Wednesday, June 25, 2008
Should FDA Approval Waive Liability?
Filed under: Regulation
, in the news...
You know who would make a logical spokesperson for medical liability policy? The guy who starred in the 1998 remake of The Parent Trap. That's right, Dennis Quaid is making the case that he should be able to sue pharma giant Baxter over a dosing error that nearly killed his baby twins...
Quaid last month urged Congress to preserve patients' rights to sue drug and device makers in state courts, after his twin newborns nearly died after accidentally overdosing on a blood-thinning drug sold by Baxter International. He has sued the company.
While Quaid's example is clearly ridiculous on account of the fact that it was a facility error, not Baxter's, Reuters goes on to highlight that...
...Democrats in Congress are considering legislation to protect a patient's ability to sue drugmakers if the Supreme Court further restricts the lawsuits, backing so-called "pre-emption" of state laws by federal.
This all, of course, comes in the wake of the recent decision that the manufacturer of a device that's gone through the PMA process cannot be held liable.
That said, the effect upon medical innovation of leaving the door open to liability at a state level would be disastrous. At best, it increases the legal overhead associated with doing business as a device or drug manufacturer, thus further increasing the cost of medical care.
However, worse than that, it takes the focus off of the root cause: the purpose of the FDA is to ensure the safety and efficacy of the medical products on the market. If a faulty product slips through (as is inevitably the case), the liability lies with the arbiter of "good enough": the FDA.
If being good enough for the FDA isn't, then the federal government might as well dissolve the agency and spend our tax dollars elsewhere, letting case law (and lay-person juries) decide what the public requires in terms of safety. Obviously a less desirable solution, but it remains the only logically intact one should we leave the door open for every ambulance chaser to try and extract a ransom from big-name medical manufacturers.
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examples: <b>Bold</b> <i>Italic</i>
