The FDA's Sept 6 warning letter to Epipen manufacturer Meridian (a division of Pfizer) condemns the company for knowingly shipping out defective products that led to the death of the customers who paid hyper-inflated prices for the devices, which Meridian manufactured for notorious pharma profiteers Mylan.
According to the FDA, the company received hundreds of complaints about defective auto-injectors and failed to act on them, despite the obvious culprit -- a "deformed" component.
Regulators like the FDA and FTC typically have to warn a company before assessing penalties against it, operating on a kind of two-strikes-and-you're-out basis. This letter itself carries no penalties apart from public shaming, but it does set up the companies for massive fines.
The agency went on to note that, during an inspection earlier this year, Meridian employees said that they did not disassemble the “vast majority” of failed devices customers sent back to them. Meridian received 171 such “complaint samples” between 2014 and 2017. But employees said they were only allowed to take devices apart if it was “approved by management.” Yet Meridian noted that disassembly was the only way to determine why a device failed.
Days after the inspection, Mylan recalled tens of thousands of injectors.
Meridian Medical Technologies, Inc. a Pfizer Company 9/5/17
FDA slams EpiPen maker for doing nothing while hundreds failed, people died
[Beth Mole/Ars Technica]
(Image: Greg Friese, CC-BY)
Economists like Alberto Alesina and Silvia Ardagna reshaped the world when their theories of "expansionary austerity" were put into effect after the 2008 crisis: the idea that governments could "increase taxes, cut spending, and grow strongly" was powerfully tempting to the world's leaders, who saw in them a way to pull out of a recessionary […]
Over 1,000 Google employees have signed a petition urging senior management to reconsider the company's plan to launch a censored Chinese search product (codename: Dragonfly), a revolt that's been in the works since the news broke; the employees demand transparency about the project and point out that it violates the Association of Computing Machinery's code […]
Grant Burningham interviewed me for his Bots and Ballots podcast (MP3), covering a bunch of extremely timely tech-politics issues: Facebook and the impact of commercial surveillance on democratic elections; Alex Jones, censorship and market concentration; and monopolism and the future of the internet.
The Adobe Creative Cloud suite is the foundation on which many creatives build their careers, but some of its programs, like Photoshop and InDesign, are notoriously complex, making it difficult for aspiring designers, photographers, and the like to break into their field. But, don’t get discouraged. The Pay What You Want: Adobe CC A-Z Lifetime Bundle […]
From self-driving cars to Siri, we’ve already gotten a taste of what AI can do, and now this groundbreaking technology is making its way to education and revolutionizing the way we learn new languages. Mondly uses state-of-the-art speech recognition to help you speak foreign languages like a true local. Lifetime subscriptions are on sale for […]
We’ve all used Excel at some point in our careers, but chances are most of us have only scratched the surface of what this ubiquitous program can do. From automating simple tasks to presenting data through beautiful charts and PivotTables, Excel brings a ton of utility to the table that can make a huge impact […]