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“In short, the evidence available to date does not make a strong case that restricting malpractice liability would have a significant effect, either positive or negative, on economic efficiency. Thus, choices about specific proposals may hinge more on their implications for equity–in particular, on their effects on health care providers, patients injured through malpractice, and users of the health care system in general.”


Why would the Supreme Court take a citizens right away to seek justice?

“Daniel Troy served as chief counsel for the U.S. Food and Drug Administration from 2001 to 2004. Starting September 2, 2008, he will be head counsel for the pharmaceutical company GlaxoSmithKline. Before his stint at the FDA, Troy "fought the agency on behalf of the right to use medical-journal articles to suggest off-label uses for drugs and medical devices."

The following is from Sidley Austin LLP presented to the Advanced Medical Technology Association.

Setting the Stage – A Supreme Court Friendly to Business?

  • Supreme Court has increased the business cases on its docket, especially in the areas of patent, antitrust, preemption, and securities law.
  • Nearly all of the Court’s rulings on business cases have been in favor of he business.
  • February 20, 2008: “quite a hat trick” three pro-business decisions (including Riegel) in one day, comments Robin Conrad of the U.S. Chamber of Commerce. Tony Mauro, The Majority Flexes Its Muscles, Legal Times, Feb. 25, 2008.
  • Ms. Conrad earlier remarked that the 2006-07 term was the strongest showing for the business community in the past 30.
  • Justice Alito, most notably, “has taken bullets for business in the term just ended.” Tony Mauro, Roberts Court Takes a Pro-Business Stance, N.Y.
    Law Journal, July 5, 2007.
  • “The business docket is a very rich part of the docket and one in which the
    Roberts court to date has proven very sympathetic to the concerns of
    corporate defendants.” U.S. Solicitor General Paul D. Clement.


“Moreover, there is very little FDA oversight once a device reaches doctors and patients. In fact, even the best designed and most reliable clinical studies by their very nature cannot duplicate all aspects and hazards of everyday use. Moreover, while manufacturers are supposed to report defects and injuries, the FDA has admitted that there is ‘severe underreporting” of defects and injuries.

Given the FDA’s limitations, it is crucial that an individual have a right to seek redress. When defective medical devices reach the market, whether or not approved by the FDA, patients are often injured. Those injured are often left temporarily unable to work or to enjoy normal lives, and in many cases never fully recover. State tort law provides the only relief for patients injured by defective medical devices and should not be foreclosed.

Not only does access to State court mean that a person injured can receive fair compensation, but there are other advantages. Such suits aid in exposing dangers and serve as a catalyst to address their consequences. Through discovery, litigation can help uncover previously unavailable information on adverse effects of products that might not have been caught during the regulatory system. Litigants can demand documents and information on product risks that might not have been shared with the FDA. In this way, the public as a whole is alerted to dangers in medical products…”
Most of us take for granted that what we see in the media is fairly accurate, factual and the truth. But how much of the truth are we really getting? Remember the the hot coffee lawsuit?

“The indictment charges Norian with a total of 52 felony counts: conspiracy to impair and impede the lawful functions of the FDA and to commit crimes against the United States; 7 counts of making false statements in connection with an FDA inspection; and 44 counts of shipping adulterated and misbranded Norian XR in interstate commerce with intent to defraud.”

So if your son died because of this company would you not want the ability to seek justice or should I just quietly go away as my son did at 5:30 in the morning of September 14th 2006. Unfortunately I am not able to because of Riegel v. Medtronic.

The Medical Device Safety Act of 2009 will restore what was taken from us and the states.

“Needless to say, device manufacturers are not always forthcoming. Throughout the 1980s and 1990s, a device known as the Björk-Shiley heart valve malfunctioned in hundreds of the 86,000 patients it was implanted in–resulting in at least 900 deaths. Yet, according to a year-long investigation conducted by the House Subcommittee on Oversight and Investigations, the product remained on the market for years because its manufacturer "continually provided the medical community with incomplete and misleading information regarding the number of strut fractures and the severity of the problem."

Before Regal v. Medtronic it appears that growth in the medical device industry was fairly robust. When President Bush was in office I believe he ordered the FDA to speed up the approval process of medical devices. Why is it that in the past several years we have seen more medical device problems? is this the price we pay for innovation, my sixteen year old son?

Again who is it that will determine the cost of innovation? The federal government, big business or society?

How does one determine negligence or fraud if one is not allowed access to state tort laws? The FDA is a politically influenced organization as is any federal agency taking the the decision making process further away from individuals.


“The people killed, shocked, or injured by these medical devices have no place to turn for help.”

Currently, the medical device industry enjoys complete immunity for their class III medical devices, even when the devices are found to be defective and dangerous, and have even been recalled. This immunity was granted to device manufacturers following the Supreme Court’s decision in Riegel v. Medtronic last year. Prior to that decision, lawsuits served as a strong deterrent to the release of dangerous and defective medical devices. ”

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more about “Investigators: Detecting The Dangers“, posted with vodpod

So what happened? Was the FDA influenced by politics? Was the Bush administration telling the FDA to back off so that we could have more innovation? So what happens next presidential election if a President gets in that thinks we have to much regulation or the Republicans want to cut government funding?

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