Medical device investigation unearths conflicts, regulatory issues

The latest investigation from the Chicago Tribune’s Jason Grotto and Deborah L. Shelton focuses on a single medical device, yet still hits many of the health beat’s biggest narratives, primarily conflicts of interest and government regulation. In their centerpiece, they dig into the tale of a cardiologist who may or may not have tested a device he invented on patients without consent or regulatory approval. It’s in those gray areas that the story takes shape.

The device in question is an annuloplasty ring, which in 2001 was reclassified from class III to class II. In practical medical device terms, this means that new models don’t need clinical trials if they’re similar enough to devices that have already been approved. The reporters write that the rings earned this change of status in part because of the relatively low number of adverse events reported between 1991 and 1995 (465). Unfortunately, as their use has increased, so have the events.

Carpentier-McCarthy-Adams IMR ETlogix annuloplasty ring

Now that you have some idea of what they were up against, here’s a healthy excerpt from their “how we did it” sidebar, which is almost always Covering Health’s favorite part of a major investigative package.

The first hurdle in stories like these is understanding the medical science behind the device in question, which required us to gather up dozens of studies and reports on annuloplasty rings and the heart valve disease the device is intended to cure. We sifted through government documents and researched regulations as well as the history of the rings.

But writing about heart valve repair rings involves more than researching a disease and a device.

We also spent a lot of time with the patients in our stories because there is a level of trust that must be built up before people are willing to share personal information about their health. The same goes for Northwestern Memorial Hospital and surgeon, Dr. Patrick McCarthy.

We had to assure each of them that their viewpoint would be reflected in the stories. It’s a difficult balancing act that we tried to buttress with reams of documents, studies and interviews with independent sources.

For more on how Grotto and Shelton reported the story, watch for a “How we did it” article on the AHCJ website in the next couple of weeks.

If the issue sounds familiar, the storyline is similar to a 2005 investigation from The Wall Street Journal‘s David Armstrong, which found a partnership between the Cleveland Clinic – and some prominent staff members – and companies manufacturing devices used in clinical trials there.

2 thoughts on “Medical device investigation unearths conflicts, regulatory issues

  1. Larry Husten

    A few very important missing points here:

    The Tribune story is not nearly as original as it may appear (though it contains some excellent reportin). It should be noted (and it should have been cited in the story) that there was an earlier WSJ story on the exact same topic:

    However, both the Tribune and the WSJ articles fail to acknowledge that the story was originally broken and extensively covered on TheHeart.Org. (Please note that I was the editor of THO when the coverage began.)

    On the Knight Science Journalism tracker blog Paul Raeburn wrote about the WSJ’s failure to acknowledge previous coverage on THO:

    More generally, I am frequently appalled by the reluctance of many journalists to acknowledge previous reporting and original sources. This might make an interesting topic for further discussion.

  2. Don Blackmon

    Dear Sirs: I just received a Model 4100 Annuloplasty Ring 32 mm in size on May 26, 2011. I have been doing some research on this device to see if any problems have been reported concerning this device. I would like to know of any complaints or danger from this device.I believe but am not certain this may have been developed by Edwards Lifesciences LLC of Santa Ana California.If have any complaints or warnings I would certainly like to know! Thank You! I am Don Blackmon my e-mail is

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