Bioethics Discussion Blog: The Catheter Popped! But Whose to Blame?

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Sunday, February 24, 2008

The Catheter Popped! But Whose to Blame?

The ruling by the United States Supreme Court on February 20, 2008 protects medical device manufacturers from law suits by patients who have been injured by some malfunction of the device if the device has been approved and allowed to be distributed by review of the Food and Drug Administration (FDA). You can read about the decision in the Washington Post of February 21, 2008. In the Fall of this year, the Supreme Court will be deciding whether to protect pharmaceutical companies against lawsuits regarding the FDA approved drugs.


As I understand it, the Court doesn’t want the states or others to interfere with the decision making of the FDA with regard to medical devices. If the FDA finds that the devices are safe and effective and may be used, that is sufficient to deny claims against the manufacturer. If it could be proven that that the manufacturer failed to follow FDA rules or presented false or misleading information to the FDA then the manufacturer could be held liable for injuries to patients.

But if patients have been injured by a device or a drug which the FDA concludes is safe, who is responsible for the consequences? If the FDA is considered by the courts as the final decider of safety and effectiveness, shouldn’t the FDA be held responsible for any inadequate evaluation it has made? Who should be responsible party when there is harm, the manufacturer, the FDA, the physician or the patient? It appears that the current Supreme Court ruling, by protecting the manufacturer and with no recourse against the FDA, it is the patient who must ultimately bear the burden of errors in the system apparently in order not to stifle medical research and development which would be of benefit to the many patients. What do you think about the ruling and who should be responsible? Are the harms simply spontaneous accidents and therefore simply an act of God and nobody should be penalized? ..Maurice.

3 Comments:

At Wednesday, February 27, 2008 5:07:00 PM, Blogger Joel Sherman said...

A highly technical subject. IMO companies should not be liable if they pulled no tricks to get regulatory approval and if the problems that developed could not have been foreseen. This of course excludes known listed side effects from litigation if they develop.
But most suits claim that the companies hid data or waited too long to notify the medical community of the problems that later developed. They certainly shouldn't be immune from suits on that basis, and I don't think they are.

 
At Tuesday, June 03, 2008 8:26:00 AM, Blogger Maurice Bernstein, M.D. said...

For more on this topic, if you have access to the May 21 2008 issue of the Journal of the American Medical Association, you may want to read the Commentary
"The Deregulatory Effects of Preempting Tort Litigation: FDA Regulation of Medical Devices" by
Lawrence O. Gostin
JAMA. 2008;299(19):2313-2316.

The Commentary concludes with "In the end,the public is caught in a catch-22. At the same time the FDA is widely perceived as ineffectual and the hazards of widely used drugs and devices are revealed, the Supreme Court is making it more difficult for patients to discover wrongdoing, even fraud, and to be fairly compensated for their avoidable injuries." ..Maurice.

 
At Wednesday, June 04, 2008 9:38:00 AM, Blogger Joel Sherman said...

The subject is honestly too technical for me to fully comprehend. It's not clear to me when you can or can't sue. The article suggests that it's not clear to the author either. Torts may well provide the only available means of redress against corporations. Ideally a patient injured by a defective device should be entitled to automatic compensation without having to go through the legal system. And I agree if the FDA doesn't adequately review information given, they should share in the blame. On the other hand our legal system routinely profits lawyers far more than injured parties and no one can seriously believe they have consumers’ or patients’ best interests at heart. Witness the class action lawyers who are presently being sentenced to 3 years in jail for paying off witnesses to file false claims. Your article is written by a lawyer so it too is an advocate's position.

 

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