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Title: MEDICAL DEVICE SAFETY ACT-Riegel v Medtronic
Description: BILL RETURNES TO HOUSE LAWMAKERS


RETIREDINFLA - May 16, 2009 04:45 PM (GMT)
An attorney friend of mine was kind enough to forward the following excerpts to me. If this is passed, this would be HUGE to many of us. It is apparently being sponsored by Congressman Frank Pallone (D-NJ)

House lawmakers hear debate over medical device preemption.
CQ HealthBeat (5/14, Kim) reports that the House Energy and Commerce
Committee's Health Subcommittee "heard witness testimony on a measure
that would allow consumers to sue companies under state law for injuries
sustained by sophisticated medical devices" on Tuesday. Supporters of HR
1346, the Medical Device Safety Act of 2009, said "that the bill would
ensure product safety and consumer protection, while opponents argued
that the bill would stifle life-saving medical innovation and impose
unnecessary regulation on medical device companies." The bill is in
response "to a Supreme Court ruling issued last year that states that
under the Medical Device Amendments of 1976, certain medical devices
that must go through Food and Drug Administration (FDA) pre-marketing
approval are preempted from being sued for liability under state law."
That decision "has already resulted in 1,400 injury cases being thrown
out of court, said Committee Chairman Henry A. Waxman (D-CA) [a]
co-sponsor of the bill. It's the possibility of litigation that is one
of the most powerful incentives to safety, Waxman said."

NPR (5/13, Silberner) reported, "The U.S. Supreme Court ruled in
February 2008 that an OK from the Food and Drug Administration for a
high-tech medical device is all a manufacturer needs to avoid being sued
in state court." Now, "Rep. Frank Pallone (D-NJ) wants to change that."
He said, "There are problems with medical devices that arise outside of
the FDA approval process because that process is limited. ... And we
should not preclude people from suing and recovering damages if
something comes up."

Modern Healthcare (5/13, Rhea) reported that House lawmakers
"listened to testimony from experts and patients and argued the merits
of the Medical Device Safety Act of 2009." The act is "sponsored by Rep.
Frank Pallone Jr. (D-N.J.)" and "would negate the Supreme Court's
decision in last year's Riegel vs. Medtronic case, which involved a
Medtronic-manufactured balloon catheter that ruptured inside the patient
during coronary artery surgery."

Below is contact information for Congressman Pallone if you wish to write or call his office.

Frank Pallone
67/69 Church Street
Kilmer Square
New Brunswick, NJ 08901
732-249-8892

Kim

Birdbomb - May 16, 2009 05:26 PM (GMT)
QUOTE (RETIREDINFLA @ May 16 2009, 09:45 AM)
<snip>important stuff

Below is contact information for Congressman Pallone if you wish to write or call his office.

Frank Pallone
67/69 Church Street
Kilmer Square
New Brunswick, NJ 08901
732-249-8892


Kim


:Yeah That: :Yeah That: :Yeah That: :Yeah That: :Yeah That: :Yeah That: :Yeah That: :Yeah That:

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Kim, THANK YOU for such a wonderful find! This man needs to have a look around our website.


RETIREDINFLA - May 16, 2009 06:05 PM (GMT)
Hi

I wasn't able to find that information. It was very new. Last week, actually. As I said, a dear friend who is an attorney found it for me. SO, I give him the credit and thanked him for all of us!!

I plan to write him (Pallone) a letter this coming week. (when my attention span isn't so poor). I will ask that he visit our site.

I am originally from New Jersey so perhaps the Congressman and I will have a certain kindred spiriting...;-)

I do believe that letters to him, either outlining our experiences or just thanking him for his efforts, may go a long way!

PLEASE, get your letters out!!!

God Speed to all of us, Kim

Dispatch - May 16, 2009 08:17 PM (GMT)
:D :wavetowel2: :D :Great!: :D :Great!: :D :wavetowel2: :D

And a big AMEN!

B)



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