Anyone who still says that Bush is not one-sided in favor of big business is just lying to themselves. Once again, he gets his way and big business benefits while people suffer.
Justices Shield Medical Devices From Lawsuits
By LINDA GREENHOUSE
Makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the Food and Drug Administration approved the device before it was marketed and it meets the agency’s specifications, the Supreme Court ruled on Wednesday.
The 8-to-1 decision was a victory for the Bush administration, which for years has sought broad authority to pre-empt tougher state regulation.
In 2004, the administration reversed longstanding federal policy and began arguing that “premarket approval” of a new medical device by the F.D.A. overrides most claims for damages under state law. Because federal law makes no provision for damage suits against device makers, injured patients have turned to state law and have won substantial awards.
The Bush administration will continue its push for pre-emption in another F.D.A. case that the court has accepted for its next term, on whether the agency’s approval of a drug, as opposed to a device, pre-empts personal injury suits. Drugs and medical devices are regulated under separate laws.
There have been numerous cases where these manufacturers have put shoddy workmanship into their devices and caused people to die. They put their bottom line against the health of the people who have to use them.
These people do not get to choose which brand of device goes into them. That means free market principles, which cause manufacturers to make better products in order to make more sales, does not apply.
All they have to do is pay doctors and hospitals to use their products. They pay these doctors by hiring them as consultants. In return the doctors use their products in their patients. The patient is not asked, “Which brand of defibrillator do you want us to use in case you have a heart attack?
So this law shields the manufacturers from any liability if the FDA approved them before marketing the product. So after the approval, the manufacturer can downgrade how they manufacture the product or how they do quality control and they cannot be sued.
Another victory for Bush. Another victory for Big Business. Another loss for the people that live in this country and have no choice what medical device is implanted into them.
Justices Add Legal Complications to Debate on F.D.A.’s Competence By GARDINER HARRIS
The Institute of Medicine, the Government Accountability Office and the F.D.A.’s own science board have all issued reports concluding that poor management and scientific inadequacies have made the agency incapable of protecting the country against unsafe drugs, medical devices and food. Randall Lutter, the F.D.A.’s deputy commissioner for policy, said that the agency was responding to reports of its deficiencies and improving.
Before President Bush took office, F.D.A. officials said that courts provided patients additional protection. In a 1997 brief, the agency’s chief lawyer wrote that “even the most thorough regulation of a product such as a critical medical device may fail to identify potential problems.”
With Wednesday’s ruling, those efforts proved successful for device makers. Two more cases, one to be argued Monday and the other in October, will determine whether drug makers will benefit as well. In his majority opinion, Justice Antonin Scalia wrote that the F.D.A.’s interpretation of its rules deserves “substantial deference.” Since the administration now interprets those rules to provide similar liability protection to drug makers, Justice Scalia’s opinion suggests that the court may soon provide a liability shield to pharmaceutical companies, too.
Now Bush wants this to apply to drugs that pharmacuetical companies push on us through doctors that they also hire as consultants and give trips and bonuses to for prescibing them.
Bush got congress to approve a law that said that senior citizens cannot negotiate on the price they pay for drugs, now he wants to make sure that when bad drugs are sold by the pharmaceutical companies that kill people, no one can sue them.
I can’t wait to see Bush get out of the white house. it will take years to repair the damage he has done to all of us and to this country.