May 2008 Congressional Hearing On Federal Preemption Of Drug And Medical Device Lawsuits

Committee Will Hear From A Diverse Set Of Witnesses On The Various Aspects Of This Controversial Legal Doctrine

(Posted by Tom Lamb at DrugInjuryWatch.com)

On May 14, 2008 the House of Representative's Committee on Oversight and Government Reform will convene a hearing to explore the legal doctrine of federal preemption in the context of product liability lawsuits involving FDA-approved drugs and medical devices.

The announcement for this May 14 federal preemption hearing is currently on the Committee on Oversight and Government Reform web site (accessed 5/12/08):

Should FDA Drug and Medical Device Regulation Bar State Liability Claims?
Committee on Oversight and Government Reform
Wednesday, May 14, 2008, 10:00 AM at 2154 Rayburn House Office Building

It is expected that the Committee should offer live streaming video of this hearing on their website: http://www.oversight.house.gov

At this May 2008 hearing, members of Congress and those in attendance will likely hear from each of these scheduled witnesses:

• Actor Dennis Quaid and his wife Kimberly, parents of newborn twins, Thomas Boone Quaid and Zoe Grace Quaid, who were victims of a heparin overdose;
• William Maisel, director of the Medical Device Safety Institute, Department of Medicine, Beth Israel Deaconess Medical Center, Boston;
• Aaron Kesselheim of the Harvard Medical School's Division of Pharmacoepidemiology; David Kessler, professor of pediatrics and epidemiology and biostatistics at the School of Medicine, University of California, San Francisco;
• David Vladeck, professor of law at the Georgetown University Law Center;
• Gregory Curfman, editor of the New England Journal of Medicine;
• Christine Ruther, president and chief engineer for C&R Engineering, Inc.; and,
• Utah State Representative David Clark (R) of the National Conference of State Legislatures.

As you may know, the U.S. Supreme Court’s ruling in Riegel v. Medtronic this past February dealt American patients a serious set-back in terms of holding medical device companies legally liable for their unsafe products when, in an 8-to-1 vote, the Supreme Court held that state tort claims regarding medical devices were preempted if the FDA had granted premarket approval for a medical device. 

Looking forward, in October 2008 (what will likely still be) the same Supreme Court hears oral arguments in the case Wyeth v. Levine, relating to the issue of whether the federal preemption doctrine ought to prohibit drug injury cases.

For reasons I have written about previously, I believe that patients should not be pre-empted, or prohibited, from filing lawsuits against medical device and pharmaceutical companies.

Let us know what you think about this federal preemption doctrine in the context of medical device and drug injury cases by submitting a Comment to this article, below, or by taking part in a poll on this issue -- "What if you were hurt by a drug and couldn't sue?" -- over on the HeyMonkeyBrain! part of Squidoo.

P.S.  You can read the transcripts from this May 2008 Congressional hearing on FDA federal preemption being applied so as to prohibit legal liability claims involving prescription drugs and medical devices, including Chairman Henry Waxman's opening statement and the testimony of Dennis Quaid as well as all other witnesses.  (5/19/08)

Comments

[Tom Lamb]

Your breakdown of how we have gotten to (or been "taken" to) this bad situation is direct and exact.

We can only hope for some new legislation in Washington that will remove the federal preemption legal defense from the arsenal of drug and medical device companies in lawsuits filed by injured patients.

If others have an opinion on this important public policy issue, please post a comment, here.

Thanks for reading Drug Injury Watch.

Tom Lamb

[Philip Rudnick]

Its the perfect crime pulled off by Bush, the Republican Party, Big Pharma, FDA managers and two Big-Pharma-connected lawyers.The scenario:
1.Big Pharma enriches the campaign coffers of Bush and the Republican Party.
2.Bush, with congressional support, appoints Troy and Gottlieb to executive positions at the FDA.
3.Both lawyers immediately announce and implement the provisions of "Federal Preemption", a Big Pharma-conceived strategy:
a) All that the FDA needs to justify "preliminary approval" of a drug is a preliminary study "demonstrating" safety and efficacy.
b) The drug manufacturer superficially accumulates selectively favorable data, discarding unfavorable data as "not relevant".
b) A safety report "based on" this data is ghostwritten, submitted for his signature to a paid academic "expert", and then submitted to the FDA.
c)The FDA now has all the legal justification it needs to grant preliminary approval to the drug.

d)From this point on, even if the details of the nature of the "safety" report are eventually uncovered, both Big Pharma lawyers and FDA lawyers defend the drug manufacturer against state-court- initiated lawsuits of drug harm.
4. A pro-industry Supreme Court sides with them.
The winners?
Big Pharma
Bush and the Republican Party
The FDA officials - they go on to retirement as Big Pharma executives (I have the documentation of this).
The perfect crime.