let us understand that this legislation before us today sets a very high threshold before punitive damages can be awarded. I think what this amendment is doing is using the FDA as a cover for manufacturers whose products have caused real harm to consumers. Even in cases where the manufacturers' behavior has been egregious, malicious, or knowingly negligent, there is a high standard for collection of awards. Title II of the bill states that in order to collect punitive damages, a claimant must be able to show by clear and convincing evidence that a manufacturer specifically intended to cause harm or engage in conduct that illustrated a conscious, flagrant indifference to the safety of others. If a plaintiff who is injured can maintain that threshold and show that a company acted with flagrant disregard for the safety of others, why should a drug company be protected because of the FDA approval? The FDA approval does not mean that the FDA is there as a watchdog, to be sure that the company, after it has that approval, is doing everything it properly should. The FDA may never know about the complaints that the company has had that the product that they manufacture is now causing a lot of harm to people, yet they continue to sell it.
Editor's note · Context
Discussing the implications of legislation on punitive damages and FDA approval.
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