Friday, December 03, 2010

More on Biotronik's Exploding ('Venting'?) ICD

According to MedPageToday, it appears an earlier case report that was mysteriously withdrawn from the peer-reviewed journal Europace will soon be republished:
A controversial article about problems with an implanted cardiac device -- published by and then withdrawn from the journal Europace -- has been resubmitted and is under review, according to the journal's editor.

"I expect that a decision on publication will be made very shortly," John Camm, MD, of St. George's University of London, told MedPage Today in an e-mail.
Hopefully, the journal will explain why they failed to notify their readers about the withdrawl as well. To withdraw an article of such signficance to their readership without explanation should not be tolerated by the scientific community.

Several other issues:
  1. Perhaps even more concerning this whole ordeal has been the FDA's management of the device report made to them in May. It seems public reporting of Biotronik's filing did not appear on the MAUDE database until after my blog post was published in October.

    If this is their policy to withhold reports in patients that are injured for this length of time irrespective of "cause," there are bigger concerns with the government's policies that should be immediately addressed.
  2. I should also explain my rationale for my "defensive blogging" earlier, too.

    The Fair Use Act of US Copyright law has been a favorite place for malicious lawyers to attack bloggers who republish content in their blogs. Irrespective of whether or not one could defend their actions in the court of law on the consitutional basis of "free speech."

    But when challenged, as soon as a lawyer gets involved, thanks to the large costs involved, you've "lost" your case even before going to trial. I did not need that expense at the time, so I caved and withdrew the pictures I had published (note: they have since been republished on the blog, courtesy of Google cache, but have included a pdf of my copy of the entire case report in this blog post).


Dennis said... talks and lawyers sue. Thanks to huge empires like Google who can withstand the onslaught the truth has a chance.

Blogger said...

Thanks for this follow up. We're all watching this.

Chas said...

You didn't cave, and even if you did, you made up for it. Thank you for reporting on this -- curious minds wanting to know, etc.

There's still no information about how badly this fellow was injured. Hope he can use his arm!

The Happy Hospitalist said...

Thanks for the update doc. We live in a world driven by fear, I mean lawyers. What a sad world that is.

Anonymous said...

Actually, it would be the original publisher who would bring the suit, not the lawyer. I'm sure the publishers would just as soon you not have violated the law, thus saving them the cost of their lawyers as well.