Replies

This is NOT the way to resolve the issue of tort reform. While I sympathize with the medical industry, I am employed by it, the way to tackle this is to limit attorney's fees, not simply do away with the public's right to justifiable recourse.

Is there a one of us who can say that John Edwards should have been able to make $50 million dollars off the misfortune of the public? Take the exorbitant profit out of litigation (for attorneys), and you'll see a lot less frivolous law suits.

If we can still get doctors to go to school for a decade including internships, for $80k per year, there's no reason in the world that attornies need to make $50 million in order to protect the public.

I would also favor a capitation of one half million dollars per plaintiff, as long as any maintenance fees for related medical care was covered in total on top of that.

Let's review a case that I am aware of. One pharmaceutical company applied for FDA approval to market it's product in the U.S. The product was already being marketed in Europe. That being the case, the FDA reviewed the submitted documentation and the approval sailed through. Thirteen months later, the product was abruptly taken off the market. Subsequently, it was found that serious problems had been manifested in patients in Europe, before U.S. approval.

During the 13 or so months the product was on the market in the U.S., $110 million dollars worth was sold. The FDA fined this pharmaceutical firm $30 million dollars. Through a loopehole, that fee was later rescinded. The fine was never levied. Serious damage was done to patients.

Can the government tell me that these patients should have been prevented from recourse? That would be absurd.

It would also be absurd to think this pharmaceutical company shouldn't be put on probation for something like this, and executives prosecuted resulting in long prison terms for them.

###This is NOT the way to resolve the issue of tort reform###

I agree - I buy bad motor oil for my car and the engine blows, I should recieve some form of compensation.

I get a undertested drug and am incapcipated I should be compensated also.

you need some mechanisim to keep the drug companies honest.

I like the limitation idea on the lawyers take to keep them from raiding companies like the drug,tobaccoand food companies like Mcdonalds just because they have more money than they do.

Drugmakers Prefer Silence On Test Data

The Washington Post ^ | July 6, 2004 | Shankar Vedantam

Posted on 07/06/2004 11:10:59 PM EDT by neverdem

Firms Violate U.S. Law By Not Registering Trials

The pharmaceutical industry has repeatedly violated federal law by failing to disclose the existence of large numbers of its clinical trials to a government database, according to the Food and Drug Administration.

Doctors and patients say that compliance with the law would go a long way toward addressing their growing concerns that they are not being given the full picture about the effectiveness of many drugs because they are not told about drug trials that fail. The issue has gained urgency with recent disclosures that the publicly available research on treating children with antidepressants obscured the fact that in most studies, the drugs were no better than sugar pills. Drugmakers chose not to publish those studies.

The 1997 law is so little known that scientific journal editors and professional medical associations have recently debated whether to create a system of private incentives for disclosure of trials. When she was told the law already requires companies to register trials, Catherine DeAngelis, editor in chief of the Journal of the American Medical Association, said, "That's a surprise to me. Tell me why it's not enforced."

Although the law was primarily passed for other reasons, DeAngelis said it could very well address her concerns.

The FDA acknowledges it has not enforced the law -- officials said the statute did not spell out penalties or explicitly give the agency authority to crack down on violators.

____________________________________________________________

Now that the companies have to submit the results of all tests of their drugs prior to FDA approval, as long as the FDA approved the drug, that should be the end of the matter, at least if it was prescribed for the approved indications. Docs should have patients sign waivers for adverse or allergic drug reactions. The same holds true for medical devices. The Congress needs to amend the law to give the FDA enforcement authority in order to levy fines where appropriate.