Newly Introduced Legislation Would Protect Legal Rights of Patients Harmed By Defective Medical Devices

Bills Sponsored By Waxman And Pallone In The House As Well As Kennedy And Leahy In The Senate Would Right The Wrong Of Riegel Decision By U.S. Supreme Court

(Posted by Tom Lamb at DrugInjuryWatch.com)

On June 26, 2008 Congressmen Henry Waxman (D-Calif.) and Frank Pallone (D-N.J.) along with 62 bipartisan supporters introduced HR 6381, the Medical Device Safety Act of 2008.

We previewed this new Congressional bill regarding preemption in our post, "Court's Riegel Preemption Ruling Would Be Negated With Bill Sponsored By Democrats In Congress", a couple of weeks ago.

Further, it is expected that soon after the upcoming July 4th Congressional recess there will be a companion bill introduced by Senators Ted Kennedy (D-Mass.) and Patrick Leahy (D-Vt.).

The same day that this Waxman-Pallone preemption bill was announced, the consumer advocacy group Public Citizen issued a press release, "Bills Would Restore Rights Of Patients Injured By Faulty Medical Devices", from which we get this perspective:

The Medical Device Safety Act of 2008 would overrule the U.S. Supreme Court's February decision in Riegel v. Medtronic, which held that the 1976 federal law that gives the Food and Drug Administration (FDA) authority to regulate medical devices also severely limits the right of injured patients to sue device manufacturers....

"The possibility of being held liable for injuries their products cause creates an invaluable incentive for manufacturers to make their products as safe as they can, to revise labels as soon as they become aware that they are inadequate and to remove unsafe products from the market," said Public Citizen lawyer Allison Zieve, who argued on behalf of the Riegels in Riegel v. Medtronic. "By eliminating this possibility, the Supreme Court decision removed a significant layer of consumer protection, which makes passage of the Medical Device Safety Act of 2008 so essential."...

"Given the FDA's failure to prevent numerous medical device tragedies in recent years, the continued availability of common-law remedies is essential," Public Citizen President Joan Claybrook said.

The thoughts expressed by Ms. Zieve and Ms. Claybrook in the June 26 Public Citizen press release were similar to some testimony that the House Committee on Oversight and Government Reform heard at a May 14, 2008 hearing, where the main issue was whether FDA regulations should preempt, and thereby prohibit, state law product liability claims involving prescription drugs and medical devices approved by the FDA.

At that May 2008 Congressional hearing David Vladeck, a professor at the Georgetown University Law Center, said the Riegel decision "takes away the manufacturer's incentive to protect the public by preventing or correcting errors as soon as they become manifest." Professor Vladeck went on to state that patients who were implanted with defective Guidant Corporation defibrillators, for example, would not be allowed to file any claim for legal compensation due to the Riegel decision -- a situation about which Vladeck said, "That just isn't right.  That's not the way we do things in this country."

We will monitor developments in the House concerning this Medical Device Safety Act of 2008  (HR 6381) and watch for the companioin bill expected to be introduced soon in the Senate by Senators Kennedy and Leahy.

As always, we welcome any and all opinions about this issue of federal preemption in the context of drug injury and medical device litigation.  You can submit your Comment, below.

P.S.  We have learned that Congressman Waxman wrote a June 26, 2008 letter to FDA Commissioner Andrew von Eschenbach, requesting certain agency documents about preemption written since January 20, 2001, including those documents related to the FDA’s intervention in specific drug injury product liability cases.  (6/28/08)