Sunday, July 25, 2004
THE FDA AS A SHIELD:
DB linked to this New York Times article today:
In a Shift, Bush Moves to Block Medical Suits
What if the company lies?
As I have pointed out previously the FDA is not immune to pressure placed on it by device manufacturers.
Employing the intellectually suspect "slippery slope" argument, shouldn't every item manufactured according to governmental regulations: airplanes, cars, boats, and fire-resistant children's sleepwear be immune from lawsuits?
One of DB's commenters suggests that such a system would eliminate or minimize the use of medications or devices in an "off label" fashion. In theory, a drug maker should not be held liable for "off label" uses since the company has not advocated those uses. The FDA does not look kindly on companies promoting "off label" uses for their medications, a lesson that cost Warner-Lambert $430 million to learn.
I believe that if the FDA approves a device or medication, based on honest information provided by the manufacturer and if the manufacturer provides honest and prompt reporting of adverse effects, then FDA approval should provide immunity from suits. The companies may have to give up some "proprietary" information. But if it can escape liability, they may be willing to do so.
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DB linked to this New York Times article today:
In a Shift, Bush Moves to Block Medical Suits
The Bush administration has been going to court to block lawsuits by consumers who say they have been injured by prescription drugs and medical devices.
The administration contends that consumers cannot recover damages for such injuries if the products have been approved by the Food and Drug Administration. In court papers, the Justice Department acknowledges that this position reflects a "change in governmental policy," and it has persuaded some judges to accept its arguments, most recently scoring a victory in the federal appeals court in Philadelphia.
Allowing consumers to sue manufacturers would "undermine public health" and interfere with federal regulation of drugs and devices, by encouraging "lay judges and juries to second-guess" experts at the F.D.A., the government said in siding with the maker of a heart pump sued by the widow of a Pennsylvania man. Moreover, it said, if such lawsuits succeed, some good products may be removed from the market, depriving patients of beneficial treatments.
What if the company lies?
Ancure® system (Guidant)Should that be handled by the FDA, a lawsuit, or a criminal proceeding?
This device has a flexible, unsupported fabric graft prosthesis that is actively fixed in place on the ends by wire hooks that penetrate the vascular tissue. On 3/16/01, Guidant suspended production and announced a recall of all existing inventory. The company reported to the FDA that they had failed to report many device malfunctions and adverse events, including severe vessel damage associated with problems with the deployment of the device. There were also manufacturing changes that were not properly reported to the FDA. The manufacturer told FDA that an internal audit revealed problems with their complaint handling system, manufacturing quality systems, documentation procedures and training. The FDA is reviewing the firm's Corrective Action Plan that addresses these problems. Once we receive evidence that the firm has appropriately changed their systems and procedures, and the FDA has reviewed their regulatory submissions, we will assess whether the product can be returned to the market.
As I have pointed out previously the FDA is not immune to pressure placed on it by device manufacturers.
Employing the intellectually suspect "slippery slope" argument, shouldn't every item manufactured according to governmental regulations: airplanes, cars, boats, and fire-resistant children's sleepwear be immune from lawsuits?
One of DB's commenters suggests that such a system would eliminate or minimize the use of medications or devices in an "off label" fashion. In theory, a drug maker should not be held liable for "off label" uses since the company has not advocated those uses. The FDA does not look kindly on companies promoting "off label" uses for their medications, a lesson that cost Warner-Lambert $430 million to learn.
I believe that if the FDA approves a device or medication, based on honest information provided by the manufacturer and if the manufacturer provides honest and prompt reporting of adverse effects, then FDA approval should provide immunity from suits. The companies may have to give up some "proprietary" information. But if it can escape liability, they may be willing to do so.
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