (AdvaMed), which is calling for new federal regulations of mass tort advertising to protect device manufacturers from lawsuits bankrolled by third-party funders.

For the first half of 2023, $6.2 million worth of legal ads targeted five kinds of medical devices:

Pelvic mesh: $3.5 million Hernia mesh: $1.9 million CPAP machines: $532,000 Physiomesh: $262,000 Military earplugs: $54,000

Spending on the top five device categories totaled just under $11 mil…

AdvaMed takes aim at device lawsuits funded by third parties

The Advanced Medical Technology Association (AdvaMed) is asking for new regulations to protect device manufacturers from lawsuits bankrolled by third-party funders.

Ahead of a U.S. House Committee on Oversight and Accountability hearing on the topic tomorrow, AdvaMed General Counsel and Chief Policy Officer Chris White submitted a letter in which he said “most mass tort litigation against medical device manufacturers is fueled by banks, private equity firms and hedge funds.”

AdvaMed wants new federal regulations of mass tort advertising like laws passed in Tennessee and Texas.

“The influx of billions of dollars of third-party litigation funding has fundamentally changed the dynamics of mass tort litigation,” White wrote. “These financiers are injecting huge amounts of investment capital into creating litigation regardless of the merits,” White wrote in the letter. “They start by funding mass marketing campaigns on TV, radio,…

FDA hits Olympus with warning letters after factory inspections

The FDA today released warning letters against Olympus Medical Systems Corp. and Olympus Corp. subsidiary Aizu Olympus following inspections of their endoscope and reprocessor manufacturing facilities.

The warning letters allege medical device reporting (MDR) and quality system violations at the manufacturing operations.

An Olympus representative told Medical Design & Outsourcing that the medtech manufacturer would issue a public response as soon as today.

FDA issued the first letter to Aizu Olympus President and CEO Yasuo Takeuchi on Nov. 2, 2022, following a July 5-8 inspection. The warning letter covers the company’s endoscope and automated reprocessing equipment manufacturing operations in Aizuwakamatsu, Fukushima, Japan.

FDA issued the second letter to Olympus Medical Systems President Tomohisa Sakurai on Dec. 12, 2022, following a Sept. 6-9 inspection. That warning letter covers the company’s gastrointestinal and surgical end…

FDA hits Olympus with warning letters after factory inspections

The FDA today released warning letters against Olympus Medical Systems Corp. and Olympus Corp. subsidiary Aizu Olympus following inspections of their endoscope and reprocessor manufacturing facilities.

The warning letters allege medical device reporting (MDR) and quality system violations at the manufacturing operations.

“Olympus’ highest priority is providing patients and users with safe and effective medical devices that comply with all applicable legal and regulatory requirements,” the company said in a statement to Medical Design & Outsourcing. “For that reason, we are committed to working together with FDA to address concerns.”

FDA issued the first letter to Aizu Olympus President and CEO Yasuo Takeuchi on Nov. 2, 2022, following a July 5–8 inspection. The warning letter covers the company’s endoscope and automated reprocessing equipment manufacturing operations in Aizuwakamatsu, Fukushima, Japan.

FDA issued …

ResMed finds a solution to semiconductor shortage, as well as some humor in it

ResMed (NYSE:RMD) can’t go back in time to solve its semiconductor shortage, but it’s found a solution that might be the next best thing — for now.

President and COO Rob Douglas (serving as interim president of Sleep and Respiratory Care at ResMed after Jim Hollingshead left to be CEO of Insulet) offered an update on the San Diego-based company’s supply chain issues as it tries to capture more of the market while Philips works through its recall.

ResMed President and COO Rob Douglas [Photo courtesy of ResMed]

“We’ve been managing a higher than normal rate of decommits coupled with a competitor recall that sucked all the inventory out of our systems and out of all of our customers’ systems as well,” Douglas said Wednesday at the William Blair Growth Stock Conference. “And so there is a huge shortage of devices. … We joke that the head of our supply cha…

FDA can’t explain record-low medical device recalls

Medical device product recalls were down 14.3% in the federal government’s fiscal year 2021, according to a recent Medical Design & Outsourcing analysis of recall data.

The drop was the biggest since the FDA began publicly reporting the data in 2013, and came as the regulating agency put more emphasis on fighting the COVID-19 pandemic.

We reached out to the agency for more information and connected with FDA press officer Jim McKinney, who said in an email that the FDA could not speculate on the significant reduction in device recalls and recall events, but that the numbers should not be viewed as an indicator of general safety.

The following has been lightly edited for space and clarity.

MDO: We found that medical device recalls were down 14.3% and device recall events were down 18.1% in fiscal 2021. Why was the recall rate down? Was it driven by COVID-19?

McKinney: The number of devices recalled in a year is not an indicator of t…