We have written many times about the failures of the FDA to protect the American public from dangerous medications. Dr. David Graham at the FDA testified in 2004 that he estimated somewhere between 70,000 and 100,000 lives were lost as the result of Vioxx. It has recently been estimated that the lives of 22,0000 patients could have been saved if U.S. regulators had been quicker to remove a Bayer drug used to stem bleeding during open heart surgery, according to a medical researcher interviewed by CBS television’s 60 Minutes program. The drug Trasylol was withdrawn in November 2007 at the request of the FDA after it was linked to kidney failure requiring dialysis. It had been given to as many as a third of all heart bypass patients in the United States at the height of its use. Dr. Dennis Mangano said in the CBS broadcast that Bayer failed to disclose to the FDA during a FDA advisory panel meeting in September 2006 that the drug maker had conducted its own research which confirmed the same dangers established by the study. Bayer will certainly face a growing number of product liability lawsuits filed by patients who have taken this medicine. Our firm is investigating and handling those claims at this time.
The prospect of product liability litigation is a huge deterrent to drug companies. Even with this deterrent in place, we have seen the catastrophes caused by dangerous drugs being approved by the FDA and put on the market, like Vioxx and Trasylol. Can you imagine the potential catastrophes coming down the pike for consumers and patients if the U.S. Supreme Court rules this year that drug companies can never be sued for the harms their drugs cause if the medication was approved by the FDA? No matter how many deaths or injuries they cause, the drug companies could never be held accountable by the courts if preemption becomes a reality. The Supreme Court, by granting pharmaceutical companies immunity from lawsuits, will have surely turned on the green light for drug companies to push the envelope relating to safety on the medications they are willing to sell without adequate testing to an unknowing public. A catastrophe for patients and a potential catastrophe for the law would be a certainly if the Supreme Court rules for the drug industry and against the American people on this issue. Our firm has been fighting federal preemption and we encourage all of our readers to call or write your Senators and Representatives in Washington and ask them to stand up for the Constitutional right to trial by jury.
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