Friday, February 22, 2008

Welcome New York Times Readers

We've (yes, there are two of us) finally been noticed by the newspaper of record, The New York Times, in today's article on the immediate aftermath of Riegel in other litigation involving PMA devices.

So here's a warm welcome to the Times' readers. Look around. And prepare for cognitive dissonance, as the positions stated in this blog are nothing like those you've been accustomed to reading.

Oh, and about the article, the Supreme Court didn't think it mattered in Riegel, but that case in fact also involved a PMA supplement product - just like the Fidelis lead litigation that the article discusses. You just have to look to the Second Circuit's opinion, Riegel v. Medtronic, Inc., 451 F.3d 104, 120, 132 (2d Cir. 2006) (pages mentioning supplement), aff’d, 2008 WL 440744 (U.S. Feb. 22, 2008), to find that out.

For those interested in the preemption track record of PMA supplement (and other PMA equivalent) devices, look here.


Anonymous said...

It's clear that this wasn't the best case that plaintiff firms could have brought before the FDA, but lets not try to deceive people into thinking that you guys are angels. What are you hourly rates? $1000 an hour maybe? Who is really getting rich off of medical device and pharmaceutical cases?

What will your side do if no one needs your defense work?

Anonymous said...

sorry my mistake

"brought before the Supreme Court"

Anonymous said...

The facts of Riegel are of no consquence in this debate.

The FDA is not a joke. But they are hardly an effective watchdog and, given the revolving door of FDA to industry, more funding is not going to solve the problem.

Does anyone really believe that this was Congress' intent? Does anyone really think that without any comment, Congress expected this result.

You are right, by the way, Congress is going to fix this unless the next president is John McCain. But mark my words, otherwise it will be fixed.

You guys win but this is a win of industry over a small minority of people in this country who are very hurt.

Also, and I'm just curious, have you guys ever taken a position on here that is anything other than exactly other than the drug company party line? You guys are smart as heck and I love this blog but does all of this genius go to any indepedent thoughts of your own as opposed artculating well the Industry Manifesto?

Ron Miller

Professor Mac said...

For those of you who have never worked with medical products, been on the front lines of a critical hospital procedure, or been the reciprient of a problem drug or medical product - allow me to share some enlightenment. Injuries from medical products occur quite regularly, but it is the instances where such injuries were "avoidable" that has drawn the ire of these discussions. As attorneys and lobbyst, you can spin all you want. But for the rest of us, we need to know the facts. We need to know that mfr's or FDA or some other mechanism can assure safe use of today's medical products. This Riegel ruling seems to have circumvented the original intent of Congress's PMA practices, and how best they should be modernized today. Yes, leave it to the USSC to cause sweeping changes in policy for which they know nothing about, and for which as I can infer from your comments neither do you. Your experience with medical products is in the spin and defense business.

My primary concern with the Riegel ruling is not so much with limiting or barring civil claims, as it is with the FDA's current and miserable record of oversight of health care products, most specifically, its sad state of criminal enforcement. For instance, Most ever FDA criminal investigation arises out of civil discovery. Without it, how will FDA conduct this aspect of their agency's responsibilities.

Of interest to FDA's criminal enforcement and this discussion, last year I filed a complaint with the FDA's criminal division on unlawful marketing and reporting of a Medtronic shunt device. It is rare for any scientist or user patient to ever initiate such a proceeding. Public Citizen even claims they have never initiated such a proceeding. Though this product is not covered by a PMA, I believe my concern still stands in that FDA is not equipped to investigate manufacturers for criminal misconduct. And I believe the criminal misconduct aspect of Riegel is where the USSC errored in their opinion. And of course, had any of them actually worked with a problem medical product, they would have beeter understood the implications of their decision.