Court's Riegel Preemption Ruling Would Be Negated With Bill Sponsored By Democrats In Congress

New Legislation Would Permit U.S. Patients To Sue Medical Device Companies If Product Caused Harm

(Posted by Tom Lamb at DrugInjuryWatch.com)

In the first part of June 2008 we learned that Representative Frank Pallone (D-NJ), who is Chairman of the House Energy and Commerce Health Subcommittee, and Representative Henry Waxman (D-CA), who is Chairman of the House Oversight and Government Reform, intend to introduce federal legislation in the next several weeks that would explicitly state that no FDA regulation should be interpreted such that it preempts a patient's ability to sue a medical device company under state law in a products liability lawsuit.

A June 10, 2008 article, "Preemption Ruling Threatened by Draft Bill", published online at FDAnews Drug Daily Bulletin, previewed this federal legislation that would reverse the Riegel v. Medtronic decision handed down by the U.S. Supreme Court earlier this year:

Bill sponsor Rep. Frank Pallone (D-N.J.) said the court’s decision ignores congressional intent and 30 years of experience in which “FDA regulation and tort liability have played complementary roles in protecting consumers from device risks.”

Lawmakers want to change that by amending the FDCA with the Medical Device Safety Act of 2008. It would add a subsection to the FDCA stating, “Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.”

The legislation would apply to cases pending on the date of its enactment as well as claims for injuries sustained prior to its enactment. But cases dismissed on preemption grounds prior to its enactment could not be resurrected.

A spokesman for Pallone’s office said the bill would be introduced in the next several weeks.  

The draft bill is available at www.fdanews.com/ext/files/FinalBill.pdf

We have expressed previously our opposition to any federal preemption of patient lawsuits against medical device or pharmaceutical companies, so we welcome and support this new FDA bill sponsored by Congressmen Pallone and Waxman.

Let us know what you think about this federal preemption issue.  Please be assured that all comments, pro and con, will be published (unless they are not G-rated).