August 2008 Senate Counterpart of HR 6381, Medical Device Safety Act 2008, Which Was Sponsored By Congressmen Waxman And Pallone
(Posted by Tom Lamb at DrugInjuryWatch.com)
In a June 27, 2008 article, "Newly Introduced Legislation Would Protect Legal Rights of Patients Harmed By Defective Medical Devices", we said that soon after the July 4th Congressional recess there would be a bill introduced by Senators Ted Kennedy (D-Mass.) and Patrick Leahy (D-Vt.) which would essentially correspond to HR 6381, the Medical Device Safety Act of 2008, introduced on June 26, 2008 by Congressmen Henry Waxman (D-Calif.) and Frank Pallone (D-N.J.).
On August 1, 2008 the the Senate counterpart of the Medical Device Safety Act of 2008 was introduced on the Senate floor by Senator Patrick Leahy.
The August 12, 2008 edition of FDAnews Device Daily Bulletin published an online report, "Senators Introduce Their Version of Anti-Preemption Bill", which provides us with some context:
Following the Riegel decision, Kennedy, who chairs the Senate Health, Education, Labor and Pensions Committee, threatened to create legislation to override the court. He said Congress never intended for FDA approval to give immunity to manufacturers from liability for injuries caused by faulty devices.
"The FDA used to be the gold standard, but the agency has come under scrutiny recently. If manufacturers are putting faulty devices on the market, they must be held accountable to the patients who use them, the way Congress always intended. I will continue to fight for legislation like this that puts the health and safety of Americans ahead of manufacturers’ interests," Sen. Barbara Mikulski (D-Md.), a co-sponsor of the bill, said.
Both the House bill and the Senate bill are intended to ensure that injured patients are not prevented by the Food, Drug and Cosmetic Act (FDCA) from filing product liability lawsuits against medical device companies under state tort laws.
Not surprisingly, the device makers have come out against these bills. As regards the legislation recently introduced by Senators Kennedy and Leahy, from the August 12 FDAnews Device Daily Bulletin report:
The device industry warns the bill would result in more lawsuits and ultimately higher healthcare costs. "If enacted, this legislation would create a patchwork approach to medical device approvals where state courts would effectively review and regulate medical devices," AdvaMed President and CEO Stephen Ubl said.
We welcome all points of view on this important federal preemption issue. You can express your opinion, here, by submitting a Comment to this post.