Posts
These organizers have written a letter to Congress in support of HR 1346/S 540, THE MEDICAL DEVICE SAFETY ACTOn March 31st, Medical Device Patients from around the country will travel
to Washington, DC and ask Congress to pass the Medical Device Safety Act.
Now is the time to contact your Senators and Representatives to enlist their support for this measure.
Thanks Jaynesday. The business friendly shield of “FDA approved” is wearing thin. Hopefully, the patients traveling to DC will bring awareness to the injustice being served to many Americans.
ReplyDeleteIf you get a chance, read the information at the site. It is put together very well.
ReplyDeleteAgree. Good site. No ADDA. But good site.
ReplyDelete(Actually, very good!)
Thanks for the link I sent an email to my Congressman requesting that he support the proposed legislation.
ReplyDeleteJimK
An interesting article copied from the site that explains the progression of preemption
ReplyDeleteby -
W. Eskridge, Overriding Supreme Court Statutory Interpretation Decisions
The Evolution of the Supreme Court’s Decision in Riegel v. Medtronic
The Supreme Court’s decision in Riegel v. Medtronic gives medical device manufacturers total immunity for their defective devices. This decision was based on the use of the word “requirements” in the Medical Device Amendments of 1976 (MDA). The Supreme Court traditionally has declined to afford total immunity to members of any industry in the absence of a clear congressional intent. In the early 1990s, however, the Court began to depart from its traditional approach. The addition of new Supreme Court Justices facilitated this movement towards strict constructionism (i.e., literal interpretation of the text of a statute) and away from the analysis of laws in the context of legislative history and social policy. The Court’s decision in Riegel is the result of a gradual change in approach culminating in a much broader interpretation of “requirements” than was ever intended by Congress.
Our system of checks and balances requires Congress to consider the real world impact of its laws, as it is the body that is answerable to the will of the people. Congress also has the duty to overturn decisions that do not adhere to its legislative intent, as it did with 124 Supreme Court decisions between 1967 and 1990[1]. Given that the Court used a literal interpretation of the MDA and a fractured Supreme Court opinion to render its decision, it is up to the Congress to overturn Riegel and restore proper checks and balances. Here’s the history:
Prior to 1992 – The Supreme Court recognized the distinction between state tort law and state statutes/ regulations.
The Court consistently recognized state tort law serves a different and complementary function to state statutes and regulations. See United Construction Workers v. Laburnum Construction Corp., 347 U.S. 656 (1954); Int’l Union v. Russell, 356 U.S. 634 (1958); Silkwood v. Kerr-McGee Corp., 464 U.S. 238 (1984); English v. General Electric Co., 496 U.S. 72 (1990).
The Court would not afford total immunity to defendants absent clear and manifest evidence that Congress intended to do so. Silkwood v. Kerr-McGee Corp., 464 U.S. 238 (1984).
1992 – The Supreme Court ignored the distinction between state tort law and state statutes/regulations. Cipillone v. Liggett Group, Inc., 505 U.S. 504 (1992).
The Court granted immunity to the Liggett Group under the Public Health Cigarette Smoking Act of 1969, relying on the word “requirements” to find that the statute included common law and, therefore, afforded immunity to cigarette companies from certain tort claims. The fractured Court issued concurring opinions, resulting in a plurality, not a majority decision.
1992-2005 – The Supreme Court wavered between Silkwood and Cipillone approaches.
The Court did not grant immunity to Medtronic for claims based on one of its defective pacemakers, which the FDA had approved based on its 510(k) process (i.e., approval was based on the fact that the pacemaker was “substantially equivalent” to another device that had received FDA approval). Medtronic v. Lohr, 518 U.S. 470 (1996).
In a case based on decidedly unique circumstances, the Court affords total immunity to a defendant automobile company. Geier v. Honda Motor Co., 529 U.S. 861 (2000).
The Court does not afford immunity to Dow but does again determine that the word “requirements” in the applicable statute includes common law and that Congress intended for pesticide companies to have immunity from certain tort claims relating to labeling of risks. Bates v. Dow Agrosciences, 544 U.S. 431 (2005).
2008 – In Riegel, strict constructionist justices led the Court back to Cipillone, finding that the word “requirements” in the MDA should be interpreted to afford complete immunity to medical device manufacturers. The Riegel decision gives great weight to the Cipillone analysis of “requirements,” which applied to a limited statute and was not adopted by a majority of the Court. The Justices in Riegel failed to properly consider Congressional intent or the historical context when the MDA was enacted in 1976. It is now Congress’ duty to respond.
[1]W. Eskridge, Overriding Supreme Court Statutory Interpretation Decisions, 101 Yale L. J. 331 (1991).
Sorry the author was not Eskridge.
ReplyDeleteI am one of the patients who went through this horror of having to redo my leads in my heart due to the negligence of MEDTRONICS. I went to WASHINGTON DC. TO LOBBY. I represented the state of FLORIDA. I had to go through this NIGHTMARE within 19 months of the first surgery. WE ARE ANGRY. OUR CONSUMER RIGHTS HAVE BEEN VIOLATED. WE ARE AMERCIAN CITIZENS, CONSUMERS WHO TRUSTED THIS COMPANY to allow our surgeons to provide us with a product that God Forbid we went into cardiac arrest. These leads would shock our hearts back, to prevent SUDDEN CARDIAC DEATH. 15 PEOPLE HAVE ALREADY DIED.....I sat with a Mother who lost her only daughter, age 31. SHE WAS DEVISTATED.
ReplyDeleteWE WILL WIN. WE WILL BE VALIDATED. WE WILL NOT BE VICTIMS, AND WE SHALL PUT MEDTRONICS OUT OF BUSINESS. THEY DESERVE THAT. 240,000 people all over the world have been affected with "defective heart leads". WE WERE ALL VERY STRONG. AND RESPECTED BY MANY SENATORS, CONGRESSPEOPLE, etc on LOBBY DAY. WE WON'T GIVE UP EVER !! MY LIFE HAS NEVER BEEN THE SAME.
Anonymous,
ReplyDeleteThanks for your comments. I can sympathize with your situation (a little). My mother had a device implanted in her that caused serious reaction and infection. After 3 weeks of intense suffering she passed away.
What a terrible thing to have something implanted in your body that you can not trust.
Adding insult to injury by in effect saying "we will not allow you to hold the manufacturer accountable for their lack of care" is at best cruel.