There are two recent Supreme Court rulings that may impact people with disabilities. First, an 8 to 1 vote on Feb. 20 says if makers of medical devices try hard to ensure the devices are safe, and if the FDA agrees those makers thoroughly tested the devices, then even if there’s a design flaw the manufacturer can’t be sued.
The device in this case was a Medtronics-manufactured balloon catheter that burst during Charles Riegel’s 1996 angioplasty. Riegel, who died three years ago, filed the suit under New York law. This Court says brawny federal liability laws with “preemption” clauses trump puny little state laws that cry, “unfair!”
What especially stinks about this ruling is it reverses a 1996 ruling that if there’s something wrong with a product then the manufacturer can be sued under state law. Back then, Clinton’s FDA agreed manufacturers of faulty products can be sued. But in 2004, Bush’s FDA decided these cases undermine the government’s authority, and this Court sides with Bush.
But wait … there’s hope … Yesterday the Court voted 4-to-4 that if a drug company withholds or misrepresents information and folks get hurt then those folks can still sue, even if the FDA approved the drug. This case involved a diabetes drug called Rezulin, since taken off the market, that can cause serious liver damage. This case was filed under a Michigan law that shields drug companies against lawsuits if those companies act in good faith. But the Michigan law does not protect companies that withhold or misrepresent information that might have kept a drug from being approved if shared with the government, as the plaintiffs allege the makers of Rezulin did. Some think the difference in state laws explains why three more judges voted on the consumers’ side in this ruling.
Fortunately for everyone who takes prescription drugs, Chief Justice Roberts sat this vote out since he’s a stockholder in Pfizer, the parent company of Rezulin-maker Warner-Lambert. Since the Court tied, the lower court’s judgment stands and the people who say they were hurt by Rezulin will have their day in court.
Rarely on the side of angels, the Bush administration stayed the anti-consumer course by entering this case on the side of the drug company and arguing that “permitting lay juries to ‘second-guess’ the adequacy of a drug application would interfere with the agency’s ‘exercise of its expert judgment.’” But Bush’s own FDA says it’s now dangerously overstressed and underfunded. So, as usual, Bush is defending a policy that can’t possibly work for anyone but Big Business.
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