[not a Medtronic device, but some Chinese electric acupuncture stimulation machine, Kent Young, Chinatown]
Another way the Bush Administration and its Republican cronies has screwed the nation: this time by gutting consumers rights to legal redress. Bridget Robb used a faulty Medtronic device and nearly died. Robb wanted to sue for the months of medical fees, but:
her lawyer told her that is probably not an option because of a clause the Food and Drug Administration has written into its policy on what kinds of standards medical devices like hers must meet. Because the defibrillator passed the FDA’s tests and was deemed safe, the company that made it may be immune from legal action.
Since 2005, lawsuit limits like the one protecting Medtronic and other manufacturers have been included in dozens of agency rules covering everything from drugs to car parts, shielding them from consumer suits if their products are approved by federal agencies. And it has often been done at the behest of the White House, critics say, with little input from Congress.
That has prompted a debate over whether the unprecedented increase in benefits granted to product makers is fair to consumers or even constitutional.
[From Critics blast feds’ legal shields for manufacturers — chicagotribune.com]
The same impulse that shields telecom companies from having to explain why they were allowed to break the law of the land without repercussion1 created this clause. If your widget causes harm, you should have to pay the consequence. The FDA is so corrupted that having one’s widget deemed safe might be as simple as taking an FDA official out to a strip club, or promising a salaried position when the FDA official resigns. Despicable.
Footnotes:Consumer advocates and some law professors argue that the anti-lawsuit clauses undermine consumers’ rights and make it difficult to hold businesses accountable for faulty products. And they say the federal government should not be blocking lawsuits that are permitted by individual states.
“I’ve been here since the second Reagan administration, and I’ve never seen anything like this,” said Michael Bird, federal affairs counsel for the National Conference of State Legislatures. “This is not what the framers of the Constitution had in mind.”
An example of this arose in 2006, when a Consumer Product Safety Commission regulation on flame-retardant mattresses limited the ability of consumers to win cases under state laws if their mattresses caught on fire.
Around that time, the FDA approved a rule on drug labeling that included a similar clause. That year, parents whose son killed himself while taking the antidepressant Paxil sued maker GlaxoSmithKline for failing to disclose that Paxil increases suicide risk. They lost their case because, the judge wrote, “federal law pre-empts plaintiffs’ instant action.”
Some complain that the Bush administration pushed these regulations through the federal agencies it controls instead of trying to move them through Congress. Passing a bill requires hearings and public debate, while an agency often can change its rules with little fanfare.
In 2007, the National Highway Traffic Safety Administration began including lawsuit-protection language in its rules on door locks, safety restraints and crash protection for cars. Now NHTSA may insert such a clause in proposed standards on how strong a car’s roof must be to prevent injuries from rollovers.
- FISA, if you’ve forgotten. We’ve discussed that travesty a number of times. [↩]