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Staying open to cardiac stents

Kai Ryssdal Dec 8, 2006

KAI RYSSDAL: Dick Cheney’s got one. Maybe your Aunt Millie does too. Something called a cardiac stent. Steel webbing in the heart to keep clogged arteries open. The Food and Drug Administration’s been holding a conference in Washington this week. Trying to figure out if stents help or hurt in the long run. This afternoon an advisory panel recommended no change in the rules. The data’s just too uncertain. But It wasn’t just medical device makers sitting in on the meetings. Heather Won Tesoreiro’s been covering the story for the Wall Street Journal.

HEATHER WON TESOREIRO: Personal injury lawyers . . . there has been a real surge in mass torts related to the pharmaceutical industry and the medical device industry in recent years as mass torts like tobacco and asbestos have started to dry up, personal injury lawyers are turning towards the pharmaceutical and medical device industries.

RYSSDAL: Now does the fact that heart stents are approved by the FDA, does that immunize the makers from personal injury lawsuits?

TESOREIRO: There was legislation enacted in 1976 to essentially give medical device makers a layer of protection from product liability lawsuits. So there is protection under the law. However, there are, you know, exceptions and various, you know, ways that lawyers can certainly . . . and plaintiffs can certainly use to advance their suits.

RYSSDAL: Do you think the heart stent is gonna become the next Vioxx? You know, Merck’s painkiller that got pulled from the market?

TESOREIRO: Sure, well, just by way of comparison, there’re an estimated 20 million Americans who took Vioxx and there are roughly 5 million people in the U.S. who have stents, so much smaller numbers. But certainly the issue with Vioxx or any drug is that once patients find out that there’s a danger, they can stop taking the drug. If it’s withdrawn, they must stop taking the drug. With a medical device, you’re looking at surgery, and it’s a bit more involved to remedy the problem.

RYSSDAL: One of the issues in all the Merck and Vioxx lawsuits is whether or not Merck marketed it improperly. That is, didn’t tell people of the risks. Is that a concern with these stents that the patients aren’t being advised of possible risks?

TESOREIRO: That will certainly be something that the plantiff’s attorneys look at. Whether the warnings were adequate and whether there was information that they knew about that they should have included in their label.

RYSSDAL: Are the plantiff’s attorneys making special efforts to dig up clients and to find people to bring these lawsuits, as they did with Merck and Vioxx? I mean they set up special Internet sites, the whole deal.

TESOREIRO: Sure, yeah, there are a couple of websites out there already that are aimed at, you know, attracting clients and many personal injury lawyers right now are assessing claims. And one of the things that they’re looking at is if somebody with a stent had a heart attack or had a heart incident, did a routine test afterwards. . . was it able to show that the heart attack or clot occurred where the stent is in place? And as of now, at this point, that’s a gold standard for deciding whether or not a case has potential merit.

RYSSDAL: Do you know how the lawyers are doing as they try to get these clients?

TESOREIRO: Yes, you know, the numbers, at this point, the numbers are still relatively small. Some personal injury lawyers are taking a more conservative approach and will likely gauge how and whether they’ll pursue these cases based on the FDA panel results. But for the ones that have already started signing up plantiffs, you know, we’re hearing, you know, five dozen, handful. So it’s still relatively early.

RYSSDAL: Heather Won Tesoreiro’s a reporter with the Wall Street Journal. Thanks for your time, Heather.

TESOREIRO: Thank you.

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