Last week, Fortune posted online an exposé titled “Bad to the bone: A medical horror story.” The story centers around Norian XR, a calcium compound bone void filler linked to the deaths of at least five patients who had the projected injected into their spines. The product was made by Synthes (West Chester, Pa), a maker or orthopedic products that was acquired last year by Johnson and Johnson for a whopping $19.7 billion.
The subject matter isn’t exactly new: In 2010, Synthes agreed to a $23 million settlement related to the use of Norian. In 2011, a federal judge sentenced four executives at the company to jail time for their role in the illegal testing and promotion of the bone cement for the use of vertebroplasty, a procedures in which bone cement is injected into the spine.
The Fortune piece does, however, provides a glimpse into the culture of Synthes at the time, providing an enigmatic portrayal of the company’s enigmatic CEO, Swiss billionaire Hansjörg Wyss, and a backstory about the backstage wrangling over the company’s push to test Norian for off-label uses amounting to “human experimentation.”
To look at the story from a different angle, we reached out to Nora Iluri, PhD, founder of Qmed partner Clarimed/DeviceMatters, a platform that tracks adverse event patient outcomes and other postmarket data. The research revealed that, for makers of calcium compound bone void fillers in general, compliance is subpar. 94.17% of adverse reports for the products were filed by manufacturers compared to 97% across the broader category of bone cements and fillers. The low number could indicate potential underreporting among manufacturers of this device category. Also, in the category, almost none of the adverse events were investigated to determine their root cause.
In 2011, for makers of calcium compound bone void fillers, Synthes was responsible for the most reported adverse events, having increased from 0 in 2008 to 22 in 2011. To provide a bit of background: the proposed merger with Johnson & Johnson had been discussed and reviewed by the Federal Trade Commission beginning in April 2011.
"Looking at Synthes’ reporting overall, their adverse event reports more than doubled from 2010 to 2011 and 2012 partial year is already higher than 2011 was," says Iluri. "Although deaths are rare and therefore any death should have come up for investigation by Synthes, calcium compound bone void fillers are not a big portion of the adverse events reported by [the company] and could have easily gotten forgotten in the noise."
- Automating your Quality Management System: Pitfalls & Essentials - Webcast
- 3D Printing for Surgical Devices and Medical Models - Webcast
- The Power of Extractable/Leachable Chemistry Testing for Medical Devices - Webcast
- Changing a Colorant in an Approved Medical Device, What Should I Know? - Webcast
- Reduce Risk! Control Costs! Get to Market Faster! The Customer Solution Centre is Your Pathway to Successful Device Development. - Webcast
- Innovating within Cost Constraints to Get More Bang for Your Buck - Webcast